Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Mar 10;10(3):e0120630.
doi: 10.1371/journal.pone.0120630. eCollection 2015.

Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital

Petra Czarniak  1 , Lewis Bint  2 , Laurent Favié  3 , Richard Parsons  1 , Jeff Hughes  1 , Bruce Sunderland  1
Affiliations

Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital

Petra Czarniak et al. PLoS One. .

Abstract

Purpose: To estimate the prevalence of off-label and unlicensed prescribing during 2008 at a major paediatric teaching hospital in Western Australia.

Methods: A 12-month retrospective study was conducted at Princess Margaret Hospital using medication chart records randomly selected from 145,550 patient encounters from the Emergency Department, Inpatient Wards and Outpatient Clinics. Patient and prescribing data were collected. Drugs were classified as off-label or unlicensed based on Australian registration data. A hierarchical system of age, indication, route of administration and dosage was used. Drugs were classified according to the Anatomical Therapeutic Chemical Code.

Results: A total of 1,037 paediatric patients were selected where 2,654 prescriptions for 330 different drugs were prescribed to 699 patients (67.4%). Most off-label drugs (n = 295; 43.3%) were from the nervous system; a majority of unlicensed drugs were systemic hormonal preparations excluding sex hormones (n = 22, 32.4%). Inpatients were prescribed more off-label drugs than outpatients or Emergency Department patients (p < 0.0001). Most off-label prescribing occurred in infants and children (31.7% and 35.9% respectively) and the highest percentage of unlicensed prescribing (7.2%) occurred in infants (p < 0.0001). There were 25.7% of off-label and 2.6% of unlicensed medications prescribed across all three settings. Common reasons for off-label prescribing were dosage (47.4%) and age (43.2%).

Conclusion: This study confirmed off-label and unlicensed use of drugs remains common. Further, that prevalence of both is influenced by the clinical setting, which has implications in regards to medication misadventure, and the need to have systems in place to minimise medication errors. Further, there remains a need for changes in the regulatory system in Australia to ensure that manufacturers incorporate, as it becomes available, evidence regarding efficacy and safety of their drugs in children in the official product information.

PubMed Disclaimer

Conflict of interest statement

Competing Interests: The authors have no competing interests in relation to this paper. All authors have completed the Unified Competing Interest Form (available on request from the corresponding author). These declare no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the past three years; and no other relationships or activities that could appear to have influenced the submitted work.

Figures

Fig 1
Fig 1. Age distribution of inpatients, outpatients and emergency department patients.
See this image and copyright information in PMC

References

    1. O'Donnell CP, Stone R, Morley C (2002) Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics 110 (5): e52–e52 - PubMed
    1. Sinha Y, Cranswick NE (2007) How to use medicines in children: Principles of paediatric clinical pharmacology. J Paediatr Child Health 43 (3): 107–111 10.1111/j.1440-1754.2007.00970.x - DOI - PubMed
    1. Turner S, Longworth A, Nunn A, Choonara I (1998) Unlicensed and off label drug use in paediatric wards: prospective study. BMJ 316: 343–345 - PMC - PubMed
    1. Turner S, Gill A, Nunn T, Hewitt B, Choonara I (1996) Use of "off-label" and unlicensed drugs in paediatric intensive care unit. Lancet 347 (9000): 549–550 - PubMed
    1. Conroy S, McIntyre J, Choonara I (1999) Unlicensed and off-label drug use in neonates. Arch Dis Child Fetal Neonatal Ed 80 (2): F142–144; discussion F144–145 - PMC - PubMed

LinkOut - more resources