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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