HOSPITAL FORMULARY SYSTEM

Minor Project Report

Submitted to

Chhattisgarh Swami Vivekanand Technical University, Bhilai, (C.G.) in the

partial fulfillment of the requirements for the degree of

Bachelor of Pharmacy

Supervised by Submitted by
Mrs.Disha Kesharwani. Roshan Kumar Singh
Assistant Professor B. Pharm. VII sem.

Columbia Institute of Pharmacy, Raipur, Chhattisgarh 2023-24

1
 DECLARATION BY THE CANDIDATE

I the undersigned solemnly declare that the report of the thesis work entitled,
HOSPITAL FORMULARY SYSTEM is based on my own work carried out during the
course of my study under the supervision of Mrs. Disha Kesharwani.

I assert that the statements made and conclusions drawn are an outcome of my
review work. I further declare that to the best of my knowledge and belief the
report does not contain any part of any work which has been submitted for the
award of degree/diploma/certificate in this University or any other University of
India or abroad.

(Signature of the Candidate)

Name of the candidate: Roshan Kumar Singh

Enrolment No: BJ2932

2
 FORWARDING LETTER

This is to acknowledge that Mr. ROSHAN KUMAR SINGH, student of B. Pharm.

VII sem. has completed his major project work titled HOSPITAL FORMULARY
SYSTEM under the supervision of Mrs.Disha Kesharwani in the partial
fulfilment of the requirement for the award of degree of Bachelor of Pharmacy
by Chhattisgarh Swami Vivekanand Technical University, CSVTU, Bhilai, (C.G.),
India.
The project report is forwarded to the examiner for evaluation.

Date: Signature and Seal of Principal

Place: CIP, Raipur Prof.Ravindra Kumar Pandey

3
 CERTIFICATE OF THE SUPERVISOR

This is to certify that the work incorporated in the thesis, HOSPITAL FORMULARY
SYSTEM” is a record of review work carried out by ROSHAN KUMAR SINGH, B.
Pharm. VII sem. bearing Enrolment No.: BJ2932 under the supervision of Mrs.Disha
Kesharwani for the award of Degree of Bachelor of Pharmacy of Chhattisgarh Swami
Vivekanand Technical University, Bhilai (C.G.), India.

To the best of my knowledge and belief the thesis;

i. Embodies the work of the candidate himself,

ii. Has duly been completed,
iii. Fulfils the requirement of the Bachelor degree of the University and
iv. Is up to the desired standard both in respect of contents and
language for being referred to the examiners.

Mrs. Disha Kesharwani

(Signature of the Supervisor)

4
 ACKNOWLEDGEMENT

First of all, I take this opportunity to offer devotional prostration at the feet of the
almighty and my beloved parents.
During the course of my major project work, I got help, advice, suggestions and co-
operation from many people. Some advices influenced, inspired and helped me in
completing this thesis. A task becomes easier when you get the moral support and
encouragement, and if these names are not listed, the project work and the thesis
would remain incomplete.
Firstly, I would like to convey my honest unforgettable regardful thanks and
gratitude to Respected Prof.Ravindra Kumar Pandey, Principal, Columbia Institute
of Pharmacy, Raipur, who from day-to-day busy schedule had spend his valuable
time to motivate at various levels and put me on right path to complete my project
properly. Without his able assistance, my project would not have been completed
authentically. I extend my sincere gratitude towards him. And wish to receive the
same in future as well.
I wish to express my sincere and very special thanks to Mrs. Disha Kesharwani,
Associate Professor, Columbia Institute of Pharmacy, Raipur, for his valuable
supervision which helped me for the collection and compilation of the review work.
I express my sincere gratitude to Resp. Shri Kishore Jadwani Sir, Chairman, Jan
Pragati Education Society, Raipur, and Resp. Shri Harjeet Singh Hura Sir, Secretary,
Jan Pragati Education Society, Raipur for providing a stand up for rising and for
enhancing the study skills. I am highly thankful for the support & blessings received
from other teachers, friends, who have directly or indirectly put forward their ideas,
suggestions, moral, support & encouragement at every stage in preparing this
report.
Last, but not the least I am grateful to my family for bearing me throughout the
compilation of this project. Their strong & continuous support was my strength at all
stages.

Roshan Kumar Singh

5
S. No. Content Page
No.

1. INTRODUCTION
2. FORMULARY SYSTEM,GUIDELINES
3. MAIN PARTS OF FORMULARY SYSTEM,CATOGORIES

4. PREPRATION OF HOSPITAL FORMULARY SYSTEM

5. DISTRIBUTION OF FORMULARY SYSTEM,REVISION
6. REVISION REQUIREMNT AND PROCEDURE,ROLE OF HOSPITAL
FORMULARY SYSTEM

7. PHARMACY AND THEARAPEUTIC COMMITTEE

8. ORGANISATION OF HOSPITAL PHARMACY SERVICE
9. HOSPITAL DRUG AND THERAPEUTIC COMMITTEE
10. DIFFERENCE BETWEEN DRUG LIST AND HOSPITAL FORMULARY
11. REFERENCE

6
 INTRODUCTION

The hospital formulary system is a method whereby the medical staff of a hospital with
the help of pharmacy and therapeutic committee selects and evaluate medical agents
and their dosage form which are considered to be most useful in the patient care.
The hospital formulary system provides the information for procuring, prescribing,
dispensing and administration of drugs under brand/generic names.

• The first hospital formulary in India was published in 1968 by the Department of
Pharmacy, CMC, Vellore.

