ASBASJSM COLLEGE OF PHARMACY (AN AUTONOMOUS COLLEGE) BELA

TOPIC-1

PHARMACY AND THERAPEUTIC COMMITTEE

One of the methods or mode of ensuring the proper rationality in the use of drugs is that the hospital
organize and constitute, The Pharmacy and Therapeutic Committee.

Definition: The pharmacy and therapeutic committee is a policy framing and recommending
body to the medical staff and the administration of hospital on matters related to therapeutic use of
drugs.

This committee is composed of physicians, pharmacists and other health professionals selected with the
inclusion of medical staff.

Objective of the PTC: The PTC has 3 major roles to play. These are

1) Advisory

2) Educational

3) Drug safety and adverse drug monitoring

1) Advisory:

 The committee recommends the adoption of policies or assists in the formulation of broad
professional policies regarding evaluation, selection and therapeutic use of drugs in the hospital.
 The committee serves in an advisory capacity to medical staff and hospital administration in all
matters pertaining to the use of drugs, including the investigational drugs.
 It makes recommendations concerning the drugs to be stocked in hospital patient care areas.
 The committee advises the pharmacy in implementation of effective drug distribution and control
procedures.

2) Educational:

 The committee recommends or assists in the formulation of functions, designed to meet the needs of
professional staff like the physicians, nurses, pharmacist and other health care practitioners, for the
complete current knowledge of the matter related to the drugs and their use.
 The committee evaluates the problems related to the distribution and administration of medications,
including medication incident.
 The committee develops and compiles a formulary of drugs and prescriptions of formulations
accepted for use in the hospital.
 The committee should minimize duplication of the same basic drug, drug safety, and cost.
 It establishes or plans suitable educational schemes for the hospital’s professional staff on the matters
related to the use of drugs.

3) Drug safety and adverse drug monitoring: This function is assigned to or taken up by the PTC and
it should be continuous scheme of exerting vigilance.

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ORGANIZATION OF PTC:

Composition of PTC may varies from hospital to hospital. It is composed of:

 At least three physicians from the medical staff

 Pharmacist
 A representative of the nursing staff
 An hospital administrator with his/her designated an ex-officio members
 CHAIRMAN: Medical super indent or senior doctor appointed by the hospital executive board.
 SECRETARY: Chief hospital pharmacist if not junior pharmacist or pharmacy technician.
 MEMBERS: All Medical staff including representation from each and every department.

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OPERATIONS OF PTC:

 This committee should meet regularly at least six times in the year and also as and when necessary.
 The committee can invite its meetings persons within or outside the hospital who can contribute
specialized or unique knowledge, skills and judgements.
 The agenda and the supplementary materials should be prepared by the Secretary and furnished to
the committee members well in advance so that the members can study them properly before the
meeting.
 A typical agenda may consists of the following categories in general:
1) Minutes of the previous meeting.
2) Review of the contents of the Hospital Formulary for purpose of bringing it up to date, and deleting
of products not considered necessary for use;
3) Information regarding new drugs which may have become commercially available.
4) Review of side effects, adverse drug reactions, toxic effects, drug interactions of drugs reported by
various units of the hospital and brought to notice of the committee by DIC.
6) Review of Drug Safety in the hospital.
7) Reports of various sub-committees.
8) Report of medical audit.
9) Any other matter with the permission of chair.
10) Vote of thanks.
The minutes of all meeting hold should be prepared by the secretary and a permanent records of these
minutes should maintained in the hospital.

FUNCTIONS OF PTC:

1. Advisory committee to medical staff, administration and pharmacy: The PTC is a valuable
resource that can provide advice to medical staff, nurses, administration, pharmacy and other
departments and groups within the hospital. The PTC can advise on all issues, policies and guidelines
concerning the selection, distribution and use of medicines. Usually a DTC will provide advice and an
executive body, usually the pharmacy or hospital management, will implement it.
2. Development of drug policies: The PTC is the most appropriate body to develop drug policies
within a hospital or group of health facilities, since the committee members will have the most
experience and training in drug therapy and supply.
 Drug policies may vary in different hospitals and countries, but all hospitals should have specific
policies concerning.
 Criteria for inclusion of medicines on the formulary list (essential medicines list (EML)
 Standard treatment guidelines and treatment algorithms, which should be the basis of formulary
selection Periodic use of medicines not on the formulary list, for example restricting their use to
specified prescribers on a named patient basis only, or only allowing 10% of the hospital
medicines budget to be spent on them.
 Expensive or dangerous medicines, such as third-generation antibiotics or oenological drugs,
which are restricted to certain practitioners, departments or patients (structured order forms may
be used to implement this policy).
 Drugs that are under investigation for safety or efficacy.

