National Medication Standards
National Medication Standards
National Medication
Practice Standard
Ministry of Health
Republic of Maldives
Contents
Acknowledgment ................................................................................................................................................................. 5
Abbreviations ........................................................................................................................................................................ 6
Glossary ................................................................................................................................................................................... 7
Introduction .......................................................................................................................................................................... 9
Methodology ......................................................................................................................................................................... 10
Standards ................................................................................................................................................................................ 11
Standard 2: Standardised processes for prescribing, administering, and monitoring medicines.. ............ 14
Recommendations ............................................................................................................................................................... 34
References .............................................................................................................................................................................. 37
Assistant Professor Asma Ibrahim Sulaiman, Dean Faculty of Health Sciences, Villa College
Fathimath Limya, Health Quality & Safety Compliance Analyst, Quality Assurance and Regulations Division,
Ministry of Health
Gulisthan Esa, General Nurse, Quality Assurance and Regulations Division, Ministry of Health
DOCUMENT RECORD
Medication practice standards are crucial guidelines that ensure safe, effective, and responsible use of medications
in healthcare settings. It also outlines accountabilities and responsibilities when performing all activities like, but
not limited to storage, administration, dispensing, inventory management and safe disposal. These standards help
reduce medication errors, adverse drug reactions, and other safety risks, ultimately safeguarding patient well-
being and ensuring staff safety. Standardized medication practices facilitate communication and collaboration
among healthcare team members, including physicians, nurses, pharmacists, and other allied health professionals.
Consistent practices will ensure that everyone involved in patient care understands their roles and responsibilities
regarding medication management. Additionally, having a consistent reporting system and providing care based
on guidelines can help prevent 75% of occurrence of harm in to hospitalized patients (Mohammed et al., 2022)
Compliance with medication practice standards demonstrates commitment to patient safety and quality of care,
fostering trust and confidence among patients, their families, and the broader community. Patients are more likely
to trust healthcare providers and institutions that adhere to recognized standards of practice. Updating and
publishing these standards also bring about accountability of Ministry of Health to orient staff on these standards
and conduct audits to ensure compliance.
I sincerely appreciate the ongoing support provided by the World health organization, throughout the
development of this standard, I would like to acknowledge EBPHC Maldives For the scoping review and
development of the current guideline. I also extend my gratitude to all stakeholders, individuals and my team at
Quality Assurance and Regulatory Division of Ministry of Health who have contributed to the development of
this standard.
The effectiveness of this standard hinges upon its adoption by healthcare professionals and stakeholders across
both government and the public sector. I urge all health care professionals to use the standards for safety and
quality of patient care.
Thasleema Usman
For the purpose of this standard, the following terms are defined as stated below.
Adverse drug reaction (ADR) is defined as a noxious or unintended reaction to drug or agent which occurs at
doses used in humans for prophylaxis, diagnosis, therapy or for the modification of physiological function. This
excludes accidental/unintentional overdose (Coleman & Pontefract, 2016).
Patients: The people, patients or residents who benefit from registered nursing care. A patient may be an
individual, a family, group, community, or population.
Controlled Drugs: medicines that can only be supplied by a pharmacist on prescription and are subject to tight
restrictions because of their potential to produce addiction. These includes Buprenorphine, fentanyl,
hydromorphone, methadone, morphine, oxycodone, talpentadol and pethidine (Yun et al., 2015).
Compound: means for the purpose of these guidelines, the extemporaneous preparation and supply of a single
‘unit of issue’ of a therapeutic product intended for supply for a specific patient in response to an identified need.
The practice of compounding is classified in these guidelines as either simple or complex compounding. Unless
otherwise stated, the guidance provided in these guidelines applies to both simple and complex compounding
(Australian Commition on Safety and Quality in Healthcare, 2022; Pharmacy Board of Australia, 2017).
Simple compounding means the preparation and supply of a single ‘unit of issue’ of a therapeutic product intended
for supply for a specific patient in response to an identified need. It routinely involves the compounding of
products from formulations published in reputable reference (Australian Commition on Safety and Quality in
Healthcare, 2022; Pharmacy Board of Australia, 2017).
