PRA/GPP/GUD/083

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MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD

GUIDELINES FOR GOOD PHARMACY PRACTICE IN KENYA

MAY 2024

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The author of this document is the Pharmacy and Poisons Board, a State
Corporation under the Ministry of Health, Republic of Kenya. It may be
reproduced or adopted on condition that the recommended citation below is
made.

Recommended citation: The Republic of Kenya, Ministry of Health, Pharmacy

and Poisons Board, Guidelines for Good Pharmacy Practice in Kenya. Rev. No.
0. 2024

©Pharmacy and Poisons Board, 2024

All rights reserved:

No part of this publication may be reproduced, stored in a retrieval system,

or transmitted in any form, or by any means, electronic, mechanical,
photocopying, recording, scanning, or otherwise, without prior written
permission from the Pharmacy and Poisons Board.

For clarifications, comments, or suggestions, please contact:

The Chief Executive Officer Pharmacy and Poisons Board

P.O. Box 27663 – 00506, Nairobi Telephone: 0709770100

Email:[email protected]

Website: www.pharmacyboardkenya.org

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PRA/GPP/GUD/083 GUIDELINES ON GOOD Revision No. Effective Date:

PHARMACY PRACTICE 0 XX/XX /2024
IN KENYA
Review Date:
XX/XX/2029

Prepared by:

Name…………………………………………………………….

Sign……………………………………………………………….

Date……………………………………………………………….

Reviewed by: Director, Pharmacy Practice

Name…………………………………………………………….

Sign……………………………………………………………….

Date……………………………………………………………….

Checked by: Head, Quality Management

Name…………………………………………………………….

Sign……………………………………………………………….

Date……………………………………………………………….

Authorized by: Chief Executive Officer

Name…………………………………………………………….

Sign……………………………………………………………….

Date……………………………………………………………….

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TABLE OF CONTENTS
ABBREVIATIONS AND ACRONYMS 10
DEFINITION OF TERMS 11
ACKNOWLEDGMENT 13
FOREWORD 14
PREAMBLE 15
EXECUTIVE SUMMARY 16
CHAPTER I 17
INTRODUCTION 17
CHAPTER 2 23
STANDARDS FOR PHARMACY SERVICES 23
STANDARD 1: Provision of Supply Chain Management Services for Health
Products and Technologies (HPTs) 23
Task 1.1. Selection and quantification of HPTs 23
Task 1.2. Procurement of HPTs 24
Task 1.3 Re-packaging of pharmaceuticals 25
Task 1.4. Storage and Distribution of HPTs 25
Task 1.5. Waste Management and Disposal of Pharmaceutical Waste 26
STANDARD 2: Compounding of Sterile, non-sterile and cytotoxic preparations 29
Task 2.1. Non-Sterile Compounding 29
Task 2.2 Sterile-compounding and Aseptic Dispensing 30
Task 2.3. Cytotoxic Preparation and Reconstitution 31
Task 2.4. Intravenous additives services 32
Task 2.5. Total parenteral nutrition preparation and counselling 33
STANDARD 3: Provision of HPT Dispensing Services 37
Task 3.1 Prescription processing 37
Task 3.2. Selection, Preparation and labelling of prescribed medicine 39
Task 3.3. Medication use counselling 40
Task 3.4 Recording keeping 40
STANDARD 4 Provision of Internet Pharmacy (Online) Services 43
Task 4.1. Registration of Internet pharmacy services 43
Task 4.2. Dispensing 44
Task 4.3. Information and advice 44
Task 4.4 Delivering of medicines 44
Task 4.5. Record keeping 44

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STANDARD 5: Provision of Primary Health Care Services 46

Task 5.1. Perform basic individual health assessment 47
Task 5.2. Pharmacy based Point-of-care (POC) testing for Screening, diagnosis
and monitoring 47
Task 5.4 Vaccination Services 48
Task 5.5. Reproductive Health Services 49
Task 5.6. Mother and Child Health Services 51
Task 5.7 Nutrition Services 54
Task 5.8 Medication Safety 54
Task 5.9 Disease Control and Prevention 55
Task 5.10 Management of minor and common ailments 56
Task 5.11 Public health emergency preparedness and response 57
Task 5.12 Health Education and Promotion 58
Task 5.13 Training and Research 58
STANDARD 6: Provision of effective medication therapy management (MTM)
services 61
Task 6.1. Collecting necessary information about the patient 61
Task 6.2. Assessing the information and analysing the therapeutic effect of the
patient’s medication 61
Task 6.3. Developing an individualised patient-centred care plan 62
Task 6.4. Implementing the care plan 62
Task 6.5. Monitoring patient progress and outcomes 62
Task 6.6 Transition of care 63
Task 6.7 Ambulatory Care 63
STANDARD 7. Provision of Drug Information services to clinicians and patients 65
Task 7.1 Provision of Drug Information 65
STANDARD 8: Provision of Clinical Pharmacy Services 67
Task 8.1. Regular participation in ward rounds 72
Task 8.2. Antimicrobial Stewardship (AMS) 72
Task 8.3. Multidisciplinary Team (MDT) Collaboration 73
Task 8.4. Comprehensive Counselling to Patients and Caregivers 73
Task 8.5. Management of Adverse Drug Events (ADEs) 73
Task 8.6. Drug Information 74
Task 8.7. Designing & Implementing Individualised Drug Dosing Regimens 74
Task 8.8. Collaboration with other Pharmacy specialties and Healthcare
Workers 74
Task 8.9. Development of Treatment Protocols and Treatment Guidelines 75

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Task 8.10. Research 75

Task 8.11. Documentation and Reporting 75
STANDARD 9: Provision of Therapeutic Drug Monitoring and Clinical
Pharmacokinetic Services 79
Task 9.1. Therapeutic Drug Monitoring 79
Task 9.5. Clinical Pharmacokinetics services 81
STANDARD 10: Provision of Pharmacogenomics services 84
Task 10.1. Provision of pharmacogenomics services 84
STANDARD 11: Provision of Clinical Toxicology Services 87
Task 11.1. Provision of toxicology service 87
STANDARD 12. Pharmacovigilance and Pharmacoepidemiology Services 90
Task 12.1. Pharmacovigilance Services 90
Task 12.2. Pharmacoepidemiology Services 91
STANDARD 13. Handling and control of narcotic and psychotropic Substances
and Rehabilitative services 94
Task 13.1. Handling and dispensing of Narcotic and Psychotropic Substances94
Task 13.2. Patient-centred care in treating drug abuse patients 95
Task 13.3. Smoking Cessation 95
Task 13.4. Medication Assisted Treatment (MAT) 95
Task 13.5. Pharmacy Services in Residential and Nursing Homes 96
STANDARD 14. Radiopharmacy services 97
Task 14.1 Manufacturing of radiopharmaceuticals 97
Task 14.2. Dispensing of radiopharmaceuticals 98
Task 14.3 Disposal of Radiopharmaceuticals 99
STANDARD 15: Provision of Complementary, Traditional and Alternative
medicine services 102
Task 15.1. Evaluation of Patient 102
Task 15.2. Develop Treatment Plan 103
Task 15.3. Consultation and/or Referral 103
Task 15.4. Documentation of Medical Records 103
Task 15.5. Dispensing of CTAM products 103
STANDARD 16: Pharmaceutical Marketing 107
Task 16.1 Promotion of ethical pharmaceutical formulations 107
Task 16.2 Provision of scientific information regarding the HPT 107
Task 16.3 Use of promotional materials and samples to aid the provision of
scientific information 108
STANDARD 17 Industrial Pharmacy Service 109

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Task 17.1. Formulation Research and Development 109

Task 17.2. Manufacturing 110
Task 17.3. Quality Control 111
Task 17.4. Quality Assurance 111
Task 17.5 Authorised Person Role 113
STANDARD 18: Provision of Pharmacy Education, Teaching and Research
Services 116
Task 18.1 Teaching and Learning 116
Task 18.2 Scholarship and Research 117
Task 18.3 Continuing Education 117
Task 18.4 Community service 118
Task 18.5 Academic Leadership 118
Task 18.6 Consultancy 119
STANDARD 19: Regulatory Affairs and Enforcement 121
Task 19.1: Compliance with Regulations 121
Task 19.2: Regulatory Inspection for compliance with good practices (GxP) 122
Task 19.3: Market authorization (Product Registration) 123
Task 19.4: Licensing of Establishments and Personnel 124
Task 19.5: Vigilance 125
Task 19.6: Market Surveillance 125
Task 19.7: Quality Control, Laboratory testing, and Lot Release 125
Task 19.8: Regulation of Clinical Trials 126
STANDARD 20: Provision of Clinical Trial and Research Services 128
Task 20.1 Clinical Investigational Drug Trials 128
Task 20.2: Inventory management 130
Task 20.3: Critical appraisal of research publications and identification of
research gaps 130
Task 20.4: Disseminating evidence 130
STANDARD 21: Provision of Leadership, Administration, Policy Formulation, and
Quality Assurance Services 132
Task 21.1. Planning 132
Task 21.2. Organizing 133
Task 21.3. Workforce planning and management 134
Task 21.4. Leading 135
Task 21.5 Communication 136
Task 21.6. Control 137
Task 21.7. Policy formulation and development 138

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Task 21.8. Quality assurance 139

STANDARD 22: Provision of Sport Pharmacy Services 141
STANDARD 23: Provision of Veterinary Pharmacy Services 143
CHAPTER THREE 147
LEVELS AND SCOPE OF PRACTICE 147
3.1. Levels of pharmacy professionals 148
3.2. SCOPE OF PRACTICE FOR PHARMACEUTICAL TECHNOLOGISTS 149
3.2.1. Pharmaceutical Technologist Intern 149
3.2.2. Pharmaceutical Technologist 149
3.3. SCOPE OF PRACTICE FOR PHARMACISTS 163
3.3.1. Pharmacist Intern 163
3.3.2. Pharmacist 163
3.4. SCOPE OF PRACTICE OF SPECIALIST PHARMACIST 179
3.4.1. Pharmacist Specialist 179
3.4.2. Pharmacist Sub-Specialist 184
CHAPTER FOUR 186
CATEGORIZATION AND STANDARDS FOR PHARMACY FACILITIES 186
4.1. CATEGORIZATION OF FACILITIES FOR PHARMACY SERVICE 186
4.1.1. Categorization of Health Facility Pharmacy Premises 186
4.1.2. Categorization of Community Pharmacy Premises 186
4.1.3. Categorization of Wholesale, Distribution and Manufacturing 186
4.1.4. Categorization of Pharmacy Training Institutions 187
4.2. STANDARDS FOR HEALTH FACILITY PHARMACY PREMISES 187
4.2.1. Level 2 Facility: Dispensary 187
4.2.2. Level 3 Facility: Health Centre Pharmacy 191
4.2.3. Level 4 Hospital Pharmacy 196
4.2.4. Level 5 Hospital Pharmacy 201
4.2.5. Level 6 Hospital Pharmacy 209
4.1. STANDARDS FOR COMMUNITY PHARMACY PREMISES 216
4.1.1. Level 2A: Dispensing Pharmacy 216
4.1.1. Level 2B: Dispensing Pharmacy 218
4.1.2. Level 3: Pharmaceutical Care Centers 221
4.1.3. Level 4 Specialty Pharmaceutical Care Centers 224
4.2. STANDARDS FOR WHOLESALE, DISTRIBUTION AND MANUFACTURING
229
4.2.1. Wholesale and Distribution 229

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4.2.2. Manufacturing 233

4.3. STANDARDS FOR PHARMACY TRAINING INSTITUTIONS 236
4.3.1. Higher or Tertiary Level Teaching Institutions 236
4.3.2. Middle -Level Colleges 239
CHAPTER FIVE 242
HUMAN RESOURCE WORKLOAD GUIDELINES 242
5.1. Dispensing/ Outpatient Pharmacy (Community and Hospital) 242
5.2. Pharmaceutical Care Centres/ Chronic care pharmacies (CCPs) 242
5.3. Inpatient Pharmacy (Unit Dose Dispensing) 243
5.4. Supply chain management 243
5.5. Clinical Pharmacy Services 243
5.6. Specialized Pharmacy Service 244
CHAPTER SIX 248
IMPLEMENTATION GUIDELINES 248
ANNEX I STANDARD PRESCRIPTION 251
ANNEX II REFERRAL SYSTEM 252
LIST OF CONTRIBUTORS 254

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ABBREVIATIONS AND ACRONYMS

PPB: Pharmacy and Poisons Board

GPP: Good Pharmacy Practice
MTC: Medicine and Therapeutics Committee
AMS: Antimicrobial Stewardship
MTM: Medication Therapy Management
HMIS: Health Management Information Systems
HPTs: Health Products and Technologies
KPA: Kenya Pharmaceutical Association
PSK: Pharmaceutical Society of Kenya
TVET: Technical Vocational Education and Training
CUE: Commission for University Education
KCSE: Kenya Certificate of Secondary Education
MoH: Ministry of Health
TATC: Training and Assessment Technical Committee
CPD: Continuous Professional Development
WHO: World Health Organization
FIP: International Pharmaceutical Federation
KEML: Kenya Essential Medicines List
KEMCL: Kenya Essential Medical Laboratory Commodities List
GMP: Good Manufacturing Practices
TPN: Total Parenteral Nutrition

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DEFINITION OF TERMS

The Board: The Pharmacy and Poisons Board (PPB).

Pharmacist: A holder of a Bachelor of Pharmacy degree or its equivalent from
a recognized institution, and whose name has been entered in the Register of
Pharmacists in Kenya.
Pharmacist Specialist
Compounding
Pharmaceutical Technologist: A holder of a Diploma in Pharmaceutical
Technology or its equivalent from a recognized institution, and whose name
has been entered in the Roll of Pharmaceutical Technologists in Kenya.
Superintendent: The person who is overall in charge of ensuring regulatory
compliance.
Pharmacy: The premises upon which a pharmacy business is conducted, and
it includes: the portion of the premises where health products and
technologies are for sale, dispensing; and professional service rooms
Premises: Fixed portion of any building, structure or vessel leased, used, or
controlled by the licensee in the conduct of the pharmacy business registered
by the Board at the address for which the registration was issued under the
Pharmacy and Poisons Act and includes all those areas where health products
and technologies are or are intended to be, sold or supplied, prepared,
dispensed, compounded, manufactured or stored.
Consultation Services: Pharmaceutical services provided in accordance with
approved professional qualifications and as licensed by the Board. A separate
room within registered premises may be considered and approved for such
services.
Internship: A one-year structured training program carried out under the
supervision of a PPB-approved preceptor, during which a graduate has an
opportunity to consolidate his/her knowledge and skills to enable him/her to
be a competent pharmacist in Kenya
Preceptor: A pharmacist approved by the board to be responsible for the
supervision of a person undertaking an internship as part of the process
leading to registration as a Pharmacist in Kenya

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Health Products and Technologies: Medicines, vaccines, blood and blood

products and medical devices, including diagnostics, food supplements,
cosmetics, radiopharmaceuticals, cells, tissues and organs, complementary
and alternative medicines, and borderline products
Manufacture: Any process carried out in the course of making a product or
medicinal substance and includes packaging, blending, mixing, assembling,
distillation, processing, changing of form or application of any chemical or
physical process in the preparation of a medicinal substance or product; but
does not include dissolving or dispensing of the product by diluting or mixing
it with some other substances used as a vehicle for administration.

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ACKNOWLEDGMENT

The Pharmacy and Poisons Board wishes to express its appreciation to all
those who put in the effort and valuable contributions in developing this
guideline on Pharmaceutical Services in Kenya.

Special gratitude is extended to the various stakeholders from the Ministry of

Health, Professional associations (PSK and KPA), Partners, Pharmacy
establishments, the Pharmaceutical industry and Practitioners whose
research, participation and input led to the successful development of this
guideline.

Finally, the Board also wishes to thank all PPB staff for their contribution,
dedicated work, and coordination in the publication of this guideline.

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FOREWORD

The Pharmacy and Poisons Board is committed to regulating the Pharmacy

Profession and ensuring competency to practice. Further, it is committed to
ensuring the availability of medical products and health technologies in Kenya
which satisfy the needs of all citizens for the prevention, diagnosis and
treatment of diseases using safe, efficacious, high quality and cost-effective
pharmaceutical products.

Pursuant to this mission, these guidelines have been developed with the aim
of promoting the provision of quality pharmaceutical care in Kenya. The
guidelines are based on universal norms and values, both in the private and
public pharmacy practice sectors, and the promotion of the health and quality
of life of patients. The guidelines will be utilised by all practicing Pharmacists,
Pharmaceutical Technologists, Pharmacy Specialists and other healthcare
professionals who provide a pharmaceutical-related service to patients.

The success of this initiative will ultimately depend on the active contribution
and cooperation of every stakeholder, and all should strive to uphold the
standard of practice while providing pharmaceutical services.

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PREAMBLE

There is a clear need for the Pharmacy profession to evolve and become visible
through its mission and vision of providing cost-effective pharmaceutical care
services to society. For this reason, there has to be a basic level of quality
assurance component in every pharmaceutical care service and the related
establishment in which it is offered. The mandate of the Board, in serving the
public interest and in terms of its statutory obligation, is to ensure that
pharmaceutical services are appropriate to meet the healthcare needs of the
people.

Pharmacy personnel, as healthcare providers, play a crucial role in enhancing

access to healthcare and narrowing the gap between the potential benefit of
medications and the actual value realized, and they should be included in any
comprehensive health system. Furthermore, the increasingly complex and
diverse nature of Pharmacy personnel involvement in the healthcare system
and public health necessitates the constant maintenance of their competency
with up-to-date skills and expertise.

This guideline is meant to give pharmacy specialists, pharmacists, and

pharmaceutical technologists, a description of how they might help the people
they serve by enhancing access to healthcare, health promotion, and
medication use.

To support pharmacy specialists, pharmacists and pharmaceutical

technologists, these guidelines provide for a collaborative framework with
professional associations for quality assurance and improvement of
pharmaceutical services in Kenya. This collaboration will include the
implementation of the standards for pharmacy services and practice goals as
well as providing certification programmes and CPD activities.

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EXECUTIVE SUMMARY

These Good Pharmacy Practice Guidelines provide a comprehensive

framework for the practice of pharmacy in Kenya. The document covers
various standards for pharmacy services, levels and scope of practice for
personnel, and categorization and standards for pharmacy facilities. It aims
to ensure that the pharmaceutical services provided to patients are of high
quality, safe and effective.

Chapter 1 introduces the guidelines, provides background information on the

document and the requirements of good pharmacy practice. The objectives of
the guidelines are also outlined in this chapter.

Chapter 2 covers the 23 standards for pharmacy services. Each standard is

characterized by specific performance criteria and tasks that must be carried
out. The tools and key performance indicators for measuring the effectiveness
of each service are also provided, as are the resources required for each
standard.

Chapter 3 outlines the levels and scope of practice for personnel, from
pharmaceutical technologists to specialist pharmacists. Categorization and
standards for various types of pharmacy facilities, from health facility
pharmacy premises to pharmacy training institutions, are also covered in
Chapter 4.

Chapter 5 provides guidelines for human resource workload, with a particular

focus on dispensing and pharmaceutical care services. Chapter 6 provides
guidelines for implementing the standards and includes the development of
facility-level practice guidelines, board-certified training programs, and
enforcement of compliance with the standards.

This comprehensive document aims to help provide better quality care for
patients in Kenya and improve overall health outcomes. By following the
guidelines, pharmaceutical practitioners in Kenya can provide high-quality,
safe, and effective pharmaceutical services to their clients. The document will
also serve as a crucial resource in the areas of training and quality assurance.

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CHAPTER I

INTRODUCTION

1.1. Background

Pharmaceutical services play a pivotal role in optimizing healthcare delivery

and ensuring the well-being of the population. However, in Kenya, like many
other developing countries, challenges within the pharmaceutical sector have
hindered the attainment of optimal health outcomes for its citizens. This
introductory chapter aims to delineate the critical areas of concern and
outline the necessity for implementing comprehensive Good Pharmacy
Practice (GPP) guidelines in Kenya.

1.1.1. Definition of Good Pharmacy Practice (GPP)

GPP is the practice of pharmacy that responds to the needs of the people who
use pharmacy services to provide optimal, evidence-based care.
To support this practice, a national framework of quality standards and
guidelines must be established.

1.1.2. Problem Statement

Kenya's pharmaceutical sector faces multifaceted challenges, ranging from

issues pertaining to drug accessibility, and quality assurance of services to
regulatory compliance. The absence of standardized practices and regulatory
frameworks has contributed to suboptimal patient care and compromised
health outcomes.

1.1.3. Extent of the Drug Therapy Problem

Medications are the most widely used intervention in healthcare. However,

their inappropriate use and misuse have led to high drug-related morbidity
and mortality. For instance, in the USA, medications are now the 3rd leading
cause of death after cancer and cardiovascular diseases. It is estimated that
over $200 billion a year is spent in direct costs on medication-related
problems. The estimated annual cost of prescription drug-related morbidity
and mortality resulting from non-optimized medication was $528.4 million in
2016, 16% of the health budget. These problems include poor prescribing
habits, poor quality drug products, lack of adequate medication monitoring,

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and poor medication adherence, among others. Local studies attest to this
public health problem, which could be worse. A majority of the problems,
however, are avoidable.

Globally, various countries have developed policies to curb this escalating cost
of medication use. This includes major changes to Pharmacy curricula that
address the clinical competencies of pharmacy graduates in addition to
product-related competencies. Additionally, various Pharmaceutical Care
programs, including Medication Therapy Management (MTM) have been
developed, aimed at improving Patients’ clinical and economic outcomes.
Several studies have demonstrated a positive impact of these services. One
such study, based on 10 years of Experience in providing MTM services in a
Large Integrated Health Care System, demonstrated improved clinical
outcomes and cost savings. In another study, a comparison of the return on
investments (ROI) in two Medication Therapy Management Practice Models
was made, with both models resulting in positive ROI (1:12-1:21)

1.1.4. Justification for Good Pharmacy Practice Guidelines in Kenya

The GPP guidelines provide a framework in which the pharmacy practice in

Kenya is guided by standardized, evidence-based guidelines rather than being
dictated solely by current practices. Pharmacy services must adhere to
stipulated standards to ensure the delivery of safe, effective, and cost-efficient
pharmaceutical care to all patients.

At the core of the GPP philosophy is the recognition that pharmacy

professionals play a pivotal role in safeguarding public health by working
within their scope of practice. By adhering to defined roles and
responsibilities, pharmacy professionals can mitigate the risks of medication
errors, prevent toxicities, and optimize therapeutic outcomes for patients.

The GPP document underscores a commitment to professionalism,

standardization, and patient-centred care in the practice of pharmacy in
Kenya. By adhering to these principles, pharmacy professionals can fulfil their
mandate to provide high-quality pharmaceutical services that meet the needs
and expectations of the population while contributing to improved health
outcomes and reduced healthcare costs.

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Furthermore, the guidelines facilitate regulatory efforts by providing a

framework for assessing and monitoring pharmacy services. They ultimately
aim to enhance public health outcomes and patient satisfaction and play a
critical role in promoting excellence and consistency in pharmacy practice.

1.1.5. Benefits of Good Pharmacy Practice

The adoption of Good Pharmacy Practice (GPP) offers a host of benefits to both
the nation and its populace. GPP guidelines establish precise standards for
pharmacy services, ranging from robust supply chain management to the
provision of primary health care, medication therapy management, and
clinical pharmacy services. These standards serve as cornerstones for
ensuring the quality and effectiveness of pharmaceutical care, ultimately
resulting in improved health outcomes and decreased healthcare
expenditures.

Good Pharmacy Practice enhances medication and patient safety, addresses

antimicrobial resistance (AMR), streamlines healthcare processes leading to
cost savings, minimizes drug therapy issues, standardizes pharmacy
practices, and elevates patient satisfaction levels. Additionally, GPP facilitates
enhanced recording and reporting practices, thereby enabling more informed
decision-making processes within healthcare settings. Moreover, through
comprehensive guidance and regulation, GPP contributes to the mitigation of
substance abuse, particularly narcotics and psychotropic substances.

Additionally, GPP fosters uniformity in pharmacy service provision by

advocating for standardized nomenclature for pharmacy premises, such as
dispensary pharmacies or pharmaceutical care centers. This standardization
ensures consistency and clarity in service delivery, further enhancing the
overall quality of pharmaceutical care.

Implementing GPP offers significant economic benefits by optimizing

healthcare expenditure through improved quality and cost-effectiveness.
Research and evidence-based findings underscore the positive impact of GPP
on health outcomes, reinforcing the need for its adoption as a fundamental
component of healthcare delivery.

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Finally, GPP promotes professional development within the pharmacy sector.

By setting clear standards and guidelines for education, training, and
professional conduct, GPP encourages continuous learning and skill
enhancement among pharmacy practitioners. This emphasis on ongoing
professional development ensures that pharmacy professionals stay abreast
of the latest advancements in pharmaceutical care and fosters a culture of
excellence and innovation within the field.

1.2. Legal and Policy Framework

The rationale for GPP in Kenya is multifaceted, encompassing legal,

constitutional, policy, and evidence-based considerations. By anchoring GPP
within existing legal frameworks, policy priorities, and global best practices,
Kenya can advance towards achieving universal access to high-quality
pharmaceutical products and services, ultimately improving health outcomes
for its citizens.

1.2.1. The Constitution and Laws of Kenya

The establishment of robust Good Pharmacy Practice (GPP) guidelines in

Kenya is not only a strategic imperative but also a constitutional obligation
aligned with the provisions of the Constitution of Kenya. Article 43 of the
Constitution enshrines the right to the highest attainable standard of health
services for all citizens. GPP is essential for upholding this constitutional right
by ensuring the delivery of safe, effective, and quality pharmaceutical care to
the populace.

The Pharmacy and Poisons Board Act (CAP 244) provides a legal framework
for regulating pharmacy practice in Kenya. The Pharmacy and Poisons Board
(PPB)'s strategic plan, particularly Objective 4.2, emphasizes the development
and implementation of GPP guidelines to enhance pharmaceutical service
delivery.

1.2.2. Policies

The GPP guidelines find solid grounding in various policy documents. The
Universal Health Coverage (UHC) Policy 2020-2030, a government priority
under the Bottom-up Economic Transformation Agenda (BETA), aims to
ensure all Kenyans have access to affordable and quality essential health

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services without suffering financial hardship. This has been enhanced by the
recent enactment of the Social Health Insurance Act, Primary Care Act, Digital
Health Act, and Facilities Improvement Financing Act.

The Kenya Universal Health Coverage Policy (2020-2030) also identifies the
need to improve access to essential HPTs. The availability, accessibility,
quality, and pricing of medicines, vaccines, and other Health Products and
Technologies (HPTs) are identified as key components for the success of UHC.
Strengthening the capacity for forecasting and quantification, promoting an
open procurement system to leverage on economies of scale, strengthening
local manufacturing, enhancing commodity security, Human Resource for
Health (HRH) rationalization, and integration of alternative medicines into the
health system are some of the essential components.

Other policy frameworks, such as Vision 2030, Kenya Health Policy 2014-
2030, and the Kenya National Pharmaceutical Policy (KNPP) 2012, provide
strategic direction to ensure the availability of affordable, high-quality health
products and technologies while also promoting local production and
research. Appropriate medicine use is also a vital complementary goal. These
policies recognize the pivotal role of pharmacy practice in promoting the
achievement of these goals, equity, and desired health outcomes.

1.2.3. Global Best Practices

These guidelines are aligned to global policies and best practices. The Joint
FIP/WHO Guidelines on Good Pharmacy Practice (WHO TRS N0.961, 2011)
serves as a global standard for ensuring the quality of pharmacy services. It
establishes uniform standards for pharmacy practice, helping to ensure the
safety, efficacy, and appropriateness of pharmaceutical care provided to
patients. It also contributes to professional development by promoting
continuous improvement and adherence to ethical principles.

1.3. Scope and Operationalization

Towards a smooth operationalization of these guidelines, there is a need to

review and update other existing Ministry of Health (MoH) policies and
guidelines, which includes reviewing and updating the Kenya National
Pharmaceutical Policy(KNPP), anchorage within the Kenya Essential Health

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Package (KEPH) in line with KEPH levels (Level 1-Level 6) of health facilities
categorization to include levels of pharmacy practice and provide for
registration of pharmacies as service delivery points, updating the Kenya
Master Facility List (KMFL) and codes which would allow for service delivery
within pharmacies (including community pharmacies) and reporting into
Kenya Health Information System (KHIS).

In order to guarantee provider reimbursement under the Social Health

Authority (SHA), there is a need to define an essential pharmaceutical product
and services package in line with GPP guidelines. This will contribute to
Universal Health Coverage (UHC) as part of the Bottoms Up Economic
Transformation Agenda (BETA).

The standards outlined within GPP will require adoption by all

pharmaceutical industry sectors, such as training and curricula development,
community and hospital pharmacy practice, manufacturing, research, etc;
thus, a robust implementation framework for all the affected sectors will be
required. PPB will thus require partnerships and engagement of key
stakeholders such as investors, professional bodies, and associations to
realize the anticipated outcomes.

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CHAPTER 2

STANDARDS FOR PHARMACY SERVICES

STANDARD 1: Provision of Supply Chain Management Services for Health

Products and Technologies (HPTs)

The supply chain of all HPTs shall be maintained to ensure that safe,
efficacious and cost-effective HPTs are availed at each point of care.
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Description
Selection, quantification, procurement, pre-packaging of pharmaceuticals,
storage, waste management & disposal, and distribution of HPTs are
important activities in the supply chain management of HPTs.

Performance Criteria

Task 1.1. Selection and quantification of HPTs

1.1.1. Written policies for selecting and quantifying Health Products and
Technologies (HPTs) shall be available at all service delivery units.
1.1.2. The Medicines and Therapeutics Committee shall be in place to oversee
the selection, quantification, and rational use of HPTs.
1.1.3. HPTs shall be selected and quantified from various sources, including
the Kenya Essential Medicines List (KEML), Kenya Essential Medical
Supplies List (KEMSL), Kenya Essential Diagnostics List (KEDL), Kenya
National Formulary, County/Hospital Formulary, stock control cards,
and consumption data from daily activity registers.
1.1.4. Kenya National Formulary, County/Hospital Formulary, and/or the
Kenya Essential Medicines List, along with Kenya Standard Treatment
Guidelines, shall serve as the basis for medication therapy. These
resources promote the rational use of medicines and support
antimicrobial stewardship (AMS).
1.1.5. Relevant quantification techniques shall be applied to determine the
requirement for HPTs for the facility.
1.1.6. Pharmaceutical usage review programs should be developed to optimize
patient outcomes on a cost-effective basis. These programs help ensure

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that HPTs are used appropriately and provide maximum benefit to

patients.
1.1.7. The selection and quantification processes shall be documented in
accordance with the relevant laws and regulations.

Task 1.2. Procurement of HPTs

1.2.1. A procurement policy should be in place to ensure the transparency

and efficiency of HPTs' procurement process.
1.2.2. Procured HPTs should align with the facility's current needs, as
determined through the selection and quantification process.
1.2.3. Only reputable suppliers, licensed by the Pharmacy and Poisons Board
(PPB) including distributors and manufacturers, should be chosen
based on quality aspects such as adherence to Good Manufacturing
Practices and Good Distribution Practices.
1.2.4. Central contracts, purchasing agreements, or Memoranda of
Understanding (MoUs) should be adhered to when applicable,
1.2.5. An updated price list should be adhered to ensure the procurement of
HPTs at the most favourable prices.
1.2.6. Adequate records of purchase for inventory control should be
maintained, complying with legal and audit requirements. They should
also establish a system for reporting errors and withdrawing defective
products.
1.2.7. All orders should be placed on official documents carrying a unique
order number. The order and receipt documents shall include relevant
information such as dates, product descriptions, quantities, supplier
and customer details, batch numbers, and expiry dates.
1.2.8. The procurement process should be supported by a reliable
information management system.
1.2.9. The procurement process should be transparent, professional, and
ethical to promote availability, access, and accountability to relevant
governing and legal entities.
1.2.10. The procurement process should adhere to strong quality assurance
principles.

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1.2.11. Contingency plans for shortages of medicines and emergency

purchases should be established to ensure the timely availability of
products.

Task 1.3 Re-packaging of pharmaceuticals

1.3.1. For each product to be packed, a master pre-packing document should

be compiled, specifying the product's name, pharmaceutical form and
strength, pack size, list of required packaging materials, and method of
packaging
1.3.2. Re-packaging activities should be performed in accordance with the
provisions of the Pharmacy and Poisons Act and adhering to Good
Manufacturing and Distribution Practices.
1.3.3. Re-packaging should be carried out exclusively under the required
temperature and humidity conditions to maintain product integrity.
Personnel should be adequately provided with protective gear to prevent
possible contamination and potential health hazards.
1.3.4. All re-packaging operations should be confined to a separate area
designated for this purpose, physically separated from other working
areas, and with restricted access.
1.3.5. A packaging record should be maintained for each batch of medicine
packed for a period of three years.
1.3.6. Strict attention should be given to securing all stored labels, plastic
bags, and pre-printed materials to prevent mix-ups between packaging
materials.
1.3.7. Unused, damaged, or unacceptable labels or plastic bags bearing a
specific batch number and packaging date should be discarded and
noted on the packaging record.
1.3.8. All labels and plastic bags should contain the delegated packaging
batch number and/or packaging date, approved name of substances (if
applicable), strength, quantity, or volume of medicine, expiry date,
name and address of the packaging institution, and any necessary
additional information such as storage conditions and warnings.

Task 1.4. Storage and Distribution of HPTs

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1.4.1. The storage of HPTs should follow the Good Storage and Distribution
Practices.
1.4.2. Storage areas should have sufficient cold storage equipment and space,
with shelving constructed from smooth, easy to clean, and impermeable
materials that are easy to maintain in a hygienic condition.
1.4.3. The storage areas for medicines should be well-ventilated, pest free and
secure with controlled temperature and humidity to protect against
deterioration, pest damage, unauthorized access, and theft.
1.4.4. The storage areas should be spacious enough to allow for the orderly
arrangement of stock and proper stock rotation. Stock rotation shall be
done on a "FIRST EXPIRY, FIRST OUT" (FEFO) or "FIRST IN - FIRST
OUT" (FIFO) basis, ensuring that stock with the earliest expiry dates or
received first (where expiry dates are not available) is used first.
1.4.5. Special security measures should be instituted when dealing with
controlled substances.
1.4.6. Regular stock takes and checks should be conducted to identify any
excess or short-dated HPTs that can be redistributed or to ensure
proper inventory management.
1.4.7. Accurate and complete records of all activities related to the handling
and distribution of HPTs should be maintained. These records should
be clearly documented, dated, and retained for a minimum of five years.

Task 1.5. Waste Management and Disposal of Pharmaceutical Waste

1.5.1. A robust waste management system should be implemented in

accordance with national protocols and procedures.
1.5.2. Patients a nd the public should be encouraged to return their expired
or unused health products and technologies (HPTs) to authorized points
designated by the Pharmacy and Poisons Board. They should also
be provided with appropriate information and guidance on how to safely
dispose of expired or unused medicines, promoting responsible and
environmentally friendly practices.
1.5.3. The list of HPTs to be disposed of should be quantified and
documented, in collaboration with the Medicines and Therapeutics
Committee (MTC) or relevant disposal committee.

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1.5.4. Approval should be granted for the disposal of HPTs from the
Pharmacy and Poisons Board and National Environmental
Management (NEMA) as per the applicable regulations.

Tools and Key Performance Indicators (KPIs) for Supply Chain

Management Services
Tools KPIs
1. Temperature Monitoring Log % of readings out of the manufactured
recommended temperature range of the
dispensing and storage area
2. Expiry monitoring chart Utilization of the expiry tracking chart
number of expired products quarantined for
disposal
updated Expiry tracking chart
Number of short expiry and commodities
actively being monitored and actions taken
3. F058 forms An updated detailed list of expired HPTs
4. Procurement Policy Evidence of adherence to the Procurement
Policy
5. Quotation, LPOs, Delivery Percentage of HPTs ordered that will be
note, goods received note delivered on time
Order fill rate
6. S3 Card (Bin card/Stock Utilization of FIFO FEFO
control card)) Consumption data
7. Health facility quantification Quantification of HPT requirements for facility
and budget tool

Resources required for Supply chain management services

1. The Public Procurement and Asset Disposal Act

2. Commodities price list
3. Pharmaceutical waste management guidelines
4. HPT Policy
5. Quantification manual
6. SOP for Selection, quantification, distribution, and Storage
7. Treatment guidelines
8. Donning and doffing guidelines
9. Occupational health and safety guidelines
10. Medicines & Therapeutic Committee (MTC) guidelines
11. Kenya Essential Medicines List (KEML)
12. Kenya Essential Medical Supplies List (KEMSL)
13. Kenya Essential Diagnostics List (KEDL)

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14. Kenya National Formulary, County/Hospital Formulary,

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STANDARD 2: Compounding of Sterile, non-sterile and cytotoxic

preparations

Compounding services shall be provided in a manner that caters to the

specific medication needs of patients, ensuring accurate dosing, appropriate
packaging, and safe administration of the pharmaceutical products.
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Description
Compounding refers to the preparation of medication by mixing or altering its
dosage form, strength, or delivery system to suit individual patient needs, and
should only be done under specific circumstances. Compounded preparations
must adhere to safety standards outlined by international pharmacopoeias or
recognized references.

Performance Criteria

Task 2.1. Non-Sterile Compounding

2.1.1. Non-sterile compounding activities shall be performed as per the

Pharmacy and Poisons Act's provisions and adhere to Good
Compounding Practices.
2.1.2. There should be an established Compounding Formulae and Standard
Operating Procedures (SOPs) for all compounding processes.
2.1.3. Compounding procedures should be documented in clear
instructional form, applicable to the provided facilities, and capable of
being replicated by different individuals.
2.1.4. The compounded drug or blood product should be prepared in
accordance with the written compounding formula, a detailed
preparation process and the SOPs.
2.1.5. Compounding activities shall only be performed by qualified and
trained personnel with the necessary expertise and knowledge. All
individuals involved in the compounding process shall maintain high
standards of personal cleanliness to prevent contamination.
2.1.6. Comprehensive records, including the Batch Compounding Record
(BCR) shall be maintained throughout the compounding process.

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2.1.7. An efficient system shall be established to facilitate the prompt recall

of any compounding batch or product if necessary.
2.1.8. Adequate hand-washing facilities should be conveniently available to
all personnel involved in the compounding process to maintain proper
hygiene.
2.1.9. Storage areas should have sufficient space, properly arranged and
equipped to ensure the dry, clean, and orderly placement of materials
and products, maintaining controlled conditions of temperature and
humidity.
2.1.10. All necessary weighing and measuring instruments shall be
periodically calibrated, and detailed records of the calibration process
shall be maintained.
2.1.11. After compounding, the product shall be transferred to a suitable
container, securely closed, and properly labelled with all the details
including the expiry date.
2.1.12. A reliable source of information, such as pharmacopoeias or peer-
reviewed published journals, shall be used to assign an appropriate
beyond-use date to each compounded drug or blood product. In the
absence of a reliable source, pharmaceutical knowledge should guide
the determination of the beyond-use date.

Task 2.2 Sterile-compounding and Aseptic Dispensing

2.2.1. Sterile-compounding and aseptic dispensing shall be conducted in a

cabinet equipped with a high-efficiency particulate air (HEPA) filter,
located in a room with a clean-air environment, that meets the
requirements of reliable sources such as the BP, USP, or WHO
Guidelines for Sterile Products.
2.2.2. A safe work system shall be implemented throughout the preparation
process, with appropriate safeguards to ensure that the final product
remains stable and safe throughout its shelf life.
2.2.3. Only staff who have received training in pharmaceutical aseptic
technique and have it within their scope of practice shall provide aseptic
dispensing services.

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2.2.4. Procedures shall be established to ensure accurate dosage calculations

and the use of appropriate containers for the intended route of
administration.
2.2.5. Accurate records shall be kept for each sterile product prepared.

Task 2.3. Cytotoxic Preparation and Reconstitution

2.3.1. Cytotoxic preparations shall be prepared and reconstituted in a

cabinet equipped with a high-efficiency particulate air (HEPA) filter,
located in a room with a clean-air environment, that meets the
requirements of reliable sources such as the BP, USP, or ISOPP
standards for safe handling of cytotoxic preparations and WHO
Guidelines for Sterile Products.
2.3.2. Procedures and policies shall be in place to minimize the hazards
associated with handling, preparation, packaging, labelling,
transportation and administration of cytotoxic medicines.
2.3.3. Ensure that staff involved in the preparation, administration, and
disposal of cytotoxic agents shall receive adequate training due to the
potential hazards to patients, staff, and visitors.
2.3.4. Facilities should be suitable for the type of cytotoxic preparation,
regardless of the scale of preparation.
2.3.5. Proper records of prescribing, dispensing, and administration of
cytotoxic medicines shall be maintained.
2.3.6. The institution shall appoint a designated pharmacist to regularly
revise cytotoxic drug handling policies.
2.3.7. Preparation and reconstitution of cytotoxic medicines shall be carried
out within an approved safety cabinet.
2.3.8. When reconstitution needs to occur in a hospital ward, a clean, quiet,
well-lit, and well-ventilated area shall be available that minimizes
interruptions and is away from food and high traffic. Immediate access
to eye wash facilities, treatment agents, and hot and cold water should
be available. Ideally, part of this area should be dedicated exclusively
to the preparation of cytotoxic medicines. A strict aseptic technique
shall be followed for injectable preparations.

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2.3.9. Any special recommendations provided by the manufacturer of

cytotoxic medicines shall be adhered to.
2.3.10. Accidental spillage or contamination of the operator shall be
addressed appropriately as per established procedures, including
treating the skin, eyes, and other affected surfaces.
2.3.11. Thorough cleaning of the working area used for the preparation or
reconstitution of cytotoxic medicines shall be performed in accordance
with established procedures.
2.3.12. The disposal of all excess medicine, equipment, and protective clothing
used in the preparation of cytotoxic medicines shall be in accordance
with established procedures.
2.3.13. There shall be established procedures procedures for administering
cytotoxic medicines to patients, that balance operator protection and
patient comfort. Include details on actions to be taken in case of
extravasation and disposal of excreta from patients receiving cytotoxic
medicines.
2.3.14. A register of all employees routinely handling cytotoxic medicines shall
be maintained.
2.3.15. Acute exposure episodes shall be documented, and affected employees
shall be referred for appropriate medical examination.
2.3.16. Personnel handling cytotoxic medicines shall undergo routine medical
examinations and blood tests as per established procedures.
2.3.17. Personnel working in a cytotoxic reconstitution service shall be
regularly rotated.

Task 2.4. Intravenous additives services

2.4.1. Standard policies and procedures for preparing and

administering intravenous (IV) solutions shall be established.
2.4.2. Only staff who have received training in pharmaceutical aseptic
technique and have it within their scope of practice shall handle IV
solutions.
2.4.3. Safeguards shall be in place to ensure the stability and safety of the
solution throughout its administration to the patient.

