Pharmacotherapy in children requires medicinal products in age-appropriate dosage forms and flexible dose strengths. Healthcare professionals often encounter a lack of licensed and commercially available formulations, which results in the need for manipulation. This study aimed to investigate the nature, frequency and preventability of the manipulation of medicinal products before oral drug administration to paediatric inpatients in Germany. A prospective, direct observational approach was used. Two thousand and three medication preparation processes (MPP) in 193 patients were included in the analysis. Medicines were manipulated in 37% of oral administrations, affecting 57% of the patients. The percentage of manipulations was highest in infants/toddlers (42%) and lowest in adolescents (31%). Antiepileptics were most frequently manipulated (27%), followed by vitamins (20%) and drugs for acid-related disorders (13%). Fifty-six per cent of all manipulations were off-label. In 71% of these, no alternative appropriate medicinal product was commercially available. These results demonstrate that the manipulation of medicinal products before oral administration is common in paediatric wards in Germany. About half of the manipulations were off-label, indicating that no suitable formulation was available. Evidence-based guidelines for manipulations are required, with the overall aim of improving the safety of paediatric drug therapy.

Background Drug therapy in pediatric patients is a complex process. Children are subject to continuous growth and variation in drug-metabolizing enzyme activity, requiring continuous adaption of dosages. In Germany, currently no publicly available database exists that provides evidence-based information on drug dosages in pediatrics. For local drug dosing support, a prototype database has been developed within the Children's Hospital, Erlangen. A user-centered development process was initiated to establish an online platform for evidence-based dosing recommendations, as well as pharmacological and pharmaceutical drug information in pediatrics. Objectives The objectives of the study were to survey the demand for such a platform and to assess the usability of the different versions of the developed system. Methods The developed prototype was evaluated in a pluralistic walkthrough with prospective end users. After a redesign, the second prototype of the online platform underwent an online usability testing based on a tailored questionnaire and the System Usability Scale (SUS) (n = 12). Results Eleven of 12 participants expressed a demand for an online platform for pediatric dosing recommendations. The majority of the participants requested the integration of extended features, such as drug–drug interaction alerts, or information on adverse effects, pharmacokinetics, and pharmacodynamics. Particularly noteworthy is the demand for an online calculator; 5 of a total of 15 participants explicitly requested a calculator for dosages (based on age, weight, body surface) and glomerular filtration rate. The usability of the second prototype was rated “good to excellent” with a median SUS of 81.25. Conclusion Local domain experts demand an online platform for pediatric dosing recommendations. The application of the user-centered design approach enabled the development of a prototype suitable for practical use. Multiple additional required functionalities have been identified, whereby the importance of an online calculator for patient–individual dosing recommendations was particularly emphasized.

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.

The authors wish to make the following corrections to the affiliation and acknowledgments part [...]

Background Metamizole use is controversially discussed due to its potentially serious adverse drug reactions (ADRs). In Germany, however, it remains a popular analgesic and antipyretic drug. Objective The aim of this study was to discuss the safety profile of metamizole in children by analysing the inpatient prescription patterns and presenting the metamizole-related ADRs at a paediatric hospital between 2015 and 2020. Methods Metamizole utilisation data were retrospectively analysed from electronic medical records. ADRs were prospectively recorded via the hospital’s stimulated reporting system and analysed accordingly. Patients aged < 18 years admitted to one of the general wards of the department of paediatrics and adolescent medicine of a German university hospital between June 2015 and May 2020 who received at least one drug therapy within their inpatient stay were included in the analysis. Causality of ADRs was rated according to the World Health Organisation causality assessment. Results In 31.7% (3759/11,857) of the inpatient stays of 7809 patients, metamizole was administered. Metamizole exposure was highest in adolescents (37.9%) and lowest in newborns (9.9%). Overall, metamizole was administered parenterally in about 90%. Three cases of agranulocytosis, one allergic shock and one rash with possible or higher causality to metamizole treatment were reported. Three of these occurred prior to hospitalisation. All patients recovered without remaining harm. Discussion Metamizole is commonly used in paediatric inpatients in Germany. Serious ADRs occur but rarely. Continuous monitoring of drug therapy through, for example, stimulated reporting systems ensures that serious ADRs are detected, and appropriate interventions can be introduced.

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.

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