Complex compounding means the preparation and supply of a single ‘unit of issue’ of a therapeutic product that
is intended for supply for a specific patient and that requires or involves special competencies, equipment,
processes or facilities. Examples are sterile preparations and preparations containing ingredients that pose an
occupational health and safety hazard (such as cytotoxins or hormones), micro-dose single unit dosage forms
containing less than 25mg (or up to 25 per cent by weight or volume) of active ingredient and sustained-release or
other modified-release preparations (Pharmacy Board of Australia, 2017).
Cold chain management: the system of transporting and storing temperature-sensitive medicines and vaccines,
within their defined temperature range at all times, from point of origin (manufacture) to point of administration,
to ensure that the integrity of the product is maintained (Gogou et al., 2015).
Distribution: systematic and reliable delivery of medicines to all health care facilities (Pharmacy Board of
Australia, 2017).
Guideline: a principle or criterion that guides or directs action. Guideline development emphasises using clear
evidence from the existing literature, rather than expert opinion alone, as the basis for advisor materials (Nursing
and Midwifery Board Ireland, 2020)
Healthcare Professional: professionals who are qualified by education and/or experience to provide health care
and are practicing medical practitioners, dental practitioners, nurses, midwives, allied health professionals
(Healthcare Professional Act, 2015).
Medication: In this document, medication refers to all scheduled drugs, over the counter medication, blood and
blood products, biologics, vaccines, and natural health products (Department of Health, 2020) .
Medicines Management: Medicines management covers a number of tasks including prescribing, ordering,
dispensing, receiving/transporting, storing, assessing, preparing, assisting, administering, disposing and reviewing
individuals with their medicines (Nursing and Midwifery Board Ireland, 2020; Pharmacy Board of Australia, 2017).
Medication Reconciliation: A process for obtaining and documenting a complete and accurate list of a patient’s
current medicines upon admission and comparing this list to the prescriber’s admission, transfer and/or discharge
orders to identify and resolve discrepancies(Stark et al., 2020).
Near Miss: An event, situation, or error that took place but was captured before reaching the patient (Institute for
Safe Medication Practices, 2009).
Over the counter medications: Medications that can be sold without prescription (Department of Health, 2020).
Omission: failure to do something, especially something that a person has a moral or legal obligation to do.
Protocol: an established set of rules used to complete tasks or a set of tasks (Stevenson, 2010).
Scheduled frequencies are frequencies such as TWICE a day, THREE times a day.
Storage: the site/place and conditions under which medicines are kept until dispensing or administration
(Pharmacy Board of Australia, 2017).
Scheduled medications include all maintenance doses administered according to a standard, repeated cycle of
frequency (e.g., q4h, QID, TID, BID, daily, weekly, monthly, annually) (Australian Commition on Safety and
Quality in Healthcare, 2022; Stark et al., 2020).
Self-administration: the independent use of a medication by a patient in a manner that supports the management
and administration of their medications.
Time critical medicines are defined as medicines were early or delayed administration by more than 30 minutes
from the prescribed time for administration may cause harm to the patient or compromise the therapeutic effect
resulting in suboptimal therapy (Pharmacy Board of Australia, 2017).
This document serves as a comprehensive guide, addressing a wide spectrum of aspects related to medications,
from their development and manufacturing to distribution, prescription, and administration. By outlining
standardized protocols and criteria, the National Medication Standard Document aims to harmonize practices
across the healthcare system, fostering consistency and accountability.
Regulatory Compliance: Providing a framework for compliance with national regulations, ensuring that
all stakeholders in the medication supply chain adhere to legal requirements and industry best practices.
Safety Protocols: Outlining safety standards and protocols for the prescription, dispensing, and
administration of medications to minimize adverse events and enhance patient safety.
Education and Training: Facilitating the continuous education and training of healthcare professionals
to ensure a knowledgeable workforce capable of implementing and adhering to the established
standards.
These standards always apply to all regulated members regardless of role or practice setting and are
specific to medication management. The standards are grounded to code of ethics in Health
Professionals Act HPA.
Standards
These standards identify the expectations for regulated members for medication management. The criteria in the
following standards illustrate how the regulated member must meet the standard, and all criteria must be met to
achieve the standard. It is e criteria are not written in order of importance.
03 Preparation/compounding
Dispensing
Storing
High risk medication
Disposing
05 Medication reconciliation
Adverse drug reaction
1.1.2 Low-level risk-reduction strategies (i.e. staff education and information) should be used
together with high-leverage risk-reduction strategies, such as forcing functions and fail safes
(such as limiting access or use, constraints, barriers or standardisation.
