HOSPITAL
FORMULARY — COMPLETE NOTES
1.
DEFINITION
A hospital formulary is a continuously
revised compilation of medicines, pharmaceutical dosage forms and relevant
information that reflects the current clinical judgment of the medical
staff.
In
simple words:
Hospital formulary = An approved and regularly
updated list of medicines used in a hospital.
It helps healthcare professionals select medicines that
are effective, safe, appropriate and economical for patient
care.
2.
HOSPITAL FORMULARY SYSTEM
The hospital formulary system is a
method by which the medical staff, with the help of the Pharmacy and
Therapeutics (P&T) Committee/Drugs and Therapeutics Committee (DTC),
selects and evaluates medicines and their dosage forms that are most useful for
patient care.
The
hospital formulary provides information for:
- Procuring medicines
- Prescribing medicines
- Dispensing medicines
- Administration of medicines
3.
ORIGIN OF HOSPITAL FORMULARY
- The
first hospital formulary in India
was published in 1968
by the Department of Pharmacy, Christian Medical
College (CMC), Vellore.
- A
hospital formulary for government hospital/teaching institutions was later
published at Government
Medical College, Trivandrum, Kerala.
⭐ Exam point:
1968 → CMC Vellore → First hospital formulary in
India
4.
ADVANTAGES OF HOSPITAL FORMULARY
1.
Promotes rational drug therapy
Helps healthcare professionals select medicines
appropriately based on efficacy, safety and evidence.
2.
Controls drug cost
Avoids unnecessary duplication and use of unnecessarily
expensive medicines.
3.
Provides cost-effective treatment
Helps select medicines that provide good therapeutic
outcomes at reasonable cost.
4.
Promotes evidence-based prescribing
Medicine selection can be based on evidence-based
treatment guidelines.
5.
Standardizes treatment
Reduces unnecessary variation in treatment between
different healthcare professionals.
6.
Improves quality of patient care
Appropriate medicine selection can improve the quality
and safety of treatment.
7.
Helps inventory control
Helps the pharmacy determine which medicines need to be
stocked and in what quantities.
8.
Provides information about available medicines
Physicians can easily know which medicines are available
in the hospital pharmacy.
9.
Easy to use
A good formulary should be:
- Complete
- Concise
- Updated
- Easy to use
10.
Helps healthcare professionals
It acts as a common reference for:
- Medical
staff
- Pharmacy
staff
- Nursing
staff
11.
Reduces treatment variation
Promotes more uniform and standardized treatment
practices.
12.
Facilitates medicine management
The formulary provides a systematic approach to selection,
procurement, storage, distribution and use of medicines.
5.
DISADVANTAGES OF HOSPITAL FORMULARY
1.
Restricts physician choice
The physician may not always be able to prescribe the
particular brand or medicine of their choice.
2.
Limited selection
Only selected medicines may be routinely available in the
hospital.
3.
Risk of inferior-quality selection
If proper selection procedures are not followed, an
inferior-quality product may be selected.
4.
Savings may not reach the patient
Hospitals may purchase medicines in large quantities at
reduced prices, but the reduction in purchase cost may not necessarily be
passed on to the patient or third-party payer.
Easy
memory:
Restriction → Limited choice → Quality risk →
Savings may not reach patient
6.
TYPES OF HOSPITAL FORMULARY
There are three basic types:
- Open formulary
- Closed or restricted formulary
- Incentive-based formulary
6.1
Open Formulary
An open formulary serves mainly as a guide.
- Physician
may prescribe any medicine.
- The
physician is encouraged to use medicines included in the formulary.
Key
point:
Formulary = Guide, not strict restriction.
6.2
Closed or Restricted Formulary
A closed/restricted formulary specifies the medicines
that are routinely covered or permitted.
- Non-formulary
medicines require prior
authorization or special approval.
Key
point:
Non-formulary drug → Authorization required
6.3
Incentive-Based Formulary
An incentive-based formulary is a hybrid between
open and closed formularies.
- Formulary
medicines are preferred.
- Patients
may have to pay a higher
price for non-formulary medicines.
Key
point:
Non-formulary drug → Higher patient cost
7.
MEMBERS INVOLVED IN PREPARATION OF HOSPITAL FORMULARY
The Drugs and Therapeutics Committee
(DTC)/Pharmacy and Therapeutics Committee (P&T Committee) has the
major responsibility for preparing and implementing the formulary.