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 Generic substitution and therapeutic interchange.
 Drug representatives and promotional literature.
3. Evaluating and selecting medicines for the formulary list: Perhaps the most important function of
a PTC is the evaluation and selection of medicines for the essential medicines list or formulary list.
Drugs should be selected on the basis of the standard treatment guidelines or protocols that have been
developed or adapted for use in the hospital or health facilities. The evaluation of medicines requires
significant expertise and time commitment and a rigorous, transparent approach.
4. Assessing medicine use to identify problems: Appropriate changes within the formulary list or other
interventions may correct a number of problems in how medicines are used. It is important for the
PTC to identify the priority problems and make appropriate recommendations.
5. Appropriate methods to identify drug use problems include:
• Aggregate drug consumption data review including ABC and VEN analysis and use of defined daily
dose (DDD) methodology.
• Monitoring indicators of medicine use, including adherence to standard treatment guideline• drug
use evaluation (DUE), also known as drug utilization review.
• Monitoring adverse drug reactions and medication errors.
• Antimicrobial resistance surveillance.
6. Conducting effective interventions to improve medicine use: There is no point in a PTC collecting
information on drug use problems if nothing is done to correct the problems identified. The PTC is
the main body within a hospital, or group of health facilities, responsible for ensuring that drug
information is provided to health staff and also for conducting interventions to promote more rational
drug use. Monitoring and supervision, audit and feedback, educational programmes, in-service
training, use of standard treatment guidelines, provision of unbiased drug information, prescribing
restrictions and automatic stop orders are some important interventions.
7. Managing adverse drug reactions: Adverse drug reactions (ADRs) are serious in terms of patient
harm (morbidity and mortality) and avoidable economic costs. One large meta-analysis estimated that
ADRs cause 3-4% of all hospital admissions in the USA and that in 1994 the incidence of ADRs was
6.7% (2.2 million events) with 106 000 fatalities (Lazarou et al. 1998). These estimates should be
viewed with caution because of the heterogeneity among studies and small biases in the sample, but
the data nevertheless suggest that ADRs are a large and serious problem.
8. Managing medication errors: Medication errors occur in all health-care settings, no matter how
good the healthcare staff are at prescribing, dispensing and administering medicines. Even if there is
no error on the part of health-care staff, patients may take drugs incorrectly. Causes are numerous and
include lack of knowledge, tiredness of staff, careless work attitudes, poor procedures, lack of
policies, unfamiliar dosage forms and human error. PTCs can reduce such errors by monitoring,
analyzing, reporting errors and implementing corrective action.
9. Information dissemination and transparency: The PTC must disseminate information about its
activities, decisions and recommendations to the staff who must implement the PTC’s decisions.
This may seem obvious, but it is often forgotten. Inadequate dissemination of information leads to a
loss of credibility. It is also very important that the PTC operates in such a way as to ensure
transparency of all its decisions and to avoid conflict of interest. In particular, members should either
have no relationship with pharmaceutical companies or declare it openly so that conflicts of interest
can be avoided. The only acceptable contact with pharmaceutical companies is to ensure the flow of
information about their drug products in a way that is as unbiased as possible.

