Abstract
Background: Off-label use is frequent in paediatrics but that does not necessarily mean that the risk-benefit ratio is negative. Nevertheless, evidence-based data is essential for safe drug therapy. In Germany, there is no publicly available compendium providing transparent, evidence-based information for paediatric pharmacotherapy to date. This work describes the development of a web-based paediatric drug information system (PDIS) for Germany and its evaluation by health care professionals (HCP). Methods: Since 2012, a PDIS is being developed by the authors and is supported by the Federal Ministry of Health since 2016. Dosing recommendations were established based on systematic literature reviews and subsequent evaluation by clinical experts. The prototype was evaluated by HCP. Based on the results, the further development was concluded. Results: 92% of HCP believed that the PDIS could improve the quality of prescribing, as currently available information is deficient. Besides the license and formulations, dosing recommendations were the most relevant modules. A dosage calculator was the most wanted improvement. To facilitate sustainability of future development, a collaboration with the Dutch Kinderformularium was established. As of 2021, the database will be available to German HCP. Conclusion: The fundamentals for a German PDIS were established, and vital steps were taken towards successful continuation.
Highlights
Due to the lack of evidence from valuable clinical studies, and because drug development historically focused on adults, children have reduced access to licensed medicines leading to high off-label and unlicensed use [1]
A well-structured, web-based prototype of a paediatric drug information system (PDIS) was developed by the project team aiming to support health care professionals (HCP) as best as possible within the medication process
Paediatric Use Marketing Authorisation (PUMA), have failed so far predominantly regarding the availability of generic paediatric medicines, off-label use will remain high for the paediatric population in the future [16]
Summary
Due to the lack of evidence from valuable clinical studies, and because drug development historically focused on adults, children have reduced access to licensed medicines leading to high off-label (up to 79%) and unlicensed use (up to 15%) [1]. At increased risk for adverse drug reactions and medication errors [2]. The expected improvement for generic drugs frequently used off-label in children has not been realised. This work describes the development of a web-based paediatric drug information system (PDIS) for Germany and its evaluation by health care professionals (HCP). Dosing recommendations were established based on systematic literature reviews and subsequent evaluation by clinical experts. Results: 92% of HCP believed that the PDIS could improve the quality of prescribing, as currently available information is deficient.
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