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WHO Essential Medicine List, India's National List of Essential Med & Rational Use of Drugs
1. Essential Medicines List: Concept and Procedures
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WHO
ESSENTIAL MEDICINES LIST
WHO
ESSENTIAL MEDICINES LIST
Dr. AMREEN SABA ATTARIYA
POST GRADUATE STUDENT
DEPT OF PHARMACOLOGY
M.R. MEDICAL COLLEGE,
GULBARGA, INDIA
2. Essential Medicines List: Concept and Procedures
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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
3. Essential Medicines List: Concept and Procedures
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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
4. Essential Medicines List: Concept and Procedures
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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.
5. Essential Medicines List: Concept and Procedures
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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-EMLca separate list for children up to 12 years
Latest editions 19th adults & 5thchildren in April
2015(ammended Nov2015)*
*“WHO Model List of Essential Medicines: 18th list”, 2015.
6. Essential Medicines List: Concept and Procedures
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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
7. Essential Medicines List: Concept and Procedures
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19th WHO Model List of Essential Medicines - 2015
Report of the WHO Expert Committee, 2015
8. Essential Medicines List: Concept and Procedures
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Evolution of the WHO EML with Number of
Additions & Deletions
9. Essential Medicines List: Concept and Procedures
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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
10. Essential Medicines List: Concept and Procedures
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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
11. Essential Medicines List: Concept and Procedures
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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
12. Essential Medicines List: Concept and Procedures
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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
13. Essential Medicines List: Concept and Procedures
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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)
14. Essential Medicines List: Concept and Procedures
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Trend for the Number of Medicines for Non-
Communicable Diseases
15. Essential Medicines List: Concept and Procedures
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Trend for the Number of Medicines for Non-
Communicable Diseases…
Despite projections by the WHO that NCDs73% 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
16. Essential Medicines List: Concept and Procedures
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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
17. Essential Medicines List: Concept and Procedures
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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
18. Essential Medicines List: Concept and Procedures
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Expansion of therapy classes(1977-2013)*
*“Selection of Essential Medicines – a Background Paper for theWorld
Medicines Situation 2010 Report”, 2009
19. Essential Medicines List: Concept and Procedures
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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
20. Essential Medicines List: Concept and Procedures
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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
22. Essential Medicines List: Concept and Procedures
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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
23. Essential Medicines List: Concept and Procedures
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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
24. Essential Medicines List: Concept and Procedures
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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”,
25. Essential Medicines List: Concept and Procedures
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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
26. Essential Medicines List: Concept and Procedures
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PRESCRIBERS
Prescribe rationally in conformity with health, social &
economic criteria
Transparent & accurate info on healthcare & drug therapy to
patients & public
27. Essential Medicines List: Concept and Procedures
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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
28. Essential Medicines List: Concept and Procedures
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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
29. Essential Medicines List: Concept and Procedures
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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
30. Essential Medicines List: Concept and Procedures
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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
31. Essential Medicines List: Concept and Procedures
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Current Process and Steps in Updating
WHO Model EML
32. Essential Medicines List: Concept and Procedures
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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”.
33. Essential Medicines List: Concept and Procedures
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Number of countries with NLEM
National Essential Drugs List
< 5 years (127)
> 5 years (29)
No NEDL (19)
Unknown (16)
34. Essential Medicines List: Concept and Procedures
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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.
35. Essential Medicines List: Concept and Procedures
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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
37. Essential Medicines List: Concept and Procedures
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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
2007average 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.
38. Essential Medicines List: Concept and Procedures
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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
39. Essential Medicines List: Concept and Procedures
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Median Availability of Selected Generics in Public and Private
Health Facilities
Across Low and Middle Income Level Countries
40. Essential Medicines List: Concept and Procedures
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Comparison of Medicines for Selected
NCDs and CDs
41. Essential Medicines List: Concept and Procedures
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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,……………………………………….
