Clinical Setting Influences Off-Label and Unlicensed Prescribing in a Paediatric Teaching Hospital

Abstract

PurposeTo estimate the prevalence of off-label and unlicensed prescribing during 2008 at a major paediatric teaching hospital in Western Australia.MethodsA 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.ResultsA 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%).ConclusionThis 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.

Safety and Efficacy of Off-label and Unlicensed Medicines in Children

“…Our results were in accordance with those of previous studies,1114 demonstrating that lower the age of a child, the more likely doctors are to use off-label or unlicensed prescriptions. A more recent study also reported that most off-label prescriptions occurred in infants and children, with percentage > 60% 10. On the other hand, one report from a French hospital showed that adolescents (12–18-year-old) and children (2–11-year-old) received the highest number of off-label/unlicensed prescriptions (46.8% and 45%, respectively) 9.…”

Discontinuities and disruptions in drug dosage guidelines for the paediatric population

“…The greatest discontinuities we observed were a result of a switch in dosing guidelines between a set dose or a dose based on weight, which commonly occurred between ages 12 and 14. The Center for Drug Evaluation and Research generally categorizes paediatric age groups into: neonates (birth to one month); infants (1 month to two years); children (2-12 years) and adolescents (12)(13)(14)(15)(16). Though in their working guidance for industry document, the Food and Drug Administration recognizes these specific age groups do not necessarily need to be used in studies but alternative age groupings based on physiology should be scientifically supported [24].…”

Off-Label and Unlicensed Prescribing in Pediatric Inpatients With Nephrotic Syndrome in a Major Teaching Hospital: An Indonesian Context

“…It has been evident that off-label studies have been carried out in a range of pediatric settings, and intriguingly, the evident reveals a similar fact highlighting the high rate of off-label use in children [2,3,[6][7][8]. However, it is interesting to note that limited studies have been done on the off-label drug use in the area of pediatric nephrology.…”