gms | German Medical Science

In a previous study we observed ADRs in 13.8 % of hospitalised children, 2.5% of children were hospitalised because of an ADR. Antibiotics were the most frequently ADR-associated drugs predominantly causing gastro-intestinal symptoms. Aim of the current study: Analysis of the documented medication prescribed for all hospitalised children with the diagnoses "respiratory infections" and "epilepsy" using pre-specified definitions of ADRs and standardisation of methods.

Data collection between 01.03.2003 and 25.05.2003 on 2 general paediatric wards and the paediatric intensive care unit at Helios Klinikum Wuppertal (Germany). ADR collection by daily ward rounds, chart review, interview of nurses and physicians, parents and patients. Documentation of the medication of all hospitalised children with respiratory diseases and epilepsy as well as all children with ADRs into an Microsoft ACCESSÒ database. Causality was evaluated by the WHO- and Naranjo-Score.

715 children were admitted during the study period, 198 suffered from an airway disease (27.7%), 23 (3.2%) children had a diagnosis of epilepsy. In the total paediatric population 67 ADRs occurred in n = 41 children (5.7%). 27 of them had a respiratory illness (65.9%) and 6 children an epilepsy (14.6%). 44.8% of ADRs were mild, none was fatal. 37 of the 67 ADRs were gastro-intestinal side effects (55.2%) and 7 were CNS symptoms (10.4%).

Antibiotics were responsible for 41 ADRs (61.2%) followed by antiepileptics (13.4%).

In contrast to our previous study we observed a lower number of ADRs, however, a comparable spectrum of symptoms and causative drugs. The introduction of very strict definitions and the implementation of a second algorithm for causality assessment may have a major influence on the results. Antibiotics are still the major cause for ADRs in paediatrics and the indication for their prescriptions should be carefully monitored.