CHAPTER 11–Pharmacy and Therapeutic Committee

CHAPTER 11–Pharmacy and Therapeutic Committee

11.1 Introduction
A large number of drugs are available for the treatment of diseases. The use of many of
these drugs is complex. A large number of hospital patients receive drugs and medicines,
essentially those belonging to the modern system of medicine popularly known an allopathic
system, as major part of the treatment for diseases. It may be the sole mode of treatment the
potential and demonstrated benefits of the drugs available and complexities surrounding their
effective use, it is of great importance that the hospital using those drugs on the patients should
organize sound basis for maximizing the rational use of drugs. One of the methods or mode of
ensuring the proper rationality in the use of drugs is that the hospital organizes and constitutes,
“The Pharmacy and Therapeutic Committee”.

11.2 Pharmacy and Therapeutic Committee (PTC)

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. It is an advisory group of medical staff and serves as the organizational line of
communication between the medical staff and pharmacy department. The committee consists of
physicians, pharmacists and other health professionals. It is a body of the medical staff and
administration of hospital to recommend the matters related to therapeutic use of drugs.

11.3 Objective of the Pharmacy and Therapeutic Committee

The Pharmacy and Therapeutic Committee has three major roles to play. These are:
 Advisory: The committee recommends the adoption of policies or assists in the
formulation of broad professional policies regarding evolution, 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 area. The committee advises the pharmacy in the implementation
of effective drug distribution and control procedures.
 Educational: The committee recommends or assists in the formulation of functions,
designed to meet the needs of the professional staff viz. the physician, nurses,

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pharmacists and other health care practitioners, for the complete current knowledge of the
matters related to drugs and their use. The committee evaluates the problems related to
the distribution and administration of medications, including medication incident, it
reviews adverse drugs reactions occurring in the hospital and to initiate and/or direct the
drug activity studies and to review and study the results of such activities. The committee
develops and compiles a formulary of drugs and prescriptions of formulations accepted
for use in the hospital. It also provides for its constant revision the selection of items to be
included in the formulary will be based on the objective evaluation of their therapeutic
duplications merits, safety, cost etc.
 Drug safety and adverse drug monitoring: With the advent and increase of each new
class of therapeutic agents, the scope, knowledge and responsibility of the hospital
pharmacist increases proportionately. Along with its increase responsibility also devolves
on him the moral, legal and professional obligations on ensuring safety in handling and
administration of drugs. Unfortunately, the safety aspects are more or less taken for
granted by pharmacy, medical and nursing profession, less so in western countries but
very much so in our country. This tendency is perhaps due to the fact that the pharmacy
accidents resulting in serious injury or death of the patients are relatively infrequent.

11.4 Functions and Scope of Pharmacy and Therapeutic Committee

1. The PTC develops, compiles and approves the hospital formulary system sponsored by
the medical staff. The medical staff adapts the formulary to the needs of the individual
hospital.
2. The committee promotes rational therapeutics and prevents duplication, waste, confusion.
3. The committee develops written policies / procedures to afford guidance in appraisal,
selection, procurement, storage, distribution and use of drugs.
4. It also develops policies regarding drug safety.
5. The committee’s recommendations are adopted by the medical staff.
6. The formulary is subjected to constant review and revision.
7. The committee minimizes duplication of the same basic drug, drug entity / products.
8. The committee helps to development of training programmes for professional staff in
drug use.

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9. The PTC studies problems related to drug administration, distribution, drug reactions,
drug stocking, and drug use.
10. The PTC advices the pharmacy regarding drug distribution and control procedures.
11. To review adverse drug interactions occurring in hospital.

11.5 Organization of Pharmacy and Therapeutic Committee

To carry out the functions of PTC efficiently, a proper organizational structure is
necessary. However the composition and operation of PTC varies from hospital to hospital
depending on its size, location.
 The PTC committee should be composed of
• At least three physicians,
• A pharmacist
• A nurse representatives
• An hospital administrator
 A chairman should be appointed from amongst the physician representatives. A
pharmacist usually works as a secretary.
 The meeting of the committee should be at least six times per year and whenever
necessary.
 An agenda should be prepared by the secretary and submitted to the committee to the
committee members within sufficient time before the meeting.
 The secretary should prepare the minutes of committee meeting and maintain the
permanent records of the hospital.
 The recommendations of the committee shall be presented to the medical staff for its
adoption or recommendation.

