89

PHARMACY AND THERAPEUTICS COMMITTEES

AND THE HOSPITAL FORMULARY
Joseph S. Bertino, Jr.

INTRODUCTION 1233 Physicians 1234 Conflicts of Interest for P&T

THE P&T COMMITTEE 1233 Nurses 1234 Committee Members 1235
Functions of the P&T Administrator 1234 Communication and
Committee 1233 House Staff 1234 Implementation of P&T
Membership 1233 Risk Manager 1234 Committee Decisions 1235
Chair 1233 Subcommittees 1234 Other Functions of the P&T
Secretary 1233 Meetings 1234 Committee 1235
Pharmacists and Role of the Subspecialist on the THE FORMULARY 1235
Pharmacologists 1233 P&T Committee 1235 SUMMARY 1236

members, 9 to 15 voting members (always an odd number) seems

INTRODUCTION
Almost every patient who is admitted to a hospital receives drug
therapy. Drug therapy accounts for a substantial percentage of cost to
an institution. While drugs are life saving, they also have the potential
to cause morbidity and mortality. The Pharmacy and Therapeutics
(P&T) Committee stands as the decision-making body concerning
drug use for most institutions.
The concept of a P&T Committee has been around for decades;
however, the committee has become substantially more important over
the past 20 years. This committee is paramount to the drug decision
process in hospitals. Formularies stem from P&T Committees and help
provide useful, cost-effective, and safe therapeutic choices to clinicians.
This chapter explores in detail the P&T Committee and the use of
formularies in an institutional setting.
THE P&T COMMITTEE
Functions of the P&T Committee
The P&T Committee has a number of functions in an institution.
These include objective appraisal and evaluation of drugs for the for-
mulary, and reviews and updates of the appropriateness of the formu-
lary system in light of new drugs and new indications, uses, or warnings
affecting existing drugs. The most important aspect is the use of evi-
dence-based principles to assess safety, efficacy, ease of dosing, impact
on pharmacy and nursing time, potential for medication errors, and,
lastly, economic impact of decisions. More functions of the P&T Com-
mittee are discussed later.
Membership
The P&T Committee is a compilation of members from a variety of
general practice and subspecialty areas in the hospital (Fig. 89-1). P&T
Committees are generally included as part of the medical staff bylaws
and, thus, a committee that is essential and mandated. The members
of the committee are very diverse, including physicians, pharmacists,
nurses, and administrators. Importantly, it is essential that the P&T
Committee be manageable in size. Too many members make decision
making slow and difficult. While there is no “correct” number of
appropriate. A survey in the 1990s suggested that, for a teaching hos-
pital, the average number of members was 19.3, with approximately
65% being physicians.1 A somewhat typical composition of the com-
mittee would be as follows.
Chair
The chair is a physician, generally with high standing among members
of the medical staff and administration. Often a subspecialist is selected,
but this is not a prerequisite. Generally, the physician does not have
formal clinical pharmacology training, however. The P&T Committee
chair’s job is to provide leadership, resolve disputes, and set an example
for the use of rational drug therapy in the institution. In addition, the
chair recommends to the Chief Executive Officer, Director, or medical
staff which individuals should be appointed to the P&T Committee.
The P&T Committee may be the most important hospital committee
because its decisions affect patient care, length of stay, and cost of care
for almost every patient. The decisions of the committee also affect
anyone prescribing, monitoring, or administering drugs to patients.
For these reasons, the actions of the committee may be very contro-
versial among some individuals. The P&T Committee chair functions
as the public representative to members of the institution to deal with
these political issues.
Secretary
Generally this individual has been the Director of Pharmacy. The rea-
soning for this is that the Director of Pharmacy oversees (but does not
control) the pharmaceutical budget for the institution. The secretary’s
job is to schedule meetings, assist in setting the agenda, contact indi-
viduals to present data to the committee, write the minutes for the
meetings, and coordinate follow-up. Unfortunately, since the Director
of Pharmacy often reports to an administrator with business training
and not a clinician, the overseeing administrator sometimes feels the
need to be more involved than appropriate in the decision-making
process for drug use. This is clearly inappropriate and must be avoided.
