WHO Programme for International Drug
MonitoringMary Couper and Shanthi Pal
Quality Assurance and Safety of MedicinesMedicines Policy and Standards
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WHO Programme for International Drug
Monitoring
WHO HQ + WHO HQ + 6 Regional 6 Regional
officesoffices
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
NationalNational CentresCentres
Technical Briefing Seminar Geneva 22-26 September 2008|3 |
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)
Technical Briefing Seminar Geneva 22-26 September 2008|4 |
Regional Offices of WHO
AFRO (Brazzaville)
AMRO/PAHO (Washington DC)
EMRO (Cairo)
EURO (Copenhagen)
SEARO (New Delhi)
WPRO (Manila)
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Director-General- Dr Margaret Chan
Health Action in Crises
Representatives of theDirector-General a.i.
Polio Eradication
Link toRegional Offices
NoncommunicableDiseases andMental Health
Family andCommunity Health
Health Security and Environment
Health Systems and Services
MEDICINES
Information, Evidenceand Research General Management
HIV/AIDS, TB andMalaria and neglected Tropical diseases
WHO structure at headquarters
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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
Technical Briefing Seminar Geneva 22-26 September 2008|7 |
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
Technical Briefing Seminar Geneva 22-26 September 2008|14 |
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
Technical Briefing Seminar Geneva 22-26 September 2008|16 |
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
Technical Briefing Seminar Geneva 22-26 September 2008|17 |
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
Technical Briefing Seminar Geneva 22-26 September 2008|18 |
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
Technical Briefing Seminar Geneva 22-26 September 2008|23 |
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
Technical Briefing Seminar Geneva 22-26 September 2008|24 |
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 + WHO HQ + 6 Regional 6 Regional
officesoffices
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
NationalNational CentresCentres
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WHO Collaborating Centrethe Uppsala Monitoring Centre
established as a foundation 1978based on agreement Sweden – WHO (1978 and
revised 2002) international administrative boardWHO Headquarters responsible for policyStaff 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
Technical Briefing Seminar Geneva 22-26 September 2008|30 |
WHO Programme for International Drug
Monitoring
WHO HQ + WHO HQ + 6 Regional 6 Regional
officesoffices
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
NationalNational CentresCentres
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WHO International Drug Monitoring Programme August 2008
Technical Briefing Seminar Geneva 22-26 September 2008|32 |
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
National Centres participating in the Programme August 2008
Technical Briefing Seminar Geneva 22-26 September 2008|33 |
ESP 2%
SWE 2%
THA 2%
NLD 2%
OTHER 11%
AUS 5%
FRA 5%
CAN 5%
DEU 6%
GBR 12%
USA 48%
Top ten contributors to WHO database
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National Centres - flow of information
WHO CollaboratingCentre (UMC)WHO Headquarters
National Centres
Medical practice
Manufacturers
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Requirements for joining the WHO Programme
programme for collection of spontaneous ADR reports established
a National Centre designated by Ministry of Healthtechnical competence to fulfil WHO reporting
requirements
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Process for joining WHO Programme
1. Ministry of Health (or equivalent) designates National Centre Ministry of Health
National Centre
the UMCWHO-HQGeneva
1
23
4
52. Ministry of Health sends
formal application to WHO-HQ, Geneva
3. National Centre sends sample reports to the UMC4. UMC notifies WHO-HQ that reports are compatible5. WHO-HQ advises Ministry of Health of admittance to the Programme
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Drug safety is a global responsibility.
WHO cannot work alone. With increasing global awareness and much under-reptorting much work remains.
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Website addresses
http://www.who.int/medicines– http://www.who.int/medicines/areas/quality_safety/
safety_efficacy/en/index.html
http://www.who-umc.org
Thank YouThank You
Merci beaucoup !Merci beaucoup !