CHAPTER 5

Pharmacy and
Therapeutics
Committee
 PHARMACY AND THERAPEUTICS
COMMITTEE (P&TC)
 The pharmacy and therapeutics committee is an
advisory group of medical staff and serves as an

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organizational line of communication between
medical staff and pharmacy department.

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 This committee is composed of physicians,
pharmacists, and other healthcare professionals
selected with the guidance of the medical staff.
 American College of Surgeons first recognized a
need for a formal liaison between medical staff
and pharmacy department in hospitals.
 The adoption of the Minimum Standard for
hospital pharmacies in 1953 by American College
of Surgeons was the cause of establishing
pharmacy and therapeutics committee (P & TC).2
 COMPOSITION AND MEMBERSHIP
 The pharmacy and therapeutics committee is
composed of at least three physicians, a

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pharmacist, a nurse and an administrator.
 All of the committee members are either appointed

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or elected officially.
 A chairman from member physicians is appointed
while a pharmacist usually is designated as
secretary who also serves as its full voting member.
 The pharmacist is fully responsible for developing
agenda and preparation and distribution of the
minutes of meetings.

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 The composition of this committee varies from
hospital to hospital. Larger hospitals may include
representatives of all vital sub-specialties of
surgery and medicine, pharmacy and nurses.

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 A committee with larger number of physician
representatives is justifiable to acquire an ample

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competence and learned opinion to rule on all
categories of drugs.
 If large group is not present it is to compensate
the shortage of representation, an advisory
subcommittee to the pharmacy committee
consisting of heads of all medicine subdivisions is
suggested.

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 The recent advances in pharmacy expertise
in number of therapeutic specialty areas
further supports the concept of

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subcommittee within actual pharmacy and
therapeutics committee.

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 For example, an oncologist along with a
clinical pharmacist specialized in oncology
could provide the appropriate expertise to
the pharmacy and therapeutics committee
in this area of drug therapy.

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5/11/2019 Hospital Pharmacy Noman ul Haq
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 PURPOSES OF COMMITTEE
 Itsprime objective of P&TC is to achieve optimal
patient care and safety through rational drug
therapy in an institution.

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 This objective of the committee is accomplished by
playing an advisory and educational role in an
institution.

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 Under advisory role, the committee recommends
adoption of, or assists in formulation of policies
regarding evaluation, selection, and therapeutic
use of drugs.
 To play its educational role, the committee
advises or assists in the formulation of programs
designed to meet the needs of professional staff
(physicians, nurses, pharmacists, and other
healthcare practitioners) for complete current
knowledge on matters related to drugs and their
use. 7
 ORGANIZATION AND OPERATION
The organization and operation of the pharmacy and
therapeutics committee might vary from hospital to

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hospital, the following generally will apply:
1. A chairman from among the physician representatives
should be appointed. A pharmacist usually is

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designated as secretary.
2. The committee should meet regularly, at least six times
per year, and more often when necessary.
3. The committee can invite within or outside the hospital
some specialists who can contribute specialized skills
and judgments on particular matters.
4. An agenda and supplementary materials (including
minutes of the previous meeting) is prepared by the
secretary and submitted to committee members in
sufficient time before the meeting so as they can 8

properly review the material.

5. Minutes of committee meetings are prepared by
the secretary and maintained in permanent
records of the hospital.
Action taken by or recommendations of the

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6.
committee are subject to review and approval by
the executive committee of medical staff.