42. Essential Medicines List: Concept and Procedures
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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
46. Essential Medicines List: Concept and Procedures
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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.
47. Essential Medicines List: Concept and Procedures
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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
48. Essential Medicines List: Concept and Procedures
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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.
49. Essential Medicines List: Concept and Procedures
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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.
50. Essential Medicines List: Concept and Procedures
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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.
56. Essential Medicines List: Concept and Procedures
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Practical Applications of EML
Policy making
Management
Selection
Procurement
Distribution
Quality assurance
Financing
57. Essential Medicines List: Concept and Procedures
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Promoting rational use
Training of health Professionals
For providing medicines information & education
Cost effective therapy
58. Essential Medicines List: Concept and Procedures
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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
59. Essential Medicines List: Concept and Procedures
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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
61. Essential Medicines List: Concept and Procedures
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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
62. Essential Medicines List: Concept and Procedures
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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.
63. Essential Medicines List: Concept and Procedures
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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
64. Essential Medicines List: Concept and Procedures
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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
65. Essential Medicines List: Concept and Procedures
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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 rxcost effectiveness
Key responsibilties of govt, pharmac companies, prescribers, public, patient,
consumers & mass media
66. Essential Medicines List: Concept and Procedures
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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
67. Essential Medicines List: Concept and Procedures
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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
68. Essential Medicines List: Concept and Procedures
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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.
Editor's Notes
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 & adequate information
at a price the individual & community can afford.
Addition of new drugs is based on documented evidence of efficacy, relative efficacy, safety and comparative cost-
effectiveness
while reasons for deletions include lack of proof of effectiveness,
unacceptable side effects or availability of safer or more effective alternatives.
Significant net change was observed in the 1979 list, probably since the list was in the process of
being developed and established
•• Addition of fixed dose combinations for tuberculosis to the list contributed to the significant
change observed in 1998
•• Addition of agents in 2003 is mainly attributed to the inclusion of anti-retroviral drugs to the EML
•• Significant change observed in 2007 can be attributed to the inclusion of various newly developed
vaccines to the list, including hepatitis A vaccine, rotavirus vaccine, etc.
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.*
In case of doubt, medicines may also be listed as complementary on the basis of consistent
higher costs or less attractive cost-effectiveness in a variety of settings
The importance of ensuring access to appropriate medicines for treating NCDs is reflected in the
consistent increase in the number of medicines for NCDs in the WHO EML
The selection of the original EPI vaccines was made on programmatic criteria rather than
consideration of disease burden. A few vaccines, such as YF and JE, have regional importance based
on prevalence. The WHO EML included JE after 27 years of inclusion of YF, even though there is no
evidence that the disease burden of YF is greater than JE
Additions and deletions across therapy areas in the EML reflect the evolving focus areas and public
health challenges.
Anti-infectives appear to be the area with the highest increase, presumably driven
by the addition of therapies for evolving health concerns such as tuberculosis, malaria, and HIV.