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10. Policy Development:The P&T committee formulates policies regarding evaluation, selection,
diagnostic and therapeutic use, and monitoring of medications and medication-associated products
and devices. The P&T committee should establish and assist in programs and procedures that ensure
safe and effective medication therapy (e.g., clinical care plans, treatment guidelines, critical
pathways, disease management protocols). Members of the P&T committee, or their representatives
from appropriate specialties (including pharmacists), should participate in or direct the development
and review of such programs or procedures, which should be kept current.
11. Communication and Education: The P&T committee ensures that mechanisms are in place to
communicate with health care professionals, patients, and payers about all aspects of the formulary
system, including changes made to the formulary or policies and how formulary system decisions are
made. The P&T committee also recommends or assists in the formulation of educational programs
designed to meet the needs of professional staff, patients, families, and caregivers on matters related
to medications and medication use. The P&T committee should establish or plan suitable educational
programs on matters related to medication use for staff involved in the care of patients and the use of
medications.
ROLE OF PTC IN “EMERGENCY DRUG LISTS”
 The Time Factor is necessary for the Pharmacy and Therapeutics Committee of a hospital to get
prepared boxes containing emergency drugs which should be always available readily for use at the
bed‐side.
 List of such drugs and other supplies should compiled by Committee, and it should find their place
in “Emergency Kits”.
 After the emergency boxes have been placed in the wards, it is very essential and compulsory that a
system is developed whereby they are checked daily either by the hospital pharmacists or by nursing
supervisor responsible for the ward.
 A) Supplies to be maintained in Emergency Box:
i. Syringes of various range Two each of 1 ml. i.e tuberculin or insulin syringe, 2 ml. syringe
and 5 ml. syringe; and one each of 10ml and 20ml syringe.
ii. Needles, preferebly two each of 16’, 18’, 20’, 21’, 23’, and 26’,
iii. Files for breaking the ampoule
iv. Torniquets
v. Airway equipment
vi. Ryles tube
 B) Drugs for Emergency Box: These may selected in consultation with the physician but the
following list is illustrative only
i. Aminophylline 0.25 g/ml
ii. Amylnitrite glass capsules for inhalation
iii. Atropine sulphate 0.4mg/ml
iv. Caffeine sodium benzoate 0.5g/2 ml.
v. Calcium Gluconate 1 g/10 ml
vi. Digoxin 0.25 mg/ml
vii. Diphenylhydantoin sodium 50 mg/ml
viii. Epinephrine Hcl/1 mg/ml
ix. Heparin 10.000 units/ml
x. Hydrocortisone 100mg

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xi. Magnesium sulphate injection 10%, 50%
xii. Isoproterenol 1:100
xiii. Mannitol injection 25%
xiv. Nalorphine Hcl-10 mg/2ml
xv. Neostigmine methyl sulphate 0.25mg/ml
xvi. Norepinephrine Injection 0.2%
 C) Supplies for Cabinet Utility Room
i. Venuous cannulation set.
ii. Each set 12&17 venous catheters
iii. Pieces 6’’shock blocks
iv. Oxygen catheters
v. Sterile suction catheters
vi. Razor with blades
vii. Package sterile gelatine sponge
viii. Resuscitation tube.
 D) Other emergency supplies:
i. Resuscitation carts
ii. Phlebotomy sets
iii. Oxygen equipments
iv. Tracheotomy sets
v. Dextran and tubing
vi. Burn sheets

NB: Each hospital may modify this list by adding or deleting items as found necessary.

POLICES OF PTC IN DRUGS FORMULARY:

Formulary Principles :

The HealthPartners Pharmacy and Therapeutics Committee develops and maintains its formulary
based on these guiding principles. These principles reflect the 6 AIMS (safe, timely, effective,
equitable, efficient, and patient centered). These principles are prioritized in descending order (i.e.
effectiveness isweighted most heavily, followed by safety issues, and then by cost).
Formulary decisions are made following a careful review of these often‐competing principles.

1. Proven effectiveness documented in the medical literature. The primary consideration will be the degr
ee to which a medication produces clinically desirable effects. Beneficial effects are assessed on the st
rength of scientific evidence including peer‐reviewed medical literature, pharmacoeconomic studies,
a nd outcomes research, and standards of practice including treatment protocols and evidence‐based
pra ctice guidelines such as Institute for Clinical Systems Improvement (ICSI). Randomized
controlled tr ials are weighted most heavily,followed by non‐randomized trials, case reports, and
medical pinion.
2. Maximizing safety and minimizing the potential for errors. The safety risk / benefit of a product will
be compared with other treatments.We will minimize the potential for errors caused by product chara