Pharmacists and Pharmacologists
Clinical pharmacists and clinical pharmacologists, often MDs and
PharmDs, serve as the “workhorses” for the P&T Committee. These
individuals gather data, coordinate medical utilization reviews, and

1233

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 1234 Section 19 Practical Therapeutics
Medical Staff
P+T Committee
Chairman
Secretary
Internist Surgeon OB-GYN
(Pharmacist)
FIGURE 89-1 • Structure of the P&T committee.
present evidence-based information on efficacy, toxicity, comparative
therapeutic use, and pharmacoeconomic data. Unfortunately, recent
information suggests that pharmacoeconomic data available are sparse,
often not timely, and not often used.2 However, there are some data to
dispute this assessment.3
Practice: Practical Therapeutics
Other representatives from the Pharmacy Department may be in-
cluded as members.
Physicians
Individuals from each department, including medicine, surgery, pedi-
atrics, psychiatry, obstetrics-gynecology, and others are essential. In
addition, subspecialists from areas with high-cost or high-risk drug
use, such as oncology, infectious diseases, critical care, and cardiology,
should be included in committee decisions at least on an ad hoc basis.
Nurses
Representatives of nursing are important members of the P&T Com-
mittee. While often the Chief Nursing Executive is suggested as a rep-
resentative to the committee, it is essential for a nurse who practices
at the bedside or who directly supervises nurses practicing at the
bedside to be included. Oftentimes the nurse member will offer insight
into the impact of formulary decisions on nursing time and nursing
care.
Administrator
An administrator, to whom none of the P&T Committee members
directly reports (in an effort to avoid potential conflicts of interest), is
a useful addition to the committee. This individual should serve as a
nonvoting member or an ad hoc, nonvoting member. Many problems
can arise when an individual such as the Director of Pharmacy, serving
as the P&T Committee secretary, reports to the administrator on the
P&T Committee. This sometimes presents a significant conflict of
interest.
House Staff
House staff (such as chief residents) may be included, but should
function in a nonvoting capacity. House staff are often the individuals
targeted by pharmaceutical company representatives with “freebies.”
Thus, house staff should generally serve as nonvoting representatives
on the P&T Committee to avoid potential conflicts of interest.
Risk Manager
In recent years, with the concern over medication errors, a risk manager
has often been appointed as a member of the P&T Committee. While
these individuals can offer useful input, caution must be exercised in
having the “risk” override the potential for benefit for formulary addi-
tions. Often risk managers have limited (or outdated) clinical experi-
ence that causes undue work burden for the committee and delays
implementation of important drug-related decisions for patient care.
While patient safety is very important, this aspect has sometimes over-
shadowed the other important functions of the P&T Committee. The
risk manager should provide useful and practical insight into the
“risks” involved with medication selection and use. However, the sce-
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Clinical
Pediatrician Psychiatrist Nurse Pharmacist
Pharmacist
or
Pharmacologist
nario in which every possibility for medication error is considered,
while being of interest, may sidetrack decision making for an institu-
tion. Risk, as with any other decision on the use of drugs, must be
balanced. No drug will ever be 100% safe to use.
Subcommittees
In addition to the main P&T Committee, given the complexity of many
drug therapies, P&T Committees often develop subcommittees (e.g.,
oncology and infectious diseases) to review formulary addition requests
and make recommendations to the full committee. Oftentimes, sub-
specialists assist in these assessments but do not serve as members of
the P&T Committee.
Meetings
Meeting frequency should be based on the institution size and need.
This is generally written into the medical staff bylaws. For small insti-
tutions (<100 beds), quarterly meetings may be appropriate. For larger
institutions that have more complex patients and many subspecialties,
meetings one or two times a month are appropriate. This entails a
substantial amount of work by the secretary, clinical pharmacist, and
clinical pharmacologist members in particular. In large hospitals,
almost a full-time equivalent (FTE) position (or more than one) can
be dedicated to this. Administration in particular needs to recognize
this and provide adequate financial support to the P&T Committee as
a separate line item. Traditionally, the function of the P&T Committee
is done by volunteers with no budget for the committee. Just as Insti-
tutional Review Boards have found that, in order to do their job, there
is a need for dedicated FTEs and a budget, P&T Committees must
have the personnel and financial support to function at the high level
expected.
The format of meetings needs to be standardized, with time limits
put on presentations and discussion as directed by the chair. Meeting
duration of over 90 minutes shows decreasing return in terms of
productivity.