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Medical staff Hospital Administrators Pharmacist

Chairman (Physician) (Director) Secretary
Co-chairman (Physician) Nursing staff

PHARMACY AND THERAPEUTIC COMMITTEE

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

Neo-plastic Anti-infective Cardiovascular Gastro-intestinal C.N.S agents Endocrinology
Drugs Drugs Hypnotics agents
Diuretics Autonomic Analgesics & Antidiabetic
Cardiacglycosides Laxtives Antipyretics agents
Hypotensive Anticonvulsants Anti-inflammatory
Vasodilators Psychotherapeutics agents
Spasmolytic Sedatives
Hormones
Anticonvulsants Thyroid preparations

11.5.1 Operation or agenda of PTC

The committee can invite its meetings persons within or outside the hospital who can contribute
specialized or unique knowledge, skills and judgments. The agenda and the supplementary
materials should be prepared by the secretary and furnished to committee members well in
advance so that the members can study them properly before the meeting. Generally, because of
the broad scope enjoyed by this committee, it is necessary that many interesting subjects may
rightfully be placed in the agenda for discussion. A typical agenda may consist of the following
categories in general:
1. Minutes of previous meeting.
2. Review of the contents of the hospital formulary for the 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 or adoption of investigational drugs currently under processing in the hospital.

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5. 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 the
Drug Information Centre.
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

11.6 Policies of Pharmacy and Therapeutic Committee

The use of drugs in hospital is controlled by establishing different policies. Following are the
examples of thoroughness required.
1. Proposal of a new drug for the hospital formulary shall be submitted on a formulary
request form to the pharmacy department.
2. Drugs evaluated and approved by the committee will assigned to one of the following
categories:
 Formulary drug: FDA approved drug which is essential for good patient care and
with well-established usage. Once accepted as a formulary drug, it may be
prescribed by all members of the attending and house staffs.
 Drugs approved on a conditional trial period: A drug approved by FDA for
general use but which the committee will evaluate for a 6 to 12 month period final
consideration. During this period, the drug may be prescribed by all members of
the attending and house staff.
 Specialized formulary drug: FDA approved drug recommended for use in
specialized patient care.
 Investigational drugs: FDA approved drug for a specific use by its principal
investigator and designated associates. Such drugs are not commercially
available.
3. Drugs which do not qualify for the four categories listed above shall be considered as
“Non-Formulary Drugs” and will not be stocked in the pharmacy.

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4. The committee is responsible for the rules and regulations which governs pharmaceutical
company representative’s activities in hospital.
5. The pharmacy department is authorized to dispensed drugs according to policies and
procedures of the committee.
6. The pre-signing of blank prescriptions or drug orders is prohibited.
7. Drug Recall: After receiving the drug recall notice, all the drugs will be removed and
replaced. This information is sent to all the staff and respective hospital department.
8. The pharmacy department is authorized to dispense drugs according to policies and
procedures of the committee. According to the formulary system, all drugs will dispensed
on the basis of generic names to avoid duplicate inventory and achieve a cost saving.
Physicians may specify a specific brand name drug when deemed necessary.
9. The committee is responsible for the rules and regulations which governs pharmaceutical
company representative activities within the hospital.
10. Inpatient Prescription:
a. Routine Drug Orders: A physician’s medication order written on inpatient order form
is deemed a legal prescription. A legible copy of the medication order must be
forwarded to the Pharmacy and must include following information:
 The patients address information.
 The name of the nursing unit.
 The name and strength of each drug.
 The directions for frequency of administration.
 The route of administration.
 The signature of the prescribing physician.
 The date and time that the order was written.
Order written by medical students must be countersigned by a member of the medical
staff.
b. I.V. Orders: Orders for intravenous medications must be written in the same manner
as routine drug orders and must include the following addition information.
 The exact quantity of the drugs which must be added.
 The exact volume and name of the infusate solution.
 Specific directions for administration such as IV drip, IV bolus, IV push, etc.

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 Specific times to hang infusate solution and drip rate.

