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Introduction
• 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.
•Pharmacy and Therapeutic Committee:- The pharmacy and therapeutics
committee is a policy farming and recommending body to the medical staff and
the administration of hospital on matters related to therapeutics use of drug.
This committee is composed of physician, pharmacists and other health
professionals selected with the inclusion of medical staff.
• Drug and Therapeutics Committees: A Practical Guide provides guidance to
doctors, pharmacists, hospital managers and other professionals who may be
serving on DTCs and/or who are concerned with how to improve the quality
and cost efficiency of therapeutic care. It is relevant for all kinds of DTCs -
whether in public or private hospitals and whether at district or tertiary
referral level.
 Drug and Therapeutics Committee-also called a Pharmacy and Therapeutics
Committee.
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The committee designated to

 ensure the safe and effective use of medicines in the facility or area under its
jurisdiction,
 Evaluates the clinical use of drugs,
 Develops policies for managing drug use,
 Administers and manages the formulary system.

Definitions:
•Formulary Committee:- The committee dedicated to selecting, developing,
and maintaining list of approved drugs for the hospital or clinic.
•Formulary:- A list of drugs that are approved for use in the healthcare system
by authorized prescribers.
•Formulary System:- A system of periodically evaluating and selecting drugs
for the formulary, maintaining the formulary, and providing information in a
suitable manual or list.
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Why DTCs Are Important

• Drugs can save lives and improve quality of life but are expensive
(30-40% budget), widely misused and can be dangerous (ADRs
common).
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Why are drug and therapeutics committee needed?

 Essential medicines are one of the most cost-effective ways of saving
lives and improving health.
 Increasing costs and lack of resources often result in public health
systems being unable to procure sufficient medicines to meet patient
demand.
 Despite this medicines are often managed and used inefficiently and
irrationally. This may be due to many factors, for example
Inadequate training of health staff
Lack of continuing education and supervision, or
Lack of update, reliable
Unbiased drug information
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 Particular areas of insufficiency and drug use problems include:

Poor selection of medicines, without consideration for relative
efficacy, cost-effectiveness or local availability.
Inadequate quality, wastage, or use of unnecessary expensive
medicines.
Prescribing not in accordance with standard treatment protocols
Poor dispensing practices resulting in medication errors, and patients
lack of knowledge about dosing schedules
Patients not adhering to dosing schedule and treatment advice
Inefficient use of medicines affects the safety and quality of
therapeutic care and wastes resources.
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• Important benefits of a DTC:

Select effective, safe, high quality, cost-effective drugs for the
formulary.
Improve the use of drugs.
Management of antimicrobial resistance
Improved quality of patient care and health outcomes.
Increased staff and patient knowledge
Decreases adverse drug reaction (ADRs) and medication errors.
Improved drug procurement and inventory management.
Management of drug costs.
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• Objective of the Pharmacy and Therapeutics Committee

The pharmacy and therapeutics committee has three major roles
to play. These are:
1) Advisory
2) Educational
3) Drug safety and adverse drug monitoring
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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.
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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.
It establishes or plans suitable educational scheme for the
hospital professional staff on the matters related to the use
of drugs.
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The committee develops and compiles a formulary of

drugs and prescriptions of formulations accepted for
use in the hospital.
The committee should minimise duplication of the
same basic drug, drug safety, and cost.
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Drug safety and adverse drug monitoring:

The function is assigned to or taken up by PTC to ensure
safety to patients by keeping continues vigilance.
The P&T Committee maintains a formulary of medications
approved for routine patient care, reviews drug use and
adverse drug reactions, and establishes procedures for
prescribing, dispensing, and administering drugs in the
hospital.
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RESPONSIBILITY:
 Preparation of hospital formulary
 Publishing of a pharmacy education bulletin
 The supervision of Investigational use of drugs
 “Automatic stop order” for dangerous drugs
 Assisting in preparation of emergency kits or carts
 Reporting and investigation adverse drugs reactions
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• COMPOSITION/ ORGANIZATION OF PTC

It varies from hospital to hospital.