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2.4.4. The pharmacy shall have access to reliable information sources on IV

medication administration, compatibility, and stability.
2.4.5. Before admixtures for administration are supplied, they shall
be inspected for the presence of particulate matter as per documented
procedures.
2.4.6. Appropriate quality control tests shall be performed to monitor IV
additive procedures.
2.4.7. An efficient system for the distribution of ready-prepared admixture
solutions shall be established.
2.4.8. All intravenous additives shall be used appropriately within their
specified shelf life and unwanted admixtures shall be promptly removed
from the ward area.
2.4.9. Accurate records of each admixture, including appropriate labelling,
shall be maintained.

Task 2.5. Total parenteral nutrition preparation and counselling

2.5.1. The preparation of Total Parenteral Nutrition (TPN) solutions shall take
place in a cabinet equipped with a high-efficiency particulate air (HEPA)
filter, situated in a room with a clean air environment.
2.5.2. A safe system of work shall be established and maintained throughout
the TPN solution preparation process, including safeguards to ensure
the stability and safety of the solution during administration to the
patient.
2.5.3. Accurate batch control records of all TPN solutions prepared and issued
for administration to patients shall be maintained.
2.5.4. A uniform standard for labelling TPN solutions shall be established and
maintained.
2.5.5. A Total Parenteral Nutrition (TPN) consultation service shall be
provided by a multidisciplinary nutrition advisory team.

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Tools and Key Performance Indicators (KPIs) for Compounding and Pre-
Packing
Tools KPIs
1. Master List of documents Number of compounding and pre-packaging
procedures performed according to written
documentation
2. Master list of equipment Number of required pieces of equipment
available in good working order as per the
equipment master list
3. Area layout drawings Adequate dedicated areas with required
utilities are available for compounding and
prepackaging activities
4. Compounding formulae, Number of compounding instruction forms
checklist, instructions, and and SOP record forms correctly filled in
record form prescribed format
5. Pre-packing SOP, instructions Number of Pre-packing instruction forms and
and record form SOP record forms correctly filled in prescribed
format
6. Compounding register Number of preparations compounded and
meeting specifications as per order
7. Pre-Packing register Number of preparations pre-packed as per
work order
8. Compounding Label Format Compounded preparations are labelled
correctly
9. Pre-packing Label Format Prepacked preparations labelled correctly
10. Materials Inventory form Proportion of required materials in stock, with
no discrepancy between physical and
theoretical stocks
11. Specification sheets for The number of materials having specification
materials, containers and sheets
packaging materials
12. Staff training and qualification Number of qualified staff trained on
records compounding / pre-packaging procedures
13. Temperature and All record forms filled correctly, temperature
Humidity Monitoring and humidity in areas within limits.
Record Form
14. Cleaning records All cleaning record forms filled out correctly,
and the area kept clean and neat on visual
inspection.
15. Balance calibration record Balance within calibration validity period
form
16. Materials Disposal Record All rejected or expired material disposed of
form within 60 days
17. Aseptic dispensing area layout Adequacy of area, utilities, and equipment
drawings available for the service as per guidelines (IV
admixtures, TPN, cytotoxics)
18. Master list of documents Presence of aseptic dispensing instructions,
SOPs, and records (IV admixtures, TPN,
Cytotoxics)

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Tools KPIs
19. Aseptic dispensing register Number of preparations aseptically prepared
and dispensed as per order for each category
(IV admixtures, TPN, Cytotoxics)
20. Aseptic dispensing label Number of aseptically dispensed preparations
format labelled correctly
21. Personnel qualifications and Number of qualified staff trained on aseptic
training records dispensing techniques
22. Terms of Reference (TORs) and Presence of a nutrition advisory team
minutes of the nutrition
advisory team
23. Cleaning record forms Adequacy of cleaning procedures for each
aseptic dispensing procedure performed
24. Equipment master list and Number of aseptic dispensing equipment
maintenance records available in good working condition
25. Distribution (issue) list form Accurate records of distribution/issue of
aseptically prepared preparations
(admixtures, TPN, cytotoxics)
26. I.V. additives inventory form Number of IV additives in stock vs stock-outs
27. TPN Preparation Register Number of TPN preparations made vs number
of orders
28. Cytotoxics preparation Number of hazardous, safety incidents e.g.
incidents register acute exposure, accidental spillages reported
in the period and their resolution
29. Personnel Protective Number of PPEs available for procedures vs
equipment and clothing number of personnel
inventory for cytotoxics
preparation
30. Medical records for personnel Number of personnel with up-to-date medical
involved in the preparation of records
cytotoxics
Resources required for Compounding and Pre-Packing
1. Suitable Good Compounding Practices Guidelines document
2. Approved procedures (including cleaning procedures)
3. Approved compounding formulas
4. Approved standards of quality references such as:
a. Pharmaceutical Compounding and Dispensing - The
Pharmaceutical Press
b. BP (British Pharmacopeia),
c. USP (United States Pharmacopeia), or
d. NF (National Formulary)
5. Guidelines for the Conduct of Sterile Pharmaceutical Services in
Healthcare Institutions (MoH Singapore)
6. EAC Good Manufacturing Practices Compendium (sterile products).
7. Reference materials for TPN and cytotoxics preparation
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8. SOPs for aseptic dispensing procedures

9. Institutional TPN Policy
10. Institutional cytotoxic drug handling policy
11. WHO standards

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STANDARD 3: Provision of HPT Dispensing Services

Dispensing services shall ensure accurate and safe issuance of health

products and technologies to clients, facilitating proper medication
management and adherence to prescribed treatment regimens.
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Description
Dispensing involves the interpretation and evaluation of a prescription,
selection, manipulation, or compounding of medicine, labelling and supply of
the medicine in an appropriate packaging and counselling the patient to
ensure the safe and effective use of HPTs.
Good dispensing practices ensure that the right drug, at the right dose, in the
right dosage form, through the right route of administration, and for the right
duration, is dispensed for the patient's condition, and delivered to the right
patient, in the prescribed dosage and quantity, with clear instructions, and
in a package that maintains the potency and stability of the drug. In addition,
good dispensing practice encompasses the dispensing of over-the-counter
medicines, verification of prescribed medicines for suitability, record keeping
and appropriate referral.
Performance Criteria

Task 3.1 Prescription processing

3.1.1. Prescription-only medicines shall only be dispensed with a valid

prescription.
3.1.2. HPTs should be prescribed on standard prescription format ensuring
the following information
a) The details of the patient- Name, Age, Sex, Address
b) Type of diagnosis, Name of the medicine
c) Dosage form, Dose of the medicine
d) Route of administration, Frequency of administration
e) Duration of therapy, Total quantity to be dispensed
f) Refill information (if applicable)
g) Name, registration number and signature of prescriber
h) Date of prescription

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3.1.3. Only OTC/nonprescription medicines may be given on the customer's

request
3.1.4. Prescription shall be received from the client in a professional and
dignified manner by a duly trained and licensed person.
a) Under no circumstances should an untrained person attempt to
read or discuss the prescription with the client.
3.1.5. The service provider shall ensure that the person requesting the
product is the intended user by gathering sufficient information about
the patient and the condition(s) being treated.
3.1.6. The legality, authenticity and completeness of the prescription shall be
confirmed before dispensing, through
a) Checking the history of overuse, under-use or misuse of
medicines by the patient.
b) Checking for overwriting. Check Fake/false prescription
c) Any doubt on the prescription (i.e. name of the medicines or
directions, or if it appears that an error has been made by the
prescriber), should be examined closely and, if necessary
discussed/consulted with other pharmacists or the prescriber
himself/herself without arousing doubts or fears in the patient.
d) Checking the medicine, and checking the pharmaceutical form,
strength, appropriate dosage, presentation, method of
administration and duration of treatment;
3.1.7. The appropriateness of the medication for the patient and the indication
for which the medication is prescribed should be evaluated.
3.1.8. The dose, frequency and duration of prescribed medicine should be
verified for correctness, as per MOH standard treatment guideline and
other reputable protocols, for being within the standard minimum and
maximum range.
3.1.9. The dose of prescribed medicine should be verified in case of children,
and for all categories of potent /dangerous drugs.
3.1.10. Any suspected under dose/overdoses or inappropriate dosing should
always be referred to the prescriber.
3.1.11. The safety of the prescribed medicines and contraindications should
be assessed.

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3.1.12. The prescription should be evaluated for drug interactions (drug/drug,

drug/food, drug/disease) and treatment duplications.

Task 3.2. Selection, Preparation and labelling of prescribed medicine

3.2.1. Availability of prescribed medicines should be checked and efforts made

to arrange for the medicines to be made available to the client.
3.2.2. Extemporaneous preparations shall be prepared as per the standard
protocols and guidelines.
3.2.3. The medicines shall be inspected for quality per the manufacturer's
summary of product characteristics.
3.2.4. The quantity of medicine or HPTs to be dispensed should be computed
to confirm that it is appropriate for the patient, and that the product
can be supplied in such quantity.
3.2.5. The required quantity of medicines should be appropriately collected
from the shelves or store.
3.2.6. Pre-packing and labelling of patient packs should be performed as per
current regulations and labels must include batch number, expiry date,
quantity dispensed, name of the patient, direction for use and special
precautions.
3.2.7. Packaging material that is appropriate for the medicine being
dispensed, shall be selected.
3.2.8. Medicine containers shall be labelled with the correct directions and
any other information necessary for the safe, proper, and effective use
of the medicine.
a) Labelling of dispensed products must be clear, legible and indelible.
Lettering must as far as possible be mechanically printed;
b) Pharmacy labels should be printed, typewritten or handwritten
stickers. The label should not fade when exposed to water or
sunlight.
3.2.9. The following information should be indicated on the label

a) the generic name of the product or each active ingredient, where

applicable,
b) the strength, dose, frequency of administration and total quantity,
c) expiry date or use by date
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d) prescriber’s name,
e) the name of the person for whom the medicine is dispensed, (The
name of the patient)
f) the directions for use, (Instructions for the patient)
g) the name and business address of the dispenser, (pharmacy/ drug
store)
h) date of dispensing,
i) special precautions and advisory labels as applicable
3.2.10. Cautionary/advisory labels and instructions must always be used;

Task 3.3. Medication use counselling

3.3.1. Patients and clients shall be provided with appropriate advice and
information on how to use medicines correctly and effectively to achieve
optimal therapeutic outcomes.
3.3.2. Detailed advice and information should be given to patients on how to
use medicines safely and effectively to maximize therapeutic outcomes.
3.3.3. Upon customer request, over-the-counter (OTC) or nonprescription
medicines shall only be dispensed if they are the most suitable choice
for the patient's condition(s) or symptoms.
3.3.4. Written information shall be provided, whenever possible, to
complement oral communication.
3.3.5. Patient information leaflet, containing the necessary details about the
medicines in English or the local language, shall be made available,
whenever possible.
3.3.6. Information or services related to health promotion offered to patients
shall be up-to-date, and in accordance with relevant local and national
guidelines.
3.3.7. Upon dispensing, the prescription or a copy of the prescription shall be
promptly signed and dated, for accountability.

Task 3.4 Recording keeping

3.4.1. Patient medication profile/record shall be developed and maintained

preferably in a validated electronic format or in the form of a manual

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prescription book, in a manner that guarantees the confidentiality of

individual patient data.
3.4.2. The following information should be captured in a patient medication
record:
1. Patient details
a) the patient's full name
b) the address and telephone number of the patient;
c) the patient's age or date of birth;
d) the patient's gender;
e) current weight of the patient;
f) Name of prescriber and date of prescription
g) Name of the dispenser and date of collection
h) any known allergies of the patient;
i) any possible reactions of the patient towards medicine
j) family history;
k) idiosyncrasies or negative reactions of the patient towards
medicine;
l) the presence of other factors, e.g. smoking;
m) chronic conditions or disease states of the patient; and
n) the identity of any other medicine or devices currently being
used by the patient, and any related information indicated by
a medical or other health care professional.
2. Prescriber detail
a) the name of the prescriber and date of consultation;
b) Qualification and registration number
3. Dispenser detail
a) the name of the pharmacist, pharmacy technologist of intern
b) Qualification and registration number
4. Details of medicine
a) a list of all medicines and quantities dispensed (prescription
as well as non-prescription)

3.4.3. Prescription records shall be retained for a minimum period of five years
from the date of dispensing.

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3.4.4. Confidentiality about patient information shall professionally be

maintained in compliance with the Data Protection Act.
3.4.5. Standard procedures for the disposal of prescriptions shall be
established and documented.
Tools and Key Performance Indicators (KPIs) for Dispensing services
Tools KPIs
1. Standard prescription Percentage of dispensed prescriptions
format Average dispensing time (Average fill time)
2. Good Dispensing Practices Average patient counselling time
Checklist Recorded and filed prescriptions
Percentage of patients counselled on
medication use
3. Patient medication profile Systems and documentation of follow-up
evaluation
4. Medication error Number of medication errors identified and
documentation form reported
5. Prescription dispensing Number of prescriptions dispensed
activity register form Number of patients served
6. OTC dispensing record form Documentation of Over-the-counter
medicines dispensed
7. Label and medicine Utilization of appropriate cautionary labels
information Printed medicine information for clients
8. Data Protection Act Adherence to the provision of the act

Resources for Dispensing services

1. International Pharmaceutical Codex guidelines
2. British National Formulary (BNF) or Drug Index
3. Martindale
4. Pharmacopoeia
5. Poison management texts and reference books
6. Pharmacology and therapeutics text and reference books
7. Standard treatment guidelines or protocols
8. SOP for disposing of prescriptions

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STANDARD 4 Provision of Internet Pharmacy (Online) Services

Internet pharmacy services shall enhance the convenience and access

to pharmaceutical products and services, while ensuring that the
quality, confidentiality and security of the online transactions meet or
surpass that of face-to-face services.
------------------------------------------------------------------------------------------------------------
Description
A registered pharmacy that offers to dispense HPTs and/or provides other
professional services over the internet, or makes arrangements for the supply
of such products or provision of such services over the internet must comply
with this standard. An internet pharmacy service should not be a substitute
for a face-to-face consultation with a pharmacist or other appropriate
healthcare professional, but when used safely and appropriately, online
access to medicines and healthcare advice can offer benefits to clients.
Performance criteria

Task 4.1. Registration of Internet pharmacy services

4.1.1. All pharmacies intending to provide services online to the general

public must be registered by the Pharmacy and Poisons Board (PPB)
and listed as registered online pharmacies. They shall prominently
display the Health safety code provided by the PPB on every page of
their website.
4.1.2. A pharmacy offering online services shall adhere to the following
criteria:
a) have physical premises registered with the PPB, from which the sale
and supply of HPTs take place, meeting the necessary requirements.
b) A person conducting an internet/online pharmacy business shall be a
qualified pharmacist or pharmaceutical technologist owner, or if the
pharmacy is owned by a 'body corporate' (e.g., a company), a
superintendent pharmacist or pharmaceutical technologist.
c) Individuals purchasing HPTs online can verify the legitimacy of the
website by checking if it is registered and can further verify the Health
safety code for authentication.

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Task 4.2. Dispensing

4.2.1. Patients shall receive, at least, the same level of quality pharmaceutical
care, regardless of whether the service is provided online or in person
at the pharmacy premises.
4.2.2. The dispensing of HPTs by internet pharmacies shall be as per Standard
3 above.

Task 4.3. Information and advice

4.3.1. Patients shall receive consistent and high-quality pharmaceutical care,

regardless of whether the service is provided online or in-person at the
pharmacy premises.
4.3.2. Patient health information shall be collected, recorded and used in a
manner that protects confidentiality and privacy.
4.3.3. All information about specific products shall comply with the market
authorization, the patient information leaflet (PIL), and relevant
legislative requirements.
4.3.4. Relevant legislation regulating advertising or publicity of online
services shall be adhered to.

Task 4.4 Delivering of medicines

4.4.1. Systems, and procedures shall be established to secure the delivery of

medicines to the intended user in a confidential, timely and safe
manner.
4.4.2. Integrity of the cold chain medicines shall be maintained
4.4.3. Medicines shall be packed, transported, and delivered in a manner that
preserves their integrity, quality, and effectiveness.

Task 4.5. Record keeping

4.5.1. All records for online consultations and supplied medicines shall be
maintained, ensuring the prevention of abuse or misuse and
maintaining a verifiable audit trail.

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Tools and Key Performance Indicators (KPIs) for Internet Pharmacy

services
Tools KPIs
1. Standard prescription ● Percentage of dispensed prescriptions
format ● Average dispensing and medication use
2. Good Dispensing Practices counselling time
Checklist ● Record and file of prescriptions for 5
years
3. Patient medication profile Systems and documentation of follow-up
evaluation
4. Medication error Number of medication errors reported
documentation form
5. Digital counselling platform Patient counselling records

6. Prescription dispensing ● Number of prescriptions dispensed

activity register form ● Number of patients served
7. Label and medicine ● Availability and utilization of
information appropriate cautionary labels
● Printed medicine information for clients
8. Data Protection Act Adherence to the provision of the act
9. Monitoring and evaluation ● Adherence to good dispensing practices
form ● Validation of IT equipment and software
● quality of professional services

Resources for Internet Pharmacy services

1. International Pharmaceutical Codex guidelines

2. British National Formulary (BNF) or Drug Index
3. Martindale
4. Pharmacopoeia
5. Poison management texts and reference books
6. Pharmacology and therapeutics text and reference books
7. Standard treatment guidelines or protocols
8. SOP for disposing of prescriptions
9. Guidelines for Internet Pharmacy Services in Kenya
10. Pharmacovigilance online-reporting tools
https://pv.pharmacyboardkenya.org/

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STANDARD 5: Provision of Primary Health Care Services

Primary Health Care (PHC) shall be in a manner that addresses the various
health concerns in the community, including proactive health management
and referral, disease prevention and early detection, continuous monitoring of
disease and treatment outcomes, and promotion of wellness across diverse
populations.
--------------------------------------------------------------------------------------------------------------------
Description
Primary healthcare services are pivotal in safeguarding and enhancing
community health across a broad spectrum of critical services. These
encompass immunization, reproductive and maternal-child healthcare,
nutritional advice, disease prevention strategies, tuberculosis detection, HIV
counseling/testing, antiretroviral treatments, Post-Exposure Prophylaxis,
Pre-Exposure Prophylaxis, support for sexual and gender-based violence
survivors, and emergency readiness. Moreover, they prioritize health
promotion, educational outreach, and the continual advancement of
healthcare through ongoing training and research endeavors. Within the
framework of Kenya's Universal Health Coverage, rigorous health
assessments, screenings, and monitoring play a vital role in curbing
preventable conditions such as diabetes, cardiovascular diseases, and
chronic kidney diseases. This approach is not only cost-effective but
significantly boosts overall population health. Screening and risk assessment
processes are designed to systematically identify at-risk individuals within a
community, assess their risk levels, and facilitate necessary referrals. These
measures, crucial for pre-emptive healthcare, are executed with the intent of
enabling effective treatment or management for identified individuals, rather
than for diagnosis or immediate alteration of medical treatments.

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Performance Criteria

Task 5.1. Perform basic individual health assessment

5.1.1. Screening and monitoring HPTs shall be dispensed for the public to use
at home with appropriate information.
5.1.2. Basic health assessments including subjective and
objective assessments shall be conducted as per standard MOH
protocols.
5.1.3. Basic health assessments shall include
a) body temperature,
b) blood pressure,
c) heart rate/pulse
d) respiratory rate
e) Body mass index
f) Nutritional assessment
5.1.4. In emergency situations, service providers may use their professional
judgement to prescribe and dispense prescription-only medicine.

Task 5.2. Pharmacy based Point-of-care (POC) testing for Screening,

diagnosis and monitoring

5.2.1. HPTs used for point-of-care testing shall be dispensed to the

public with appropriate instructions for use at home.
5.2.2. Patients' eligibility for screening, monitoring, or rapid diagnostic tests
shall be assessed based on established criteria.
5.2.3. Appropriate screening, monitoring, or rapid diagnostic tests shall be
based on patient needs, medical history, and relevant guidelines.
5.2.4. Pharmacy-based Point-of-care (POC) testing shall include, but not
limited to
a) Rapid diagnostic testing including HIV/syphilis, pregnancy, malaria,
haemoglobin and others as recommended by MOH..,
b) Blood glucose testing
c) Cholesterol testing
d) Blood pressure measurement
e) Influenza and strep throat tests

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f) COVID-19 tests
g) INR testing
h) HIV screening
5.2.5. Point-of-care (POC) testing shall be performed as per MOH protocols
and standard procedures and results shall be interpreted accurately.
5.2.6. Quality assurance protocols shall be adhered to ensure the reliability
and accuracy of screening, monitoring, and rapid diagnostic tests.
5.2.7. Records of screening, monitoring, and rapid diagnostic tests shall be
performed.
5.2.8. Education and counselling shall be given to patients regarding the
importance of regular health screening and monitoring.
5.2.9. The results of the pharmacy based screening and monitoring readings
shall be interpreted.
5.2.10. Advice on dietary changes, physical activity, weight management,
stress reduction, and smoking cessation shall be provided to clients.
5.2.11. Accurate and up-to-date records shall be maintained.

Task 5.4 Vaccination Services

5.4.1. Vaccination services shall only be provided by certified pharmacists in

a recognized facility.
5.4.2. Patients and clients will be screened before vaccination as per MOH
guidelines.
5.4.3. Vaccinations that can be administered shall include and not limited to:
a) BCG vaccine
b) Polio vaccine
c) Penta Valent vaccine
d) PCV 10 vaccine
e) Pneumococcal polysaccharide vaccine (PPSV) vaccine
f) Measles vaccine
g) Rotavirus vaccine
h) Rubella vaccine
i) Mumps vaccine
j) Chickenpox
k) Hepatitis A vaccine

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l) HPV vaccine
m) Cholera vaccine
n) Meningococcal vaccine
o) Malaria vaccine
p) Yellow Fever vaccine
q) Tetanus vaccine
r) Typhoid vaccine
s) Rabies vaccine
t) Hep B vaccine
u) COVID vaccine
v) Immunoglobulins
w) Anti-snake Venom
x) Flu vaccine
y) Vaccines for other emerging and existing conditions
5.4.4. Adverse events following immunisation (AEFIs) shall be routinely
monitored and appropriate action taken in accordance with established
protocols.
5.4.5. Reference shall be made to WHO guidelines for universal
precautions for preventing HIV and Hepatitis virus transmission.
5.4.6. Package inserts shall be reviewed before administering a vaccine.
5.4.7. Patient vaccination cards shall be accurately filled out and
documented.
5.4.8. Disposal of vaccines shall be conducted with the disposal committee at
the Sub-County
5.4.9. In collaboration with pharmacovigilance (PV) specialists, the service
provider shall participate in the multi-disciplinary teams (MDTs)
for the Investigation and management of AEFIs.

Task 5.5. Reproductive Health Services

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5.5.1. The linkage between private community pharmacies and public health
facilities shall be established to facilitate comprehensive reproductive
care for clients and effective referral services.
5.5.2. The reproductive health services shall include
a) Supporting routine antenatal care services
b) Family planning
c) Assessment, management and referral of clients with reproductive
health risks,
d) Assessment, management and referral of patients with sexually
transmitted infections (STIs) and Reproductive tract infections (RTIs) as
per MOH protocol
e) Counselling, management and referral of Sexual and Gender-based
violence as per MOH protocol
5.5.3. Family planning services shall only be provided by certified personnel
in a recognized facility
5.5.4. Basic physical examination and contraceptive counselling services shall
be conducted before initiating oral and injectable contraceptive
services.
5.5.5. Clients receiving pharmacy-initiated oral and injectable contraceptives
should undergo a comprehensive physical evaluation at least once a
year by a medical practitioner or an authorised reproductive health
clinic.
5.5.6. Service-related data shall be collected, analysed, and reported in
accordance with the guidance of the Ministry of Health.
5.5.7. An effective and efficient referral system shall be established and
maintained for provision of reproductive health services
and management of side effects and adverse drug reactions.
5.5.8. Integrated health services shall be provided including screening for
sexually transmitted infections/HIV counselling & testing and
provision of dual contraceptive methods for clients at risk.
5.5.9. Service providers shall advise and provide details to the clients on how
to do a Breast Self-Examination (BSE) to check for breast lumps and
any changes.

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5.5.10. Age-appropriate support to youth and adolescent groups on substance

abuse support, HIV counselling and testing, mental health
counseling/services, and prevention of unwanted
pregnancy/abortions.

Task 5.6. Mother and Child Health Services

5.6.1. Pregnant mothers shall be provided with advice on nutrition,

vaccination, pregnancy-related medicine supplementation and referred
for antenatal services
5.6.2. Pharmacy-based Maternity services shall be provided as per MOH
protocol including but not limited to:
a) Preconception care
i. Provision of iron and folic acid supplementation, and other
appropriate supplements depending on the health status of
the patient and any other underlying medical conditions or
risks
ii. Assess for any current medication which may negatively
affect sperm quality, conception or pregnancy outcomes.
Screening for underlying medical conditions e.g. anaemia,
diabetes mellitus, hypertension, STIs among others
iii. Management of underlying medical conditions
iv. Provision of information, education and counselling on
lifestyle modifications such as healthy diet, weight
management, physical exercise among others
b) Antenatal care
i. Provision of preventive measures e.g. antenatal prophylaxis
with Anti-D immunoglobulin in non-sensitized Rh-negative
women at 28 - 34 weeks of gestation to prevent RhD allo
immunization in consultation with a medical practitioner
ii. Provision of preventive anti-helminthic treatment
iii. Provision of iron and folic acid supplementation, and other
appropriate supplements depending on the health status of
the patient and any other underlying medical conditions or
risks

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iv. In malaria endemic areas, provide intermittent preventive

therapy, and insecticide-treated nets among others
v. Provision of tetanus toxoid vaccination
vi. Provision of HIV prevention and treatment medication to the
pregnant women
vii. Screen for medical conditions e.g. anaemia, hyperglycemia,
elevated BP
viii. Management of underlying medical conditions
ix. Provision of information, education and counselling
on danger signs during pregnancy and measures to take,
healthy diet during pregnancy, routine ANC visits among
others
x. Refer to appropriate medical practitioner where the patient
presents with symptoms beyond the scope of the pharmacy
provider
xi. Assess for and advice on any current medication which may
negatively affect pregnancy outcomes
d) Postnatal care
i. Screening for underlying conditions e.g. anaemia,
hyperglycaemia, elevated blood pressure and manage as per
MOH protocols
ii. Assessing for and advice on any current medication which
may negatively affect the breastfeeding newborn
iii. Provision of family planning methods to allow for child spacing
iv. Assessing for signs of postpartum depression and refer for
appropriate management
v. Nutritional support for the breastfeeding mother
vi. Provision of HIV prevention and treatment medication to the
mother and child
vii. Re-emphasize and support on elements of post-natal care for
mother and newborn, including identification of underlying
issues and referral
5.6.3. Pharmacy-based newborn care services shall be provided as per MOH
protocol including but not limited to

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a) antiseptic
b) child growth monitoring
c) Guidance on Breastfeeding
d) Administer childhood immunization services
e) Advice on hygiene practices
5.6.4. Pharmacy-based Childhood health services shall be provided as per
MOH protocol including but not limited to
a) Deworming
b) Management of Uncomplicated Malaria
c) Management of cough, cold, and fever
d) Management of mild to moderate acute malnutrition
e) Management of suspected measles
f) Management of diarrhoea and mild to moderate dehydration
5.6.5. Prevention of Mother to Child HIV Transmission services shall be
provided as per the MOH protocols, including
a) Counselling on appropriate infant feeding practices in HIV
b) HIV Testing services
c) Highly Active Anti-Retroviral Therapy
d) ARV prophylaxis for children born of HIV+ mothers
5.6.6. Mothers shall be advised on breastfeeding and alternative milk
products, the safe use of medicines while breastfeeding, and the range
of breastfeeding accessories and equipment available.
5.6.7. Childhood health services shall be provided including
a) Guidance on Breastfeeding
b) Deworming
c) Management of Uncomplicated Malaria
d) Management of cough, cold, and fever
e) Management of mild to moderate acute malnutrition
f) Management of suspected measles
g) Management of diarrhoea and mild to moderate dehydration
5.6.8. Childhood health services shall be provided with comprehensive
knowledge, emphasizing the importance of early referrals.
5.6.9. Infants with complex symptoms, shall be promptly referred to childcare
specialists.

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Task 5.7 Nutrition Services

5.7.1. Patients shall be educated on healthy nutrition, vitamin and mineral

supplementation, appropriate diets, weight reduction and healthy
lifestyle.
5.7.2. Nutrition education and counselling services shall be provided
including
a) Community-based growth monitoring and promotion
b) Diet Diversification
c) Multisectoral engagement on food security and nutrition
d) Health education on appropriate infant and young child feeding
e) Workplace support for breastfeeding
f) Micronutrient supplementation (e.g vitamin A, IFA)
5.7.3. Malnutrition prevention and management services shall be provided
including
a) Promotion of healthy diets and physical activity
b) Promotion of growth monitoring
c) Promotion of exclusive breastfeeding for the first 6 months of an infant
d) Early initiation of breastmilk
e) Integrated management of acute malnutrition
5.7.4. Patients shall be educated on weight reduction and healthy lifestyle
5.7.5. Appropriate nutritional counselling service shall be provided to
specialist patient groups, such as those with diabetes, hypertension,
lipid disorders, elderly patients, stoma patients, terminally ill patients,
and pregnant women.
5.7.6. Sports nutrition pharmacy services shall be provided including but not
limited to
a) Supplementation for athletes
b) Counseling on anti-doping
5.7.7. Patient counselling shall be conducted on potential drug-food and
drug—herb interaction.

Task 5.8 Medication Safety

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5.8.1. A comprehensive medication safety management system,

encompassing policies, procedures, and protocols designed to minimize
medication errors and adverse drug events, shall be implemented.
5.8.2. Verification of medication sources, as part of the procurement process,
to prevent the entry of counterfeit or substandard drugs into the supply
chain, shall be ensured.
5.8.3. Proper storage conditions for all medications, in accordance with
manufacturers' guidelines and regulatory requirements, to preserve
their efficacy and safety, shall be maintained.
5.8.4. A protocol for verifying the accuracy and appropriateness of all
prescriptions, including checks for correct patient information,
medication, dosage, route, and frequency, shall be established.
5.8.5. Double-check procedures for dispensing high-risk medications and for
the care of patients at increased risk of medication-related harm shall
be implemented.
5.8.6. Access to up-to-date drug information and resources, to support safe
medication dispensing practices, shall be ensured.
5.8.7. Comprehensive patient counseling, providing information on
medication purpose, proper administration, potential side effects, and
interactions, shall be provided.
5.8.8. Medication reconciliation at all transition points of care, to prevent
discrepancies and ensure continuity of care, shall be performed.
5.8.9. A system for the timely reporting and analysis of medication errors and
adverse drug events, including near misses, shall be established.
5.8.10. Participation in national or regional medication error reporting
systems, to contribute to broader medication safety efforts, shall be
engaged in.
5.8.11. Regular review of medication safety practices and outcomes, to identify
areas for improvement, shall be conducted.
5.8.12. Collaboration and communication with prescribers and other
healthcare providers, to ensure coordinated care and medication
safety, shall be fostered.

Task 5.9 Disease Control and Prevention

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5.9.1. Service providers shall monitor, manage and coordinate HPTs during
disease outbreaks:
5.9.2. Public Health Programs (HIV, TB, Malaria, Neglected & Tropical
Diseases (NTDs), Non-Communicable Diseases (NCDs) shall be
coordinated and integrated
5.9.3. Offer Pre & Post-Exposure Prophylaxis (PEP/PrEP) Services (including
HIV counselling, testing, PEP/PrEP prescribing and dispensing, follow
up and referral services)
5.9.4. Public and private supply chain management of HPTs across PHC shall
be coordinated for disease control and prevention
5.9.5. Strategies shall be developed for screening, prevention and prophylaxis
of disease outbreaks
5.9.6. Relevant data shall be collected, analysed and submitted to KHIS for all
facilities in the Sub-County.
5.9.7. Perform order rationalizations and allocations (Perform Data Quality
Audits and Service Quality Assessments (SQAs) of HPTs
5.9.8. Participate in the County and National Performance and Data reviews
and validation

Task 5.10 Management of minor and common ailments

5.10.1. Common ailments, including but not limited to constipation,

diarrhoea, piles, hay fever, head lice, nappy rash, chicken pox,
threadworms, sore throat, minor skin infections, eye infections, mouth
ulcers, cold sores, acne, dry eyes, dermatitis, mild pain managment,
vaginal thrush, oral thrush, scabies, ringworm, may be diagnosed
based on presenting symptoms, medical history, and if necessary,
physical examination, adhering to best practice guidelines.
5.10.2. Treatment selection for common ailments shall align with current
clinical guidelines, ensuring treatments are appropriate for the
condition being managed and considering patient safety and efficacy
of the options available.
5.10.3. Patients shall be provided with clear information regarding their
condition, treatment options, medication usage, potential side effects,
and self-care measures to manage symptoms effectively.

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5.10.4. Criteria for referral to appropriate healthcare provider shall be

established for cases beyond the scope of pharmacy practice or when
complications are suspected, ensuring timely and appropriate care.
5.10.5. Systems shall be in place for the follow-up and monitoring of patients
to assess treatment effectiveness, adherence, and to manage or
mitigate any adverse effects, with adjustments made to the treatment
plan as necessary.
5.10.6. Patient encounters, assessments, treatment recommendations, and
any follow-up actions shall be documented accurately and
confidentially in accordance with data protection and privacy
regulations.
5.10.7. Continuous professional development shall be available to keep
abreast of the latest evidence-based practices, treatment modalities,
and product knowledge relevant to the management of common
ailments.
5.10.8. Engagement in quality improvement activities shall be undertaken to
enhance the management of common ailments, including the
evaluation of service delivery, patient satisfaction, and outcomes, to
identify areas for improvement and implement corrective actions.

Task 5.11 Public health emergency preparedness and response

5.11.1. The response to public health emergencies shall be conducted with

adequate planning, designing, monitoring and evaluation
5.11.2. Facilities shall ensure adequate preparedness for any possible public
health and other emergencies by putting in place the right
organizational structures, emergency supplies and procedures.
5.11.3. First aid, basic life support and referral services shall be provided
5.11.4. Emergency supply chain services shall be availed including people and
processes, commodity planning and warehousing, storage and
logistics.
5.11.5. The pharmacy team shall participate as part of the Rapid Response
Teams
5.11.6. Staff shall be trained in the development of emergency strategic,
operational and incident action plans

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5.11.7. Staff shall be trained in emergency response, infection prevention and

control and HPT waste management

Task 5.12 Health Education and Promotion

5.12.1. Health education and promotion services shall be provided on

a) prevention of communicable diseases
b) prevention of non-communicable diseases
c) health risk factor reduction
d) Harmful effects of Substance abuse (Cocaine, Heroin, glue, khat, bhang
Tobacco, alcohol, etc)
e) harmful effects of Prescription and non-prescription drug misuse and
abuse
f) Counselling on strategies to enhance healthy behaviour change
5.12.2. Health and wellness services shall be provided including
a) Health education on benefits and approaches to improving physical
activity
b) Nutritional assessment and dietary counselling
5.12.3. Community participation and inter-sectoral collaboration: school
health, MDAs, AMR
5.12.4. Mental health education and counselling services shall be provided
including
a) Screening, management and referral for behavioural disorders, and
neuro-developmental disorders as per MOH protocols
b) Rehabilitation for substance-related and addictive disorders
c) Management of affective and psychoactive disorders

Task 5.13 Training and Research

5.13.1. Supervision during internship and mentorship shall be provided to

Pharmacist interns and pharmaceutical Technologists on attachment
within the sub-county health facilities and private retail/community
pharmacies (Preceptorship)
5.13.2. Operational research shall be conducted on relevant public health
pharmacy service indicators

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5.13.3. Continuous professional development and medical education

activities shall be organized.
Tools and Key Performance Indicators (KPIs) for Primary Health Care
services
Tools KPIs
1. Patient nutrition screening Number of patients screened for nutritional
tool deficiencies
2. Immunization screening Number of patients screened before
tool immunization
3. Expiry monitoring chart Utilization of expiries tracking chart
Number of expired products quarantined for
disposal
Number of short-dated commodities being
monitored
4. Cold chain monitoring Percentage of commodities being monitored
chart that meet the cold chain criteria for storage and
transportation
5. Patient referral form Number of patients being referred

6. Patient immunization card Number of immunizations done

(refer to MOH KEPI)
7. Charter of additional Number of inquiries for additional services
services offered
8. Clients/patients summary Number of clients/patients screened (minor
tool ailments, Rapid tests, HTN, DM, comorbid)
9. Data collection & Number of interventions
intervention tool
10. Patient consent form Number of patient consent forms signed
11. Record of the number of Number of CPD points attained
CPD events and training
subscribed for and
attended
12. SOPs for carrying out basic Number of staff trained on SOPs for carrying out
health assessment tests, basic health assessment tests, screening &
equipment calibration & monitoring, equipment calibration &
communication with communication with relevant healthcare
relevant healthcare professionals reviewed and signed.
professionals

Resources Required for Primary Health Care Services

1. Mother and child health guidelines

2. Immunization guideline
3. National nutrition guideline
4. Kenya Reproductive Health Policy
5. National Family planning guideline

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6. National Guidelines for Provision of Adolescent & Youth Service in

Kenya
7. Kenya Quality Model for Health (KQMH)
8. Kenya Primary Healthcare (PHC) Concepts of Operations
9. Kenya Essential Package for Health
10. National Guidelines on Use of ARVs
11. HIV Testing Services Guidelines
12. Health assessment and screening text or reference books or online
resources
13. Safe patient assessment protocol reference text or online resources
14. British National Formulary (BNF) current version

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STANDARD 6: Provision of effective medication therapy management

(MTM) services

MTM services shall be provided in a manner that optimizes medication

therapy, improves treatment outcomes, and promotes overall health and well-
being of patients.
--------------------------------------------------------------------------------------------------------------------
Description
A thorough evaluation of the patient's medication regimen is essential to
ensure all their drug-related needs are addressed. This includes verifying that
the regimen is suitable for the patient's condition, maximally effective, safest
among available options, and that the patient can and will adhere to it.
Additionally, it's crucial to ensure the regimen is cost-effective. Any identified
drug therapy problems should be promptly resolved or prevented. This
process aims to optimize medication therapy, ensuring it aligns with the
patient's condition, safety, efficacy, and cost considerations. Furthermore,
medication therapy management involves collaborative planning with other
healthcare professionals and the patient/caregiver, as well as necessary
follow-up to monitor progress and make adjustments as needed.

Performance criteria

Task 6.1. Collecting necessary information about the patient

6.1.1. The necessary subjective and objective data that is comprehensive,

relevant and accurate shall be gathered about the patient to obtain a
thorough understanding of their medical/medication history and
clinical condition. relevant and accurate.
6.1.2. These data shall be collected from history taking including
immunization and preventive care, patient assessment, patient medical
records and medication profiles. Immunization and preventive care
assessment is also done.

Task 6.2. Assessing the information and analysing the therapeutic

effect of the patient’s medication

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6.2.1. Collected information shall be analysed to assess the clinical effects of

the patient's therapy within the context of their overall health goals.
6.2.2. The analysis shall include determining whether the drug regimens meet
all the requirements for appropriateness, effectiveness, safety,
adherence and cost-effectiveness. If any of these drug related needs are
not met, then drug related problems shall be identified.

Task 6.3. Developing an individualised patient-centred care plan

6.3.1. An individualized care plan that is patient-centred, evidence-based, and

cost-effective shall be developed to resolve any drug therapy problems
identified. This shall include
a) Developing the problem list according to the patient's condition(s)
b) Writing a statement of intervention for each of the problems identified,
including non-drug therapy approaches, patient education and
counselling.
c) Developing an implementation and monitoring plan which addresses all
drug therapy problems
d) Supporting Care Continuity and Transitions.

Task 6.4. Implementing the care plan

6.4.1. Appropriate interventions shall be implemented to prevent or resolve

medication therapy problems. These shall include:
a) Initiating, Modifying, Discontinuing, or Administering Medication
Therapy
b) Providing Education and Self-Management Training
c) Initiating the Coordination of Care
d) Identify monitoring parameters for safety and effectiveness of
medication therapy
e) Scheduling Follow-Up Care

Task 6.5. Monitoring patient progress and outcomes

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6.5.1. Medication Effectiveness, Safety, and Patient Adherence shall be

monitored, including
a) Assessing Clinical Endpoints and
b) Evaluating Outcomes of Care

Task 6.6 Transition of care

6.6.1. Conducting medication reconciliation and document

6.6.2. The medication action or treatment plan shall be discussed and
developed in collaboration with the transiting patients
6.6.3. Patient education, counselling, and resources shall be provided to
enhance patients’ understanding about the use of medications and to
improve adherence
6.6.4. The necessary documents shall be provided for coordination of care
6.6.5. The service provider shall review the patients’ discharge records, verify
follow-up appointments, and schedule appointments as needed to
address patient concerns with healthcare team
6.6.6. Provision medication therapy management shall be linked with
population health policies and interventions.

Task 6.7 Ambulatory Care

MTM in Ambulatory care is an Integrated, accessible medication management

services for ambulatory patients in a wide variety of settings, including
community pharmacies, clinics and physician offices
6.7.1. Clinically-focused medication therapy management shall
be conducted and findings or interventions shall be communicated to
other providers
6.7.2. Comprehensive Medication Therapy Review (CMTR) shall be facilitated
for the transition of care appointments for patients with a recent
hospital discharge
6.7.3. Patient education and counselling shall be provided
6.7.4. Preventive care and wellness screenings shall be provided
6.7.5. The service provider shall participate in collaborative management of
the patient in multidisciplinary team across cadres

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6.7.6. Chronic disease state management services that include ordering,

interpreting, and monitoring point of care laboratory tests shall be
provided.

Tools and Key Performance Indicators (KPIs) for Provision of MTM

Services
Tools KPIs
1. Medication Action Plan Number of MAP filled
2. Personal medication list Number of Personal medication list filled
3. MTM Standardized Toolkit Number of patients’ Medication Records
forms filled
Number of interventions done and
documented
Number of patient education sessions
done and documented
4. Collaborative drug therapy Number of Collaborative Drug Therapy
management agreement Management agreements (CDTMA)
signed and documented

Resources Required for Provision of MTM Services

1. Drug information software (Lexicom, Medscape, UpToDate, and others)

2. Pharmacopoeias
3. Drug Interaction checker
4. Martindale
5. Standard treatment guidelines
6. Clinical guidelines
7. MTM Manual
8. MTM Standardised Tools

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STANDARD 7. Provision of Drug Information services to clinicians and

patients

Comprehensive, accurate, and up-to-date drug information shall be provided

to health care workers and patients in a way that empowers them to make
informed decisions, ensuring safe and effective medication use, and fostering
better health management.
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Description
The goal of this service is to ensure that appropriate advice is available in a
timely manner to meet the needs of healthcare workers. The advice could
range from rationally selecting medications within a specific class of drugs to
supporting formulary review to selecting an appropriate dosage regimen for
an individual patient. Drug information service is established within a
hospital, it must be maintained and expanded in collaboration with other
established drug information centers. This service shall consider the unique
needs of healthcare workers and patients. Drug information services must
adhere to the standards outlined below.

