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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 Child2017;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.

BackgroundPharmacotherapy in children is complex requiring individual dosages of an active substance which are often not compatible with commercially available medicinal products.1–2Manipulations of medicinal products, e.g. splitting or mortaring of tablets are common practice and often unavoidable although they entail risks for the patient as they can affect dosing accuracy, bioavailability and integrity of the dosage form.3–4In this study we aim to determine how many medicines have to be manipulated before administration in a hospital setting in Germany.MethodsA prospective observational approach was used to determine all manipulations of drugs orally administered on two wards of a German childrens hospital. A pharmacist systematically observed the nurses and documented all steps of the medication preparation processes for 7 days. Data was analysed using descriptive analysis. Types of manipulations were evaluated on the basis of the relevant summary of product characteristics (SmPC).ResultsDuring the pilot phase 170 medication preparation processes were monitored. In 36,5% (n=62) of the observed processes medicines had to be manipulated. 54,3% (n=19) of the patients were affected by at least one manipulation. 48,4% (n=30) of all manipulations were unauthorized by the relevant SmPC affecting 37,1% of the patients. In 60,0% the reason for unauthorized manipulation was unsuitable strength of the available formulation. Dosage forms affected by unauthorized manipulations were tablets (n=28) and granules (n=2). Active substances most frequently involved in unauthorized manipulations were Omeprazole (n=11), Phenobarbital (n=7) and Topiramat (n=3).ConclusionOverall, these results reveal that manipulations to medicines prior to administration are frequent on paediatric wards in Germany. About half of the manipulations are unauthorized indicating that no suitable paediatric formulation is available. Further investigation is needed to determine the preventability and the risks associated with the overall aim of improving safety of drug therapy in children.ReferencesSchirm E, Tobi H, de Vries TW, Choonara I, De Jong-van den Berg LT. Lack of appropriate formulations of medicines for children in the community. Acta paediatrica(Oslo, Norway:1992) 2003;92(12):1486–9.Richey RH, Craig JV, Shah UU, Nunn AJ, Turner MA, Barker CE, et al. MODRIC - Manipulation of drugs in children. International journal of pharmaceutics. 2013;457(1):339–41.Bjerknes K, Boyum S, Kristensen S, Brustugun J, Wang S. Manipulating tablets and capsules given to hospitalised children in Norway is common practice. Acta paediatrica(Oslo, Norway:1992) 2017;106(3):503–8.Paparella S. Identified safety risks with splitting and crushing oral medications. Journal of emergency nursing: JEN: official publication of the Emergency Department Nurses Association2010;36(2):156–8.Disclosure(s)Nothing to disclose