P. Montastruc et al., A PROSPECTIVE INTENSIVE STUDY OF ADVERSE DRUG-REACTIONS IN URBAN GENERAL-PRACTICE, Clinical drug investigation, 10(2), 1995, pp. 117-122
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 examin
ed and 20 ADRs were observed. Results of this study of ADRs by urban p
hysicians were compared with a similar study by a French physician in
rural medical practice using the same method. In the present study, cu
taneous (n = 6) and neurological (n = 6) ADRs were the most frequent u
ntoward effects observed. The main drugs involved in the study were ps
ychotropic (5 cases), nonsteroidal anti-inflammatory (n = 5) and anti-
infectious (n = 4) agents. The prevalence rate of ADRs was 1% of the c
onsultations/visits (2.2 ADRs/general practitioner/month), which was i
dentical 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 p
ractitioners throughout the 'departement' to the Midi-Pyrenees regiona
l Pharmacovigilance Centre. On the basis of this comparison, we estima
ted that the under-reporting rate of ADRs was approximately 1/3000.