Hospital Formulary

Hospital Formulary

Content

•       Organization and contents of a hospital formulary

•       Necessity of having a hospital formulary

Objective

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

Introduction

Definition:

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

                                    or

2.  Alphabetically within therapeutic class

                                    or

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:

•       Size

•       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

Introduction

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

•          Planning 

•          monitoring

•          evaluating

•          updating

•          education

  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)

Appointment

•       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

•          Competence

•          Efficiency

•          Independence

•          Consistency

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

•       Format

•       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

Summary

•       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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