1.1.3 A regular review of incidents and near-misses and the use of prospective analysis and re-design
of systems to prevent recurrence of the same errors.
1.1.4 Pharmacists who compound products must have appropriate risk management processes in
place to manage risks associated with the compounded product and the workplace (for
maintenance of facilities, quality assurance of products including microbial testing,
occupational health and safety adherence, professional indemnity insurance arrangements, etc.).
1 . 1 .5 Conduct routine audits of medication management practices to ensure safe and effective care
for patients.
1.1.6 The healthcare service to develop an information system to collect and review data related to
medication practices for improvement.
1.2.2 The healthcare service has processes to support its workforce to understand and fulfill their
assigned safety and quality roles and responsibilities.
1.2.3 Develop clear roles and responsibilities for clinical governance within the health care service.
Number of people who fill these roles depends on the size of the service. (In a health center or
small clinic- One person can fulfill all of these roles, while atoll hospital few people can fill all
of these roles).
Healthcare professionals: Work within, and are supported by, well designed clinical
systems to deliver safe, high-quality clinical care. Healthcare providers are responsible for
the safety and quality of their own professional practice and codes of conduct.
Managers: Are primarily responsible for ensuring that the systems that support the
delivery of health care are well-designed and perform effectively. Where managers are not
owners, they advise and inform the owners/ governing body, and operate the service within
the agreed strategic and policy parameters.
Governing body: Are ultimately responsible for ensuring the service is well run and
delivers safe, high-quality health care. They do this by establishing a strong safety culture
through an effective clinical governance system, satisfying themselves that this system
operates effectively, and ensuring there is an ongoing focus on quality improvement.
1.2.4 The healthcare service provides its workforce with orientation and training for their safety and
quality roles on commencement with the service when safety and quality responsibilities
change and when new healthcare services are introduced.
2.1.1 Accurate patient weight should be documented on the medication chart for all patients.
2.1.2 The route of administration for the medicine must be clearly identified. The use of multiple
routes of administration in one prescription should be avoided for the same medicine (for
example, intravenous paracetamol / oral paracetamol)
2.1.3 Where required, the strengths of medicines must be clearly visible in terms of the dosage unit or
dose per volume of liquid, for example, mg per ml.
2.1.4 Dose adjustments must be considered when prescribing a high-risk medicine for patient groups
such as overweight or underweight patients, and patients with existing clinical conditions (such
as renal or hepatic impairment) that may affect drug metabolism and excretion.
2.1.5 Therapeutic guidelines should be followed for medicines where dosing is complex and the
duration of therapy substantially increases the risk of toxicity, for example, aminoglycosides.
2.1.6 When prescribing IV antibiotics, use hourly (known as interval) frequencies (e.g., 6 hourly),
rather than scheduled frequencies (e.g. FOUR times a day). This will reduce the risk of
additional, unintended doses being scheduled and the nurses having to do extensive
rescheduling.
2.1.7 Local health service policy/ guidelines will outline when nurses can initiate medicines and will
specify a limitation on nurse-initiated medicines such as “for one dose only” or “for a maximum
of 24 hours only”. Generally, the capacity applies to a limited list of medicines only. Typically,
this includes simple analgesics, aperients, antacids, cough suppressants, sublingual nitrates,
inhaled bronchodilators, artificial tears, sodium chloride 0.9% flush, or IV infusion to keep IV-
line(s) patent as per local policy.
2.2.1 Only an authorized health care professionals (i.e., doctor, registered nurse, CHW) can take
telephone orders.
2.2.2 Local Health service policy/guidelines will outline whether telephone orders are allowed and
under what circumstances they are to be used.
2.2.3 Verbal orders should not be given to administer an unprescribed medicine, except in an
emergency.
2.2.5 Authentic electronic mail orders and orders given through telemedicine can be accepted (text
messages from prescriber’s mobile phone should not be accepted). However, verification must
be made whenever necessary.
2.2.6 Faxed and printed email orders should be filed in patient’s charts.
2.2.7 The prescriber should confirm the order by signing in the patient’s chart as soon as possible and
not later than 6 hours.
Maldives National Medication Standard Version 2, 2024 Page 15
2.3 Criteria: Administering
2.3.1 The healthcare practitioner administering the medication should review the patient’s
medication chart before administering the medication to the patient.
