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Pharmacovigilance: databases accessible to the public

Full public access to pharmacovigilance databases is already in place in 4 countries, but is still a long way from being a reality in France.

In order to improve the quality and safety of care, access to data on adverse effects is crucially important, both for patients and for healthcare professionals.

At the 32nd French pharmacovigilance conference, a team from Lyon presented the findings of a study of 4 countries that allow public access to pharmacovigilance data: the USA since 1998, the Netherlands since 2003, Canada and the UK since 2005.

All four databases contain reports of adverse effects that have occurred in the respective countries.

They all list the types of adverse effects and their outcome. Access to data varies from one country to another. Some databases also include cases reported internationally. In the UK, information is presented generally, with no information on the patients' age or gender, while in the other three countries each report specifies the patient's age and gender. The Canadian and Dutch databases report the seriousness of the adverse effects.

Access to pharmacovigilance data has existed in these 4 countries for several years. When will there be wider access in France and throughout the  European Union?

©Prescrire 1 April 2012

"Publicly accessible pharmacovigilance databases" Prescrire Int 2012; 21 (126): 99. (Pdf, subscribers only).
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