Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials.
OBJECTIVE
To investigate the knowledge and views of a range of healthcare professionals (consultant paediatricians, general practitioners (GPs), community pharmacists and paediatric nurses) regarding the use of unlicensed/off-label medicines in children and the participation of children in clinical trials.


METHODS
A regional study in which a survey instrument with 39 items was issued to 500 randomly selected GPs, all community pharmacists (n = 512), 50 hospital consultants and 150 paediatric nurses in Northern Ireland.


RESULTS
Approximately half (46.5%) of the 1,212 healthcare professionals approached responded to the questionnaire. The majority of respondents indicated their familiarity with the term unlicensed (82.9%) or off-label (58.6%) prescribing with the most frequently quoted reason for such prescribing being younger age (33.6%). Apart from community pharmacists, most respondents reported having gained their knowledge through personal experience. Even though a large percentage of respondents expressed concerns about the safety (77.8%) or efficacy (87.9%) of unlicensed/off-label prescribing in children, only 30.7% reported informing parents/guardians of these concerns on the use of such medicines in children. In addition, only 56% of respondents believed that unlicensed/off-label medicines should undergo clinical trials in children. Overall, 28.4% of respondents (20.1% of GPs, 41.4% of community pharmacists, 27.7% of paediatric nurses and 94% of consultant paediatricians) indicated their willingness to be actively involved in, and recruit their patients for paediatric clinical research.


CONCLUSIONS
The use of unlicensed and off-label medicines remains a major issue in paediatric medicine. Until such times as more licensed medicines are available for children, clear guidance should be developed to allow consistency in practice across the spectrum of healthcare professionals who are involved with such medicines in their routine practice.
Clinical and Practice Research Group, School of Pharmacy, Medical Biology Centre, Queen's University Belfast, 97 Lisburn Road, BT9 7BL Belfast, UK.
Tareq
T
Mukattash
Ahmed F
AF
Hawwa
Karen
K
Trew
James C
JC
McElnay
D000293:Adolescent; D000328:Adult; D001291:Attitude of Health Personnel; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004346:Drug Information Services; D004348:Drug Labeling; D011307:Drug Prescriptions; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008009:Licensure, Pharmacy; D008297:Male; D009660:Northern Ireland; D056687:Off-Label Use; D010372:Pediatrics / Q000379:methods* / Q000592:standards; D010594:Pharmacies; D011795:Surveys and Questionnaires; D055815:Young Adult
Eur J Clin Pharmacol. 2008 Feb;64(2):201-5
17972069
Drug Saf. 2002;25(1):1-5
11820908
Arch Dis Child. 2000 Dec;83(6):502-5
11087286
Br J Clin Pharmacol. 2008 Dec;66(6):838-45
19032725
Eur J Clin Pharmacol. 2007 Jan;63(1):81-5
17124577
Pediatrics. 2003 Apr;111(4 Pt 1):722-9
12671103
Eur J Clin Pharmacol. 2004 Jul;60(5):349-53
15146302
N Engl J Med. 2002 Oct 31;347(18):1462-70
12409558
BMJ. 1998 Jan 31;316(7128):343-5
9487167
Br J Clin Pharmacol. 2005 Aug;60(2):145-9
16042667
Arch Dis Child. 2009 Jun;94(6):474-7
19208673
Eur J Pediatr. 2009 Dec;168(12):1473-8
19277709
Br J Clin Pharmacol. 2007 Jul;64(1):90-5
17324238
JAMA. 2003 Aug 20;290(7):950-1
12928474
Eur J Pediatr. 2005 Sep;164(9):552-8
15912383
Acta Paediatr. 1999 Sep;88(9):965-8
10519338
Arch Dis Child. 2006 Jul;91(7):584-7
16443615
Br J Clin Pharmacol. 2001 Jul;52(1):77-83
11453893
Br J Clin Pharmacol. 1999 Jul;48(1):5-8
10383552