The committee should contain representatives from the
major stakeholders.
Important
members:
1. Clinicians/Physicians
- Representatives from major specialties such as:
- Medicine
- Surgery
- Pediatrics
- Obstetrics and Gynecology
- Infectious diseases
- General practice
2. Clinical
Pharmacologist
- If available
3. Pharmacist
- Usually Chief/Deputy Chief Pharmacist
4. Nurse
- Usually senior nurse or infection-control nurse
5. Hospital
Administrator
- Represents administration and finance
6. Clinical
Microbiologist
- If available
7. Laboratory
technician/representative
- Where appropriate
8. Medical/Hospital
Records Department representative
⭐ Easy memory:
Doctor + Pharmacist + Nurse + Administrator +
Pharmacologist + Microbiologist
8.
CRITERIA FOR MEDICINE SELECTION
Selection of medicines depends on several factors:
- Pattern
of prevalent diseases
- Treatment
facilities
- Training
and experience of available personnel
- Financial
resources
- Genetic
factors
- Demographic
factors
- Environmental
factors
9.
WHO CRITERIA FOR SELECTION OF MEDICINES
These are important for examination purposes.
1.
Efficacy and safety
Only medicines with adequate evidence regarding:
- Efficacy
- Safety
should be selected.
Evidence should come from appropriate clinical studies
and experience in general use.
2.
Quality
The selected medicine should have adequate quality,
including:
- Appropriate
dosage form
- Adequate
bioavailability
- Stability
- Proper
storage conditions
- Appropriate
conditions for use
3.
Comparison of similar medicines
When two or more medicines are similar, compare them
based on:
- Efficacy
- Safety
- Quality
- Price
- Availability
4.
Total treatment cost
Selection should consider the total cost of
treatment, not merely the unit price of the medicine.
Example:
A medicine costing ₹10 per tablet may actually be more
expensive overall if it requires a longer duration of treatment.
5.
Cost-effectiveness
When medicines have similar therapeutic effects,
selection should be based on cost-effectiveness.
Cost-effectiveness means achieving the desired
therapeutic outcome at a reasonable cost.
6.
Pharmacokinetic properties
Selection may also depend on:
- Absorption
- Distribution
- Metabolism
- Excretion
- Half-life
- Dosing
frequency
7.
Local considerations
Selection may be influenced by:
- Storage
facilities
- Availability
of equipment
- Availability
of suppliers/manufacturers
- Local
hospital requirements
8.
Single-ingredient medicines
Essential medicines should generally be formulated as single
compounds.
Fixed-dose
combinations are acceptable only when:
- The
dose of each ingredient is appropriate for the intended population, and
- The
combination has a proven advantage over the individual medicines given
separately.
The advantage may relate to:
- Therapeutic
effect
- Safety
- Patient
compliance
10.
STEPS IN PREPARATION OF HOSPITAL FORMULARY
Step
1 — Identify common diseases
Identify the most common diseases treated in the hospital
by consulting the different medical departments.
For each disease, identify the appropriate first-choice
treatment using standard treatment guidelines.
⬇️
Step
2 — Expert evaluation
Experts are brought together to identify appropriate
treatments for common health problems.
The WHO Model List of Essential Medicines
can be used as a starting point.
⬇️
Step
3 — Assess hospital capability
Consider:
- Hospital
facilities
- Available
staff
- Training
of staff
- Ability
of staff to safely handle and use specific medicines
⬇️
Step
4 — Prepare draft list
Prepare a draft list of medicines.
Send the draft to different departments for their
comments.
⬇️
Step
5 — DTC/P&T Committee review
The Drugs and Therapeutics Committee considers the
comments and provides feedback.
⬇️
Step
6 — Evidence-based review
Information should be discussed and evaluated using evidence-based
reviews wherever possible.
⬇️
Step
7 — Prepare final formulary
After final selection, prepare the final list.
For each medicine, prepare an appropriate drug
monograph.
11.
CONTENTS OF DRUG MONOGRAPH
A drug monograph contains important information about
each medicine.