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7. Policies, rules and regulations regarding use of
drugs in hospital are to be in accordance with
the Drug Rules.
8. Liaison with other hospital committees
concerned with drug use (e.g., infection control,
and medical audit) is maintained.
9. Actions of the committee should be routinely
communicated to the various healthcare
personnel involved in patient care. 9
 FUNCTIONS AND SCOPE
 This committee serves in an evaluative,
educational and advisory capacity to medical
staff and administration in all matters

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pertaining to use of drugs in the institution.
The list of other committee's typical functions is
offered as a guide:

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1. Developing and updating formulary of drugs
accepted for use in hospital based on objective
evaluation of their relative therapeutic merits,
safety and cost.
2. Establishing programs and procedures for
ensuring safe and effective drug therapy at
economic cost.
3. Monitoring and evaluating adverse drug
reactions in healthcare setting and to make
appropriate recommendations to prevent their
occurrence. 10
4. Initiating and/or directing drug use review
programs and studies, review the results of such
activities, and make appropriate
recommendations to optimize drug use.
Establishing or planning suitable educational

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5.
programs for the institution's professional staff
on matters related to drug use.
Participation in quality-assurance activities

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6.
related to distribution, administration. and use
of medications.
7. Advising pharmacy department in the
implementation of effective drug distribution
and control procedures.
8. Making recommendations concerning drugs to
be stocked in hospital patient-care areas.
9. To disseminate information on its actions and
approved recommendations to all healthcare
staff. 11
 EFFECTIVE PHARMACY AND THERAPEUTICS
COMMITTEE
The prerequisites for an effective committee are as

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follow:
1. Have clearly defined tasks.
2. Selected members have some definite

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relationship to the tasks to be accomplished.
3. Superiors and subordinates not to be served on
the same committee.
4. Developed interpersonal relationships before
they can move on to effective problem solving.
5. Support of the groups of individuals to whom the
results of their deliberation are to be submitted.
6. Must clearly differentiated from staff groups
whose major role is to communicate events and 12

to develop managerial competence of members.

 FREQUENCY OF MEETINGS
 The size of hospital, variety of drugs used
will dictate the number and frequency of

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meetings of therapeutics committee.

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 The committee should meet at least once
per quarter, and in the busier institutions
at least monthly.

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 COMMITTEE AGENDA
 A successful meeting depends upon an
interesting agenda.

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The general-categories, which an agenda may have
are as follow:

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1. Minutes of the previous meeting
2. Review of a specified section of the formulary for
up-dating and deletion of drugs.
3. New commercially available drugs.
4. Investigational use drugs currently under
research in hospital.
5. Review of adverse drug reactions reported in
institution. 14
6. Drug safety in hospital.
 POLICIES OF THE COMMITTEE
 In order to avoid any misunderstanding amongst
membership and subsequently by medical staff,

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comprehensive policies regarding the control of
use of drug in hospital are to be established.

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 These policies are to be reviewed regularly to
make them current.
 Following are all the aspects for which pharmacy
and therapeutics committee formulates policies to
control of drug use in the hospital:

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Policies concerning formulary:
 Proposal of new drug for hospital formulary

 Drug evaluation and approval for:

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 Formulary drug
 Conditionally approved drug

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 Specialized formulary drug
 Investigational drug
Policies concerning drug recall:
 Some defect or deficiency in finished product.

 By drug authority, pharmacy department, or

manufacturer.

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Policies regarding inpatient prescription orders:
 Routine drug orders.
 Intravenous orders.
 Total parenteral nutrition (TPN).

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 Self-medication.
 Medication brought to hospital by patients.

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 Automatic stop orders.
 Prescribing controlled drugs.
 Discharge prescriptions.
 Emergency (STAT) orders.
Policies related to outpatient prescription

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 ROLE OF P&TC IN HOSPITAL
The committee has important roles in the following:
Role in pharmacy department:

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 Pharmacy departments utilize , the committee
structure to coordinate and effectively integrate

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requisite aspects of planning, development,
implementation, and control of designated activities.
 The pharmacy and therapeutics committee, with a
well-developed formulary system provides an
assurance of a rational drug therapy program.
 Help in performing drug usage reviews or drug usage
evaluation studies and therapeutic drug monitoring.
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 Determination of drugs to be studied, appropriate
usage criteria, collects data, evaluates actual
usage data against approval criteria and makes
recommendations for improvement in appropriate

