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WHO Programme for International Drug Monitoring

Posted on: Thursday, 16 June 2005, 03:00 CDT

The WHO Programme for International Drug Monitoring was launched in 1968 as a pilot project of ten countries with established national reporting systems for ADRs. Since then, many more countries worldwide have developed national pharmacovigilance centres for the recording of ADRs and the reporting network has expanded significantly. Currently, a total of 86 countries participate in the International Drug Monitoring Programme. The Programme depends on a WHO Collaborating Centre based in Sweden (Uppsala Monitoring Centre), which is responsible for maintaining the global ADR database. VIGIBASE now contains more than three million ADR reports.

Structure of the WHO Programme for International Drug Monitoring

As part of its work, the WHO Collaborating Centre analyses the reports in the database to:

* identify early warning signals of serious adverse reactions to medicines;

* evaluate the hazard; and

* undertake research into the mechanisms of action to aid the development of safer and more effective medicines.

WHO also plays an important role in the provision of expert advice through an advisory committee, on all matters of safety of medicines. Its aim is to facilitate consistent policies and action among member countries and to advise those who may be concerned about action taken in another country.

The success of the WHO International Drug Monitoring Programme is entirely dependent on collaboration with national pharmacovigilance centres. Such centres provide an essential pool of experience and competence which has been instrumental in the continuous development of the WHO programme. Ideally every country should have a national pharmacovigilance system.

WHO International Drug Monitoring Programme: membership

References

1. World Health Organization. Policy perspectives on Medicines. Pharmacovigilance: ensuring the safe sue of medicines. Available at http://www.who.int/medicines

2. Lazarou, J. et al. Incidence of ADR in hospitalized patients: a meta-analysis of prospective studies. Journal of the American Medical Association, 279:1000-1005 (1998).

3. World Health Organization. Safety monitoring of medicinal products. The importance of pharmacovigilance. Geneva, 2002.

4. World Health Organization. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Annex 3. Technical Report Series, No. 850. 1995.

5. World Health Organization. Aide Memoire for a national strategy for safe drugs and their appropriate use. 2001. http:// www.who.int/medicines/library/qsm/ aidemem_drug_safety.pdf

6. WHO Collaborating Centre for International Drug Monitoring. Expecting the worst. Crisis management. Uppsala, 2002. http:// www.who-umc.org

7. WHO Collaborating Centre for International Drug Monitoring. Effective communications in pharmacovigilance: the Erice Report. Uppsala, 1998. http://www.whoumc.org

8. WHO Collaborating Centre for International Drug Monitoring. Dialogue in pharmacovigilance - more effective communication. Uppsala, 2002. http:// www.who-umc.org

9. World Health Organization. Safety of medicines. A guide to detecting and reporting adverse drug reactions. WHO/EDM/QSM/2002.2. http://www.who.int/medicines

10. The WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden (the Uppsala Monitoring Centre) www.who- umc.org

11. World Health Organization. Safety monitoring of medicines. Guidelines for setting up and running a pharmacovigilance centre. Geneva, 2000. http:// www.who.int/medicines

12. Linquist, A.M. seeing and observing in international pharmacovigilance. Uppsala, WHO Collaborating Centre for International Drug Monitoring, 2003.

13. Van Boxtel, CJ., Santoso, B., Edwards, I.R. Medicine benefits and risks. In: International Textbook of Clinical Pharmacology. John Wiley & Sons, Chichester, 2001.

Copyright World Health Organization 2005

Source: WHO Drug Information

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