WHO Programme For International Drug Monitoring

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 + WHO
6 Regional Collaborating
offices Centre, Uppsala
National
Centres
2| Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

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)

WHO structure at headquarters
Director-General
Dr Margaret- Chan
Representatives of the Link to

Director-General a.i. Regional Offices
Health Action
Polio Eradication in Crises
Noncommunicable
HIV/AIDS, TB and
Diseases and
Malaria and neglected Health Systems and Mental Health
Tropical diseases Services
MEDICINES
Family and
Community Health
Health Security and
Environment Information, Evidence
and Research 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

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/

10 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |
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
WHO HQ + WHO
National
Centres

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

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
WHO HQ + WHO
National
Centres

WHO International Drug Monitoring Programme
August 2008

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

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%

National Centres - flow of information
Medical practice
National Centres
Manufacturers
WHO Headquarters 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

Process for joining WHO Programme
1. Ministry of Health (or equivalent)

designates National Centre Ministry of Health
1
1. Ministry of Health sends National

formal application to
5 2 Centre
WHO-HQ, Geneva
• National Centre sends 3
sample reports to the
UMC the UMC
1. UMC notifies WHO-HQ
that reports are WHO-HQ
compatible
1. WHO-HQ advises Ministry
Geneva 4
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_efficac
y/en/index.html
 http://www.who-umc.org

Thank You
Merci beaucoup !

WHO Programme For International Drug Monitoring

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WHO Programme For International Drug Monitoring

Caricato da

Copyright:

Formati disponibili

WHO Programme for

2| Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 The Director-General (Office Term 5 years; Nominated by

3| Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 AMRO/PAHO (Washington DC)

 SEARO (New Delhi)

4| Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

Representatives of the Link to

5| Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 Reviews of Specific Medicines

 Advisory Committee Meetings on Medicines and Vaccines

 Annual meeting of National PV centres, October 2008

6| Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 Pharmacovigilance for antimalarials, 2008

 WHO Restricted List 2008 in press

 Web page: http://www.who.int/medicines/

7| Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

Assessment of hepatotoxicity of kava

Pharmacovigilance for antiretrovirals

13 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

14 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 Vigimed discussion group

15 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 ICH EWG M5 Data Elements and Standards for Drug

 ICH E2B M Harmonization of electronic transfer of

 Maintenance of Controlled Vocabularies

 EWG on Developmental Safety Update Reports

16 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 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

 New position at UMC for vaccine safety

17 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 Not enough data on safety is known

 A new programme for monitoring ADRs is being set up in

18 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 Joint terminology meetings

 Joint fund raising proposal

 Joint cohort event monitoring studies proposed

19 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 Joint training courses

 Joint reviews of specific antimalarials

 Collaboration on development of pregnancy register

20 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 Publication on Safety of Herbal medicines

 Joint training courses on safety of herbal medicines

21 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 Advice on labelling for specific medicines in intestinal

 Advice on safe use in pregnancy for medicines used in

 Advice on safety of medicines for children

22 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

Need for WHO to have a mechanism for accepting ADR

23 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 Advice on toxicity for medicines to be deleted

 Advice to the editors of the WHO Model Formulary on

24 | Techn ical Brie fing Semi na r G en eva 22-26 Septemb er 200 8 |

 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