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use of the drug studied.
 Monitoring of adverse drug reactions and

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medication errors as a part of the quality
assurance standards of the medical staff.
 Help to establish standards and specifications for
all drugs, chemicals, diagnostic agents and other
preparations used in patients, and pharmaceutical
equipment for the purchase.
 provide guidelines for generic drug selection.
 provide a policy structure on the manner in which
in- and outpatients drug distribution. 19
Role in formulary development:
 Developing, maintaining and updating of hospital
formulary.
 Evaluate drugs for to be admitted into or rejected

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from entry into the hospital formulary.
 Development of drug evaluation process and a

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standard form for its accomplishment
 Assistance in policy formation.
 Advising and helping in the preparation of
formulary. .
 Selection of information to be provided.
 Selection, of the contents of formulary.
 Decision of for the format of formulary.
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Role in generic selection:
 Prescription is economical because of the possibility
of selection of low cost brands.
 Guide on various criteria of generic drug selection.

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 The generic drug products can be selected based on
qualitative or quantitative assessments.

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 The qualitative assessments may include a previous
experience with the generic drug product.
 The quantitative assessment is the costs.

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Role in drug safety:
 Drug products, along with therapeutic effects
also have side effects.
 Though the side effects have rare chances

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leading to any serious injury or patient death
yet on the part of a physician or pharmacist,
patient's life is not game of chances.

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The pharmacy and therapeutics committee can
insure safeness of drug use in an institution by
ascertaining the:
1. Employing of a qualified pharmacist to
supervise pharmacy department.
2. Restriction of performing judgment-based jobs
by the non-pharmacist personnel.
3. Employing of a sufficient number of qualified
personnel to allow for adequate coverage of the
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pharmacy seven days per week.
4. Satisfactory arrangements for off-hour
dispensing in absence of a licensed pharmacist.
5. Employing of number of personnel matching
with the pharmacy workload.

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6. Availability of adequate, safe work space, and
safe storage facilities for pharmacy.

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7. Availability of equipment necessary to safely
and adequately carry out the modern practice of
pharmacy.
8. Implementation of automatic stop order
regulation for narcotics and controlled drugs.
9. Existence of policy regarding use of research
drugs in the hospital.
10. Existence of an up-to-date hospital drug 23
formulary and formulary system.
11. Segregation of poisonous materials from non-
poisonous materials in the pharmacy and on the
nursing stations.
12. Separate storage of external use preparations

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from internal use medications in the pharmacy
and on the nursing stations.
Checking and assuring of quality, asepsis, and

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13.
apyrogenicity and sterility if applicable, of the
products prepared in hospital pharmacy., `
14. Involvement of hospital pharmacist for a
teaching. program to acquaint nursing and
medical staff with new drugs.
15. Periodical inspection of nursing stations for the
purpose of removing, deteriorated and outdated
drugs as well as to check all labels for legibility.
16. Availability, of an adequate reference library 24
having texts on pharmacology, toxicology and
posology in the hospital pharmacy.
Role in adverse drug reaction:
 An effective monitoring program for ADR or
adverse drug experience (ADE) can reduce

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treatment expenditure, minimize patient
morbidity and help overall patient care.

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 The pharmacy and therapeutics committee can
prepare a standard adverse drug reaction report
form that can be made available on every nursing
station.
 Under ADR reporting program, pharmacy and
therapeutics committee advise the following:

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1. Medical staff is to report an ADR to chairman
pharmacy and therapeutics committee.
2. Sometimes, allowance has also been given to
patient for reporting a reaction on a standard

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form. This can be effective in detecting both
common and rare ADRs even in outpatients.