Performance Criteria

Task 7.1 Provision of Drug Information

7.1.1. Health facilities shall establish a Drug Information Centre (DIC) to

provide drug information services to healthcare workers and clients
7.1.2. The drug information needs of patients, non-patients and healthcare
workers shall be assessed and evaluated.
7.1.3. Appropriate and comprehensive background information related to the
drug information request or query shall be gathered.
7.1.4. Systematic approach to address drug information needs shall be used.
7.1.5. Relevant and applicable drug information shall be synthesized and
evaluated for relevance and validity.
7.1.6. Drug information shall be communicated to patients, caregivers, and
healthcare workers in a clear and understandable manner.
7.1.7. The drug information center shall prepare drug information bulletins,
technical update forums on drug information for health care workers.

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Tools and Key Performance Indicators (KPIs) for Drug Information

Services
Tools KPIs
1. Adverse drug reaction Number of ADRs reported
reporting form
2. Drug information query Number of drug information queries
form answered
3. Attendance form for CPD or Number of CPD and Drug information
Drug information activity forums organized

Resources required for Drug Information Services

1. Drug information software (Lexicom, Medscape, UpToDate and others)

2. Pharmacopoeias
3. Drug Interaction checker
4. Martindale

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STANDARD 8: Provision of Clinical Pharmacy Services

Clinical pharmacy services shall be provided in a manner that prevents

and/or addresses drug therapy problems, optimizes medication management,
improves therapeutic outcomes, and enhances overall quality of care of
patients.
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Description

Clinical Pharmacy Services refers to the specialized area of pharmacy practice

that focuses on the safe, effective and cost-effective use of medications in
patient care. It involves the application of the pharmacist’s knowledge and
skills to optimize medication therapy outcomes. Clinical pharmacy services
encompass various activities, such as medication review, patient counselling,
drug information provision, medication therapy management, and
collaborative decision-making with other healthcare professionals. These
services aim to enhance patient outcomes, improve medication adherence,
prevent medication errors, and promote rational and cost-effective medication
use. Pharmacist specialists/Pharmacists shall actively be involved in ward
rounds and outpatient clinics in the evaluation of patients, review of
treatment sheets and identification, resolution and prevention of drug therapy
problems (DTPs) in all areas of specialization. These areas include pediatrics,
surgery and anaesthesiology, internal medicine, infectious disease,
psychiatry, and mental health, and emergency and critical care, among
others.
The clinical pharmacy services in health facility include:

1. Paediatrics Pharmacotherapy

Pharmacists offer specialized pharmaceutical care tailored to pediatric

patients, ensuring the safe and effective use of medications. They focus on
optimizing treatment regimens and addressing the unique medication needs
of children, considering factors such as age-appropriate dosing, medication
formulations, and potential developmental considerations.

2. Surgical and Anaesthesiology Pharmacotherapy

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Pharmacists provide vital support in pre-operative and post-operative

medication management for surgical patients. They collaborate with surgical
teams to ensure optimal medication use before, during, and after surgical
procedures,

3. Critical Care Pharmacotherapy

Pharmacists play a critical role in managing medication therapy for patients

in intensive care units and other critical care settings. They are responsible
for designing, monitoring and evaluating complex medication regimens to
ensure their optimal use. including ensuring appropriate dosing, monitoring
for potential drug interactions and addressing medication-related issues that
may arise in critically ill patients.

4. Emergency Care Pharmacotherapy

In the fast-paced and high-stress environment of the emergency department

which involves the use of medication associated with high risk of errors and
major adverse events, pharmacists provide prompt and effective
pharmaceutical interventions. They collaborate with healthcare teams to
deliver timely and accurate medication management, ensuring optimal
patient treatment outcomes in critical and time-sensitive situations.

5. Obstetrics and Gynecology Pharmacotherapy

Pharmacists offer comprehensive pharmaceutical care for women's health,

providing specialised support in medication management during the pre-
conception period, pregnancy, childbirth, and the post-partum period. They
also offer pharmacotherapy for various gynaecological disorders. The
Pharmacist also provides pharmaceutical care during contraception services.
They ensure the safe and effective use of all medications for women,
considering the unique physiological changes and specific healthcare needs
associated with obstetrics and gynaecology and associated co-morbidities.

6. Infectious Disease Pharmacotherapy

Pharmacists play a crucial role in managing infectious diseases, including the

optimization of antimicrobial and antiparasitic therapies and the prevention
of antimicrobial resistance. They collaborate with healthcare teams to ensure

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the appropriate selection of anti-infective agents and monitor treatment

efficacy.
The Pharmacist will also be involved in antimicrobial stewardship which
entails coordinated efforts to optimize the use of antimicrobial agents such as
appropriate prescribing, dosing, and duration of antimicrobial therapies. They
also implement strategies to minimize the development of antimicrobial
resistance, promote the judicious use of antibiotics, and enhance patient
outcomes through the application of evidence-based practices and clinical
guidelines.

7. Psychiatry and Mental Health Pharmacotherapy

Pharmacists provide comprehensive pharmaceutical care to patients with

mental health disorders. They collaborate with mental health professionals to
manage psychotropic medications, optimize treatment regimens, and monitor
therapeutic effectiveness and potential adverse effects, contributing to holistic
well-being and improved quality of life for patients with mental health
conditions. The pharmacist also manages and rehabilitates patients with drug
and substance abuse disorders and co-morbidities.

8. Palliative and Hospice Care Pharmacotherapy

Pharmacists in palliative and hospice care focus on optimizing medication

management for patients receiving end-of-life care. They prioritize symptom
control, pain management, and supportive care through the appropriate use
of medications, ensuring patient comfort, dignity, and quality of life during
their palliative and hospice care journey. Pharmacists counsel patients to
enhance adherence to medication, they educate on the use of medical devices,
dose adjustments in the setting of organ damage, perform medication order
review and reconciliation including opioid equianalgesic conversions among
others.

9. Oncology Pharmacotherapy

Within the realm of oncology, pharmacists provide specialized pharmaceutical

care to cancer patients. They oversee the safe and effective use of anticancer
agents, manage supportive care medications, and monitor treatment-related
adverse effects, contributing to improved treatment outcomes and the overall

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well-being of patients undergoing cancer therapy. They also manage co-

morbidities in cancer patients and oncological emergencies. They also manage
patients who undergo surgery and radiotherapy.
The Pharmacist is involved in the preparation, dosing, administration and
mitigating of the side effects of chemotherapy. They ensure the safe handling
and disposal of cytotoxic and radioactive agents.

10. Internal Medicine Pharmacotherapy

Pharmacists in internal medicine provide comprehensive pharmaceutical

care for patients with complex medical conditions. They collaborate with
healthcare teams to optimize medication regimens, manage chronic diseases,
and address multiple comorbidities, ensuring the safe and effective use of
medications to improve patient health outcomes and overall well-being. The
pharmacist participates in the selection of appropriate drug regimens,
identifying and managing drug related problems, monitoring and evaluating
the drug regimens, providing drug information to the health care providers,
medication use counseling to patients, advising on the use of medical devices.
The Pharmacist participates in the provision of the following sub-specialities:

11. Haematological disorders pharmacotherapy

Pharmacists in haematology provide specialized pharmaceutical care for

patients with blood disorders. They oversee medication management for
conditions such as anemia, coagulation disorders, and blood cancers,
ensuring appropriate treatment regimens, monitoring for adverse effects, and
promoting patient education to improve overall haematological health and
treatment outcomes.
Pharmacists specializing in anticoagulation therapy play a critical role in the
management and monitoring of patients on anticoagulant medications. They
ensure appropriate dosing, monitor for complications, and provide patient
education on anticoagulation therapy, contributing to the prevention of
thrombotic events and minimizing the risk of bleeding complications in high-
risk patient populations

12. Pulmonary disorders pharmacotherapy

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Pharmacists in pulmonology provide specialized pharmaceutical care for

patients with respiratory conditions. They collaborate with healthcare teams
to manage respiratory medications, promote inhaler technique education, and
optimize treatment regimens for patients with asthma, chronic obstructive
pulmonary disease (COPD), and other pulmonary disorders, thereby
improving respiratory function and quality of life.

13. Endocrine disorders pharmacotherapy

Pharmacists in endocrinology provide comprehensive pharmaceutical care for

patients with endocrine disorders, such as diabetes, thyroid disorders, and
hormonal imbalances. They collaborate with healthcare teams to optimize
medication therapy, promote lifestyle modifications, and provide patient
education to achieve optimal disease management and improve overall
endocrine health.

14. Cardiovascular disorders pharmacotherapy

Pharmacists in cardiology focus on managing medication therapy for patients

with cardiovascular conditions. They work closely with healthcare teams to
optimize medication regimens for heart disease, hypertension, and other
cardiac-related disorders, aiming to improve cardiovascular health, prevent
complications, and reduce the risk of adverse cardiac events.

15. Ambulatory Care Pharmacotherapy

Pharmacists in ambulatory care focus on providing comprehensive

pharmaceutical care in outpatient settings including acute and chronic
disease states, through medication therapy management, and offer patient
education and counselling to promote medication adherence in order to
improve health outcomes and quality of life for patients.

16. Renal Disorders Pharmacotherapy

Pharmacists in nephrology provide specialized pharmaceutical care for

patients with renal disorders, including those undergoing dialysis and renal
transplant recipients. They focus on medication management tailored to renal
function, mitigate drug-related complications, and promote optimal
medication use to improve overall renal health and patient outcomes.

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17. Immunological disorders pharmacotherapy

Pharmacists in immunology and transplantation play a crucial role in

managing medication therapy for patients undergoing organ transplantation
and those with immune-mediated disorders. They ensure the appropriate use
of immunosuppressive medications, monitor for adverse effects, and promote
medication adherence to prevent rejection and enhance the overall success of
transplantation and immunological therapies.

18. Geriatrics Pharmacotherapy

Pharmacists in geriatrics focus on providing pharmaceutical care tailored to

the unique needs of the elderly population. They address age-related
medication challenges, polypharmacy concerns, and medication adherence
issues, aiming to promote optimal health outcomes and enhance the quality
of life for elderly patients.

19. Neurological disorders pharmacotherapy

Pharmacists in neurology provide specialized pharmaceutical care for patients

with neurological disorders. They collaborate with healthcare teams to
manage medication therapy for conditions such as epilepsy, multiple
sclerosis, and neuropathic pain, aiming to optimize treatment regimens,
manage symptoms, and improve overall neurological health and patient
quality of life.

Performance Criteria for clinical pharmacy services

Task 8.1. Regular participation in ward rounds

8.1.1. Medication-related expertise shall be provided by active participation in

regular ward rounds and support to healthcare teams.
8.1.2. Medication-related issues shall promptly be identified and treatment
regimens shall be optimized during ward rounds.
8.1.3. Effective communication on medication recommendations and
interventions shall be made to the multidisciplinary team for patient-
centred care.

Task 8.2. Antimicrobial Stewardship (AMS)

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8.2.1. Evidence-based antimicrobial stewardship strategies shall be

implemented to optimize antimicrobial use and minimize the
development of antimicrobial resistance.
8.2.2. Antimicrobial prescribing patterns shall be monitored and timely
intervention made to promote appropriate antimicrobial selection,
dosing, and duration of therapy.
8.2.3. The service provider shall Collaborate with infectious disease specialists
and other healthcare professionals to promote antimicrobial
stewardship best practices and ensure patient safety.

Task 8.3. Multidisciplinary Team (MDT) Collaboration

8.3.1. The service provider shall actively engage in multidisciplinary team

meetings to contribute pharmaceutical expertise to patient care plans.
8.3.2. Medication-related perspectives shall be integrated into the overall
treatment plans developed by the multidisciplinary team.
8.3.3. The service provider shall effectively communicate and collaborate with
various healthcare professionals to ensure comprehensive patient care
and optimal treatment outcomes.

Task 8.4. Comprehensive Counselling to Patients and Caregivers

8.4.1. Comprehensive medication counselling shall be provided to patients

and their caregivers, including detailed information on medication use,
potential side effects, and adherence strategies.
8.4.2. Counselling sessions shall be tailored to the individual patient's needs,
health literacy level, and cultural background to promote better
understanding and adherence to prescribed medication regimens.
8.4.3. Patients and caregivers shall be empowered through effective
communication and education on the importance of medication
adherence and management of treatment-related concerns.

Task 8.5. Management of Adverse Drug Events (ADEs)

8.5.1. Diverse drug events in hospitalized patients shall be identified and

assessed through systematic monitoring and pharmacovigilance.

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8.5.2. Proactive measures shall be implemented to prevent the occurrence and

recurrence of adverse drug events including medication reconciliation
and patient risk assessment.
8.5.3. Adverse drug events interventions taken, and follow-up plans shall be
documented to ensure patient safety and promote evidence-based
practice.

Task 8.6. Drug Information

8.5.4. Accurate and timely drug information shall be provided to healthcare

professionals, patients, and caregivers to facilitate informed decision-
making and safe medication use.
8.5.5. Reliable resources and evidence-based literature shall be utilised to
address drug-related inquiries and provide recommendations for
appropriate medication management.
8.5.6. Knowledge dissemination and educational initiatives shall be promoted
within the healthcare facility to enhance drug information awareness
and promote best practices in medication therapy.

Task 8.7. Designing & Implementing Individualised Drug Dosing

Regimens

8.7.1. Drug dosing regimens shall be designed based on patient-specific

factors, such as age, weight, renal and hepatic function, and
comorbidities, to optimize therapeutic outcomes and minimize the risk
of adverse events.
8.7.2. Pharmacokinetic and pharmacodynamic principles shall be applied to
develop individualized dosing strategies and therapeutic drug
monitoring plans for complex medication regimens.
8.7.3. Dosages shall be monitored and adjusted based on patient response
and clinical indicators to ensure the safe and effective use of
medications.

Task 8.8. Collaboration with other Pharmacy specialties and Healthcare

Workers

8.8.1. Service providers shall engage in inter-professional collaboration with

pharmacy specialties, including clinical specialists and pharmacists in

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different practice settings, to facilitate comprehensive patient care and

knowledge sharing.
8.8.2. Service providers shall effectively collaborate with other health care
professionals including physicians, nurses, and allied healthcare staff,
to promote integrated care and enhance patient outcomes.
8.8.3. Service providers shall participate in interdisciplinary initiatives and
quality improvement projects to foster a culture of collaborative practice
and continuous learning within the healthcare environment.

Task 8.9. Development of Treatment Protocols and Treatment

Guidelines

8.9.1. Service providers shall contribute to the development and review of

evidence-based treatment protocols and guidelines within the hospital
setting to standardize medication practices and improve patient safety.
8.9.2. Service providers shall intergrate clinical expertise and best available
evidence to guide the development of comprehensive and patient-centric
treatment protocols for specific disease states or therapeutic areas.
8.9.3. Service providers shall collaborate with key stakeholders to ensure the
successful implementation and adherence to established treatment
protocols and guidelines to enhance the quality and consistency of
patient care.

Task 8.10. Research

8.10.1. Service providers shall conduct research that contribute to

the advancement of clinical pharmacy practice and the development
of evidence-based interventions for improved patient outcomes.
8.10.2. Research findings shall be disseminated through publications,
presentations, and educational forums to promote the integration of
research evidence into clinical practice and foster a culture of
continuous improvement and innovation.

Task 8.11. Documentation and Reporting

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8.11.1. Documentation of all clinical pharmacy interventions, medication

reviews and recommendations shall be done, in an a,ccurate and
timely manner, in the patient's medical records.
8.11.2. Reporting and communicating significant findings and outcomes shall
be done to the healthcare team for continuous quality improvement
and patient safety.
8.11.3. Comprehensive and organized records shall be maintained to facilitate
continuity of care and ensure adherence to regulatory standards and
guidelines.

Tools and Key Performance Indicators for Clinical Pharmacy Practice

Tools Key Performance Indicators
1. Pharmacotherapy Number of patients reviewed, Number of
workup form pharmaceutical care plans done, Number of Clinical
Pharmacist interventions made, Number and type
of drug therapy problems identified and resolved
2. Pharmacist Consultation Number of CMEs done, Number of entries in
Log, Pharmacy Activity consultation log, number of ward visits done,
Schedule, Pharmacist number of prescriptions reviewed, number of
Intervention Form patients reviewed and counselled, number of drug
information consults done
3. Therapeutic Drug Number of TDM requests made, Number of TDM
Monitoring request and interventions mad
intervention form
4. Patient Medical Record Number of medication action plans done, Number
Form of family and patients’ education sessions done,
Number of interventions done
5. Antimicrobial Number of antimicrobial stewardship activities
stewardship activities undertaken, number of antimicrobial stewardship
form, an antimicrobial rounds undertaken, number of patients reviewed
order form for appropriate antimicrobial use, number of
antibiotic order sheets filled, number of antibiotic
stop orders done, number of pre-authorization
antibiotic request forms approved
6. Pharmacovigilance Number of PV reports filled and submitted, Number
online-reporting tools of interventions done, number of patients reviewed
https://pv.pharmacyboa for adverse drug reactions, number of AEFI reports
rdkenya.org/ filled and submitted, number and types of drugs
reviewed for quality
7. Family Planning Service Number of women offered family planning services
and Referral form and referred
8. Vaccine screening and Number of staff screened and vaccinated for
consent form selected communicable diseases
9. Chemotherapy Order and Number of treatments reviewed,
Check Form Number of interventions made

Resources Required for Clinical Pharmacy Practice:

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1. Cipolle RJ, Strand LM, Morley PC. Pharmaceutical Care Practice. New
York. McGraw-Hill,1998:1.
2. Brushwood DB, Hepler CD. Redefining Pharmacist Professional
Responsibility. In Knowlton CH, PennaRP, eds. Pharmaceutical Care.
New York. Chapman & Hall, 1996: 195-214.
3. Westerlund T et al. Pharmacy Practitioners’ Views on Computerised
Documentation of Drug Related Problems. Ann Pharmacother. 2003;
37: 354-60.
4. Glynn, M.& Drake, W.M. (2017). Hutchison's Clinical Methods.An
Integrated Approach to Clinical Practice (24th Edition). Philadelphia:
Elsevier.
5. L. Michael Posey, Gary C Vee, Vicki Ellingrod, Joseph T DiPiro, Thomas
D Nolin, Stuart T. Haines. DiPiro’s Pharmacotherapy: A
Pathophysiologic Approach, 12th Edition, 2023.
6. Koda Kimble and Young’s Applied Therapeutics: The Clinical Use of
Drugs, 2023.
7. Martindale
8. Therapeutic Drug Monitoring Handbook
9. Brunton, L., Chabner, B., Knollman, B. (2010). Goodman and Gilman's
The Pharmacological Basis of Therapeutics. 12 th Edition. McGraw-Hill
Professional, NY, USA
10. Longo,D., Fauci, A., Kasper,D., Hauser,S., Jameson, J., Loscalzo,
J. (2011).Harrison’s Principles of Internal Medicine. 19 th edition.
Volumes 1 & 2. McGraw-Hill Professional.
11. Walker, R. & Whittlesea, C. eds. (2011). Clinical Pharmacy and
Therapeutics, 5th Edition. Churchill Livingstone, Oxford, UK
12. Wiffen, P., Mitchell, M., Snelling, M., Stoner, N. (2012). Oxford
Handbook of Clinical Pharmacy. 2nd Edition. Oxford University Press,
USA.
13. Ministry of Health, Kenya, National Antimicrobial Stewardship
guidelines
14. Ministry of Health, Kenya, Diagnostic Stewardship Handbook
15. BNF, Paediatric BNF
16. Kenyatta National Hospital Surgical Prophylaxis Guidelines

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17. Kenya Cancer Treatment Guidelines

18. Kenya Essential Medicines List, National Drug Formulary,
19. Ministry of Health, AWaRe Classification of antimicrobials
20. Ministry of Health Kenya, Standard Treatment Guidelines
21. National AMS policy, 2017
22. National Action Plan on Antimicrobial Resistance 2017
23. Lexicom Drug Information Handbook
24. Infection Prevention and Control Guidelines
25. Basic Paediatric protocols
26. Medscape, Micromedex Drug Information Resources

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STANDARD 9: Provision of Therapeutic Drug Monitoring and Clinical

Pharmacokinetic Services

Therapeutic drug monitoring and clinical pharmacokinetic services ensure

medication safety and efficacy by adjusting dosages based on individual
patient responses.
--------------------------------------------------------------------------------------------------------------------

Description
Therapeutic drug monitoring (TDM) is a vital clinical practice that involves the
measurement of specific drug levels in a patient's bloodstream at set intervals
to achieve and maintain an optimal therapeutic concentration, thereby
customizing dosage regimens for individual patients. This approach is
particularly crucial for drugs with narrow therapeutic indexes, significant
pharmacokinetic variability, or those where achieving target concentrations is
challenging, as well as for medications with a known potential for both
therapeutic and adverse effects. Examples of drugs commonly subjected to
TDM include anti-epileptic drugs like phenytoin and valproic acid, certain
antibiotics such as vancomycin and aminoglycosides, immunosuppressants
like tacrolimus and cyclosporine, antiarrhythmic medications including
amiodarone and digoxin, lithium for bipolar disorder, theophylline for asthma
and COPD, the anticoagulant warfarin, and methotrexate, used both as an
immunosuppressant and in chemotherapy.
Clinical pharmacokinetics complements this by predicting the optimal dosage
and dosing schedules to ensure the drug reaches therapeutically effective
concentrations at the action site, taking into account the drug's absorption,
distribution, metabolism, and excretion.

Performance criteria

Task 9.1. Therapeutic Drug Monitoring

9.1.1. Standardizing operating procedures (SOPs) shall be developed and

utilized for the collection, handling, and processing of biological
samples for therapeutic drug monitoring.
9.1.2. Developing protocols for sample collection, storage, transportation,
and analysis shall be developed to ensure the accuracy, reliability, and

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consistency of TDM results across different laboratory settings and

testing methodologies.
9.1.3. Systematic approach shall be implemented to collect and assess
pertinent patient-specific data shall be implemented.
9.1.4. Standardized assessment tools and documentation methods shall be
utilized to evaluate the clinical necessity and appropriateness of
therapeutic drug monitoring
9.1.5. Precise measurement and analysis of drug concentrations shall be
conducted in patient samples to facilitate appropriate dosage
adjustments.
9.1.6. Timely results shall be provided to healthcare providers to enable
prompt therapeutic interventions and dosage adjustments.
9.1.7. Comprehensive interpretation of drug concentration data in the
context of individual patient factors, such as age, weight, renal
function, and concomitant medications, shall be offered.
9.1.8. TDM results and pharmacokinetic recommendations shall be
effectively communicated to healthcare teams, including pharmacists,
physicians, and nurses.
9.1.9. Potential drug interactions, adverse effects, or toxicity based on TDM
results shall be identified and alerted to healthcare providers.
9.1.10. Patient and caregiver education regarding the importance of TDM,
dosage adjustments, and medication adherence to optimize
therapeutic outcomes shall be provided.
9.1.11. Quality improvement initiatives shall be implemented to enhance the
accuracy, efficiency, and effectiveness of TDM and clinical
pharmacokinetic services.
9.1.12. Accurate and complete records of TDM results, pharmacokinetic
calculations, interventions, and follow-up actions shall be maintained
in patient medical records or electronic health systems.
9.1.13. Adherence to relevant regulatory requirements, standards, and
guidelines governing TDM and clinical pharmacokinetic practices shall
be ensured.
9.1.14. Patient outcomes, such as therapeutic response, adverse reactions,
and medication adherence, shall be monitored and evaluated to assess

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the impact of TDM and pharmacokinetic interventions on clinical

outcomes.

Task 9.5. Clinical Pharmacokinetics services

9.5.1. Pharmacokinetic consultations shall be provided to healthcare

professionals, including physicians, nurses, and other members of the
healthcare team, to guide drug dosing decisions, individualize therapy,
and optimize drug regimens based on patient-specific factors (e.g., age,
renal or hepatic function).
9.5.2. Pharmacokinetic calculations, such as clearance, volume of
distribution, half-life, and loading/ maintenance dose calculations,
shall be performed to determine appropriate dosing regimens to achieve
desired drug concentrations in patients.
9.5.3. Potential drug-drug interactions and drug - food interactions and drug-
disease or other substances that may affect pharmacokinetics shall be
assessed.
9.5.4. Patients shall be monitored for adverse drug events related to
pharmacokinetic factors, such as drug accumulation or suboptimal
drug levels, and make appropriate recommendations to prevent or
manage these events.
9.5.5. Therapeutic drug dosing regimens shall be optimized by considering
patient-specific factors, therapeutic goals, and pharmacokinetic
parameters which includes adjusting doses based on drug
concentrations, patient response, and potential interactions.
9.5.6. Drug dosing guidelines and protocols shall be developed and
implemented based on pharmacokinetic principles and evidence-based
practice.
9.5.7. Education and training shall be provided to healthcare professionals,
including physicians, pharmacists, and other staff members, on
pharmacokinetic principles, drug dosing optimization, and the
interpretation of pharmacokinetic data.
9.5.8. Quality improvement research related to clinical pharmacokinetics
shall be conducted.

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9.5.9. Pharmacokinetic consultations, interventions, and recommendations

shall be documented.

Tools and Key Performance Indicators (KPIs) for TDM and CPK Services

Tools KPIs
1. TDM work up form percentage of patients whose drug therapy is optimized
based on TDM and CPK results

2. TDM patient Ensure that drug concentration measurements are

monitoring form accurate and reliable to guide dosing adjustments

3. ADE reports, number of adverse drug reactions reported and assess

Pharmacovigilance the impact of TDM and CPK services in reducing ADRs.
online-reporting tools
https://pv.pharmacyb
oardkenya.org/
4. HMIS percentage of patients achieving therapeutic goals for
drug efficacy and safety following TDM and CPK-guided
interventions
5. Turnaround Time for time taken from sample collection to result reporting to
Results ensure timely decision-making in patient care.

6. Utilization Rate of frequency of TDM and CPK service utilisation by

TDM and CPK Services healthcare providers and departments within the
institution

Resources required for TDM and CPK Services

Ette, E. I., & Williams, P. J. (2006). Pharmacometrics: The Science of
Quantitative Pharmacology. In Pharmacometrics: The Science of
Quantitative
Pharmacology. https://doi.org/10.1002/9780470087978
Lucas, C. J., Galettis, P., & Schneider, J. (2018). The pharmacokinetics
and the pharmacodynamics of cannabinoids. In British Journal of
Clinical Pharmacology (Vol. 84, Issue 11).
https://doi.org/10.1111/bcp.13710
Batchelor, H. K., & Marriott, J. F. (2015). Paediatric pharmacokinetics:
Key considerations. British Journal of Clinical Pharmacology, 79(3).
https://doi.org/10.1111/bcp.12267
Kiang, T. K. L., Wilby, K. J., & Ensom, M. H. H. (2015). Clinical
pharmacokinetic and pharmacodynamic drug interactions associated
with antimalarials. In Clinical Pharmacokinetic and Pharmacodynamic

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Drug Interactions Associated with Antimalarials.

https://doi.org/10.1007/978-3-319-10527-7
Jann, M. W., Penzak, S. R., & Cohen, L. J. (2016). Applied clinical
pharmacokinetics and pharmacodynamics of psychopharmacological
agents. In Applied Clinical Pharmacokinetics and Pharmacodynamics
of Psychopharmacological Agents. https://doi.org/10.1007/978-3-
319-27883-4
Brunton, L. L., Chabner, B. A., & Knollmann, B. C. (2011). Goodman &
Gillman. The Pharmacological Basic of Therapeutics. In Goodman
and Gilman The Pharmacological Basis of Therapeutics
Applied Biopharmaceutics and Pharmacokinetics. (1981). Annals of
Internal Medicine, 94(6). https://doi.org/10.7326/0003-4819-94-6-
826_2
Modeling in Biopharmaceutics, Pharmacokinetics, and
Pharmacodynamics. (2006). In Modeling in Biopharmaceutics,
Pharmacokinetics, and Pharmacodynamics.
https://doi.org/10.1007/0-387-31910-7

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STANDARD 10: Provision of Pharmacogenomics services

Pharmacogenomic services shall facilitate personalized medicine by assessing

individual genetic variations and tailoring treatment plans accordingly.
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Description
Pharmacogenomics is a field of study that explores the relationship between
an individual's genetic makeup and their response to medications. It
combines the disciplines of pharmacology (the study of drugs) and genomics
(the study of genes and their functions) to understand how genetic variations
can influence an individual's response to drugs.
The goal of pharmacogenomics is to personalize medicine by identifying
genetic factors that may affect drug metabolism, efficacy, and safety. By
understanding a person's genetic profile, healthcare professionals can make
more informed decisions about drug selection, dosage adjustments, and
potential risks of adverse drug reactions.
Implementing pharmacogenomics in clinical practice can have several
benefits. It can improve medication effectiveness, reduce adverse drug
reactions, minimize trial and error in drug selection, optimize dosage
regimens, and enhance overall patient care. It holds promise for a wide range
of therapeutic areas, including oncology, psychiatry, cardiovascular disease,
and infectious diseases.
Pharmacist specialists in pharmacogenomics services play a crucial role in
optimizing medication therapy based on an individual's genetic makeup. Their
primary responsibility is to apply their knowledge of pharmacogenomics,
which is the study of how genes affect a person's response to drugs, to
personalize medication regimens for patients.

Performance criteria

Task 10.1. Provision of pharmacogenomics services

10.1.1. Pharmacogenomic testing procedures shall be performed as per

regulatory standards.

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10.1.2. Appropriate genetic tests that impact the metabolism and action of
drugs shall be performed and results are interpreted.
10.1.3. Appropriate Patient-specific information shall be gathered to assess
the need for pharmacogenomic testing, including medical history,
current medications, and family history.
10.1.4. The most appropriate medications for individual patients shall be
selected, considering genetic variations that may influence drug
response and tailored treatment plans shall be recommended to
optimize therapeutic outcomes.
10.1.5. Patients shall be educated about pharmacogenomic testing and its
impact on their medication therapy.
10.1.6. Patients' response to medications shall be monitored and necessary
adjustments will be made based on the genetic information.
10.1.7. Proper documentation shall be maintained as per ethical guidelines,
maintaining patient privacy and confidentiality.
10.1.8. Pharmacogenomic testing and interpretation shall be integrated into
routine clinical practice.
10.1.9. Personalized medicine approaches shall be advocated for, in order to
foster awareness among healthcare professionals about the benefits of
pharmacogenomics.

Tools and Key Performance Indicators (KPIs) for pharmacogenomic

Services
Tools KPIs
1. HMIS, pharmacogenomics number of pharmacogenomic interventions or
work-up form recommendations made to healthcare
providers, aiming for a steady increase
2. ADR reports, reduction in adverse drug reactions among
Pharmacovigilance online- patients receiving pharmacogenomic-guided
reporting tools therapy compared to standard care
https://pv.pharmacyboardke
nya.org/
3. Patient care plan, the percentage of healthcare providers who
pharmacogenomics work-up implement pharmacogenomic
forms recommendations into patient care plans
4. Training reports, CPD number of training sessions or educational
attendance form programs provided to healthcare professionals
on pharmacogenomics annually

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5. Turnaround Time for Test average time from test order to result delivery
Results: to healthcare providers, with goals to reduce
turnaround times.

Resources required for Pharmacogenomic Services

Langman, L. J., & Dasgupta, A. (2012). Pharmacogenomics in Clinical

Therapeutics. In Pharmacogenomics in Clinical Therapeutics.
https://doi.org/10.1002/9781119959601
Feng, X., & Xie, H. G. (2016). Applying pharmacogenomics in
therapeutics. In Applying Pharmacogenomics in Therapeutics.
https://doi.org/10.1201/b19000
Barnes, J. (Ed.). (2022). Pharmacovigilance for Herbal and Traditional
Medicines: Advances, Challenges and International Perspectives.
Springer https://link.springer.com/book/10.1007/978-3-031-
07275-8
Padmanabhan, S. (2014). Handbook of Pharmacogenomics and Stratified
Medicine. https://doi.org/10.1016/C2010-0-67325-1
Pharmacogenomics in Precision Medicine. (2020). In Pharmacogenomics
in Precision Medicine. https://doi.org/10.1007/978-981-15-3895-7

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STANDARD 11: Provision of Clinical Toxicology Services

Clinical toxicology services shall provide timely identification and management

of potential poisoning or drug-related toxicities.
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Description
Clinical toxicology involves researching, preventing, and treating diseases
caused by chemicals, drugs, and toxins. Special attention is paid to chemical
exposure levels and the effects that exposure can have on people. Clinical
toxicology is especially useful when dealing with people who are poisoned or
who have overdosed, so it is beneficial for medical professionals and first
responders.

Performance criteria

Task 11.1. Provision of toxicology service

11.1.1. Toxicological consultation services shall be provided to healthcare

professionals, to assist in the management of patients exposed to toxic
substances or experiencing poisoning.
11.1.2. Poison information shall be provided based on inquiries from
healthcare professionals and the public.
11.1.3. Toxicology screenings shall be conducted through urine drug screens
or blood toxicology tests, and results shall be interpreted to aid in
diagnosing and managing toxic exposures.
11.1.4. Availability of antidotes shall be ensured through standard supply
chain management channels.
11.1.5. Patients shall be monitored for adverse drug reactions and medication-
related toxicities.
11.1.6. Poison control centres shall provide expert guidance in managing
poison exposures.
11.1.7. Healthcare professionals, patients, and the public shall be educated
about poison prevention, medication safety, and the proper use,
storage, and disposal of medications and toxic substances.

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11.1.8. Research and surveillance activities shall regularly be conducted to

identify emerging toxicological issues, monitoring trends in poisoning
incidents, and evaluating the effectiveness of treatment strategies.
11.1.9. Toxicology consultations, poison exposures, treatment
recommendations, and outcomes shall be documented.

Tools and Key Performance Indicators for Clinical Toxicology services

Tools Key Performance Indicators

Time-Tracking Software or Time taken from receiving a toxicology inquiry to
ticketing system: to track the providing initial advice or intervention. Target:
time taken from receiving a Within 30 minutes.
toxicology inquiry to providing
initial advice or intervention.

Quality Assurance Software Percentage of advice or information provided that

or clinical toxicology service aligns with current best practices and guidelines.
data collection form Target: ≥ 95% accuracy rate.
Electronic Health Record Percentage of cases successfully resolved or
Systems: HMIS appropriately referred. Target: ≥ 90%.
Measurement of patient outcomes (e.g., reduction
in symptoms, recovery without complications)
attributable to toxicology interventions. Target:
Improvement noted in ≥ 85% of cases managed.

Training reports, Attendance Percentage of pharmacy staff completing annual

form for CPD training in clinical toxicology and staying current
with best practices. Target: 100% of pharmacy
staff annually.
Toxicology work up form Measure of the accessibility (e.g., via phone, in
person, online) and availability (24/7 service
provision) of the toxicology service. Target: 24/7
availability and multiple accessible contact
methods.
Patient medical record form, Percentage of toxicology interventions accurately
Toxicology request and documented and reported in patient records.
monitoring form Target: ≥ 95% accuracy and completeness.

Resources required for Clinical Toxicology Services

Balali-Mood, M., & Abdollahi, M. (2014). Basic and clinical toxicology of
organophosphorus compounds. In Basic and Clinical Toxicology of
Organophosphorus Compounds. https://doi.org/10.1007/978-1-
4471-5625-3
Barile, F. A. (2019). Barile’s Clinical Toxicology. In Barile’s Clinical
Toxicology. https://doi.org/10.1201/9780429154829

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Gossel, T. A., & Bricker, J. D. (2018). Principles Of clinical toxicology,

third edition. In Principles Of Clinical Toxicology, Third Edition.
https://doi.org/10.1201/9780203742167
Barile, F. A. (2010). Clinical toxicology: Principles and mechanisms.
In Clinical Toxicology: Principles and Mechanisms, Second Edition.
Schulz, M., Schmoldt, A., Andresen-Streichert, H., & Iwersen-Bergmann,
S. (2020). Revisited: Therapeutic and toxic blood concentrations of
more than 1100 drugs and other xenobiotics. Critical Care, 24, 1-4.
Ketha, H., & Garg, U. (2020). Toxicology Cases for the Clinical and
Forensic Laboratory. In Toxicology Cases for the Clinical and Forensic
Laboratory. https://doi.org/10.1016/C2017-0-04108-3

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STANDARD 12. Pharmacovigilance and Pharmacoepidemiology Services

Pharmacovigilance and Pharmacoepidemiology services shall ensure

comprehensive monitoring, assessment, and management of medication-
related adverse events and epidemiological trends, thereby enhancing drug
safety and promoting public health.
-------------------------------------------------------------------------------------------------------------------

Description
Pharmacovigilance refers to the science and activities related to the detection,
assessment, understanding, and prevention of adverse effects or any other
drug-related problems associated with the use of medications. It involves
collecting, monitoring, and analyzing data on the safety of drugs throughout
their lifecycle to ensure their continued safe use in the population. These
efforts contribute to the ongoing evaluation and improvement of drug safety
profiles.
Pharmacoepidemiology is the study of the use and effects of drugs in large
numbers of people. It is a growing discipline that applies epidemiological
techniques to study drug use in a large population. It combines clinical
pharmacology with epidemiology. By combining pharmacology and
epidemiology disciplines, a pharmacoepidemiologist applies epidemiology
principles to study the effects of medications on human populations.
Performance Criteria

Task 12.1. Pharmacovigilance Services

12.1.1. All counties shall have a pharmacovigilance or medication safety

officer/manager who shall be a Pharmacist.
12.1.2. Facilities shall have medication reconciliation officer who shall be a
pharmacist.
12.1.3. Surveillance of safety and quality issues related to HPTs should
regularly be conducted.
12.1.4. Adverse events shall be reported following the established guidelines
for reporting adverse events in Kenya.
12.1.5. Appropriate instructions shall be provided to patients to minimize
future adverse effects.

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12.1.6. Periodic AE reports shall be prepared in line with Pharmacovigilance

guidelines.

Task 12.2. Pharmacoepidemiology Services

12.2.1. Health plans and policies shall be developed to provide access to

medications in a quality manner, and at an affordable cost, to a variety
of population groups.
12.2.2. Routine pharmacoepidemiological studies shall be conducted to
understand how a drug is prescribed, and used, and what outcomes,
both positive and negative, can be attributed to the drug product in
the population.
12.2.3. The findings of pharmacoepidemiology studies shall be communicated
to healthcare professionals to help them make .informed decisions at
the individual-patient and population levels.
12.2.4. Drug use evaluations shall be conducted for products associated with
high risks of adverse outcomes, high costs, and high volumes and
advise the medicines and therapeutics committees.
12.2.5. To mitigate risks and enhance patient safety, the rate and risk factors
for drug-related events in populations shall be identified.
12.2.6. Healthcare systems should be evaluated in terms of drug use
interventions for specific illnesses, and health-related behavior that
impacts drug use in the population
12.2.7. Pharmacoepidemological data, including laboratory data, diagnoses,
drugs prescribed, and other clinical information, shouldhall be
documented using the relevant database.
12.2.8. Medication adherence rates and the outcomes associated with
adherence in large populations shall be monitored.

Tools and Key Performance Indicators (KPIs) for Provision of

Pharmacovigilance and Pharmacoepidemiology Services
Tools KPIs

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1. Adverse drug reaction reporting Number of Adverse drug reactions

tool reported
2. Poor quality medical products Number of poor-quality HPTs reported
and health technologies reporting
tool
3. Medication error reporting tool Number of Medication errors reported
4. Medical devices incident Number of Medical device incidents
reporting tool reported
5. Adverse events following Number of adverse events following
immunizations: reporting tool immunizations reported
6. Blood transfusion reaction Number of Blood transfusion reactions
reporting tool reported
7. Active TB drug-safety monitoring Number of Active TB drug-safety
and management tool monitoring and management tools utilized
8. Adverse events investigation form Number of Adverse event investigations
initiated
9. Online Pharmacoepidemiologic Number of adverse events reviewed,
database (a database with all number of interventions made after review
reported adverse reactions from of adverse events, Number and types of
drugs, blood and blood products, patient populations from which ADRs are
and vaccines) reported, number and types of
pharmacoepidemiologic studies
conducted from the database, number
and types of drug use policies developed
from pharmacoepidemiologic studies,
number of policy statements released to
the public regarding drugs.

Resources required for Provision of pharmacovigilance and

pharmacoepidemiology services

1. Guidelines for the establishment of qualified person for

pharmacovigilance
https://web.pharmacyboardkenya.org/pharmacovigilance/ OR https:
//pv.pharmacyboardkenya.org/

2. Guidance for Industry and FDA Staff: Best Practices for Conducting and
Reporting Pharmacoepidemiologic Safety Studies Using Electronic
Healthcare Data

3. Guideline on good Pharmacovigilance practices (GVP), Module VIII –

Post authorization safety studies

4. Guidance for the format and content of the protocol of non-

interventional post-authorization safety studies

5. Guidance for the format and content of the final study report of
noninterventional post-authorization safety studies

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STANDARD 13. Handling and control of narcotic and psychotropic

Substances and Rehabilitative services

Control of dangerous drugs, including narcotic and psychotropic substances,

and rehabilitative services shall be made available to ensure regulatory
compliance, safe dispensation, and effective rehabilitation, fostering a secure
and conducive healthcare environment.
---------------------------------------------------------------------------------------------------------------------

Description
Narcotic and psychotropic substance abuse is a matter of great concern, and
pharmacy personnel, in collaboration with other HCWs, are at the forefront of
this fight. Drug rehabilitation is therefore the process of medical or
psychotherapeutic treatment for dependence on psychoactive substances
such as alcohol, opioids, marijuana, cocaine, and other addictive substances.
Pharmaceutical personnel are pivotal in the rehabilitative care of patients in
dependence and addiction states. These treatments involve rehabilitative
medicine under the direct supervision of a licensed pharmacist.
The role extends to rational, timely, and directly observed therapies (DOTs)
and counselling on medication use, all targeted to achieve the intended
treatment goals. Pharmacists also participate in psychological counselling in
addition to drug therapies, in collaboration with other healthcare workers due
to the complexity of these therapies.

Performance criteria

Task 13.1. Handling and dispensing of Narcotic and Psychotropic

Substances

13.1.1. Narcotic and Psychotropic substances shall be stored and handled in

accordance with the law and ensure maximum control of addictive
medication.
13.1.2. Narcotic and Psychotropic substances shall only be prescribed using
special colour-coded prescriptions by qualified healthcare workers
authorised to do so by law.
13.1.3. Narcotic and Psychotropic substances shall be handled and dispensed
by a duly licensed Pharmacist.

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13.1.4. Proper documentation including prescriptions, local purchase orders

(LPOs), treatment sheets, and controlled drug register/book shall be
maintained at all times.
13.1.5. Continuous training shall be provided on the handling of Narcotic and
Psychotropic substances.

Task 13.2. Patient-centred care in treating drug abuse patients

13.2.1. Standard Operating Procedures for all purposes associated with the
dispensing of controlled medication with regard to rehabilitative
medicine shall be maintained.
13.2.2. All services shall align with relevant clinical guidelines and program
guidelines
13.2.3. Patient-centered care shall be provided in treating drug abuse
patients.
13.2.4. Patients, authorized representatives, and other healthcare
professionals shall be served diligently and in a timely manner to
ensure that the needs of patients and the community are met in a
consistent manner.
13.2.5. All activities including service provision, refusal to dispense or patient
complains should be documented.

