Hospital Formulary

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:

1. Procuring medicines
2. Prescribing medicines
3. Dispensing medicines
4. 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:

1. Open formulary
2. Closed or restricted formulary
3. 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:

1. The dose of each ingredient is appropriate for the intended population, and
2. 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:

1. Non-proprietary/generic name
2. Synonyms
3. Available brands
4. Cost
5. Reconstitution
6. Administration
7. Dosage forms
8. Indications
9. Contraindications
10. Precautions
11. Dose
12. Pregnancy-related risk information
13. Adverse effects
14. 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:

1. WHO Formulary
2. British National Formulary (BNF)
3. 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

1. Open → Guide
2. Closed/Restricted → Authorization for non-formulary medicines
3. 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