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Copyright ©ERS Journals Ltd 2004
Unlicensed and off-label prescription of respiratory drugs to children
1 Dept of Paediatrics, Sophia Children's Hospital, 2 Pharmacoepidemiology Unit, Depts of Epidemiology and Biostatistics and Internal Medicine, 3 Dept of Medical Informatics, Erasmus University Medical Centre, Rotterdam, and 4 Drug Safety Unit, Inspectorate for Health Care, The Hague, the Netherlands. 5 Division of Pediatric Clinical Pharmacology, Children's National Medical Center, and 6 Depts of Pediatrics and Pharmacology, The George Washington University, Washington DC, USA
CORRESPONDENCE: B.H.C. Stricker, Dept of Epidemiology & Biostatistics, Erasmus Medical Centre Rotterdam, PO Box 1738, 3000 DR, Rotterdam, the Netherlands. Fax: 31 104089382. E-mail: b.stricker@erasmusmc.nl
Keywords: children, drug use, epidemiology, off-label, respiratory, unlicensed
Received: February 11, 2003
Accepted September 26, 2003
This work was supported by the Sophia Foundation for Scientific Research through a research grant (SSWO project no. 293).
Many respiratory drugs are not available in formulations suitable for infants and toddlers. Efficacy and safety research is mostly restricted to older children. However, respiratory drugs are frequently used in children for common diseases like asthma, upper and lower respiratory tract infections, rhinitis and sinusitis. The unlicensed and off-label use of respiratory drugs in children were studied.
A population-based cohort study was conducted by using the computerised medical records in the Integrated Primary Care Information project. The study population comprised a random sample from all children aged 0–16 yrs who were registered with a general practitioner in 1998. All prescriptions for respiratory drugs during the study period were classified according to their licensing and off-label status.
The study population comprised 13,426 patients (51.7% male, median age 8.7 yrs), of whom 2,502 (19%) received 5,253 prescriptions for respiratory drugs in 1998. A total of 3,306 (62.9%) prescriptions concerned licensed drugs. Of the remaining 1,947 prescriptions (37.1%), 882 (16.8%) were unlicensed for use in children, and 1,065 (20.3%) were prescribed off-label. The 1-yr cumulative risk of receiving an unlicensed or off-label prescription was 45% among children with at least one prescription for a respiratory drug.
This population-based study showed that a large proportion of respiratory drugs prescribed by the general practitioner are unlicensed for use in children, or licensed but prescribed in an off-label manner. Results have to be interpreted with caution because they may unjustly suggest inaccurate prescribing, whereas it may be difficult to treat children with respiratory symptoms and diseases, because for many respiratory drugs paediatric data on safety and efficacy are insufficient. These findings underline the importance of research on suitable formulations, dosages and efficacy of respiratory drugs in children.
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