Main
contents:
- Non-proprietary/generic name
- Synonyms
- Available brands
- Cost
- Reconstitution
- Administration
- Dosage forms
- Indications
- Contraindications
- Precautions
- Dose
- Pregnancy-related risk information
- Adverse effects
- Drug interactions
Easy
sequence:
Name → Synonyms → Brands → Cost → Reconstitution
→ Administration → Dosage form → Indication → Contraindication → Precaution →
Dose → Pregnancy → ADR → Interactions
12.
MANAGING A FORMULARY — ADDING AND DELETING DRUGS
A formulary should be actively managed
rather than continuously expanded.
When
adding a new medicine:
The committee should compare it with existing medicines
regarding:
- Efficacy
- Safety
- Convenience
- Cost
When
deleting a medicine:
If a new medicine has:
- Better
efficacy
- Better
safety
- Lower
price
then serious consideration should be given to deleting
the older medicine.
Why?
If the new medicine is better, there may be little reason
to continue keeping the less useful medicine.
Important
principle:
Addition of a new medicine should trigger a
review of existing medicines for possible deletion.
Otherwise, the formulary may become unnecessarily large.
13.
FORMULARY MANAGEMENT PROCESS
The formulary management process involves different
groups.
Main
process:
Pharmacy Staff
↓
Medical Staff
↓
Professional Staff
↓
Medical Executive Committee / Health System Board
↓
P&T Committee
↓
Drug Review Panel
↓
Medication Use Review
↓
Safety Committee
↓
Medical and Hospital Staff Notification
P&T
Committee responsibilities:
- Review
medicines
- Evaluate
medicines
- Make
recommendations
- Formulate
policies
- Implement
formulary decisions
14.
MAINTAINING A FORMULARY
A formulary must be regularly reviewed and
updated.
Important
points:
1. A
formulary may become a collection of older or less-effective medicines
if not properly maintained.
2. The
entire formulary should be reviewed periodically, commonly every 2–3
years.
3. Medicines
within each therapeutic class should be systematically evaluated.
4. New
non-formulary medicines should be compared with existing medicines.
5. Requests
for:
- Addition of new medicines
- Deletion of old medicines
should be reviewed.
6. Therapeutic
classes should undergo systematic review.
7. Medicine-use
problems should be identified and resolved.
8. All
DTC decisions should be documented/minuted.
15.
IMPROVING ADHERENCE TO A FORMULARY
A well-maintained formulary does not
automatically ensure that prescribers will follow it.
Therefore, hospitals should use specific methods to
improve adherence.
1.
Review non-formulary medicine requests
All requests for non-formulary medicines should be
reviewed.
Possible actions include:
- Add
the medicine to the formulary
- Educate
the prescriber about its non-formulary status
- Restrict
or prohibit its use when appropriate
2.
Restrict non-formulary drug samples
The use of non-formulary drug samples
within the hospital should be controlled or prohibited according to hospital
policy.
3.
Therapeutic interchange
Establish:
- Procedures
- Approved
drug lists
for therapeutic interchange/substitution.
4.
Easy access to the formulary
Make the formulary easily available.
Copies may be kept:
- At
drug-ordering locations
- In
clinical departments
- In
pocket manuals/reference materials
5.
Involve medical staff
Medical staff should participate in formulary
decisions.
This increases acceptance and adherence.
6.
Communicate formulary changes
All important formulary changes should be clearly
communicated to:
- Doctors
- Pharmacists
- Nurses
- Other
hospital staff
7.
Establish procedures for clinical trials
Clear procedures should be established for clinical
trials involving non-formulary medicines.
⭐ Easy memory:
Review → Restrict samples → Therapeutic
interchange → Easy access → Involve doctors → Communicate changes → Clinical
trials
16.
EXAMPLES OF FORMULARIES
Standard
references:
- WHO Formulary
- British National Formulary (BNF)
- Indian National Formulary (INF)
Hospital-specific
formularies in India:
Examples include:
- Kasturba Hospital, Manipal
- Christian Medical College Hospital,
Vellore
- KLE Hospital, Belgaum
17.
ROLE OF PHARMACIST IN HOSPITAL FORMULARY
The pharmacist has a key role in preparation,
implementation and maintenance of the hospital formulary.
1.
Member of DTC/P&T Committee
The pharmacist participates in the DTC/P&T Committee
and helps develop:
- Policies
- Procedures
- Medicine-selection
criteria
- Drug-use
policies
2.
Preparation of formulary
The Chief Pharmacist has primary
responsibility for the preparation of the hospital formulary, in coordination
with the appropriate committee and medical staff.