 Specific directions for continuing or discontinuing any IV medications.
c. Total Parenteral Nutrition (TPN):
 TPN designed to serve as a nutritional infusion providing essential amino
acids, carbohydrates, and electrolytes for patient incapable of ingestion,
digestion, or absorbing food substances given by mouth.
 Ordering: The TPN mixtures may only be prescribed by an authorized house
staff physician in conjunction with a dietician through consultation.
 Following the original order, subsequent orders must be confirmed every
morning and recorded on a card designated for that specific patient
 A 24 hour supply is to be ordered by the physician each morning.
 Only electrolytes and vitamins may be added to hyper-alimentation solutions.
d. Self-Medication: Only nitroglycerine and antacids may be left at the patient’s bedside
for self-administration if so ordered by the physician. The quantity of nitroglycerine
is limited to 10 tablets which must be counted by the nurse at the conclusion of each
shift and charted in the patients’ medical record. Antacids must be recorded and
replenished in the same manner.
e. Medication brought to the Hospital by Patients: Medication brought into the hospital
by the patient may not be kept at the patient’s bedside. Medications are shown to the
physician, and then send home with responsible family member or friend.
f. Automatic Stop Orders: Automatic stop order requirements for medications are:
 24 hours for Schedule II Control drugs (narcotics).
 7 days for all other drugs.
g. A new medication order must be written by the physician if a change is wanted in
route of administration or in dosage.
h. Discharge Prescriptions: A separate prescription is required for each medication
which the patient is to take home. Each prescription must contain the following
information:
 Patient address information.
 Name of the drug and strength.
 Quantity to be dispensed.

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 Specific instructions for patient administration.

 Number of refills.
 Signature and printed name of physician.

11. Outpatient Prescribing:

a. The hospital requires that a prescription be written for any drug or medical supply
which is to be dispensed for hospitalized patients at discharge, clinic patients, and
employees. Such prescriptions may only be written on hospital prescription forms in
compliance with all regulatory agencies.
b. Information requires on prescription:
 Address patient’s information.
 Date
 Name and strength of medication
 Quantity to be dispensed
 Specific information for patient administration
 Specific number of refills
 Signature and printed name of the physician.
c. Prescription for control drugs have special requirements, which are as follows:
 All control drug prescription requires the physician number.
 Narcotics are limited to a 30 days’ supply and no refills. These prescriptions
are valid for 5 days and are not valid if there are cross-outs, or any evidence of
tampering.
 Drugs like, medium acting barbiturates, are limited to a 30 days supply and
may be refill up to 5 times within 6 months of issuance date.
 Drugs like, benzodiazepines and cough preparations, may be refilled 5 times
within 6 months of issuance date.

11.7 Automatic Stop Orders for Dangerous Drugs

All drug orders for narcotics, sedatives, hypnotic anticoagulants, and antibiotics
(administered orally or parenterally) shall be automatically discontinued after 48 hours unless the

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order indicates an exact number of doses to be administered, or the attending physician, re-order
the medication. This is an example of automatic stop order.
All order for narcotics, sedative and hypnotics must be re-written every 24 hours. All
P.R.N. (Pro Ne Rata) and standing order for all medications except narcotics, sedatives and
hypnotics shall expires at 10 am 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.
In India at present, this kind of system of issuing “Automatic stop orders for Dangerous
Drugs” is not practiced except for hospitals like Cristian Medical Hospital, Vellore or Jaslok
Hospital, Mumbai, Escort group, Mayo Hospital etc.

11.8 Role of PTC in Developing “Emergency Drug Lists”

Since time factor is of very great urgency to most true emergency situation, it is
absolutely necessary for the Pharmacy and Therapeutic Committee of a hospital to get prepared
boxes containing emergency drugs which should be always available readily for use at bed-side.
List of such drugs and other supplies should be compiled by the committee, and it should find
their place in “Emergency Kits”.
Once it is decided to what should be the contents of such boxes and the responsibility of
its stocking is assigned, the units should be prepared and places on each specified place in the
clinic, in the emergency ward and in special procedure room of the department of radiology.
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 by the hospital
pharmacists or by nursing supervisor responsible for the ward. Each hospital may modify this list
by adding or deleting items as found necessary. Following is the list of suggested drugs and other
articles which may be maintained in the Emergency Box:
11.8.1 Supplies to be maintained in Emergency Box
 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 10 ml and 20 ml syringe.
 Needles, preferably two each of 16’, 18’, 20’, 21’, 23’ and 26’.
 Files for breaking the ampoule.
 Bandages.

