The availability and age‐appropriateness of medicines authorized for children in the Netherlands

• Published in: British journal of clinical pharmacology 2011-09, Vol.72 (3), p.465-473
• Main Authors: van Riet‐Nales, Diana A., de Jager, Karin E., Schobben, Alfred F.A.M., Egberts, Toine C.G., Rademaker, Carin M.A.
• Format: Article
• Language: English
• Subjects: Adolescent; Age Factors; Biological and medical sciences; Child; Child, Preschool; dosage forms; Drug Approval; excipients; General pharmacology; Health Knowledge, Attitudes, Practice; Humans; Infant; Medical sciences; medicine; Miscellaneous; Netherlands; Paediatric Clinical Pharmacology; Pharmaceutical Preparations - administration & dosage; Pharmaceutical Preparations - supply & distribution; Pharmacology. Drug treatments; Practice Patterns, Physicians' - standards; Public health. Hygiene; Public health. Hygiene-occupational medicine
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1111/j.1365-2125.2011.03982.x

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Children are entitled to safe, efficacious, child and parent friendly (i.e. age‐appropriate) medicines. However, off‐label and unlicensed paediatric prescription rates in hospital range from 36% (surgical and medical wards) to 93% (neonatal wards), which indicates a general lack of age‐appropriate medicines for children. In 2007, the European Union issued the Paediatric Regulation aiming at better medicines for children by, for example, increasing the number of authorized paediatric medicines. WHAT THIS STUDY ADDS • This study reviews the availability and age‐appropriateness of medicines for children in the Netherlands, herewith providing a baseline for an estimation of the effect of the European Paediatric Regulation in the near future. This study also provides a tool for the evaluation of the child authorization status of medicines on the basis of the information in the Summary of Product Characteristics (SPC) and for the assessment of key aspects of the age‐appropriateness of paediatric formulations. AIM To study the number of medicines and active chemical entities that are authorized and commercially available for children in the Netherlands and to evaluate the age‐appropriateness of the available paediatric medicines. METHODS The availability of paediatric medicines and active chemical entities was studied with the help of a Dutch medicines database and the Summary of Product Characteristics. Medicines were categorized with respect to their route of administration, type of oral dosage form and therapeutic category. The age‐appropriateness was assessed on three aspects: dose capability, suitability of the dosage form and inclusion of potentially harmful excipients. RESULTS Three thousand five hundred and forty‐two paediatric medicines containing 703 different active chemical entities were identified. This equalled half of all the medicines and chemical entities available for human use. The percentage of paediatric medicines increased with age and varied for the route of administration from 22% (dermal) to 81% (inhalation) and for the therapeutic category from 11% (uro‐genital, sex hormones) to 89% (anti‐parasites). The appropriateness of the paediatric medicines with respect to their authorization status, dose capability and dosage form increased with age from 27–88%. Fifty‐two percent of all oral paediatric liquid formulations contained a potentially harmful excipient. CONCLUSION This study confirms the limit