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3. Based on the reports from all hospital health
care members, a data bank for ADRs occurrence
can be formulated for study and to implement
an effective prevention program.
4. Besides, ADR reporting, other monitoring
schemes may include P&TC-supported post
marketing surveillance carried out
collaboratively by hospital pharmacy and
pharmaceutical industry. 26
Drug product defect reporting program:
 A defect in drug may be anything which, in a
professional opinion, is considered to be defective
or undesirably associated with the product.

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 This defect can impaired therapeutic effect of the
product and prone-to effect the health of a
patient adversely.

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The Reportable defects may include:
1. Inadequate packaging.
2. Confusing or inadequate labels or labeling.
3. Deteriorated, contaminated, or defective dosage
forms.
4. Changed taste, color etc.
5. Inaccurate fill or count of a drug product.
6. Faulty drug delivering apparatus.
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Role in control of narcotic and controlled
drugs:
 Proper and safe administration of dangerous
drugs can be achieved by an automatic stop order

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in force.
 A policy can be implemented whereby all drug

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orders for oral or parenteral controlled drugs shall
be automatically discontinued after 48 hours.
 This condition is to be waived off for orders
indicating:
 an exact number of doses to be administered
 an exact period of time for which medication is
specified
 reordering of the medication by attending
physician. 28
Role in drug utilization review:
 One of the significant activities of therapeutics
committee is performing drug usage reviews
(DUR) or drug usage evaluation (DUE) studies.
 The drug use review is an authorized,

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structured, ongoing system for improving
quality of drug use within a hospital
involving, both pharmacy and medical staff

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collaboratively.
 This can be accomplished by development of an
evaluation process for prescribing, dispensing,
administering, and ingesting of prescription
drugs.
 DUR leads to corrective measures that will
improve use of drugs.
 It also helps identifying problems in drug use,
reduce adverse drug reactions, optimize drug
therapy and minimize drug-related expenditures.
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 The committee, with active involvement of
pharmacy, determines drugs to be studied,
determines appropriate usage criteria, collects
data, and evaluates actual usage data against

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approval criteria.
 This data can also be incorporated in

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retrospective, concurrently or prospective reviews
for a continuing surveillance of drug utilization.
 The pharmacy records such as purchasing,
monthly usage data, drug profiles for in-and out-
patient, patient charge, adverse drug reaction
reports, and others can also be used for DUR.
 Review of these data bases usually leads to the
study of drugs that are of substantial clinical or
financial import. 30
Role in patient-care audits:
 Patient-care audits use clear-cut measurable
process and outcome criteria applied to a

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sufficiently large number of patient records to
evaluate quality of care being provided.

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 The review of patient's therapy record helps
ascertaining effect of drug therapy on patient's
stay in hospital.
 A goad and effective therapy coupled with good
clinical care can reduce the patient's length of
institutional stay.
 The pharmacy and therapeutics committee
provides a framework for pharmacist to 31
participate in patient care audits.
Role in developing emergency drug lists:
 The emergency treatment requires readily
availability of emergency drug or "STAT"" boxes
containing drugs and supplies at emergency

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treatment sites.
The pharmacy and therapeutics committee in this
connection:

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1. Develops a content list of supplies for emergency
box
2. Instructs pharmacist and nursing service
supervisors of their joint responsibility for
stocking and ready availability of box at all the
times.
3. Develops a program. whereby each emergency
box is checked at each sites, daily either by the
hospital pharmacist or by the nursing supervisor32
responsible for the ward.
Role in safe drug administration:
 The drug administration to patients is
considered the job of nurses and

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members of medical staff ask them to
administer drugs.

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 The pharmacy and therapeutics
committee devises a system of necessary
educational and training programs be
instituted for safe administration of
drugs to patients.

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Role in drug research:
 It is the responsibility of committee to
develop procedures for the introduction,

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of research drugs into an institution.
 The human subjects committee and the

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pharmacy and therapeutics committee
approve an investigational drug in a
hospital.
 The P & TC can also advise any aspect of
drug research relating the
investigational drug use.
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THE END
Next Chapter
Chapter 6
Hospital
Formulary