Proton pump inhibitors in general medicine. Comparison of routine practices with marketing authorization indications.

OBJECTIVE To determine whether inaugural prescriptions for proton pump inhibitors (PPI) written by general practitioners in the Grenoble region are in non-compliance with the indications of the French drug marketing authorization. METHODS The study was conducted on all inaugural PPI prescriptions written by general practitioners in Grenoble region between March 1 and March 31, 2004. Analyses were performed on a random sample of 600 representative prescriptions. A questionnaire was sent to the general practitioners who had written these prescriptions. There were 255 responses which could be analyzed. RESULT Among the 19,983 prescriptions for PPIs written in March 2004, 4, 442 (22.8%) were first-time treatments. 85.9% of them were issued by general practitioners. The main reasons for prescription identified in the study sample were the association with other drugs [56.1%; 95%CI 50.0-62.2], gastroesophageal reflux disease [29.4%; 95%CI 23.8-35.0] and dyspepsia [11.4%; 95%CI 7.5-15.3]. The rate of non-compliance with the marketing authorization was 46.3% [95%CI 40.2-52.4], including 20.4% [95%CI 15.5-25.3] for inappropriate medical indications. CONCLUSION General practitioners were the principal prescribers of inaugural PPI treatments. Even after excluding prescriptions which were non-compliant because of a regulatory problem, one out of five prescriptions were written for inappropriate medical indications.