Pattern, severity, and preventability of adverse drug reactions from a Northern Indian tertiary care facility: A retrospective analysis

Abstract

Background Over the years, it has been observed that adverse drug reaction (ADR) is a major cause of mortality and morbidity and a major cause of concern for all healthcare professionals. ADR is a leading cause for hospitalisation and increases the financial burden of the patient. Thus, it is imperative that we need steps and strategies to decrease the burden of ADRs and effectively reduce the cost of therapy to treat ADR. Objective This study evaluated the pattern, severity, and preventability of ADRs in a tertiary care hospital. Methods A retrospective observational study of all the ADR reports due to medications submitted to the ADR monitoring centre in a Northern Indian tertiary care hospital from October 2017 to December 2019. Causality assessment of the ADRs was done using the WHO-UMC causality assessment scale, and the severity was assessed using the modified Hartwig scale. Furthermore, the preventability of the ADR was assessed using the Schumock and Thornton scale. Results A total of 252 ADRs were reported. A maximum number of the ADRs (33%) were due to antimicrobials followed by analgesics (16%) and antihypertensives (10%). Amongst the analgesics, a majority of ADRs were associated with Diclofenac (16 ADRs). Amlodipine was associated with maximum ADRs (10) amongst the antihypertensives. The ADRs of gastrointestinal systems (34.5%) were most common among all system organ class (SOCs) followed by skin and subcutaneous tissue disorders (32%). Majority of ADRs were probable and mild in severity. According to the Schumock and Thornton preventability scale 69% were not preventable while 12% were definitely preventable. Conclusions Antimicrobials were associated with majority of ADRs with gastrointestinal system being the most commonest organ involved. It was also observed that most of the ADRs were not preventable but some were definitely preventable. The awareness regarding preventability of ADRs needs to be emphasised and further studies to elaborate on the preventability of ADRs needs to be carried out.