WHO Essential Medicine List, India's National List of Essential Med & Rational Use of Drugs

Essential Medicines List: Concept and Procedures
1 |
WHO
ESSENTIAL MEDICINES LIST
WHO
ESSENTIAL MEDICINES LIST
Dr. AMREEN SABA ATTARIYA
POST GRADUATE STUDENT
DEPT OF PHARMACOLOGY
M.R. MEDICAL COLLEGE,
GULBARGA, INDIA

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Outline of the presentation
 Background
 Evolution of WHO- Essential Medicine List(EML) (1977-2013)
 Approach for Revising/Updating the WHO Model EML
 Use of WHO Model EML and Implementation by National Health Systems
 Factors Affecting the Implementation of EML on Country Level
 Model EML
 India-National List of Essential Medicines(NLEM)
 Rational use of drugs
 Summary & References

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 GUIDING PRINCIPLE: A limited range of carefully
selected essential drugs leads to Better health care, Better
drug management & at Lower costs
 DEFINITION: That satisfy the priority health care
needs of the population at all time.
 SELECTION: with due regard to public health relevance,
evidence of efficacy and safety, and comparative cost-effectiveness*
ESSENTIAL MEDICINES
*WHO, [Online]. http://www.who.int/topics/essential_medicines/en

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EM are intended to be available
–at all times
– adequate amounts
–appropriate dosage forms
–assured quality & adequate information
–at a price the individual & community can
afford.

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First country to compose its EML Tanzania in 1970
HISTORY OF WHO MODEL LIST OF ESSENTIAL
DRUGS
… 39 yrs of EML
• 1977 First Model list published, 204 active substances
List is revised every 2 years by WHO Expert Committee
April 2003 revised Model list --- 315 active substances
2007-EMLca separate list for children up to 12 years
Latest editions 19th adults & 5thchildren in April
2015(ammended Nov2015)*
*“WHO Model List of Essential Medicines: 18th list”, 2015.

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CRITERIA FOR DRUG SELECTION FOR EML
Evidence of efficacy & safety
Relative cost effectiveness
Pharmacokinetics
Availability
Desired dosage form, bioavailability & stability ensured
Single compounds , in some cases FDCs

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19th WHO Model List of Essential Medicines - 2015
Report of the WHO Expert Committee, 2015

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Evolution of the WHO EML with Number of
Additions & Deletions

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Significant changes from 1977 - 2013
Significant net changes in 1979 list
1988-Addition of FDC for TB
2007- newly developed vaccines for Hep-A,
rotavirus etc.
2013- Anti-retroviral drugs

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CORE & COMPLEMENTARY LISTS
Core List Medicines
 minimum drug needs for a basic health care system
 most cost-effective drugs for priority conditions
Based on:
Efficacy & safety
Cost-effectiveness

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Complementary List Medicines : Treat a priority condition
Require special:
Diagnostic or monitoring facilities
Medical care
Training
Consistently higher cost or minimal cost-effectiveness

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SYMBOLS
square box symbol () - similar clinical performance
within a pharmacological class.
a- age or weight restriction on use of medicine
[c] -complementary list
[c] -specific indication for restricting its use in children

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EML 2013 in numbers
Adult List
374 – total number of drugs/medicines
– Core list: 282 (FDC: 23)
– Complementary list: 68 (FDC: 1)
Pediatric List
278 in total
– Core list: 206 (FDC: 11)
– Complementary list: 60 (FDC: 1)

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Trend for the Number of Medicines for Non-
Communicable Diseases

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Trend for the Number of Medicines for Non-
Communicable Diseases…
Despite projections by the WHO that NCDs73% of
death burden & 60% of disease burden by 2020*
The ratio of medicines for NCD medicines to total
number of medicines in the WHO EML is constant at
~15% from 1977-2013
* WHO NCD surveillance strategy

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Trend for Inclusion of Vaccine
WHO-Expanded Program on Immunization -1974 to cover 6 diseases*
*MA Miller, JT Sentz., Chapter 12,“Vaccine-Preventable Diseases”, in: DT Jamison, RG Feachem,
MW Makgoba, et al., editors. “Disease and Mortality in Sub-Saharan Africa”, 2nd
edition. Washington (DC): World Bank; 2006.
DIPHTHERIA PERTUSIS
TETANUS
TB POLIOMYELITIS MEASLES

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Evolution of Vaccines in the WHO EML with
Number of Additions and Deletions
Cholera
HIB
Hepatitis A
JE
Pneumococcal
Rotavirus
varicella

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Expansion of therapy classes(1977-2013)*
*“Selection of Essential Medicines – a Background Paper for theWorld
Medicines Situation 2010 Report”, 2009

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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
4. Post-marketing surveillance
5. Price indication for public sector use
6. Review by WHO disease programme; define safety ,
comparative cost-effectiveness and public health relevance
7. Submission to WHO Expert Committee on Essential Drugs

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PROCESS
EVIDENCE BASED & TRANSPARENT
Applications - addition/deletion /modification
Peer-reviewed by Expert Committee(EC)
Comments invited from any one interested
EC makes final decisions

