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  • P101 Extending the Dutch Paediatric Formulary across Europe: successful development of country specific, parallel, paediatric drug formularies

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ESDPPP 2019
Poster Presentations
P101 Extending the Dutch Paediatric Formulary across Europe: successful development of country specific, parallel, paediatric drug formularies
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  1. T Van der Zanden1,2,3,
  2. A Neubert4,
  3. J Zahn4,
  4. S Wimmer4,
  5. M de Hoop5,
  6. T Rosness6,7,
  7. C Kjeldby-Høie8,
  8. A Teigen9,10,
  9. C Male11,
  10. E Rauch11,
  11. F Lagler12,
  12. W Rascher4,
  13. S de Wildt2,3,13
  1. 1Department of Paediatrics, Erasmus MC – Sophia Childrens Hospital, Rotterdam
  2. 2Department of Pharmacology and Toxicology, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen
  3. 3Dutch Knowledge Center Pharmacotherapy for Children, Den Haag, The Netherlands
  4. 4Department of Paediatrics and Adolescents Medicine, Universitätsklinikum Erlangen, Erlangen, Germany
  5. 5KNMP, Den Haag, The Netherlands
  6. 6The Norwegian Medicines Manual for Health Personnel
  7. 7The Faculty of Mathematics and Natural Sciences, School of Pharmacy
  8. 8Sykehusapoteket, Rikshospitalet, Oslo
  9. 9Sykehusapoteka Vest HF, Stavanger
  10. 10Medicines for Children Network, Bergen, Norway
  11. 11Department of Paediatrics, Medical University Vienna, Vienna
  12. 12Institute for Inborn Errors of Metabolism, Paracelsus Medical University, Salzburg, Austria
  13. 13Department of Paediatric Surgery, Erasmus MC – Sophia Childrens Hospital, Rotterdam, The Netherlands

Abstract

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 formularies has started.

References

  1. van der Zanden T, De Wildt S, Liem T, Offringa M, de Hoog M. Developing a pediatric formulary for the netherlands. Arch Dis Child 2017;Apr;102(4):357–61.

Disclosure(s) Tjitske van der Zanden is managing director of the Dutch Paediatric Pharmacotherapy Expertise Network; Saskia de Wildt is medical director of Dutch Paediatric Pharmacotherapy Expertise Network. The other authors have no financial disclosures relevant to this article.

https://doi.org/10.1136/archdischild-2019-esdppp.139

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