 It composed of :
 At least three Physicians from the medical staffs.
 A pharmacist,
 A representative of the Nursing staff and
 An hospital administrator with his/her designated an ex-officio
member of the committee one of the Physician may be appointed
as the Chairman of PTC.
 The Pharmacist functioning as Secretary & therefore he is designated
as the “SECRETARY” of the committee.
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COMPOSITION AND FUNCTIONS OF PHARMACY AND THERAPEUTICS COMMITEE 15

Medical staff Hospital administrators Pharmacist

Chairman (Physician) (Director) (Secretary)
Co-chairperson (Physician) Nursing staff
Joint-Secretary

PHARMACY AND THERAPEUTICS COMMITTEE

Sub-Committee Sub-Committee Sub-Committee Sub-Committee Sub-Committee Sub-Committee

(Neo-Plastics) (Anti-infectives) a) Cardio- vascular Drugs a) Gastro intestinal Drugs a) C.N.S agents a) Endocrinology agents

b) Diuretics b) Autonomic b) Analgesics & antipyretics b) Antidiabetic agents

c) Cardiac glycosides c) laxatives c) Anticonvulsants c) Anti-inflammatory agents

d) Hypotensives d) Psychotherapeutics d) Hormones

e) Vasodilators e) Respiratory &cerebral e) Thyroid- preparations

stimulants

f) Spasmolytics

g) Anticoagulants f) Sedatives & Hypnotics

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Operations of PTC
 The committee should meet regularly, at least 6 times per year
& when necessary.
 They may invite to its meetings person within or outside the
hospital who can contribute specialized or unique knowledge,
skills and judgement.
 Minutes of the meeting should be recorded by secretary &
maintained permanently in hospital.
 The agenda and the supplementary materials should be
prepared by secretary & submitted to committee members
well in advance, so that the can study them before the
meeting.
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Typical Agenda consists of…

 Minutes of previous meeting.
 Review of content of hospital formulary for up-dating & deleting of
products not considered as necessary for use.
 Information regarding new drugs which may have become commercially
available.
 Review and/or adoption of investigational drugs currently under
processing in the hospital.
 Review of investigational drugs currently used in hospital.
 Review of side effects, ADRs, drug interaction, toxic effects reported.
 Review of drug safety in hospital.
 Reports of various sub-committees.
 Report of medical audit.
 Any other matter with the permission of chair.
 Vote of thanks.
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The minutes of all meeting hold should be prepared by

the secretary (the pharmacist-member) and permanent
records of these minutes should be maintained in the
hospital.

The recommendations of the committee should be

presented to the medical staff or its appropriate committee
for its adoption or recommendations.
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Functions
 To serve in as an advisory committee to the medical staff & hospital
administration regarding drugs (including investigational drugs).
 To develop a formulary of drugs accepted for use in the hospital and
provide for its constant revision where, selection is made based on
safety, cost, therapeutic benefits.
 To establish / plan suitable educational programs for the staff so as to
update their knowledge about drugs of their use.
 To review ADRs occurring in hospital.
 To make recommendation concerning drugs to be stocked in hospital
patient care area.
 To advice the pharmacy in the implementation of effective drug
distribution and control procedure.
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 To review drug utilization in hospital and promote optimum

standards for rational drug therapy.
 To participate in quality assurance activities related to the
distribution, administration and use of medicines.
 To assist the pharmacy department in the development and
review of policies, rules, and regulation regarding the use of
drugs in hospital.
 To make categories of the drugs used in the hospital.
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Role of PTC in Drug Safety

 It is the moral, legal and professional obligation of the pharmacist.
 Drug safety includes responsibility from dispensing of drugs to drug-
administration and to observe possible adverse effect.
 PTC can play a major role in ensuring drug safety.

Following guidelines may serve the committee in ascertaining the

adequate safety factor of the hospital pharmacy drugs safety:
 The hospital must employ a qualified and registered pharmacist as
the chief pharmacist.
 The hospital must provide adequate safe work space, and storage
facilities.
 The hospital should have the firm policy regarding the use of research
drugs in the hospital and its clinics.
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 Role of PTC in ADR monitoring

 An adverse reaction is defined as any unusual or unexpected
harmful reaction from a drugs.