In the past, discussion of new drugs proposed were preceded by
a lengthy (5 to 20 pages) written review by the clinical pharmacist/
pharmacologist. In the opinion of this writer, with 25 years of P&T
Committee experience, these reviews are rarely read by the committee
members and are extremely time consuming to prepare (unless one
uses a therapeutic review subscription service). Better use of this time
would be a short (5- to 10-minute) slide presentation using evidence-
based information, with discussion of important points in order to
facilitate decision making. The discussion points should include ther-
apeutic efficacy, drug toxicity, assessment of risks of therapy, drug
administration issues, and any agent-specific issues (e.g., for an anti-
biotic, whether its use should be restricted to reduce the potential for
resistance). In addition, cost implications must be considered. Unfor-
tunately, very few pharmacoeconomic data that are not generated “in
house” are available in the literature to assist in this decision-making
process.3 Additionally, it is inappropriate for representatives from a
pharmaceutical company to attend P&T Committee or subcommittee
meetings.
 Chapter 89 Pharmacy and Therapeutics Committees and the Hospital Formulary
Role of the Subspecialist on
the P&T Committee
While subspecialists may not be regular members of the P&T Com-
mittee, their input is important in decision making for drugs that will
be used in patients whom they either treat or consult on. Unfortu-
nately, in some therapeutic areas, agents are often added to the hospi-
tal formulary based on anecdotal experience, drug company promotion,
and availability of samples with few hard data.4 Use of drugs for
unlabeled indications should be evaluated using an evidence-based
approach. Thus, it is essential for the subspecialist to provide objective
input into the decision-making process. This is an extremely difficult
area to deal with, and many institutions have struggled with this.
Conflicts of Interest for P&T
Committee Members
In reality, it is difficult for any P&T Committee member to be objective
all of the time. Important considerations for revealing conflicts of
interest in an attempt to bring as much objectivity to the P&T Com-
mittee as possible include the following:
• Yearly financial disclosure following U.S. Food and Drug Admin-
istration (FDA) guidelines for investigators.5 These should be filed
with the P&T Committee chair. The chair should file his or her
disclosure statement with the President of the medical staff.
• Full disclosure at the beginning of each meeting for any member
who may have a conflict of interest for any agenda item. The
member in conflict should refrain from any discussion and should
not vote on the item. In theory, the member should be excused
from the discussion and this documented in the meeting minutes.
Conflicts include receipt of any financial support, trips, junkets,
academic materials (e.g., textbooks), and the like from a drug
company that markets the drug under consideration.
Communication and Implementation
of P&T Committee Decisions
The absolute importance of prompt, accurate communication of P&T
Committee decisions on drug therapy cannot be ignored. Following a
P&T Committee meeting and finalization of the minutes (which
should be complete and outline the entire decision-making process),
decisions made should be immediately conveyed to physicians, house
staff, nurses, pharmacists, and others involved with patient care. This
can be in the form of e-mail, short written communications, flyers, and
personal interactions with groups. These communications need to be
concise and informative and cover important points or they will be
ignored. Lengthy communications will result in a large amount of
work being wasted and create new problems for individuals such as
pharmacists who have to implement decisions of the P&T Committee.
This is the area where full support of the chair, department chairs, and
the medical staff is an absolute. The P&T Committee chair has
the responsibility to facilitate this support. In addition, access to the
P&T Committee minutes for anyone in the institution to review is
important.
Pharmacists often bear the brunt of P&T Committee decision
making with prescribers and nurses. These negative interactions take
away from the team environment essential to patient care and must be
dealt with immediately by the P&T Committee chair or the depart-
ment chair. Once decisions are made, it is imperative for all members
of the house staff, medical staff, pharmacists, and nurses to support
these decisions and work as a team to carry them out and optimize
patient care.
Other Functions of
the P&T Committee
Besides reviewing drugs and selecting them for addition to the hospi-
tal formulary, the P&T Committee also has other important functions.
These include
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1235
1. Formulating and maintaining ongoing review of drug safety
policies. This includes involvement in Physician Order Entry
software, pharmacy software systems, use of approved abbre-
viations, order writing, and establishment of policies for
improving drug safety.
2. Assisting in standardization of instrumentation for drug deliv-
ery (e.g., intravenous infusion pumps).
