Transcript WHO Programme for International Drug

WHO Programme for
International Drug
Monitoring
Mary Couper and Shanthi Pal
Quality Assurance and Safety of Medicines
Medicines Policy and Standards
WHO Programme for International Drug
Monitoring
WHO HQ +
6 Regional
offices
WHO
Collaborating
Centre, Uppsala
National
Centres
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Secretariat of WHO
 The Director-General (Office Term 5 years; Nominated by
the Executive Board; Elected by Member States)
 Staff
(Health professionals, other experts and support staff
working at HQ in Geneva, 6 Regional Offices and
representatives throughout the world)
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Regional Offices of WHO
 AFRO (Brazzaville)
 AMRO/PAHO (Washington DC)
 EMRO (Cairo)
 EURO (Copenhagen)
 SEARO (New Delhi)
 WPRO (Manila)
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WHO structure at headquarters
Director-General
Dr Margaret
- Chan
Representatives of the
Director-General a.i.
Polio Eradication
HIV/AIDS, TB and
Malaria and neglected
Tropical diseases
Health Security and
Environment
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Health Action
in Crises
Health Systems and
Services
MEDICINES
Information, Evidence
and Research
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Link to
Regional Offices
Noncommunicable
Diseases and
Mental Health
Family and
Community Health
General Management
Drug safety activities in WHO HQ
 Publications
 Reviews of Specific Medicines
 Advisory Committee Meetings on Medicines and Vaccines
 Training Courses
 Collaborative activities
 Annual meeting of National PV centres, October 2008
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Publications
 6 issues of Pharmaceutical Newsletter also available
on-line
 Promoting Safety of Medicines in children, 2007
 Pharmacovigilance for antimalarials, 2008
 WHO Restricted List 2008 in press
 Web page: http://www.who.int/medicines/
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Specific publications
 Assessment of hepatotoxicity of kava
 Pharmacovigilance for antiretrovirals
 Amodiaquine + artemisinine
 Articles in journals
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Advisory Committee on Safety of
Medicinal Products (ACSoMP)
 The Advisory Committee on Safety of Medicinal
Products shall provide advice to the Assistant
Director-General of the Health Technology cluster in
WHO and through him to the Collaborating Centre
for International Drug Monitoring (the Uppsala
Monitoring Centre), and to the Member States of
WHO, on pharmacovigilance policy and issues
related to the safety and effectiveness of medicinal
products.
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Sharing information
 Annual meeting of national pharmacovigilance centres: An
important forum for national PV centres to meet and
discuss matters of common interest
– Problems of Current Interest
– Turkey, Tunisia, New Zealand, Amsterdam, New Delhi, Dublin
Geneva, Belgium, Argentina, Sweden
 Vigimed discussion group
 ICDRA
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Collaboration with ICH
 ICH MedDRA Management Board
 ICH EWG M5 Data Elements and Standards for Drug
Dictionaries
 ICH E2B M Harmonization of electronic transfer of
International Case Safety Reports
 Maintenance of Controlled Vocabularies
 EWG on Developmental Safety Update Reports
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Collaboration with Vaccines
 Advisory Committee on Vaccine Safety June 2008
 Joint reviews of specific vaccines
 Project for improving vaccine signal detection
 Global Network for Post-marketing Surveillance of
Newly Pre-qualified Vaccines
 New position at UMC for vaccine safety
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Collaboration with Visceral Leishmaniasis
 New medicines for visceral leishmaniasis are being
developed
 Not enough data on safety is known
 A new programme for monitoring ADRs is being set up in
India, Nepal and Bangladesh
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Collaboration with HIV/AIDS
 Joint training programmes
 Joint terminology meetings
 Joint fund raising proposal
 Joint cohort event monitoring studies proposed
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Collaboration with Malaria
 Investigation of specific antimalarials
– Amodiaquine-artesunate
 Joint training courses
 Joint reviews of specific antimalarials
– Artemisinine derivatives in pregnancy
– Chlorproguanil-dapsone
 Collaboration on development of pregnancy register
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Collaboration with Traditional Medicines
Programme
 Participation in meetings
 Publication on Safety of Herbal medicines
 Joint training courses on safety of herbal medicines
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Collaboration with Parasitic Disease
Programme
 Advice to Lymphatic filariasis programme on mass drug
administration
 Advice on labelling for specific medicines in intestinal
parasitic diseases
 Advice on safe use in pregnancy for medicines used in
intestinal parasitic diseases
 Advice on safety of medicines for children
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Lymphatic filariasis
Almost 110 million people targeted for MDA under the
WHO-recommended strategies of administering either
diethylcarbamazine citrate (DEC) plus albendazole or
ivermectin plus albendazole.
