who programme for international drug monitoring

WHO Programme for International Drug

MonitoringMary Couper and Shanthi Pal

Quality Assurance and Safety of MedicinesMedicines Policy and Standards

Technical Briefing Seminar Geneva 22-26 September 2008|2 |


Monitoring

WHO HQ + WHO HQ + 6 Regional 6 Regional

officesoffices

WHO WHO Collaborating Collaborating

Centre, UppsalaCentre, Uppsala

NationalNational CentresCentres


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)


Regional Offices of WHO

AFRO (Brazzaville)

AMRO/PAHO (Washington DC)

EMRO (Cairo)

EURO (Copenhagen)

SEARO (New Delhi)

WPRO (Manila)


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


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


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/


Specific publications

Assessment of hepatotoxicity of kava

Pharmacovigilance for antiretrovirals

Amodiaquine + artemisinine

Articles in journals


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.


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


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


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


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


Collaboration with HIV/AIDS

Joint training programmes

Joint terminology meetings

Joint fund raising proposal

Joint cohort event monitoring studies proposed


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


Collaboration with Traditional Medicines Programme

Participation in meetings

Publication on Safety of Herbal medicines

Joint training courses on safety of herbal medicines


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


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


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


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


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



Monitoring


officesoffices





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


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



Monitoring


officesoffices





WHO International Drug Monitoring 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

National Centres participating in the Programme August 2008


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


National Centres - flow of information

WHO CollaboratingCentre (UMC)WHO Headquarters

National Centres

Medical practice

Manufacturers


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


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


Drug safety is a global responsibility.

WHO cannot work alone. With increasing global awareness and much under-reptorting much work remains.


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

http://www.who.int/medicines



Thank YouThank You

Merci beaucoup !Merci beaucoup !

who programme for international drug monitoring

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