3. Maintaining ongoing review of medication usage, adverse
effects, and so forth. These medical use evaluations or drug
utilization reviews should be performed on drugs that are
expensive, those with narrow therapeutic-to-toxic ratios, or
those used for unlabeled indications. These reviews provide
information on whether the drugs are being used properly,
appropriately, safely, and in a cost-effective fashion. Often data
for these reviews are collected by students, pharmacy residents,
or pharmacists and presented in a concise fashion to the P&T
Committee.
4. Providing support for the Pharmacy Department. In many
institutions, the Pharmacy Department is administratively
placed under a nonclinician administrator with business train-
ing but no clinical training. In some instances, this individual
Practice: Practical Therapeutics
puts cost considerations first and disregards the more important
functions of the Pharmacy Department, including clinical ser-
vices and efficient medication delivery. Oftentimes, the P&T
Committee is the only clinical oversight and the initial support
for the Pharmacy Department. In addition, the P&T Committee
can use its influence to change policy and institute new pro-
grams in the Pharmacy Department. For example, in some insti-
tutions, a pharmacist serves as an “antibiotic stewart,” reviewing
antibiotic use and changing things according to protocols. 6 In
some instances, these programs were the result of P&T Com-
mittee recommendations.
5. Reviewing the Formulary, with publication either on line or in
a hard copy format.
6. Formulating policy on the use of drugs in an institution.
7. Formulating treatment guidelines for drug use and disease
treatment in an institution.
8. Reviewing all medication incidents of a certain level of
severity to look for trends and make recommendations for
improvement.
9. Establishing and planning educational programs for members
of the medical staff, house staff, pharmacists, nurses, and
others.
10. Establishing policy for the conduct of business by representa-
tives of pharmaceutical companies in an institution. This is
a particularly sensitive issue because of the pervasiveness of
“entitlement” of individuals in the medical field or gifts from
pharmaceutical company representatives. Some institutions
have stopped completely the provision of education, meals,
giveaways, and the like from pharmaceutical company
representatives.
11. Establishing policy for the acquisition and use of sample medi-
cations in an institution. It is important to note that sample
medications must be handled in the same way as other medica-
tions and need to be obtained, stored, labeled, tracked, and
dispensed properly (following pertinent state pharmacy laws).
Overall, the P&T Committee is very important to the functioning
of the institution. Since nearly 100% of patients admitted to the hos-
pital receive some drug therapy, a group that objectively evaluates
efficacy, toxicity, safety, and cost considerations is essential.
THE FORMULARY
The Formulary is often a misunderstood concept. To some, the For-
mulary represents a “list” of drugs available in the institution. However,
the Formulary is a concept that translates to a document that regulates
drug use in the institution and guides clinicians in the proper use of
drugs. An institution can have either an open or closed Formulary.
An open Formulary (very unusual nowadays) allows any drug to be
 1236 Section 19 Practical Therapeutics
available in the institution for use. Since many drugs duplicate the
pharmacologic effects and indications of other agents, the need for an
open Formulary is essentially outdated.
A closed formulary is one that restricts drugs in each category to the
most efficacious, safe, cost-effective agent(s). For example, if six β-
blockers are available commercially, the P&T Committee will often
pick one or two that are effective, can be used via multiple routes of
administration, can be used with relative safety, and are cost effective.
In addition, in a closed formulary system, some drugs will be restricted
for use to certain groups because of potential for adverse effects or cost.
An example would be the drug drotecogin, which might be restricted
to use by intensivists or infectious disease physicians. This agent would
be restricted because of its potential for toxicity, specificity of use, and
cost. Additionally, some drugs may be available for use by all in the
institution, but require approval by specific groups before they can be
used. An example is the need for approval for certain broad-spectrum
antibiotics by an infectious diseases physician or pharmacist before the
drug can be ordered for a patient.6 The rationale behind this type of
restriction has to do with antibiotic “stewardship”—promoting ratio-
nal use of the drug, controlling antibiotic-resistant organisms, and
controlling costs.6
Practice: Practical Therapeutics
Other facets of a closed formulary may be the broad restriction of
large numbers of drugs based on the potential for toxicity. In these
cases, only certain clinicians can use these agents, and in many circum-
stances, these clinicians must write the specific orders for these agents
before they can be administered to a patient. An example in many
institutions is that of oncologic drugs. Because of tragedies with inap-
propriate dosing and administration of these drugs to patients in the
past, many institutions allow only board-certified oncologists or onco-
logic surgeons to order these drugs and only certified oncology nurses
to administer these agents. In many instances, no other clinician
is allowed to write the orders for these agents, unless they are being
used for nononcologic indications (i.e., methotrexate for rheumatoid
arthritis).
