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(2003; 20 pages) [French] [Spanish]
Pharmacovigilance: detecting and reporting adverse drug reactions
Safety of Medicines: A Guide to Detecting and Reporting Adverse Drug Reactions. Why Health Professionals Need to Take Action1presents some alarming information. Problems with medicines - known as adverse drug reactions (ADRs) - are the 4th to 6th largest cause of mortality in the USA. WHO is promoting pharmaco-vigilance2 to help prevent medicines-related morbidity and mortality. Collecting reports of ADRs is key to pharmacovigilance.
1 Published in 2002. See also The Importance of Pharmacovigilance, published in 2002 and available at: http://whqlibdoc.who.int/hq/2002/a75646.pdf.
2 Pharmacovigilance consists of methods to identify and quantitatively assess the risks related to the use of medicines in the entire population, or in specific population subgroups.
WHO's international ADR monitoring database was made available for national pharmacovigilance centres in 2002. It is the cornerstone of the WHO Programme for International Drug Monitoring operated by the Uppsala Monitoring Centre (UMC) in which 68 countries now participate. The programme held its 25th annual meeting in 2002. A new procedure introduced by UMC in 2002 focuses on detecting serious ADRs associated with newer drugs and drug-ADR combinations.
In the last two years, special efforts have been made to improve pharmacovigilance in the Newly Independent States (NIS), following a request from eight NIS countries for assistance. Widespread economic and social changes had affected health care in general and the pharmaceutical sector in particular in these countries, with negative impacts on not only availability, but also the quality of essential medicines.
In 2000, a project - Development of National Systems for Drug Monitoring in Newly Independent States - was launched, covering Armenia, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Ukraine and Uzbekistan. Evaluation showed that monitoring and evaluation of ADRs varied enormously. For example, Armenia, the Russian Federation and Ukraine each had a pharmaco-vigilance system in place, but these were not highly developed. Recommendations were made to countries depending on their population size, economic and social conditions, and level of existing expertise. For example, since Kazakhstan, the Russian Federation and Ukraine each have a large population and extensive territory, it was recommended that they each establish several regional pharmacovigilance centres, as well as a national pharmaco-vigilance centre.
Country progress in collecting information on adverse drug reactions (ADRs)
Cuba became a member of the WHO Programme for International Drug Monitoring in 1994. In 1998, the Cuban system of pharmacovigilance collected around 900 reports. In 1999, responsibility for drug safety monitoring and promotion of ADR reporting became part of continuous education activities, resulting in a dramatic increase in the number of reports. In 2001, the national pharmacovigilance centre received 16 295 ADR reports. The reporting rate per capita is now the world’s highest.
Ghana became a full member of the WHO Programme for International Drug Monitoring in 2001. The spontaneous reporting system in Ghana is reported as going well, with increasing acceptance of the programme by prescribers, dispensers and the general public. Training courses on ADR reporting have been held.
New Zealand was one of the founding members of the WHO Programme for International Drug Monitoring. New Zealand’s national monitoring centre for adverse reactions collects and evaluates spontaneous reports of adverse reactions to medicines, vaccines, herbal products, dietary supplements, and blood products. Its database now holds over 48 000 reports and provides New Zealand-specific information on adverse reactions to these products, and serves to support clinical decision-making when unusual symptoms are thought to be therapy-related.
Growth of membership of International Drug Monitoring Programme since its inception in 1968
To help in this task, WHO guidelines on setting up and running a pharmacovigilance centre were translated into Russian and distributed. Additionally, four pharmacovigilance training seminars, using the "train-the-trainers" principle, were conducted. A further 200 educational and information seminars and meetings on pharmacovigilance were organized for health care providers.
Concurrently, national pharmaco-vigilance systems were established in all eight countries through passing of special legislation and/or regulations. Five of the countries also joined the WHO International Drug Monitoring Programme. In Kazakhstan, Russia and Ukraine, 30, 15 and 25 regional ADR centres respectively have also been set up. Reporting of ADRs is now well under way and a national database to collect information on ADRs has been established in each country. Armenia and Russia now publish special bulletins on drug safety, while the other countries include drug safety information in their drug bulletins.