• The first hospital formulary for the development of government hospital

teachings was published in 1997 at Government Medical College, Trivandrum.

The need for Hospital Formulary:

• The increasing number of new drugs manufactured and marketed by drug

companies.

• Increasing complexity of untoward effects of modern potent drugs.

• Newer sales promotion strategies of pharmaceutical industry.

 The public interest in getting possible health care at lowest possible cost.

Fig no-1

 Closed formulary: A list of medications (formulary) which limits access of a

1
 practitioner to some medications . A closed formulary may limit drugs to specific
physicians, patient care areas, or disease states via formulary restrictions.

 Drug formulary: A formulary is a continually updated list of medications and related

information, representing the clinical judgment of pharmacists, physicians, and
other experts in the diagnosis and/or treatment of disease and promotion of health.

 Drug monograph: A written, unbiased evaluation of a specific medication. This

document includes the drug name, therapeutic class, pharmacology, indications for
use, summary of clinical trials, pharmacokinetics/dynamics, ad- verse effects, drug
interactions, dosage regimens, and cost.

 Drug therapy guidelines: A document describing the indications, dosage regimens,

duration of therapy, mode(s) of administration, monitoring parameters and special
considerations for use of a specific medication or medication class.

 Drug use evaluation (DUE): A process used to assess the appropriate- ness of drug
therapy by engaging in the evaluation of data on drug use in a given health care
environment against predetermined criteria and standards.

The hospital formulary is the cornerstone of medication management in the hospital,

and it should be the principal concern of the DTC. The issues related to medication.

The following list provides general guidelines for the hospital setting.

• Limit the formulary list to conserve resources—stocking all medicines on the

national formulary is usually not necessary.

• Eliminate generic duplication—only one brand or label of each generic medicine

should be routinely stocked.

• Minimize the number of strengths stocked for the same medication; multiples of
lower strengths can be used for infrequently needed higher strengths.

• Select medications for the formulary based on diseases and conditions treated
at the facility.

• Specify formulary medicines of choice for common therapeutic indications.

Medicines of choice should be selected by comparing efficacy, safety, toxicity,
pharmacokinetic properties, bioequivalence, and pharmaceutical and therapeutic
2
 equivalence. Cost- effectiveness and availability should be primary
considerations, evaluating alternatives as described in Chapters 10 and 17. After
medicines of choice are selected, they form the basis for standard treatment
guidelines and for therapeutic substitution programs (see below).

• Include second-line alternatives to medicines of choice as needed, but minimize

therapeutic duplication.

The Formulary System

A drug formulary is a continually updated list of medications and related information,

representing the clinical judgment of pharmacists, physicians, and other experts in the
diagnosis and/or treatment of disease and promotion of health.

It is often described as a list of medications routinely stocked by the health care system.
The formulary was developed by hospitals in the 1950s as a management tool. It was
initially used to assure that physicians had an adequate and consistent supply of
medications for their day-to-day needs. A key purpose of the formulary was to
discourage the use of marginally effective drugs and treatments.

Over time, the formulary has evolved beyond a simple list of medications. It is now one
element of a system that includes medication use policies, a pharmacy and therapeutics
committee, medication use evaluation, and formulary management.
The formulary, today, can be more accurately defined as a continually updated list of
medications and related information, representing the clinical judgment of pharmacists,
physicians, and other experts in the diagnosis and/or treatment of disease and
promotion of health.

Formularies are fundamental to the formulary system—defined as an ongoing process

which methodically evaluates medications on an ongoing basis for inclusion or
exclusion, establishes guidelines for optimal medication use, and develops policies and
procedures for prescribing, dispensing, and administering medications. The formulary
system is managed by the pharmacy and therapeutics committee or equivalent group
—made up of an organized team of medication system expert.
 GUIDELINE FOR HOSPITAL FORMULARY.

a) The governing body of the hospital shall appoint a pharmacy and therapeutic
committee composed of physician and pharmacist which will prepare the hospital
formulary system.
3
b) The medical staff in the governing body shall sponsor and outline the purpose,
organization function and scope of the hospital formulary system. it should adopt
the principle as per the need of particular hospital.

c) The pharmacy and therapeutic committee shall develop policy and procedure
governing the hospital formulary and the medical staff shall adopt these policies
and procedures subject to administrative approval.

d) The policy and procedures shall afford guidance in the appraisal, selection,
procurement, storage, distribution, use, safety procedures and other matter relating
to drug in the hospital and shall be published in the hospital’s formulary or other
media available to the member of medical staff.

e) The medical staff shall adopt the policy formula, and procedure for including drugs in
the formulary by their non proprietary names even though proprietary names
continue to being use in the hospital physicians.

f) In the absence of written policies approved by the medical staff related to the
operation, the hospital shall make it certain that the nursing personnel are informed
in writing though its system of news of communication that there exits the formulary
system in the hospital and the procedure governing its operations.

i) In the formulation of policies and procedure the term substitute or substitution

should be avoid since these term have been used to imply the unauthorized dispensing of
entire different drug, neither of which takes place under a properly operated hospital
formulary system.

j) It shall be made known to the medical staff about the changes in the working in the
hospital formulary system or in the content of the hospital system.

k) Provision shall be made for the appraisal of the member of the medical staff for
the use of the drug not include in the formulary or the investigational drugs.

l) The pharmacist with the advice and guidance of the pharmacy and therapeutic
committee, shall ascertain the quantity and source of supply of all drugs, chemical,
biological and pharmaceutical preparation used for diagnosis and treatment of patient.

m) labeling of drug and medicine container with non proprietary name of the content
always should be proper. The use of proprietary name other than that describing the
4
actual content is not correct and proper if it is used in a manner that can be taken as
description of the content. Formulary contents & organization.