Task 13.3. Smoking Cessation

13.3.1. Written information shall be provided on how to stop/reduce smoking

to patients
13.3.2. Patients in smoking cessation shall be assisted and an up-to-date
knowledge provided based on the optimum ways of stopping smoking.
13.3.3. Clients will be adviced on available products to assist in smoking
cessation.
13.3.4. Anti-smoking products shall be dispensed with appropriate patient
education.

Task 13.4. Medication Assisted Treatment (MAT)

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13.4.1. Healthcare products for MAT shall be availed and dispensed in

accordance with the prescribed dosages following good dispensing
practice in a directly observed therapy approach.
13.4.2. The counselling services for medication use shall be documented.
13.4.3. Patient’s current medication order and DDA-related records will be
updated and linked to the healthcare plan.

Task 13.5. Pharmacy Services in Residential and Nursing Homes

13.5.1. Appropriate medications and pharmaceutical care services shall be

provided in nursing homes to optimize patient health outcomes.
13.5.2. Aspects of polypharmacy, medication review, and therapeutic drug
monitoring shall be reviewed in order to realize optimal treatment
outcomes.

Tools and Key Performance Indicators (KPIs) for Provision of

Rehabilitative Services and Control of Narcotic and Psychotropic
Substances
Tools KPIs
1. Drug Utilization Report (DUR) Number of DUR forms filled
forms
2. Daily Methadone dispensing Number of Methadone doses dispensed
register
3. Narcotics and psychotropics Number of Narcotic and Psychotropic
register, substances registered

Resources Required for Provision of Rehabilitative Services and Control

of Narcotic and Psychotropic Substances
The National Protocol for Treatment of Substance Use Disorders in Kenya

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STANDARD 14. Radiopharmacy services

Radiopharmacy services, including the manufacturing, dispensing, and safe

handling of radiopharmaceuticals, shall ensure precise and reliable
administration of these specialized medications, promoting accurate diagnosis
and effective treatment outcomes.
-------------------------------------------------------------------------------------------------------------------

Description
Radiopharmaceuticals are radioactive sterile and non-sterile drugs that are
used to diagnose, monitor, and treat diseases. Radiopharmaceuticals are used
in diagnostic procedures and for therapeutic purposes. For example, during
diagnostic procedures involving radiopharmaceuticals, the body is exposed to
small amounts of radiation to observe organ function. Radiopharmaceuticals
used for therapeutic purposes are generally administered in larger amounts
to ensure that therapeutic doses of radiation are delivered to specific disease
sites.
This section defines minimum standards for the operation of nuclear
pharmacies involved in the manufacture, compounding, labeling, dispensing,
delivering, repackaging, and supply of radiopharmaceuticals pursuant to a
prescription drug or medication order.

Performance criteria

Task 14.1 Manufacturing of radiopharmaceuticals

14.1.1. Facilities shall obtain approval from the Kenya National Radiation
Authority (KENRA) and the PPB for the handling and importation of
radioactive drugs.
14.1.2. Nuclear pharmacy practice shall be performed by adhering to accepted
standards and complying with good manufacturing practices,
compounding standards, and aseptic compounding standards.
14.1.3. Appropriate radiation safety and containment techniques shall be
employed when manufacturing, preparing, pre-packaging,
repackaging and compounding radiopharmaceuticals.

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14.1.4. Only authorized and licensed radio-pharmacists and pharmacists

shall have the responsibility to oversee the entire operation of a
radiopharmacy, including the manufacture, repackage,pre-packing or
dispensing of radiopharmaceuticals.
14.1.5. Pharmacists licensed by the Kenya National Radiation Authority may
manufacture and dispense SPECT radiopharmaceuticals under the
supervision of a radio pharmacist to maintain quality and safety
standards.
14.1.6. The manufacture of cold kits, which are used in radiopharmacy shall
comply with good manufacturing practices and approved guidelines by
the PPB.
14.1.7. Sites involved in the manufacture of therapeutic radioactive drugs,
whether using a cyclotron or nuclear reactor, shall be under the
supervision of a radio pharmacist.
14.1.8. Procedures performed in hospital radiopharmacy shall be categorized
into operational levels 1, 2, and 3. Each level shall have specific staff
qualifications, training, facilities, equipment, procedures, record
keeping, quality assurance (QA), and quality control (QC)
requirements. Pharmacists shall provide essential advice and
expertise at each level.

Task 14.2. Dispensing of radiopharmaceuticals

14.2.1. Radiopharmaceuticals shall only be dispensed or supplied to

practitioners or facilities authorized by the Radiation Board and PPB
to possess, use, and administer such drugs.
14.2.2. Radiopharmaceuticals shall be transferred to individuals authorized
to possess them in accordance with regulations.
14.2.3. Facility requirements shall include a shielded dispensing station
within a laminar airflow, a proper waste disposal system as per KENRA
guidelines, and radiation monitoring for staff.
14.2.4. Radiopharmaceuticals shall not be dispensed directly to patients.
14.2.5. The amount of radioactivity in each individual dose of a
radiopharmaceutical shall be determined using a dose calibrator,

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appropriate radiometric methods, or decay calculation methods

immediately prior to dispensing.
14.2.6. Radiopharmaceuticals shall only be dispensed upon a non-refillable
prescription drug order or a contingency prescription drug order from
a practitioner or facility authorized by the Radiation Board and PPB to
possess, use, and administer.
14.2.7. The container of a radiopharmaceutical shall appropriately be labeled.

Task 14.3 Disposal of Radiopharmaceuticals

14.3.1. Relevant requirements for disposal of radiopharmaceuticals shall be

adhered to.
14.3.2. Nuclear pharmacies shall have adequate space and equipment,
commensurate with the scope of services provided, and as required by
the Radiation Board license or as required by Sterile Compounding
Standard, Compounding Standards of Practice, or other applicable
rules of the board.
14.3.3. Radionuclide generators shall be stored and operated in at least an
ISO 8 cleanroom or its equivalent.

Tools and Key Performance Indicators (KPIs) for Provision of Radio-

pharmacy services
Tools KPIs
1. Quality management system (QMS) All required documents available,
and manufacturing documents (See current, and in the correct format
Industrial Pharmacy Tools)
2. Radiopharmaceutical radiolabeling Number of doses prepared and
and compounding logbook (aseptic & dispensed correctly
non-aseptic)
3. Dose calibration record form Number of doses prepared and
calibrated correctly
4. Radioiation exposure monitoring Number of exposure monitoring forms
forms correctly filled as per prescribed
frequency
5. Radiopharmaceutical compounding Number of doses prepared and
logbook dispensed correctly
6. Batch manufacturing records Number of doses prepared and
dispensed correctly
7. Personnel training schedule and Number of training records up to date
records as per schedule

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8. Physician's prescription, LPO, All doses dispensed as per prescription

Delivery notes, Radiopharmaceutical and documented
dispensing form
9. Radiopharmaceuticals label format Number of doses prepared and labeled
correctly
10. Radiopharmaceutical Waste Storage Radiopharmaceutical waste is stored
and Disposal Form and disposed of promptly as per
relevant guidelines and SOP
11. Regulatory inspection checklist, Number and classification of inspection
reports, and outcomes findings, CAPA compliance status

Radiopharmaceutical facility
1. All pharmacies handling radiopharmaceuticals shall have non-sterile and
sterile preparation/dispensing areas, Radioactive material
shipping/receiving area; Radioactive material storage area, Radioactive
waste decay area and a Radioactive fume hood.
2. The nuclear pharmacy restricted area shall be secured against
unauthorized personnel and must be enclosed and lockable.
3. Radiation detection equipment such as radionuclide calibrators and
contamination monitors shall be available.
4. The radiopharmacy dispensing area should be a separate, dedicated, and
secure area.
5. All work surfaces should be smooth and impermeable and should permit
easy cleaning and decontamination. Pipework and any cables should be
encased and properly laid to facilitate cleaning and decontamination.
6. The space should be sufficient to accommodate all essential equipment
and accessories and should allow enough room for at least two staff
members to operate simultaneously.
7. The work areas should maintain satisfactory lighting, temperature, and
humidity to ensure operator comfort, optimum equipment performance,
and expected radiopharmaceutical stability.
8. There should be enough space for a laminar flow hood, a pharmaceutical
isolator, or other environmental cabinets. Sufficient space is needed to
locate L-shaped lead shields for handling radiopharmaceuticals, a
radionuclide calibrator with adequate lead shielding around it, and
shielded sharps waste storage containers (one for short-lived radionuclides
and the other for long-lived radionuclides) as well as for storage of non-
radioactive waste containers.
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9. A separate shielded area is required for used generators and radioactive

waste as applicable.
10. Radiation detection equipment such as radionuclide calibrators and
contamination monitors

Resources required for Radiopharmacy services

1. WHO GMP Guidelines TRS 986 and Annexures.

2. EAC GMP Compendium and referenced Annexures.
3. IAEA operational guidance on hospital Radiopharmacy
4. EANM guidelines on current Good Radiopharmacy practice
5. European Commission on good manufacturing practice for medicinal
products for human and veterinary use, annex 3: Manufacture of
radiopharmaceuticals
6. Nuclear Regulatory Act
7. Kenya Pharmacy and Poisons Board guidelines: Qualification and
Experience Requirements and Responsibilities for Key Personnel of
Licensed Manufacturers of Medical Products and Health Technologies
Kenya; Medicines Evaluation and Registration; Good Distribution
practices for Pharmaceuticals; Transportation of Pharmaceuticals; Safe
Management of Pharmaceutical Waste;

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STANDARD 15: Provision of Complementary, Traditional and Alternative

medicine services

Complementary, Traditional and Alternative medicine services will be

provided to integrate alternative therapeutic approaches, providing holistic
and patient-centred care, and fostering a comprehensive healthcare
experience for all individuals seeking diversified treatment options.
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Description

Complementary, Traditional and Alternative medicine (CTAM) refers to a

broad range of approaches and therapies that mainstream Western
(conventional) medicine does not commonly use, accept, study, understand,
or make available. A few of the many CTAM practices include the use of
acupuncture, herbs, and other natural remedies, homeopathy, therapeutic
massage, and other traditional forms of medicine to promote well-being or
treat health conditions. People use CTAM treatments and therapies in a
variety of ways. Therapies may be used alone, as an alternative to
conventional therapies, or in addition to conventional, mainstream therapies,
in what is referred to as a complementary or an integrative approach. Many
CTAM therapies are called holistic, which generally means they consider the
whole person, including physical, mental, emotional, and spiritual aspects.

Performance criteria

Task 15.1. Evaluation of Patient

15.1.1. A comprehensive policy that outlines the standards and safety

requirements for providing complementary, traditional and alternative
medicine (CTAM) therapies shall be established.
15.1.2. A thorough medical history and physical examination of the patient
shall be conducted.
15.1.3. Patient's medical records, including conventional diagnostic methods
shall be reviewed.
15.1.4. The evaluation process shall be documented in the patient's medical
record.

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15.1.5. Conventional and alternative medical options shall be discussed with

the patient or guardian, along with a comprehensive understanding of
the risks and benefits associated with the recommended treatment.
15.1.6. Potential interactions between the recommended treatment and any
ongoing or recommended treatments shall be assessed.

Task 15.2. Develop Treatment Plan

15.2.1. Standalone or adjunct complementary treatments shall be provided

to patients based on a documented treatment plan.
15.2.2. The offered treatment shall meet the following criteria:
a) Favourable Risk/Benefit Ratio: The treatment should demonstrate a
favourable balance between potential risks and benefits when
compared to other treatments recommended for the same condition.
b) Reasonable Expectation of Patient Outcome: The treatment should be
based on a reasonable expectation that it will result in a positive patient
outcome, whether therapeutic or prophylactic.
c) Expected Greater Benefit: The treatment should be chosen with the
anticipation that it will provide a greater benefit compared to receiving
no treatment at all.

Task 15.3. Consultation and/or Referral

15.3.1. Patients could be referred for further evaluation and treatment when
necessary.
15.3.2. Monitoring the patient's progress and treatment outcomes.
15.3.3. Fully inform clients about potential adverse reactions associated with
the treatment and be made aware of possible interactions between
herbal remedies, medications, and food.

Task 15.4. Documentation of Medical Records

15.4.1. Accurate and complete records shall be maintained within the facility

Task 15.5. Dispensing of CTAM products

15.5.1. Staff involved in the sale of complementary medicines shall undergo

appropriate training to ensure their understanding of these products.

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15.5.2. Only complementary medicines that have been evaluated and deemed
effective and suitable for the treatment of specific conditions shall be
stocked.
15.5.3. The client must be provided with relevant information about the usage
and effectiveness of all complementary medicine products

Tools and Key Performance Indicators (KPIs) for Complementary,

Traditional and alternative medicine (CTAM) Services
Tools KPIs
1. Survey platforms like Percentage of patients reporting satisfaction with
Survey Monkey to conduct their CTAM services experience, targeting an
satisfaction surveys annual increase.
2. Electronic Health Records Improvement in Clinical Outcomes
(HMIS) to track patient Percentage of patients who adhere to their
progress and outcomes prescribed CTAM treatment plans over a set
period, aiming for a quarterly increase.

3. Service Accessibility the number of days available for CTAM

appointments
the average wait time for scheduling,

4. List of resource materials Access to up-to-date training materials on CTAM;

for CTAM service delivery
5. Staff establishment experts or practitioners for delivering training.
6. Integration with Evaluate the extent of CTAM integration into
Conventional Medicine broader healthcare services, measured by the
Practices number of collaborative patient cases or inter-
professional meetings held.
7. Training report/ CPD Percentage of staff completing required CTAM
attendance training and certification programs annually,
striving for 100% compliance
8. Schedule of patient the number of patient education sessions
education session and conducted and the engagement rate on CTAM-
reports related content, targeting a yearly increase in
both.
9. ADR reports Keep track of the number of regulatory
compliance audits passed and safety incidents
reported, aiming for zero safety incidents and full
compliance with regulations.

Resources required for Complementary, Traditional and alternative

medicine Services
Di Stefano, V. (2020). Holism and complementary medicine. In holism and
complementary medicine. https://doi.org/10.4324/9781003115984

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Ministry of Health Malaysia. (2017). Traditional and Complementary

Medicine Blueprint 2018-2027: Health Care. In Traditional and
Complementary Medicine Division Ministry of Health Malaysia.
Weir, M. (2020). Law and Ethics in Complementary Medicine. In Law and
Ethics in Complementary
Medicine. https://doi.org/10.4324/9781003116264
Liang, Y. Z., Xie, P., & Chan, K. (2004). Quality control of herbal
medicines. In Journal of Chromatography B: Analytical Technologies
in the Biomedical and Life Sciences (Vol. 812, Issues 1-2 SPEC.
ISS.). https://doi.org/10.1016/j.jchromb.2004.08.041
Egbuna, C., Mishra, A. P., & Goyal, M. R. (2020). Preparation of
Phytopharmaceuticals for the Management of Disorders: The
Development of Nutraceuticals and Traditional Medicine. In
Preparation of Phytopharmaceuticals for the Management of
Disorders: The Development of Nutraceuticals and Traditional
Medicine. https://doi.org/10.1016/B978-0-12-820284-5.09996-2
Ghosh, D., & Mukherjee, P. K. (2019). Natural Medicines Clinical Efficacy,
Safety and Quality. In CRC Press (Vol. 1).
Duke, B. L. (2015). Chinese herbs and herbal medicine: Essential
components, clinical applications and health benefits. In Chinese
Herbs and Herbal Medicine: Essential Components, Clinical
Applications and Health Benefits.
Chirali, I. Z. (2014). Traditional Chinese Medicine Cupping Therapy: Third
Edition. In Traditional Chinese Medicine Cupping Therapy: Third
Edition. https://doi.org/10.1016/C2009-0-63931-3
Herbal Medicine in India. (2020). In Herbal Medicine in
India. https://doi.org/10.1007/978-981-13-7248-3
Luo, G., Wang, Y., Liang, Q., & Liu, Q. (2012). Systems Biology for
Traditional Chinese Medicine. In Systems Biology for Traditional
Chinese Medicine. https://doi.org/10.1002/9781118313367
Milne, G. W. A., Zhou, J., Xie, G., & Yan, X. (2018). Traditional chinese
medicines: Molecular structures, natural sources and applications.
In Traditional Chinese Medicines: Molecular Structures, Natural
Sources and Applications. https://doi.org/10.4324/9781315193441

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STANDARD 16: Pharmaceutical Marketing

Pharmaceutical marketing services shall be a practice that is informative, and

ethical, which adheres to industry standards and regulatory guidelines to
facilitate the effective promotion and dissemination of HPTs and services.
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Description:
Pharmaceutical marketing involves the promotion of medicines to medical
practitioners and other cadres of healthcare workers who are allowed to
prescribe this category of medications through pharmaceutical
representatives. “Pharmaceutical Representative '' means a person who
markets or promotes HPTs to healthcare professionals (HCPs).
Performance criteria

Task 16.1 Promotion of ethical pharmaceutical formulations

16.1.1. Pharmacy and Poisons Board guidelines and code of conduct relating
to the promotion of Health Products and Technologies (HPTs) shall
be adhered to.
16.1.2. Information that is useful to HCPs shall be provided using promotional
literature and medical/scientific papers published in recognized
medical/scientific journals.
16.1.3. Information provided should be capable of substantiation by reference
to the approved labelling or scientific evidence.
16.1.4. Excellent customer service shall be provided and good client
relationships should be maintained.

Task 16.2 Provision of scientific information regarding the HPT

16.2.1. Continuous learning and professional development should be

undertaken by pharmaceutical marketers and they are expected to
stay up-to-date with industry trends, the products they represent, new
products and regulations.
16.2.2. Documentation and reporting of any emerging issues regarding the
quality and standards of products should be made as per the
requirements in the GDP guidelines.

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Task 16.3 Use of promotional materials and samples to aid the

provision of scientific information

16.3.1. Provide or offer items of medical utility and promotional aids to

healthcare providers and appropriate administrative staff.
16.3.2. Supply samples (except medicines under schedule 4) to healthcare
providers in order to enhance patient care. Samples shall not be
damaged, expired or tampered HPTs. Samples shall be marked “free
sample” or “not for sale”. Samples shall not be sold.
16.3.3. Keep a record of samples supplied.
16.3.4. All promotional materials shall comply with the Pharmacy and Poisons
Board Guidelines on The Advertisement and Promotion of HPTs.

Tools and KPIs for Pharmaceutical Marketing Services

Tools KPIs
Online resources, medical/scientific Educational material developed
journals and reference text

Record of request for substantiating Record of substantiating

references from HCPs. references provided to HCPs.

Record of all CME/CPD events attended Number of CME / CPD points

/subscribed subscribed to attained.

Record of documentation and reporting (to Number of quality and standard

the company being represented) of issues reports to the regulator (PPB) as
raised regarding the quality and/or per the GDP guidelines
standard of HPTs being promoted
Record book for HPT samples provided to Available duly filled record for the
HCPs provision of HPT samples as per
GDP guidelines

Resources required for Pharmaceutical Marketing Services

1. Guidelines for Advertisement and Promotion of Health Products and
Technologies
2. Guidelines on Continuing Professional Development in Pharmacy
3. Guidelines for Scheduling of Health Products and Technologies

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STANDARD 17 Industrial Pharmacy Service

Industrial pharmacy services encompassing the development, manufacturing,

and quality assurance of medicinal products will be in strict adherence to
Good Manufacturing Practice guidelines and other relevant regulations and
standards.
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Description
Industrial pharmacy is a discipline which includes manufacturing,
development marketing and distribution of drug products including quality
assurance of these activities. Manufacturing is defined as all operations
including purchasing of material, processing, production, packaging,
releasing, storage and shipment of medicines and related substances in
accordance with quality assurance and related controls.
WHO Guide to Good Manufacturing Practices for Pharmaceutical Products
requires that products are not sold or supplied before an Authorised Person
has certified that each production batch has been produced and controlled in
accordance with the requirements of the marketing authorization and any
other regulations relevant to the production, control and release of the
pharmaceutical products. In addition, WHO GMP guidelines require that
personnel must have the necessary qualifications and practical experience to
carry out their responsibilities.
Authorised Persons (usually the Company Pharmacist and/or Head of Quality
Unit in a pharmaceutical manufacturing facility) and other key personnel
should be suitably qualified, experienced and competent for the types of
manufacturing operations undertaken by the manufacturer for whom they
work.
Performance criteria

Task 17.1. Formulation Research and Development

This task should be done by

17.1.1. Designing a quality product and its manufacturing process in
accordance with the principles of Quality by Design outlined in ICH
Q8 R (2).

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17.1.2. Applying a scientific approach and principles of quality risk

management in the development of pharmaceutical formulations.
17.1.3. Defining the design space and establishing a control strategy for the
product under development, ensuring compliance with regulatory
requirements.
17.1.4. Ensuring that critical aspects of drug substances, excipients,
container closure systems, and manufacturing processes are
identified.
17.1.5. Through a comprehensive assessment, identify the critical formulation
attributes and process parameters.
17.1.6. Prepare a Product Development Report, documenting the formulation
development process.

Task 17.2. Manufacturing

17.2.1. Manufacture Safe, Quality and Efficacious Medicines while complying

with Good Manufacturing Practices (GMP) by ensuring:
a) That all manufacturing processes are clearly defined and undergo
systematic reviews for associated risks.
b) Qualification and validation activities are performed to verify and
validate manufacturing processes, equipment, and systems.
c) The responsible individuals provide all necessary resources for
manufacturing operations.
d) That manufacturing procedures are executed correctly and that
personnel are adequately trained to perform their assigned tasks.
e) That in-process controls are performed within the production area to
monitor and verify the ongoing manufacturing processes.
f) The maintenance of detailed records during the manufacturing process
to demonstrate compliance with the defined procedures and
instructions.
g) That any significant deviations from established procedures shall be
fully recorded and investigated.
h) Regular checks are conducted on yields and reconciliation of quantities
to ensure that there are no discrepancies outside acceptable limits.

17.2.2. Proper storage and distribution of the manufactured products.

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Task 17.3. Quality Control

17.3.1. All quality control (QC) procedures should be established, validated,

and implemented by the pharmacist, ensuring accountability
throughout the process.
17.3.2. Necessary and relevant tests should be carried out on materials and
products to maintain quality standards.
17.3.3. Methods and personnel approved by the QC department should be
used to take samples of starting materials, packaging materials,
intermediate products, bulk products, and finished products.
17.3.4. Detailed records demonstrating that all required sampling,
inspecting, and testing procedures have been carried out should be
maintained meticulously.
17.3.5. A comprehensive product assessment, including a review and
evaluation of relevant production documentation, should be
conducted.
17.3.6. Sufficient samples of starting materials and products should be
retained for future examination if necessary.
17.3.7. Reference standards used in testing should be evaluated,
maintained, and stored properly to ensure their integrity and
reliability.
17.3.8. Correct labelling of containers holding materials and products
should be ensured to prevent mix-ups and errors.
17.3.9. The stability of active pharmaceutical ingredients and products
should be monitored to ensure their continued efficacy and safety.
17.3.10. Environmental monitoring activities to ensure compliance with Good
Manufacturing Practice (GMP) requirements should be implemented.
17.3.11. Active engagement in Quality Risk Management (QRM) programs, in
accordance with written procedures, should be maintained to
mitigate potential risks.

Task 17.4. Quality Assurance

17.4.1. Pharmaceutical products should be designed and developed in

alignment with Good Manufacturing Practice (GMP), Good Laboratory
Practice (GLP), and Good Clinical Practice (GCP) requirements.
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17.4.2. Written specifications for production and control operations should

be clearly defined and compliant with GMP regulations.
17.4.3. Clear job descriptions outlining managerial responsibilities should be
in place to ensure effective leadership and oversight of
pharmaceutical manufacturing processes.
17.4.4. Adequate arrangements should be made to ensure the availability of
correct starting and packaging materials.
17.4.5. Necessary controls on starting materials, intermediate products, bulk
products, and in-process controls, calibrations, and validations
should be carried out as per defined procedures.
17.4.6. Finished products should be processed and checked according to
specified procedures.
17.4.7. Pharmaceutical products should not be supplied
until authorised persons certify each production batch's compliance
with marketing authorization and relevant regulations.
17.4.8. Effective management processes should be established for
outsourced activities.
17.4.9. Satisfactory arrangements should be in place for proper storage,
distribution, and handling of pharmaceutical products throughout
their shelf-life.
17.4.10. Procedures for conducting self-inspections and/or quality audits
should be established to evaluate the effectiveness and applicability
of the PQS regularly.
17.4.11. Products and processes should be monitored, and results should be
considered in batch release and deviation investigations.
17.4.12. Arrangements should be in place for the prospective evaluation and
approval of planned changes.
17.4.13. Regular reviews of pharmaceutical product quality should be
conducted to ensure process consistency and identify areas for
improvement.
17.4.14. Effective monitoring and control systems should be developed and
used to establish and maintain a state of control over process
performance and product quality.

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17.4.15. Continual improvement should be facilitated through the

implementation of quality improvements based on
current processes and product knowledge.
17.4.16. A system for Quality Risk Management (QRM) should be in place to
identify, assess, and mitigate risks throughout the product life cycle.
17.4.17. Deviations, suspected product defects, and other problems should be
promptly reported, investigated, and recorded.
17.4.18. Complaints about products should be thoroughly investigated, and
appropriate measures should be taken to prevent their recurrence.
17.4.19. A robust system should be established and maintained to facilitate
the recall of any batch of product, if necessary.

Task 17.5 Authorised Person Role

The Pharmacist as the Authorised Person shall:

17.5.1. Ensure that each batch of pharmaceutical products is manufactured,

controlled, and checked in compliance with the applicable Laws of
Kenya, marketing authorization requirements, standards of Good
Manufacturing Practice (GMP), and pharmacovigilance requirements.
17.5.2. Ensure compliance with technical or regulatory requirements related
to the quality of finished products and the approval/certification of the
release of the finished product batch for sale or supply.
17.5.3. Perform controlled batch release procedures to ensure that each batch
of a product has been manufactured and checked in accordance with
the requirements of its marketing authorization (MA), principles and
guidelines of GMP, and other applicable legal requirements. Batches
shall only be released for sale or supply after certification by
the authorised person(s) and shall remain under appropriate
quarantine until authorised for distribution.
17.5.4. Ensure that the entire supply chain of the active substance and
pharmaceutical product is documented and available for inspection by
relevant authorities, including manufacturing sites of starting
materials, packaging materials, and any other materials identified as
critical through a risk assessment of the manufacturing process.

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17.5.5. Ensure that all sites involved in the manufacture and analysis of
pharmaceutical products, both within Kenya and for export, are
compliant with the terms of Kenyan marketing authorization as well
as any applicable export marketing authorization.
17.5.6. Act as the company pharmacist and serve as the technical link
between the manufacturer and regulatory authorities.
17.5.7. Review, certify and submit product registration dossiers in the
prescribed format to the regulatory authorities (application for
products Marketing Authorization)
17.5.8. Maintain product dossiers with the regulatory authorities by applying
for annual retention and notification of any variations and post-
approval changes.
17.5.9. Establish a system for pharmacovigilance and market surveillance in
line with the relevant standards and guidelines.

Tools and Key Performance Indicators (KPIs) for Industrial Pharmacy

Tools KPIs
Product Development Report Number of products developed, scaled up to
Forms manufacturing, process validated
and commercialised
QMS and Manufacturing Presence of a functional Pharmaceutical
Documents and Records: Quality Management System in line with EAC
GMP Compendium and WHO TRS 986. All
● Quality Manual and Quality procedures carried out as per governing
Policy policies, SOPs and protocols and recorded in
● Site Master File appropriate record forms.
● Validation Master Plan,
qualification and validation
protocols and reports
● Pharmacovigilance Master
File
● Standard Operating
Procedures and Records
● Labels applied to containers,
equipment and premises
● Specifications and testing
procedures
● Specifications for starting and
packaging materials
● Specifications for
intermediate, bulk and
finished products
● Master formulae, Batch
Processing and packaging
Instructions and Records

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Tools KPIs
Quarterly Quality Metrics Report ● The number of batches initiated of the
product and released to the market.
● The number of specification-related
rejected batches of the product, rejected
during or after manufacturing.
● The number of initiated batches pending
disposition for more than 30 days.
● The number of out-of-specification (OOS)
results for the product, including stability
testing.
● The number of batch release and stability
tests conducted for the product.
● The number of OOS results for batch
release and stability tests for the product
that are invalidated due to lab error.
● The number of product quality complaints
received for the product.
● Number of Product Recalls carried out
● If the associated product quality reviews
(PQRs) were completed within 30 days of
the annual due date for the product.
● Senior Management Engagement—Was
each PQR reviewed and approved by the
following: (1) The head of the quality unit,
(2) the head of the manufacturing unit.
● Corrective Action and Preventive Action
(CAPA) Effectiveness - Number of open
CAPAs, percentage of Corrective actions
involving re-training of personnel (i.e., a
root cause of the deviation is lack of
adequate training)
Self-Inspection SOP, checklist, Number of self-inspections carried out,
reports and CAPA follow-up classification of findings and CAPA status
Regulatory inspection SOP, Number of critical, major and minor inspection
checklist, reports and outcomes findings for manufacturer, Compliance and
CAPA status

Resources required for Industrial Pharmacy

1. The Pharmacy and Poisons Board guidelines: Qualification and

Experience Requirements and Responsibilities for Key Personnel of
Licensed Manufacturers of Medical Products and Health Technologies
Kenya;
2. The Pharmacy and Poisons Board guidelines: Medicines Evaluation and
Registration;
3. The Pharmacy and Poisons Board guidelines: Good Distribution
Practices for Pharmaceuticals;

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4. The Pharmacy and Poisons Board guidelines: Transportation of

Pharmaceuticals;
5. The Pharmacy and Poisons Board guidelines: Safe Management of
Pharmaceutical Waste;
6. References – WHO GMP Guidelines TRS 986 and Annexures.
7. EAC GMP Compendium and referenced Annexures.
8. ICH Guidelines – Pharmaceutical Development (Q8), Quality Risk
Management (Q9), Pharmaceutical Quality Systems (Q10)

STANDARD 18: Provision of Pharmacy Education, Teaching and

Research Services

The Pharmacist/Pharmacist Specialist shall demonstrate competency in

teaching and learning, scholarship and research, community service, and
continuing education.
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Description
Pharmacy education involves a comprehensive training process that prepares
individuals to become licensed pharmacists. It includes a pre-clinical followed
by a curriculum covering pharmaceutical sciences, clinical practice, and
patient care. Experiential learning in various healthcare settings is an integral
part of education. After graduation, licensure exams are required, and
continuing education ensures pharmacists stay updated with advancements
in the field to provide optimal pharmaceutical care.
Performance Criteria

Task 18.1 Teaching and Learning

18.1.1. Engage in designing and updating the pharmacy curriculum to ensure

it aligns with current educational standards, emerging trends in
pharmacy practice, and evolving healthcare needs.
18.1.2. Deliver lectures, facilitate discussions, and conduct interactive
learning sessions to impart knowledge and skills to pharmacy
students.
18.1.3. Serve as preceptors during experiential learning rotations, guiding and
mentoring students in various pharmacy practice settings.

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18.1.4. Develop assessment methods, such as exams, quizzes, and practical

evaluations, to measure students' understanding and proficiency.
18.1.5. Serve as an academic and research advisor to pharmacy and other
students, providing guidance on course selection, career paths, and
professional development.
18.1.6. Participate as a trainer in pharmacy-related trainings/workshops and
serve as a supervisor for students conducting research in the facility
where s/he works.

Task 18.2 Scholarship and Research

18.2.1. Be responsible for planning, conducting, and leading research studies

in their area of expertise.
18.2.2. Disseminate their research findings through publication in reputable
scientific journals.
18.2.3. Actively pursue research funding through grant applications and other
funding opportunities.
18.2.4. Provide guidance and mentorship to students, residents, and fellow
researchers engaged in research projects.
18.2.5. Actively collaborate with other researchers, both within and outside
their institution, to enhance research outcomes.
18.2.6. Engage in scholarly activities, such as conducting research, reviewing
and publishing scientific papers, and presentations at conferences.
18.2.7. Adhere to ethical guidelines and regulatory requirements governing
research.
18.2.8. Actively participate in discussions and initiatives related to research
policy development and innovation in pharmacy.
18.2.9. Participate in the review of research proposals in institutional ethics
and research committee (Institutional review board) for compliance
with research ethical standards and clinical trials.

Task 18.3 Continuing Education

18.3.1. Engage in continuous professional development to stay current with

advancements in pharmacy practice. They participate in educational
programs, attend conferences, and pursue additional certifications or

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advanced degrees to enhance their teaching abilities and maintain

expertise in their respective areas.
18.3.2. Make appropriate contributions to his/her profession (for example,
editorial work for scholarly journals, membership in professional
committees and associations nationally and internationally,
organization of conferences, engaging with industry and other sectors
of society through consultancy work).
18.3.3. Serve as instructors in continuing education programs. They deliver
lectures, facilitate discussions, and provide interactive learning
experiences to help practicing pharmacists update their knowledge,
acquire new skills, and enhance their clinical practice. They utilize
effective teaching strategies and technologies to engage learners and
promote active participation.

Task 18.4 Community service

18.4.1. Provide community service by engaging in activities outside the

university to benefit the wider community, including service as a
resource person/organizer at workshops, and seminars; providing
advice to community organizations; participating in community
projects; membership in government commissions, and parastatal
boards.

Task 18.5 Academic Leadership

18.5.1. Actively participate in departmental and institutional committees,

contributing to decision-making processes, curriculum planning, and
policy development.
18.5.2. Lead departments/sections/directorates in Schools of Pharmacy or
University or Colleges
18.5.3. Lead schools of pharmacy in universities or colleges
18.5.4. Lead teaching and research institutions/ directorates
18.5.5. Foster the professional development of junior faculty, provide
mentorship, guidance and resources to enhance the teaching skills of
faculty, promote scholarly activity and support career advancement.

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18.5.6. Organize seminars, workshops and conferences to facilitate ongoing

facility development and promote a culture of continuous learning
18.5.7. Serve as an advocate for the pharmacy profession by actively
participating in a professional organization and contributing to policy
discussions.

Task 18.6 Consultancy

18.6.1. Bring their specialized knowledge and expertise in all pharmacy

competency areas to offer evidence-based recommendations.
18.6.2. Assist healthcare institutions in implementing quality improvement
initiatives related to pharmacy services.
18.6.3. Support healthcare institutions in meeting regulatory requirements in
accreditation standards.
18.6.4. Offer strategic guidance to relevant stakeholders in health care policy
development and other international and national guidelines in their
areas of competence.
18.6.5. Assess the clinical and economic value of new health products and
technologies.
18.6.6. Collaborate with healthcare organizations to develop strategies for risk
assessment and mitigation within the healthcare system
18.6.7. Provide guidance and consulting services to multidisciplinary teams
within the healthcare sector.

Tools and KPIs for Pharmacy Education, Teaching and Research

Tools KPI
Teaching schedule Number of courses taught
Number of practical/laboratory classes taught
Scholarly activity record Number of peer-reviewed original research
form papers published
Number of review articles published
Number of conference presentations made
Number of grants won
Community service record Number of community service engagements

Resources for Pharmacy Education, Teaching and Research

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1. Checklist for inspection for diploma in pharmacy (Refer PPB

/PRA/RED/GDL/001)
2. National minimum standards for BPharm Programs in Kenya (Refer
PPB Guideline)
3. PPB Degree/Diploma Inspection Checklist
4. CUE Academic Programmes Checklist
5. PPB - Standards for Bachelor of Pharmacy Programmes in Kenya
6. THE UNIVERSITIES ACT
7. CUE - Standards and Guidelines for University Academic Programmes
8. CUE - Universities Standards and Guidelines
9. Faculty handbook

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STANDARD 19: Regulatory Affairs and Enforcement

The Pharmacist and pharmaceutical technologist shall safeguard and promote

public health by adhering to laws, regulations and guidelines governing the
pharmaceutical industry as well as participating in the enforcement of these
regulations.
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Description
Regulatory Affairs and enforcement processes are crucial in the
pharmaceutical industry to ensure compliance and maintain quality
standards. These processes safeguard public health, ensure product efficacy,
and maintain the integrity of the pharmaceutical supply chain.
The Pharmacy and Poisons Board enforces regulations governing various
aspects including pharmaceutical research and development, manufacturing,
trade, storage, distribution, marketing and post-marketing surveillance, as
well as the training and practice of Pharmacy. Such regulations include Good
Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good
Pharmacy Practices (GPP), Good Distribution Practices, Training Standards,
and Good Vigilance Practices (GVP), among others.
Pharmacy professionals are responsible for understanding and adhering to all
applicable laws, regulations, and guidelines related to pharmacy practice.
They must ensure that their pharmacy operations and practices are in
compliance with these regulatory requirements. Pharmacy professionals are
also responsible for assessing compliance with the regulations, and reporting
any non-compliance issues to the PPB.
Performance criteria

Task 19.1: Compliance with Regulations

19.1.1. Accurate and up-to-date records and documentation, as required by

CAP 244, PPB guidelines, and other relevant regulatory bodies, should
be maintained meticulously.
19.1.2. Proactive preparation for inspections and regulatory audits should be
undertaken by conducting internal assessments,
reviewing organisation policies, procedures, and practices to ensure
compliance with regulatory standards.

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19.1.3. Cooperation with regulatory authorities during inspections and audits

should be demonstrated.
19.1.4. Appropriate corrective actions should be taken if deficiencies or non-
compliance issues are identified during an inspection.
19.1.5. Active engagement in continuous quality improvement efforts should
be demonstrated to ensure ongoing compliance with regulatory
requirements.
19.1.6. Ongoing training and education regarding regulatory requirements
and standards should be undertaken and provided.
19.1.7. Collaboration with internal stakeholders, including managers,
pharmacy staff, and other healthcare providers, should be facilitated
to develop and implement strategies for maintaining regulatory
compliance.
19.1.8. Prompt reporting of any adverse events, medication errors, or other
incidents, as required by regulatory bodies, should be ensured.

Task 19.2: Regulatory Inspection for compliance with good practices

(GxP)

19.2.1. Accurate and objective records of applications for inspection,

inspection reports, CAPA records, regulatory decisions, and
enforcement actions should be maintained diligently.
19.2.2. Applications for inspection and licensing of clinical trial sites,
manufacturing sites, and wholesale dealers' premises, along with
variations to these licences, should be assessed for compliance with
regulations and requirements.
19.2.3. Regulatory inspections of distribution channels (throughout the
supply chain) for compliance with Good Distribution Practices
requirements should be planned and performed, including pre-
approval, routine, and investigative inspections.
19.2.4. The impact of facility non-compliance or deviations on clinical
practices and public health should be evaluated thoroughly.
19.2.5. The adequacy of CAPAs to address the root cause(s) of issues or
problems identified during inspections should be determined.

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19.2.6. Regulatory decisions on facilities, based on appropriate

documentation reviews and inspections, should be made or
recommended as applicable.
19.2.7. Regulatory action and adequate follow-up to ensure the effectiveness
of the action taken should be instituted.
19.2.8. Fundamental standards and processes related to planning,
coordination, and conduction of the inspection process should be
developed and maintained, overseeing and coordinating activities of
inspectors and evaluators to ensure compliance with regulations,
standards, and quality assurance.
19.2.9. Regulatory inspections of manufacturing facilities, testing
laboratories, clinical research organisations, and distribution
channels for compliance with applicable national and international
requirements, such as GxPs, should be planned and performed.
19.2.10. Desk assessments/reviews based on available information, such as
inspection reports from other stringent regulatory authorities (SRAs),
should be performed.
19.2.11. Reports based on multiple sources of information, including analysis
and observations, consultation with colleagues, precedents,
literature searches, or information from other regulatory authorities,
should be written.
19.2.12. The impact of facility non-compliance or deviations on clinical
practices and public health should be evaluated.
19.2.13. The adequacy of CAPAs to address the root cause(s) of issues or
problems identified during inspections should be determined.
19.2.14. Regulatory decisions on facilities, based on appropriate
documentation reviews and inspections, should be made or
recommended as applicable.
19.2.15. Regulatory action and adequate follow-up to ensure the effectiveness
of the action taken should be instituted.

Task 19.3: Market authorization (Product Registration)

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19.3.1. Fundamental standards and processes for the HPT evaluation process
should be developed and maintained to ensure compliance with
regulations, standards, and quality assurance.
19.3.2. Accurate and objective records of applications for market
authorization, assessment/evaluation reports, query records,
regulatory decisions, and the register of approved products and
technologies should be maintained.
19.3.3. The application of scientific principles, regulatory requirements, and
best practices in the review of applications and technical documents
for market authorization, registration, or post-approval changes
should be ensured. This includes the chemistry, manufacturing
processes, controls, quality of a drug substance or product, and
bioavailability or bioequivalence data.
19.3.4. Reports should be composed based on a comprehensive analysis of
multiple sources of information, including analysis and observations,
consultation with colleagues, precedents, literature searches, or
information from other regulatory authorities.
19.3.5. Regulatory decisions on individual products should be made or
recommended based on thorough reviews of documentation,
inspections, and, if applicable, laboratory testing.

Task 19.4: Licensing of Establishments and Personnel

19.4.1. Pharmacists are tasked with establishing, overseeing, and maintaining

rigorous standards for licensing processes, ensuring compliance with
regulations, maintaining accurate records, evaluating
various licence applications, and making or recommending regulatory
decisions based on thorough reviews of documentation and inspection
19.4.2. Pharmacists are responsible for establishing, overseeing, and
maintaining stringent standards for licensing processes, ensuring
adherence to regulations, meticulous record-keeping, evaluating
diverse licence applications, and making or advising on regulatory
decisions after comprehensive reviews of documentation and
inspections.

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Task 19.5: Vigilance

19.5.1. Designing the set-up of a drug- or disease-related register to monitor

ADRs / AEFIs shall involve addressing data collection, database
structure, data fields, data validation and analysis, and the potential
for record linkage, access, and confidentiality.
19.5.2. Training should be provided to all cadres of health care providers and
the general public on the detection and reporting of medication errors,
ADRs, AEFIs, poor quality, and substandard HPTs.
19.5.3. Applying pharmacoepidemiology knowledge in the critical appraisal of
vigilance reports should be prioritised.
19.5.4. Studies should be designed to investigate suspected rare serious
ADRs / AEFIs and address risk factors and possible distortions.
19.5.5. Performing a root cause analysis using appropriate tools for drug-
related medication errors, and substandard & falsified medical
products should be conducted.
19.5.6. Assessing the performance of the PV system through inspection,
audit, and using QA and benchmarking tools should be regular.
19.5.7. Decisions shall be made or recommended on regulatory actions for
individual products based on appropriate reviews of documentation,
inspections, and laboratory testing (if applicable).