 Every case of adverse drug reaction must be first reported by

attending physician to chairman of PTC. The ADR including
acute drug poisoning of any drug like narcotics, barbiturates
and amphetamine.

 The Attending Physician Should Complete the “ADR Report

form”.
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Automatic stop order:
 All drug order for narcotics, sedatives, hypnotics, anticoagulants and
antibiotics shall be automatically discontinued after 48 hours.

(a) Unless the order indicates an exact no. of doses to be

administered.
(b) Exact period of time for medication is specified.
(c) Attending physician records the medication.

 All orders for narcotics, sedatives and hypnotics must be written

every 24 hours.
•All P.R.N (pro re nata) and standing order for all medications except
narcotics, sedatives and hypnotics shall expire at 10.00 am on the 7th day
unless renewed or an hour which may be determined by the pharmacy
and therapeutics committee in consultation with concerned medical
staff and recommend to the hospital administration.
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Role of PTC in developing Emergency drug list

• It is absolutely necessary for the PTC of a hospital to get

prepared boxes i.e. “Emergency drug boxes” containing
emergency drugs which should be always available readily use
at bed-side.
• These emergency boxes or “kits” should be checked daily either
by hospital pharmacist or nursing superior responsible for the
ward.
• These emergency boxes should be placed in all the wards.
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supplies to be maintained in
emergency box
A) 1) Syringes :1ml,2ml…
2) Needles : 16’, 18’…
3) Files for breaking the ampoules.
4) Tourniquets
5) Airway equipment
6) Ryle tube.
B) Drugs for emergency box:
Aminophylline 0.25g/ml
Amylnitrates glass capsules
Atropine sulphate 0.4mg/ml
Calcium gluconate 1g/10ml
Digoxin 0.25mg/ml. etc…
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Supplies for cabinet utility room
• Venous cannulation set
• Each set of 12&17 venous catheters
• Oxygen catheters
• Sterile suction catheters
• Razor with blades
• Package sterile gelatin sponge
• Resuscitation tube
Other emergency supplies
• Resuscitation cards
• Phlebotomy sets
• Oxygen equipments
• Tracheotomy sets
• Dextran and tubing
• Burn sheets
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ROLE OF PTC IN DRUG UTLIZATION REVIEW

• Drug utilization includes prescribing, dispensing, administering

and ingesting of prescription of drugs.
• Hospital pharmacist should take medication history that should
include following information:
(1) Medication being taken at the time of admission, during
admission home remedies (OTC drugs)
(2) Drug- allergies and idiosyncrasy towards food products.
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ROLE OF PTC DRUG PRODUCT DEFECT

REPORTING
• The drugs purchased by hospital maybe defective in quality it is
for the committee to get information about the defective drug
products and to inform it first to the manufacture for appropriate
action.
• If satisfactory answer is not obtained from the manufacture or
supplier then it should be reported to FDA.
Drug defect form
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XYZ HOSPITAL
 
Address ------------------------------------------ Date received----------
 
HOSPITAL PHARMACIST’S DRUG DEFECT REPORT
Reference No-------
 
1. Trade Name------------------ Dosage form-------------
Strength -----------------.
2. Lot No. ------------------- EXP Date-------------------
3. Date of purchased-----------
4. Name of supplier---------------------------
5. Name and address of the manufacturer-------------------
 
6. Reporting pharmacist’s name. ------------------------------
7. Defects Noted or suspected----------------------------------
 
Signature of the Chairman
Date----------------- Pharmacy and Therapeutics Committee
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PTC is the backbone of the

hospital pharmacy and its
services, and therefore, it
should properly organized.
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• Role of the DTC:-

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• DTC Structure and Organization

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• Operation of Pharmacy and Therapeutics Committee/

Typical agenda
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Role of Pharmacy and Therapeutics Committee (PTC)

in Drug-Safety
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• Automatic Stop Orders for Dangerous Drugs

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