# The formulary should consist of three main parts:

1. Information on hospital policies & procedures concerning drugs.

2. Drug products listing

3. Special information

A. Information on hospital policies & procedures concerning Drugs

# Categories of drugs

Eg: formulary drugs, non formulary drugs, etc.

ii. Brief description of the PTC including its membership , responsibilities and
operation.

iii. Hospital regulations about prescribing, dispensing & administration of drugs

including writing of drug orders, verbal drug orders, automatic stop orders, self
administration of drugs by patients.

iv. Pharmacy operating procedures such as prescription labeling, handling of drug

information request and outpatient prescription policies.

v. Information on using the formulary: It includes how formulary entries are arranged
and the information contained in each entry.

B. Drug products listing

a) Formulary item entries:
 Alphabetically by generic name
 Alphabetically within therapeutic class

b) Type of information

•Generic name of the product

•Dosage form, strength, packaging
5
 •Active ingredients
•Adult/pediatric dose
•Route of administration, Cost etc

c) Indexes to the drug products listing:

•Generic name/brand name
•Therapeutic /pharmacological index

C. Special information

•Hospital approved abbreviations

•Rules for calculating pediatric dosages
•List of sugar free drugs
•Metric conversion tables
•Poison control information
•Table of drug interactions

Formularies are fundamental to the formulary system—defined as an ongoing process

which methodically evaluates medications on an ongoing basis for inclusion or exclusion,
establishes guidelines for optimal medication use, and develops policies and procedures
for prescribing, dispensing, and administering medications. The formulary system is
managed by the pharmacy and therapeutics committee or equivalent group—made up of
an organized team of medication system experts.

There are advantages and disadvantages to a formulary system. The primary advantage is
that it provides a systematic method to review scientific evidence on clinical
effectiveness and cost effectiveness in drug selection decision, thus potentially improving
health outcomes while reducing costs. A major disadvantage, however, is that an overly
restrictive formulary system may potentially reduce the quality of care by limiting access
to clinically indicated medications.

Preparation of a hospital formulary

• It is a principal responsibility of the pharmacy and therapeutic committee. How ever it is

also rests primarily on the chief pharmacist service etc.

• The committee is free to make necessary decisions, regarding the material to be included
in the formulary and pharmacist undertaken the production of the formulary
that is compiling and printing etc.

6
• Irrespective of the decision arrived at in respect of above. it will be necessary to
formulate a series of rules of guidelines which the committee may to evaluate drugs for
admission to the formulary or the list of drugs.

• If it is decided that the publication is to be a formulary, a decision must be reached as to

the possible contents other than the section on various therapeutic agents.

1. section on prescription writing.

2. section governing the use of drug.

3. Section on diagnostic reagent and normal pathological investigational reagent etc.

4. Section on pharmaceutical classification etc which are good guidelines for

pharmacist and nurses.

5. Poision and their antidote.

6. Posological tablet.

7. Other useful data and feature e.g. tablet of metric weight and measure and their
equivalent of apothecary” and household measures, calculation and dosages for
various age group especially of children.

8. it should also be decided at the outset, as what short of format should the
formulary adopt and how should be its
a)size

b)printed or cyclostyled

C)whether lose leaf or bound, the advantage of the former are that addiction
and deletion of pages of various section or main body of the drug list are possible.

■ ■ ■
Key Point . . .
The formulary has evolved beyond a list of medications to a
system that manages the drug use process.

. . . So what?
7
Standard definitions of formularies refer to them as static
compilations of recommended medications in a pharmacy. In
truth, they are really dynamic entities that consist of a
constantly changing medication list, policies and procedures
 Fig no-2 ( Key points of formulary)

Pharmacy Medical Professional

Medication Use
Management
Drug Review Panel
Evaluates drugs for
consideration and
makes recomendations
Pharmacy & Therapeutics
Committee
Safety Committee
* Review and Act on Evaluates medication
safety and makes
Medication Use
recommendations to
Review Review the
success of
implementation and
Medical and Hospital Staff
Notification
* Newsletters
* Department Meetings
* Alliance with
Pharmaceutical

F i g n o - 3 ( I N T R O D U C T ION TO H O S P ITAL AND HEALT H - S Y S T E M P H

A R M A C Y ) P R A C T I CE
The physical appearance & structure of the formulary is important influence on its
use. The formulary should be visually pleasing, easily readable and should appear
professional.

1. Introductory information
•Acknowledgement
•List of abbreviations
•Intended usage of the formulary manual
•Generic Name
8
•Dosage Form, Strength
•Indications
•Pharmacological Actions
•Precautions
•Side effects
•Dosage Form, Frequency, Drug Interactions

2. Basic information of the drug

3. Supplementary information on each drug

•Price
•Regulatory Category
•Storage Guidelines
•Patient counselling Information
•Brand names
•Principles of prescription writing
•Strength of prescribed medication must be given in
accepted metric system
•Correct dispensing guidelines
•Prevention and Reporting of ADRs

4. Prescribing & dispensing guidelines

5. General drug use advice

•Use of IV drugs
•Special situations like pregnancy, breastfeeding liver/kidney diseases
•Poisoning information and Antidotes
•Treatment of snake bites and insect bites
•Children’s dose
•Renal adjustments
•Metric units