Need for WHO to have a mechanism for accepting ADR
reports from Public Health Programmes
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Collaboration with Essential Medicines List
and WHO Model Formulary
 Safety reviews for new medicines to be included on the
15th EML in 2009
 Advice on toxicity for medicines to be deleted
 Advice to the editors of the WHO Model Formulary on
pharmacovigilance section
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WHO HQ training courses
 Two PV training courses 1) CEM 2) Advanced PV, Ghana, June 2007
 PV training course December, UAE, 2007
 ARV follow-up course, Suriname March 2008
 ARV toxicity management course April 2008
 Advanced French-speaking course May 2008
 Advanced Antimalarial PV Ghana June 2008
 Training course for public health programmes in Sierra Leone, August, 2008
 Introductory PV course in Philippines September 2008
 Technical Briefing Seminar ,Switzerland, September 2008
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Identifying reports of medication errors: the
'patient safety' pilot project
 Project to define an extended role for national PV centres
 Partners: WHO, UMC, Moroccan PV Centre
 Prospective and retrospective analysis of database to track
reports of medications errors
 Project concluded March 2008; plans to expand to other
centres
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WHO Programme for International Drug
Monitoring
WHO HQ +
6 Regional
offices
WHO
Collaborating
Centre, Uppsala
National
Centres
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WHO Collaborating Centre
the Uppsala Monitoring Centre
 established as a foundation 1978
 based on agreement Sweden – WHO (1978 and revised
2002)
 international administrative board
 WHO Headquarters responsible for policy
 Staff of about 50
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WHO Collaborating Centre (Uppsala
Monitoring Centre)
 Collection & processing of data: maintaining & developing
the international adverse drug reaction database > 4
million reports
 Regular screening of data to issue signals
 Research
– new ADR findings, new methodology, technology, methods of
communication
 Information centre
 Training centre
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WHO Programme for International Drug
Monitoring
WHO HQ +
6 Regional
offices
WHO
Collaborating
Centre, Uppsala
National
Centres
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WHO International Drug Monitoring Programme
August 2008
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National Centres participating in the Programme
August 2008
86 countries
participate in the WHO Programme on International Drug
Monitoring
Include Argentina, Ghana, Kenya, Nepal, Netherlands,
Nigeria, Russia, Sri Lanka, Tunisia, Uganda, USA
31 Associate Members
Include Ethiopia, Sierra Leoneq and Sudan
Countries not yet participating include Namibia and Slovenia
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Top ten contributors to WHO database
OTHER 11%
NLD 2%
THA 2%
SWE 2%
ESP 2%
AUS 5%
USA 48%
FRA 5%
CAN 5%
DEU 6%
GBR 12%
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National Centres - flow of information
Medical practice
National Centres
Manufacturers
WHO Headquarters
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WHO Collaborating
Centre (UMC)
Requirements for joining the WHO
Programme
 programme for collection of spontaneous ADR reports
established
 a National Centre designated by Ministry of Health
 technical competence to fulfil WHO reporting requirements
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Process for joining WHO Programme
1.
Ministry of Health (or equivalent)
designates National Centre
2. Ministry of Health sends
formal application to WHOHQ, Geneva
Ministry of Health
2
5
5. WHO-HQ advises Ministry of
Health of admittance to the
Programme
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National
Centre
3
3. National Centre sends
sample reports to the UMC
4. UMC notifies WHO-HQ
that reports are compatible
1
the UMC
WHO-HQ
Geneva
4
Drug safety is a global responsibility.
WHO cannot work alone. With increasing
global awareness and much underreptorting much work remains.
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Website addresses
 http://www.who.int/medicines
– http://www.who.int/medicines/areas/quality_safety/safety_efficac
y/en/index.html
 http://www.who-umc.org
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Thank You
Merci beaucoup !