2.3.2 Healthcare professionals administering any medicine should have current knowledge of
indication, mechanism of action, dosage, precautions, contraindications, interactions with food
or other medicines, and side effects of the medication.
2.3.3 All healthcare professionals administering medicines should have knowledge of and skills if
using any equipment for administering medicine (eg. nebulisers, infusion pumps etc).
2.3.4 Medicines should be scheduled so that medicine is administered on the same times each day
and doses are spaced appropriately so that medicine levels are stable. When a new medicine is
started outside the regime, then a stat dose can be given.
2.3.5 All healthcare services ensure policies should outline standardized medication administration
times to accommodate the timing of meals, minimize disturbances to night sleep of the patient
(last dose any scheduled medications should not be later than 10 pm) and to eliminate the need
for individual interpretation of when the medications should be given.
2.3.6 Exceptions to standard drug administration times may be appropriate for patients who self-
administer chronic medications, stagger numerous piggyback IV medications, or keep a time-
critical chronic medication on the same schedule used before admission. (While it may seem
best to try to keep patients who take any type of chronic medication on the same
administration schedule they were using at home, medication administration throughout the
day during nonstandard times is prone to omissions; thus, administration during standard
times is recommended. QID medicines should be given at 6 am, 12 pm, 6 pm, and 10 pm. TID
medicines should be given at 6 am, 2 pm and 10 pm. BID medicines should be given at 6 am and
6 pm or 8 am and 8 pm. These times should also be used in transcribing.
2.3.7 The healthcare practitioner writing the order must enter the frequency and administration
time(s) when writing the medication order. Time should be entered using the 24-clock (this
nomenclature is the global standard).
2.3.8 Disposable syringes must not be reused, single-dose vials should not be used for multiple
dosages, and a new syringe must be used each time to draw medication from a multi-dose vial
(Limya, 2020).
2.3.9 Health services should also define targeted timeframes for administering first doses and loading
doses of key medications, such as IV anti-infective agents, IV anticoagulants, and IV
antiepileptic medications, where timeliness is critical (e.g., an emergency department patient
with suspected sepsis should not wait several hours for the administration of a prescribed anti-
infective). The targeted timeframes for first or loading doses of medications should be
accompanied by procedures that facilitate achievement of the administration time goals.
2.3.10 Health services establish procedures for healthcare practitioners to follow if the administration
of a time-critical scheduled medication will be or has been delayed or administered early
beyond allowable expectations.
An essential component of the medication process related to the administration of medications is monitoring and
assessing the patient by healthcare practitioners.
2.4.1 Patient should be monitored after medicine administration in accordance with local protocols
and guidelines.
2.4.2 Health care Practitioners should be alerted in clinical handover to the use of any high-risk
medicines.
2.4.3 The health service practice should develop processes for managing high-risk, high-alert
medications and Look-alike, sound-alike (LASA) medications.
2.4.4 In case of an adverse drug reaction, emergency medicines and equipment should be easily
available.
A Absent
F Fasting
NA Not Available
Standard coding
reasons for
R Refused
non-administration
of a dose SA Self-administered
V Vomited
W Withheld
L On Leave
R
Patient refusing to take a regular patient if applicable. Notify the attending healthcare provider
medication and discuss alternative options with the patient, such as
Refused further education on the importance of the medication,
potential side effects, or alternative treatment options.
SA
Self-administered
This code is utilized to signify
when a patient has independently
During the hospitalization, it is crucial to highlight that
nursing/midwifery staff must observe and approve all
taken a medication. medication administrations.
V
Vomiting code is used to indicate Apply the vomiting code to indicate medication dosing
both before (unable to take) and omission, capturing instances both before (due to inability to
Vomited after (dose not absorbed) take) and after (due to non-absorption) administration.
medication dosing omission. Top of Form
W
Withheld
Used when there is a clinical reason withholding the dose should be documented and
to withhold a dose communicated to the prescriber as soon as practicable.
2.5.2 Health Service should provide clear guidelines about the appropriate actions to be taken
when a medicine is not administered within the accepted period of tolerance.
2.5.3 If there is any change in the patient treatment plan, the reason for this change and the
person(s) notified should be documented.
2.5.4 All aspects of controlled drug administration should be recorded properly in the patient
chart and then countersigned.
