ISRPTCON

2012, Kolkata

Hospital Drug
Formulary
Dr. V. M. Motghare,
Professor and head,
Department of Pharmacology,
SRTR Medical College,
Ambajogai, Maharashtra

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

The need for Hospital

Formulary
1

The increasing number of new drugs

manufactured and marketed by drug
companies.
Increasing influence of add: on drugs which
include both scientific and unscientific,
ethical and unethical.
Increasing complexity of untoward effects of
modern potent drugs.
Newer sales promotion strategies of
pharmaceutical industry.
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

 Price

3. Supplementary information on each drug

Regulatory
Storage
Patient
Brand

category

guidelines

counselling information

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
Poisoning

in special situations

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.

Milestones
ential drugs concept & rational us

Essential 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.

Essential drugs concept &

rational use

1982 Second revision of WHO Essential Drug ListTitle 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.

Essential drugs concept &

rational use

1988 Publication of several documents called for in

DGs 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

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

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.

establishing a list of
essential drugs
Drug Committee.
Benefit and safety evaluations.
International Nonproprietary(generic)names.
Quality
Cost.
Local Level of expertise.
Local Health problems.
Benefit risk ratio.

Guideline for
establishing a list of
essential drugs

Preferential
factors
equivalent drugs.

for

evaluating

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
manufacturing
production.

which
local,
facilities exist

reliable
for its

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 DRUGS
Sufficient data efficacy and safety.
Bioavailability Stability, Storage and
comparative 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 Antimicrobial 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

10% OF Total

20% of Total

70% of Total

70% of Total Budget

20% of Total Budget

10% of total Budget

Requires very strict control

Moderate Control

Loose Control

Requires wither no or low

safety stocks

Low Safety Stocks

It requires Hish
safety stocks

Needs maximum follow up

Periodic Follow up

Close Follow up

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
A
B
C

AV
BV
CV

E
AE
BE
CE

D
AD

Cat I items 15
%

BD

Cat II items
40 %

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.

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

THANK YOU !