J S McLay1, M Tanaka, S Ekins-Daukes, P J Helms. 1. Department of Medicine and Therapeutics, University of Aberdeen, Polwarth Buildings, Foresterhill, Aberdeen, UK. j.mclay@abdn.ac.uk
Abstract
OBJECTIVE: To assess current attitudes of hospital based paediatricians to off label prescribing, and the performance of clinical trials in children. DESIGN: A prospective, questionnaire based study. SETTING: 257 hospital based consultants and specialist registrars in paediatric practice in Scotland during 2003-2004. RESULTS: A 25 item questionnaire was sent to 257 hospital based paediatricians and 151 (59%) were returned completed. Over 90% of responders were familiar with the concept of, and knowingly prescribed, off label drugs; 55% of responders stated that such prescribing disadvantaged children, and 47% expressed concerns about the efficacy of off label medicines. Although 70% of responders expressed concerns about safety, only 17% had observed an adverse event, and 47% a treatment failure, while 69% did not obtain informed consent or tell parents they were prescribing off label, and 67% did not inform the family's general practitioner. Many respondents did not believe it was necessary to carry out clinical trials in children for new (46%) or generic (64%) medicines. However, 52% of respondents stated that they would be willing to undertake clinical studies and recruit their own patients (61%) or children (73%) to take part in such studies. CONCLUSIONS: Among Scottish paediatricians there is concern about off label prescribing, although the majority do not consider it necessary to inform parents or GP colleagues. The need for clinical trials in children was recognised but there was a less than wholehearted acceptance of the need for such studies, at variance with the current drive to promote clinical trials in this age group.
OBJECTIVE: To assess current attitudes of hospital based paediatricians to off label prescribing, and the performance of clinical trials in children. DESIGN: A prospective, questionnaire based study. SETTING: 257 hospital based consultants and specialist registrars in paediatric practice in Scotland during 2003-2004. RESULTS: A 25 item questionnaire was sent to 257 hospital based paediatricians and 151 (59%) were returned completed. Over 90% of responders were familiar with the concept of, and knowingly prescribed, off label drugs; 55% of responders stated that such prescribing disadvantaged children, and 47% expressed concerns about the efficacy of off label medicines. Although 70% of responders expressed concerns about safety, only 17% had observed an adverse event, and 47% a treatment failure, while 69% did not obtain informed consent or tell parents they were prescribing off label, and 67% did not inform the family's general practitioner. Many respondents did not believe it was necessary to carry out clinical trials in children for new (46%) or generic (64%) medicines. However, 52% of respondents stated that they would be willing to undertake clinical studies and recruit their own patients (61%) or children (73%) to take part in such studies. CONCLUSIONS: Among Scottish paediatricians there is concern about off label prescribing, although the majority do not consider it necessary to inform parents or GP colleagues. The need for clinical trials in children was recognised but there was a less than wholehearted acceptance of the need for such studies, at variance with the current drive to promote clinical trials in this age group.
Authors: Suzie Ekins-Daukes; Peter J Helms; Colin R Simpson; Michael W Taylor; James S McLay Journal: Eur J Clin Pharmacol Date: 2004-05-14 Impact factor: 2.953
Authors: S Conroy; I Choonara; P Impicciatore; A Mohn; H Arnell; A Rane; C Knoeppel; H Seyberth; C Pandolfini; M P Raffaelli; F Rocchi; M Bonati; G Jong; M de Hoog; J van den Anker Journal: BMJ Date: 2000-01-08