gms | German Medical Science

Background: Children and adolescents are disadvantaged in terms of drug treatment. 42-90% of hospitalised children and adolescents are treated with medications outside their product licence (off-label use), in the ambulatory area 46-64% of patients are affected [1], [2].

Due to off-label use, missing paediatric dosage forms and complex dose calculations, medication errors (ME) occur up to three times more often compared to adults. Moreover, it can be assumed that 3-5% of admissions to paediatric hospitals are due to an adverse drug event (ADE) [3], [4], [5], [6], [7]. Spontaneous reporting of ADEs is therefore an important tool to generate signals on possible safety risks of medicines in children. However, in 2008 the spontaneous reporting rate for children was only half of the reporting rate per million people compared to adults [8].

The aim of the KiDSafe Project is to significantly improve the existing shortfall in paediatric drug therapy by introducing a structured treatment procedure.

Materials and Methods: "PaedPharm" is a quality assurance procedure that will provide evidence-based information as well as specific recommendations for the use of drugs in the paediatric population to outpatient physicians, pharmacists and clinicians. PaedPharm consists of three modules:

1.

A digital paediatric drug information system,

2.

Paediatric-pharmacological quality circles and

3.

A system for mandatory national reporting of ADRs in the paediatric population.

Module 1, the drug information system, comprises information on dosing of medicines for children and adolescents as well as information of dosage forms and their application. The quality circles in Module 2 accompany the introduction of this drug information system and intend to sensitize the participants for the medication process. Module 3 aims to establish a continuous, intensified reporting of ADE, considering the characteristics of the paediatric population. KiDSafe will implement all three modules using a step-wedge design in 12 territorial clusters, each involving a children's hospital and surrounding paediatricians, psychiatrists and general physicians.

The outcome of the implementation of "PaedPharm" will be evaluated both qualitatively and quantitatively by an independent institute. The primary outcome of this project is the frequency of ADR-associated hospital admissions. These are aimed to be reduced by 33% following the implementation of PaedPharm. The qualitative analysis will use guided interviews to capture acceptance, barriers and satisfaction, while mixed method-assisted process validation will allow for identifying the rate of implementation as well as factors of success of the implementation.

Results: It is to be expected that a guided and evidence-based prescribing of drugs for children and adolescents will improve the prescription practices of paediatricians, resulting in a significant reduction in the rate of paediatric ADE. In addition to a significant improvement of paediatric medication safety burden for the patients as well as costs for the health care system can be reduced.

Conclusion: The aim of the KiDSafe project is to enhance drug therapy for the paediatric population by introducing a guided drug treatment procedure. By bundling all aspects of drug prescription for the paediatric population and through a practical and evidence-based implementation, a lasting improvement of relevant patient and quality parameters can be achieved. KiDSafe strives to achieve a comprehensive, nationwide implementation of "PaedPharm" and an inclusion of the instrument into the general practice of care in order to permanently improve drug therapy for children.