PREPARATION OF HOSPITAL FORMULARY

PREPARATION OF FORMULARY

·         Formulation is an essential part of hospital pharmacy.

·         It has been a focal point for improving drug therapy in hospitals.

·         Effectiveness of formulary system depends on the abilities of the pharmacist involved with it.

·         Although the majority of formulary decisions are made by Pharmacy and Therapeutic Committee but well planned system provides both structure and flexibility and encompasses both selection of drugs and criteria for drug use.

·         These special features allow for standardization to reduce errors, wastage and required personnel time.

Advantage:

·         To discourage the use of “less than optimal drug therapy”, and

·         To provide generic product list.

o   Generic product selection policies stimulate bio-equivalency comparison which prevents the unnecessary stocking of less than optimal products.

·         Formularies must include cost to provide relative cost data for similar drug products that are generically equivalent.

·         Today new drugs and drug therapies are more complex, so formulary system will rely more upon ‘recommended for use’ criteria for many drugs.

·         A drug that has specific advantages in a small number of patient will be included in the formulary.

Size/Shape of Formulary:

·         The initial step in the preparation of a formulary for any hospital is its size of forrmulary.

·         Although the physical appearance and structure of the formulary play an important influence on its use but

·         elaborate and expensive art work in formulary is of no use, as it is meant for professional use,

·         so it should be visually pleasing, easily readable with

·         proper grammar, correct spelling and with neat designing

·         It is the main point for improving drug therapy in hospitals and is totally depend on the abilities of pharmacist.

CONTENT OF FORMULARY

·         A typical formulary must have the following composition;

1)         Title page

2)         Names & titles of the members of the PTC

3)         Table of contents

4)         Information on hospital policies & procedures concerning drugs

a.      The pharmacy and therapeutic committee of hospital

b.      Objective and operation of the formulary systems

c.       Hospital regulations and procedures for prescribing and dispensing drugs.

d.      Hospital pharmacy services and procedures.

e.       How to use the formulary

5)         Products  accepted for use at hospital

a.      Items added and deleted from the previous edition.

b.      Generic, Brand name cross reference list.

c.       Pharmacologic/therapeutic index with relative cost codes.

d.      Descriptions of formulary drug products by pharmacological therapeutic class.

6)         Appendix

a.      Central service equipment and supply list

b.      Guidelines for calculating pediatrics doses

c.       Schedule of standard drug administration.

Preparation of formulary is a painstaking effort of any hospital to channelize its prescribing efforts. The selected generic drug guides the prescriber and offers comparison with other drugs.

MONOGRAPH OF A DRUG FOR CONTENT OF FORMULARY

·         Although the monograph of each drug is decided by PTC but it should include

o   its generic name formula (if any),

o   action dosage regimen,

o   side effect,

o   precaution

o   contra-indications.

A sample of monograph of drug is nicotinic acid hydrazine (INH) is described below.

Isoniazid (Is nicotinic acid hydrazine)

INTRODUCTION:

·         It is the anti-tubercular drug par excellence, and an essential component of all antitubercular regimens, unless the patient is not able to tolerate it or bacilli are resistant.

·         It is primarily tuberculocidal fast multiplying organisms are rapidly killed, but quiescent ones are only inhibited.

·         It acts on extracellular as well as on intracellular TB(bacilli within macrophage) is equally active in acidic and alkaline medium.

·         It is one of the cheapest anti-tubercular drugs.

·         However, most atypical mycobacteria are not inhibited by INH.

o   It inhibit phospholipid synthesis and damages the cell membrane of AFB.

o   It inhibits synthesis of mycolic acids which are constituent of bacteria cell wall.

o   So cell wall integrity is damaged.

o   Mycolic acid is present only in mycobacteria.

·         At 0.02 mg/ml concentration INH is bacteriostatic while at higher concentration it is bactericidal.

·         It acts on intracellular organism where streptomycin fails.