2.5.5 Documentation should be stored in a safe, systematic and secure manner that allows timely
and accurate retrieval, while reducing the risk of unauthorised access and failure of
confidentiality. All documents must be securely stored in accordance with professional
standards and relevant legislation.
Selection, procurement and distribution of medicines should be done based on the most current or updated
National Medicine Policy to ensure safe, effective, affordable and good quality medicines are readily available for
dispensing and administration.
3.1.1 Healthcare practitioners needs to be vigilant when preparing medications (avoid distractions
and interruptions).
Pharmacists entering the profession are expected to have had the appropriate
education and training to compound medicines and are deemed competent to
undertake ‘simple compounding’. Simple compounding may routinely involve
compounding products using other formulations for which information confirming
3.2.2.5 quality, stability, safety, efficacy and rationality is available.
3.3.1 Medicines should be dispensed only by a qualified and authorized pharmacist at the proper
time.
3.3.2 The dispensers should have the knowledge, skill and judgment to dispense the medicine
safely, effectively and ethically.
3.3.3 All orders must be reviewed for appropriateness before a medicine is dispensed. Medicine
order evaluation includes interactions, allergies, and contraindications.
3.3.4 If any problem is identified with the medicine order, it should be communicated with the
prescriber and resolved before the medicine is dispensed.
3.3.5 Dispensing for inpatients, discharges and outpatients complies with all legislative,
professional and best practice requirements for dispensing.
Label the product clearly and appropriately with name, proper route, dosage, for how long
to take, and also the expiry date.
Labeling and relevant cautionary advisory label requirements (for discharge and outpatients)
to optimise the correct medication storage, handling and administration.
Barcode scanning of dispensing label and original pack to ensure the correct selection of
medication, strength, brand, and dose form as per each label. This safety check is carried out
for all inpatient, outpatient and discharge medications, where possible.
Barcode scanning does not identify all errors, so a manual check must also occur.
Provision of a patient friendly medication list and other administration charts, e.g., complex
dosing chart, interim medication administration chart, where appropriate.
3.4.1 All essential medicines should be routinely stocked and stored in their original packaging to
render protection to the medicine and to retain information regarding batch numbers and
expiry dates.
3.4.2 Guidelines for proper and safe storage of medicines should be available in all places, such as
healthcare facilities and pharmacies.
3.4.3 All conditions necessary to maintain the stability of medicines should be followed when
storing medicines. These conditions include appropriate temperature, and humidity and
prevent exposure to harmful light. Pharmacists’ advice should be sought in identifying these
conditions.
3.4.4 The cold chain should be maintained during all aspects of vaccine storage. Vaccines should not
be stored in the door, in the bottom drawers, or adjacent to the freezer plate of refrigerators
3.4.5 Healthcare service ensure that refrigerators (or cool rooms) of adequate size are available for
the exclusive storage of vaccines or medicines that require storage between 2 °C and 8 °C.
3.4.6 Medicine stock should be replenished so as not to hinder availability for dispensing or
administration of medicine.
3.4.7 To minimize medication errors, look-alike and sound alike medicines should be stored
separately.
3.4.8 Perform a risk assessment of the processes in place for the handling, storage and distribution of
medicines using validated or locally endorsed audit and risk tools.
3.4.9 Once a medication is prepared for administration but not administered, it should be
considered as a stored medicine until administration.
3.4.10 Medicines stored in the wards, especially medicines in the emergency trolley, should be in the
readiest to- administer form.
3.4.11 Health care facility’s/pharmacy’s policies should be followed in storing controlled drugs.
3.5.1 A healthcare service that prescribes, stores, supplies and/or administers medicines has processes
to:
Any alterations or additions to the High-Risk Medicine Register require endorsement from
the Ministry of Health.
3.5.2 Each high-risk medicine included on the High-Risk Medicine Register along with its
associated individual standard will be assigned a maximum 2-year review date.
3.6.1 The Medication Safety Committee in the healthcare service will be responsible for maintaining
the High-Risk Medicine Register and ensuring risk reduction strategies are effective.
3.6.2 The High-Risk Medicines Register and individual high-risk medicine standards will be made
easily accessible to all staff involved in the management of medicines via the Policy and
Guidance Documents Register on the intranet.
3.6.3 Each medicine on the high-risk medicines register will be subjected to a comprehensive risk
assessment to reduce the risk of errors that can occur across all phases of the medicine.