Task 19.6: Market Surveillance

19.6.1. Evaluating the risk of individual products/classes of products to

public health using appropriately designed tools shall be conducted.
19.6.2. Risk-based monitoring of the quality of the finished products in all
parts of the distribution chain should be performed.
19.6.3. Making or recommending regulatory decisions on individual
products/class of products based on appropriate reviews of
documentation, surveillance reports, inspections, and laboratory
testing shall be ensured.
19.6.4. Instituting regulatory action and adequate follow-up to ensure the
effectiveness of the action taken should be prioritised.

Task 19.7: Quality Control, Laboratory testing, and Lot Release

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19.7.1. Participation in the analytical method verification, validation process,

and method transfer shall be ensured.
19.7.2. Analysis of HPTs based on established in-house or compendial
methods should be performed.
19.7.3. Participation in investigations pertaining to out-of-specification results
shall be conducted.
19.7.4. Complementing other regulatory functions such as market
authorization review (specifications, method, and validation review)
and inspection of other QC laboratories (e.g., in manufacturing
facilities) should be carried out.
19.7.5. Reviewing and verifying analytical reports to ensure compliance with
standards and regulations, and approving testing results and reports
shall be completed.
19.7.6. Making or recommending regulatory decisions such as batch/lot
release on individual products based on appropriate reviews of
analytical reports and documentation should be executed.

Task 19.8: Regulation of Clinical Trials

19.8.1. Developing and maintaining fundamental standards and processes

pertaining to the planning, coordination, and conduction of clinical
trials, and overseeing and coordinating activities to ensure compliance
with regulations, standards, and quality assurance shall be ensured.
19.8.2. Maintaining accurate and objective records of applications, review,
and approval/denial of clinical trials, and monitoring reports shall be
conducted.
19.8.3. Evaluating the design, conduct, and documentation of clinical studies
as required for compliance with Good Clinical Practice Guidelines,
such as principles of human subject protection and privacy, and
requirements for informed consent, inclusion, exclusion, and other
criteria should be performed.
19.8.4. Making or recommending regulatory decisions based on appropriate
reviews, inspections, and documentation shall be executed.

Tools and KPI for Regulatory and Enforcement Services

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Tool Key Performance Indicators

1. Inspection Number of scheduled self-inspections performed
Checklist Number of regulatory inspections
Number of non-compliance issues
2. Inspection Percentage of inspection reports complying with the
report template format
Availability of previous inspection reports
3. Corrective action Number of non-conformances investigated and acted
forms upon
Effectiveness of corrective actions undertaken
4. Training needs Number of pharmacy professionals trained in
form regulatory affairs

Resources required for regulatory affairs and enforcement

1. PPB Guidelines on good distribution practice for medical products and

health technologies in Kenya (Refer to HPT/ISE/EFS/CUD/019)
2. PPB Pharmacovigilance guidelines (Refer PPB/MIP/PMS/GUD/022)
3. WHO-Global Competency Framework for Regulators of Medical
Products draft version 1.6.4 (July 2022)
4. WHO TRS 986 Annex 2- Good Manufacturing Practices For
Pharmaceutical Products.

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STANDARD 20: Provision of Clinical Trial and Research Services

The pharmacist shall perform ethically sound clinical trials and research.
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Description
A clinical trial is defined as, any systematic study of pharmaceutical products
in human subjects, whether in patients or other volunteers, to discover or
verify the effects of, identify any adverse reactions to investigational products,
to study the absorption, distribution, metabolism, and excretion of the
products with the object of ascertaining their efficacy and safety. Clinical
trials are generally classified into Phases I to IV. Each study is required to
have a pharmacist who shall be suitably qualified and experienced to handle
investigational drug products. Within the clinical trials organisation,
pharmacists have suitable posts as clinical research coordinators, clinical
research Associates (CRA) and study statisticians. Pharmacists may even
work as principal investigators and patient educators in clinical trials.
Pharmacists can play a role in improving patients’ participation in clinical
trial studies. The abilities needed to work in a clinical research corporation
encompass knowledge of statistics, research protocol development,
certifications in human subject research, medicine, and pharmacology,
pharmacovigilance, documentation, and the capacity to journey considerably.

Performance criteria

Task 20.1 Clinical Investigational Drug Trials

20.1.1. Applying all principles of research ethics according to ICH guidelines,

local guidelines, and institutional guidelines shall be conducted.
20.1.2. Maintaining overall responsibility for investigational drugs shall be
ensured.
20.1.3. Reviewing protocols for clinical investigational drug trials shall be
completed.
20.1.4. Liaising to establish the pharmacy’s role, determine fee schedules,
and develop and implement dispensing, compounding, reconstitution
of IV products, and billing procedures should be carried out.

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20.1.5. Communicating with, and training staff anticipated to participate in

any aspect of the clinical investigational drug trial should be
conducted.
20.1.6. Maintaining all study records and documents, which include a study
summary, protocol, dispensing procedures, completed samples of
required paperwork, dispensing checklist, fee schedule, billing
procedures, and any other relevant materials for each investigational
trial, shall be ensured.
20.1.7. Maintaining and coordinating distribution of an up-to-date
investigational drug trials list shall be conducted.
20.1.8. Maintaining responsibility for the management of the inventory for
clinical investigational drug trials; ordering, replacing, and returning
study materials, according to the study sponsor policy, shall be
ensured.
20.1.9. Communicating any concerns regarding ethical issues or deviation
from policies & procedures should be conducted.
20.1.10. Assisting in ensuring the participation in all clinical trials which
involve drugs should be facilitated.
20.1.11. Attending and contributing to interdisciplinary team meetings
relating to clinical investigational drug trials shall be ensured.
20.1.12. Consulting with other pharmacy professionals to obtain
information/expertise in support of the investigational drug trials, as
required, should be conducted.
20.1.13. Maintaining the temperature and humidity records of investigational
drug storage areas shall be ensured.
20.1.14. Participating in the randomization should be conducted.
20.1.15. Reviewing the investigator’s brochure and advising co-investigators
on the handling of the investigational drugs shall be completed.
20.1.16. Ensuring recruitment of participants into the study adheres to
inclusion and exclusion criteria, paying special attention to potential
drug interactions, shall be ensured.
20.1.17. Ensuring labelling of the investigational product with the
participant’s unique identifier before handing it over for
administration in the case of injections should be conducted.

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20.1.18. Ensuring masking of investigational drugs to maintain blinding

where applicable should be ensured.

Task 20.2: Inventory management

20.2.1. Records of each stage of the handling and use of the investigational
product shall be maintained

Task 20.3: Critical appraisal of research publications and identification

of research gaps

20.3.1. A research paper shall be evaluated and derive an appropriate

conclusion based on the methodology’s strengths and weaknesses.
20.3.2. Major evidence gaps requiring further research shall be identified and
drive research directions for the area of interest.

Task 20.4: Disseminating evidence

20.4.1. Research results shall be analysed, interpreted and translated.

20.4.2. Manuscripts should be developed for publication in a peer-reviewed
journal.
20.4.3. Research findings should be presented in a scientific conference.
20.4.4. Disseminations of study findings shall be done in conjunction with the
principal investigator and other co-investigators.
20.4.5. Monitoring, Management and Reporting of adverse events due to the
investigational products.

Tools and KPI for Clinical Trial and Research

Tools KPI
Clinical trial ● Number of applic ations submitted
application ● Number of ethical approvals granted
form ● Number of clinical trials undertaken by the
investigator
● Total number of patients or participants for which
the principal investigator is responsible for the
specified date

Resources required for clinical trial and research

PPB Guidelines for the conduct of clinical trials in Kenya
(Refer PPB/PDS/CTR/GUD/003)

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STANDARD 21: Provision of Leadership, Administration, Policy

Formulation, and Quality Assurance Services

The pharmacist and pharmaceutical technologists are responsible for actively

participating in policy formulation, offering leadership and administration
services, and ensuring the maintenance of quality assurance standards.
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Description:
The role of a pharmacist and pharmaceutical technologist in leadership and
administration is multifaceted, encompassing strategic planning, resource
management, and organisational oversight. Pharmacists are tasked with
providing effective leadership to ensure the efficient use of resources,
promoting optimal healthcare outcomes for patients. In administrative
capacities, they engage in activities such as planning, organising, directing,
staffing, and controlling within healthcare systems. In addition to leadership
and administration, pharmacists and pharmaceutical technologists play a
pivotal role in policy formulation. They actively contribute to the development
and shaping of policies that guide health care practices. This involvement
extends to participating in quality assurance programs, where pharmacists
contribute their expertise to uphold and enhance the quality of healthcare
services.

Performance criteria

Task 21.1. Planning

21.1.1. Ensure the availability of policies, procedures, laws, rules and

guidelines regarding the day-to-day activities in all areas of
the organisation. These shall include:

a) The Kenya Health Policy

b) The Kenya Health Strategic Plan
c) Midterm Development Plans
d) Midterm Expenditure Frameworks
e) County Integrated Development Plan
f) Annual Development Plan (ADP)
g) Annual Work Plan (AWP)

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h) Good Pharmacy Practice Guidelines

i) Good Practice Guidelines relevant to specific area of practice (GDP,
GCP, GMP, GLP, GRP etc)
j) Institutional Standard Operating Procedures (SOPs).
k) Relevant laws and related regulations (CAP 244, 245)
l) Other emerging issues and priority areas relevant to practice
21.1.2. Develop a strategic plan that aligns with the organisation's overall
mission and vision.
21.1.3. Be involved in operational planning to ensure the efficient and effective
delivery of pharmacy services.
21.1.4. Contribute to budget planning by estimating resource requirements,
such as personnel, medications, and equipment, and providing input
on financial projections.
21.1.5. Be responsible for determining staffing needs within the pharmacy
department.
21.1.6. Actively participate in quality improvement initiatives by identifying
areas for improvement, developing action plans, and monitoring
progress.
21.1.7. Contribute to risk management planning by identifying potential risks
and developing strategies to mitigate them.
21.1.8. Lead in planning professional development activities for themselves
and their staff.
21.1.9. Collaborate with other healthcare leaders and stakeholders to ensure
that pharmacy services are integrated effectively into the overall
healthcare delivery system.

Task 21.2. Organizing

21.2.1. Play a role in designing and establishing the organizational structure

of the pharmacy department.
21.2.2. Be responsible for organizing and managing the staffing needs of the
pharmacy department.
21.2.3. Identify training needs, develop training programs, and provide
opportunities for professional growth and development.

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21.2.4. Organize and optimize workflow and processes within the pharmacy
department to ensure efficient and effective service delivery.
21.2.5. Establish and enforce policies and procedures within the pharmacy
department.
21.2.6. Coordinate activities, communicate effectively, and foster
interdisciplinary teamwork to ensure seamless integration of
pharmacy services with overall patient care.
21.2.7. Organise quality assurance activities within the pharmacy
department.
21.2.8. Organise systems for managing and utilising medication-related
information within the pharmacy department.

Task 21.3. Workforce planning and management

21.3.1. Be responsible for designing and analysing job roles within the
pharmacy department.
21.3.2. Engage in strategic workforce planning to determine the current and
future staffing needs of the pharmacy department.
21.3.3. Oversee the recruitment and selection process for hiring new
pharmacy staff.
21.3.4. Facilitate the hiring and onboarding process for new pharmacy
employees.
21.3.5. Conduct performance evaluations to assess the performance, skills,
and competencies of pharmacy staff.
21.3.6. Manage compensation and benefits programs for pharmacy staff.
21.3.7. Implement reward and recognition programs to motivate and
incentivize pharmacy employees.
21.3.8. They identify training needs, design training modules, coordinate
professional development opportunities, and encourage continuous
learning.
21.3.9. Manage employee movement within the pharmacy department,
including transfers, promotions, and career development
opportunities.
21.3.10. Oversee welfare administration programs to support the well-being of
pharmacy staff.

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21.3.11. Promote health and safety in the pharmacy workplace.

21.3.12. Manage disciplinary actions when necessary, ensuring adherence to
established policies and procedures.
21.3.13. Handle labour relations matters, including maintaining positive
relationships with labour unions or employee representatives.

Task 21.4. Leading

21.4.1. Demonstrate honesty, ethical behaviour, and a commitment to

upholding professional standards in all their actions and decision-
making.
21.4.2. Exhibit generosity, kindness, and a willingness to forgive, promoting
a supportive and inclusive work environment.
21.4.3. Display humility by recognizing and valuing the contributions of
others, fostering a collaborative atmosphere and encouraging
continuous learning and growth.
21.4.4. Show dedication to their role, team, and the profession of pharmacy
by investing time, effort, and resources to achieve shared goals and
provide excellent patient care.
21.4.5. Encourage open communication, actively listening to and considering
diverse perspectives, and fostering an environment where ideas and
feedback are valued.
21.4.6. Promote and encourage creative thinking and problem-solving,
exploring innovative approaches to improve patient outcomes,
workflows, and processes.
21.4.7. Ensure fairness in decision-making and treatment of their team
members, promoting equity, recognizing merit, and valuing diversity.
21.4.8. Assert themselves confidently, effectively communicating their
expectations, advocating for their team, and addressing conflicts or
challenges in a constructive manner.
21.4.9. Use humour appropriately to create a positive and engaging work
environment, fostering team spirit, and alleviating stress when
appropriate.

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21.4.10. Demonstrate empathy by understanding and considering the

emotions, perspectives, and needs of their team members, patients,
and colleagues.
21.4.11. Exhibit confidence in their knowledge, abilities, and decision-
making, inspiring trust and providing guidance and direction to their
team.
21.4.12. Practice self-discipline, adhering to professional standards,
regulations, and protocols, and promoting a culture of accountability
within their team.
21.4.13. Effectively communicate with their team members, colleagues, and
other stakeholders, ensuring clarity, transparency, and
understanding in all interactions.
21.4.14. Treat others with respect, valuing diversity, and creating an
environment that fosters mutual respect among team members.
21.4.15. Demonstrate courage in making difficult decisions, advocating for
what is right, and taking calculated risks to advance patient care and
improve processes.
21.4.16. Utilize their influence to inspire and motivate their team, driving
positive change, and fostering a shared vision and commitment to
excellence.
21.4.17. Delegate responsibilities appropriately, empowering team members
and developing their skills while ensuring overall accountability and
efficiency.
21.4.18. Practice self-reflection and self-awareness, continually seeking
personal and professional growth, and modelling lifelong learning to
their team.
21.4.19. Express appreciation and gratitude to their team members,
recognizing their contributions and creating a culture of appreciation
and recognition.

Task 21.5 Communication

21.5.1. Communicate clearly and transparently with their team, ensuring

that information is conveyed accurately and comprehensively.

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21.5.2. Practice active listening, attentively hearing and understanding the

concerns, ideas, and feedback of team members.
21.5.3. Provide constructive feedback to team members, recognizing and
appreciating their strengths while offering guidance for improvement.
Feedback should be timely, specific, and focused on professional
growth.
21.5.4. Promote an environment that encourages open dialogue and two-way
communication, where team members feel comfortable sharing their
thoughts, concerns, and suggestions.
21.5.5. Adapt their communication style to the needs of different individuals
and situations.
21.5.6. Conduct regular team meetings and huddles to provide updates,
address challenges, and promote collaboration.
21.5.7. Address conflicts or disagreements within the team promptly and
constructively.
21.5.8. Communicate clear expectations regarding job responsibilities,
performance standards, and professional conduct.
21.5.9. Utilize a variety of communication channels, such as in-person
conversations, emails, memos, and electronic platforms, to effectively
disseminate information and maintain ongoing communication with
the team.
21.5.10. Uphold professionalism in their communication, maintaining a
respectful and courteous tone.
21.5.11. Invest in the development of their own communication skills and
those of their team members.

Task 21.6. Control

21.6.1. Quality improvement and Performance Management. Establish clear

and measurable standards or benchmarks for various aspects of
pharmacy operations, such as quality of service, patient safety,
regulatory compliance, and productivity. These standards serve as a
basis for evaluating performance.
21.6.2. Implement effective measurement systems and tools to assess the
performance of individuals, teams, and processes.

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21.6.3. Regularly compare actual performance against established

standards.
21.6.4. Investigate the underlying reasons or causes.
21.6.5. Take appropriate corrective action when deviations from standards
occur.
21.6.6. Establish mechanisms for ongoing monitoring and control to ensure
that performance remains aligned with standards.
21.6.7. The pharmacists/Pharmaceutical technologists shall provide timely
and constructive feedback to individuals and teams regarding their
performance.
21.6.8. Continuously assess and optimize processes and workflows to
enhance efficiency, productivity, and quality.
21.6.9. Establish and enforce quality assurance protocols to ensure that
pharmacy operations comply with regulatory requirements and
industry best practices.
21.6.10. Ensure compliance with relevant laws, regulations, and policies
governing pharmaceutical practices.
21.6.11. Identify and assess risks associated with pharmacy operations and
develop appropriate control measures to mitigate those risks.
21.6.12. Initiate and lead performance improvement initiatives aimed at
enhancing overall pharmacy operations.

Task 21.7. Policy formulation and development

21.7.1. Provide their expertise and knowledge in pharmaceutical sciences,

medication management, and patient care to inform policy decisions.
21.7.2. Actively engage various stakeholders, including government agencies,
professional organizations and advocacy groups, to provide input and
feedback during the policy development process.
21.7.3. Analyze existing policies and regulations to identify gaps,
inefficiencies, and areas for improvement.
21.7.4. Participate in the development of new policies, guidelines, and
regulations related to pharmacy practice.
21.7.5. Conduct research and contribute to evidence-based practice to
support the development of effective policies.

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21.7.6. Advocate for policies that promote patient safety, medication access,
and optimal use of medications.
21.7.7. Play a role in the implementation and evaluation of policies.

Task 21.8. Quality assurance

21.8.1. Develop, implement, and monitor quality assurance processes and

procedures to ensure compliance with regulatory standards,
professional guidelines, and best practices.
21.8.2. Conduct internal audits and inspections to assess adherence to
quality standards and identify areas for improvement.
21.8.3. Collaborate with cross-functional teams, including pharmacy staff,
healthcare professionals, and regulatory agencies, to develop and
maintain quality assurance programs.
21.8.4. Provide guidance and training to healthcare workers on quality
assurance protocols, standard operating procedures, and quality
improvement initiatives.
21.8.5. Maintain accurate and comprehensive records of quality assurance
activities, including drug utilization reviews, pharmacovigilance
activities, audits, and inspections.
21.8.6. Prepare reports and documentation for internal use, regulatory
compliance, and external agencies as required.
21.8.7. Participate in quality-related meetings and committees to provide
updates, share insights, and contribute to quality improvement
initiatives.
21.8.8. Engage in continuous quality improvement efforts, staying informed
about the latest developments in pharmacy practice, regulatory
requirements, and quality assurance standards.
21.8.9. Participate in quality-related research projects, performance
improvement initiatives, and benchmarking activities to enhance the
overall quality and safety of pharmaceutical care.
21.8.10. Collaborate with healthcare workers and stakeholders to develop and
implement strategies to improve medication use processes, reduce
medication errors, and optimize patient outcomes.

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Resources required for leadership and administration

1. Health infrastructure norms and standards

2. Scheme of service / Career progression guidelines
3. Performance Appraisals
4. National human resource manuals
5. Patient satisfaction survey
6. Healthcare worker satisfaction survey

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STANDARD 22: Provision of Sport Pharmacy Services

Sports pharmacy services shall be provided to athletes, encompassing

medication management, nutritional supplements, injury prevention, and
education on doping regulations.
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Description:

Sports pharmacy is a specialized branch of pharmacy that focuses on the

unique pharmaceutical needs of athletes and active individuals. Pharmacists
in this field play crucial roles in optimizing the health, performance, and
recovery of athletes. They are trained to understand the specific
pharmaceutical requirements, nutritional requirements, potential adverse
effects and drug interactions, and nutritional supplements relevant to
athletes. Their responsibilities may include advising athletes on safe and
effective medication usage, providing personalized dietary supplements,
ensuring compliance with anti-doping regulations, and collaborating with
healthcare teams to manage injuries and enhance performance. In addition,
they may contribute to research on innovative pharmaceutical interventions
tailored to the needs of athletes, ultimately aiming to support their overall
well-being and athletic achievements.

Performance criteria

Task 22.1 Comprehensive medication review

22.1.1. A thorough medication review shall be conducted for athletes'
including medication histories, ensuring there are no
contraindications or interactions that may affect their performance
or health.
22.1.2. The nutritional needs of athletes shall be assessed, personalized
dietary recommendations and supplements provided to support the
health of athletes.

Task 22.2 Anti-Doping Education

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22.1.1. Sports people shall be educated about anti-doping regulations and

the risks associated with banned substances, ensuring compliance
with relevant sporting authorities.
Task 22.3 Medication Management
22.3.1. Sports people and athletes shall be assisted in managing medications
for chronic conditions or acute injuries, ensuring proper dosing,
timing, and adherence to treatment plans.
22.3.2. Guidance shall be provided on the safe and legal use of supplements,
by athletes
22.3.3. A multidisciplinary team and collaborative approach shall be
implemented to develop injury prevention strategies and provide
pharmaceutical interventions for the management of sports-related
injuries, such as topical analgesics or anti-inflammatory
medications.
Task 22.4 Research and Development
22.4.1. Research and development activities shall be explored to improve
innovative pharmaceutical interventions that optimize sports people
health, improve recovery times, and minimize the risk of injury.
22.4.2. Continuing education initiatives shall be implemented to update
health professionals on the latest advancements in sports pharmacy,
pharmacology, nutrition and sports medicine through participation
in continuing education programs, conferences, and professional
development activities.

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STANDARD 23: Provision of Veterinary Pharmacy Services

Veterinary pharmacy services shall be provided in accordance with standard

best practices, ensuring optimal medication management, animal health, and
adherence to regulatory guidelines
-------------------------------------------------------------------------------------------------------------------
Description:

Veterinary pharmacy services encompass the specialised field of pharmacy

dedicated to the health and well-being of animals. Veterinary pharmacy
services involve handling of veterinary pharmaceuticals including drug
design, discovery, clinical trial, formulation development, manufacturing,
regulatory affairs, compounding, wholesale and distribution operations,
dispensing, inventory management, pharmacovigilance, antimicrobial
stewardship and disposal of veterinary products, and ensuring veterinary
public health standards to safeguard both human and animal well-being.

Additionally, veterinary pharmacy services extend to areas such as nutrition,

parasitology, and preventive healthcare, offering a holistic approach to animal
health management. Through their expertise and dedication, veterinary
pharmacists contribute significantly to the welfare and quality of life of
animals worldwide.

Performance criteria

Task 23.1. Veterinary Public Health and antimicrobial Stewardship

23.1.1. Potential risks related to zoonotic diseases shall be assessed

23.1.2. A system shall be established for emergency preparedness &
response, and implementation of measures for the prevention and
control of Zoonotic diseases, including vaccination programs and
biosecurity protocols.
23.1.3. Outbreaks of infectious diseases affecting animals and humans
shall be monitored and reported to relevant authorities.
23.1.4. Veterinarians, animal owners, and the public shall be educated on
the importance of antimicrobial stewardship and responsible
antibiotic use in veterinary medicine.

Task 23.2. Compounding of Veterinary Medicines

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23.2.1. Veterinary prescriptions shall accurately be interpreted and

compounded.
23.2.2. Appropriate compounding techniques shall be utilized to prepare
veterinary formulations tailored to the unique needs of individual
animals.
23.2.3. The quality of compounded final products shall be verified
through rigorous quality control measures.
23.2.4. Compounded veterinary medications shall be labelled clearly and
accurately, to include necessary cautionary information and
storage instructions.

Task 23.3. Manufacture and quality assurance of Veterinary Medicines

23.3.1. The manufacturing and quality assurance of veterinary medicines

shall be as per the Good Manufacturing Practices for veternary
drugs by the Food and Agriculture Organization and other
relevant regulatory requirements.
23.3.2. Proper documentation shall be maintained throughout the
manufacturing and quality assurance process, including batch
records and quality control reports.
23.3.3. Regular audits and inspections shall be conducted to assess
compliance with manufacturing standards and identify areas for
improvement.

Task 23.4. Regulatory Affairs for Veterinary Medicine

23.4.1. Comprehensive dossiers shall be prepared for veterinary

medicines in compliance with regulatory requirements.
23.4.2. Necessary documentation shall be compiled and organized to
include preclinical and clinical data, to support product
registration or marketing authorization.
23.4.3. A system for collaboration with regulatory authorities shall be
implemented to address inquiries and provide requested
information promptly.

Task 23.5 Wholesale and Distribution of Veterinary Medicines

23.5.1. Necessary licenses and permits shall be obtained from teh

relevant authority for wholesale and distribution activities.
23.5.2. Reliable supply chains shall be established to ensure the
availability of veterinary medicines to veterinarians and animal
care facilities.
23.5.3. Proper storage and handling procedures shall be implemented to
maintain product integrity during transportation and storage.

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23.5.4. Inventory levels shall be implemented and procurement strategies

adjusted to meet demand while minimizing excess stock and
waste.

Task 23.6 Stock and Dispense Veterinary Medicine

23.6.1. Accurate veterinary medication dosage shall be calculated based

on species, weight, age, and medical condition.
23.6.2. Clear instructions to animal owners or caregivers on shall be
provided on medication administration and proper use of
veterinary medicines.

Task 23.7 Provide Veterinary Medicine Counselling and Manage Drug

Therapy

23.7.1. Comprehensive guidance shall be provided on medication

administration, storage, and handling to veterinarians, animal
owners, and caregivers.
23.7.2. The correct use of medication delivery devices such as syringes or
pill pockets shall be demonstrated to animal owners, .
23.7.3. Medication adherence and compliance shall be monitored by
following up with animal owners, assessing barriers to adherence,
and providing support and interventions as needed.

Task 23.8 Veterinary Medicine Supply Chain Management

23.8.1. Reputable suppliers and manufacturers of veterinary medicines

shall be identified, ensuring product quality and regulatory
compliance.
23.8.2. Accurate records of inventory levels shall be maintained.
23.8.3. Inventory control measures shall be implemented to prevent
stock-outs and minimize wastage.
23.8.4. Supply chain performance shall be monitored and any issues or
disruptions shall be addressed promptly to ensure uninterrupted
availability of essential medications.

Task 23.9 Dispose of Veterinary Medicines

23.9.1. Proper disposal protocols shall be developed and implemented for

expired or unused veterinary medicines.
23.9.2. Environmental regulations and guidelines shall be followed for
the safe disposal of pharmaceutical waste.
23.9.3. Veterinarians, animal owners, and caregivers shall be educated
on proper disposal methods to minimize environmental impact
and public health risks.

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Task 23.10 Pharmacovigilance of Veterinary Medicine

23.10.1. Mechanisms shall be established for monitoring and reporting

adverse drug reactions or medication errors associated with
veterinary medicines.
23.10.2. Reported incidents shall be investigated thoroughly, documenting
findings and implementing corrective actions as necessary.
23.10.3. All reports of adverse events relating to veterinary medicines
shall be documented, reported, and resolved.

Task 23.11 Veterinary Medicine Education to Other Professionals

23.11.1. Collaborative relationships shall be maintained with veterinary

surgeons, paraprofessionals, and other animal healthcare
professionals to promote interdisciplinary communication and
collaboration.
23.11.2. A continuous education shall be implemented to ensure
veterinary professionals stay updated on advancements in
veterinary pharmacology, compounding techniques, and animal
health & production

Task 23.12: Design and development of formulations for veterinary

medicines.
2312.1. Suitable formulations for veterinary medicines shall be
customized to site of manufacture.
2312.2. The development of veterinary formulations into pharmaceutical
products shall consider that the finished product is of high
quality, safe and efficaceous.

Task 23.13 Clinical & non-clinical trials

23.13.1. Clinical trial protocols shall be designed in consultation with
other players, suitable for the intended trials of veterinary
medicines.
23.13.2. Ethical approval for clinical trial shall be sought from relevant
authorities.
23.13.3. Clinical and non-clinical trials data shall be used to evaluate
safety and efficacy of veterinary medicines.

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CHAPTER THREE

LEVELS AND SCOPE OF PRACTICE

This chapter provides a guide on the different levels and scopes that make
up the practice of pharmacy. The "levels of pharmacy professionals," serve
to categorise people working in the pharmaceutical field based on their
academic qualifications, professional experience and breadth of on-the-job
training. The training in pharmacy occurs at diploma, undergraduate and
postgraduate level which enables one to enter into practice from either
pharmaceutical technologist or pharmacist at internship. A post-graduate
qualifies for pharmacist specialist practice level. Concurrently, the chapter
explores the "scope of practice" related to each cadre level, providing a
comprehensive overview of the permissible and potential areas of practice for
pharmacy professionals at each level. The scope of practice essentially
outlines the range of roles and responsibilities that a pharmacy professional
is authorized to undertake in accordance with their level of qualification and
experience. The delineation of levels and scopes of practice is crucial, as it
not only informs professionals of their operational boundaries but also
safeguards the public by ensuring that adequately trained and competent
individuals deliver pharmacy services.

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3.1. Levels of pharmacy professionals

1. Pharmaceutical Technologist

1. Pharmaceutical Technologist intern

2. Pharmaceutical Technologist

2. Pharmacist

1. Pharmacist Intern
2. Pharmacist

3. Pharmacist Specialist

1. Pharmacist Specialist
2. Pharmacist Sub-Specialist

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3.2. SCOPE OF PRACTICE FOR PHARMACEUTICAL TECHNOLOGISTS

3.2.1. Pharmaceutical Technologist Intern
3.2.1.1. Requirement for designation and licensing
A candidate must have the following qualifications to be appointed as an
Intern.
1. Diploma in either pharmacy or pharmaceutical technology or equivalent
qualification approved from an institution recognized by the Pharmacy
and Poisons Board
2. Successfully completed level - I pre-enrolment exam or undertaking
internship from a recognized institution
3.2.1.2. Duties and Responsibilities
Under the supervision of the facility pharmaceutical technologist, practice in
all practice areas mentioned under Section 3.2.2.2.

3.2.2. Pharmaceutical Technologist

3.2.2.1. Requirement for designation and licensing
A candidate must have the following qualifications to be appointed, enrolled,
and licensed as a PHARMACEUTICAL TECHNOLOGIST.
1. Diploma in either pharmacy or pharmaceutical technology or equivalent
qualification approved from an institution recognized by the Pharmacy
and Poisons Board
2. Enrollment certificate by the Pharmacy and Poisons Board
3. Valid annual practice license from the Pharmacy and Poisons Board
4. Member of the Kenya Pharmaceutical Association
3.2.2.2. Duties and responsibilities
a) Provide Supply Chain Management services for Health Products and
technologies (HPTs)
i. Select and quantify health products and technologies (HPTs) for level 1
and 2 health facilities and level 2 community dispensing pharmacies
based on various sources, guidelines, and formularies.
ii. Maintain proper documentation in compliance with laws and
regulations regarding the selection and quantification processes.
iii. Keep a record of inventory reports, and withdraw defective products.
iv. Place orders for HPTs using official documents with unique order
numbers and relevant information.

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v. Ensure proper storage conditions and adherence to guidelines for the

storage of HPTs, including cold-chain items and controlled substances.
vi. Conduct regular self-audit of storage areas.
vii. Implement cleaning protocols, and prevent infestation risks.
viii. Manage equipment, cleaning, and maintenance of dispensing
containers, tablet counting equipment, and refrigerators for proper
storage and dispensing of medicines.
ix. Conduct pre-packing procedures and implement quality assurance
measures.
x. Ensure the pre-packing area has appropriate conditions and adheres
to packaging standards.
b) Compounding of basic liquid and semisolid non-sterile external
preparations
i. Perform basic compounding of external preparations
ii. Document compounding procedures for traceability and
reproducibility.
iii. Maintain personal cleanliness to prevent contamination.
iv. Maintain comprehensive records for compliance and quality assurance.
v. Clean, sterilize, and maintain equipment to prevent cross-
contamination.
vi. Transfer and label compounded products accurately and securely.
c) Provide Dispensing services
i. Ensure valid and standardised prescription formats are used and
include all necessary information.
ii. Conduct prescription processing activities for HPTs
iii. Consult the pharmacist to process prescription when dispensing
HPTs for clients who require medication therapy managment service
and specialist intervention.
iv. Dispense non-prescription medicines appropriately, considering the
patient's condition and symptoms.
v. Handle prescriptions professionally and maintain confidentiality.
vi. Assess the appropriateness of prescribed medications based on patient
factors and potential interactions.

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vii. Check the availability of prescribed medicines, inform the client if they
are unavailable, and make arrangements for accessibility.
viii. Provide clear, written labels and instructions for the patient.
ix. Demonstrate and educate on the appropriate use of medical devices
x. Demonstrate the reconstitution and appropriate storage of medications.
xi. Counsel all patients on the appropriate use of medicines, using ethically
sound and culturally sensitive language.
xii. Record and file prescription transactions
xiii. Fill out paper-based or digital pharmacovigilance forms, where
applicable.
d) Internet Services
i. Provide online pharmaceutical services, including prescription
dispensing, medicine sales, and information provision on the website.
ii. Register with the Pharmacy and Poisons Board (PPB) and prominently
display the health safety code on the website pages offering medicines
for sale.
iii. Adhere to the guideline for offering internet pharmacy services, such as
operating from registered physical premises and having a qualified
pharmacist or pharmaceutical technologist as the owner or appointing
a superintendent pharmacist or pharmaceutical technologist for
corporate-owned pharmacies.
iv. Ensure equal quality of pharmaceutical care for both online and in-
person services.
v. Provide accessible advice, verify the identity of the person requesting
the product, evaluate its suitability and safety, offer counsel on its use,
implement measures to prevent misuse or abuse, advise face-to-face
consultation, when necessary, disclose their identity, and verify
prescription authenticity.
vi. Provide additional personal medication information where face to face
consultation is not applicable.
e) Provide Primary Health Care services
i. Perform basic individual health assessments
a) Perform basic health assessments including
1. body temperature,

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2. blood pressure,
3. heart rate/pulse
4. respiratory rate
5. Body mass index
6. Nutritional assessment
b) Collect subjective and objective data from patients as per
standard MOH protocols.
ii. Perform Pharmacy-based Point-of-care testing for screening,
diagnosis and monitoring
a) Assess patients' eligibility for screening, monitoring, or rapid
diagnostic tests.
b) Perform appropriate pharmacy-based point-of-care testing for
screening, monitoring, or rapid diagnostic tests based on patient
needs, medical history, and relevant guidelines. These tests
shall include, but not limited to
1. Rapid diagnostic testing including HIV/syphilis,
pregnancy, malaria, haemoglobin and others as
recommended by MOH.
2. Blood glucose testing
3. Blood pressure measurement
4. Influenza and strep throat tests
5. COVID-19 tests
6. HIV screening
c) Interpret the results of pharmacy-based point of care test
d) Counsel clients on the importance of lifestyle modification
including regular health screening and monitoring, dietary
changes, physical activity, weight management, stress
reduction, and smoking cessation among others.
e) Maintain accurate and up-to-date patient records
f) Maintain accurate and up-to-date records of
machine/equipment calibration
iii. Vaccination services
a) Screen patients and clients before vaccination as per MOH
guidelines.

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b) Refer clients for administration of vaccination to relevant health

care provider
c) Assess and monitor adverse events following immunization
(AEFIs) and take appropriate action in accordance with
established protocols.
iv. Reproductive Health Services
a) Establish an effective and efficient referral system for the
provision of reproductive health services,
b) Provide reproductive health services which shall include but not
be limited to
1. Supporting routine antenatal care services
2. Family planning
3. Assessment and referral of clients with reproductive
health risks,
4. Counselling and referral of patients with sexually
transmitted infections (STIs) and Reproductive tract
infections (RTIs) as per MOH protocol
5. Assessment and referral of patients presenting with other
reproductive health disorders as per MOH protocol
6. Counselling, and referral of Sexual and Gender-based
violence as per MOH protocol
c) Assess clients for eligibility, initiation and continuation of
contraceptives and refer them when necessary.
d) Refer clients presenting with severe adverse effects and
conditions beyond the scope of practice.
e) Refer clients on pharmacy-initiated contraception for
comprehensive evaluation at least once a year by a medical
practitioner or an authorized reproductive health clinic.
f) Evaluate and refer patients for adverse effects and other health
risks associated with the use of contraceptives
g) Advise and provide details to the clients on how to do a breast
self-examination (BSE) to check for breast lumps and any
changes.

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h) Provide age-appropriate support to youth and adolescent groups

on substance abuse support, HIV counselling and testing,
mental health counselling services, and prevention of unwanted
pregnancy/abortions.
i) Refer for HPV vaccination
v. Mother and Child Health Services
a) Counsel pregnant women on nutrition, vaccination, pregnancy-
related exercises, uptake of folic and folate tablets and refer
them for antenatal care.
b) Provide pharmacy-based Maternity services as per MOH
protocol including but not limited to:
1. Preconception care
a. Provision of iron and folic acid supplementation,
and other appropriate supplements depending on
the health status of the patient and any other
underlying medical conditions or risks
b. Provision of information, education and counselling
on lifestyle modifications such as healthy diet,
weight management, physical exercise among
others
2. Antenatal care
a. Refer clients to health facility for comprhensive
antenatal care
b. Provision of preventive anti-helminthic treatment
c. Provision of iron and folic acid supplementation,
and other appropriate supplements depending on
the health status of the patient and any other
underlying medical conditions or risks
d. In malaria endemic areas, provide intermittent
preventive therapy, and insecticide-treated nets
among others
e. Screen for medical conditions e.g. anaemia,
hyperglycemia, elevated BP

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f. Provision of information, education and counselling

on danger signs during pregnancy and measures to
take, healthy diet during pregnancy, routine ANC
visits among others
g. Refer to appropriate medical practitioner where the
patient presents with symptoms beyond the scope
of the pharmacy provider
h. Assess for and advice on any current medication
which may negatively affect pregnancy outcomes
3. Postnatal care
a. Refer clients to health facility for
comprehensivecomprhensive postnatal care
b. Screening for underlying conditions e.g. anaemia,
hyperglycaemia, elevated blood pressure and
manage as per MOH protocols
c. Assessing for and advice on any current medication
which may negatively affect the breastfeeding
newborn
d. Provision of family planning methods to allow for
child spacing
e. Assessing for signs of postpartum depression and
referring for appropriate management
f. Nutritional support for the breastfeeding mother
g. Re-emphasize and support on elements of post-
natal care for mother and newborn, including
identification of underlying issues and referral
c) Provide pharmacy-based newborn care services as per MOH
protocol including but not limited to
1. provision of antiseptics
2. child growth monitoring
3. Guidance on Breastfeeding
4. Advice on hygiene practices
d) Provide Pharmacy-based Childhood health services as per MOH
protocol including but not limited to

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1. Deworming
2. Management of Uncomplicated Malaria
3. Management of cough, cold, and fever
4. Management of mild malnutrition
5. Management of diarrhoea and mild dehydration
e) Advice mothers on breastfeeding and alternative milk products
f) Refer infants with complex symptoms to the relevant medical
practitioner.
vi. Nutrition services
a) Counsel patients on healthy nutrition, vitamin and mineral
supplementation, appropriate diets, weight management and
healthy lifestyle.
b) Provide nutrition education and counselling
c) Refer clients to nutrition specialists whenever necessary
d) Provide malnutrition prevention and management services
including
1. Promotion of healthy diets and physical activity
2. Promotion of growth monitoring
3. Promotion of exclusive breastfeeding for the first 6 months
of an infant
e) Counsel clients or patients on potential drug-food and drug-
herb interactions.
vii. Medication safety
a) Implement a comprehensive medication safety management
system that includes policies, procedures, and protocols
designed to prevent and minimize medication errors and
adverse drug events.
b) Ensure that the procurement process includes verification of
medication sources to prevent counterfeit or substandard drugs
from entering the supply chain.
c) Maintain proper storage conditions for all medications to
preserve their efficacy and safety, adhering to manufacturers'
guidelines and regulatory requirements.

