Hospital Drug Formulary

Dr. V. M. Motghare,Professor and head,

Department of Pharmacology,SRTR Medical College,

Ambajogai, Maharashtra

ISRPTCON 2012, Kolkata

Definition:  Hospital Formulary is a continually

revised compilation of pharmaceuticals including important ancillary information that reflects the current clinical judgement of the medical staff.

Formulary system is method whereby the medical staff of an institution, working through the PTC, evaluates, appraises, and selects from among the numerous available drug entities & drug products those that considered most useful in patient care.

The need for Hospital Formulary

1 The increasing number of new drugs manufactured and marketed by drug companies.

2 Increasing influence of add: on drugs which include both scientific and unscientific, ethical and unethical.

3 Increasing complexity of untoward effects of modern potent drugs.

4 Newer sales promotion strategies of pharmaceutical industry.

5 The public interest in getting possible health care at lowest possible cost.

PREPARATION OF HOSPITAL

FORMULARY

1. Introductory information

Acknowledgement

List of abbreviations

Intended usage of the formulary manual

2. Basic information of the drug Generic name, dosage form, strength Indications Pharmacological action Precautions Side effects Dosage – form, frequency Instructions Drug interactions

3. Supplementary information on each drug

Price Regulatory category Storage guidelines Patient counselling information Brand names

4. Prescribing and dispensing guidelines

Principles of prescription writing Name and address of the patient Prescribed drug should be written in

formulary terminology Strength of prescribed medication

must be given in accepted metric system.

Correct dispensing guidelines Prevention and reporting of ADRs

5. General drug use advice

Use of IV additives

Prescribing in special situations

Poisoning and antidotes

6. Other components

Formulas for various diagnostic stains, diagnostic aids

Table of common Lab-values Posological tables Index of the drugs included in the

formulary Metric units Indexes(by generic name, brand name,

therapeutic category)

7. The Format

Pharmacist decides the format before commencing work on printing and publishing in the hospital.

He has to collect formularies of some leading hospitals as well as their format.

Copies of finally published formulary may be sent to bodies like directorate general of health services, Govt of India, PCI etc.

8. Size It is sufficiently small in size so that it

could be easily carried by clinicians, nurses etc, in the pockets of their uniform or lab coats.

The hospitals may determine their own size of the formulary.

9. Type of format

Loose leaf or Bound

Printed or Mimeographed

Indexing and Assigning categories

ESSENTIAL DRUGS

Definition Essential drugs are those that satisfy the

health care needs of majority of the population and therefore should be available at all the times in adequate amounts and in appropriate dosage forms.

Essential drug list is same as limited drug list. (Synonymous terms)

Benefits of essential drug list

More cost effective drug control, management, purchase, storage, turnover and distribution. More patients treated per unit cost.

Improved drug use in terms of safety, simplified and more efficient drug information including training to health workers.

Able to define real health needs and to perform programme evaluation more effectively.

Benefits of essential drug list

Easy identification and avoidance of adverse drug reactions and interactions with fewer drugs.

Stimulation of local drug formulation and production depending on the requirement.

Are all the drugs not figuring in essential drugs list useless or redundant? List of essential drugs does not imply that

no drugs outside it are useful.

These drugs may be more expensive alternatives or useful only for uncommon ailments.

May be harmful or hazardous.

May be irrational fixed dose combination.

MilestonesEssential drugs concept & rational use

MilestonesEssential drugs concept &

rational use 1970 Concept of essential drugs (was Launched

and milestone in the field of health policy, selection of 200-250 essential drugs & odd drugs which would be sufficient to cater to 90% of the morbidity in the countries and to do it at reasonably low cost)

1975 WHA Resolution 28.66

1977 First model list of Essential Drug List TRS 615 (250 drugs)

1978 Technical Discussions WHA and Resolution WHA 31.32

1981 Establishment of the WHO Action programmed on Essential Drugs.

1982 Second revision of WHO Essential Drug List-Title Changed to “THE USE OF ESSENTIAL DRUGS” (TRS 685)

1983 Full implementation of the Action Programmed.

1985 Conference on Rational Use of Drugs in Nairobi (INRUD)

1986 WHA39.27 The Rational Use of drugs Resolution.

MilestonesEssential drugs concept &

rational use

1988 Publication of several documents called for in DG’s Report on the Revised Drugs Strategy .

1995 Sixth report of the WHO Expert Committee on The use of Essential Drugs. (WHO TRS 850)

1997 Seventh report of the WHO Expert Committee on The use of Essential Drugs. (WHO TRS 867)

2005 Fourteenth report of the WHO Expert Committee on The use of Essential Drugs. (WHO TRS 921)

2007 Fifteenth report of the WHO Expert Committee on The use of Essential Drugs.

MilestonesEssential drugs concept &

rational use

Should the essential drugs be changed from

time to time? 1977 WHO published the selection of

essential drugs (WHO TRS 615)

Regular revision of the list (1979,1982,1985-latest 2005 and 2007– 15 model List-WHO-TRS 946),and March 2009-16th model list/EML-child

The current WHO “Model List of Essential Medicines” is revised in March, 2011 and is the 17th edition for adults with 23 FDCs and 3rd edition for children.

1996 India for the first time published National Essential Drugs List

In 2003, it was revised and renamed as “National List of Essential Medicines” (NLEM).

June 2011 - third National Essential Medicine List (NEML).

It contains 348 drugs and 16 Fixed Dose Combinations.

Guideline for establishing a list of

essential drugs Drug Committee. Benefit and safety evaluations. International Non-

proprietary(generic)names. Quality Cost. Local Level of expertise. Local Health problems. Benefit risk ratio.

Guideline for establishing a list of

essential drugs Preferential factors for evaluating

equivalent drugs.