3.7.1 All controlled drugs are exclusively imported through STO. The Ministry of Health
collaborates with STO and the Narcotic Control Board to formulate the annual national
demands for controlled substances, which are then submitted to NCB (Narcotics Control
Board). NCB notifies the Ministry of Health based on these requirements, and subsequent
authorization for the importation of controlled substances is granted to STO.
3.7.2 Every establishment handling controlled drugs must adhere to storage guidelines outlined by
the MFDA. This ensures that the stocked drugs are securely maintained on the premises,
minimizing accessibility to individuals likely to misappropriate them. The security measures
implemented should meet the MFDA standards to protect both the controlled substances and
the personnel working within the establishment(Ministry of Health).
3.7.3 Maintain accurate records of controlled drugs as per MFDA guidelines, regularly cross-check
stock records, retain blue prescriptions quarterly, and keep all related records for at least two
years.
3.7.4 The handling of controlled drugs must adhere to the guidelines provided by MDFA.
3.8.1 All healthcare services implement policies, procedures, and guidelines for the disposal of
unused, unwanted, or expired medicines.
38.2 Controlled drugs are legislated to be destroyed by an authorized health practitioner and
witnessed by a second authorized healthcare practitioner in accordance with MFDA (Ministry
of Health).
3.8.3 Controlled drug waste waiting to be destroyed must be kept secure in a safe, separated from
other medicines in the safe, clearly marked for destruction, and may only be removed
immediately before destruction or being transferred for destruction.
3.8.4 Every healthcare facility should have designated personnel responsible for notifying the
Ministry of Health if controlled drugs expire or are withheld from use for any reason.
3.8.5 Upon closure or cessation of operations, the pharmacy must dispose of or transfer all records,
files, and drug stock in compliance with the directives provided by the Ministry of Health.
3.8.6 Pharmacies and healthcare facilities across the islands should forward lists of expired controlled
drugs to the nearby regional hospital or health center.|
3.8.7 Healthcare facilities handling cytotoxic drugs must:
3.8.7.1 Establish and label specific color-coded bins or use recognizable symbols (e.g.,
purple) for disposing of cytotoxic drugs, ensuring clear identification in areas where
these drugs are handled.
3.8.7.3 Provide training to staff for proper identification and exclusive use of these bins or
symbols for cytotoxic drug waste, along with regular awareness programs.
Uphold this standard to guarantee safe disposal practices and review it periodically
3.8.7.5
to align with evolving regulatory requirements.
Clinical outcomes and patient satisfaction are likely to be better when decisions about medicines are made
jointly between the person taking the medicine and the prescriber (shared decision making)(Montori et al.,
2017; Stiggelbout et al., 2012).
4.1.1 All service providers (such as hospitals, clinics, and pharmacies) ensure that people are
allowed to be involved in making decisions about their medicines in partnership with
professionals who prescribe medicines.
4.1.2 Healthcare professionals (such as prescribers, and pharmacists) ensure that people are allowed
to be involved in making decisions about their medicines. For example, healthcare
professionals can use patient decision aids to support shared decision-making and they should
ensure that people who take medicines have information about the potential benefits and
harms.
4.1.3 Healthcare professionals should take account of a person's values and preferences by discussing
what is important to them about treating or managing their condition(s) and their medicines.
4.1.4 Address concerns of problematic polypharmacy with the client, the inter-professional team,
and the authorized prescriber or most responsible healthcare practitioner.
4.2.1 Ministry of Health provides guidance and resources to health services to support them to
become more person-centered in the context of National Quality and Safety Standards.
4.2.2 The healthcare service has processes for healthcare providers to partner with patients and/or
their substitute decision-maker to plan, communicate, set, and review goals, make decisions,
and document their preferences about their current and future healthcare.
4.2.3 Healthcare service fosters partnerships with patients, carers, and families, promoting active
patient involvement, while professionals communicate tailored information addressing patient
needs, preferences, and ongoing healthcare requirements.
4.2.4 The healthcare service collaborates with patients, carers, and families to incorporate their views
and experiences into service planning, design, monitoring, and evaluation while providing
information on services, hours, costs, feedback mechanisms, and contact details for healthcare
complaints.
4.2.5 If a patient questions or expresses concern regarding a medication, stop and explore the
patient’s concerns, review the doctor’s order, and, if necessary, notify the practitioner in charge.