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d) Ensure access to up-to-date drug information and resources to

support safe medication dispensing practices.
e) Perform medication reconciliation at all transition points of care
to prevent discrepancies and ensure continuity of care.
f) Participate in national or regional medication error reporting
systems to contribute to broader medication safety efforts.
g) Regularly review medication safety practices and outcomes to
identify areas for improvement.
h) Foster collaboration and communication with prescribers and
other healthcare providers to ensure coordinated care and
medication safety.
i) Participate in medication safety programs across all levels of
health, including community pharmacies and community-
based outreaches.
j) Maintain confidentiality and data protection
viii. Disease control and prevention
a) Participate in public Health Programs (STI including HIV, TB,
Malaria, Neglected & Tropical Diseases (NTDs), Non-
Communicable Diseases (NCDs)
b) Participate in the development and implementation of
strategies for screening, prevention and control of disease
outbreaks
ix. Manage minor and common ailments
a) Assess and manage minor and common ailments, including
but not limited to constipation, diarrhoea, piles, hay fever,
head lice, nappy rash, chicken pox, threadworms, sore
throat, minor skin infections, eye infections, mouth ulcers,
cold sores, acne, dry eyes, dermatitis, mild pain managment,
vaginal thrush, oral thrush, scabies, ringworm, may be
diagnosed based on presenting symptoms, medical history,
and if necessary, physical examination, adhering to best
practice guidelines.
b) Provide patients with adequate information regarding their
condition, treatment options, medication usage, potential

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side effects, and self-care measures to manage symptoms

effectively.
c) Promptly refer patients to relevant healthcare providers for
cases beyond the scope of pharmacy practice or when
complications are suspected.
d) Maintain thorough documentation of services rendered for
the assessment and management of minor and common
ailments.
e) Participate in continuous professional development activities
to keep abreast of the latest evidence-based practices,
standard treatment guidelines, and product knowledge
relevant to the management of common ailments.
f) Engage in quality improvement activities to enhance the
management of common ailments, including the evaluation
of service delivery, patient satisfaction, and outcomes, to
identify areas for improvement and to implement corrective
actions.
x. Public health emergency preparedness and response
a) Participate in the establishment of the right organizational
structures and procedures for public health and other
emergencies as per the MOH guidelines.
b) Participate in the provision of first aid, basic life support and
referral services
c) Participate in the planning and designing of the emergency
response, and the monitoring and evaluation of the outcomes.
d) Participate in the Rapid Response Teams
e) Participate in public health education during emergency
situations
xi. Health education and promotion
a) Provide health education and promotion services including
1. prevention of communicable and non-communicable
diseases
2. health risk factor reduction

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3. harmful effects of Substance abuse (cocaine, heroin,

glue, khat, cannabis sativa, tobacco, alcohol, etc)
4. harmful effects of prescription and non-prescription
drug misuse and abuse
5. counselling on strategies to enhance healthy behaviour
6. Provision of health and wellness services including
physical activity, nutritional assessment and dietary
counselling.
b) Refer patients with suspected mental health-related disorders
c) Participate in the strengthening of multisectoral collaboration to
enhance health service provision.
xii. Training and Research in Primary Healthcare
a) Provide preceptorship and mentorship to pharmaceutical
Technologists on attachment within the primary healthcare
facilities including community pharmacies.
b) Conduct research on relevant public health pharmacy service
indicators and disseminate the findings
c) Organise continuous professional development and medical
education activities.
f) Adverse drug reaction reporting
i. Remain vigilant for the occurrence of adverse events and adverse drug
reactions associated with Health Products and Technologies during
direct interactions with patients, documenting these events in
individual Patient Medication Records.
ii. Report any occurrence of adverse events and adverse drug reactions to
the Pharmacy and Poisons Board using the prescribed reporting format.
iii. Provide appropriate instructions to patients to minimize future adverse
effects, including guidance on correct medication administration,
avoidance of specific medications or foods, restrictions on certain
activities, or consultation with the prescribing doctor.
iv. Report on any poor quality medicines to the Pharmacy and Poisons
Board using the prescribed reporting format
g) Rehabilitative services

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i. Refer all prescriptions containing narcotic and select psychotropic

medicines to be processed and dispensed by a Pharmacist.
ii. Stay updated on effective smoking cessation strategies and advise
patients on treatments.
iii. Provide readily available written information on quitting smoking.
iv. Dispense anti-smoking HPTs and encourage patients to report
progress.
v. Maintain accurate records of anti-smoking products dispensed.
vi. Offer counselling sessions and track patient progress.
vii. Promote a healthy lifestyle and raise awareness of smoking's adverse
effects.
viii. Enforce a no-smoking policy within the pharmacy premises.
ix. Ensure appropriate medication use for optimal patient outcomes.
h) Policy, quality assurance and standards
i. Provide expertise and knowledge in pharmacy practice to inform policy
decisions, actively engage with stakeholders, and represent the
pharmacy profession's interests during policy development.
ii. Analyze existing policies, regulations, and guidelines to identify areas
for improvement, assess the impact of proposed changes on patient care
and medication safety, and participate in the development of new
policies and guidelines.
iii. Conduct research, generate data, and analyze findings to support
evidence-based policy decisions and demonstrate the value of pharmacy
interventions.
iv. Advocate for policies that promote patient safety, medication access,
and optimal use of medications, while educating policymakers,
healthcare professionals, and the public about the role of pharmacists
in healthcare delivery.
v. Play a role in policy implementation, collaborating with healthcare
professionals to ensure effective integration into practice, and evaluate
the impact of policies on patient outcomes and healthcare system
performance.
i) Provide Pharmaceutical Marketing services

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i. Provide accurate and valuable information to healthcare practitioners,

emphasizing product aspects, appropriate usage, and sales techniques.
ii. Ensure the information provided is supported by approved labelling or
scientific evidence, responding objectively and in good faith to inquiries.
iii. Deliver excellent customer service to health practitioners,
demonstrating professionalism, and responsiveness, and maintaining
strong client relationships.
iv. Engage in continuous learning and professional development, staying
updated on industry trends, represented products, new offerings, and
relevant regulations.
v. Facilitate documentation and reporting of emerging quality and
standards issues, adhering to GDP guidelines, and ensuring timely
reporting and maintenance.
j) Provide Leadership and administration services

i. Engage in strategic planning by developing goals, objectives, and

initiatives for pharmacy services in collaboration with healthcare
leaders.
ii. Contribute to operational planning by assessing resource needs,
establishing workflows, and developing policies and procedures for
efficient pharmacy service delivery.
iii. Provide input for budget planning by identifying resource requirements
and aligning the pharmacy budget with financial goals.
iv. Determine staffing needs, assess workload, and contribute to workforce
planning by identifying training and development opportunities for
staff.
v. Participate in quality improvement planning, implement evidence-
based practices and optimize medication use processes.
vi. Contribute to risk management planning, ensuring compliance with
regulations, and promoting patient safety in the pharmacy department.
vii. Plan and coordinate professional development activities for staff,
including continuing education programs and support for acquiring
new knowledge and skills.

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viii. Collaborate with healthcare leaders and stakeholders to integrate

pharmacy services effectively, advocating for the role of pharmacy in
improving patient outcomes.
ix. Design and establish the organizational structure of the pharmacy
department, ensuring smooth workflow and coordination within the
department.
k) Provide inspection services
i. Understand and adhere to pharmacy laws, regulations, and guidelines.
Ensure pharmacy operations comply with regulatory requirements.
ii. Maintain accurate records and documentation as required for
inspection. This includes medication dispensing, prescription, and
inventory management records.
iii. Proactively prepare for inspections and audits. Review policies,
procedures, and practices to ensure compliance with regulatory
standards.
iv. Veterinary pharmacy service
i. Provide veterinary public health service
ii. Compound Veterinary Medicines
iii. Stock and Dispense Veterinary Medicine
iv. Provide Veterinary Medicine Counselling and Manage Drug Therapy
v. Provide Veterinary Medicine Education to Other Professionals
vi. Provide veterinary Medicine Supply Chain Management services
vii. Dispose of Veterinary Medicines
viii. Report adverse reactions of Veterinary Medicine

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3.3. SCOPE OF PRACTICE FOR PHARMACISTS

3.3.1. Pharmacist Intern

3.3.1.1. Requirements for designation and licensing

For appointment to INTERN PHARMACIST, a candidate must have
1. Bachelor of Pharmacy Degree (BPharm) or equivalent degrees including
MPharm or PharmD, from an institution recognized by the Pharmacy
and Poisons Board
2. Successfully passed the stage-1 registration exam by the Pharmacy and
Poisons Board
3.3.1.2. Duties and Responsibilities
Under the supervision of the facility Pharmacist, practice in all practice areas
mentioned under section 3.3.2.2.

3.3.2. Pharmacist

3.3.2.1. Requirements for designation and licensing

For an appointment, registration and licensing as PHARMACIST, a candidate
must have
1. Bachelor's degree in Pharmacy (Bpharm) or equivalent degrees
including MPharm and PharmD from an institution recognized by the
Pharmacy and Poisons Board
2. Registration certificate by the Pharmacy and Poisons Board
3. Valid annual practice license by the Pharmacy and Poisons Board
4. Active Member of the Pharmaceutical Society of Kenya
3.3.2.2. Duties and responsibilities
a) Perform all duties and responsibilities of pharmaceutical
technologist in section 3.2.2.2.
b) Provide Supply Chain Management services for Health Products and
Technologies (HPTs)
i. Perform all supply chain management duties and responsibilities of
pharmaceutical technologist
ii. As the head of the HPT unit, manage the selection, quantification,
procurement and distribution of HPTs at sub-county, county
and national level.

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iii. Implement a procurement policy in health facilities to ensure the

safety and availability of HPTs and adhere to purchasing agreements.
iv. As a member of the Commodity Security Technical Working Group
manage timely selection, quantification, procurement and distribution
of HPTs in health facilities.
v. Develop the facility budget for acquisition of HPTs.
vi. Utilize various sources, including the KEML, KEMSL, KEMCL,
County/Hospital Formulary, stock control cards, and consumption
data, for selecting and quantifying HPTs.
vii. Collaborate with the Medicines and Therapeutics Committee (MTC) to
oversee HPT selection, rational drug use, and Antimicrobial
Stewardship (AMS).
viii. Incorporate the National/County/Hospital formulary, Kenya Essential
Medicines List, and Kenya Treatment Guidelines for medication
therapy.
ix. Manage the formulary to ensure its accuracy and relevance to current
healthcare needs.
x. Maintain comprehensive documentation of the entire supply chain
process in compliance with laws and regulations.
xi. Implement policies and guidelines for the provision of supply chain
management of HPTs
xii. Ensure procured HPTs align with facility needs and select reputable
suppliers based on quality standards.
xiii. Supervise all pre/re-packing operations
xiv. Prepare regular report on acquisition, consumption and disposal of
HPTs.
c) Compounding of sterile, non sterile and cytotoxic preparations
i. Perform all compounding duties and responsibilities of pharmaceutical
technologist
ii. Ensure compliance with SOPs, regulatory requirements, and quality
standards in compounding processes.
iii. Prepare compounded drugs or blood products accurately and
consistently.

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iv. Calculate precise ingredient measurements and provide specific

descriptions for accurate replication.
v. Document compounding procedures clearly for traceability and
reproducibility.
vi. Perform compounding activities or assign them to qualified and trained
personnel for quality and safety.
vii. Determine appropriate beyond-use dates using reputable sources or
pharmaceutical knowledge.
viii. Maintain comprehensive records throughout the compounding process.
ix. Establish an efficient recall system for product recalls.
x. Provide adequate hand-washing facilities for hygiene practices.
xi. Ensure an aseptic dispensing environment is available and comply with
facility requirements to prevent contamination.
xii. Implement a safe system of work and appropriate safety measures to
maintain product stability throughout its shelf life.
xiii. Perform aseptic dispensing responsibilities and also assign them
to trained personnel with expertise in pharmaceutical aseptic
technique.
xiv. Establish procedures for accurate aseptic compounding and dosage
calculations.
xv. Adhere to International Society of Oncology Pharmacy Practitioners
(ISOPP) standards for the safe handling of cytotoxic preparations, GMP
and WHO Guidelines for Sterile Products.
xvi. Maintain an aseptic dispensing environment, preferably with a HEPA
filter, and comply with facility requirements.
xvii. Implement procedures to ensure accurate dosage calculations and
prevent incompatibility when adding medications to IV solutions.
d) Provide dispensing Services
i. Perform all dispensing duties and responsibilities of pharmaceutical
technologist
ii. Perform prescription processing
iii. Provide medication counselling to clients
iv. Ensure proper documentation of dispensing activities in the health
facility

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v. Supervise the dispensing process in the health facility

e) Internet Services
i. Perform all internet pharmacy service duties and responsibilities of
pharmaceutical technologist
ii. Ensure consistent and high-quality pharmaceutical care regardless of
the service delivery method (online or in-person).
f) Provide Primary Health Care services
All duties and responsibilities of a pharmaceutical technologist
i. Perform basic individual health assessments
ii. Perform Pharmacy-based Point-of-care testing for screening,
diagnosis and monitoring
a) These tests shall include, but not limited to
1. Cholesterol testing
2. INR testing
iii. Vaccination services
a) Administer vaccines as per MOH protocols
b) Assess and monitor Adverse events following immunisation (AEFIs)
and
c) Ensure adherence to guidelines on cold chain management and
good distribution practices
d) Fill and document Patient vaccine cards
e) Maintain accurate and up-to-date patient records and reporting
f) vi Dispose of vaccines as per the MOH guideline
iv. Reproductive Health Services
a) Provide reproductive health services which shall include but not be
limited to
1. Assessment, management and referral of clients with
reproductive health risks,
2. Assessment, management and referral of patients presenting
with other reproductive health disorders as per MOH protocol
b) Evaluate and manage patients for adverse effects and other health
risks associated with the use of contraceptives
v. Mother and Child Health Services

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a) Provide pharmacy-based Maternity services as per MOH protocol

including but not limited to:
1. Preconception care
a. Assessment for any current medication which may
negatively affect sperm quality, conception or pregnancy
outcomes. Screening for underlying medical conditions e.g.
anaemia, diabetes mellitus, hypertension, STIs among
others
b. Management of underlying medical conditions
c. Provision of information, education and counselling on
lifestyle modifications such as healthy diet, weight
management, physical exercise among others
2. Antenatal care
a. Provision of preventive measures e.g. antenatal prophylaxis
with Anti-D immunoglobulin in non-sensitized Rh-negative
women at 28 - 34 weeks of gestation to prevent RhD
alloimmunization in consultation with a medical
practitioner
b. Provision of tetanus toxoid vaccination
c. Management of underlying medical conditions
d. Provision of information, education and counselling
on danger signs during
b) Provide pharmacy-based newborn care services as per MOH
protocol including but not limited to
1. Evaluation for and administration of Administer oral childhood
immunization services and refer for administration of the
injectable vaccines
c) Provide Pharmacy-based Childhood health services as per MOH
protocol including but not limited to
1. Management of mild to moderate acute malnutrition
2. Management of suspected measles
vi. Provide Nutrition services
a) Provide appropriate nutritional counselling service to special patient
groups, such as those with diabetes, hypertension, renal, liver and

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lipid disorders, elderly patients, stoma patients, terminally ill

patients, and pregnant women.
b) Provide sports nutrition pharmacy services including but not limited
to
1. Supplementation for Athletes
2. Counselling on anti-doping
vii. Medication safety
a) Coordinate supportive supervision and mentorship to ensure
medication safety
b) Establish a protocol for verifying the accuracy and appropriateness
of all prescriptions, including checking for correct patient
information, medication, dosage, route, and frequency
c) Implement double-check procedures for dispensing high-risk
medications and for patients at increased risk of medication-related
harm.
d) Establish a system to ensure comprehensive patient counselling
that includes information on medication purpose, proper
administration, potential side effects, and interactions.
e) Establish a system for the timely reporting and analysis of
medication errors and adverse drug events, including near misses.
f) Coordinate Public health programs related to medication safety,
rational drug use, and disease prevention
g) Provide mentorship and sensitization to other health coordinators
and promotion officers on safe medication use.
h) Conduct drug utilization reviews to assess medication prescribing
patterns, therapeutic outcomes, and cost-effectiveness.
i) Coordinate medication safety programs across all levels of health,
including community pharmacies and community-based
outreaches.
viii. Disease control and prevention
a) Manage public Health Programs (STI including HIV, TB, Malaria,
Neglected & Tropical Diseases (NTDs), Non-Communicable Diseases
(NCDs)

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b) Assess the clients’ eligibility and provide Pre & Post-Exposure

Prophylaxis (PrEP/PEP) Services (STI including HIV counselling,
testing, PEP/PrEP prescribing and dispensing, follow-up and
referral services)
c) Coordinate public and private supply chain management of HPTs
across PHC for disease control and prevention
d) Coordinate the development and implementation of strategies for
screening, prevention and control of disease outbreaks
e) Collect, analyse and submit relevant data to KHIS for all facilities
during outbreaks.
f) Perform order rationalizations and allocations (Perform Data Quality
Audits and Service Quality Assessments (SQAs)) of HPTs
g) Participate in the County and National Performance and Data
reviews and validation.
ix. Manage minor and common ailments
x. Public health emergency preparedness and response
a) Manage the supply of HPTs in emergency/outbreak preparedness
and response including availing of personnel, warehousing facilities
and logistic support.
xi. Health education and promotion
a) Provide mental health education and counselling services including
1. Screening, management and referral for behavioural disorders,
and neuro-developmental disorders as per MOH protocols
2. Rehabilitation for substance-related and addictive disorders as
per MOH protocols
3. Management of affective and psychoactive disorders
xii. Training and Research in Primary Healthcare
a) Provide preceptorship and mentorship to Pharmacist interns and
pharmaceutical Technologists on attachment within the primary
healthcare facilities including community pharmacies.
b) Conduct research on relevant public health pharmacy service
indicators and disseminate the findings
c) Organise Continuous professional development and medical
education activities.

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xiii. Monitoring and Evaluation of Primary Healthcare

a) Participate in both periodic and routine performance reviews, data
quality reviews and other key program M & E activities involving
HPT utilization and Pharmaceutical care at different levels
b) Supervise and monitor pharmaceutical practice within the
different levels of practice
c) Prepare, monitor and enforce review, compliance with
pharmaceutical standard operating procedures and Treatment
Guidelines within the various regions
g) Provide effective Medication Therapy Management (MTM) services
i. Conduct comprehensive assessments of patients, considering
various factors to understand their overall health and identify
potential challenges or barriers.
ii. Identify and resolve medication-related issues by addressing
interactions, adverse effects, and suboptimal regimens.
iii. Educate and empower patients by providing detailed information
about their condition, medications, and self-management strategies.
Encourage their active involvement in healthcare decisions and
support the development of self-management skills.
iv. Ensure continuity of care by coordinating follow-up appointments
and transitions between healthcare settings. Collaborate with other
healthcare providers to minimize errors and promote comprehensive
care.
v. Proactively address medication and health-related problems
outlined in the care plan, taking necessary steps to optimize therapy
and engage in preventive care.
vi. Take authorized action to initiate, modify, or discontinue
medications, ensuring alignment with the care plan and within
professional expertise and scope of practice.
vii. Provide comprehensive education and self-management training to
patients or caregivers, covering medication usage, side effects, and
precautions. Empower them to manage their condition and make
informed healthcare decisions effectively.

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viii. Contribute to coordinating care among healthcare professionals

involved in the patient's treatment, communicating relevant
information and facilitating referrals or transitions when needed.
ix. Schedule and monitor follow-up care to assess progress, evaluate
therapy effectiveness, and make adjustments as necessary to
achieve and maintain therapy goals.
x. Monitor medication therapy's appropriateness, effectiveness, and
safety, utilizing health data, test results, and patient feedback.
Evaluate patient adherence and identify any barriers or challenges.
xi. Document all the activities carried out throughout the MTM services
h) Provide drug Information services to clinicians and patients
i. Anticipate and evaluate drug information needs for patients and
healthcare professionals to support safe medication use and
decision-making.
ii. Collect comprehensive background information for drug information
requests, ensuring all necessary details are obtained.
iii. Use a systematic approach to search, critically evaluate, and analyze
relevant literature, providing a thorough analysis of the evidence.
iv. Synthesize and communicate drug information effectively to
patients, caregivers, and healthcare professionals, enhancing
patient care outcomes.
v. Receive, research, answer, reference, log, and store medicine
information queries.
vi. Document the drug information services provided
i) Clinical Pharmacy Services
i. Provide clinical pharmacy service in Paediatrics, Critical care,
Obstetrics & Gynaecology, reproductive health service including
family planning, Surgical & Anaesthesia, Emergency,
Psychiatry/mental health, Palliative & Hospice, Oncology,
Immunology & Transplantation, Pulmonology, Renal, Infectious
diseases, Geriatrics, Endocrinology, Cardiology, Internal medicine,
Haematology, Ambulatory care, Neurology
ii. Assist the specialist pharmacist in provision of specialty clinical
pharmacy services

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iii. Provide pharmacotherapy services by active participation in

regular ward rounds and support to healthcare teams.
iv. Implement evidence-based antimicrobial stewardship strategies to
optimize antimicrobial use and minimize the development of
antimicrobial resistance.
v. Actively engage in multidisciplinary team meetings to contribute
pharmaceutical expertise to patient care plans.
vi. Provide comprehensive medication counselling to patients and
their caregivers, including detailed information on medication use,
potential side effects, and adherence strategies.
vii. Tailor counselling sessions to the individual patient's needs, health
literacy level, and cultural
viii. Assess adverse drug reactions among hospitalized patients
through systematic monitoring and pharmacovigilance practices.
ix. Provide accurate and timely drug information to healthcare
professionals, patients, and caregivers to facilitate informed
decision-making and safe medication use.
x. Individualise drug dosing regimens based on patient-specific
factors, such as age, weight, renal and hepatic function, and
comorbidities, to optimise therapeutic outcomes and minimise the
risk of adverse events.
xi. Engage in interprofessional collaboration with pharmacy
subspecialties, including clinical specialists in different practice
settings, to facilitate comprehensive patient care and knowledge
sharing.
xii. Contribute to developing and reviewing evidence-based treatment
protocols and guidelines within the hospital setting to standardise
medication practices and improve patient safety.
xiii. Engage in research activities to contribute to the advancement of
clinical pharmacy practice and the development of evidence-based
interventions for improved patient outcomes.
xiv. Accurately and timely document all clinical pharmacy
interventions, medication reviews, and recommendations in the
patient's medical records.

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j) Rehabilitative services and control of Narcotic and Psychotropic

substances
i. Handle and store Narcotic and Psychotropic substances
ii. Dispense Narcotic and Psychotropic substances
iii. Record and account for all Narcotics & Psychotropic substances
according to the MOH guidelines
iv. Provide appropriate rehabilitative and medication use counselling
services
k) Provision of complementary, traditional and alternative medicine
services
i. Participate in the development of policies for complementary,
traditional, and alternative medicine (CTAM) therapies.
ii. Conduct thorough patient assessment including medical history,
physical examination, and review of records.
iii. Evaluate treatment options that will include both conventional and
alternative methods taking into account the risks and benefits.
iv. Assess potential interactions between recommended treatment
and ongoing treatments, documenting findings.
v. Develop individualised treatment plans based on thorough
assessment and tailored to each patient's needs, considering
risk/benefit ratio, patient outcome expectations, and expected
greater benefit.
vi. When necessary, refer patients for further evaluation and
treatment beyond the pharmaceutical care services.
vii. Monitor patient progress and treatment outcomes, scheduling
periodic reviews and adjusting treatment plans as needed.
viii. Inform clients about potential adverse reactions, and interactions,
and provide comprehensive information on treatment risks,
benefits, and precautions. Promote patient safety and informed
decision-making.
ix. Maintain accurate and complete records within the facility.
x. Ensure accessibility and availability of records for review
l) Provide Pharmaceutical Marketing services

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i. Provide accurate and valuable information to healthcare

practitioners, emphasising product aspects, appropriate usage, and
sales techniques to increase utilisation.
ii. Ensure provided information is supported by approved labelling or
scientific evidence, respond objectively and in good faith to
inquiries, and provide relevant data.
iii. Deliver excellent customer service to healthcare practitioners,
demonstrating professionalism and responsiveness, and
maintaining strong client relationships.
iv. Engage in continuous learning and professional development,
staying updated on industry trends, representing products, new
offerings, and relevant regulations.
v. Facilitate documentation and reporting of emerging issues related
to product quality, adhering to GDP guidelines, and ensuring timely
reporting and maintenance of standards.
m) Provide Industrial Pharmacy services
i. Design quality products and manufacturing processes in compliance
with Quality by Design principles.
ii. Ensure consistent product performance and adherence to quality
standards.
iii. Apply scientific approach and risk management to assess and
mitigate formulation development risks.
iv. Establish design space and control strategies to meet regulatory
requirements.
v. Identify critical aspects of drug substances, excipients, and
manufacturing processes.
vi. Prepare comprehensive reports documenting formulation
development and key quality considerations.
vii. Conduct in-process controls to monitor manufacturing processes
and prevent quality issues.
viii. Maintain detailed records and investigate deviations from established
procedures.
ix. Ensure accurate inventory control through yield checks and
reconciliation.

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x. Ensure proper storage, labelling, and distribution of manufactured

products.
n) Provide pharmacy education at middle-level institutions
i. Deliver lectures, facilitate discussions, and mentor pharmacy
students in practice settings.
ii. Develop assessment methods to measure students' understanding
and proficiency.
iii. Advise students on course selection, career paths, and professional
development.
iv. Conduct and lead research studies, seeking funding opportunities.
v. Mentor students, residents, and researchers in projects.
vi. Present research findings, ensuring ethical compliance.
vii. Engage in continuous professional development to stay current in
pharmacy practice.
viii. Participate in research policy discussions and innovation initiatives.
ix. Support quality improvement, compliance, and patient safety in
healthcare institutions.
o) Provide leadership and administration services
i. Provide leadership at county and sub-county levels
ii. Provide leadership at community and hospital pharmacy
iii. Ensure availability of policies and procedures for day-to-day
operations in all areas of the organization.
iv. Engage in strategic planning by developing goals, objectives, and
initiatives for pharmacy services in collaboration with healthcare
leaders.
v. Contribute to operational planning by assessing resource needs,
establishing workflows, and developing policies and procedures for
efficient pharmacy service delivery.
vi. Provide input for budget planning by identifying resource
requirements and aligning the pharmacy budget with financial
goals.
vii. Determine staffing needs, assess workload, and contribute to
workforce planning by identifying training and development
opportunities for staff.

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viii. Participate in quality improvement planning, implement evidence-

based practices and optimize medication use processes.
ix. Contribute to risk management planning, ensuring compliance with
regulations and promoting patient safety in the pharmacy
department.
x. Plan and coordinate professional development activities for staff,
including continuing education programs and support for acquiring
new knowledge and skills.
xi. Collaborate with healthcare leaders and stakeholders to integrate
pharmacy services effectively, advocating for the role of pharmacy
in improving patient outcomes.
xii. Design and establish the organizational structure of the pharmacy
department, ensuring smooth workflow and coordination within the
department.
p) Provide regulatory and inspection services
i. Understand and adhere to pharmacy laws, regulations, and
guidelines. Ensure pharmacy operations comply with regulatory
requirements.
ii. Maintain accurate records and documentation as required by
regulatory bodies. This includes medication dispensing,
prescription, and inventory management records.
iii. Proactively prepare for inspections and audits. Review policies,
procedures, and practices to ensure compliance with regulatory
standards.
iv. Cooperate with regulatory authorities and provide requested
information during inspections. Address identified concerns or
findings.
v. Engage in ongoing quality improvement efforts. Update policies,
train staff, and foster a compliance culture.
q) Provide Clinical trial and research services
i. Offer drug information and support to healthcare professionals
involved in clinical investigational trials.
ii. Foster the professional growth and development of staff.

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iii. Monitor pharmacy activities to ensure compliance with study

protocols and dispensing procedures.
iv. Attend and actively contribute to interdisciplinary team meetings for
clinical investigational drug trials.
v. Monitor pharmacy activities to maintain accurate inventory records
and billing for trials.
vi. Participate in developing software programs for managing clinical
investigational drug trials.
vii. Collect and document workload measurement statistics and provide
requested data.
viii. Prepare reports, including incident reports and adverse drug
reaction reports.
ix. Take overall responsibility for pharmacy operations in the assigned
area.
x. Supervise and provide guidance to technical/support staff.
r) Provide Pharmacovigilance services
i. Manage pharmacovigilance services of the county, sub-county and
health facility
ii. Remain vigilant for the occurrence of adverse events and adverse
drug reactions associated with Health Products and Technologies
during direct interactions with patients, documenting these events
in individual Patient Medication Records.
iii. Report any occurrence of adverse events and adverse drug reactions
to the Kenya National Pharmacovigilance Centre using the
prescribed reporting format.
iv. Provide appropriate instructions to patients to minimize future
adverse effects, including guidance on correct medication
administration, avoidance of specific medications or foods,
restrictions on certain activities, or consultation with the prescribing
doctor.
v. Actively engage in the surveillance of safety and quality issues
related to Health Products and Technologies within the practice
setting

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vi. Prepare periodic adverse event reports in adherence to

Pharmacovigilance guidelines.

s) Sport pharmacy service

i. Conduct thorough medication reviews for athletes, ensuring no
interactions that could affect performance or health.
ii. Evaluate athletes' nutritional needs, offering personalized
recommendations to support training and recovery.
iii. Educate athletes on anti-doping regulations and risks associated
with banned substances for compliance.
iv. Assist athletes in managing medications for conditions or injuries,
ensuring proper dosing and adherence.

t) Veterinary Pharmacy services

i. Provide veterinary Public Health and antimicrobial Stewardship

ii. Manufacture and quality assurance of Veterinary Medicines
iii. Regulatory Affairs for Veterinary Medicine
iv. Wholesale and Distribution of Veterinary Medicines
v. Provide Veterinary Medicine Education to Other Professionals
vi. Design and development of formulations for veterinary medicines.
vii. Clinical & non-clinical trials

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3.4. SCOPE OF PRACTICE OF SPECIALIST PHARMACIST

3.4.1. Pharmacist Specialist

3.4.1.1. Requirements for designation and licensing

A candidate must have the following qualifications to be registered, licensed
and recognized as a PHARMACIST SPECIALIST.
1. Bachelor of Pharmacy Degree (BPharm) or equivalent degree including
MPharm and PharmD from an institution recognized by the Pharmacy and
Poisons Board
2. Master’s degree in any of the following: Pharmaceutical Policy analysis and
formulation; Pharmacognosy and complementary medicine; Toxicology;
Clinical Pharmacy; Pharmacovigilance and Pharmacoepidemiology;
Medicines Supplies Chain Management; Medicines Regulation; Regulatory
Affairs; Pharmaceutics; Pharmacology and Therapeutics; Molecular
pharmacology; Pharmaceutical Analysis; Sport Pharmacy; Veterinary
Pharmacy; Tropical and Infectious Diseases; Medicinal and
Pharmaceutical Chemistry; Industrial Pharmacy; Health Economics;
Epidemiology; Biostatistics; Drug Design and Development; Clinical trials;
Quality Assurance; Radiopharmacy; Public Health; or Microbiology from
an institution recognized by the Pharmacy and Poisons Board
3. Certificate of registration as PHARMACIST by the Pharmacy and Poisons
Board
4. Valid practicing licence from the Pharmacy and Poisons Board
5. Active member of the Pharmaceutical Society of Kenya
6. Must have completed a one (1) year post-Masters residency in the relevant
field
7. Certificate of recognition as pharmacist specialist

3.4.1.2. Duties and responsibilities

1. Perform all duties and responsibilities mentioned under Pharmacist in
section 3.3.2.2
2. Provide quality specialty pharmacy services in their respective fields
of specialty
3. Perform Pharmacovigilance and pharmacoepidemology services
including but not limited to

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i. Regular training of other healthcare workers on

pharmacovigilance and pharmacoepidemiology
ii. Review patients for adverse drug reactions
iii. Develop databases and registries on drug use in the population
iv. Use data to inform policy and practice
v. Routing drug use surveillance and drug utilization reviews
vi. Participate in drug forecasting
vii. Develop formulary
viii. Pharmacoeconomic evaluation
ix. Investigation of serious AEs, adverse drug reactions and AEFIs in
conjunction with the county PV focal person
x. Poor quality medicine reporting as a role for both pharmacist and
pharmaceutical technologists
xi. Data analysis and causality assessment of adverse drug reactions
xii. Pharmacovigilance and pharmacoepidemology research
xiii. Drug and vaccine safety surveillance
xiv. Medical device pharmacoepidemiology services
xv. Provision of haemovigilance services
4. Therapeutic drug monitoring and clinical pharmacokinetic
services including but not limited to
i. Ensure precise measurement and analysis of drug
concentrations in patient samples to facilitate appropriate dosage
adjustments.
ii. Provide timely results to healthcare providers to enable prompt
therapeutic interventions and dosage adjustments.
iii. Offer comprehensive interpretation of drug concentration data in
the context of individual patient factors, such as age, weight,
renal function, and concomitant medications.
iv. Effectively communicate TDM results and pharmacokinetic
recommendations to healthcare teams, including pharmacists,
physicians, and nurses.
v. Identify and alert healthcare providers to potential drug
interactions, adverse effects, or toxicity based on TDM results.

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vi. Provide patient and caregiver education regarding the importance

of TDM, dosage adjustments, and medication adherence to
optimize therapeutic outcomes.
vii. Implement quality improvement initiatives to enhance the
accuracy, efficiency, and effectiveness of TDM and clinical
pharmacokinetic services.
viii. Maintain accurate and complete records of TDM results,
pharmacokinetic calculations, interventions, and follow-up
actions in patient medical records or electronic health systems.
ix. Ensure adherence to relevant regulatory requirements,
standards, and guidelines governing TDM and clinical
pharmacokinetic practices.
x. Monitor and evaluate patient outcomes, such as therapeutic
response, adverse reactions, and medication adherence, to assess
the impact of TDM and pharmacokinetic interventions on clinical
outcomes.
xi. Provide clinical pharmacokinetic consultations to healthcare
professionals, guiding them in drug dosing decisions and the
optimization of drug regimens based on patient-specific factors
such as age, and renal or hepatic function.
xii. Perform pharmacokinetic calculations including clearance,
volume of distribution, half-life, and loading/maintenance dose
to determine the most appropriate dosing regimens for achieving
desired drug concentrations in patients.
xiii. Optimize therapeutic drug dosing regimens by carefully
considering patient-specific factors, therapeutic goals, and
pharmacokinetic parameters, including the adjustment of doses
based on drug, concentrations, patient response, and potential
interactions.
xiv. Develop and implement drug dosing guidelines and protocols
based on pharmacokinetic principles and evidence-based
practices to standardize care and improve patient outcomes.
5. Pharmacogenomics services
i. Order appropriate genetic tests and interpret results.

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ii. Gather patient-specific information, including medical history,

current medications, and family history, to assess the need for
pharmacogenomic testing.
iii. Select the most appropriate medications for individual patients.
iv. Collaborate with healthcare providers, including physicians,
nurses, and other pharmacists, to discuss the implications of
genetic test results.
v. Educate patients about pharmacogenomic testing and its impact
on their medication therapy.
vi. Monitor patients' responses to medications and make necessary
adjustments based on the genetic information.
vii. Ensure that pharmacogenomic testing procedures are performed
accurately and adhere to regulatory standards.
viii. Integrate pharmacogenomic testing and interpretation into
routine clinical practice.
6. Clinical Toxicology Services
i. Provide toxicology consultations to healthcare professionals,
including physicians, nurses, and other members of the
healthcare team
ii. Manage and respond to poison information inquiries from
healthcare professionals and the public.
iii. Perform toxicology screenings, such as urine drug screens or
blood toxicology tests, and interpret the results to aid in the
diagnosis and management of toxic exposures.
iv. Manage and ensure the availability of antidotes and other
specific therapies used in the treatment of toxic exposures.
v. Monitor patients for adverse drug reactions and medication-
related toxicities.
vi. Participate in poison control centers and provide expert
guidance in managing poison exposures.
vii. Ensure accurate and comprehensive documentation of
toxicology consultations, poison exposures, treatment
recommendations, and outcomes.
7. Radiopharmacy

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i. Dispense radiopharmaceuticals purchased from authorized

manufacturers or centralized radio pharmacies as per Kenya
National Radiation Authority (KENRA) requirements.
ii. Label radiopharmaceutical containers with necessary
information.
iii. Follow regulatory requirements for waste disposal and maintain
biohazardous waste containers.
iv. Ensure compliance with local and national regulations for
biohazardous waste disposal.
v. Maintain accurate manufacturing records to demonstrate
compliance.
vi. Conduct checks on yields and reconcile quantities for accuracy.
vii. Store and distribute products appropriately to maintain quality.
viii. Perform tests to ensure materials and products meet quality
requirements.
ix. Take authorized samples, maintain records, and investigate
deviations.
8. Pharmacy education at middle level and tertiary institutions
i. Delivery lectures and facilitate interactive learning for pharmacy
students.
ii. Mentor and guide students during experiential learning
rotations in pharmacy practice settings.
iii. Develop effective assessment methods to evaluate student's
knowledge and proficiency.
iv. Advise and support students in course selection, career paths,
and professional development.
v. Seek research funding and collaborate with other researchers to
enhance outcomes.
vi. Ensure ethical compliance in research activities and review
proposals for ethical standards.
vii. Engage in continuous professional development to stay current
in pharmacy practice.
viii. Contribute to community service, participate in committees, and
advocate for the pharmacy profession.

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9. Clinical trials and research

i. Offer drug information and support to healthcare professionals
involved in clinical investigational trials.
ii. Foster the professional growth and development of staff.
iii. Monitor pharmacy activities to ensure compliance with study
protocols and dispensing procedures.
iv. Attend and contribute to interdisciplinary team meetings for
clinical investigational drug trials.
v. Monitor pharmacy activities to maintain accurate inventory
records and billing for trials.
vi. Contribute to the development of software programs for managing
investigational drug trials.
vii. Collect and document workload measurement statistics and
provide requested data.
viii. Prepare reports, including incident reports and adverse drug
reaction reports.
ix. Take overall responsibility for pharmacy operations in the
assigned area.
x. Supervise and guide technical/support staff.

3.4.2. Pharmacist Sub-Specialist

3.4.2.1. Requirements for designation and licensing

A candidate must have the following qualification to be appointed, registered,
licensed, and recognized as a PHARMACIST SUB-SPECIALIST.
1. Bachelor of Pharmacy Degree (Bpharm) or equivalent degrees including
MPharm and PharmD from an institution by the Pharmacy and Poisons
Board.
2. Certificate of registration as PHARMACIST by the Pharmacy and
Poisons Board.
3. Valid practicing license from the Pharmacy and Poisons Board
4. Recognized and served as a PHARMACIST SPECIALIST for at least five
(5) years
5. Completed at least one Board certified/recognized professional course
or fellowship program for a duration not less than six months

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6. Be an active member of the Pharmaceutical Society of Kenya

3.4.2.2. Duties and responsibilities
1. Perform all duties and responsibilities mentioned under Pharmacist
Specialist in section 3.4.1.2.
2. Provide high-level specialty pharmacy services in their respective fields
of sub-specialty

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CHAPTER FOUR

CATEGORIZATION AND STANDARDS FOR PHARMACY

FACILITIES

4.1. CATEGORIZATION OF FACILITIES FOR PHARMACY SERVICE

4.1.1.Categorization of Health Facility Pharmacy Premises

Category Name of Practice Minimum

of facility Qualifications for
Superintendent
Level 1 Community health services Pharmaceutical
technologist
Level 2 Dispensary clinics Pharmaceutical
technologist
Level 3 Health Centre Pharmacist
Level 4 Primary Hospital Pharmacist
Level 5 Secondary Hospital Pharmacist specialist
Level 6 Tertiary Hospital, National Pharmacist specialist
teaching and referral hospital

4.1.2. Categorization of Community Pharmacy Premises

Category of Name of Premise Minimum

Pharmacy Qualifications for
Superintendent
Level 2A Dispensing Pharmacy Pharmaceutical
technologist

Level 2B Dispensing Pharmacy Board certified

Pharmaceutical
technologist
Level 3 Pharmaceutical care centre Pharmacist

Level 4 Specialty Pharmaceutical Pharmacist specialist

Care Centre

4.1.3. Categorization of Wholesale, Distribution and Manufacturing

Category Name of facility Minimum Qualifications

for Superintendent
Level 1 Warehousing Pharmacist

Level 2 Wholesale and Distribution Pharmacist

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Level 4 Local Technical Representation Pharmacist

(LTR)
Level 3 Manufacturing Pharmacist Specialist

4.1.4. Categorization of Pharmacy Training Institutions

Category of Name of facility Minimum

facility Qualification for the
Team Lead
Middle-Level TVET and colleges Pharmacist

Higher Level University Specialist Pharmacist

(PhD)

4.2. STANDARDS FOR HEALTH FACILITY PHARMACY PREMISES

4.2.1.Level 2 Facility: Dispensary

4.2.1.1. Scope of Services

Services Tasks Infrastructure and
equipment
requirements
1. Supply chain Selection and Drug Store,
management of quantification of HPTs Quarantine/Expiries
Health Products Procurement of HPTs area
and technologies Office, Incinerator,
Storage and Distribution of
(HPTs) Refrigerator, Cool
HPTs
boxes, Pallets, Waste
Waste Management and bins.
Disposal of Pharmaceutical Thermo/hygrometer,
waste Lockable cabinets,
Shelves
2. Pre-packing Pre-packing of Dispensing envelopes,
pharmaceuticals Labels
3. Dispensing of Receiving, Interpretation Dispensing space,
medication and evaluation of worktop, HMIS, Desk
prescription and chairs, Lockable
Selection, Preparation and cabinets
labeling of a prescribed Files, Reference
medicine materials, computer,
Delivery of medicine and Various documenting
Provision of information registers e.g. Antibiotic
and instruction to the registers, Narcotic
patient to ensure the safe Drug registers,
and effective use of Pharmacovigilance
medicine tools
Record keeping

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4. Provide Drug Provision of Drug

Information to Information
patients and
healthcare workers
5. Provision of
Pharmacovigilance pharmacovigilance services

4.2.1.2. Infrastructure and Equipment Requirements for

Dispensary Pharmacy
General: Facilities should comply with NEMA, and other relevant regulations,
and be easily accessible to people with disabilities.
Requirement Minimum Standards

Waiting area ● Should provide protection from the sun and other
elements and be situated near the dispensing area,
areas for counselling, and the furnishing of information
and/or consultation areas.
● Comfortable seats
● The total area should NOT be less than 150 square feet.
Dispensing area ● Should be located adjacent to the waiting area, and
clients should NOT have direct access to products
situated here.
● Products should be stored on shelves starting at a
height from the floor, which prevents contamination or
damage to products by floor debris.
● The total area should NOT be less than 150 sq ft.
● The temperature and humidity shall be controlled to be
15-3025 degrees centigrade and humidity <60% RH
(Relative Humidity). Monitoring shall be done using a
wall thermometer and humidity meter. The data
collected should be recorded manually three times a
day, preferably in the morning, noon, and evening on a
temperature log
●
● There shall be a refrigerator with a thermometer. on a
temperature log form. The temperature should be
maintained between 2 and 8 degrees centigrade and
recorded at three time points on a temperature log
form.
● There shall be a provision for adequate power backup
in case of primary power failure.
Counselling/ ● Semi-private area
Consultation
Room The area(s) could be of a modular “bank teller” type, where
a counter is utilized, offering the patient or his/her
agent/caregiver reasonable private access, or an aperture,
which is surrounded by a “telephone booth” type structure

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Requirement Minimum Standards

to prevent other persons from crowding around the patient

or his/her agent/caregiver who is communicating.
Private area
Shall occupy a space not less than 75 sq ft. It should have
a table, comfortable chairs, and shelves for reference
books. The area should be such that the pharmacist has
easy access to it from the dispensing area, and the patient
has easy access.
Drug Store ● The storage area of HPTs shall be sufficient for keeping
all inventories at appropriate stockholding levels.
● The total area should NOT be less than 300 sq ft.
● There shall be sufficient physically separated areas
with appropriate storage conditions for orderly
segregation of products namely biological, refrigerated,
and corrosive liquids and solids.
● The temperature and humidity shall be controlled to be
between 15 and 30 degrees centigrade and less than
5% RH (Relative Humidity). Monitoring shall be done
using a wall thermometer and hygrometer. The data
collected should be recorded manually three times a
day, preferably in the morning, noon, and evening.
● All instruments used for temperature monitoring shall
be calibrated, and the calibration shall be documented.
● Separate areas for receiving and issuing shall be
provided to enhance efficiency and security.
● Receiving of goods in the receiving area shall be
inspected and entered into the stock recording system,
which may be manual, computerized or both.
● Storage areas must have sufficient shelving
constructed from a smooth, easy to clean, and
impermeable material, that is easy to maintain in a
hygienic condition.
● Walls must be finished in a smooth, washable and
impermeable material, that is easy to maintain in a
hygienic condition.
● The store shall be secure to prevent unauthorised
access, theft and pest infestation.
Lockable ● The enclosure shall be clearly labelled “Quarantine
Quarantine Area”. This area shall be divided into 2 spaces, 1:
Area Damaged/expired pharmaceutical products and 2:
Biohazard sharps.
● All products and waste materials that fall within this
category shall be stored in this area.
● Disposalof pharmaceutical waste shall follow the laid
down policies.
● The area should be of adequate size but not less than
15 square feet.

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Requirement Minimum Standards

Toilet facilities There shall be provision for adequate toilet facilities

●
with a handwashing point. The minimum is 1 unisex
facility with flowing water, flushing equipment and
disposal units for feminine and children’s hygiene
products
Drug ● Shall occupy a space not less than 75 sq ft. It should
Information have a table, comfortable chairs, lockable cabinets,
Centre shelves and reference materials.
Equipment and Drug Store, Quarantine/Expiries area, Office space with
infrastructure printer
Incinerator, Refrigerator, Cool boxes, Pallets, Waste bins,
Thermohygrometer, Lockable cabinets, Shelves, Reference
materials, Dispensing envelopes, Labels, Dispensing
space, Worktop, HMIS, Computer, Phone, Reference
materials, Reporting tools, Training materials, Guidelines,
manuals and SOPs, Checklists, Meeting room

4.2.1.2. Schedule of medicines for level 2 Dispensing pharmacy

This shall be derived from the Schedule of Medicines developed or from the
Kenya Essential medicine list.