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The application form/template

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Notable changes in EML since its inception
“Essential Drugs”  “Essential Medicines,”
Experience based Evidence based
Introduction of more rational selection process
Total treatment approach cost effectiveness approach

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Important Events of EML*
*WHO, “Alliance for Health Policy and Systems Research;Medicines in
Health Systems: Advancing access, affordability and appropriate use”,
Flagship Report, 2014

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Key Responsibilities of Different Stakeholders as
Defined at the Nairobi Conference-1985*
GOVERNMENT
Establish & implement national drug policy
Create awareness among health personnel & public
Increase registration of acceptable & safe drugs by setting
up or strengthening drug regulatory authority
*WHO, “The Rational Use of Drugs - Report of the Conference of
Experts, Nairobi 25-29 November 1985”,

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PHARMACEUTICAL INDUSTRIES
Complete & unbiased product info to all -govt, prescribers &
consumers
Comply with established drug promotional criteria & adopt ethical
code for drug promotion
Respond to need of developing countries for low-cost drugs
Develop new drugs in neglected fields with high unmet needs

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PRESCRIBERS
Prescribe rationally in conformity with health, social &
economic criteria
Transparent & accurate info on healthcare & drug therapy to
patients & public

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UNIVERSITIES/ TEACHING INSTITUTIONS
Improve training of health workers in healthcare in general
& in rational use of drugs
Introduce the concept of essential drugs
Continuing education to health care providers
General education on proper health care & drug therapy

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PUBLIC , PATIENT & CONSUMER
Improve relevance & quality of information for public
Share responsibility with govt. & non-govt.
organizations for education of consumers
Support essential drug program

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MASS MEDIA
Provide relevant & balanced information on health
matters, including drug therapy
Share in public education on proper use of drug
therapy

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Use of WHO Model List
Major International Agencies -UNICEF, UNHCR-
United Nations High Commissioner for Refugees
Sub-sets: UN list of recommended essential drugs for
emergency relief, interagency New Emergency
Health Kit.
Normative Tools: WHO Model Formulary,
International Pharmacopoea, Basic Quality Tests &
development of reference standards

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Current Process and Steps in Updating
WHO Model EML

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Use of WHO Model EML & Implementation
by National Health Systems
Guides the procurement & supply in public sector
Reimbursement schemes for medicine cost, medicine donation
& local production.
95% countries have NATIONAL LIST OF ESSENTIAL
MEDICINES(NLEM)of which 86% update once in 5yrs*
Few adopt EML at sub-national or state/provincial level
*WHO, “Backgrounder and Facts for Launch of the United Nations Report Delivering on the Global Partnerships for
Achieving The Millennium Development Goals”.

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Number of countries with NLEM
National Essential Drugs List
< 5 years (127)
> 5 years (29)
No NEDL (19)
Unknown (16)

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Difference between WHO-EML & NLEM
WHO EML- insulin & metformin “Medicines used for
Diabetics”
NLEM India & China- “Hormones, Other Endocrine Medicines
WHO EML-only names of medicines & recommended
formulations & strengths
NLEM-recommended standard treatment guidelines for the
specific indication in an attempt to align the EML with the
country-specific standard treatment guidelines.

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Factors Affecting the Implementation of
EML on country level
Pricing Policy
Availability Of Essential Medicines
Reimbursement Scenario
Government Initiatives Supporting Implementation
Patent & Licensing Scenario
Healthcare Infrastructure

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Access to Essential Medicines in Public and
Private Health Facilities
No. of people without access is high
A survey in 27 developing countries in
2007average availability of EM in public
sector- 34.9%, private sector- 63.2%*
*WHO, “Continuity and Change – Implementing the Third Who Medicines Strategy 2008 m-2013”, 2009.

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Factors for Low availability of EML in public
sectors
underfunding or under-budgeting
inaccurate demand forecasting
inefficient public sector procurement & distribution of med
COMPELS PATIENTS INTO PRIVATE SECTOR
AVAILABILITY IS HIGH BUT COSTLY

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Median Availability of Selected Generics in Public and Private
Health Facilities
Across Low and Middle Income Level Countries

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Comparison of Medicines for Selected
NCDs and CDs

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Content of EML
1 Anaesthetics
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
4.1 Non-specific
4.2 Specific
5 Anticonvulsants/antiepileptics
6 Anti-infective medicines
6.1 Antihelminthics
6.2 Antibacterials
6.3 Antifungal medicines
6.4 Antiviral medicines
6.5 Antiprotozoal medicines
etc,……………………………………….

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Content of EML
7 Antimigraine medicines
7.1 For treatment of acute attack
7.2 For prophylaxis
Hormones, other endocrine medicines and cont
Immunologicals
Ophthalmological preparations
Vitamins and minerals
Medicines for diseases of joints
Ear, nose and throat medicines in children
Cardiovascular medicines
Antiparkinsonism medicines
Diagnostic agents
Diuretics
Gastrointestinal medicines

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INDIA - NLEM

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Executive Core Committee INDIA
By Ministry of Health & Family Welfare (MOHFW), GOI
Under chairmanship of
Dr VM Katoch - Secretary, Department of Health Research (DHR)
and Director General ICMR
&
Dr YK Gupta- Vice Chairman, Professor and Head, Dept of
Pharmacology AIIMS.

