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

Abstract

BackgroundsAs 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.MethodsThe 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.ResultsThe 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.ConclusionThe 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.Referencesvan 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.

Physiologically Based Pharmacokinetic (PBPK) Model-Informed Dosing Guidelines for Pediatric Clinical Care: A Pragmatic Approach for a Special Population

“…info). These formularies provide pediatric dosing guidelines for > 800 drugs, representing a large proportion of all drugs used in children globally [38]. The final list with drugs relevant for pediatric PBPK modeling can be found in the Online Supplementary Information (Resource 1).…”

Variation in Target Attainment of Beta‐Lactam Antibiotic Dosing Between International Pediatric Formularies

“…Pediatric formularies were searched to identify the dosing regimens for each antibiotic to treat each clinical infection. The following national and international formularies were chosen, in order to cover the range of regimen per drug, that are used globally: British National Formulary for Children, 26 Dutch/German Database for Pediatric Dosing (Kinderformularium), 27 German Pediatric Infectious Diseases Society Handbook, 28 Swiss Database for Dosing Medicinal Products in Pediatrics (SwissPedDose), 29 Indian National Center for Disease Control guidance, 30 Nelson's Pediatric Antimicrobial Therapy (Bradley et al), 31 Manual of Childhood Infections (Blue Book), 32 Report of the Committee on Infectious Diseases (Red Book), 33 and the WHO Pocket Book. 34 For the three infectious diseases, pneumonia, sepsis, and meningitis, dosing guidance was extracted from each formulary.…”