Concept of Essential Drugs: Chapter-I

CHAPTER-I
Concept of essential drugs
BY:
J. jayasutha
lecturer
department of pharmacy practice
Srm college of pharmacy
SRM UNIVERSITY
Definition
“Essential drugs are those that satisfy the

health care needs of majority of population”
Should available at all times
In adequate amounts
In the adequate dosage forms
History of the WHO Model List
of Essential Drugs
1977 First Model list published, ± 200 active substances
List is revised every two years by WHO Expert Committee
Last essential drug list established in the year 2010

Great importance for developing countries
Development of treatment guidelines and national formularies
Comprehensive national drug formulary
Strategies to drug procurement and supply
Drug financing and Drug donations
Research priorities for drug use
Drugs needed for specific disease

Guidelines for establishing a national programme
for essential drugs
National drug regulatory authority should be established
National drug and therapeutic committee (NDTC) should be

established
Committee includes people from

Medical
Clinical Pharmacology
Pharmacy
Public health fields
Also from other appropriate health care fields
Generic names should be used for all drugs
Concise, accurate and comprehensive drug

information should be prepared
Stability and bioavailability should be assured
Efficient administration of supply, storage and

distribution of drugs
Management of stocks and eliminate waste

Criteria for the selection
of essential drugs
Pattern of prevalent disease and treatment facilities
Level of training and experience of the personnel
Financial resources available in the country
Genetic, demographic and environmental factors
Evidence based and not suituation based
Selected drugs should have adequate data on their efficacy

and safety
Performance of drugs in general has been proved in a
variety of medical setting
Available in adequate quantities and in the dosage forms

that is recommended by NDTC
Assured quality, stability and bioavailability
Two or more drugs having same quality, stability and

bioavailability, choice on the basis of efficacy, safety,
quality, price and availability
Cost , an issue; unit cost of drug alone should not be
considered. Cost of total treatment, cost/benefit ratio
should also be considered
Comparative pharmacokinetic properties of drugs in
the same therapeutic category
Local facilities to manufacture and storage also be
considered
Should contain only single drug, combination
advantage over single drug in therapeutic effect, safety
and patient compliance
Selection of Pharmaceutical dosage forms
General utility and wide availability of the dosage forms
Tablets have wide acceptability and also cost effective
Stability of dosage form under ambient climate conditions
Established local preference
Bioavailability and pharmacokinetics of dosage forms
Selection of convenient dosage forms for selected population

Eg: Paediatric dosages, SR/CR dosage inclusion require
adequate documentation
Selection of specified salt form for a particular drug
Example: Chloramphenicol Palmitate, Amlodipine Besylate,
Erythromycin estolate
Quality Assurance and WHO certification scheme
Should confirm with required standards of good
Manufacturing practice (GMP) and quality control
Bioavailability of drugs
Should confine International Pharmacopoeia and

its standards
Nomenclature
Each pharmaceutical substance by a globally acceptable
generic name is importance
International nonproprietory (INN) names becomes an

important arm of essential drug list and is almost globally
accepted
INN periodically published by WHO for new addition of

pharmaceutical products
Brought unifomity in the names of medicine
Stop confusion and to ensure, safety of drugs for patients

Tasks after the formation of
Essential drug list
Updating the essential drug list
Essential drug list for primary health care
centres
Specialist control of drug use
Research and development
Drug information and education activities
Making a list of reserve microbials
Post registration drug studies
Updating the essential drug list-Continuous process
WHO guiding principles

