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On-label paediatric drug product information in Switzerland - the neglected child
Lukas Higi1,2, David Palmero3,4, Thomas Rudolf von Rohr4,5
1Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland lukas.higi@outlook.com.
Insights
Information in drug labels for children is often incomplete. This study identified 16 key missing topics in paediatric drug information, aiming to improve safety and efficacy for pediatric patients.
Area of Science:
- Pharmaceutical Sciences
- Paediatric Pharmacology
- Regulatory Affairs
Background:
- Healthcare professionals require comprehensive age-dependent pharmaceutical data for pediatric drug use.
- Summary of Product Characteristics (SmPC) often lack complete information for authorized pediatric medicines.
Purpose of the Study:
- To enhance the quality and completeness of SmPC information for pediatric drug authorizations.
- To increase awareness among regulatory authorities and market authorization holders regarding pediatric-specific drug information needs.
Main Methods:
- Compiled a list of critical topics for safe and effective pediatric drug use based on clinical pharmacist expertise.
- Assessed identified topics against Swiss statutory reporting obligations.
- Analyzed the implications of missing information for clinical practice using selected examples.
Main Results:
- Identified 16 missing or incompletely reported topics crucial for pediatric drug use.
- Key missing information includes authorized ages, posology, contraindications, stability, and administration details.
- A significant portion of these topics (44%) require clarification regarding reporting obligations under current regulations.
Conclusions:
- Proposed a list of indispensable pediatric-specific information for authorized medicinal products.
- Emphasized the critical need for comprehensive labeling of drugs with pediatric authorization across all age groups.
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.
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