Selection of essential medicines Richard Laing and Deidre Dimancesco TBS 2011 Department of...

Selection of essential medicines

Richard Laing and Deidre DimancescoTBS 2011

Department of Essential Medicines & Pharmaceutical Policies TBS 2008

Department of Essential Medicines & Pharmaceutical PoliciesTBS 2011 (2)

Outline

What are essential medicines and why have them? How are they selected? Linking with treatment guidelines Linking with evidence New developments


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

(Report to WHO Executive Board, January 2002)


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.


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 March 2011 list contains 358 active substances

See Comparative analysis Next revision 20013

http://www.who.int/entity/medicines/publications/essentialmedicines/EMLsChanges1977_2011.xls


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


The essential drugs concept is nearly universal

Countries 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.


So what?

Evidence of impact – health outcomes Delhi state improved availability of supply studies of lack of essential medicines

Evidence of impact – policy, advocacy Indirect evidence through impact of listing ARVs Linkage with pricing policies Linkage with import policies


Outline



Process

Application lodged

Reviewed internally, published on web

External expert review and comment

Public commentWHO department

comment

Expert Committee review and

recommendation


Recommendation based on…

Public health need

Evidence of comparative effectiveness and safety

Global experience of use / suitability

Cost (indicative prices only)

NOT patent

No formal cost-effectiveness assessment


Outline



The ideal

WHO treatment guideline developed Treatment recommendation made Proposal to update list to reflect new guideline Potential to influence practice



Outline



Cochrane reviews

Over 50% of medicines on the 14th list have a relevant Cochrane review

Useful source of information Some reviews raise questions over inclusion on the list

e.g. antacids, allopurinol

http://apps.who.int/emlib/MedicineDisplay.aspx?Language=EN&MedIDName=3%40acetylsalicylic acid

http://apps.who.int/emlib/MedicineDisplay.aspx?Language=EN&MedIDName=3%40acetylsalicylic%20acid






The WHO Essential Medicines Library:

WHOModel List

WHO Model Formulary(search)


The WHO Essential Medicines Library,

WHOModel List

Summary of clinical guideline

Reasons for inclusionSystematic reviewsKey references

WHO Model Formulary

Link to price information

Quality information:- Basic quality tests- Intern. Pharmacopoea- Reference standards

Clinical guideline

WHO clusters

MSHUNICEF

MSF

WHO/QSM

WHO/EMP

WHO/EC, Cochrane, Guideline Clearing House

Statistics:- ATC- DDD

WCCs Oslo/Uppsala

Selection


The WHO Model List of Essential Medicines is a model product, model process and public health tool

Independent Membership of the Committee, careful consideration of conflict of interest

Transparent process, standard application, web review Link to evidence-based clinical guidelines Systematic review of comparative efficacy, safety, cost-

effectiveness and public health relevance Rapid dissemination, electronic access Regular review


Outline



The need for essential medicines for children

When appropriate medicines for children are not available fractions of adult doses are often used

Can be hard for the child to take Can result in under dosing or over dosing

Syrups which are easier to take are more costly and have more difficult storage/shelf life

Some conditions require children to take several medicines daily


Ideal medicines for children

Flexible oral solid dosage forms where possible

Pleasant taste

Stable, long shelf life, not liquid

Simple dosing schedules, weight based

Packaging and labelling to enhance adherence


Are essential medicines for children available?


Essential medicines for children

A temporary subcommittee was established by the Executive Board in 2007

To prepare a Model List of Essential Medicines for Children To determine suitability criteria for dosage forms of medicines

for children To review feasibility of manufacturing appropriate formulations

for those priority medicines for which no dosage form for children exists

To identify clinical research gaps regarding safety and efficacy of medicines for children

Since then a separate EML has been maintained


3rd WHO Essential List of Medicines for Children

Expert Committee meeting March 2011

Total of 269 medicines on the list Core list: 199 meds Complementary list: 59 meds

Next meeting 2013


Priority essential medicines for children

Use of the WHO EML for children to select Those medicines that:

Address the main burden of disease in children Have evidence of benefit Are included in current treatment guidelines Are commercially available

Priority list launch in March 2011


Causes of death in under 5s

Black et al. Lancet, 2010WHO. The World Health Statistics 2010

8.1 million deaths per year


Priority medicines for major causes of mortality and morbidity in children, palliative care and child survival

Pneumonia Amoxicillin - dispersible, scored tablets 250 mg and 500 mg or equivalent flexible oral solid dosage form, in blister packs of 10

Gentamicin - injection 20 mg/ml Ampicillin - powder for injection 500 mg and 1g

Procaine benzylpenicillin - powder for injection 1 g and 3 g Ceftriaxone - powder for injection 250 mg and 1 g

Oxygen - medicinal gas

Diarrhoea ORS - sachets of 200 ml; 500 ml and 1 litre, appropriate flavour Zinc - 20 mg scored dispersible tablet or equivalent flexible oral solid dosage form

Malaria Artemisin combination therapy (ACT) - strengths and combinations according to WHO treatment guidelines 2010, dispersible tablet or flexible oral solid dosage form and dose

optimized

Artesunate - rectal and injection dosage forms 50-200 mg

Neonatal sepsis Gentamicin - injection 20 mg/ml Procaine benzylpenicillin - powder for injection 1 g and 3 g

Ceftriaxone - powder for injection 250 mg and 1 g

HIV Standard regimen for first-line anti-retroviral treatment: 1 non-nucleoside reverse transcriptase inhibitor plus 2 nucleoside reverse transcriptase inhibitors such as the fixed dose combination of lamivudine + nevirapine + zidovudine - tablet 30 mg + 50 mg + 60 mg ; 150 mg+ 200 mg + 300 mg For treatment of specific conditions, see the latest WHO treatment guidelines.

Palliative care and pain Paracetamol - variable flexible oral solid dosage forms

Morphine - granules 20 mg; 30 mg; 60 mg; 100 mg; 200 mg; injection 10 mg/ml; oral liquid 10 mg/5 ml; variable flexible oral solid dosage forms

Vitamin A deficiency Vitamin A - capsule 100 000 IU strength


Priority medicines for children

National essential medicine list as a starting point Priority medicines in national treatment guidelines Verify the supplier of a quality product Ensure that the priority medicines are licensed Make sure that the priority medicines are in the supply chain Check that health professionals know how to use the priority

medicines Check that there is consumer demand



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