If the issue is not resolved, the patient could notify MFDA.
Medication reconciliation means that the medicines the patient should be prescribed match those that are
prescribed. Transition points of care are particularly prone to unintended changes in medication regimes and
other medication errors.
5.1.1 All registered healthcare practitioners involved in Medicine Reconciliation (MR) are
responsible and accountable for the accuracy and quality of information provided to support
the medicine reconciliation process at a given point in time.
5.1.2 Each organisation ensures that each healthcare practitioner involved with medicine
reconciliation meets minimum education and training requirements every year. Learnings from
the measures are incorporated into ongoing implementation and education and training
requirements.
5.1.3 An all-encompassing staff training initiative is regarded as one of the essential elements
contributing to the success of medication reconciliation.
5.1.4 Training should prioritize two fundamental aspects: the method of conducting patient
interviews to construct accurate and comprehensive best possible medication histories, and the
development of critical thinking skills needed for effective medication reconciliation(World
Health Organization, 2014).
5.1.5 The healthcare practitioner compares the collected medicines, allergies and ADR list against
the prescribed information, such as the medication chart, identifying and documenting any
discrepancies.
5.1.6 Adopt a standardised form for collecting pre-admission medicines and reconciling variances.
5.1.7 At each transition point all changes that have occurred to the patient’s medicines, allergies and
ADR list will be documented, dated, and communicated to ensure the care of the patient is
continued.
5.1.8 Establish specific time frames within which medicines should be reconciled for all patients (< 24
hours, within 4 hours for high-risk medicines) of admission, transfer, and discharge.
5.1.9 Provide clinicians ready access to drug information and a pharmacist consult when needed
5.1.10.1 Maintaining an updated medication list or bringing their medications during hospital
admission, preadmission visits, or outpatient appointments, presenting this list to
healthcare providers during each encounter. This can be facilitated through educational
materials and tools designed to assist patients in independently managing their
medication lists. The Medication Reconciliation SOP Implementation Guide offers
examples of educational resources and tools to involve patients effectively
5.1.10.2 Advocating for themselves by voicing concerns if they suspect an error has occurred
with their medications.
5.1.11 When transferring a patient from one facility to another the following must be included with
the transfer documents
5.1.11.2 A completed transfer summary with the key elements relating to medications that are
applicable to the discharge summary.
5.2.2 The healthcare practitioner must elicit, and document known medicine allergies and ADRs
experienced by a patient before their current admission.
5.2.3 Organizational policies, procedures, and guidelines on recording known medication allergies
must be available and up to date. These documents should:
Identify the healthcare practitioner responsible for recording information on known drug
allergies and ADRs. (Patients may be more familiar with the term allergy, than ADR, so this
may be a better prompt).
Provide a clear outline of information needed (for example, type of reaction, severity, and how
it was managed)
Describe where and when it is appropriate to record a known allergy or adverse reaction to
substances other than medicines, such as food, in the patient’s medicine allergy and ADR
history.
5.2.4 Provide orientation, training, and education to healthcare practitioners, and review the work
practices for:
Documenting known drug allergies and ADRs in the patient’s ADR history
Referring to a patient’s medicine allergy/ADR history before, or at the point of, decision-
making when prescribing, dispensing, or administering medicines.
5.2.5 Conduct audits of medicine allergies and ADRs and provide information to healthcare
practitioners through medication safety bulletins, in-service orientation sessions, case reports,
or grand rounds.
6.1.1 The healthcare service has processes to ensure that healthcare providers have the qualifications,
knowledge and skills required to perform their role by:
6.2.1 act within the law and adhere to Maldives Food and Drug Authority standards and professional
guidance when administering medicines to patients. It is expected that all nurses and midwives
have current nursing registration and licensing.
6.2.2 comply with local policies, protocols, guidelines and standards for high-risk medicines.
6.2.3 be knowledgeable about the therapeutic effects and side effects of the medication, its
interactions with food or other medications, and contraindications indication, mechanism of
action, dosage, precautions, and contraindications.
6.2.4 be knowledgeable about the medications they administer and those that their clients are
taking, whether prescribed, over the counter, or natural health products.
6.2.7 should recognize their level of competence in relation to medication administration and take
measures to develop their competence.
6.2.8 are expected to honor patients' rights and autonomy during the informed consent process,
acknowledging their right to refuse medication. The decision to withhold a medication may be
made by the nurse or midwife, guided by specific clinical rationale(s).