6. Miscellaneous Section Management of hospital formulary

Formulary Management Principles . The formulary is a periodically revised list of
medicines that reflects the current judgment of the medical staff. The formulary
system utilizes the medical and pharmacy staff to evaluate, appraise, and select
from among the numerous available medicines those products that are the most
efficacious, safest, of adequate quality, and available at a reasonable price. When
completed, the formulary should conform to the following principles—

9
a. Medicines should be selected based on the needs of the community; they should
treat the locally identified diseases and conditions.

b. The formulary list should have a limited number of medicines, only those
necessary to provide for the needs of the hospital or clinic; duplication of agents
that have therapeutic equivalence should not occur.

c. International nonproprietary names (INN) (i.e., generic names) should be used.

d. Combination (fixed-dose) products should be used only in specific proven conditions

(e.g., to treat tuberculosis).

e. The formulary must be consistent with any national or regional formulary or

approved standard treatment guidelines.

f. Medicines should be restricted to appropriate practitioners. Distribution of the

formulary

•Copies of the formulary should be placed at each patient care unit including clinics &
the emergency room.

•Each division of the pharmacy (IP pharmacy, OP pharmacy, drug information

centre etc) should receive a copy.

•Head of the department as well as each member of the medical staff should
receive a copy. Revision of formulary

•The PTC holds meetings to discuss about the revision of the formulary.

•The annual revision is necessary because of the changes in the drug products,
removal of certain drugs from the market and changes in the hospital policies.

•The addition of details of a drug is done by attaching the supplement sheets at the
back of the formulary.

•The addition of any drug to the formulary is a complex decision.

•All steps prior to the addition or deletion of a drug must be reported to the medical
staff. Maintaining a Formulary System

10
•The formulary maintenance process is dependent on two key components:

a) additions and deletions of medicines, and

b) therapeutic medicine class reviews.

•Additions and deletions should be handled following specific policies and

procedures developed for the PTC. A transparent methodology must be developed
for these important decisions concerning addition or deletion of a medicine.

•Routine medicine class reviews are important to maintain the formulary. The
medicine class review involves the evaluation of a complete section of medicines (e.g.,
cephalosporin antibiotics).

•To maintain the formulary, regularly scheduled meetings must be established

and attended by committee members. Ideally, the committee would meet monthly or,
at the very least, every four months.

•Selecting medicines for the formulary should follow carefully considered policies
and procedures for determining the most useful medicines. These policies
should be followed routinely and accurately each time an evaluation is needed.

1. A request for addition of a medicine to the formulary, which can be made only
by a physician or pharmacist, is done by completing a “Request for
Addition/Deletion” form.

2. Medicine information resources should be obtained, including primary

literature, international newsletters, standard treatment guidelines, textbooks, and
Internet sources.

3. The evaluation is performed using established criteria

4. The medication information monograph is written. The medication monograph

should include details about the medicine obtained from several information
sources At a minimum, the monograph should include
 Pharmacology
 Pharmacokinetics
 Efficacy compared to placebo and other medicines
 Clinical trial analysis
 ADRs
 Medicine interactions
11
  Cost comparison
 Sources of supply (to ensure availability)

5. Expert opinions and recommendations should be obtained from knowledgeable

and respected physicians and pharmacists.

6. The PTC makes a formulary decision (at the PTC meeting). Information should
be presented to the PTC at a regularly scheduled meeting.

7. The results of the evaluation and PTC’s recommendations and actions must be
disseminated to the health care staff in the form of minutes or newsletters, or
through department meetings.

Distribution of formulary

 A hospital formulary is an important written document that contains the list of

preparations including important information which reflects the current clinical
views of medical staff.
A formulary is the painstaking effort of any hospital to guide medical and
paramedical staff.
 The formulary is very educative and useful to the members of the “Health Care
Team”
 Hence copies of the formulary should be placed at each patient care unit,
including clinics, out-patient care areas, and emergency room.Revision
requirement and procedure.

#Revision:

In the formulary, entry of the new drug is a very complex procedure. There is needed
to take help from various experts for the inclusion of new drugs in the list. Reference
books such as Indian Pharmacopeia, British Pharmacopeia, United State of
Pharmacopeia, and National Formulary are used while preparation of drug list for
entry of new drugs.
If there is no information or whose formula is not disclosed in official Pharmacopoeia
then the entry of new drug is not made in the formulary. There are policy guidelines
and opinions of the medical staff are taken for inclusion or deletion of drugs in a
formulary.

Usually, formularies need to be revised annually and there should be a certain system
12
 for revision. One method for the revision is to attach supplementary sheets to the back
covers of formulary books and the second method of revision is the inclusion of sheets
by different colour pages for the cover of each edition of the formulary, this method
will help to reduce any confusion between the current and past condition of the
formulary.

#REVISION REQUIREMENT AND PROCEDURE

 Generally, for addition, deletion, change in the drug products, removal of drug
from the market, change in the hospital policies and procedures the formulary
needs revision annually.
 There are two methods for the revision of the formulary.
 One method is to attach a separate sheet to the back cover of formulary books.
 The second method is by using a different color for the cover of each edition of
the formulary.

Which will help to reduce any confusion between present and past editions?
Revision in the formulary should incorporate the regular review of selected categories
to ensure that.

 Only the most cost-effective products are used.

 Such review may lead to the deletion of certain drugs.
 During revision and preparation of the formulary system.
 Cost-effectiveness
 Cost-benefit analysis methods are generally used.