Anti-neoplastic agents, hormones, and vaccines are the other therapy areas with the highest number
of drugs added to the original list
Applications invited & received - addition/deletion /modification
Peer-reviewed by Expert Committee(EC) members (2 or 3 independent reviewers)
Comments invited from any one interested (WHO Depts., Professional Societies, International agencies, Academia)
EC makes final decisions
1. Use of the term “Essential Medicines” as an alternative to “Essential Drugs,” reflecting the
common use of the term “medicines” to describe pharmaceutical preparations used in
clinical practice
2. Evolution from being experience-based to evidence-based
3. Introduction of a more rationalized selection process where research evidence was relied upon for
evaluating comparative benefit and safety of specific medicines
4. Use of a comparative cost-effectiveness approach which is presented as a range of cost per routine
outcome (e.g., cost per case, cost per cure, cost per month of treatment) compared to older
methods where cost of the total treatment was taken into account
GOVERNMENT
Establish and implement national drug policy with national health policy
Create awareness of EML among health personnel & public
Increase registration of acceptable & safe drugs by setting up or strengthening drug regulatory authority
Provide complete and unbiased product information to all concerned -governments, prescribers and consumers
Comply with established drug promotional criteria & adopt ethical code for drug promotion
Respond to the need of developing countries for low-cost drugs
Develop new drugs in neglected fields with high unmet needs
Prescribe rationally in conformity with health, as well as social and economic criteria
Provide transparent and accurate information on healthcare and drug therapy to patients and public
Improve training of health workers in healthcare in general and in rational use of drugs
Introduce the concept of essential drugs
Provide continuing education for health care providers
Provide general education on proper health care and drug therapy also to those not training as health workers
Improve the relevance and quality of information for the public
Share responsibility with govt. and non-govt. organizations for the education of consumers on drug matters
Support essential drug program
Provide relevant and balanced information on health matters, including drug therapy
Share in public education on the proper use of drug therapy
Major international agencies (UNICEF united nations childrens emergency fund, UNHCR-United Nations High Commissioner for Refugees) base their catalogue on WHO Model List
Sub-sets: UN list of recommended essential drugs for emergency relief (85 drugs); interagency New Emergency Health Kit (55 drugs for 10,000 consultations)
Normative tools: WHO Model Formulary, International Pharmacopoea, Basic Quality Tests, and development of reference standards follow the WHO Model List
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 Model list contains only the names of medicines and recommended formulations and
strengths,
while the lists for some of the countries also include the recommended standard treatment
guidelines for the specific indication in an attempt to align the EML with the country-specific
standard treatment guidelines
--Access to EML is improved but still the no. of people without access is high
--Survey done for measuring medicine availability, price, affordability & price components
--A survey in 27 developing countries in 2007average availability of EM in public sector was only 34.9%, while in the private sector was 63.2%
The square box symbol is primarily intended to indicate similar clinical performance within a
pharmacological class
The a(in square box) symbol indicates that there is an age or weight restriction on use of the medicine
c- complementary
c- specific indication for restricting its use to children
The Core-Committee was constituted by the Ministry of Health & Family Welfare (MOHFW), Government of India, under the chairmanship of Dr VM Katoch, the then Secretary, Department of Health Research (DHR) and Director General, Indian Council of Medical Research (ICMR), and Dr YK Gupta, Professor and Head, Department of Pharmacology, All India Institute of Medical Sciences (AIIMS) as the Vice Chairman.
The medicine should be approved/licensed in India.
– The medicine should be useful in disease which is a public health problem in India.
– The medicine should have proven efficacy and safety profile based on valid scientific evidence.
– The medicine should be cost effective.
– The medicine should be aligned with the current treatment guidelines for the disease.
– The medicine should be stable under the storage conditions in India.
– When more than one medicine are available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost-effectiveness.
The medicine has been banned in India.
– There are reports of concerns on the safety profile of a medicine.
– A medicine with better efficacy or favorable safety profiles and better cost-effectiveness is now available.
– The disease burden for which a medicine is indicated is no longer a national health concern in India.
– In case of antimicrobials, if the resistance pattern has rendered a medicine ineffective in Indian context.
Medicines in NLEM are listed with reference to the levels of healthcare, namely, Primary (P), Secondary (S) and Tertiary (T). There are 209 medicine formulations listed for all levels of health care (P, S, T), 115 medicine formulations for secondary and tertiary levels (S, T) and 79 medicine formulations for the tertiary level (T).
a guiding document for
State governments to prepare their list of essential medicines
b) Procurement and supply of medicines in the public sector
c) Reimbursement of cost of medicines by organizations to its employees
d) Reimbursement by insurance companies
e) Identifying the ‘MUST KNOW’ domain for the teaching and training of health care professionals
Rational use of drugs is based on rule of right
It shd fulfil SANE criteria