Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions

Abstract

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Off‐label use of medicine in children is common, as few medications are licensed for use in this population.• There is concern about off‐label use of medicines in children due to lack of knowledge about safety beyond the indication area described in the official product information documented in the licensing material.WHAT THIS STUDY ADDS• One‐fifth of all ADRs reported over a decade in Danish children were associated with off‐label prescribing of medicines.• Serious ADRs from off‐label prescribing primarily appeared in therapeutic groups: allergens, dermatologicals and sex hormones.• Until more clinical studies are conducted in children, prescribers and carers must be aware of the risk of potentially serious ADRs from off‐label prescribing, and the safety of off‐label prescribing in the paediatric population should be closely monitored.AIM To identify adverse drug reactions (ADRs) associated with off‐label prescribing of medicines in a paediatric population.METHODS We analysed spontaneous ADR reports for children from ages 0 to 17 years submitted to the Danish national ADR database from 1998 to 2007. We defined off‐label prescribing as prescriptions outside the licensed age group. Off‐label ADRs were categorized by therapeutic group, age of child, type and severity. The unit of analysis was one ADR.RESULTS We analysed 4388 ADRs for children reported in the national database. Approximately 17% of reported ADRs were associated with off‐label use, 60% of them serious. More than one half of off‐label ADRs were reported in adolescents. Serious ADRs due to off‐label prescribing are more likely to be reported for hormonal contraceptives (ATC group G), anti‐acne preparations (ATC group D) and allergens (ATC group V).CONCLUSION One‐fifth of all ADRs reported over a decade in Danish children was associated with off‐label prescribing, and serious ADRs due to off‐label prescribing were primarily present in three therapeutic groups: sex hormones, dermatologicals and allergens. There is a need for more research into the prescribing of these medicines in the teenage population, as well as tighter reporting and monitoring of ADRs for medicines prescribed off‐label in the paediatric population.

Evaluation of attitudes towards treatment in adolescents with attention deficit hyperactivity disorder (ADHD)

“…The fifth factor is associated with preoccupations and concerns about side effects of medications in the future. Concerns about future side effects of medications, a recurrent topic in these families, is somehow coherent with recent publications in scientific journals [1,16] and with what parents may read in the media or hear on the news [23]. Once again, it is crucial that clinicians prescribe treatments according to current guidelines [30,50], and that side effects of the medications are monitored and prevented [27].…”

Off-Label Prescribing in Pediatric Outpatients

“…8 In 25 As concluded in the review from Mason et al, 28 it seems that there is no consistent evidence suggesting a greater risk related to off-label prescribing, perhaps because of the heterogeneity in prescribing settings or practices considered in the studies. Indeed, some studies found high rates of off-label prescribing of mental health or cancer medications.…”

Prescribing practices for pediatric out-patients: A case study of two teaching hospitals in Nigeria

“…A high incidence of unapproved use of drugs (prescribing outside the recommended dosage, indication, route of administration, or age of patient) and unlicensed use of drugs in the pediatric population has been reported [28]. A study conducted in the Europe and Australia indicated that 80 -93 % of neonatal medications were off-labelled or unlicenced, with an overall off-label prescription rates of between 25 % and 60 % across populations and mostly seen in children less than 2 years of age and also in adolescents [29,30].…”