Availability of age-appropriate paediatric formulations in the Netherlands: the need in daily clinical practice remains
Drug development for children has long been a neglected area compared with adult drug development. Low prevalence of disease and the resulting low return on investment, together with ethical and practical barriers, have not been providing enough incentives for pharmaceutical corporations to invest time and resources into bringing appropriately tested paediatric medicines to the market. It was recognised that specific legislation was needed to address this issue. Following the example of the US Best Pharmaceuticals for Children Act, the EU Paediatric Regulation (EC)1 No 1901/2006 was adopted in December 2006.1. Full article for download – quick overview here:
Abstract
Objectives: To quantify the availability of authorised, age-appropriate paediatric medicines in clinical practice in the Netherlands and to identify gaps by assessing dispensing practice in a paediatric hospital.
Methods
The availability of age-appropriate formulations was assessed by conducting a survey on the use of pharmacy compounded medicines among the paediatric hospitals in the Netherlands, and by analysing dispensing data of oral medication from the inpatient pharmacy of the largest paediatric hospital in the Netherlands. The age-appropriateness of the dispensed formulations was assessed on two aspects: dose-capability and acceptability. Liquid drug products that are unsuitable due to the presence of potentially harmful excipients, were identified based on the dosage in clinical practice. Results For 129 out of 139 drug substances included in the survey (93%), at least one of the eight respondents stated to use a pharmacy compounded product to meet the needs of their paediatric patients. The age-appropriateness of medicines dispensed from the inpatient pharmacy increased with age and was higher for non-intensive care unit (ICU) patients than for ICU patients. We identified 15 drug products causing excipient exposure above the European Medicines Agency-recommended values.
Conclusions
This study confirms there is still a large need for age-appropriate formulations in daily clinical practice. Pharmacy compounding for paediatric patients remains essential for many indications. The need for potentially harmful excipients in compounded products should be critically assessed. Download the full publication here: availability-of-age-appropriate-paediatric-formulations-in-the-netherlands.pdf