Introduction: Most paediatric medicines have not undergone extensive clinical trials in children and as a necessity are frequently prescribed off-label, a practice which is recognised to be associated with an increased risk of adverse drug reactions (ADRs).
Aims: To assess the use of routinely acquired healthcare data to identify medication utilisation and specifically drug discontinuation, as a signal for possible ADR occurrence in children: using orlistat as an exemplar.
Methods: Prescribing data held within the Primary Care Clinical Informatics Unit (PCCIU) database was used to assess prescribing and discontinuation of orlistat in children aged 18 years and younger, for the period 20062009. This drug was selected because it is not licensed for paediatric use and is associated with a significant ADR profile in adults. Orlistat discontinuation was defined as a cessation of a prescription within: <1, 13, 46 and >6 months of the index prescription.
Results: During the study period 82 children were newly prescribed orlistat; (618 years, 81.7% females).
67% had a weight recorded prior to treatment, BMI SDS (0.54 to 5.4, mean 3.13).
53.7% of children discontinued orlistat within one month of the index prescription, and 74.4% within 3 months.
Using routinely collected healthcare data permitted the identification of children prescribed orlistat, the discontinuation rate, assessment of age, gender, BMI, SIMD score and adherence to treatment guidelines.
Conclusion: Our preliminary data confirms that routinely collected primary care healthcare datasets can be effectively used to assess medication prescribing profile and drug discontinuation in children. The 1 month discontinuation of 54% observed in this study is approximately double that reported for adults, but within the reported paediatric ADR prevalence of 30100%, supporting the use of medication discontinuation as a potential signal for ADRs.
09 - 11 Nov 2011
British Society for Paediatric Endocrinology and Diabetes