Preventability, predictability, severity and causality assessment of adverse drug reactions reported from a teaching hospital in chhattisgarh: A retrospective analysis

Abstract

Background and Objectives: Adverse Drug Reactions (ADRs) can lead to significant morbidity, rarely mortality and financial burden over the patient. ADRs that can be prevented can be considered as form of medication error sometimes. This study assessed the preventability, predictability and severity of ADRs using different assessment scales. Methods: ADR Monitoring Centre under newly established teaching hospital in Chhattisgarh collected ADR reports from different healthcare professionals during the period from November 2016 to November 2018. Analysis of the reported ADRs was done for their causality assessment, demographic details of patients, most common drug class responsible for the ADR. Seriousness and preventability of ADRs were analysed by using WHO Causality Scale and Modified Schumock and Thornton Scale respectively. Severity of ADRs was assessed by Modified Hartwig and Siegel Scale. Results: Totally 288 ADRs were reported in a 2-year period. 92.01% ADRs were non serious. 44.8% were mild, 53.81% moderate and 1.39% were severe ADRs. Causality assessment showed: 5.21% certain, 54.86% probable, 39.24% possible and 0.69% unlikely ADRs. Around 26% ADRs were definitely and probably preventable and 27.78% ADRs were predictable. The highest number (32.29%) of ADRs were reported to antimicrobials. 11.15% ADRs were reported to NSAIDs, in that 37.5% ADRs were due to NSAIDs combination. Conclusion: Many ADRs in this study are non-serious, preventable and predictable. Management of such ADRs through therapeutic interventions would be beneficial in a better patient outcome. Multidisciplinary strategies involving physicians, pharmacists, other healthcare professionals and patient education and awareness about ADRs are needed for prevention of ADRs.

Keywords

• pharmacovigilance
• preventability of adrs
• severity of adrs