E-DRUG: How to apply for a WHO essential drug?
--------------------------------------------------------
[copied from www.who.int/medicines; WB]
The next WHO Expert Committee on the selection and use of essential
medicines will be held 31 March - 4 April 2003.
If you want to include, change or delete an essential drug, the following
information is necessary. Send the application before 15 November 2002 to:
Dr Hans Hogerzeil
WHO/EDM
CH-1211 Geneva 27
Switzerland
Email: hogerzeilh@who.int
INFORMATION TO BE INCLUDED IN AN APPLICATION FOR INCLUSION, CHANGE OR
DELETION OF A MEDICINE IN THE WHO MODEL LIST OF ESSENTIAL MEDICINES
1. Summary statement of the proposal for inclusion, change or deletion
2. Name of the focal point in WHO submitting the application
3. Name of the organization(s) consulted and/or supporting the application
4. International Nonproprietary Name (INN, generic name) of the medicine
5. Whether listing is requested as an individual medicine or as an example
of a therapeutic group
6. Information supporting the public health relevance (epidemiological
information on disease burden, assessment of current use, target
population)
7. Treatment details (dosage regimen, duration; reference to existing WHO
and other clinical guidelines; need for special diagnostic or treatment
facilities and skills)
8. Summary of comparative effectiveness in a variety of clinical settings:
� Identification of clinical evidence (search strategy, systematic
reviews identified, reasons for selection/exclusion of particular data)
� Summary of available data (appraisal of quality, outcome measures,
summary of results)
� Summary of available estimates of comparative effectiveness
9. Summary of comparative evidence on safety:
� Estimate of total patient exposure to date
� Description of adverse effects/reactions
� Identification of variation in safety due to health systems and patient
factors
� Summary of comparative safety against comparators
10. Summary of available data on comparative cost1 and cost-effectiveness
within the pharmacological class or therapeutic group:
� range of costs of the proposed medicine
� comparative cost-effectiveness presented as range of cost per routine
outcome (e.g. cost per case, cost per cure, cost per month of treatment,
cost per case prevented, cost per clinical event prevented, or, if possible
and relevant, cost per quality-adjusted life year gained)
11. Summary of regulatory status of the medicine (in country of origin,
and preferably in other countries as well)
12. Availability of pharmacopoieal standards (British Pharmacopoeia,
International Pharmacopoiea, United States Pharmacopoeia)
13. Proposed (new/adapted) text for the WHO Model Formulary
Note: The information on cost and cost-effectiveness should preferably
refer to average generic world market prices as listed in the International
Drug Price Indicator Guide [http://erc.msh.org; WB], an essential
medicines pricing service provided by WHO and maintained by Management
Sciences for Health. If this information is not available, other
international sources, such as the WHO, UNICEF and M�decins sans Fronti�res
price information service, can be used. All cost analyses should specify
the source of the price information.
After submission to WHO, the process is as follows:
1. The secretary of the Expert Committee checks the application for
completeness
2. A summary of the application is posted on the WHO web site1 for review
and comments (http://www.who.int/medicines/)
3. Specialist assessment(s) are made of the data on comparative efficacy,
safety and cost-effectiveness, in close collaboration with relevant
departments in WHO
4. The outcome of these assessments is summarized by an expert invited to
attend the next meeting of the Expert Committee as a member ("the
presenter") who formulates a draft recommendation for the Committee
5. The draft recommendation and proposed text of the WHO Model Formulary
are reviewed by the relevant department in WHO and members of relevant
expert advisory panels. They are also posted on the WHO web site for
comments, for a minimum of 30 days
6. The presenter reviews the comments and formulates a final text for
consideration by the Expert Committee
7. The Expert Committee reviews and adopts the application as a
recommendation to the Director-General
[end]
--
To send a message to E-Drug, write to: e-drug@usa.healthnet.org
To subscribe or unsubscribe, write to: majordomo@usa.healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@usa.healthnet.org
Information and archives: http://www.healthnet.org/programs/edrug.html