On-label paediatric drug product information in Switzerland – the neglected child

OBJECTIVES: Healthcare professionals who prescribe, prepare, and administer drugs to children must consider age-dependent pharmaceutical aspects. However, information on the age-appropriate use of authorised medicinal products is frequently incomplete within the Summary of Product Characteristics (SmPC). This study aims to improve the quality and completeness of the information provided by the SmPC for products with paediatric authorisation and to create greater awareness from both regulatory authority and market authorisation holders. METHODS: We created a list of topics that are particularly relevant for safe and effective drug use in paediatrics, but which were identified as either missing or incompletely reported. The list was compiled based on routine experience of clinical pharmacists specialised in paediatrics. Each topic was compared with the reporting obligations imposed by the statutory provisions in Switzerland. The problem of missing information for clinical practice was discussed for selected examples. RESULTS: We identified 16 missing or incompletely reported topics: 1) authorised child ages, 2) posology information, 3) age-specific contraindications, 4) update on change in state-of-the-art, 5) dissolution concentration, 6) solvents / diluents compatibility, 7) administration concentrations, 8) osmolarity / pH, 9) reconstitution / dilution stability, 10) shelf-life, 11) route of administration (central or peripheral vein), 12) infusion rates and administration duration, 13) dosing aids, 14) in-filter compatibility, 15) caution in case of extravasation, and 16) taste. Out of the 16 topics, four (25%) are not subject to any reporting obligations, seven (44%) require further clarification regarding the information to be reported under the statutory provisions, and five (31%) are subject to reporting obligations. CONCLUSION: We provide a list of topics as a proposal of indispensable paediatric-specific information that should be available for authorised products. Moreover, it is paramount that the safe and effective use of drugs with paediatric authorisation is appropriately described for all age populations within the label.