#Role of hospital formulary system

1. It provides therapeutic benefits to the patient and healthcare providers in a hospital.

2. It minimizes the chances of duplication of drugs, thereby helping in maintaining the

inventory budget.

3. It provides information about the recent and advanced development in medicines.

4. It helps in the selection of suitable drugs in a hospital.

5. It provides information related to the availability of drug stock in a hospital.

13
6. It gives information related to reported adverse drug reactions in a hospital.

7. It provides a list of emergency drugs.

8. It provides guidelines related to prescribing, procuring, dispensing, and administering

drugs in a hospital.

#Managing A Formulary List (Adding and Deleting of Drugs)

For the addition of new drugs into the hospital formulary, the hospital and therapeutic
committee should consider the therapeutic potency and equivalency to existing drugs in
terms of their safety, efficacy, or suitability of administration. For the addition and
deletion of drugs in the formulary, there is a need to consider and compare the total
cost for a course of the treatment with new medicine with the existing listed medicines.

Advantage of formulary

 To discourage the use of “less than optimal drug therapy”, and

 To provide a generic product list.
 Generic product selection policies stimulate bio-equivalency comparison which
prevents the unnecessary stocking of less than optimal products.
 Formularies must include the cost to provide relative cost data for similar drug
products that are generically equivalent.
 Today new drugs and drug therapies are more complex, so the formulary system
will
 rely more upon ‘recommended for use’ criteria for many drugs.
 A drug that has specific advantages in a small number of patients will be included
in the formulary.

Disadvantages of formulary

 Deprive the physician of his right and privilege to prescribe and obtain the brand
of his choice.
 Permits the pharmacist to act as the sole judge of whom brands of drugs are to be
purchased & dispensed.

Formulary Management

Formulary policies should include information on who may use a specific agent
(formulary restrictions), how a drug is added or deleted from the formulary, how a drug
14
is stocked, and which drugs are stocked. The formulary restriction policy should
specifically define how items are selected for formulary restriction, rationale for
selecting approved prescribers, and a method for managing the process.

A formulary policy should describe the method for drug addition and deletion as well as
nonformulary drug use. A policy should describe how an agent is added to the pharmacy
stock once it is added to the formulary and who gets to decide.

For example, the P&T committee approves the addition of a chemical entity added and
the pharmacy manager selects dosage forms, strengths, et cetera, or the P&T
committee determines the chemical entity and dosage form(s) and the pharmacy
manager selects the strengths or sizes to be stocked. The basic policies and procedures
governing the formulary system should be incorporated in the medical staff bylaws or in
the medical staff rules and regulations.

Pharmacy and Therapeutics Committee

The policy should address the committee membership, operation, and responsibilities.
Medication Prescribing, Dispensing, and Administration Organizational policies on the
prescribing, dispensing, and administration of pharmaceuticals are required and
necessary to ensure safe medication use. Such policies should address all aspects of the
medication process.
 writing medication orders or prescriptions—Defines practitioners that may write
medication orders or prescriptions in concert with state and federal regulations.
This or related policies may also include the format for order writing and
unacceptable abbreviations.
 verbal orders—Defines who may accept a verbal order and the transcription
process of such an order. This policy should address the reading back of the order
to confirm its accuracy.

 stop orders—Defines the orders that are automatically terminated, how the
prescriber is notified, if appropriate, and the method for their reinstatement.
Stop orders are often established for medications that require additional
evaluation after a specific time. Examples of stop orders are antibiotic therapy
stopped after 7 days and nesiritide therapy stopped after 24 hours

investigational drug orders—Defines how investigational drugs are managed in
the health care system. This policy should include the review process as well as
the meth- od for prescribing, dispensing, administering, and monitoring
investigational agents.
15
  controlled substances—Defines the flow of controlled substances through the
health care system. This policy should include approved prescribers, the ordering
process from the pharmacy and the vendor, the distribution and tracking of use,
discrepancy tracking and follow-up, and management of diversion.

 generic and therapeutic substitution—Defines how a drug is selected for generic

substitution and therapeutic equivalents approved by the P&T committee. It
should describe how an alternative agent may be prescribed if deemed medically
necessary.

 self-administration of medications—Defines the conditions and process for the

administration of medication by the patient in the hospital setting.

 medication samples—Defines the conditions and process for the use of

medication samples in the hospital or clinic setting.

 floor stock—Defines the criteria for selecting agents for floor stock, process for
modifying the stock, and the regular review of the stock by the P&T committee.

 definition of order interpretation— Defines the meaning of specific types of

orders including sliding scale orders, range orders, as needed orders, tapering
orders, and titrating orders.

 medication administration times—De- fines specific medication administration

times and rules for interpretation. This may include the definition of stat and
related terminology.

 adverse drug reactions—Defines an adverse drug reaction, the reporting process,

and monitoring methods.

 medication errors—Defines a medication error, the reporting process, and

monitoring methods.

 others—Other topics for policy consideration include pharmaceutical

representatives , pharmacy hours of service, emergency medications, and
medication delivery devices.

#Organization of hospital pharmacy services

16
In organizing hospital pharmacy services, both the way in which the staff is organized
and the physical layout of the building must be considered.
Personnel
Hospital pharmacy personnel can be divided into three major categories—

 Management. Management includes the chief pharma- cist and sometimes deputy
chief pharmacists, who are responsible for procurement, distribution, and control of
all pharmaceuticals used within the institution and for management of personnel
within the pharmacy department.