Thus, in the closed Formulary, drugs can be classified as either
“formulary” or “nonformulary.” Formulary drugs are subject to the
restrictions noted earlier. Nonformulary drugs encompass the rest. As
one might expect, when the P&T Committee has objectively evaluated
a Formulary choice and admitted the drug to the Formulary, there may
be individuals who are upset at the P&T Committee choice. This can
set into motion a series of events where the clinician writes a prescrip-
tion for a nonformulary drug, and the order is sent to the pharmacist,
who is then pressured to fill the nonformulary order. This defeats the
formulary process and must be quickly addressed.
Reasons given for ordering nonformulary drugs include:
1. The patient has been on the nonformulary drug prior to admis-
sion and the clinician wants to continue it despite having appro-
priate formulary alternatives.
2. The patient believes that a generic equivalent of the drug he or
she is taking is less effective than the brand name (an inappropri-
ate argument given the process that is in place by the FDA for
approval of generic medications).
3. The clinician, using anectodotal data, believes that the nonfor-
mulary drug is “better” than the formulary agent (not evidence
based).7,8
These scenarios should be avoided through education of clinicians
and patients and support by clinicians of the P&T Committee deci-
sion-making process. This support must start with the medical staff
and chiefs of service. In addition, making the obtaining of nonformu-
lary medications difficult (not stocking them in the institution, requir-
ing that a written form be filled out along with the order, allowing up
to 48 hours to obtain a nonformulary medication) is a way of forcing
the use of formulary medications. In no instance should the patient be
allowed to use his or her own medications, as the pharmacist and
prescriber cannot assume that the medication has been stored properly
or is not expired. While this may seem draconian to the reader, these
techniques, in the face of a valid P&T Committee Formulary process,
are appropriate. Another method is to allow “therapeutic substitution”
of one formulary agent for a nonformulary agent. This has been com-
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monly done with proton pump inhibitors, fluoroquinolones, oral
cephalosporins, and histamine2 blockers, to name a few of the
categories.
Other ways to enforce the formulary process without relying on the
above-mentioned tactics is the incorporation of clinical pharmacists
into day-to-day patient care. Pharmacists rounding with teams, seeing
patients, and working with nurses has been shown to be cost effective
and result in more appropriate drug use.9-11 Unfortunately, with the
shortage of pharmacists, these individuals may be relegated to dispens-
ing rather than clinical activities. With the availability of highly sophis-
ticated automatic dispensing systems and the broad and appropriate
use of pharmacy technicians, there is little reason for the pharmacist
to be involved with dispensing activities in the pharmacy. This is an
area that needs to be acutely addressed; while many institutions have
been far ahead on this issue, others remain in the past in this regard.
The use of pharmacists for dispensing functions is antiquated, is not
cost-effective, and should be discouraged. Time is better spent in being
at the bedside, guiding clinicians in appropriate drug use, writing
orders (to reduce the writing of inappropriate orders), and monitoring
patients’ drug therapy for efficacy, adverse events, and safety. There is
a significant body of literature showing the utility of clinical pharma-
cists in medication use.9-11
As noted, the Formulary is not a document but a process. Besides
the list of available medications in the institution, the Formulary
should contain the following:
1. Information on how drugs can be requested for P&T Committee
review
2. Compilation of drug treatment guidelines
3. Drug information useful for day-to-day patient care
4. Conversion tables for medications
5. Generic-to–brand name conversions
6. Specific state laws for prescribing medications
In the recent past, institutions have moved from a paper Formulary
document to on-line documents that can be accessed at the bedside
and updated continuously. When coupled with a good Physician Order
Entry system, safe and effective prescribing can be implemented. These
steps should result in greater patient safety, economic benefits, and a
greater degree of implementation of P&T Committee recommenda-
tions with the resultant benefits.
SUMMARY
The P&T Committee is essential in formulating drug policy in an
institution. The Formulary is a process developed by the P&T Com-
mittee that directs individuals in how to use drugs.
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