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cteristics such as name, dosage form, and packaging that pose threats to patient safety or increase the
potential for errors in the health care system.
3. Optimizing pharmacoeconomics. The overall value of a drug or therapy will be compared with existig
treatments to assess pharmacy costs in relation to medical outcomes. We will consider direct and indi
rect pharmacy and medical costs.We will take into consideration and give preference to those agents
that optimize the use of financial and service resources over the largest potential population.
4. Emphasis on products essential to health.
5. Significant improvements in patient convenience, adherence, and satisfaction.We will review more fa
vorably products that have significant improvements in patient convenience, adherence, and satisfacti
on. Examples include variables such as dosing convenience, variety of dosage forms, taste, ability to
crush or divide doses, and storage requirements (refrigeration).
6. The formulary will support standard treatment algorithms.
7. Long term stability of formulary decisions. Changes to the formulary will be minimized for member
care continuity.
8. The formulary will serve as a guideline for the vast majority of patients.
a.Utilization management programs such as prior authorization, step‐edits, MD‐edits, quantity
limits,and age limits will be applied to promote appropriate utilization.
b.A “Formulary Exception” process will be readily available, easy to use, and timely.
c. A “Transition of Care” policy will be available to assist members transitioning to HealthPartners.

AUTOMATIC STOP ORDERS FOR DANGEROUS DRUGS:

 All Drug Orders for narcotics, sedatives, hypnotic anticoagulants, and antibiotics shall be
automatically discontinued after 48 hours unless the order indicates an exact number of doses to be
administered, or the attending physician, re-orders the medication.
 All orders for narcotics, sedative and hypnotics must be rewritten every 24 hours.
 In India, at present, this kind of system of issuing “ASODD” is not practiced except for hospitals like
Christian Medical Hospital Vellore or Jaslok Hospital, Mumbai Escort group, Mayo Hospital etc.

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TOPIC-2

DRUG INFORMATION SERVICES

Introduction: It is the current, relevant, critically examined data about drug and drug use for given
patient or situation. Many institutes run DIC(Drug Information Center) for the provision of drug
information, to every group/kind of people from any place.

DIC: Drug information center is new concept in hospital pharmacy operation is usually located in
separate section of pharmacy containing large number of reference texts, journals, reprints and
brochures. Sometimes they are also equipped with electronic data processing equipments and have a
full time director and adequate secretarial assistance.

HISTORY: First DIC was developed in University of Kentucky in 1960. In United states 80%
of theHospitals having DIC.

Need of drug information:

 The no of drugs in the international market has increased very much.

 The newer drugs are generally more potent & selective, and formulations becoming increasingly
complex.
 The literature on drugs has also expanded and covers a wide range of information.
 To introduce a new drug into the practice, the professionals need to evaluate the given information.
 A simple, quick reference to a pharmacopoeia or formulary is no longer sufficient.

Aims and objectives of drug information services:

 The provision of information to health professionals on specific problems related to the use of drugs
in particular patients.
 The provision of information to officials in government agencies to optimize the decision making
process.
 The preparation and development of guidelines and formularies.
 To improve patient compliance and to provide a guide to responsible self medication.
 To develop and participate in continuing education programs.
 To participate in undergraduate and graduate teaching programs.
 To develop educational activities regarding the appropriate use of drugs for patients in the
community.
 To prepare and distribute material on drugs to health personnel in the form of a drug Information
bulletin and/or other media.
 To develop and participate in research programs.

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The Sources of information/Resources available

1. Primary Source: Information is presented by authors without any evaluation by a second party.
Provides must current information about drugs. Examples; articles published in journals(eg British
Medical Journal), thesis, magazines, bulletins etc. They contain scientific information, research and
review articles where books contains a compilation of information so that there is big lag time
between a discovery o an idea and its publication.
Periodicals are further classified into:
a) Primary periodicals: They contains reports of original research.
b) Secondary periodicals: They contains that portion of original research which is according to their
needs in the condensed form.