When two or more drugs are therapeutically equivalent, preference should be given to:-

The drug which has the most thoroughly investigated on therefore,best understood with respect to its beneficial properties and limitations;

Guideline for establishing a list of

essential drugs The drug posscessing clinical utility for

the treatments of more than one condition or disease;

The drug with the most favourable pharmacokinetic properties.e.g.,to improve compliance, to minimize risk in various pathophysiological status etc.

Drugs that are in a dosage form that is easy for the health staff to dispense or easily and safely administrated to the patient;

Guideline for establishing a list of

essential drugs Drug that are easy for the patient to take;

Drugs, pharmaceutical products and dosage forms with favourable stability under anticipated local conditions for which storage facilities exist;

Drugs for which local, reliable manufacturing facilities exist for its production.

Fixed Ratio Combinations

Fixed ratio combinations are only acceptable if one or more of the following considerations are satisfied.

The concomitant value of more than one drug is clinically documented.

The therapeutic benefit of the combination is greater than the sum of each of the individual components.

Fixed Ratio Combinations

The combination is safer than is the use of an individual drug.

The cost of the combination product is less than the sum of the individual components.

Compliance is improved by use of the combination.

Fixed Ratio Combinations

Sufficient drug ratios are available to permit dosage adjustments that are satisfactory for use by the majority of the population.

Periodic review of drug list

The essential drug list may need to reviewed yearly or whenever necessary, to incorporate significant new therapeutic advances and information.Generally new drugs should be introduced only if they offer distinct advantages over drugs previously selected.If, on the basis of new information, drugs already on the list are found to no longer posses a favourable benefit/risk ratio, they should be replaced by safer drugs.

Criteria for selection of

Essential Drugs Choice of drugs depends on :

Pattern of prevalent diseases Treatment facilities Training and experience of health personnel Financial Resources Other factors – Genetic, Demographic,

Environmental.

Criteria for selection of Essential Drugs

WHICH DRUGSSufficient data – efficacy and safety.Bioavailability – Stability, Storage andcomparative Pharmacokinetic data.

If two drugs with similar pharmacokinetic profile is available , Select the drug having good relative efficacy, safety, quality, cost of total drug therapy, availability ,cost benefit ratio, local-regional manufactures, Indigenous – traditional drugs.

Criteria for selection of

Essential Drugs Formulation as Single compound.

Ease of administration and compliance.

Local manufacture and storage.

Fixed dose combination approved by WHO on the basis of efficacy, safety, tolerability, compliance and dose range.

Guideline for selection of Pharmaceutical

dosage form Type of dosage form (Tablet, Capsules, SR

preparation) based on kinetic ,bioavailability, stability and local preference.

Strength of the drugs (Dose range, pediatric preparation)

Exclusion of the drugs (Low solubility, unpredictable bioavailability, Newer dosage forms)

Selection of Anti-microbial agents

Sensitivity of micro organisms.

Prevalence of type of infection.

Resistance to Anti microbial agents. (AMA)

Availability of AMA (Safe, Effective, Cheap)

Cost of the drugs.

Essential Drug List Who should prepare it? How many drugs?

(WHO Model list, National, regional level, Hospital and primary health centre)

Which drugs? (effective, safe, cheap, for common ailments)

Revision and updating of the list yearly.

Inventory Control Objectives

Maximum customer services. Minimum inventory investment. Low cost plant operation. ABC Analysis:-(Always better control

technique.) A Item – Costly items (FEW) B Item – Neither costly nor cheap C Item - Comparatively cheaper in cost

Classification of Drugs ABC analysis of drugs.

Base on their cost and expenditure. Category A – 10% of the total items

consume 70% of the budget. Category B – 20% of the total items

consumes 20% of the budget. Category C – 70% of the total items

consumes 10% of the budget.

No A ITEMS B ITEMS C ITEMS

1 10% OF Total 20% of Total 70% of Total

2 70% of Total Budget 20% of Total Budget 10% of total Budget

3 Requires very strict control Moderate Control Loose Control

4 Requires wither no or low safety stocks

Low Safety Stocks It requires Hish safety stocks

5 Needs maximum follow up Periodic Follow up Close Follow up

6 Handled by senior officers (AP or Prof)

Handled by middle Management (Pharmacist

cl-II)

Handle by Pharmacist

Classification Of Drugs V E D Analysis – according to their

criticality in patient care.

V – Vital drugs. – 10% of the total , they are vital lifesaving drugs and their absence cannot be accepted. They have got to be administered to the patients. No drugs are available as substitutes for these items. Therefore every effort has to be made, at whatever cost to avoid out-of stock position for any of these items.

Classification Of Drugs E – Essential drugs – Constituting 40% of the

total items. And their absence can be tolerated for short stretches of time. They could be made available within a day or two and alternative medicines made available for use in their place.

Classification of Drugs D – Desirable Drugs (N-Non essential

items.) Constitute 50% of the items. And their non-availability can be tolerated for longer period of time. They may be required for treatment of chronic and less serious patients.

Combination Of A B C And V E D Analysis

V E D

A AV AE AD Cat I – items 15 %

B BV BE BD Cat II – items 40 %

C CV CE CD Cat III – items 45 %

Take Home Message ….

E - efficacy S - safety S - storage and stability. E - ease of administration ( dosage form). N - need of population. T - total cost. I - irrational combination to avoid A- available L - listing regularly ( updating)

Take home message ….

“Essential Drug Concept Is

Not A Short Cut To Escape

From Therapeutic Jungle,

But To Choose, Use, Store,

The Right Kind Of Hidden

Treasure In It”.

THANK YOU !

“The desire to take medicines is one feature which distinguishes man, the animal from his fellow creatures. It is one of the most serious difficulties with which we have to contend”

William Osler

1891