[A general practitioner's one year record of adverse drug reactions]

To systematically record and analyse every adverse drug reaction (ADR) observed by one general practitioner (GP) over the course of one year of practice.

Every ADR reported by patients, or discovered upon questioning, was collected and classified as either serious or non serious and as labelled or unlabelled. Suspected drugs were classified according to their pharmacological group, therapeutic class and médical specialty.

We observed 163 ADRs for 7074 medical acts (2.29 per 100 consultations). Of these, 12 were serious and labelled, 5 non serious and unlabelled (0.17 and 0.07 per 100, respectively). Ninety drugs were involved. Of the 34 therapeutic classes involved analgesics accounted for 30.1% of ADRs. Of the 57 pharmacological groups opiates were associated with 18.5% of ADRs. Among the 18 medical specialties, rheumatology accounted for 33.1% of ADRs. Based on the data collected, the average French GP could be expected to report 9.8 ADRs per year (6.9 serious and 2.9 unlabelled), resulting potentially in 388,502 serious ADRs reported in France annually, in contrast to the 759 actually declared in 2008.

Under-reporting of ADRs by GP is confirmed. Mainly analgesics and opiates are concerned. Serious and unlabelled AEs could be better recorded and reported by GPs.