A Prospective Intensive Study of Adverse Drug Reactions in Urban General Practice

Abstract

This was a prospective study of adverse drug reactions (ADRs) over a 3-month study period reported by 3 urban physicians who were in general practice in southwestern France. A total of 2094 patients were examined and 20 ADRs were observed. Results of this study of ADRs by urban physicians were compared with a similar study by a French physician in rural medical practice using the same method. In the present study, cutaneous (n = 6) and neurological (n = 6) ADRs were the most frequent untoward effects observed. The main drugs involved in the study were psychotropic (5 cases), nonsteroidal anti-inflammatory (n = 5) and anti-infectious (n = 4) agents. The prevalence rate of ADRs was 1% of the consultations/visits (2.2 ADRs/general practitioner/month), which was identical to that previously observed in a rural medical practice. ADRs involving psychotropic drugs were more frequent (p < 0.05) in urban (25%) than in rural (6%) medical practices. We compared the 1% rate in this study with the ADR rate based on spontaneous reports by general practitioners throughout the ‘departement’ to the Midi-Pyrenees regional Pharmacovigilance Centre. On the basis of this comparison, we estimated that the under-reporting rate of ADRs was approximately 1/3000.