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The Concept of Essential Medicines and the WHO Model List of Essential Medicines Technical Briefing Seminar 2 nd November 2012 Dr Krisantha Weerasuriya Department of Essential Medicines and Health Products (EMP) World Health Organization,

The Concept of Essential Medicines and the WHO Model List of Essential Medicines

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The Concept of Essential Medicines and the WHO Model List of Essential Medicines. Technical Briefing Seminar 2 nd November 2012 Dr Krisantha Weerasuriya Department of Essential Medicines and Health Products (EMP) World Health Organization,. Essential medicines. - PowerPoint PPT Presentation

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Page 1: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

The Concept of Essential Medicines and the

WHO Model List of Essential Medicines

Technical Briefing Seminar

2nd November 2012

Dr Krisantha Weerasuriya

Department of Essential Medicines and Health Products (EMP)

World Health Organization,

Page 2: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

Essential medicines

The concept of essential medicines

A limited range of carefully selected essential medicines leads to better health care, better drug management, and lower costs

Definition of essential medicines

Essential medicines are those that satisfy the priority health care needs of the population

Selection of essential medicinesSelected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.

Page 3: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

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

2002 Revised procedures approved by WHO

Last revision (March 2011) contains approx. 325 active substances

The first list was a major breakthrough in the historyof medicine, pharmacy and public health Médecins sans Frontières, 2000

Page 4: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

Why is it 'model'

Model for process of selection (Is it the first example of Health Technology Assessment?)

Model list

Model to facilitate efforts to 'improve health' of population

Procurement and Supply

Regulation

Quality

Rational Use

Availability Access Equity

Page 5: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

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 can afford.

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.

Page 6: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

Department of Essential Medicines and Health Products

The Essential Medicines Target

S S

All the drugsin the world

Registered medicines

National list ofessential medicines

Levels of use

Supplementaryspecialistmedicines

CHWdispensary

Health center

Hospital

Referral hospital

Private sector

Page 7: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

National Essential Drugs List

< 5 years (127)> 5 years (29)No NEDL (19)Unknown (16)

156 countries with EDLS

1/3 within 2 years

3/4 within 5 years

Number of countries with a national list of essential medicines

Page 8: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

Use of the WHO Model List of Essential Drugs

156 countries have a national list of essential drugs, of which 81% have been updated in the last 5 yearsCountries with an official selective list for training, supply, reimbursement or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists.

Major international agencies (UNICEF, UNHCR, IDA) base their catalogue on the 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

Page 9: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

Model process :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 countries

> Effective and safe medicine on the market4. More experience under different field circumstances; post-marketing

surveillance5. Price indication for public sector use6. 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 guideline7. Submission to WHO Expert Committee on Essential Drugs

> Medicine included in WHO Model List

Page 10: The Concept of Essential Medicines and the WHO Model List of Essential Medicines
Page 11: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

Process - Evidence Based and Transparent

Applications invited - addition/deletion/modification Format available; Deadline a few months before next EC All applications go online

Applications peer reviewed by experts Peer reviews go online

Comments invited from any one interested (WHO Depts., Professional Societies, International agencies, Academia)

Comments go on line

Expert Committee makes final decisions Report goes on line

Page 12: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

Criteria For Expert Committee approval

• Effective and safe medicine – based on clinical trials data, post marketing surveillance, pharmacovigilance, regulatory approvals

• Regulatory approval in a number of countries - indicates availability, efficacy, safety

• Available in most parts of the world and ease of use in different settings - necessary for access

• Public health need - indicated by burden of disease, populations served, annual estimates of use, guideline recommendations

• Affordable for most health care systems - costs comparisons, cost benefit

• Recommended in Guidelines especially by WHO programmes – indicates public health need, efficacy, safety

Page 13: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

The WHO Model Essential Medicines List is NOT

A list of cheap drugs for developing countries

All the drugs for all the diseases in the world – medicines in it are for priority health conditions

Drugs of unproven efficacy

One that has "latest drugs" – they have to be proven in practice before they are adopted

One that has multiple medicines from the same therapeutic category (one beta blocker out of the 50+) – How many benzodiazepines does the United Kingdom have? How many of them are available through the NHS?

Page 14: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

Department of Essential Medicines and Health Products

Page 15: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

National Essential Medicines Lists :Implementation in Countries (156!)

1. How operational is it in Low and Middle Income countries?(Is procurement tied to the NEML?)

2. What are the LMICs that have the best implementation of the National Essential Medicines List?

3. What is the underlying factor for success in these countries?

(Current Controversy – misoprostol in prevention of post-partum haemorrhage by trained health care workers WHERE oxytocin is not available)

Page 16: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

National Essential Medicines Lists :Implementation in Countries (156!)

1. An overall coordinated health service in a country is necessary (Public + Private Sector) (United Kingdom?)

2. How important is the private (for profit) sector in health care in LMICs?

3. The Essential Medicines List is a good gatekeeper to the Medicines Supply of the Government Sector but is ignored by the Private Sector

4. Even in the public sector how common are the other tools for implementing the Essential Medicines List – Formularies, Standard Treatment Guidelines, Drug Information Centres?(British National Formulary)

Page 17: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

Conclusion

Essential medicines is a global concept

There is global implementation of the principle BUT it is done in some countries (especially HICs) by other names

The adoption of the Essential Medicines Concept and the List is almost universal in LMICs BUT the implementation is far from universal

Is a comprehensive health care system that values cost-effective medicines, a pre-requisite for implementing the Essential Medicines List?

Page 18: The Concept of Essential Medicines and the WHO Model List of Essential Medicines

Conclusion

Dr K Weerasuriya, Medical Officer Medicines Access and Rational Use (MAR) Essential Medicines and Health Products (EMP) World Health Organization CH-1211 Geneva 27 Switzerland

email: [email protected] Comments and Questions welcome There are Notes in some of the slides which explain the issue

further.