On the basis of scope they are classified as under:

a) Scientific Periodically: They contain original research articles which is reviewed by experts who
are eminent scientific e.g. journal of pharmaceutical sciences.
b) Professional Periodicals: They contains articles which have the practical aspects. They are less
technically and scientifically oriented as compare to the articles presented in the scientific
periodicals. E.g. Pharmacy times, American journal of pharmaceutical education.
c) Commercials Periodicals: They contain information that is useful to the trade people i.e.
information regarding the new products into the market, price change information, etc. e.g. drug
index, drugs topics.
2. Secondary source: The original source has been evaluated by second party other than the publisher.
Modified and rearranged form. Secondary sources consists of reviews of primary reports. These
provide a personal perspective of the literature and can include comments on how the author might
apply the information in practice.
•Medline
•International Pharamaceutical Abstracts
•Chemical Abstracts
•IOWA drug Information Service
•DRUGDEX
•Martindale
•POISINDEX
3. Tertiary source: Information obtained from primary and secondary source and arranged in a
manner to represent a composite of the available information. Examples; Representative form
Pharmacopeias - BP, USP, IP, BNF etc., Encyclopedia Dictionaries Guides, text books. Tertiary
resources are summaries of the primary and secondary published literature. Printed textbooks are the
main example and these are characterized by a slow rate of revision compared to secondary sources
• AHFS-Drug information Book; Australian Medicine Handbook
• Avery’s Drug Treatment
•Basic skills in interpreting Lab data
•Drug information handbook
•Drug interactions Stockley/ Facts and comparison
•Handbook of injectables

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•Harrisons Principles of Internal Medicine
•Martindale, Pharmacopoeias, Physicians desk ref
•Merck index, Merck manual,
•BNF, USP, Australian formulary

Other Sources: The DIC also receives information from

 The public and hospitals about the Adverse effects of any drug
 Local drug lists
 National Formularies
 Hospital Formularies
 Internet
 Phone calls to Manufacturers
 Government and Non-government organizations and also to other DIC’s

Drug information bulletin:

 It publishes the latest developments in medical sciences, the newly introduced drugs, new indication
and other information regarding drugs.
 One of the PTCs duties is to assist the pharmacist in conducting a teaching program within the
hospital through a pharmacy publication.
 The methods employed to disseminate interdepartmental information are usually bulletins, bulletin
board notices and committee meetings.
 The bulletin normally publishes the latest development in the medical sciences, the newly introduced
drugs, new indications for certain drugs, newer drug delivery systems, updates on drug interactions
and ADRs.
 Pharmacist is normally held responsible for its publication however; contributions are obtained from
pharmacists, physicians and nursing and other interested groups like therapeutic dietician for food
drug interactions for publishing the bulletin.
 The contents should however be educative and informative.

POISON INFORMATION CENTER

PCC(Poison control center): For the provision of service regarding poison and related danger, and to
manage with the poisoning Cases Concept initiated in chicago in 1953.

PCC were established for two reasons:

 To provide rapid access to information valuable in assessing and treating poisonings.

 To assist with poisoning prevention.

FUNCTIONS:

 Assess and treatment recommendations during poisoning via 24-hour emergency telephone services.
 Provide public and professional educational programs.

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 To collect data on poisonings.
 To perform research.
 Assist the public and health care providers during hazardous material spills.

COMPUTERIZED SERVICES

Computerized services: These information systems are organized to serve the needs of developed as
well as developing countries on co-operative basis as these are established to store recorded
information and retrieve it expeditiously and provide free exchange of information among scientists
in various countries. The major International information systems & services are INIS, AGRIS,
INSPEC, BIOSIS, MEDLARS, MEDLINE etc. Computer- based products & services

 AVLINE (Audio-Visual Online)

 CANCERLIT (Cancer Literature)
 CATLINE (Catalogue Online)
 CHEMLINE (Chemical Dictionary Online)
 TOXLINE (Toxicology information Online)
 SDILINE (Selective Dissemination of Information Online)
 SERLINE (Serials Online)
 POPLINE (Population Information Online)

