Hospital registration of adverse drug reactions in electronic health records: importance and contribution to pharmacovigilance

Abstract

Background: Adverse drug reactions (ADRs) cause a considerable amount of mortality and morbidity. However, they are vastly underreported. Information on registered ADRs in hospitals may provide a large real world data source that can be used to ensure patients’ safety. Purpose: To quantify the contribution of hospital registration of ADRs in electronic health records (EHR) to pharmacovigilance purposes. Design: An observational retrospective study using data from the Jeroen Bosch Hospital in the Netherlands in 2019. Methods: Serious and previously unknown ADRs registered systematically in the corresponding fields of EHRs were assessed. Results: During the study period, data on 1010 patients were included. Patients aged on average 63 (±17.6) years and the majority was female (66.2%). In total, 1630 ADRs were registered. The most frequent ADRs were ‘nausea’ and ‘vomiting’ and the most involved therapeutic drug groups were opioids and NSAID’s. Fifty eight serious ADRs (5.2%) were registered. Tubulointerstitial nephritis was the most frequently registered serious ADR and was mainly associated with antibacterials for systemic use. A total of 264 previously unknown ADRs (16.2%) were registered of which ‘malaise’ was the most frequent unknown ADR and tramadol was the most involved drug. Additionally, 25 ADRs (1.5%) were registered that may be attributable to 10 drugs that are under additional monitoring. Conclusion: Hospital registration of ADRs in EHRs provides information on serious and unknown ADRs which are normally challenging to assess during clinical trials. Widespread use of ADR registration can have tremendous value for pharmacovigilance. However, several improvements are needed to optimize this registration.