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 Airway equipment.
 Ryle’s tube.
11.8.2 Drugs for Emergency Box
These are selected in consultation with physician but the following list is illustrated only
 Aminophylline 0.25 gm/ml
 Amylnitrite glass capsule for inhalation
 Atropine Sulphate 0.4 mg/ml
 Caffeine sodium benzoate 0.5 gm/2 ml
 Calcium gluconate 1 gm/10 ml
 Digoxin 0.25 mg/ml
 Diphenylhydantoin sodium 50 mg/ml
 Epinephrine hydrochloride 1 mg/ml
 Heparin 10.000 units/ml
 Hydrocortisone 100 mg
 Magnesium Sulphate injection 10 %, 50 %
 Isoproterenol 1:100
 Mannitol injection 25 %
 Nalorphine hydrochloride 10mg /2 ml
 Neostigmine methyl Sulphate 0.25 mg/ml
 Procainamide 50 mg/ml
 Protamine Sulphate 20 mg/ml
 Saline for injection 9 %, 30 ml
 Sodium molar lactate solution
 Water for injection 20 ml
11.8.3 Supplies for Cabinet Utility Room
 Venous cannulation set
 Each set 12 & 17 venous catheter
 Pieces 6” shock blocks
 Oxygen catheters
 Sterile suction catheters
 Razor with blades

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 Package sterile gelatin sponge

 Resuscitation (Artificial respiration) tube
11.8.4 Other Emergency Supplies
 Resuscitation (Artificial respiration) carts
 Phlebotomy sets
 Oxygen equipment
 Tracheotomy sets
 Dextran and tubing
 Burn sheets

11.9 Role of PTC in Drug Safety

Drug safety is the major area of responsibility of the hospital pharmacist. The increased
responsibility also includes the moral, legal and professional obligation of the hospital
pharmacist for ensuring safety in handling and administration of drugs. Since, drugs are potent
substances, there is a need to create safety awareness in all hospital department. Unfortunately,
in our country dispensing the drug “exactly as prescribed by doctor” is the job of pharmacist and
rest all responsibilities one given upon doctor. PTC can play major role in ensuring the drug-
safety. The following are the guidelines issued by the committee to ensure the adequate safety in
handling and administration of drugs.
1. The hospital must employ a qualified; at least a registered pharmacist with at least B.
Pharmacy degree as the ‘Chief Pharmacist’ and the rest are may be at least diploma
holders in pharmacy.
2. The hospital should not permit non-pharmacist personnel to dispense drugs and allied
materials.
3. The hospital must employ a sufficient numbers of qualified personnel considering the
work load of a pharmacist and allow for adequate coverage of the pharmacy seven days a
week.
4. The hospital must provide adequate safe, work space, and storage facilities for the
pharmacy.
5. The pharmacy should have equipment necessary to safety and adequately carry out the
modern practice of pharmacy.

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6. The hospital must have an ‘automatic stop order’ regulation for dangerous drugs e.g.
narcotics hypnotics, anticoagulants etc.
7. The hospital should have the firm policy regarding the use of research drugs in the
hospital and its clinics.
8. The hospital should have a drug formulary which periodically revised and kept upto date.
9. The hospital should not permit any person other than a registered pharmacist into the
pharmacy “outside its working hours”.
10. The poisons and poisonous materials should be adequately separated from non-poisonous
materials in the pharmacy and in the wards etc.
11. The external use preparations should be separated from internal use medications in the
pharmacy and in the wards etc.
12. The pharmacy manufactured products for patients use if any, must have adequate during
the processing and also in the final products.
13. The hospital should provide or to the chief pharmacist sufficient help to permit him to
engage in a teaching programme to familiarize the nursing and resident staff with new
drugs and to teach the students nurses the basic course of pharmaceutical mathematics
and pharmacology.
14. All nursing drug statistics should be periodically inspected for the purpose of removing
deteriorated and outdated drugs as well as to check all labels for legibility.
15. The pharmacy should have an adequate reference library which contains texts on
pharmacology, toxicology, posology and journals containing adequate information on
newer developments in the pharmaceutical world.