MEDLINE is a literature database of life sciences and biomedical information introduced in 1971. It
includes medicine, nursing, pharmacy, dentistry, veterinary medicine & health care. It can be
searchable via PubMed & NLM‟s National Center for Biotechnology Information‟s Entrez system.
MEDLINE uses Medical Subject Headings (MeSH) for information retrieval. Engines designed to
search MEDLINE (such as PubMed &Entrez) generally use a Boolean expression combining MeSH
terms, words in abstract and title of the article, author names, date of publication, etc. More than
6,000 of the world's leading biomedical journals are indexed in MEDLINE. Selection is based on the
recommendations of a panel, the Literature Selection Technical Review Committee (LSTRC), based
on scientific policy and scientific quality. PubMed is a free database comprises more than 22 million
citations for biomedical literature from MEDLINE, life science journals, & other online books.
Citations may include links to full- text content from PubMed Central & publisher websites.
Available via the NCBI Entrez retrieval system.MedlinePlus is a free web service produced &
maintained by NLM. Provides consumer health information for patients, families, & health care
providers. Brings together information from the US. NLM, the National Institutes of Health (NIH),
other US.govt.agencies& health related organizations.

DIFEERENT COMPUTERIZED SERVICES IN DIC:

 Maintenance of records: Various records like patient medication history, current treatment, financial
records etc. are maintained in computer by feeing accurate data. Computer work as a data base
manager. MEDLINE is a data base package used for this purpose. In which wholedata about patient is
recorded.
 Inventory control: it is very important because it maintain balance between stock in hand and capital
investment. Computers are used to detect the items which has attained by minimum order level. It
then prepares a list and purchase order for supplies. There are 2 system of inventory:

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1) Periodic inventory control system: In this system stock level are checked manually and the
amount of inventory in hand is compared with minimum and maximum stock maintained in the
computers. Computers helps in placement of orders to different suppliers after checking their
terms and condition.
2) Perpetual system: In this system computer tells us about the present position of the drugs
because they are received, they are entered in the initial stock to get the current stocks. As the
drugs are delivered to the various department the quantities are subtracted accordingly.
 Medication monitoring: To meet the goal of optimum drug therapy, medication monitoring is
essential. The prescription of a particular patient is receive over a period of time is entered and serves
as chronological patient drug profile. It helps in suggesting drugs along with their dosage schedule for
medication monitoring. Computers provided two types of information:
1) Pharmacokinetic information: “NONLINE” is a computer program which can predict
pharmacokinetic parameters easily. These parameters include volume of distribution,
bioavailability, rate of clearance etc.
2) Non pharmacokinetic information: It includes various allergic reactions, drug interactions,
adverse drug reactions etc. for this 2 computers programme is used MEDIPHOR, PAD
 Drug information services: Computers have become an important tool for clinical pharmacist in
drug information services. Computer aided drug design helps in new design of drug formulae
possessing desired pharmacological action.CD-ROM technology has helped a lot in the evolution of
compact electronics libraries.
 Data storage and retrieval: National library medicine created a computerized medical information
retrieval system. It is a data base containing around 300 bio medical journals since 1966. “BIOSIS” is
produced by bioscience information services containing various biological abstract.
 Marketing and distribution: It involves processing of orders, invoicing, maintenance of records,
billing etc.
 Pharmaceutical industry: Complete computerized programme are available for drug manufacture
and for quality control management. Information for the beginning of process for finished product is
available.
 Hospital pharmacy and retail pharmacy: computers have a hospital pharmacist in keeping overall
patient care like maintenance of a patient record, entry of prescription etc. all data stored in computer.

RETRIEVAL OF INFORMATION:

This can be illustrated by an example of registration in hospitals. A person who wishes to see a senior
doctor has to fill a request slip. This slip contains a relevant data i.e. name, age, sex etc. The operator
then feeds data from request slip to computers. The process in this case include examining the
availability of senior doctor and determining whether data suits to patient or not. As a result of this
process some information is output. The output may be in the printed Performa, if the senior doctor is
available or otherwise a message may be issued by computer turning down the request.

In hospital, management of data is essential for effective retrieval of information. Data management
involves creating, modifying, deleted and adding data in patient files and using this to generate
reports and these reports are shared by many doctors for further investigation as they are
connected through various personal computers. Some popular data base management
system(DBMS) package for personalcomputers are:

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