·         Isoniazid penetrates intracellularly and diffuse into macrophages and necrotic centers and useful in all type of tuberculosis.

 

 

PHARMACOKINETICS

·         INH penetrate all body tissue like tubercular cavities, placenta and meninges and absorbed orally.

·         Mainly it is metabolized in liver and metabolization pathway is acetylation and excreted through urine.

·         Rate of isoniazid acetylation shows genetic variation as follows:

o   Fast Acetylators (30-40% of Indians) t^1/2 of INH 1 hr

o   Slow Acetylators (60-70% of Indians) t^1/2 of INH 3 hr

·         Peripheral neuritis appears to be more common in slow acetylators.

Interactions

·         INH may rise the blood pressure by inhibiting the metabolism of phenytoin, carbamazepine and warfarin.

·         Aluminium hydroxide inhibits INH absorption.

·         It also stimulates appetite in contrast to PAS.

·         Patient condition will improve.

·         Improvement in temperature, cough, and sputum conversion occurs.

·         INH should not be used alone because of the danger of bacterial resistance.

·         When INH used alone the resistance develop in five months.

·         Resistant bacteria take up very little of the drug.

Toxicity

·         INH cause peripheral neuritis, deficiency of vitamin B₆ and hepatitis in aged person may be serious.

·         Retard the formation of GABA by inhibiting the glutamic acid decarboxylase in brain and results convulsions in brain

Contra-indication-Contraindicated in case of Epilepsy, severe renal damage.

 

DISTRIBUTION OF FORMULARY&REVISION OF FORMULARY

·         Hospital formulary is an important written document which contains the list of preparations including important information’s which reflects the current clinical views of medical staff.

·         Formulary is the painstaking effort of any hospital so as to guide medical and paramedical staff.

·         The formulary is very educative and useful to the members of “Health Care Team” and

·         Hence copies of formulary should be placed at each patient care unit, including clinics, out-patient care areas and emergency room.

Revision of Formulary

·         Selected drugs are entered in the formulary but the entry of a new drug is a complex procedure, the members alone are not competent to evaluate each therapeutic agent.

·         Committee take help from various experts for inclusion of specialized drug and

·         Any formulation whose formula is not disclosed cannot be entered in the formulary.

·         The PTC makes certain guidelines for inclusion or deletion of drug in the formulary with the consultation of medical staff.

Revision Requirement and Procedure:

·         Generally for addition, deletion, change in the drug products, removal of drug from the market, change in the hospital policies and procedures the formulary need revision annually.

·         There are two methods for the revision of formulary.

o   One method is to attach a separate sheet to the back cover of formulary books.

o   Second method is by using a different color for the cover of each edition of the formulary

o   Which will help to reduce any confusion between present and past edition.

·         Revision in the formulary should incorporate regular review of selected categories to ensure that

o   Only the most cost effective products are used.

·         Such review may leads to the deletion of certain drugs.

·         During revision and preparation of formulary system,

o   Cost effectiveness and

o   Cost benefit analysis methods are generally used.

SIGNIFICANCE OF HOSPITAL FORMULARY

·         Any prescription either generic/chemical or proprietary name written by the physician is the legal permit to dispense a particular drug.

·         When formulary adopted continuous prescription system, the pharmacist has to obey the prescriber and dispense only the brands prescribed.

·         If the prescriber is not aware about the prescription written in the formulary,

o   The pharmacist should inform him about the same and explain him about the use of drugs from the formulary.

In the present scenario, each and every hospital should adopt a formulary for good health practice and good inventory control measure that provide a wide choice for the physician to fulfill the needs of patients.

Advantages of formulary

·         Therapeutic

·         Economic

·         Educational

·         Rational drug use

Disadvantages of formulary

·         Deprive the physician of his right and privilege to prescribe and obtain the brand of his choice.

Permits the pharmacist to act as the sole judge of whom brands of drugs are to be purchased & dispensed.