Transcript Hospital Drug Formulary - Indian Society for Rational

ISRPTCON 2012, Kolkata
Hospital Drug
Formulary
Dr. V. M. Motghare,
Professor and head,
Department of Pharmacology,
SRTR Medical College,
Ambajogai, Maharashtra
Definition:
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Hospital Formulary is a continually revised
compilation of pharmaceuticals including
important ancillary information that reflects the
current clinical judgement of the medical staff.
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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
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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
manual
usage of the formulary
2. Basic information of the drug
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Generic name, dosage form, strength
Indications
Pharmacological action
Precautions
Side effects
Dosage – form, frequency
Instructions
Drug interactions
3. Supplementary information on
each drug
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Price
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Regulatory category
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Storage guidelines
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Patient counselling information
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Brand names
4. Prescribing and dispensing
guidelines
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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
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Use of IV additives
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Prescribing in special situations
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Poisoning and antidotes
6. Other components
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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
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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
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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.
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The hospitals may determine their own size
of the formulary.
9. Type of format
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Loose leaf or Bound
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Printed or Mimeographed
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Indexing and Assigning categories
ESSENTIAL DRUGS
Definition
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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.
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Essential drug list is same as limited drug list.
(Synonymous terms)
Benefits of essential drug list
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More cost effective drug control, management,
purchase, storage, turnover and distribution.
More patients treated per unit cost.
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Improved drug use in terms of safety, simplified
and more efficient drug information including
training to health workers.
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Able to define real health needs and to perform
programme evaluation more effectively.
Benefits of essential drug list
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Easy identification and avoidance of adverse drug
reactions and interactions with fewer drugs.
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Stimulation of local drug formulation and
production depending on the requirement.
Are all the drugs not figuring in essential
drugs list useless or redundant?
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List of essential drugs does not imply that no drugs
outside it are useful.
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These drugs may be more expensive alternatives or
useful only for uncommon ailments.
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May be harmful or hazardous.
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May be irrational fixed dose combination.
Milestones
Essential drugs concept & rational use
Milestones
Essential drugs concept & rational use
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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)
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1975 WHA Resolution 28.66
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1977 First model list of Essential Drug List TRS 615 (250
drugs)
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1978 Technical Discussions WHA and Resolution WHA
31.32
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1981 Establishment of the WHO Action programmed on
Essential Drugs.
Milestones
Essential drugs concept & rational use
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1982 Second revision of WHO Essential Drug List-Title
Changed to “THE USE OF ESSENTIAL DRUGS” (TRS 685)
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1983 Full implementation of the Action Programmed.
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1985 Conference on Rational Use of Drugs in Nairobi
(INRUD)
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1986 WHA39.27 The Rational Use of drugs Resolution.
Milestones
Essential drugs concept & rational use
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1988 Publication of several documents called for in DG’s
Report on the Revised Drugs Strategy .
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1995 Sixth report of the WHO Expert Committee on The use
of Essential Drugs. (WHO TRS 850)
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1997 Seventh report of the WHO Expert Committee on The
use of Essential Drugs. (WHO TRS 867)
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2005 Fourteenth report of the WHO Expert Committee on
The use of Essential Drugs. (WHO TRS 921)
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2007 Fifteenth report of the WHO Expert Committee on
The use of Essential Drugs.
Should the essential drugs be changed
from time to time?
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1977 WHO published the selection of essential
drugs (WHO TRS 615)
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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
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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.
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1996 India for the first time published
National Essential Drugs List
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In 2003, it was revised and renamed as
“National List of Essential Medicines”
(NLEM).
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June 2011 - third National Essential Medicine List
(NEML).
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It contains 348 drugs and 16 Fixed Dose
Combinations.
Guideline for establishing a list of
essential drugs
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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
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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
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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
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Drug that are easy for the patient to take;
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Drugs, pharmaceutical products and dosage forms
with favourable stability under anticipated local
conditions for which storage facilities exist;
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Drugs for which local, reliable manufacturing
facilities exist for its production.
Fixed Ratio Combinations
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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
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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
combination.
improved
by
use
of
the
Fixed Ratio Combinations
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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
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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
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Choice of drugs depends on :
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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
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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
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Formulation as Single compound.
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Ease of administration and compliance.
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Local manufacture and storage.
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Fixed dose combination approved by WHO on the
basis of efficacy, safety, tolerability, compliance
and dose range.
Guideline for selection of
Pharmaceutical dosage form
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Type of dosage form (Tablet, Capsules, SR
preparation) based on kinetic ,bioavailability,
stability and local preference.
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Strength of the drugs (Dose range, pediatric
preparation)
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Exclusion of the drugs (Low solubility,
unpredictable bioavailability, Newer dosage
forms)
Selection of Anti-microbial agents
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Sensitivity of micro organisms.
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Prevalence of type of infection.
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Resistance to Anti microbial agents. (AMA)
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Availability of AMA (Safe, Effective, Cheap)
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Cost of the drugs.
Essential Drug List
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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
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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
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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
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V E D Analysis – according to their criticality in
patient care.
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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
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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
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D – Desirable Drugs (N-Non essential items.)
Constitute 50% of the items. And their nonavailability 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 ….
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E - efficacy
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S - safety
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S - storage and stability.
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E - ease of administration ( dosage form).
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N - need of population.
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T - total cost.
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I - irrational combination to avoid
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A- available
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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”.
“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
THANK YOU !