Improving the supply of medicines to children and adolescents by increasing drug therapy safety (KiDSafe)

In the supply of medicines, children and adolescents are at a disadvantage with regard to their safety and proven efficacy.

The effects of drugs are often only tested on adults. Accordingly, many drugs are used off-label in children and adolescents, i.e. outside the officially approved area of application. Often, there is a lack of sufficient information on the child-appropriate form of the drug as well as on the application, dosage or dosage form. Adverse drug reactions (german: Unerwünschte Arzneimittelwirkungen, UAW) and medication errors (german: Medikationsfehler, MF) are the result. In order to reduce such supply deficits in drug therapy and to improve the medical supply of drugs in pediatrics and make it safer, the KiDSafe project aims to raise awareness of the correct use of drugs in children and adolescents. Therefore, the Klinikum Erlangen implements a corresponding intervention in 12 pediatric clinics and about 240 referring pediatric practices throughout Germany, which is evaluated by us.

In total, the intervention comprises three modules:

• Modul 1: Use of a web-based drug information system with dosage database (PaedAMIS)
• Modul 2: Participation in pharmacological quality circles (PaedZirk)
• Modul 3: Systematic recording of ADR and MF in children and adolescents (PaedReport)

The implementation of this intervention will be evaluated in the form of a cluster-randomized controlled study with stepped-wedge design of a cross-sectional type. A combination of quantitative and qualitative methods (mixed methods) will be used to assess the extent to which the intervention could be successfully implemented and whether it can reduce the number of inpatient admissions to pediatric hospitals due to adverse drug reactions and medication errors.

The qualitative process evaluation measures acceptance, intensity of use, implementation relevance, sufficiency and satisfaction via (mainly telephone) interviews and participatory observation. Target groups are the (potential) users of PaedAMIS and participants of PaedZirk, namely physicians in private practice or psychiatrists.

Funding:
Innovationsfond beim Gemeinsamen Bundesausschuss (G-BA), neue Versorgungsformen

Partners:

• Universitätsklinikum Erlangen
• Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP Stuttgart)
• Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
• Universitätsklinikum Würzburg
• Universität Leipzig
• Universitätsklinikum Leipzig
• Universitätsklinikum Aachen
• Leibniz-Institut für Präventionsforschung und Epidemiologie - BIPS GmbH
• Techniker Krankenkasse