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
- Categories
of drugs and relevant considerations surrounding the use of the drugs - Brief
description of the PTC, membership, responsibilities and operations - Hospital
regulations governing the prescribing, dispensing and administration of
drugs - Pharmacy
operating procedures: Hours of service, OP prescription policies,
pharmacy charging system, prescription labelling, packaging practices etc - 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