Must accomodate local situations to meet health needs of
majority of population
Extent to which country establish EDL
Guiding essential drug list by WHO is a contribution to solve
problems
Need to include additional drugs for rare disease. Eg: TB drugs
in India
Exclusion does not mean rejection
Public health issue, epidemiological changes, new drugs
availability, progress in pharmacological and pharmaceutical
knowledge
Essential drug list for primary
health care centres
Existing system of medicine
National health infrastructure
Pattern of endemic diseases
Supplies
Specialist control of drug use
Adequate specialist skills and complemaentary resources
needed before the introduction of new drugs. Examples of
situation requiring specialist control of drug use
Use of reserve antibiotics for multiresistant bacteria
Adequate regimen for TB and leprosy
Use of antineoplastic, immunosupressive agent,
antiretrovial agent
Research and development
Pharmaceutical aspects
Development of drug procurement, drug
quality, processing, packaging and distribution
Clinical and epidemiological aspect
To assess efficacy, safety, genetic and ethnic
difference
Educational aspects
Development of training programme
Drug information and education activities
Develop formulary and drug information sheet on
all drugs in EDL
Continual education programme on all aspects of
medical care, disease pattern, selection of
antimicrobials , diagnostic and other therapeutic
guidelines
Making a list of reserve microbials
Amoxicillin plus clavulianic acid

Ceftriaxone
Ceftazidine
Vancomycin etc…
Post registration drug studies
Some drugs fail to produce benefit. Reasons are
Clinical trial does not Iinclude groups like children,
pregnant women, old people
Genetic and environment factors differs from
population to population
Unexpected use of drugs, data on overdose not
available
Poor manufacturing practice
Post registration drug studies help to estimate
future demands, quantify drug inventory,
evaluate drug use
Thank you

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CHAPTER-I

Concept of essential drugs

“Essential drugs are those that satisfy the

 1977 First Model list published, ± 200 active substances

 List is revised every two years by WHO Expert Committee

 Last essential drug list established in the year 2010

 Development of treatment guidelines and national formularies

 Comprehensive national drug formulary

 Strategies to drug procurement and supply

 Drug financing and Drug donations

 Research priorities for drug use

 Drugs needed for specific disease

 National drug regulatory authority should be established

 National drug and therapeutic committee (NDTC) should be

 Committee includes people from

 Concise, accurate and comprehensive drug

 Stability and bioavailability should be assured

 Efficient administration of supply, storage and

 Management of stocks and eliminate waste

 Level of training and experience of the personnel

 Financial resources available in the country

 Genetic, demographic and environmental factors

 Evidence based and not suituation based

 Selected drugs should have adequate data on their efficacy

 Available in adequate quantities and in the dosage forms

 Assured quality, stability and bioavailability

 Two or more drugs having same quality, stability and

 Tablets have wide acceptability and also cost effective

 Stability of dosage form under ambient climate conditions

 Established local preference

 Bioavailability and pharmacokinetics of dosage forms

 Selection of convenient dosage forms for selected population

 Should confine International Pharmacopoeia and

 International nonproprietory (INN) names becomes an

 INN periodically published by WHO for new addition of

 Brought unifomity in the names of medicine

 Stop confusion and to ensure, safety of drugs for patients

WHO guiding principles

 Amoxicillin plus clavulianic acid

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1977 First Model list published, ± 200 active substances

List is revised every two years by WHO Expert Committee

Last essential drug list established in the year 2010

Development of treatment guidelines and national formularies

Comprehensive national drug formulary

Strategies to drug procurement and supply

Drug financing and Drug donations

Research priorities for drug use

Drugs needed for specific disease

National drug regulatory authority should be established

National drug and therapeutic committee (NDTC) should be

Committee includes people from

Concise, accurate and comprehensive drug

Stability and bioavailability should be assured

Efficient administration of supply, storage and

Management of stocks and eliminate waste

Level of training and experience of the personnel

Financial resources available in the country

Genetic, demographic and environmental factors

Evidence based and not suituation based

Selected drugs should have adequate data on their efficacy

Available in adequate quantities and in the dosage forms

Assured quality, stability and bioavailability

Two or more drugs having same quality, stability and

Tablets have wide acceptability and also cost effective

Stability of dosage form under ambient climate conditions

Established local preference

Bioavailability and pharmacokinetics of dosage forms

Selection of convenient dosage forms for selected population

Should confine International Pharmacopoeia and

International nonproprietory (INN) names becomes an

INN periodically published by WHO for new addition of

Brought unifomity in the names of medicine

Stop confusion and to ensure, safety of drugs for patients

Amoxicillin plus clavulianic acid