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

• Published in: Gastroentérologie clinique et biologique Vol. 31; no. 1; pp. 78 - 83
• Main Authors: Levy-Neumand, Olivier, Carniaux, François, Bonaz, Bruno, Durand, Aurélie, Roblin, Xavier
• Format: Journal Article
• Language: English
• Published: Paris Elsevier Masson SAS 2007; Masson; Elsevier Masson
• Subjects: Algorithms; Biological and medical sciences; Cross-Sectional Studies; Drug Industry; Drug Prescriptions; Drug Prescriptions - statistics & numerical data; Family Practice; Female; France; Gastroesophageal Reflux; Gastroesophageal Reflux - drug therapy; Gastrointestinal Agents; Gastrointestinal Agents - therapeutic use; General aspects; Human health and pathology; Humans; Hépatology and Gastroenterology; Life Sciences; Male; Medical sciences; Middle Aged; Physician's Practice Patterns; Practice Guidelines as Topic; Practice Patterns, Physicians; Proton Pump Inhibitors; Proton Pumps; Questionnaires; Surveys and Questionnaires; France; Marketing authorization; Human; Indication; Medical prescription; General practice; Comparative study; Proton pump inhibitor
• ISSN: 0399-8320
• DOI: 10.1016/S0399-8320(07)89330-4

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.
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.
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.
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.
Mesurer la non conformité des instaurations d’inhibiteurs de la pompe à protons, au regard de l’autorisation de mise sur le marché.
La population étudiée était l’ensemble des instaurations d’inhibiteurs de la pompe à protons par les médecins généralistes sur la région grenobloise du 01/03/2004 au 31/03/2004. Un tirage aléatoire a permis se sélectionner un échantillon représentatif de 600 prescriptions. Un questionnaire a été envoyé aux médecins généralistes à l’origine de ces prescriptions. Le nombre de dossiers exploitables était de 255.
Sur les 19 983 prescriptions d’inhibiteurs de la pompe à protons de mars 2004, 4 442 prescriptions (22,8 %) étaient des instaurations de traitement. 85,9 % d’entre elles provenaient des médecins généralistes. Sur l’échantillon étudié, les principaux motifs de prescription étaient l’association à d’autres médicaments (56,1 %; IC 95 %: 50,0-62,2), le reflux gastro-œsophagien (29,4 %; IC 95 %: 23,8-35,0) et la dyspepsie (11,4 %; IC 95 %: 7,5-15,3). Le taux de non conformité au regard de l’autorisation de mise sur le marché était de 46,3 % [IC 95 %: 40,2-52,4] dont 20,4 % [IC 95 %: 15,5-25,3] pour indication médicale non validée.
Les médecins généralistes étaient les principaux prescripteurs d’inhibiteurs de la pompe à protons en instauration de traitement. Même après exclusion des non conformités vis à vis de l’AMM, les indications médicales non validées représentaient une prescription sur cinq.