Spontaneous reporting of adverse drug reactions: who reports and what?

Pharmacoepidemiol Drug Saf. 1998 Sep;7(5):323-9. doi: 10.1002/(SICI)1099-1557(199809/10)7:5<323::AID-PDS374>3.0.CO;2-8.


A survey among Bordeaux pharmacovigilance centre 'users' and 'non-users' was conducted in Aquitaine, France. Two hundred physicians having reported to the centre at least one adverse drug reaction (ADR) during the past 3 years were matched to a randomly selected sample of 400 physicians who did not report. They were asked to anonymously fill out a postal questionnaire collecting data on their individual characteristics, including their practice mode, and on ADRs that they observed and reported during the past 12 months. The number of questionnaires returned was 151 (25%), of which 76 were from users (38%) and 75 from non-users (19%). The two groups had very close individual characteristics. All but three responders had observed at least one ADR during the past 12 months. For the different types of ADRs defined in terms of seriousness and labelling, more users had seen ADRs than non-users but among those who observed them, the numbers of ADRs seen were similar in both groups. In any case, the more recent the drug, the more prone to report were the physicians.