6.3.1 Healthcare professionals should establish and maintain trusting relationships with patients
6.3.2 Prompt reporting of any medication-related errors, whether actual or potential, is imperative.
Immediate corrective action must be taken.
6.3.3 Healthcare professionals should exercise professional judgment responsibly when asked to
disclose confidential information about patients or administered medications.
6.3.4 Honest and truthful information and guidance must be provided to patients, families, or legal
guardians. Communication should be tailored to the age and cognitive ability of the recipient.
6.3.5 In the event of an adverse occurrence, nurses and midwives are obligated to prioritize patient
safety. This involves promptly monitoring the patient's health status and taking necessary
actions to minimize or prevent further harm.
2. Healthcare organisations to develop no-interruption zone policy for safe preparation and administration of
medication.
3. Healthcare organisations ensure that specific recommendations for the safe procurement and storage of
anaesthetic medicines are included in any policies, procedures, or protocols, to minimise risks from these
medicines.
4. Evaluate the use and implementation of storage or delivery systems for safety, quality, and security risks.
5. Ensure that policies, procedures and protocols for safe handling, storage and distribution of medicines are
evidence based and comply with legislative requirements.
6. Perform audits of compliance with policies, procedures and protocols for handling, storage, and
distribution of medicines. Consider temperature-sensitive medicines and safety controls, such as separating
look-alike packaging or electronic alerts.
7. Develop guidance on effective processes to ensure the integrity of the cold chain that includes:
Audits of temperature control of storage facilities, including room temperature, refrigeration, and
frozen storage
Regular testing and maintenance schedules for temperature alarms and temperature recording
devices
8. Install alarms to monitor refrigerators and cold rooms, as well as medicine storage areas (including
pharmacy departments), where temperatures would ideally be maintained below 25 °C (according to the
manufacturer’s instructions)
10. Establish systems for identifying, reporting, and learning from medicines-related patient safety incidents.
Organisations should support a person-centred, 'fair blame' culture that encourages reporting and
learning from medicines-related patient safety incidents.
Health care practitioners should explain to patients, and their family members or carers where
appropriate, how to identify and report medicines-related patient safety incidents.
11. In an hospital setting, accurately list all the person's medicines (including prescribed, over-the-counter and
complementary medicines) and carry out medicine’s reconciliation within 24 hours or sooner if clinically
necessary, when the person moves from one care setting to another – for example, if they are admitted to
hospital.
12. All health care settings should ensure that a designated healthcare professional has overall organisational
responsibility for the medicine’s reconciliation process. The process should be determined locally and
include:
organisational responsibilities
responsibilities of healthcare practitioners involved in the process (including who they are
accountable to)
13. Organisations should ensure that medicines reconciliation is carried out by a trained and competent
health professional – ideally a pharmacist, pharmacy technician, nurse or doctor – with the necessary
knowledge, skills and expertise including:
a. effective communication skills
b. technical knowledge of processes for managing medicines
c. therapeutic knowledge of medicines uses.
14. Health Clinics or small hospitals that are part of a local health network or private hospital group
should adopt or adapt and use the established process for documenting a patient’s history of
medicine allergies and ADRs, as a component of past medical history.
15. In outpatients’ departments (OPD) or clinics, healthcare professionals must elicitelicit, and
document known medicine allergies and ADRs experienced by a patient before their admission.
16. Organisations should consider involving a pharmacist with relevant clinical knowledge and skills
when making strategic decisions about medicines use or when developing care pathways that
involve medicines use.
17. Ministry of Health to develop a tool kit that provide information, resources and quality
improvement (QI) tools for managers and clinicians to improve Med Rec in health services.
20. Communicate with patients in a way that supports effective partnerships and shared decision making, to
the extent that the patient chooses.
21. Patients can play a vital role in preventing medication errors when they have been encouraged to ask
questions and seek answers about their medications.
Documentation
22. National standard medication charts should be introduced to healthcare facilities to improve the safe use
of medicines. The charts support the delivery of appropriate care for hospitalised patients to help
communicate information consistently between clinicians on the intended use of medicines for an
individual patient.
23. National standard medication charts can be adapted into different versions for adults
24. Healthcare professionals are advised to use clinical discretion and consideration of the circumstances for
individual patients when using the charts for patient medication management in acute care settings.
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