Unlicensed and off label prescribing of drugs in general practice

摘要

AIM—To determine the incidence andnature of unlicensed and off label prescribing of drugs for children ingeneral practice.
METHODS—A retrospective analysis ofall prescriptions for one year involving children (aged 12 years orunder) from a single suburban general practice in the English Midlands.Prescribed drugs were categorised as licensed, unlicensed (without aproduct licence), or used in an off label way (outside the terms oftheir product licence).
RESULTS—During 1997 there were 3347 prescription items involving 1175 children and 160 different drugs. Atotal of 2828 (84.5%) prescriptions were for licensed medicines usedin a licensed way; 10 (0.3%) were for unlicensed medicines; and 351 (10.5%) were licensed medicines used in an off label way. For 158 (4.7%) the information was insufficient to determine licence status.
CONCLUSION—This is the first studyto show that a significant number of drugs prescribed for children bygeneral practitioners are off label and highlights the anomalies andinadequacies of drug information for prescribers.