 Professional staff. These professionals are qualified pharmacists who procure,

distribute, and control medications and supervise support staff for these activities. In
some facilities, pharmacists provide clinical consulting services and medicine
information.

 Support staff. The support staff category often includes a combination of trained
pharmacy technicians, clerical personnel, and messengers .The smallest hospitals may
have only two or three pharmacy staff members, with the chief pharmacist as the
only pharmacist. Larger teaching hospitals that provide extensive pharmaceutical
distribution and clinical services may have more than 100 staff members.

The cornerstone for a well-functioning medication sys- tem is an up-to-date manual

of policies and procedures. Staff members should be familiar with the manual and
adhere to it.

#Physical organization

The extent of the pharmacy’s physical facility is determined by the size of the hospital
and the services provided. A large pharmacy department might have the following
sections within one physical space or in separate locations through- out the hospital—
• Administrative offices
• Bulk storage
• Narcotic or dangerous drug locker
• Manufacturing and repackaging
• Intravenous solution compounding
• Inpatient and outpatient dispensing
• Medicine information resource center
• After-hours pharmacy
• Emergency medicine storage
17
 (List of drugs, chemicals & dressing material)
Inpatient dispensing is sometimes done from satellite pharmacies throughout the
hospital. In larger hospitals, satellite pharmacies are beneficial because they enable a
shorter turnaround time for individual medication orders, especially in distribution
systems that dispense medications packaged for individual patients. Satellites also
increase the pharmacist’s presence in the patient care area, facilitating interactions with
medical staff, nursing staff, and patients, and thus ultimately improving patient care.
With satellite pharmacies, there is reduced need for ward stocks.

However, each satellite requires a certain minimum inventory level of pharmaceuticals.

A system with multiple satellites most likely has a higher total inventory level than that
of a central pharmacy system. The higher inventory and additional personnel costs
needed to staff satellite pharma- cies may be justified by reductions in pharmaceutical
supply costs (because there is less wastage) and improvements in patient care. Whether
or not multiple satellite pharmacies serve inpatients, separate pharmacies often serve
inpatients and outpatients. illustrates how a hospital phar- macy with separate inpatient
and outpatient departments is organized in one African country.

Most commonly, the committee designated to ensure the safe and effective use of
medications in the hospital is the DTC. The American Society of Health-System
Pharmacists’ guidelines on DTCs state that “medication use is an inher- ently complex
and dangerous process that requires constant evaluation. Organizations need to
implement tools and processes necessary to meet the goals of using medications
effectively and safely” (ASHP 2008).
S. No. Drugs Common Side Effects

ABORTIFACIENTS, UTERINE STIMULANTS

1 Methyl Nausea, vomiting, rise in BP occasionally. Cardiac
Ergometrine arrhythmia, tachycardia, anaphylaxis, hemorrhage
0.2 mg/ ml, Inj. may occur.
At higher doses, it can decrease milk secretion.
2 Misoprostol Breathing problems, nausea, vomiting, watery
25mcg,tab diarrhea, uterine cramps, uterine contractions,
3 Misoprostol vaginal bleeding, flushing, shivering, fever, malaise,
100mcg,Tab. fall in BP, tachycardia, and chest pain.
18
 4 Misoprostol
200mcg,Tab.
5 Oxytocin Uterine contractions and water intoxication
51I.U/ml,Inj.
ALKALIZING AGENT
6 Syp disodium Stomach cramps & flatulence. Over dosage or too
hydrogen citrate rapid
administration can cause metabolic alkalosis
(especially in renal impairment).
ALPHA-1 BLOCKER
7 Tamsulosin 4 mg The most commonly reported side effects are
(for BHP abnormal
*
treatment) ejaculation, influenza-like symptoms, headache,
dizziness, and rhinitis.
AMINOGLYCOSIDE ANTIBIOTICS (BACTERICIDAL)
8 Amikacin 500 mg All aminoglycosides have the potential to induce
vial,Inj. ototoxicity, renal toxicity, and neuromuscular
9 Framycetin Skin blockade. Toxic effects on the eighth cranial
Cream 15 w/w, nerve can result in hearing loss, loss of balance,
20gm Tube or both. They primarily affect auditory function.
10 Framycetin Cochlear damage includes high frequency
sulphate deafness and usually occurs before clinical
impregnated hearing loss. Macular infarction sometimes
dressing leading to permanent loss of vision has been
10 cm*10 cm reported following intravitreous administration.
11 Gentamycin Skin rash, drug fever, headache, paraesthesia,
80 mg/2mlvial, nausea
Inj.
12 Gentamycin Eye/
Ear Drop*

ANALGESICS-ANTIINFLAMMATORY
13 Acetyl Salicylic Acid Generally mild and infrequent but high incidence
Tab.(soluble),350 mg of gastro- intestinal irritation with slight
asymptomatic blood loss, increased bleeding time,
bronchospasm and skin reactions in hypersensitive
patients. Gastro-intestinal hemorrhage

