Hospital Formulary

Hospital Formulary


       Organization and contents of a hospital formulary

       Necessity of having a hospital formulary


After completion of this lecture, student will be able to:

       Describe the organization and contents of a hospital formulary

       Explain the necessity of having a hospital formulary



Hospital formulary system is an ongoing process where hospital medical staff with the help of Pharmacy and therapeutics committee, selects and evaluates from among the numerous drug products available in the market place, those it considers to be most useful for patient care

Formulary Content and Organization

Primary Objectives

To provide the hospital staff with the information such as:

1. Drug products approved for use by the PTC

2. Therapeutic information about each products

3. Hospital policies and procedures governing the use of drugs

4. Special information such as- drug dosing rules, abbreviations, sodium content of various formulary items, nomograms, etc

Three Main Parts of Formulary

       Part I - Information on hospital policies and procedures concerning drugs

       Part II - Drug products listing

       Part III  - Special information

Part I - Information on hospital policies and procedures concerning drugs

  1. Categories of drugs and relevant considerations surrounding the use of the drugs
  2. Brief description of the PTC, membership, responsibilities and operations
  3. Hospital regulations governing the prescribing, dispensing and administration of drugs
  4. Pharmacy operating procedures: Hours of service, OP prescription policies, pharmacy charging system, prescription labelling, packaging practices etc
  5. Information on using the formulary: How the formulary entries are arranged, reference to the sources for detailed information

Part II: Drug Products Listing

Formulary item entries:                                              

1.       Alphabetically by generic name


2.  Alphabetically within therapeutic class


3. Combination of two systems: the drugs are arranged in the alphabetical order plus special sections such as dermatological, diagnostic etc

Part III: Special information

       Table of equivalent dosages of similar drugs (corticosteroids)

       Abbreviations used in hospital

       Calculation of doses for elderly and pediatrics

       List of items available from central supply

       List of items in emergency cart

       Dosing guides for renal impaired

       Poison antidote charts

       Prescription blanks, model ADR report forms, formulary request forms

       Drug interaction lists, diagnostic tests, etc

Preparation of the formulary

       Prime responsibility of PTC

       Through the  chief pharmacist

       Decisions to taken

1.  What type of publication will best suit?

       Own formulary, drug list or purchased formulary

2.  Formulate a series of rules or guidelines to evaluate drugs for admission to the formulary or the list of drugs

3. In case of formulary – decision on the possible contents

       Prescription writing -

       Use of drugs -

       Normal laboratory values -

       Dose calculation for pediatrics

       Pharmacological index

4. Type of format of formulary:


       Loose leaf or bound

       Printed or mimeographed/photocopies

       Categorizing and indexing

Guiding Principles for the Admission or Deletion of Drugs

       Clinical value of the drug is proven based on the experience by the general or the specialists

       Drug is recognized by the FDA/WHO

       Dependable manufacturer having reputation of supporting research activities

       No secret compositions or ingredients

       No multiple ingredient products in case the single ingredient in it can provide the same therapeutic benefit

Infection Control Committee


The infection control committee (ICC) provides leadership and act as a clearing house of infection for the hospital

Constitution of ICC

       Chaired by a physician with training and interest in hospital epidemiology and infection prevention

       Other members include:

a)      Microbiologist

b)      Surgeon

c)       Representatives from operation theatres, central sterile supply department, and ICU

d)      Infection control practitioner

e)      Pharmacist

Role of ICC:

          To prevent, identify and control nosocomial infections from the community brought into hospital.

