Background In paediatrics, 80% of the prescribed drugs are off label or unlicensed. From previous research its known that the amount of adverse drug reactions (ADR’s) in off label or unlicensed drugs are higher in comparison to drugs who are registered.1 Reporting ADR’s in The Netherlands is voluntary and can be done at Lareb, the Dutch national network for collecting and investigating ADR’s. We aim to determine the quantity of reported and missed ADR’s in paediatric medium care wards in an aca-demic hospital in The Netherlands.
Methods Retrospective study of all patients who were hospitalised in June 2016 on the paediatric medium care ward in an academic hospital. Two researchers in-dependently looked at discrepancy in the numbers of ADR’s which were reported in the medical file by medical doctors (MD’s), and the number of ADR’s the researchers found based on the medical file. MD’s working at the ward were not informed about the study.
Results 323 patients were hospitalised in June 2016; 310 patients received one or more drugs. 57 ADR’s (possible ADR’s included) were reported in the medical file by MD’s. The researchers found 67 ‘missed’ ADR’s by reading the medical files. In total, 67 children (21.6%) suffered from one or more ADR’s (reported ADR’s and missed ADR’s added together). None of the ADR’s reported in the medi-cal file by MD’s, was reported to Lareb (the Dutch national network for collecting and investigating ADR’s).
Conclusion more than 50% of (possible) ADR’s are not reported in the medical file. Possible explanations are:
1) the poor training in ADR recognition, 2) MD’s think expected ADR’s don’t need to be reported, and 3) MD’s may have struggle admitting ADR’s because they feel like causing them by prescribing the drug.
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