19
14 Acetyl Salicylic Acid(occasionally major) also other hemorrhage (e.g.
Tab. 150 mg subjunctival). Other undesirable effects common
with anti-inflammatory doses; gastrointestinal
discomfort or nausea, ulceration with occult
bleeding (but occasionally major hemorrhage);
hearing disturbances such as tinnitus (leading
rarely to deafness), vertigo, confusion, rarely
edema and blood disorders, particularly
thrombocytopenia.
15 Diclofenac Sodium Upset stomach, nausea, heartburn, diarrhea,
25mg/ml, 3ml constipation, gas, headache, drowsiness, and
amp,Inj. dizziness,
16 Diclofenac Sodium swelling of the hands or feet (edema), sudden or
50mg, tab. unexplained weight gain, hearing changes (such as
17 Diclofenac Sodium ringing in the ears), mental/mood changes,
Gel, 15gm tube difficult/painful swallowing, unusual tiredness may
18 Diclofenac occur. It can cause temporary infertility in women,
Suppository 12.5mg , particularly those who take it regularly. Bone
25mg , and 100 mg marrow depression and renal failure are noted
infrequently. These conditions may be life-
threatening and/or irreversible, if detected too
late. It induces warm antibody hemolytic anemia
by inducing antibodies to Rh antigens. Diclofenac
may disrupt the normal menstrual cycle. Mental
health side effects have been reported. These
symptoms are rare, but exist in significant enough
numbers to include as potential side effects. These
include depression, anxiety, irritability,
nightmares, and psychotic reactions. It does
increase the risk of myocardial
infarction.
19 Ibuprofen 400 mg, Gastric discomfort, nausea and vomiting, though
Tab. less than aspirin or indomethacin, are still the
20 Ibuprofen 200 mg, most common side effects. Gastric erosion and
Tab. occult blood loss are rare. CNS side effects include
headache, dizziness, blurring of vision, tinnitus and
depression. Rashes, itching and other
hypersensitivity phenomena are infrequent.
However, these drugs precipitate aspirin-induced
asthma. Fluid retention is less marked than that
20
 with phenylbutazone. They are not to be
prescribed to pregnant women and should be
avoided in peptic ulcer patient.

ANTI-ACNE
21 Tretinoin 0.025% In patients treated with the recommended daily
cream, 20 g doses of tretinoin the most frequent undesirable
effects are consistent with the signs and
symptoms of the hypervitaminosis A syndrome (as
for other retinoids). Retinoic acid syndrome has
been reported in many acute promyelocytic
leukemia patients (up to 25% in some centers)
treated with tretinoin. Retinoic acid syndrome is
characterized by fever, dyspnoea, acute
respiratory distress, pulmonary infiltrates, pleural
and pericardial effusions, hypotension, edema,
weight gain, hepatic, renal and multi-organ failure.
Retinoic acid syndrome is frequently associated
with hyperleukocytosis and may be fatal.
ANTI-ALLERGIC DRUGS
22 Tab Fexofenadine 120 Sedation, diminished alertness and concentration,
mg* light headedness, motor incoordination, fatigue and
tendency to fall asleep are the most common.
Epigastric distress and headache are also common.
Fexofenadine is teratogenic in animal but not in
humans; caution is nevertheless to be exercised during
pregnancy. Acute overdose produces central
excitation, tremors,muscular incordination,
convulsions, flushing, hypotension, and fever. Death is
due to respiratory and cardiovascular failure.
ANTIAMOEBIC
22 Metronidazole 400mg, Dryness or irritation of the skin may be
Tab.* experienced after application to unbroken skin.
23 Metronidazole Systemic metronidazole therapy may
5mg/ml, 100ml occasionally cause an unpleasant taste in the
Bottle* mouth,furred tongue, nausea, vomiting, gastro-
24 Syp. Metronidazole/ intestinal disturbance, urticaria, angioedema and
metrogyl 200 mg/5ml anaphylaxis. Drowsiness, dizziness, headache,
ataxia, skin rash, pruritis and darkening of urine
21
 have been reported, but rarely.

ANTIANGINAL
25 Glyceryl Trinitrate
0.5mg, Tab. Adverse effects are mostly due to vasodilatation.
26 Tab Isosorbide-5- These includes: fullness in head, headache,
mononitrate* flushing,weakness, sweating, dizziness, fainting,
27 Isosorbide dinitrate and rarely rashes and methemoglobinemia.
5mg, Tab*
28 Monosorbitrate 10 mg
Tab
29 Nitro Glycerin 5mg/l,
5ml amp.

ANTIARRHYTHMICS-LOCAL ANAESTHETICS
30 Lignocaine 2%, 50 ml Occasional local skin irritation may occur.
vial, Inj. Systemic adverse reactions are usually the result
of high plasma concentrations due to high
dosage, rapid absorption or may result from
hypersensitivity, idiosyncrasy or diminished
tolerance on the part of the patient. Such
reactions involve excitatory and/or depressant
actions on the CNS characterized by nervousness,
dizziness, convulsions, unconsciousness and
possible respiratory arrest. Cardiovascular
reactions are depressant and may include
hypotension, myocardial depression, bradycardia
and possibly cardiac arrest.

ANTIASTHMATICS
31 Aminophylline Adverse events are usually a consequence of
0.25g/10ml/amp, Inj. gastrointestinal irritation, stimulation of the
central nervous

