Essential Drug List &
Rational Use of Drug
Presented By- Santu
The concept of essential medicines
A limited range of carefully selected essential
drugs leads to
Better health care
Better drug management
Definition of essential medicines
Essential medicines are those that satisfy the
priority health care needs of the population at
History of the WHO Model List
of Essential Drugs
1977 First Model list published, ± 200 active
List is revised every two years by WHO Expert
April 2003 revised Model list contains 315 active
2007, a separate list for children up to 12 years
Latest, The 18th edition for adults and the 4th
edition for children were released in April 2013
Number of countries with a national list
of essential medicines
National Essential Drugs List
< 5 years (127)
> 5 years (29)
No NEDL (19)
156 countries with EDL
1/3 within 2 years
3/4 within 5 years
Full description of essential drugs
(Expert Committee Report, April 2002)
Definition: Essential medicines are those that satisfy the
priority health care needs of the population
Selection criteria: Essential medicines are selected with
due regard to disease prevalence, evidence on efficacy and
safety, and comparative cost-effectiveness
Purpose: Essential medicines are intended to be available
within the context of functioning health systems at all times, in
adequate amounts, in the appropriate dosage forms, with
assured quality, and at a price the individual and the community
Implementation: The implementation of the concept of
essential medicines is intended to be flexible and adaptable to
many different situations; exactly which medicines are regarded
as essential remains a national responsibility.
The Essential Medicines Target
All the drugs
in the world
National list of
Levels of use
National List of Essential
Medicines of India
The first National List of Essential Medicines of India was
prepared and released in 1996.
The list was subsequently revised in 2003.
2011, publication of revised list containing 348 drugs.
In comparison to NLEM 2003, number of medicines deleted
is 47 and 43 medicines was added.
3 category included
S → Secondary
T → Tartiary
o P,S,T containing 181 drugs
o S,T containing 106 drugs
o T containing 61 drugs.
The WHO Model List of Essential Medicines is a
model product, model process and public health
Model product: list of essential drugs with information
Core list: minimum drug needs for a basic health care
system, listing the most cost-effective drugs for priority
conditions (selected on the basis of burden of disease
and potential for safe and cost-effective treatment).
Complementary list: essential drugs for priority diseases
which are cost-effective but not necessarily affordable or
for which specialised health care facilities may be
needed; and essential drugs for less frequent diseases
Seven steps to get a new medicine on
the WHO Model List of Essential Drugs
1. Identification of public-health need for a medicine
2. Development of the medicine; phase I - II - III trials
3. Regulatory approval in a number of countries
> Effective and safe medicine on the market
4. More experience under different field circumstances; post-marketing
5. Price indication for public sector use
6. Review by WHO disease programme; define comparative
effectiveness and safety in real-life situations, comparative cost-
effectiveness and public health relevance
> Medicine included in WHO treatment guideline
7. Submission to WHO Expert Committee on Essential Drugs
> Medicine included in WHO Model List
PROCESS ADOPTED FOR REVISION OF
NLEM India (2011)
National List of Essential Medicines 2003
Consultation meetings with Experts
Deliberation on Evidence based criteria for addition and deletion of
medicines from the NLEM
Therapeutic area wise group discussion
(Group composition: Clinicians, Pharmacologists, Pharmacists,
Scientists and Regulators)
REVISION PROCESS contd…
Presentation by groups in open house discussion
Deliberations/ discussion and reasoning for additions/
Draft recommendations for NLEM
Consideration and adoption of NLEM by the Core
WHO Model List of Essential
WHO model formulary,
National Formulary of India
2010 (Pre print Version),
Textbooks of Pharmacology,
Scientists, Senior Residents,
Junior Residents and PhD
Scholar of Dept of
Pharmacology, AIIMS, New
Content of EDL
1.1 General anaesthetics and oxygen
1.2 Local anaesthetics
1.3 Preoperative medication and sedation for short-term procedures
2 Medicines for pain and palliative care
2.1 Non-opioids and non-steroidal anti-inflammatory drugs (NSAIDs)
2.2 Opioid analgesics
2.3 Medicines for other common symptoms in palliative care
3 Antiallergics and medicines used in anaphylaxis
4 Antidotes and other substances used in poisonings
6 Anti-infective medicines
6.3 Antifungal medicines
6.4 Antiviral medicines
6.5 Antiprotozoal medicines
7 Antimigraine medicines
7.1 For treatment of acute attack
7.2 For prophylaxis
Hormones, other endocrine medicines and cont
Vitamins and minerals
Medicines for diseases of joints
Ear, nose and throat medicines in children
Rational use of Drug
The rational use of drugs requires that patients receive medications
appropriate to their clinical needs, in doses that meet their own individual
requirements for an adequate period of time, and at the lowest cost to them
and their community.
WHO conference of experts Nairobi 1985
appropriate drug considering efficacy, safety, suitability for the
patient, and cost
appropriate dosage, administration, duration
correct dispensing, including appropriate information for patients
patient adherence to treatment
Examples of Irrational Drug use
Prescribing drugs of no proven value.
Unnecessary prescribing for self limiting
Over dosing and under dosing.
Prescribing costly drugs.
Using injections when oral drugs would sufficient.
Why does irrational use continue?
Very few countries regularly monitor drug use
They have insufficient funds.
They lack of awareness.
There is insufficient knowledge of concerning the
cost-effectiveness of interventions.
Many Factors Influence Use of Medicines
Strategies to Improve Use of Drugs
– Providers and patients
Guide clinical practice
– Information systems
– Drug supply / lab capacity
– Market or practice controls
Inform or persuade
– Health providers
Use of Medicines
Goal: to inform or persuade
Training for Providers
Continuing in-service medical education (seminars, workshops)
Face-to-face persuasive outreach e.g. academic detailing
Clinical supervision or consultation
Clinical literature and newsletters
Formularies or therapeutics manuals
Persuasive print materials
Audio tapes, plays
Goal: to structure or guide decisions
Changes in selection, procurement, distribution to
ensure availability of essential drugs
Essential Drug Lists, morbidity-based quantification, kit systems
Strategies aimed at prescribers
targeted face-to-face supervision with audit, peer group
monitoring, structured order forms, evidence-based standard
course of treatment packaging, labelling, generic substitution
Goal: to offer incentives to providers an
Avoid perverse financial incentives
Goal: to restrict or limit decisions
Banning unsafe drugs - but beware unexpected results
substitution of a second inappropriate drug after banning a first
inappropriate or unsafe drug
Regulating the use of different drugs to different
levels of the health sector e.g.
licensing prescribers and drug outlets
scheduling drugs into prescription-only & over-the-counter
Regulating pharmaceutical promotional activities
A) Drug Selection :
The selection and range of drugs should be
based on the essential drug concept.
Strict inventory control and cost effective
procurement should be practiced.
Procure the most cost effective drugs in the right
Select reliable suppliers of high quality products.
Ensure timely delivery.
Achieve the lowest possible total cost.
B) Inventory control :
Monitoring of drug stocks and
minimizing out of stock.
Restrict the number and brands of
Drugs with overdue expiry dates should
not be dispensed or stored.
All the drugs required to health facility
should be kept in stock.
C) Information and education
Interact with other healthcare
professionals and inform them about
new drugs and availability of drugs.
Suitable programes should be evolved
to raise awareness of ADR.
Patient should be counseled.
D) Pharmaceutical care :
This aims to optimize the patients health
related quality of life and achieve
positive and cost effective clinical
An evidence based approach must be
Pharmacists must collect subjective
information regarding the patient’s
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