3.
Procurement and supply
With the advice and guidance of the DTC/P&T
Committee, the pharmacist should ascertain:
- Quantity required
- Source of supply
of drugs, chemicals, biological products and
pharmaceutical preparations used for diagnosis and treatment.
4.
Ensure drug quality
The pharmacist should ensure that drug quality is
not compromised because of economic considerations.
Important
point:
Low price should not be the reason for selecting
an inferior-quality medicine.
5.
Promote rational drug use
The pharmacist helps ensure that medicines are:
- Appropriate
- Safe
- Effective
- Properly
stored
- Properly
supplied
- Used
according to hospital policy
18.
GUIDELINES FOR HOSPITAL FORMULARY
1.
Formation of P&T Committee
The governing body of the hospital should appoint a Pharmacy
and Therapeutics Committee consisting of appropriate physicians and
pharmacists.
2.
Define purpose and scope
The medical staff should define:
- Purpose
- Organization
- Functions
- Scope
of the hospital formulary system.
3.
Develop policies and procedures
The P&T Committee should develop policies regarding:
- Appraisal
- Selection
- Procurement
- Storage
- Distribution
- Use
- Safety
of medicines.
4.
Protect physician's professional judgment
The system should maintain the responsibility and
professional judgment of the physician.
5.
Use generic names
Medicines should be included in the formulary using their
non-proprietary/generic names, even though proprietary/brand
names may continue to be used in clinical practice where appropriate.
6.
Inform nursing personnel
Nursing staff should be informed in writing about:
- The
existence of the formulary
- Procedures
governing its operation
7.
Avoid inappropriate use of "substitution"
The terms substitute/substitution should
be used carefully because they may imply unauthorized replacement of one drug
with another.
8.
Inform staff about changes
Medical staff should be informed about changes in:
- Formulary
contents
- Policies
- Working
procedures
9.
Non-formulary and investigational drugs
There should be procedures for evaluating requests for:
- Non-formulary
medicines
- Investigational
medicines
10.
Pharmacist's responsibility
The pharmacist, with advice from the DTC/P&T
Committee, should ascertain the:
- Quantity
- Source
of supply
of drugs and pharmaceutical preparations used in the
hospital.
11.
Proper labeling
Drug containers should be properly labeled with
the non-proprietary/generic name of the contents.
⭐ COMPLETE HOSPITAL FORMULARY
— ONE-PAGE REVISION
Definition
Continuously revised list of medicines and dosage
forms approved/used by a hospital.
Purpose
Procurement + Prescribing + Dispensing +
Administration
First
hospital formulary in India
1968 → CMC Vellore
Advantages
Rational therapy + Cost control + Evidence-based
prescribing + Standardization + Inventory control + Better quality of care
Disadvantages
Restricts choice + Limited brands + Possible
quality risk + Savings may not reach patient
Types
- Open → Guide
- Closed/Restricted → Authorization for
non-formulary medicines
- Incentive-based → Higher cost for
non-formulary medicines
Main
committee
DTC/P&T Committee
Members
Doctors + Pharmacist + Nurse + Administrator +
Clinical Pharmacologist + Microbiologist
Medicine
selection
Efficacy + Safety + Quality + Cost + Availability
+ Pharmacokinetics + Local factors
Preparation
Disease identification → Expert evaluation →
Hospital capability → Draft list → Department comments → DTC review → Evidence
review → Final list → Drug monographs
Drug
monograph
Generic name + Synonyms + Brands + Cost +
Reconstitution + Administration + Dosage form + Indications + Contraindications
+ Precautions + Dose + Pregnancy + ADRs + Interactions
Formulary
management
Add appropriate drugs + Delete unsuitable/old
drugs + Compare therapeutic alternatives
Maintenance
Periodic review + Therapeutic-class review +
Add/delete medicines + Identify medicine-use problems + Document DTC decisions
Improving
adherence
Review non-formulary requests + Restrict samples
+ Therapeutic interchange + Easy access + Medical staff involvement +
Communicate changes + Clinical-trial procedures
Examples
WHO Formulary + BNF + Indian National Formulary +
Hospital-specific formularies
Pharmacist's
role
DTC participation + Formulary preparation +
Procurement + Quantity/source determination + Quality assurance + Rational drug
use