22
32 Aminophylline system and effects on the cardiovascular
100mg, Tab. system. Hypotension, arrhythmias and
convulsions may follow intravenous injection,
particularly if the injection is too rapid, and
sudden deaths have been reported.
Hypersensitivity reactions, metabolic
disturbances such as hypokalaemia,
hypophosphataemia, and
hyponatraemia,headache, insomnia, confusion,
restlessness, hyperventilation, anxiety,
vertigo/dizziness, tremor, visual disturbances,
palpitations, tachycardia, cardiac arrhythmias,
hypotension, nausea, vomiting, abdominal pain,
diarrhea, gastro-esophageal reflux,
gastrointestinal bleeding, rash, erythema,
pruritus, urticaria, exfoliative dermatitis may
occur. Higher doses may result in hyperthermia
and extreme thirst.
33 Ephedrine Severe allergic reactions (rash hives itching;
Hydrochloride difficulty breathing; tightness in the chest
30mg/ml,1ml,amp, swelling of the mouth, face, lips, or tongue)
Inj. changes in skin appearance; changes in vision
chest pain difficulty with urination dizziness;
fainting fast or irregular heartbeat loss of
consciousness mood changes nausea
nervousness; numbness in an arm or leg
34 Etophylline 231mg + They have a narrow margin of safety. Dose-
Theophylline 69mg, dependent toxicity includes dyspepsia,
Tab. headache, nervousness, insomnia, agitation,
35 Etophylline 169.4mg flushing, hypotension, delirium, increased
+ Theophylline muscle tone, convulsions, shock, arrhythmia
50.6mg, and even death. The irritant property is
2ml amp, Inj. reflected in gastric pain (with oral), and pain at
site of i.m. injection.

23
The difference between a hospital formulary and a drug list is :

Hospital Formulary:

The hospital formulary is a list of pharmaceutical agents with important pieces of

information which reflects the current clinical views of the medical staff.

The hospital formulary system is a method whereby the medical staff of a hospital with
the help of a pharmacy and a therapeutic committee selects and evaluate medical
agents and their dosage form which are considered to be most useful in patient care.

The hospital formulary system provides the information for procuring, prescribing,
dispensing, and administering drugs under non-proprietary or
Proprietary (brand) names in instances where drugs have both names.

Drug List :

drug List means a list of pharmaceutical products which is available to Network

Participants, Members, physicians, or other healthcare providers for purposes of
providing information about the coverage and tier status of individual pharmaceutical
products.

DURABLE MEDICAL EQUIPMENT PROVIDER.....means a duly licensed durable medical

equipment provider, when operating within the scope of such license.
A ‘‘Participating Durable Medical Equipment Provider’’ means a Durable Medical
Equipment Provider who has a written agreement with Blue Cross and Blue Shield of
llinois or another Blue Cross and/or Blue Shield Plan to provide services to you at the
time services are rendered.

24
A ‘‘Non-Participating Durable Medical Equipment Provider’’ means a Durable Medical
Equipment Provider who does not have a written agreement with Blue Cross and Blue
Shield of Illinois or another Blue Cross and/or Blue Shield Plan to provide services to you
at the time services are rendered.
EARLY ACQUIRED DISORDER.....means a disorder resulting from illness, trauma, injury,
or some other event or condition suffered by a child prior to that child developing
functional life skills such as, but not limited to, walking, talking, or self-help skills. Early
Acquired Disorder may include but is not limited to, Autism or an Autism Spectrum
Disorder and cerebral palsy.

REFERENCES

1. Kozma CM, Reeder CE, Lingle EW. Expanding Medicaid drug formulary coverage. Effects on
utilization of related services. Med Care. 1990 Oct;28(10):963-977.

2. Posey LM. Formularies and quality of care: Pharmacoeconomics drives revisionist thinking. The
Consul- tant Pharmacist.1996 May;11(5).

3. Blumenthal D, Herdman R, eds. Description and Analysis of the VA National Formulary. VA

Pharmacy Formulary Analysis Committee, Division of Health Care Services, Institute of Medicine;
2000.

4. Formulary Management. The Academy of Managed Care Pharmacy’s concepts in managed care
pharma- cy. Academy of Managed Care Pharmacy. Available at: http://www.amcp.org/amcp.ark?
p=AAAC630C. Accessed June 20, 2010.

5. Tanielian T, Harris K, Suárez A, et al. Impact of a Uniform Formulary on Military Health-system

Prescribers: Baseline Survey Results. National Defense Research Institute and Rand Health; 2003.

6. White paper: formulary development at express scripts. Available at: http://www.express-

scripts.org/re- search/formularyinformation/development/formularyDevelopment.pdf. Accessed
June 20,2010.

7. American Society of Health-System Pharmacists. ASHP Statement on Medication Use Policy

Development.
8. Bethesda, MD: American Society of Health-System Pharmacists; draft.

9. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital
settings: prescribing and transcribing 2007. Am J Health-Syst Pharm. 2008. 65: 827-843.

10. American Society of Health-System Pharmacists. ASHP guidelines on the pharmacy and
therapeutics committee and the formulary system. Am J Health-Syst Pharm. 2008; 65:1272-1283.

11. American Society of Health-System Pharmacists. Principles of a sound formulary system. Bethesda,

25
 MD: American Society of Health-System Pharmacists; 2000, 2006.

12. www.cjcp.ca/pdf/CJCP08027e171-e177_mittmann.pdf> Pedersen, C. A., P. J. Schneider, and D. J.

Scheckelhoff. 2008. National Survey of Pharmacy Practice in Hospital Settings: Prescribing and
Transcribing—2007. American Journal of Health-System Pharmacy 65(9):827–43.

13. Rational Pharmaceutical Management (RPM) Plus Program. 2007. Drug and Therapeutics
Committees Training Course. Arlington, Va: Management Sciences for Health.
http://www.msh.org/projects/ rpmplus/Resources/TrainingInitiatives/All-DTC-Training-Guides.
cfm 2004. Assessment of Production Cost and Quality Assurance Processes in the Catholic
Diocesan Hospital Pharmacies of Ghana. Arlington, Va: Management Sciences for Health.

THAN
K YOU

26