          The committee sets infection control policy and involved in






  Responsibilities of ICC

       Development of written standards for hospital sanitary and sepsis

       Development and promotion of procedures and techniques for meeting the standards and monitoring compliance with them

       Development and implementation of a system for  reporting and evaluating data concerning infection in the hospital patients and personnel population

Role of Pharmacist:

       Actively participate in the affairs of the ICC

       Establish and operate an antibiotic use review programme and improve quality of antibiotic therapy

       Develop and conduct continuous education  programme  for hospital staff concerning anti-microbial drug products and their use

       Assure  the  microbiological integrity of all parts distributed by the pharmacy

Composition of the IEC (ICMR Guidelines 2000)

       Multi-disciplinary, multi- sectorial

       Minimum 5 members, preferably not more than 12-15, (Balanced age & gender distribution)

       Quorum of 5 at least (50%)

       Chairperson from outside the Institute

       Member Secretary from within institution

       Suggested mix: Basic medical scientists, clinicians, legal expert, social scientist/ NGO rep, philosopher/ethicist/theologian, Lay member

       Additional members co-opted as per need ( specialists, specific communities, patient groups etc)


       Authority by which appointed

       Membership requirements

       Terms of Reference

       Conditions of appointment

Responsibilities of an IEC

       To protect the dignity, rights and well-being of potential research participants

       To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs

       To assist in the development and education of a research community responsive to local health care requirements

An IEC should demonstrate





Review Procedures Mandate

       Review new proposals

      Risk / benefit assessment

      Consent procedures, confidentiality, justice issues to be looked into

       Evaluate progress of ongoing studies ( annual, more frequently if required);

       (see that no harm is caused to research subjects)

       Assess Final Reports ( look at post-trial benefit issues, commercialization etc)

    NOTE: IEC should have SOPs for each of the above Multi-center Trials

Basic Ethical Review Procedures

       Scientific review must be done before ethical review

       All biomedical research proposals involving human subjects must be reviewed and cleared by an appropriately constituted IEC or IRB, before initiating the studies

       Review only in formal meetings and not through circulation

       IEC should also continuously monitor the study to ensure that ethical guidelines are followed    

       Submission of Application (Deadlines)

       Decision making process

       Interim Review

       Record Keeping

       Special Considerations

Review Procedures What to look for in an application


       Project protocol in full (justification for study, objectives, methods, I/E criteria, recruitment procedures, statistical considerations, Consent Forms/procedures, Safety information on interventions to be used)

       CV of investigator(s); Institutional facilities

       Source of funding for study; agreements relating to publication of results

       Confidentiality procedures

       Data  Handling Procedures

       Procedures for handling adverse events

       Proposed arrangements for compensation/ reimbursements

       Clearances from Regulatory Authorities

       Willingness to comply with national/international GCP protocols

       Statement on probable ethical issues, and how these will be addressed

Review Procedures Decision Making Process

       Decision by consensus, to be communicated in writing, and in detail

       Conflicts of interest to be addressed, if any

       Reasons for decision to be recorded

       Reversing a decision or discontinuing a trial possible, if good & sufficient reasons exist

       Consider any amendments to protocol, adverse events, new information likely to influence study etc

       Investigator &/or patient /interested parties may be asked for inputs

       Investigator &/or patient /interested parties may be asked for inputs

       Subject experts may be invited, and opinions recorded

       Decisions to be taken only in the absence of non-members

Review Procedures Record Keeping

Documents to be dated, filed & preserved

       Constitution & composition of the IEC

       CVs of all members

       SOPs of the IEC

       National & International Guidelines

       Copies of protocols submitted to IEC

       All correspondence with IEC members & investigators reg: application, decision and follow-up

       Agenda of all IEC meetings

       Minutes of all IEC Meetings with Chairperson’s signature

       Copies of decisions communicated to applicants

       Record of notifications issued for premature termination of a study with reasons

       Final Reports of studies with microfilms , CDs and video recordings

       Records to be maintained for at least 15 years ( if not permanently), after completion/termination of study

Review Procedures Special Considerations

       Research involving children, pregnant & lactating women

       Vulnerable subjects

       Those with diminished autonomy

       Commercialization of research

       International collaboration


       Hospital formulary system is an ongoing process where hospital medical staff with the help of  Pharmacy and therapeutics committee, selects and evaluates from among the numerous drug products available in the market place

       Primary objectives are Drug products approved for use by the PTC Therapeutic information about each products

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