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4.2.2.Level 3 Facility: Health Centre Pharmacy

4.2.2.1. Scope of services

Services Tasks Infrastructure and

equipment requirements
1. Supply chain Selection and Drug Store,
management of quantification of HPTs Quarantine/Expiries area,
Health Products Office, Incinerator,
and technologies Refrigerator, Cool boxes,
(HPTs) Procurement of HPTs Pallets, Trolleys, Waste
Storage and Distribution bins,
of HPTs Thermometer,hygrometer,
Waste Management and Lockable cabinets, Shelves
Disposal of Refrigerator
Pharmaceutical waste
2. Compounding Compounding of Compounding Space,
and Pre-packing Pharmaceuticals Weighing balance, Mortar
and pestle,
Slab, Spatula, weighing
paper, Beakers, Filter
papers, Graduated
cylinders, Hotplates,
measuring cylinders,
Pipettes, Mixer/stirring
rod, Reference
materials/Compendium
Pre-packing of Dispensing envelopes,
pharmaceuticals
3. Dispensing of Receiving, interpreting, Dispensing space,
medication and evaluating Worktop, HMIS, Desk and
prescriptions chairs, Lockable cabinets,
Selection, Preparation Files, Shelves, and
and labelling of reference materials,
prescribed medicine computers, refrigerator
Delivery of medicine and
Provision of information
and instructions to the
patient to ensure the safe
and effective use of
medicine
Recording keeping
4. Provide Drug Provision of Drug
Information to Information
patients and
healthcare
workers

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Services Tasks Infrastructure and

equipment requirements
5. Primary Health Provision of HPTs to
Care Community Health
Promoters
Monitoring the use of
HPTs among the CHPs
Mother and child health

Immunization,
●
family planning,
child wellness etc
Nutrition Advice
6. Provision of
Pharmacovigilance pharmacovigilance
services

4.2.2.2. Infrastructure and Equipment Requirements for a

Health Centre Pharmacy
General: Facilities should comply with NEMA, and other relevant regulations,
and be easily accessible to people with disabilities.
Requirements Minimum standards
Waiting area ● Should be covered and situated near the
dispensing area, areas for counselling, and
the furnishing of information and/or
consultation areas.
● The total area should NOT be less than 300
sq ft.
Dispensing area ● Should be located adjacent to the waiting
area, and clients should NOT have direct
access to products situated here.
● Products should be stored on shelves
starting at a height from the floor, which
prevents contamination or damage to
products by floor debris.
● The total area should NOT be less than 300
sq ft.
● The temperature and humidity shall be
controlled to be 25 degrees centigrade and
humidity <60% RH (Relative Humidity).
Monitoring shall be done using a wall
thermometer and humidity meter. The data
collected should be recorded manually three
times a day, preferably in the morning, noon,
& evening.
● The refrigerator shall have a fridge
thermometer and be monitored and recorded

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Requirements Minimum standards

at three-time points. The temperature should
be maintained between 2 and 8 degrees
centigrade.
● There shall be a provision for adequate power
backup in case of primary power failure.
Counselling/Consultation ● Semi-private area
Room
The area(s) could be of a modular “bank teller”
type, where a counter is utilized, offering the
patient or his/her agent/caregiver reasonable
private access or an aperture, which is
surrounded by a “telephone booth” type
structure to prevent other persons from
crowding around the patient or his/her
agent/caregiver who is communicating.

● Private area

Shall occupy a space not less than 75 sq ft. It

should have a table, comfortable chairs and
shelves for reference books. The area should be
such that the pharmacist has easy access to it
from the dispensing area, and the patient has
easy access.
Compounding area ● Can be a designated space within the
dispensing area adjacent to the water source.
● All compounding equipment and reference
materials shall be located in the work area
where compounding will be conducted.
● The total area should NOT be less than 50sq
ft.
Drug Store ● The storage area of HPTs shall be sufficient
to keep all inventories at appropriate
stockholding levels.
● The total area should NOT be less than 300
sq ft.
● There shall be sufficient physically separated
areas with appropriate storage conditions for
an orderly segregation of products, namely
biological, refrigerated, inflammable and
corrosive liquids and solids, cytotoxic drugs,
Dangerous Drugs and Psychotropic
Substances.
● The temperature and humidity shall be
controlled to be 15 to 30 degrees centigrade
or below and <5% RH (Relative Humidity).
Monitoring shall be done using a wall
thermometer and humidity meter. The data
collected should be recorded manually three

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Requirements Minimum standards

times a day, preferably in the morning, noon
& evening.
● All instruments used for temperature
monitoring shall be calibrated, and the
calibration shall be documented.
● Separate areas for receiving and issuing shall
be provided to enhance efficiency and
security.
● Received goods in the receiving area shall be
inspected and entered into the stock
recording system, which may be manual,
computerized or both.
● Storage areas must have sufficient shelving
constructed from a smooth, washable, and
impermeable material, that is easy to
maintain in a hygienic condition.
● Walls must be finished in a smooth,
washable and impermeable material, that is
easy to maintain in a hygienic condition.
Quarantine Area . ● The enclosure shall be clearly labelled
“Quarantine Area”. This area shall be divided
into 2 spaces, 1: Damaged/expired
pharmaceutical products & 2: Biohazards
sharps.
● All products and waste materials that fall
within this category shall be stored in this
area.
● Disposal shall follow the policy for disposal of
pharmaceutical waste.
● The area should be of adequate size but not
less than 15 square feet.
Toilet facilities ● There shall be provision for adequate toilet
facilities . The minimum being 1 unisex
facility with flowing water, flushing
equipment and disposal units for feminine
and children’s hygiene products
Drug Information Centre ● Shall occupy a space not less than 75 sq ft.
It should have a table, comfortable chairs,
lockable cabinets, shelves and reference
materials.
Infrastructure and Drug Store, Quarantine/Expiries area, Office
equipment space with printer
Incinerator, Refrigerator, Cool boxes, Pallets,
Waste bins, Thermohygrometer, Lockable
cabinets, Shelves, Reference materials,
Dispensing envelopes, Labels, Dispensing
space, Worktop, HMIS, Computer, Phone,
Reference materials, Reporting tools, Training
materials, Guidelines, manuals and SOPs,

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Requirements Minimum standards

Checklists, Meeting room, Compounding Space,
Weighing balance, Mortar and pestle, Slab,
Spatula, Weighing paper, Beakers, Filter papers,
Graduated cylinders, Hotplates, Measuring
cylinders, Pipettes, Mixer/stirring rods

4.2.2.3. Schedule of medicines for level 3 Dispensing pharmacy

This shall be derived from the Schedule of Medicines developed or from the
Kenya Essential medicine list.

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4.2.3.Level 4 Hospital Pharmacy

4.2.3.1. Scope of services

Services Task Infrastructure and

equipment
requirements
1. Supply chain Selection and Drug Store,
management of quantification of HPTs Quarantine/Expiries
Health Products Procurement of HPTs area, Office, Incinerator,
and technologies Storage and Distribution Refrigerator, Cool boxes,
(HPTs) of HPTs Pallets, Trolleys, Waste
bins,
Waste Management and Thermometer/hygromete
Disposal of r, Lockable cabinets,
Pharmaceutical waste Shelves,logistic
management information
system
2. Compounding Compounding of Compounding Space,
and Pre-packing Pharmaceuticals Weighing balance,
Mortar and pestle,
Slab, Spatula, weighing
paper, Beakers, Filter
papers, Graduated
cylinders, Hotplates,
measuring cylinders,
Pipettes, Mixer/stirring
rod, Reference
materials/Compendium
Pre-packing of Dispensing
pharmaceuticals envelopes,bottles, and
labels
3. Dispensing of Receiving, interpreting, Dispensing space,
medication and evaluating Worktop, HMIS, Desk
prescriptions and chairs, Lockable
Selection, Preparation cabinets,
and labelling of Files, Shelves, and
prescribed medicine reference materials,
Delivery of medicine and computers, registers
Provision of information
and instructions to the
patient to ensure the safe
and effective use of
medicine
Recordkeeping
4. Primary health Provision of HPTs to
care services Community Health
Promoters

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Services Task Infrastructure and

equipment
requirements
Monitoring the use of
HPTs among the CHPs
Mother and child health
services
(Immunization, family
planning, child wellness
etc)
Nutrition and health
5. Effective Collect necessary Consultation room,
medication information about the Lockable cabinets, Desk
therapy patient and chairs, BP machine,
management Assess the information Stethoscope, point-of-
(MTM) collected and analyze the care RDT kits,
clinical effects of the Glucometer,
patient’s therapy i.e. Weighing scale, IR
Medication therapy thermometer,
review and Tongue depressor,
Develop an individual computers, consult
patient centered care forms, reference
plan i.e. the Medication materials
related action plan and
the Personal medication
records
Implement care plan
Monitor patient progress
and outcomes
Document and follow up
6. Drug Provision of Drug Drug information center:
Information to information Room, Lockable
patients and cabinets, Desk and
healthcare chairs, Computer,
workers Shelves
Phone, Reference
materials
7. Provide quality Paediatric Clinical Clinical pharmacy Office
Clinical pharmacy Pharmacy Service in each ward: space,
services Surgical and Desk and chairs,
Anaesthesiology Clinical Lockable cabinets,
Pharmacy Services Computer
Reference materials
Critical Care Pharmacy
Emergency Department
Clinical Pharmacy
Practice

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Services Task Infrastructure and

equipment
requirements
Clinical Pharmacy
Practice in Obstetrics and
Gynaecology
Infectious Disease
Clinical Pharmacy
Services including
Antimicrobial
stewardship
Oncology Clinical
Pharmacy services
Renal Clinical Pharmacy
services
8 Clinical Provision of clinical Resource center, Phone,
toxicology services toxicology services Reference materials,
9. Provision of Screening and
Pharmacovigilance pharmacovigilance monitoring equipment,
services antidotes
10. Handling and Handling and dispensing MAT Clinic: Room, Desk
control of narcotic of narcotic and and chairs, Lockable
and psychotropic psychotropic substances cabinets,
substances, and Patient-centered care in HMIS, Automated
Rehabilitative treating drug abuse dispensing machines
services patients. (MAT), Narcotic registers
Provision of Smoking
cessation services
Provision of Medication-
assisted treatment (MAT)
Provision of the above
services in residential and
nursing homes.
11. Leadership Planning, organizing, Office, Meeting room,
and directing, staffing and Computer, Desk and
administration controlling of activities in chairs, Lockable
the healthcare systems. cabinets, Reference
materials
12 Clinical trial Conducting clinical trials Room, Computer, Desk
and research and research and chairs, Lockable
cabinets,protocols

4.2.3.2. Infrastructure and Equipment Requirements for Level

4 hospital pharmacy

General: Facilities should comply with NEMA, and other relevant regulations,
and be easily accessible to people with disabilities.

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Requirements Minimum standard

Waiting area Same Standard as Level 3 Facility
Dispensing area
Counselling/Consultation
Room
Compounding area
Drug Store
Toilet facilities
Medication Therapy ● Weighing machine, thermometer, blood
Management pressure machine, oximeter, pill pack boxes,
consultation Room medication therapy management health
management system (MTMHMS)

Have sufficient size and accommodations to

comfortably seat at least three people (two for
interactive video) at a table
Be private, so that when a typical patient is
sitting or standing in the consulting area, the
patient cannot be seen by others (including
other patients, customers and employees)
Be used entirely for enhancing patient outcomes
and not used as a storage room for merchandise
or other non-related items
Be accessible to the patient without having to
traverse through dispensing or storage areas
Be enclosed sufficiently to prevent typical
patient consultation conversations from being
heard from other areas of the business
Be enclosed sufficiently to prevent noise from
other areas of the business from interference
with or distraction from typical conversation in
the consulting area
Clinical pharmacy The facility shall have a Clinical Pharmacy
services Office Services office in each ward
Quarantine Area ● The enclosure shall be clearly labelled
“Quarantine Area”. This area shall be divided
into 2 spaces, 1: Damaged/expired
pharmaceutical products & 2: Biohazards
sharps.
● All products and waste materials that fall
within this category shall be stored in this
area.
● Disposal shall follow the policy for disposal of
pharmaceutical waste.
● The area should be of adequate size but not
less than 15 square feet.
● There shall be provision for adequate toilet
facilities . The minimum is one unisex facility
with flowing water, flushing equipment and

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Requirements Minimum standard

disposal units for feminine and children's
hygiene products
Drug and poisons Shall occupy a space not less than 75 sq ft. It
Information Centre should have a table, comfortable chairs,
lockable cabinets, shelves, com and reference
materials.
Infrastructure and Drug Store, Quarantine/Expiries area, Office
equipment space with printer
Incinerator, Refrigerator, Cool boxes, Pallets,
Waste bins, Thermohygrometer, Lockable
cabinets, Shelves, Reference materials,
Dispensing envelopes, Labels, Dispensing
space, Worktop, HMIS, Computer, Phone,
Reference materials, Reporting tools, Training
materials, Guidelines, manuals and SOPs,
Checklists, Meeting room, Compounding Space,
Weighing balance, Mortar and pestle, Slab,
Spatula, Weighing paper, Beakers, Filter papers,
Graduated cylinders, Hotplates, Measuring
cylinders, Pipettes, Mixer/stirring rod,
Consultation room, BP machine, Stethoscope,
point-of-care RDT kits, Glucometer, Weighing
scale, IR thermometer, Tongue
depressor, Screening and monitoring
equipment, Examination room, Examination
couch, Medical examination torch, Automated
dispensing machines (MAT),

4.2.3.3. Schedule of medicines for level 4 Dispensing pharmacy

This shall be derived from the Schedule of Medicines developed or from the
Kenya Essential medicine list.

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4.2.4.Level 5 Hospital Pharmacy

4.2.4.1. Scope of services

Services Task Infrastructure and

equipment
requirements
1. Supply chain Selection and Drug Store,
management of quantification of HPTs Quarantine/Expiries
Health Products Procurement of HPTs area, Office, Incinerator,
and technologies Storage and Distribution of Refrigerator, Cool boxes,
(HPTs) HPTs Pallets, Trolleys, Waste
bins,
Waste Management and Thermo/hygrometer,
Disposal of Pharmaceutical Lockable cabinets,
Waste Shelves, Logistic
management information
system
2. Compounding Compounding of Compounding Space,
and Pre-packing Pharmaceuticals Weighing balance,
Mortar and pestle,
Slab, Spatula, weighing
paper, Beakers, Filter
papers, Graduated
cylinders, Hotplates,
measuring cylinders,
Pipettes, Mixer/stirring
rod, Reference
materials/Compendium
Pre-packing of Dispensing envelopes,
pharmaceuticals bottles and labels
3. Dispensing of Receiving, interpreting, Dispensing space,
medication and evaluating Worktop, HMIS, Desk
prescriptions and chairs, Lockable
Selection, Preparation and cabinets,
labelling of prescribed Files, Shelves, and
medicine reference materials
Delivery of medicine and
Provision of information
and instructions to the
patient to ensure the safe
and effective use of
medicine
Recording keeping
4. Primary health Provision of HPTs to
care Community Health
Promoters, Monitoring the
use of HPTs by the CHPs.

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Services Task Infrastructure and

equipment
requirements
Mother and child health
services(Immunisation,
Family planning
Nutrition and health
5 Aseptic Aseptic dispensing services Clean room, Class 2A2
dispensing Aseptic Dispensing, biosafety cabinet,
services Infection prevention and Aseptic dispensing
control guidelines
Intravenous additive
services
Total parenteral nutrition
preparation and
counselling
Cytotoxic preparation and Class 3 biosafety cabinet
Reconstitution cleanroom
6. Effective Collect necessary Consultation room,
medication information about the Lockable cabinets, Desk
therapy patient and chairs, BP machine,
management Assess the information Stethoscope, point-of-
(MTM) collected and analyze the care RDT kits,
clinical effects of the Glucometer,
patient’s therapy Weighing scale, IR
Develop an individual thermometer,
patient-centred care plan and Tongue depressor
Implement care plan
Monitor patient progress
and outcomes
6. Drug Provision of Drug Drug and poison
Information to Information information: Centre,
clinicians and Counselling room, Filing
patients cabinet, Computer with
internet,
7. Quality Clinical Pediatrics Clinical Clinical pharmacy Office
pharmacy services Pharmacy Service in each ward: space,
Surgical and Desk and chairs,
Anaesthesiology Clinical Lockable cabinets,
Pharmacy Services Computer
Reference materials
Critical Care Pharmacy
Emergency Department
Clinical Pharmacy Practice
Clinical Pharmacy Practice
in Obstetrics and
Gynaecology

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Infectious Disease Clinical
Pharmacy Services
Antimicrobial stewardship
Psychiatry and Mental
Health Pharmacy Services
Palliative and Hospice Care
Clinical Pharmacy Services
Oncology Pharmacy
Service
8. Therapeutic Therapeutic drug Protocols, computers,
drug monitoring monitoring services reference materials,
services connection to a reliable
blood analyzer
9. Pharmacogenomic services Protocols,computers,
Pharmacogenomic reference materials,
services connection to a DNA
sequencing service,
appropriate software
10 Clinical Clinical toxicology services Appropriate soft ware,
toxicology services protocols, computers,
reference materials,
connection to a reliable
forensic laboratory
11. Pharmacovigilance services Computer with internet.
Pharmacovigilance Filing cabinet.
Reporting tools,
appropriate software
12. Handling and Handling and dispensing of Lockable cabinet within
control of narcotic narcotic and psychotropic the pharmacy, and
and psychotropic substances counselling room.
substances and Patient-centred care in Narcotics register,
Rehabilitative treating drug abuse Interconnection with a
services patients. national central register
Smoking cessation for narcotics utilisation
Medication-assisted
treatment (MAT)
13. Preparation/compounding Class 2B2 biosafety
Radiopharmacy of radiopharmaceuticals cabinet with radiation
services shielding, clean room,
Dispensing of
Radiopharmacy
radiopharmaceuticals
guidelines, Dosimeter
ring and body, Isolation
room for iodine patients,
Sharps container
radiation shielded,

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equipment
requirements
Syringe shields,
Dosimeter ring and body,
Disposal of Shielded transport
radiopharmaceuticals containers, survey-
meters, Decay tank
14. Clinical trials Conduct Clinical trials and Room, Protocols,
and research research Computer, Reference
materials,desk and
chairs, Lockable cabinets

4.2.4.2. Infrastructure and Equipment Requirements for Level

5 Hospital Pharmacy

Facilities should comply with NEMA, and other relevant regulations, and be
easily accessible to people with disabilities.
Requirements Minimum standards
Waiting area ● Should provide protection from the sun and
other elements and be situated near the
dispensing area, areas for counselling and
the furnishing of information and/oultation
areas.
● The total area should NOT be less than 450sq
ft.
Dispensing area ● Should be located adjacent to the waiting
area and clients should NOT have direct
access to products situated here.
● Products should be stored on shelves starting
at a height from the floor which prevents
contamination or damage of products by floor
debris.
● The total area should NOT be less than 450sq
ft.
● The temperature and humidity shall be
controlled to be 15-30 degrees
centigrade and <60% RH (Relative
Humidity). Monitoring shall be done using a
wall thermometer and humidity meter. The
data collected should be recorded manually 3
times a day, preferably in the morning, noon,
and evening.
● The refrigerator shall have a
fridge thermometer and be monitored and
recorded at three time points. The

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temperature should be maintained between 2
and 8 degrees centigrade.
● There shall be a provision for adequate power
backup in case of primary power failure.
Counselling/Consultation ● Semi-private area
Room
The area(s) could be of a modular “bank teller”
type, where a counter is utilized, offering the
patient or his/her agent/caregiver reasonable
private access or an aperture, which is
surrounded by a “telephone booth” type
structure to prevent other persons from
crowding around the patient or his/her
agent/caregiver who is communicating.

● Private area

Shall occupy a space not less than 150 sq ft. It

should have a table, comfortable chairs and
shelves for reference books. The area should be
such that the pharmacist has easy access to it
from the dispensing area, and the patient has
easy access.
Medication Therapy ● Weighing machine, thermometer, blood
Management pressure machine, oximeter, pill pack boxes,
consultation Room MTMHMS,reference materials

Have sufficient size and accommodations to

comfortably seat at least three people (two for
interactive video) at a table
Be private, so that when a typical patient is
sitting or standing in the consulting area, the
patient cannot be seen by others (including
other patients, customers and employees)
Be used entirely for enhancing patient outcomes
and not used as a storage room for merchandise
or other non-related items
Be accessible to the patient without having to
traverse through dispensing or storage areas
Be enclosed sufficiently to prevent typical
patient consultation conversations from being
heard from other areas of the business
Be enclosed sufficiently to prevent noise from
other areas of the business from interference
with or distraction from typical conversation in
the consulting area

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Compounding area ● Can be a designated space within the
dispensing area adjacent to the water source.
● All compounding equipment and reference
materials shall be located in the work area
where compounding will be conducted.
● The total area should NOT be less than 100
sq ft.
Clinical pharmacy The facility shall have a Clinical Pharmacy
services Office Services office in each ward with computer,
working desk, reference material, consult forms
Radio pharmacy services The facility shall have a Radiopharmacy services
office office and radiopharmaceutical
production/compounding facility as per the
GMP standard
Drug Store ● The storage area of HPS shall be sufficient for
keeping all inventories at appropriate
stockholding levels.
● The total area should NOT be less than 600
sq ft.
● There shall be sufficient physically separated
areas with appropriate storage conditions for
orderly segregation of products namely
biological, refrigerated, inflammable and
corrosive liquids and solids, cytotoxic drugs,
Narcotic and Psychotropic Substances.
● The temperature and humidity shall be
controlled to be 25 degrees centigrade or
below and 75% RH (Relative Humidity).
Monitoring shall be done using a wall
thermometer and humidity meter. The data
collected should be recorded manually 3
times a day, preferably in the morning, noon,
and evening.
● All instruments used for temperature
monitoring shall be calibrated, and the
calibration shall be documented.
● Separate areas for receiving and issuing shall
be provided to enhance efficiency and
security.
● Receiving of goods in the receiving area shall
be inspected and entered into the stock
recording system which may be manual,
computerized or both.
● Storage areas must have sufficient shelving
constructed from a smooth, washable and
impermeable material, that is easy to
maintain in a hygienic condition. Pallets for
bulky items

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● Walls must be finished in a smooth,
washable, and impermeable material, which
is easy to maintain in a hygienic condition.
Quarantine area ● The enclosure shall be clearly labelled
products, biohazard “Quarantine Area”. This area shall be divided
waste and sharps into 2 spaces, 1: Damaged/expired
awaiting disposal. pharmaceutical products & 2: Biohazards
sharps.
● All products and waste materials that fall
within this category shall be stored in this
area.
● Disposal shall follow the policy for disposal of
pharmaceutical waste.
● The area should be of adequate size but not
less than 15 square feet.
Toilet facilities There shall be provision for adequate toilet
facilitie The minimum is 1 unisex facility with
flowing water, flushing equipment and disposal
units for feminine and children’s hygiene
products
Drug Information Shall occupy a space not less than 300 sq ft. It
Poison Information should have a table, comfortable chairs,
Center lockable cabinets, shelves and reference
materials.
Infrastructure and Drug Store, Quarantine/Expiries area, Office
equipment space with printer
Incinerator, Refrigerator, Cool boxes, Pallets,
Waste bins, Thermohygrometer, Lockable
cabinets, Shelves, Reference materials,
Dispensing envelopes, Labels, Dispensing
space, Worktop, HMIS, Computer, Phone,
Reference materials, Reporting tools, Training
materials, Guidelines, manuals and SOPs,
Checklists, Meeting room, Compounding Space,
Weighing balance, Mortar and pestle, Slab,
Spatula, Weighing paper, Beakers, Filter papers,
Graduated cylinders, Hotplates, Measuring
cylinders, Pipettes, Mixer/stirring rod,
Consultation room, BP machine, Stethoscope,
point-of-care RDT kits, Glucometer, Weighing
scale, IR thermometer, Tongue
depressor, Screening and monitoring
equipment, Examination room, Examination
couch, Medical examination torch, Automated
dispensing machines (MAT), Theraputic drug
monitoring machine

4.2.4.3. Schedule of medicines for level 5 Dispensing pharmacy

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This shall be derived from the Schedule of Medicines developed or from the
Kenya Essential medicine list.

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4.2.5.Level 6 Hospital Pharmacy

4.2.5.1. Scope of services

Services Tasks Infrastructure and

equipment requirements
1. Supply chain Selection and Drug Store,
management of quantification of HPTs Quarantine/Expiries area,
Health Products Procurement of HPTs Office, Incinerator,
and technologies Refrigerator, Cool boxes,
Storage and
(HPTs) Pallets, Trolleys, Waste bins,
Distribution of HPTs
Thermo/hygrometer,
Waste Management and Lockable cabinets, shelves,
Disposal of logistic management
Pharmaceutical waste information system
2. Compounding Compounding of Compounding Space,
and Pre-packing Pharmaceuticals Weighing balance, Mortar
and pestle,
Slab, Spatula, Weighing
paper, Beakers, Filter
papers, Graduated
cylinders, Hotplates,
Measuring cylinders,
Pipettes, Mixer/stirring rod,
Reference
materials/Compendium
Pre-packing of Dispensing envelopes and
pharmaceuticals labels, bottles
3. Dispensing of Receiving, interpreting, Dispensing space, Worktop,
medication and evaluating HMIS, Desk and chairs,
prescriptions Lockable cabinets,
Selection, Preparation Files, Shelves, and reference
and labelling of materials
prescribed medicine
Delivery of medicine and
Provision of information
and instructions to the
patient to ensure the
safe and effective use of
medicine
Recording keeping
4. Primary health Mother and child
care health (Immunisation,
Family planning
services, baby wellness
services)
Nutrition and health

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equipment requirements
5. Aseptic Aseptic dispensing Clean room, Class 2A2
dispensing services biosafety cabinet, Aseptic
services Aseptic Dispensing, dispensing guidelines
Infection prevention and
control
Intravenous additive
services
Total parenteral
nutrition preparation
and counselling
Cytotoxic preparation Class 3 biosafety cabinet
and Reconstitution cleanroom
6. Effective Collect necessary Consultation room, Lockable
medication information about the cabinets, Desk and chairs,
therapy patient BP machine, Stethoscope,
management Assess the information point-of-care RDT kits,
(MTM) collected and analyze Glucometer,
the clinical effects of the Weighing scale, IR
patient’s therapy thermometer,
Develop an individual and Tongue depressor
patient centred care
plan
Implement care plan
Monitor patient progress
and outcomes
7. Drug Provision of Drug Drug and poison
Information to Information information:
clinicians and centre Counselling room,
patients Filing cabinet, Computer
with internet,
8. Clinical Paediatric Clinical Clinical pharmacy Office in
pharmacy services Pharmacy Service each ward: space, Desk and
Surgical and chairs, Lockable cabinets,
Anaesthesiology Clinical Computer
Pharmacy Services Reference materials
Critical Care Pharmacy
Emergency Department
Clinical Pharmacy
Practice
Clinical Pharmacy
Practice in Obstetrics
and Gynecology
Infectious Disease
Clinical Pharmacy
Services

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equipment requirements
Antimicrobial
stewardship
Psychiatry and Mental
Health Pharmacy
Services
Palliative and Hospice
Care Clinical Pharmacy
Services
Oncology pharmacy
Service
9 Therapeutic Therapeutic medicine Computer with internet,
medicine monitoring services Protocols, Laboratory with
monitoring drug level measurement
services capacity, access to a reliable
10. Pharmacogenomic blood analyzer, connection
Pharmacogenomic services to a DNA sequencing service,
services appropriate software.
11. Clinical Clinical toxicology Drug and poison information
toxicology services services centre.
Toxicology laboratory.
12. Pharmacovigilance Computer with internet.
Pharmacovigilance services Filing cabinet.
Reporting tools
13. Handling and Handling and Lockable cabinet within the
control of narcotic dispensing of narcotic pharmacy, and counselling
and psychotropic and psychotropic room.
substances and substances Narcotics register and
Rehabilitative patient-centred care in interconnection with a
services treating drug abuse national central register of
patients. narcotics utilisation.
Smoking cessation
Medication-assisted
treatment (MAT)
13. Preparation / Class 2B2 biosafety cabinet
Radiopharmacy compounding of with radiation shielding,
services radiopharmaceuticals Clean room, Radiopharmacy
Dispensing of guidelines, Dosimeter ring
radiopharmaceuticals and body, an Isolation room
for iodine patients, Sharps
container radiation shielded,
Syringe shields, Dosimeter
ring and body,
Disposal of Shielded transport
radiopharmaceuticals containers, survey meters,
and tank

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equipment requirements
14. Clinical trials Conduct clinical trials Room, Computer, Desk and
and research and research chairs, Lockable cabinets,
protocols

4.2.5.2. Infrastructure and Equipment Requirements for Level

6 Hospital Pharmacy

General: Facilities should comply with NEMA, and other relevant regulations,
and be easily accessible to people with disabilities.
Requirements Minimum standards
Waiting area Should be provided with protection from the sun
and other elements and be situated near the
dispensing area, areas for counselling, and the
furnishing of information and/or consultation
areas.
The total area should NOT be less than 600 sq
ft.
Dispensing area Should be located adjacent to the waiting area
and clients should NOT have direct access to
products situated here.
Products should be stored on shelves starting at
a height from the floor which prevents
contamination or damage of products by floor
debris.
The total area should NOT be less than 600 sq
ft.
The temperature and humidity shall be
controlled to be15-30 degrees centigradeand -
60% RH (Relative Humidity). Monitoring shall be
done using a wall thermometer and humidity
meter. The data collected should be recorded
manually 3 times a day, preferably in the
morning, noon, and evening.
The refrigerator shall have a fridge thermometer
and be monitored and recorded at three-time
points. The temperature should be maintained
between 2 and 8 degrees centigrade.
There shall be a provision for adequate power
backup in case of primary power failure.
Counselling/Consultation ● Semi-private area
Room
The area(s) could be of a modular “bank teller”
type, where a counter is utilized, offering the
patient or his/her agent/caregiver reasonable
private access or an aperture, which is

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Requirements Minimum standards

surrounded by a “telephone booth” type
structure to prevent other persons from
crowding around the patient or his/her
agent/caregiver who is communicating.

● Private area

Shall occupy a space not less than 150 sq ft. It

should have a table, comfortable chairs and
shelves for reference books. The area should be
such that the pharmacist has easy access to it
from the dispensing area, and the patient has
easy access.
Medication Therapy Weighing machine, thermometer, blood
Management consultation pressure machine, oximeter, pill pack boxes,
Room MTMHMS, reference materials.
Have sufficient size and accommodations to
comfortably seat at least three people (two for
interactive video) at a table
Be private, so that when a typical patient is
sitting or standing in the consulting area, the
patient cannot be seen by others (including
other patients, customers and employees)
Be used entirely for enhancing patient outcomes
and not used as a storage room for merchandise
or other non-related items
Be accessible to the patient without having to
traverse through dispensing or storage areas
Be enclosed sufficiently to prevent typical
patient consultation conversations from being
heard from other areas of the business
Be enclosed sufficiently to prevent noise from
other areas of the business from interference
with or distraction from typical conversation in
the consulting area
Compounding area Can be a designated space within the dispensing
area adjacent to the water source.
All compounding equipment and reference
materials shall be located in the work area
where compounding will be conducted.
The total area should NOT be less than 100 sq
ft.
Clinical pharmacy The facility shall have a Clinical pharmacy
services Office services office in each ward with a working table,
computer, reference materials, consult forms.
Radio pharmacy services The facility shall have a Radiopharmacy services
office office and radiopharmaceutical
production/compounding facility as per the
GMP standard

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Requirements Minimum standards

Drug Store The storage area of HPS shall be sufficient for
keeping all inventories at appropriate levels.
The total area should NOT be less than 900 sq
ft.
There shall be sufficient physically separated
areas with appropriate storage conditions for
orderly segregation of products namely
biological, refrigerated, inflammable and
corrosive liquid and solids, cytotoxic drugs,
Dangerous Drugs and Psychotropic Substances.
The temperature and humidity shall be
controlled to be15-30 degrees centigrade and
60% RH (Relative Humidity). Monitoring shall be
done using a wall thermometer and humidity
meter. The data collected should be recorded
manually 3 times a day, preferably in the
morning, noon, and evening.
All instruments used for temperature
monitoring shall be calibrated, and the
calibration shall be documented.
Separate areas for receiving and issuing shall be
provided to enhance efficiency and security.
Receiving of goods in the receiving area shall be
inspected and entered into the stock recording
system which may be manual, computerized or
both.
Storage areas must have sufficient shelving
constructed from a smooth, washable and
impermeable material, which is easy to maintain
in a hygienic condition, pallets for bulky items.
Walls must be finished in a smooth, washable
and impermeable material, that is easy to
maintain in a hygienic condition.
Quarantine area The enclosure shall be clearly labelled
“Quarantine Area”. This area shall be divided
into 2 spaces, 1. Damaged/expired
pharmaceutical products & 2. Biohazards
sharps.
All products and waste materials that fall within
this category shall be stored in this area.
Disposal shall follow the policy for disposal of
pharmaceutical waste.
The area should be of adequate size but not less
than 15 square feet.
Toilet facilities There shall be provision for adequate toilet
facilities . The minimum is one unisex facility
with flowing water, flushing equipment and
disposal units for feminine and children’s
hygiene products

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Drug and Shall occupy a space not less than 450 sq ft. It
PoisonInformation Center should have a table, comfortable chairs,
lockable cabinets, shelves and reference
materials.
Infrastructure and Drug Store, Quarantine/Expiries area, Office
equipment space with printer
Incinerator, Refrigerator, Cool boxes, Pallets,
Waste bins, Thermohygrometer, Lockable
cabinets, Shelves, Reference materials,
Dispensing envelopes, Labels, Dispensing
space, Worktop, HMIS, Computer, Phone,
Reference materials, Reporting tools, Training
materials, Guidelines, manuals and SOPs,
Checklists, Meeting room, Compounding Space,
Weighing balance, Mortar and pestle, Slab,
Spatula, Weighing paper, Beakers, Filter papers,
Graduated cylinders, Hotplates, Measuring
cylinders, Pipettes, Mixer/stirring rod,
Consultation room, BP machine, Stethoscope,
Point of care RDT kits, Glucometer, Weighing
scale, IR thermometer, Tongue
depressor, Screening and monitoring
equipment, Examination room, Examination
couch, Medical examination torch, Automated
dispensing machines (MAT),

4.2.5.3. Schedule of medicines for level 6 Dispensing pharmacy

This shall be derived from the Schedule of Medicines developed or from the
Kenya Essential medicine list.

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4.1. STANDARDS FOR COMMUNITY PHARMACY PREMISES

4.1.1.Level 2A: Dispensing Pharmacy

4.1.1.1. Scope of Pharmaceutical services in Dispensing

Pharmacy

Services Task Infrastructure and

equipment requirement
1. Supply chain Selection and Drug Store,
management of quantification of HPTs Quarantine/Expiries area,
Health Products Office, Incinerator,
and technologies Procurement of HPTs Refrigerator, Cool boxes,
(HPTs) Waste Management and Pallets, Trolleys, Waste bins,
Disposal of Thermo/hygrometer,
Pharmaceutical waste Lockable cabinets, Shelves
2. Dispensing of Receiving, Interpretation Dispensing space, Worktop,
OTC medications, and evaluation of HMIS, Desk and chairs,
select Prescription prescription. Lockable cabinets,
only medicines, Selection, Preparation Files, Shelves, and reference
and ADR and labelling of material.
Reporting prescribed medicine
Delivery of medicine and
Provision of information
and instruction to the
patient to ensure the
safe and effective use of
medicine.
Consult or refer where
necessary.
Recording keeping
3. Compounding Compounding of basic Compounding room, and
of basic liquid and liquid and semisolid compounding equipment
semisolid non- non-sterile external
sterile external preparations
preparations Pre-packing of Dispensing envelopes and
pharmaceuticals labels

4.Provide Drug Provision of Drug Patient counselling /

Information to Information consultation area.
clinicians and
patients
5. E-Pharmacy Registration of Internet Computer/internet,
(Internet) Services pharmacy services Dispensing area & table,
Dispensing storage area, Labelling
Information and advice material and reference texts

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4.1.1.2. Infrastructure and Equipment Requirements for a

Level 2 Dispensing Pharmacy

Facilities should comply with NEMA, and other relevant regulations, and be
easily accessible to people with disabilities.
Infrastructure and equipment Minimum standard
requirements
Waiting area 170 sq feet
OTC area
Dispensing area (refrigerator 90 sq feet
location)
Compounding area (water basin Should be located within the dispensing
& running water source location) area
Drug Store Well ventilated, secure, pest free,
controlled temperature and humidity.
Toilet facilities Minimum of 1 unisex toilet with disposal
units for feminine and infant hygiene
products.

4.1.1.3. Personnel Requirements

Superintendent Minimum Number required

Pharmacist or Pharmaceutical 1
technologist
Staff
Pharmaceutical Technologist 1
TOTAL 2

4.1.1.4. Schedule of Medicines in Level -2 Dispensing Pharmacy

This shall be derived from the Schedule of Medicines developed or from the
Kenya Essential medicine list.

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4.1.1.Level 2B: Dispensing Pharmacy

4.1.1.1. Scope of Pharmaceutical services in Dispensing

Pharmacy

Services Task Infrastructure and

equipment requirement
1. Supply chain Selection and Drug Store,
management of quantification of HPTs Quarantine/Expiries area,
Health Products Office, Incinerator,
and technologies Refrigerator, Cool boxes,
Procurement of HPTs
(HPTs) Pallets, Trolleys, Waste bins,
Waste Management and Thermo/hygrometer,
Disposal of Lockable cabinets, Shelves
Pharmaceutical waste
2. Dispensing of Receiving, Interpretation Dispensing space, Worktop,
OTC medications, and evaluation of HMIS, Desk and chairs,
select Prescription prescription. Lockable cabinets,
only medicines, Selection, Preparation Files, Shelves, and reference
and ADR and labelling of material.
Reporting prescribed medicine
Delivery of medicine and
Provision of information
and instruction to the
patient to ensure the
safe and effective use of
medicine.
Consult or refer where
necessary.
Recording keeping
3. Compounding Compounding of basic Compounding room, and
of basic liquid and liquid and semisolid compounding equipment
semisolid non- non-sterile external
sterile external preparations
preparations Pre-packing of Dispensing envelopes and
pharmaceuticals labels
4. Primary Health Reproductive Health Patient counselling /
Care consultation area, Medical
Mother and child health and Diagnostic equipment
Nutrition Advice /tools
Assessment and
treatment of minor
illness, health
promotion and wellness
5.Provide Drug Provision of Drug Patient counselling /
Information to Information consultation area.
clinicians and
patients

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6. E-Pharmacy Registration of Internet Computer/internet,

(Internet) Services pharmacy services Dispensing area & table,
Dispensing storage area, Labelling
Information and advice material and reference texts

4.1.1.2. Infrastructure and Equipment Requirements for a

Level 2 Dispensing Pharmacy

Facilities should comply with NEMA, and other relevant regulations, and be
easily accessible to people with disabilities.
Infrastructure and equipment Minimum standard
requirements
Waiting area 170 sq feet
OTC area
Dispensing area (refrigerator 90 sq feet
location)
Compounding area (water basin Should be located within the dispensing
& running water source location) area
Drug Store Well ventilated, secure, pest free,
controlled temperature and humidity.
Counselling/ Consultation Room 50 sq feet can be a screened-off area for
privacy and confidentiality
Toilet facilities Minimum of 1 unisex toilet with disposal
units for feminine and infant hygiene
products.

4.1.1.3. Personnel Requirements

Superintendent Minimum Number required

Board certified Pharmaceutical 1
technologist or Pharmacist
Staff
Pharmaceutical Technologist 1
TOTAL 2

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4.1.1.4. Schedule of Medicines in Level -2 Dispensing Pharmacy

This shall be derived from the Schedule of Medicines developed or from the
Kenya Essential medicine list.

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4.1.2.Level 3: Pharmaceutical Care Centers

4.1.2.1. Scope of Pharmaceutical Services in Pharmaceutical

Care Center

Services Task Infrastructure and

equipment requirement
1. Supply chain Selection and Drug Store,
management of quantification of HPTs Quarantine/Expiries area,
Health Products Office, Incinerator,
and technologies Refrigerator, Cool boxes,
(HPTs) Procurement of HPTs Pallets, Trolleys, Waste bins,
Waste Management and Thermo/hygrometer,
Disposal of Lockable cabinets, Shelves
Pharmaceutical waste
2. Compounding Compounding of Compounding Space,
and Pre-packing Pharmaceuticals (Only Weighing balance, Mortar
topicals) and pestle,
Slab, Spatula, Weighing
paper, Beakers, Filter
papers, Graduated cylinders,
Hotplates, Measuring
cylinders, Pipettes,
Mixer/stirring rod, Reference
materials/Compendium
Pre-packing of Dispensing envelopes and
pharmaceuticals labels
3. Dispensing of Receiving, Dispensing space, Worktop,
medication interpretation and HMIS, Desk and chairs,
evaluation of Lockable cabinets, Files,
prescription Shelves, and reference
Selection, Preparation material.
and labelling of
prescribed medicine
Delivery of medicine
and Provision of
information and
instruction to the
patient to ensure the
safe and effective use of
medicine
Recording keeping

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Services Task Infrastructure and

equipment requirement
4. Primary Health Immunisation Informed consent form and
Care patient screening tool.
Fridge, Fridge thermometer,
Backup secondary power
source, IR thermometer,
Syringes, needles, alcohol
swabs, cotton wool, adhesive
wound dressing, alcohol
hand rub, examination
gloves.
Reproductive Health (For depo injection)
After appropriate training
by MOH
Informed consent form and
patient screening tool.
Syringes, needles, alcohol
swabs, cotton wool, adhesive
wound dressing, alcohol
hand rub, and examination
gloves.
Mother and child health Reference texts for childhood
diseases. Appropriate
referral system.
Nutrition Advice Expanded range of
nutritional products, BMI
measuring equipment,
reference texts and online
resources.
6. Provide effective Collect necessary Consultation room, Lockable
medication information about the cabinets, Desk and chairs,
therapy patient BP machine, Stethoscope,
management Assess the information Point of care RDT kits,
(MTM) collected and analyze Glucometer,
the clinical effects of the Weighing scale, IR
patient’s therapy i.e. thermometer,
Medication therapy Tongue depressor
review i.e. the
medication related
action plan and the
personal medication
record
Develop an individual
patient-centered care
plan
Implement care plan
Monitor patient
progress and outcomes

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Services Task Infrastructure and

equipment requirement
Documentation and
follow up
7. Provide Drug Provision of Drug Online resources and text
Information to Information references, Consultation /
clinicians and counselling room.
patients Antimicrobial
stewardship
8. Health Perform basic health Informed consent form, Data
assessment, assessment collection tool, appropriate
screening, Blood pressure and equipment for each category
monitoring blood sugar monitoring
Screening, monitoring
and rapid diagnostic
tests
9. Pharmacovigilance Ability to access online
Pharmacovigilance services services, ADE reporting tools

10. Handling and Handling dispensing Lockable cabinet,

control of narcotic and documentation of Consultation/counselling
and psychotropic narcotic and room for patient counselling
substances and psychotropic services, Narcotics and
Rehabilitative substances psychotropic drug registers,
services Provision of computers
pharmaceutical care
drug abuse patients.
Providing Ssmoking
cessation services
11. E-Pharmacy Registration of Internet Computer/internet,
(Internet) Services pharmacy services Dispensing area and table,
Dispensing Labelling material and
Provision of reference texts, secure
drug Information and packaging and transporting
medication use advice material
Delivering of medicines
Documentation
Ensuring security and
confidentiality

4.1.2.2. Infrastructure and equipment Requirements for

Pharmaceutical Care Centers

General: Facilities should comply with NEMA, and other relevant regulations,
and be easily accessible to people with disabilities.