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Criteria For Inclusion Of Medicine In NLEM*
Be approved/licensed by DCGI.
Be useful in Disease which is a public health problem in India.
 Proven efficacy & safety profile based on valid scientific
evidence.
Be comparatively Cost effective.
Aligned with the current treatment guidelines for the disease.
Stable under the storage conditions in India.
*Report of core committee for revision of India NLEM Nov-2015

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Criteria for Deletion of Medicine from NLEM
Medicines banned
Availability of med with better safety, efficacy & cost-
effectiveness.
Disease burden no longer health concern.
Antimicrobials resistance pattern rendered a
medicine ineffective.

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Salient Features Of NLEM
First NLEM-1996
NLEM 2011  348 med
NLEM 2015  376 medicines(106 added & 70 deleted)
3 category included
 P→ Primary
 S → Secondary
 T → Tertiary
P,S,T ---206 drugs
S,T --- 115drugs
T --- 79 drugs.

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NLEM 2015- BEST FIT LIST
Adhering To The Basic Principles Of
Efficacy
Safety
Cost-Effectiveness
Consideration of diseases as public health problems in India.

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NLEM-2015

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Practical Applications of EML
Policy making
Management
Selection
Procurement
Distribution
Quality assurance
Financing

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Promoting rational use
Training of health Professionals
For providing medicines information & education
Cost effective therapy

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Purpose of the NLEM
Guides safe and effective treatment of priority
disease conditions of a population
 Promote the rational use of medicines
Optimize the available health resources of a
country

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NLEM-a guiding document for
State governments to prepare their list of essential medicines
Procurement and supply of medicines in the public sector
Reimbursement of cost of medicines by organizations to its
employees
Reimbursement by insurance companies
Identifying the ‘MUST KNOW’ domain for the teaching &
training of health care professionals

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Rational use of dRugs

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Rational use of Drug
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
 correct drug
 appropriate indication
 appropriate drug considering efficacy, safety, suitability for the patient & cost
 appropriate dosage, administration, duration
 no contraindications
 correct dispensing, including appropriate information for patients
 patient adherence to treatment

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Rational use of Drug*
RULE OF RIGHT
RIGHT DRUG to RIGHT PATIENT in RIGHT DOSAGE @ RIGHT
COST
SANE CRITERIA
SAFETY, AFFORDABILITY,NEED & EFFICACY
*HL Sharma & KL Sharma:Concept of EM & Rational drug use, p.no-106, 2nd
ed.

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Factors Influencing Use of Medicines
Treatment
Choices
Prior
Knowledge
Habits
Scientific
Information
Relationships
With Peers
Influence
of Drug
Industry
Workload &
Staffing
Infra-
structure
Authority &
Supervision
Societal
Information
Intrinsic
Workplace
Workgroup
Social &
Cultural
Factors
Economic &
Legal Factors

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SUMMARY
Defn: EM -that satisfy the priority health care needs of the population at
all time
Selection criteria: with due regard to public health relevance, evidence
of efficacy and safety & comparative cost-effectiveness
First model list-1977, revised every 2yrs, latest is 19th–
adults & 5th
-
children(2015)
Core list- basic min drugs for priority diseases
Complementary- which requires specialised health care facility

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SUMMARY…
 Steps for getting new drug in model list
Identification of problem devp of med regulatory approval PMS
pricing review by WHO disease program submission to WHO EC.
 Changes since inception
EDL EML, experience evidence, total rxcost effectiveness
 Key responsibilties of govt, pharmac companies, prescribers, public, patient,
consumers & mass media

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SUMMARY…
Factors affecting implementation
Pricing, availabilty, patent & licensing issues, health care infrastructure
Access to EML  public sector<<<<private sector
Uses of EML- Policy making, Management, Selection, Procurement,
Distribution, Financing, Promoting rational use, Training of health
Professionals, For providing medicines info & education, Cost effective
therapy

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SUMMARY…
INDIA –NLEM
By MOHW- Govt Of India
3 categories- pri, sec & ter
NLEM-2015—376 molecules(BEST FIT LIST)
Adheres to safety, efficacy & cost-effective approach

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References
 Understanding the Role and Use of EML: Murray Aitken Executive Director IMS
Institute for Healthcare Informatics, USA April 2015.
 WHO, [Online]. Available:
http://www.who.int/medicines/publications/essentialmedicines/en/
 WHO, “WHO Model List of Essential Medicines: 19th list”, 2015.
 Brian M. Kaiser : WHO’s EML: From Idea to Implementation
 WHO, “Essential Medicines for NCDs”, 2011.
 Report of core committee for revision of India NLEM Nov-2015
 HL Sharma & KL Sharma:Concept of EM & Rational drug use, p.no-106, 2nd
ed.

WHO Essential Medicine List, India's National List of Essential Med & Rational Use of Drugs

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