Off-label prescribing in a French hospital.
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.


METHODS
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.


CONCLUSIONS
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.
Cras
Audrey
A
Pharmacy Department, Saint-Joseph Hospital Foundation, 185 rue Raymond Losserand, 75014 Paris, France.
Conscience
Marie-Agnès
MA
Rajzbaum
Gérald
G
Lillo-Le Louët
Agnès
A
Lopez
Nathalie
N
Tersen
Isabelle
I
Bezie
Yvonnick
Y
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D004348:Drug Labeling; D011307:Drug Prescriptions; D017723:Drug Utilization Review; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage; D005602:France; D006769:Hospitals, General; D006801:Humans; D008297:Male; D008875:Middle Aged; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010595:Pharmacists; D010607:Pharmacy Service, Hospital; D010818:Practice Patterns, Physicians' / Q000592:standards*; D024382:Professional Role
D000897:Anti-Ulcer Agents; D005343:Fibrinolytic Agents; D004364:Pharmaceutical Preparations