Healthy Skepticism Library item: 10017
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Cras A, Conscience MA, Rajzbaum G, Lillo-Le Louet A, Lopez N, Tersen I, Bezie Y.
Off-label prescribing in a French hospital.
Pharm World Sci 2007 Apr; 29:(2):97-100
http://www.springerlink.com/content/h677674tk8x48572/
Abstract:
OBJECTIVE: In contrast to paediatrics patients, data concerning the extent of off-label prescribing for adult patients are limited. The aim of our study was to investigate the frequency of off-label drug use for adult patients in a French general hospital.
METHOD: The study was conducted on a Wednesday in November 2004. Prescribing was prospectively assessed on the basis of conformity with the marketing authorizations.
RESULTS: A total of 1341 prescriptions for 192 hospitalized patients were analysed. Twenty three per cent of the prescriptions were off-label. Among all patients, 70% received at least one off-label medicine. Most off-label prescriptions were related to an unapproved indication (75%). The main other reasons were dosage (14%) and dosing schedule (9%). Anti-thrombotic and anti-ulcer agents were found on more than 40% of the off-label prescriptions.
CONCLUSION: Off-label prescriptions occur frequently in the hospital and often alternatives with the proper marketing authorizations are available. An increased involvement of hospital pharmacists should reduce the incidence of off-label prescribing and thus contribute to patient safety and possibly cost reduction.
Keywords:
Adverse drug reactions - France - Hospital - Off-label prescribing - Prescribing
MeSH Terms:
Adult
Adverse Drug Reaction Reporting Systems
Aged
Anti-Ulcer Agents/administration & dosage
Drug Labeling*
Drug Utilization Review*
Female
Fibrinolytic Agents/administration & dosage
France
Hospitals, General
Humans
Male
Middle Aged
Pharmaceutical Preparations/administration & dosage*
Pharmacists
Pharmacy Service, Hospital
Physician's Practice Patterns/standards*
Prescriptions, Drug*
Professional Role
Substances:
Anti-Ulcer Agents
Fibrinolytic Agents
Pharmaceutical Preparations
