P101 Extending the Dutch Paediatric Formulary across Europe: successful development of country specific, parallel, paediatric drug formularies
Backgrounds As many drugs in paediatrics are used of off-label, prescribers across Europe face a lack of evidence-based dosing guidelines. The Dutch Paediatric Formulary (DPF) was developed to provide dosing guidelines based on best available evidence from registration data, investigator-initiated research, clinical experience and consensus (1). The DPF has recently joined forces with Germany, Norway and Austria aiming to develop multi-language, parallel, paediatric drug formularies based on the DPF. Methods The DPF database and ICT framework were extended to a duplicate database for Germany.... Mehr ...
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Dokumenttyp: | Artikel |
Erscheinungsdatum: | 2019 |
Reihe/Periodikum: | Archives of Disease in Childhood ; volume 104, issue 6, page e59.2-e60 ; ISSN 0003-9888 1468-2044 |
Verlag/Hrsg.: |
BMJ
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Sprache: | Englisch |
Permalink: | https://search.fid-benelux.de/Record/base-27429265 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | http://dx.doi.org/10.1136/archdischild-2019-esdppp.139 |
Backgrounds As many drugs in paediatrics are used of off-label, prescribers across Europe face a lack of evidence-based dosing guidelines. The Dutch Paediatric Formulary (DPF) was developed to provide dosing guidelines based on best available evidence from registration data, investigator-initiated research, clinical experience and consensus (1). The DPF has recently joined forces with Germany, Norway and Austria aiming to develop multi-language, parallel, paediatric drug formularies based on the DPF. Methods The DPF database and ICT framework were extended to a duplicate database for Germany. The dosing guidelines were translated to German and reviewed for fit with German practice. Relevant drugs and dosing recommendations were selected and country-specific information was added to address country-specific needs. Work-sharing on content development was studied in a small pilot. Results The German Pediatric Formulary (www.kinderformularium.de) was launched on 1 October 2018 within a German paediatric medication safety project (KiDSafe). At that time 119 of 769 drugs were reviewed and published in the German formulary.The dosing recommendations of the DPF show a good fit with German practice; i.e. adaptations were needed in less than 10% of the cases caused by differences in licensing status, national guidelines or availability of formulations. There were no differences in interpretation of evidence. Nine drugs - highly relevant for German practice, but not listed in the DPF, were added to the German formulary based on SmPC. The content work sharing was piloted by the development of a new monograph and the periodic revision of a monograph complying to the Dutch standard operating procedure by Germany. This pilot has shown the feasibility of work-sharing in developing and updating drug monographs. Conclusion The Dutch framework has successfully been extended to the German situation. Work-sharing on the development of dosing recommendations is feasible. Similar extension to Norwegian and Austrian nation-wide ...