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Requirement Minimum standard

Waiting area
Total of 170 sq feet
OTC area
Dispensing area (refrigerator Total of 100 sq feet
location)
Compounding area (water basin & Should be located within the
running water source location) dispensing area
Counselling/ Consultation Room Minimum of 75 sq feet
Quarantine area Minimum of 4ft x 2ft divided into 2
parts (expired/damaged drugs &
Biohazard waste/sharps
Toilet facilities Minimum 1 unisex toilet) with
disposal units for feminine and infant
hygiene products.
Drug and Poison Information Center Online resources and reference texts

4.1.2.3. Personnel Requirements

Superintendent Minimum Number required

Pharmacist 1
Staff
Pharmacist 1
TOTAL 2

4.1.2.4. Schedule of Medicines in Level -3 Pharmaceutical Care

center

This shall be derived from the Schedule of Medicines developed or from the
Kenya Essential medicine list.

4.1.3.Level 4 Specialty Pharmaceutical Care Centers

Description

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Level 4 specialist pharmacy facility offer specialized services including

medication therapy management and individualization of patients’
medication. Pharmaceutical care specialists have the opportunity to establish
a comprehensive care center that offers a wide range of specialized services or
focus their practice on a specific area of expertise.

4.1.3.1. Scope of services

Services Task Infrastructure and

equipment requirement
1. Supply chain Selection and Drug Store,
management of quantification of HPTs Quarantine/Expiries area,
Health Products Office, Incinerator,
and technologies Refrigerator, Cool boxes,
Procurement of HPTs
(HPTs) Pallets, Trolleys, Waste
Waste Management and bins, Thermo/hygrometer,
Disposal of Lockable cabinets, Shelves,
Pharmaceutical waste LMIS, computers
2. Compounding Compounding of Compounding Space,
and Pre-packing Pharmaceuticals Weighing balance, Mortar
and pestle,
Slab, Spatula, Weighing
paper, Beakers, Filter
papers, Graduated
cylinders, Hotplates,
Measuring cylinders,
Pipettes, Mixer/stirring rod,
Reference
materials/Compendium
Pre-packing of Dispensing envelops,
pharmaceuticals bottles and labels
3. Dispensing of Selection and Drug Store,
medication quantification of HPTs Quarantine/Expiries area,
Office, Incinerator,
Refrigerator, Cool boxes,
Selection, Preparation and
Pallets, Trolleys, Waste
labelling of prescribed
bins, Thermo/hygrometer,
medicine
Lockable cabinets, Shelves
Delivery of medicine and Patient counselling
Provision of information point/area, relevant drug
and instruction to the registers, Lockable filing
patient to ensure the safe cabinet
and effective use of
medicine
Documentation

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Services Task Infrastructure and

equipment requirement
4. Aseptic Aseptic Dispensing, Tools pertaining to aseptic
dispensing Infection prevention and compounding i.e. HEPA
services control filter, appropriate cytotoxic
mixing chamber, Personal
Intravenous additives protective equipment,
services weighing balances, spill
Total parenteral nutrition kits, purple bin liners etc.
preparation and
counselling
Cytotoxic preparation and
Reconstitution
5. Primary Immunisation Informed consent form and
Health Care patient screening tool.
Fridge, Fridge thermometer,
Backup secondary power
source, IR thermometer,
Syringes, needles, alcohol
swabs, cotton wool,
adhesive wound dressing,
alcohol hand rub,
examination gloves.
Reproductive Health Informed consent form and
(For administration of IM patient screening tool.
depo injection and other Syringes, needles, alcohol
parenteral family planning swabs, cotton wool,
options - after appropriate adhesive wound dressing,
training by MOH) alcohol hand rub, and
Documentation of the examination gloves, patient
commodity and service files
provided
Mother and child health Reference texts for
childhood diseases.
Appropriate referral system.
Nutrition Advice Expanded range of
nutritional products, BMI
measuring equipment,
reference texts and online
resources.
Assessment and treatment Patient counselling/
of minor illnesses, health consultation area, medical
promotion and wellness and diagnostic equipment/
tools
6. Provide Collect necessary Consultation room,
effective information about the Lockable cabinets, Desk
medication patient and chairs, BP machine,
therapy Assess the information Stethoscope, Point of care
collected and analyze the RDT kits, Glucometer,

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Services Task Infrastructure and

equipment requirement
management clinical effects of the Weighing scale, IR
(MTM) patient’s therapy i.e. thermometer,
medication therapy review Tongue depressor
i.e. the medication related
action plan and the
personal medication
record
Develop an individual
patient-centred care plan
Documentation and follow
up
Implement care plan
Monitor patient progress
and outcomes
7. Provide Drug Provision of Drug Online resources and text
Information to Information references, Consultation /
clinicians and counselling room.
patients

8. Provide Provision of Clinical Clinical pharmacy Office in

Clinical pharmacy services as each ward: space, Desk and
Pharmacy described under standard chairs, Lockable cabinets,
Services 8. Computer
Reference materials,
Consultation forms, Patient
records
9 Therapeutic Provision of Therapeutic Informed consent form.
medicine medicine monitoring Monitoring equipment and
monitoring services data collection tools.
services Patient records
Treatment protocols
10 Clinical Providing Clinical Informed consent form and
toxicology toxicology services on a 24- data collection tools.
services hour basis Online resources & text
references, Antidote stocks,
and Ability to provide out-
of-centre consultative
services including forensic
consultations.
Personal protective
equipment
Treatment protocols
11 Health Perform basic health Informed consent form,
assessment, assessment Data collection tool,
screening, Blood pressure and blood appropriate
monitoring sugar monitoring diagnostic equipment and

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Services Task Infrastructure and

equipment requirement
Screening, monitoring an Electronic medical
and rapid diagnostic tests record
12. Provision Ability to access online
Pharmacovigilan of Pharmacovigilance services, ADEreporting
ce services tools
13. Handling and Handling,documentation a Consultation / counselling
control of nd dispensing of narcotic room for patient
narcotic and and psychotropic counselling, therapeutic
psychotropic substances outcomes assessment and
substances and Providing pharmacotherapeutic
Rehabilitative pharmaceuticalcare fordru interventions.
services g abuse patients. Lockable narcotics and
Providing of smoking psychotropics
cessation services drugs cabinet
narcotics and psychotropics
Provision of Medication- drugs registers,
assisted treatment (MAT)
Provision of rehabilitation
of Residential and nursing
homes.
14. E-Pharmacy Registration of Internet Computer/internet
(Internet) pharmacy services
Services Dispensing Dispensing area & table
Information and advice Labelling material and
reference texts
Delivering of medicines Established method of
transport
Documentation Prescription record register
& prescription file
Enhancing Security and Lockable cabinet for patient
confidentiality records/information
Packaging and
transportation materials

4.1.3.2. Infrastructure Requirements

Facilities should comply with NEMA, and other relevant regulations, and be
easily accessible to people with disabilities.
Infrastructure and equipment Minimum standard
requirement
Waiting area
Total of 170 sq feet
OTC area

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Dispensing area Total of 100 sq feet

Compounding area (water basin Should be located within the dispensing
& running water source location) area
Counselling/ Consultation Room Minimum of 100 sq feet
Quarantine Area Minimum of 4ft x 2ft divided into 2 parts
(expired/damaged drugs & Biohazard
waste/sharps
Toilet facilities Minimum 1 unisex toilet with disposal
units for feminine and infant hygiene
products.
Drug Information Center Online resources and reference texts
Poison Information Center Online resources and reference texts

4.1.3.3. Personnel Requirements

Superintendent Minimum Number required

Specialist Pharmacist 1
Staff
Pharmacist 2
TOTAL 3

4.1.3.4. Schedule of Medicines

The facility may handle schedules I, II, III, VII and VIII as well as Schedule IV
class 2-5 of the PPB-approved schedules. The facility must be run by
Pharmaceutical Care Specialists.

4.2. STANDARDS FOR WHOLESALE, DISTRIBUTION AND

MANUFACTURING
4.2.1.Wholesale and Distribution

4.2.1.1. Scope of service

Services Task Infrastructure and equipment

requirement

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1. Supply Selection and Pharmaceutical warehouse requirements

chain quantification
management of HPTs ● Receiving area, Ordering/sales area,
of Health Procurement of Dispatch area, Quarantine, Record
Products and HPTs keeping, computers, LMIS, SOPs,
technologies Port Clearance shelves, pallets
(HPTs) Warehousing
Distribution Pharmaceutical Storage requirements
Waste
Management ● Controlled storage areas; Cold chain
and Disposal of storage area, Narcotic and
Pharmaceutical psychotropic substances storage
waste areas, Combustible solids and gases
storage areas, Temperature and
humidity monitoring equipment, Air
conditioning system,, Relevant
documentation

Distribution

● Loading and receiving bay, Transport

and delivery, Security of
pharmaceuticals during transit,
Monitoring storage conditions during
transit, Calibration of transport
vessels and devices, Temperature
monitoring of shipping containers,
Qualification of insulated containers
(cool boxes, etc.), Product handling
during handling
● Disposal of Pharmaceutical waste

Quarantine area for expired and

damaged product, relevant
documentation e.g. FO58 forms,
relevant policies and SOPs

4.2.1.2. Infrastructure and equipment requirements

Requirement Minimum standard

● Warehousing area ●Should comply with PPB Guidelines

for Good Distribution Practices for
● Storage areas; Medical Products and Health
technologies in Kenya
● Narcotic and ● Special storage facilities should be provided
psychotropic for Narcotic drugs, psychotropic
substances, substances, precursors, Dangerous Goods,
Combustible solids

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Requirement Minimum standard

and gases storage or other categories of goods as required by

areas applicable legislation.
● Radioactive materials, narcotics and other
hazardous, sensitive and/ or dangerous
medical products and health technologies,
as well as products presenting special risks
of abuse, fire or explosion (e.g. combustible
liquids and solids and pressurized gases)
should be stored in dedicated areas that are
subject to appropriate additional safety and
security measures that include but not
limited to lock and key, security cameras,
restricted rights of access and frisking of
persons accessing the dedicated storage
areas.
● Quarantine area ● Physical or other equivalent validated (e.g.
electronic) segregation should be provided
for the storage of rejected, expired, recalled
or returned products. The products and
areas concerned should be appropriately
identified.
● Cold chain storage ● All thermolabile products must be stored in
area a refrigerator/cold room/freezer exclusively
dedicated to medical products.
● All thermolabile products must be stored in
a refrigerator/cold room in a temperature-
regulated environment between 2 °C and 8
°C or as per the information on the product
label, and the cold chain must be
maintained at all times, and records of the
same kept for review when necessary.
● Thermolabile products that are required to
be frozen must be maintained at
temperatures in accordance with
manufacturers’ storage requirements.
● The temperature of the freezers for all
products including coolants must be
temperature monitored.
● Refrigerator, freezer or cold room must be
connected to an alarm system - in the event
of a power failure or if the temperature
limits are not met.
● Refrigerator, freezer or cold room must be
connected to a standby generator or other
emergency power system to ensure
uninterrupted power supply in the event of
a power failure.

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Requirement Minimum standard

●There must be a written procedure in place

in the event of a power failure.
● Loading and dispatch ● Dispatch procedures and transportation
area shall comply with the PPB Guidelines for
● Transport and delivery of the Transportation of Pharmaceuticals
vehicles and devices in Kenya

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4.2.2.Manufacturing

4.2.2.1. Scope of services

Services Task Infrastructure and equipment

requirement
Industrial Drug research and Manufacturing facility as per
Pharmacy development WHO TRS 986 Annex 2. Section
Practice Formulation Research 12 and EAC GMP Compendium.
and Development Drug research laboratory
Manufacturing
Quality Control
Quality Assurance
Authorized Person Role

4.2.2.2. Infrastructure and equipment requirements

Task Requirement Minimum standards

Formulation, Formulation Comply with minimum GMP

Research and R&D Laboratory requirements for specific dosage forms
Development (WHO TRS 986 and EAC GMP
Compendium)
R&D Scale Comply with minimum GMP standards
Equipment as per WHO TRS 986 and EAC GMP
Compendium.
Manufacturing Manufacturing Comply with minimum GMP standards
Facility as per WHO TRS 986 Annex 2 Section
12 and EAC GMP Compendium.
Human and veterinary products shall
not be manufactured in the same
facility.
Facilities for general non-beta lactam
products, penicillin beta-lactam
products, cephalosporin beta-lactam
products, and sex hormones are to be
dedicated only to those categories of
products.
Manufacturing Design and material of construction to
Equipment comply with minimum GMP standards
as per WHO TRS 986 Annex 2 Section
13 and EAC GMP Compendium.
In-Process Comply with minimum GMP standards
Testing and as per WHO TRS 986 Annex 2
Monitoring Equipment/instruments/ apparatus
Equipment used for measurement and testing are
within the appropriate range of

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Task Requirement Minimum standards

sensitivity, required precision and
accuracy for the tests done.
All equipment is in a calibrated state
and maintained as per schedule.
Utilities Comply with minimum GMP standards
as per WHO TRS 986 Annex 2
Systems are maintained as per
schedule.
Utilities e.g. Purified Water, Water for
Injections, compressed air, industrial
gases, air supply to process areas,
steam, pure steam, chilled water, and
electrical power meet the specified
standards suitable for the
manufactured dosage form and other
regulations e.g. environmental.
Quality QC Laboratory Comply with minimum GMP standards
Control as per WHO TRS 986 Annex 2 Section
12 (Quality Control Areas) and EAC
GMP Compendium.
QC areas should be separate from
production areas.
Quality Control Comply with minimum GMP standards
Equipment as per

● WHO TRS 986 Annex 2 Section 13

● WHO TRS 957 Annex 1
● EAC GMP Compendium.
Quality ● Office Comply with minimum GMP standards
Assurance ● Document as per
room, filing
cabinets ● WHO TRS 986 Annex 2
● Training ● EAC GMP Compendium.
room
● Computers Minimum space 100 sq. ft
● Reference Secure section for document storage
materials and filing
Training room adequate for number of
staff to be trained
Computers meet the required specs for
processor speed, memory and storage;
with internet connectivity.
Authorised ● Office Minimum space 100 sq. ft
Person roles ● Document Secure section for document storage
room, filing and filing
cabinets Training room adequate for number of
● Computers staff to be trained
● Reference
materials

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Task Requirement Minimum standards

Computers meet the required specs for
processor speed, memory and storage;
with internet connectivity.

4.2.2.3. Personnel Requirement

Refer to

● Guidance on Qualification and Experience Requirements and

Responsibilities for Key Personnel of Licensed Manufacturers of Medical
Products and Health Technologies in Kenya
● PPB Guidelines for the Establishment of the Qualified Person for
Pharmacovigilance

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4.3. STANDARDS FOR PHARMACY TRAINING INSTITUTIONS

4.3.1.Higher or Tertiary Level Teaching Institutions

Refer to the Certification Framework and Standards for Pharmacy

Programmes in Kenya (Bachelor of Pharmacy and Specialties)

4.3.1.1. Scope of service

Higher or tertiary level teaching institutions shall provide teaching, research,

student mentorship and community services as stipulated in the University
act and charter of the institution.
Scope of Service Task Infrastructure and
equipment
requirement
Teaching Classroom teaching Classrooms
Skill teaching and Laboratories
demonstration Clinical practice sites
Clinical teaching Computers and
projectors
Assessment and grading of Whiteboard
students Offices
Research Conducting basic and Office cabinets
operational research and
dissemination of findings
Student mentorship Counselling and role
modelling
Community service Provision of outreach
healthcare services

4.3.1.2. Infrastructure and equipment requirements

Requirements Minimum standards

Classrooms Follow the standards of CUE and PPB
Mandatory Pharmacy At least five dedicated Pharmacy laboratories
Laboratories
1. Pharmacognosy Laboratory
2. Pharmacology Laboratory
3. Pharmaceutical Chemistry Laboratory
4. Industrial Pharmacy Laboratory
5. Pharmacy skills development Laboratory
6. Research laboratories
Pre-clinical Pharmacy At least seven designated Pre-Clinical Pharmacy
Laboratories laboratories

1. Anatomy Laboratory

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Requirements Minimum standards

2. Biochemistry Laboratory
3. Physiology Laboratory
4. Microbiology laboratory
5. Dry Chemistry Laboratory
6. Wet Chemistry Laboratory
7. Pathology Laboratory
Departments The Board recommends at least three pharmacy
departments as per the thematic areas in
Pharmacy (Pharmacology, Pharmacognosy,
Pharmaceutics, Clinical Pharmacy,
Pharmaceutical chemistry)
Dedicated Office The institution should have a dedicated office for
the Dean, HODs/CODs, faculty and staff.
Clinical practice Sites The institution should have a collaborative
agreement (MoU) with a minimum of

1. At least one Level 5 and above hospital

2. Adequate primary health facilities
3. Adequate Community Pharmacies
4. Adequate Pharmaceutical Industries
5. Adequate Quality control and research
institutes

4.3.1.3. Personnel requirements

Personnel Minimum standards

Dean The Dean of the School of Pharmacy shall

1. Be a Registered Pharmacist by the Pharmacy and

Poisons Board,
2. Have a valid annual practice license from the PPB
3. Recognized as a Pharmacist specialist with a minimum
of MSc or above in the respective discipline or course
they teach.
4. Active member of the Pharmaceutical Society of Kenya
and other relevant society
5. Should be a senior lecturer and above
6. Fulfil all the requirements for being a university faculty
as set by CUE
Chairs/Head The Chairs/Head of the department shall
of
department 1. Be a Registered Pharmacist by the Pharmacy and Poisons
Board,
2. Have a valid annual practice license from the PPB
3. Recognized as a Pharmacist specialist with a minimum of
MSc or above in the respective discipline or course they
teach.

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Personnel Minimum standards

4. Active member of the Pharmaceutical Society of Kenya
and other relevant society
5. Relevant university teaching experience
6. Fulfil all the requirements for being a university faculty
as set by CUE
Common The faculty teaching personnel for common or supportive or
courses/pre- pre-clinical courses should have a minimum of MSc or above
clinical in the respective discipline or course they teach.
courses Number of common course faculty: 1:10 students
faculty
Clinical The faculty teaching clinical or major pharmacy-related
Core- courses shall
Courses
faculty 1. Be a Registered Pharmacist by the Pharmacy and
Poisons Board,
2. Have a valid annual practice license from the PPB
3. Recognized as a Pharmacist Specialist with a minimum
of MSc or above in the respective discipline or course
they teach.
4. Active member of the Pharmaceutical Society of Kenya
and other relevant society
5. Fulfil all the requirements for being a university faculty
as set by CUE

Number of clinical or major pharmacy course faculty: 1:10

students
Pharmacy The Pharmacy Preceptor should
preceptor
1. Be a Registered Pharmacist by the Pharmacy and
Poisons Board
2. Have a valid annual practice license from the PPB
3. Recognized as an Pharmacist by PPB
4. Be a staff of the clinical practice site
5. Active member of the Pharmaceutical Society of Kenya
and other relevant society

Number of Pharmacy Preceptor or Instructor: 1:20 students

Pharmacy The Pharmacy Instructor should
instructor
1. Be a Registered Pharmacist by the Pharmacy and
Poisons Board
2. Have a valid annual practice license from the PPB
3. Recognized as an Pharmacist by PPB
4. Be a staff of the teaching institution
5. Active member of the Pharmaceutical Society of Kenya
and other relevant society

Number of Pharmacy Preceptor or Instructor: 1:20 students

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4.3.2.Middle -Level Colleges

Refer to the Certification Framework and Standards for Diploma in Pharmacy

Programmes in Kenya.

4.3.2.1. Scope of service

Middle level colleges shall provide teaching, research, student mentorship and
community services as stipulated in the Checklist for inspection for diploma
in pharmacy (Refer PPB /PRA/RED/GDL/001).
Scope of Service Task Infrastructure and
equipment
requirement
Teaching Classroom teaching Classrooms
Skill teaching and Laboratories
demonstration Clinical practice sites
Clinical teaching Computers and
projectors
Assessment and Whiteboard
grading of students Offices
Research Conducting operational Office cabinets
research and
dissemination of
findings
Student mentorship Counselling and role
modelling
Community service Conducting outreach
services

4.3.2.2. Infrastructure and equipment requirement

Requirements Minimum standards

Classrooms Follow the standards of TVET and PPB
Mandatory Pharmacy At least three dedicated Pharmacy laboratories
Laboratories
1. Pharmacy Practice Laboratory
2. Biological Laboratory
3. Pharmaceutical Chemistry Laboratory
4. At least one dedicated Pharmacy Skills
Laboratory
Department The Board recommends that the pharmaceutical
technology program runs under the pharmacy
department.
Sections The institution should develop sections to
coordinate the relevant functions (exams,

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attachment, thematic subjects, trips, academic

advisory and others)
Dedicated Office The institution should have a dedicated office for
the Dean, HODs/CODs, faculty and staff.
Clinical practice Sites The institution should have a collaborative
agreement (MoU) with a minimum of

1. One Level 4 Hospital

2. Two primary health facility
3. Community Pharmacy
4. Pharmaceutical Industry

4.3.2.3. Personnel requirements

Personnel Minimum standards

Chairs/Head of The Chairs/Head of sections shall
Sections
1. Be a Registered PharmacistHave a valid annual
practice license from the PPB
2. Active member of the Pharmaceutical Society of
Kenya
3. Relevant teaching experience
4. Fulfil all the requirements for being a faculty as
set by TVET, PPB and other relevant colleges
Common courses The faculty teaching common or supportive courses
faculty should have a minimum of a Bachelor's degree in
the respective discipline or course they teach.
Number of common course faculty: 1:10 students
Pharmaceutical core- The faculty teaching Pharmaceutical Courses shall
Courses faculty
1. Be a Registered Pharmacist by the Pharmacy
and Poisons Board,
2. Have a valid annual practice license from the
PPB
3. Active member of the Pharmaceutical Society of
Kenya and other relevant society
4. Fulfil other requirements for being a faculty as
set by TVET, PPB and other relevant colleges

Number of clinical or major pharmacy course

faculty: 1:10 students
Pharmacy preceptor The Pharmacy Preceptor or Instructor shall

1. Be a Registered Pharmacist or Enrolled

Pharmaceutical technologist by the Pharmacy
and Poisons Board
2. Have a valid annual practice license from the
PPB

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Personnel Minimum standards

Chairs/Head of The Chairs/Head of sections shall
Sections
1. Be a Registered PharmacistHave a valid annual
practice license from the PPB
2. Active member of the Pharmaceutical Society of
Kenya
3. Relevant teaching experience
4. Fulfil all the requirements for being a faculty as
set by TVET, PPB and other relevant colleges
3. Recognized as Pharmacist or Pharmaceutical
Technologist by PPB
4. Be a staff of the clinical practice site
5. Active member of the Pharmaceutical Society of
Kenya and other relevant society

Number of Pharmacy Preceptor or Instructor: 1:20

students
Pharmacy Instructor The Pharmacy Preceptor or Instructor shall

1. Be a Registered Pharmacist or enrolled

Pharmaceutical Technologist by the Pharmacy
and Poisons Board
2. Have a valid annual practice license by the PPB
3. Recognized as a Pharmacist or Pharmaceutical
Technologist by PPB
4. Be a staff of the teaching institution
5. Be an Active member of the Pharmaceutical
Society of Kenya or Kenya Pharmaceutical
Association other relevant society

Number of Pharmacy Preceptor or Instructor: 1:20

students

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CHAPTER FIVE

HUMAN RESOURCE WORKLOAD GUIDELINES

Human resource needs should be determined by applying workload analysis,
i.e., measuring the level of effort of each position that considers the average
number of patients served per day per the health facility. The number of
personnel is calculated by analyzing one-year data of the minimum,
maximum and average patient or prescription load.
Accordingly: -

5.1. Dispensing/ Outpatient Pharmacy (Community and Hospital)

Dispensing and counselling services should allow for sufficient time to

facilitate effective communication between the pharmacist or pharmaceutical
technologist and the patient. This ensures that the patient receives the
necessary information and support to safely and appropriately use their
medication. It is crucial to consider the unique needs of each patient and
allocate ample time to address any questions or concerns they may have.
In a typical health facility or community pharmacy setting, the target average
dispensing time per prescription is generally around 10 to 15 minutes. This
timeframe encompasses tasks such as prescription verification, medication
preparation, labelling, and providing appropriate counselling to the patient.
Consequently, a pharmacist or pharmaceutical technologist is expected to
dispense an average of 50 prescriptions per day (calculated as 480 working
minutes divided by 10 minutes per prescription). To ensure the delivery of
high-quality dispensing and counselling services, healthcare facilities should
determine the average prescription turnover per month and appropriately
staff the workload. As a guideline, it is recommended to assign 1000
prescriptions per month per pharmacist or pharmaceutical
technologist to maintain optimal service quality.

5.2. Pharmaceutical Care Centres/ Chronic care pharmacies (CCPs)

Pharmaceutical care services given to patients on chronic care and inpatients

require lots of time for assessing medication-related problems, identifying

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patient therapy needs, assessing adverse drug reactions, drug interactions,

patient counselling, recording and documentation.
Pharmacists spend an average of one hour on the provision of pharmaceutical
care services for chronic patients (CCPs). This implies that the monthly
maximum load of a pharmacist will be 8 CCP/day * 24 days/month = 192
CCPs/month. Hence for the provision of quality pharmaceutical care services
for chronic care patients, it is recommended that the ratio of pharmacist to
patient should be 200 CCPs per month per pharmacist specialist/
pharmacist.

5.3. Inpatient Pharmacy (Unit Dose Dispensing)

Like the outpatient pharmacy, facility inpatient or ward-specific pharmacy

setting, the target average dispensing time per prescription is generally
around 10 to 15 minutes.
To ensure the delivery of high-quality dispensing and counselling services,
healthcare facilities should determine the average inpatient prescription
turnover per month and appropriately staff the workload. As a guideline, it is
recommended to assign 1000 prescriptions per month per pharmacist or
pharmaceutical technologist to maintain optimal service quality

5.4. Supply chain management

To effectively manage supply chain activities, which encompass medicine

storage, stock management, selection, quantification, and procurement,
health facilities should allocate a minimum of two pharmaceutical
technologists and one pharmacist for the dedicated performance of these
tasks.

5.5. Clinical Pharmacy Services

The clinical pharmacy services involve ward rounds, medication review,

patient counselling, MTM and other services as indicated in Chapter 2,
Standard 8 section of this document.

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Category Name of Catchment # of Pharmacist Clinical

of Facility area Beds Pharmacist
facility
Level 3 Health 25,000 16-24 1: 40 beds
center
Level 4 Primary 320,000 150 1:70 beds 1:70 beds
hospital
Level 5 Secondary 1,000,000 500 1:30 beds 1:60 beds
Hospital 12
ICU
12
HDU
Level 6 Tertiary 4,000,000 1:25 beds 1:50 beds
Hospital,
National
teaching and
referral
hospital

5.6. Specialized Pharmacy Service

Category of facility Level 3 Level 4 Level 5 Level 6

(16-24 (150 (500
beds) beds) beds, 12
ICU, 12
HDU)
Internal medicine 1 1 2 3
Pharmacist specialist
Pediatric Pharmacist 0 1 per 3 per 5 per
Specialist ward ward ward
Surgical and 1 per 1 per 2 per 3 per
Anesthesiology Pharmacist ward ward ward ward
Specialist
Critical Care Pharmacist 0 0 2 per 3 per
Specialist ward ward
Emergency Pharmacist 1 1 2 3
Specialist
Obstetrics and gynecology 2 per 2 per 3 per 4 per
Pharmacist Specialist ward ward ward ward
Infectious Disease 2 per 2 per 3 per 4 per
Pharmacist Specialist ward ward ward ward
Psychiatry Pharmacy 0 2 per 3 per 4 per
specialist ward ward ward
Oncology Pharmacist 0 2 per 3 per 4 per
Specialist ward ward ward
Renal Pharmacist Specialist 0 2 3 4
Radio-pharmacist 0 0 1 2

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Category of facility Level 3 Level 4 Level 5 Level 6

(16-24 (150 (500
beds) beds) beds, 12
ICU, 12
HDU)
Pharmacovigilance 0 1 2 2
specialist
Clinical toxicology 0 1 1 2
pharmacist
Compounding Pharmacist 0 1 2 2
Molecular Pharmacologist/ 0 1 2 2
Pharmacogenomics
specialists/ Clinical trial
and research specialist
Complementary and 0 1 1 2
Alternative Medicine
Specialist
Clinical Pharmacologist / 0 0 1 2
TDM specialist
Pharmaceutical Supply 0 0 1 2
Chain management
Specialist
Pharmacy managers 0 1 2 3

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Summary
Category of facility Level 2 Level 3 Level 4 Level 5 Level 6

Superintendent 1 Ph. 1 Pharmacist 1 Pharmacist 1 Pharmacist 1 Pharmacist

Tec. Specialist Specialist Specialist
Staff
Pharmacist 0 1 10 30 120
Pharmaceutical 2 4 12 20 40
technologist
Pharmacist Specialist 0 0 2 10 20
Internal medicine 0 1 1 2 3
Pharmacist specialist
Pediatric Pharmacist 0 0 1 per ward 3 per ward 5 per ward
Specialist
Surgical and 0 1 per ward 1 per ward 2 per ward 3 per ward
Anesthesiology
Pharmacist Specialist
Critical Care 0 0 0 2 per ward 3 per ward
Pharmacist Specialist
Emergency 0 1 1 2 3
Pharmacist Specialist
Obstetrics and 0 2 per ward 2 per ward 3 per ward 4 per ward
gynecology Pharmacist
Specialist
Infectious Disease 0 2 per ward 2 per ward 3 per ward 4 per ward
Pharmacist Specialist
Psychiatry Pharmacy 0 0 2 per ward 3 per ward 4 per ward
specialist
Oncology Pharmacist 0 0 2 per ward 3 per ward 4 per ward
Specialist
Renal Pharmacist 0 0 2 3 4
Specialist
Radio-pharmacist 0 0 0 1 2
Pharmacovigilance 0 0 1 2 2
specialist
Clinical toxicology 0 0 1 1 2
pharmacist
Compounding 0 0 1 2 2
Pharmacist
Molecular 0 0 1 2 2
Pharmacologist/
Pharmacogenomics
specialists/ Clinical
trial and research
specialist
Complementary and 0 0 1 1 2
Alternative Medicine
Specialist

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Clinical 0 0 0 1 2
Pharmacologist / TDM
specialist
Pharmacy 0 1 1 2 3
management
specialist

References
1. Welsh Pharmaceutical Committee, 2019: Pharmacy: Delivering a
healthier Wales
2. Elsayed TM, Elsisi GH, Elmahdawy M. Pharmacy Practice in Egypt.
Pharmacy Practice in Developing Countries: Achievements and
Challenges. Elsevier Inc.; 2016. 291–317 p. Available from:
http://dx.doi.org/10.1016/B978-0-12-801714-2.00015-0
3. South African Pharmacy Council. Pharmacy Human Resources in
South Africa. 2011.
4. World Health Organisation, Ghana Ministry of Health. Pharmaceutical
Country Profile Ghana. 2012.
5. OECD (2017), Health at a Glance 2017: OECD Indicators, OECD
Publishing, Paris. http://dx.doi.org/10.1787/health_glance-2017-en
6. Thamby SA, Subramani P. Seven-star pharmacist concept by World
Health Organization [Internet]. Vol. 6, Journal of Young Pharmacists.
2014 [cited 2020 Jul 29]. p. 1–3. Available from:
https://www.jyoungpharm.org/sites/default/files/10.5530_jyp.2014.
2.1.pdf
7. International Pharmaceutical Federation – FIP (2017). Pharmacy at a
glance – 2015-2017. The Hague, The Netherlands: International
Pharmaceutical Federation
8. Royal Pharmaceutical Society of Scotland 2030 Full Professional Vision,
(January 2022). https://www.rpharms.com/pharmacy2030
9. International Pharmaceutical Federation (FIP), Bates, I., Meilianti, S.,
John, C., & Bader, L. (2018). Pharmacy- Workforce -Intelligence : Global
Trends Report.
10. Norms and standards, Ministry of Health, Kenya

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CHAPTER SIX

IMPLEMENTATION GUIDELINES
The implementation guide aims to provide a comprehensive framework for
effectively integrating the standards outlined in this guideline into the daily
operations of pharmacy practice areas. It is intended for all pharmacy
professionals involved in the delivery of pharmaceutical services. By following
this implementation guide, it is possible to enhance the quality of
pharmaceutical services, improve patient outcomes, and align practices with
industry best practices and regulatory requirements. This guide serves as a
valuable resource to guide teams in successfully implementing the practice
guidelines and fostering a culture of continuous improvement in the
pharmacy practice.
1. Development of Facility-Level Practice Guidelines
The Pharmacy and Poisons Board shall develop practice guidelines tailored to
each level of facility. The development of facility-level practice guidelines is
crucial for the successful implementation of the pharmacy practice
guidelines. The following guidelines need to be developed

1. Level 1 Dispensing Pharmacy guidelines

2. Level 2 Pharmaceutical Care Center Pharmacy guidelines
3. Level 3 Specialty Pharmaceutical Care Center Pharmacy guidelines
4. Level 2 Dispensary Clinic Pharmacy guidelines
5. Level 3 Health Center Pharmacy guidelines
6. Level 4 Primary Hospital Pharmacy guidelines
7. Level 5 Secondary Hospital Pharmacy guidelines
8. Level 6 Tertiary Hospital Pharmacy guidelines

These guidelines should provide detailed instructions on activities specific to

each facility, as well as a list of permissible medicines. Additionally, SOPs for
speciality pharmacy services should also be developed. These SOPs will
ensure standardized practices and improve the quality of pharmaceutical
services across different types of facilities.
2. Development of Board-Certified Training Programmes

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The PPB shall develop Board Certified Training Programmes

(BCTPs) tailored for pharmacists and pharmaceutical technologists. These
comprehensive advanced training programs should encompass a range of
areas, including but not limited to
For both Pharmacists/pharmaceutical technologists:

● Supply chain management

● Primary healthcare (immunisation, family planning, nutrition),
● Pharmacy Management
● E-Pharmacy Services
● Rehabilitative Services
● Pharmacovigilance and Pharmacoepidemiology services
● Compounding services
● Aseptic dispensing services
● Pharmaceutical marketing

For pharmacists:

● Medication therapy management (MTM) services,

● Clinical pharmacy services,
● Radiopharmacy,
● Pharmacogenomic services,
● Therapeutic medicine monitoring services
● Clinical trial and research
● Industrial pharmacy services

The PPB, in collaboration with the PSK/KPA, educational institutions, and

other relevant partners, will develop the BCTPs. These programs must be
competency-based, face-to-face or online/blended training with a minimum
duration sufficient to acquire the competencies. The PPB will certify
institutions and instructors offering BCTPs. Accredited Board-certified
advanced training institutions are only permitted to deliver BCTPs using the
official training package and certified trainers.
The trainer or training institution is required to present evidence of assessing
the training program. Once satisfied with the training, assessment, and other

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relevant evaluations, the PPB shall certify the candidate as a Board-Certified

Provider.
To support the implementation of these training programs, the board will
establish a committee.
3. Enforcement of compliance with the standard
The Board shall constitute a Committee tasked with the quality assurance of
the pharmacy practice standards mentioned in Chapters 2 of this document.
The committee shall be composed of representatives from PPB, MOH, PSK and
KPA.
4. Timeline for implementation of the guideline
This guideline will come into effect in January 2024

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ANNEX I STANDARD PRESCRIPTION

PRESCRIBERS OR HOSPITAL NAME & ADDRESS*

Patient File Number: ________ Prescription number___________________

Name: ________________________________ Date: __/__/____

Age: ______________ Sex: _________ Weight: _____Kgs BMI__________

Telephone: _______________

Diagnosis: ______________________________________________________________________

Co-morbidities: __________________________________________________________________

Allergies: ________________________________________________________________________

RX**

Name of Dosage Unit of Route of Dose and Duration Total

Condition Medicine Form and measure administration frequency quantity
strength

Refill: ☐

Prescribed by: ______________________

Qualification and registration no: __________________

----------------------------------------------------------------------------------------------------------------------------- -----

FOR PHARMACY USE ONLY

Processed and Dispensed by: ______________________ Date: __/__/____

Qualification

☐ Pharmacist; PPB registration no: __________________

☐ Pharmaceutical Technologist; PPB enrolment no: __________________

Assessment (Check all that apply)

☐ Accuracy; ☐ Appropriateness; ☐ Dosage; ☐ Safety; ☐ Compliance

*A Rubber stamp with those details can suffice in absence of a letter headed prescription pad.

**The medicine name, dose, frequency clearly written

***If an electronic version, within a HMIS, it must capture all these details

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ANNEX II REFERRAL SYSTEM

Referral System
1. Pharmaceutical Technologists
Criteria for Referral
• Patients presenting with symptoms that suggest a need for
prescription-only medications.
• Adverse drug reactions or medication errors that require a clinical
intervention
• Complex medication regimens requiring a comprehensive review
• Cases where a higher level of clinical decision-making is needed
Referral Process:
• Assessment: Conduct a preliminary assessment of the patient's
condition.
• Documentation: Record the patient's details, current medications, and
the reason for referral.
• Communication: Communicate the referral to the pharmacist or
appropriate healthcare provider, providing all necessary information.
• Follow-Up: Ensure the patient follows up with the pharmacist or
appropriate healthcare provider and offer support as needed.
2. Pharmacists
Criteria for Referral
• Patients requiring specialized clinical services or diagnostic tests
• Severe or complex adverse drug reactions
• Advanced chronic disease management
• Need for specialized therapeutic interventions
Referral Process:
• Assessment: Perform a comprehensive assessment of the patient's
condition.
• Documentation: Document detailed patient information, including
medical history, current medications, and clinical findings.
• Communication: Coordinate with the Pharmacist Specialist or
appropriate healthcare provider, providing a thorough referral note.

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• Follow-Up: Ensure the patient schedules and attends the appointment

with the Pharmacist Specialist or appropriate healthcare provider and
monitor the outcome.
3. Pharmacist Specialists
Criteria for Referral
• Patients requiring multi-disciplinary care
• Severe or life-threatening conditions needing immediate medical
intervention
• Collaborative care needs involving other specialists
Referral Process:
• Assessment: Conduct an in-depth clinical assessment and diagnostic
evaluation.
• Documentation: Maintain comprehensive records of the patient's
condition, treatment plan, and reasons for further referral.
• Communication: Facilitate communication with other healthcare
providers, ensuring a detailed referral note and transfer of relevant
medical information.
• Follow-Up: Collaborate with other specialists to ensure integrated care
and continuity for the patient.

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LIST OF CONTRIBUTORS

No Name Expertise/Institution
1. Dr. F. Siyoi Chief Executive Officer, PPB
2. Dr. Tom Menge Head, HPT, Ministry of Health
3. Dr. Suge Titus K. Dean, School of Pharmacy, Kabarak
University
4. Prof. Francis Ndemo Clinical Pharmacist, Dean, School of
Pharmacy, USIU-Africa
5. Dr. Ermias M. Terefe, PhD Pharmacologist, Assistant Professor,
USIU-Africa
6. Dr. Peter Karimi, PhD Clinical Pharmacist, Lecturer, University
of Nairobi
6. Dr. Silvia Opanga, PhD Clinical Pharmacist, Associate Professor,
University of Nairobi
7. Mr. Eric Gichane Pharmaceutical Technologist, Kenya
Pharmaceutical Association
8. Dr. Simon Muigai Industrial Pharmacist, Lab and Allied
9. Dr. Jonah Maina Policy, Ministry of Health
10. Dr. James Kabiru Community Pharmacy Practice
11. Dr. Irene Weru Hospital Pharmacy Practice, Kenyatta
National Hospital
12. Dr. Jackson Lubayo Pharmacist, Koiywa Sub-County, Bomet
13. Ms. Salome Njiiri JHPIEGO/Advocacy
14. Ms. Beatrice Kwachi JHPIEGO/Advocacy
15. Dr. Wesley Oghera Informatics, KMFL, Ministry of Health
16. Dr. Nahil Dave Community Pharmacy Practice
17. Dr. Feli Oloo Pharmacist, Medical Superintendent,
Madiany Hospital
18. Ms. Salome Njiiri JHPIEGO/Advocacy
19. Ms. Beatrice Kwachi JHPIEGO/Advocacy
20. Dr. Siambi Kikete Complementary Medicine, Lecturer,
Kenyatta University
21. Dr. David Watta Hospital Pharmacy Practice, Kenyatta
National Hospital
23. Dr. Mohamed Hanif County Pharmacists Forum
24. Dr. Nyamu D.G, PhD Clinical Pharmacist, Associate Professor,
University of Nairobi
25. Dr. Emmanuel Kurgat Pharmacist, Kakamega County
26. Dr. Hillary Kagwa Clinical Pharmacist, Director of Health,
Kiambu County
27. Dr. Aisha Mongi Clinical Pharmacist, Kilifi County

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No Name Expertise/Institution
28. Dr. Elizabeth Itotia Radiopharmacist, Kenyatta University
Teaching and Referral Hospital
29. Dr. Elizabeth Kemunto Pharmacist, Nairobi County
30. Dr. Anthony Yiaile Toxicologist, Lecturer
31. Dr. Daniel Karimi USP-PQM
32. Dr. W. Ochieng Director, Pharmacy Practice, PPB
33. Dr. H. Mwavali PPB/Practice
34. Dr. R. Inyangala PPB/Practice
35. Dr. L. Kipkeno PPB/Practice
36. Dr. D. Munyoroku PPB/Inspectorate
37. Dr. Karim Wanga PPB/Product Safety
38. Dr. J. Meriakol PPB/Practice
39. Dr. L. Kipkeno PPB/Practice
40. Dr. D. Munyoroku PPB/Inspectorate
41. Dr. Pamela Nambwa PPB/Pharmacovigilance
42. Dr. Lydia Momanyi Clinical Pharmacist, Nakuru County
referral Hospital, Pharmaceutical
Society of Kenya
43. Dr. Jill Mutua Clinical Pharmacist, Bahati Sub-county
Hospital, Pharmaceutical Society of
Kenya
44. Dr. Agnes Ayoti Sub county Pharmacist, AINAMOI
45. Dr. Paul Ochieng National Association of sub-county
pharmacists
46. Mr Juma David Pharmaceutical Technologist, Kenya
Pharmaceutical Association
47. Dr. Rose Odera National Association of sub-county
pharmacists

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