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

Essential Medicines List: Concept and Procedures1 |

WHO ESSENTIAL MEDICINES LIST

Dr. AMREEN SABA ATTARIYAPOST GRADUATE STUDENT

DEPT OF PHARMACOLOGYM.R. MEDICAL COLLEGE,

GULBARGA, INDIA


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


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


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.


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.


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


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


Evolution of the WHO EML with Number of Additions & Deletions


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


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


Complementary List Medicines : Treat a priority condition

Require special:

Diagnostic or monitoring facilities

Medical care

Training

Consistently higher cost or minimal cost-effectiveness


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


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)


Trend for the Number of Medicines for Non-Communicable Diseases


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


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”, 2ndedition. Washington (DC): World Bank; 2006.

DIPHTHERIA PERTUSIS TETANUS

TB POLIOMYELITIS MEASLES


Evolution of Vaccines in the WHO EML with Number of Additions and Deletions

CholeraHIBHepatitis AJEPneumococcalRotavirusvaricella


Expansion of therapy classes(1977-2013)*

*“Selection of Essential Medicines – a Background Paper for theWorld Medicines Situation 2010 Report”, 2009


Seven steps to get a new medicine onthe WHO Model List of Essential Drugs

1. Identification of public-health need for a medicine2. Development of the medicine; phase I - II - III trials3. Regulatory approval in a number of countries4. Post-marketing surveillance5. Price indication for public sector use6. Review by WHO disease programme; define safety ,

comparative cost-effectiveness and public health relevance7. Submission to WHO Expert Committee on Essential Drugs


PROCESSEVIDENCE BASED & TRANSPARENT

Applications - addition/deletion /modification

Peer-reviewed by Expert Committee(EC)

Comments invited from any one interested

EC makes final decisions


The application form/template


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


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


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 ofExperts, Nairobi 25-29 November 1985”,


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


PRESCRIBERS

Prescribe rationally in conformity with health, social & economic criteria

Transparent & accurate info on healthcare & drug therapy to patients & public


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


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


MASS MEDIA

Provide relevant & balanced information on health matters, including drug therapy

Share in public education on proper use of drug therapy


Use of WHO Model ListMajor 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


Current Process and Steps in Updating WHO Model EML


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”.


Number of countries with NLEM

National Essential Drugs List

< 5 years (127)

> 5 years (29)

No NEDL (19)

Unknown (16)


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.


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


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.


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


Median Availability of Selected Generics in Public and Private Health Facilities

Across Low and Middle Income Level Countries


Comparison of Medicines for Selected NCDs and CDs


Content of EML1 Anaesthetics1.1 General anaesthetics and oxygen1.2 Local anaesthetics1.3 Preoperative medication and sedation for short-term procedures2 Medicines for pain and palliative care2.1 Non-opioids and non-steroidal anti-inflammatory drugs (NSAIDs)2.2 Opioid analgesics2.3 Medicines for other common symptoms in palliative care3 Antiallergics and medicines used in anaphylaxis4 Antidotes and other substances used in poisonings4.1 Non-specific4.2 Specific5 Anticonvulsants/antiepileptics6 Anti-infective medicines6.1 Antihelminthics6.2 Antibacterials6.3 Antifungal medicines6.4 Antiviral medicines6.5 Antiprotozoal medicinesetc,……………………………………….


Content of EML7 Antimigraine medicines7.1 For treatment of acute attack7.2 For prophylaxisHormones, other endocrine medicines and contImmunologicalsOphthalmological preparations Vitamins and mineralsMedicines for diseases of jointsEar, nose and throat medicines in childrenCardiovascular medicinesAntiparkinsonism medicinesDiagnostic agentsDiureticsGastrointestinal medicines


INDIA - NLEM


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.


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


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.


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 drugsS,T --- 115drugs

T --- 79 drugs.


NLEM 2015- BEST FIT LIST

Adhering To The Basic Principles Of

Efficacy

Safety

Cost-Effectiveness

Consideration of diseases as public health problems in India.


NLEM-2015


Practical Applications of EML

Policy making

Management

Selection

Procurement

Distribution

Quality assurance

Financing


Promoting rational use

Training of health Professionals

For providing medicines information & education

Cost effective therapy


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


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


Rational use of drugs


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


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.


Factors Influencing Use of Medicines

Treatment Choices

Prior Knowledge

HabitsScientific Information

RelationshipsWith Peers

Influenceof DrugIndustry

Workload & Staffing

Infra-structure

Authority & Supervision

Societal

Information

Intrinsic

Workplace

Workgroup

Social &CulturalFactors

Economic &Legal Factors


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


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


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


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


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.

http://www.who.int/medicines/publications/essentialmedicines/en/

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

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