11.10 Role of PTC in Adverse Drug Reaction

Now-a-days drug therapy is becoming complex due to increasing incidences of adverse
drug reactions, the problems can be solved at two levels – to prevent the adverse reactions once
they occur and to treat them when they have occurred. The PTC, therefore, issues guidelines for
reporting system for this purpose.
Every case of adverse reaction must be first reported by the attending physician to the
Chairman of Pharmacy and Therapeutic Committee. The attending physicians should provide
complete adverse reaction report, containing name of drug, route of administration, date of

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starting and ending the treatment, the indication for which drugs were used, adverse reactions
noted for them and steps taken to treat these. The same is then ultimately recorded in medical
records. The PTC interacts with the government bodies like, Drugs Controller General of India,
All India Institute of Medical Sciences (New Delhi), Post Graduate Institute (Chandigarh) for
consultation.

REVIEW QUESTIONS
MULTIPLE CHOICE QUESTIONS
1. Modern system of medicine is popularly known as ______ system.
A) Allopathic B) Alternative C) Homeopathic D) Ayurvedic

2. Which system is major part of the treatment for diseases?

A) Allopathic B) Alternative C) Homeopathic D) Ayurvedic

3. PTC consists of _______.

A) Physicians B) Pharmacists C) Health professionals D) All

4. PTC evaluates the problems related to the __________of medications.

A) Distribution B) Administration C) Both A&B D) None of these

5. Composition and operation of PTC varies from hospital to hospital depending on its
_____.
A) Size B) Location C) Both A&B D) None of these

6. Meeting of the committee should be at least _____times per year.

A) Two B) Four C) Six D) Eight

7. _______should prepare the minutes of committee meeting and maintain the

permanent records of the hospital.
A) Secretary B) Chairman C) joint secretary D) None of these

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8. The recommendations of the committee shall be presented to the_____ for its

adoption or recommendation.
A) Medical staff B) Chairman C) Secretary D) None of these

9. All order for narcotics, sedative and hypnotics must be re-written every _____hours.
A) 6 B) 12 C) 18 D) 24

10. Drugs like, medium acting barbiturates are limited to a _____days’ supply.
A) 10 B) 20 C) 30 D) 40

KEYS
1. A 2. A 3. D 4. C 5. C 6. C 7. A
8. A 9. D 10. C

SHORT ANSWER QUESTION

1. What is PTC?
Ans: 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.

2. Give the functions and scope of PTC.

Ans:
• The PTC develops, compiles and approves the hospital formulary system sponsored by
the medical staff. The medical staff adapts the formulary to the needs of the individual
hospital.
• The committee promotes rational therapeutics and prevents duplication, waste, confusion.
• The committee develops written policies / procedures to afford guidance in appraisal,
selection, procurement, storage, distribution and use of drugs.
• It also develops policies regarding drug safety.
• The committee’s recommendations are adopted by the medical staff.
• The formulary is subjected to constant review and revision.

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• The committee minimizes duplication of the same basic drug, drug entity / products.
• The committee helps to development of training programmes for professional staff in
drug use.
• The PTC studies problems related to drug administration, distribution, drug reactions,
drug stocking, and drug use.
• The PTC advices the pharmacy regarding drug distribution and control procedures.
• To review adverse drug interactions occurring in hospital.

3. In which hospitals in India “Automatic stop orders for Dangerous Drugs” is being
practiced?
Ans: hospitals like Cristian Medical Hospital, Vellore or Jaslok Hospital, Mumbai, Escort
group, Mayo Hospital etc.

LONG ANSWERS QUESTION

1. What are the Objectives of the Pharmacy and Therapeutic Committee?
Ans: Refer Point 11.3
2. Add a note on Role of PTC in Drug Safety
Ans: Refer Point 11.9

VERY LONG ANSWERS QUESTION

1. Add a detailed note on Organization of Pharmacy and Therapeutic Committee
Ans: Refer Point 11.5
2. What are the Policies of Pharmacy and Therapeutic Committee?
Ans: Refer Point 11.6

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