Abstract

Background Adverse drug reactions (ADRs) are an important cause of morbidity and mortality in health care. Studies have explored the ability of a hospital’s ADR database to identify common and repeated patterns of preventable adverse drug events (ADEs). Purpose To identify ADRs reported in a University Hospital over 2 years and to classify these ADRs according to the causative drug, drug class and the causality relationship. Material and methods A retrospective analysis of ADRs reported to Medicine information services (MIS), over 2 years from April 2011 to March 2013. Reports were entered in a database for documentation and further analysis. ADRs were categorised according to: Causative drug (classified according to the WHO ATC classification), Drug class and Causality (analysis according to the WHO-UMC causality assessment system). A random sample of ADRs during admission was selected for analysis of preventability and severity. Preventable ADRs (pADRs) were identified using preventability criteria adapted from Schumock and Thornton with modification. The severity of pADRs was determined according to the Hartwig Severity scale. Results A total of 1,299 ADRs were reported and documented in the MIS database between April 2011 and March 2013. The highest number of ADRs was reported in adults (n = 848, 65%), followed by the elderly >65 years old (n = 241, 19%). Causality analysis of ADR’s was completed for 1,061 ADR reports. The causality of the majority of ADRs (74%) was assessed as probable. In preventability analyses, 860 ADRs were reported in the inpatient setting. A random sample of 162 ADRs was selected for the preventability analysis. Out of 135 ADR’s, only 28 (20.7%) were considered preventable. Conclusion Analysis of a hospital ADR database identified preventable adverse effects from medicines. Although this method is not representative of all preventable ADRs, it is a starting point to identify high-risk areas that can be targeted to improve the quality of the drug-use system. References and/or acknowledgements No conflict of interest.

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