ADR profile among healthcare workers on Hydroxychloroquine prophylaxis in a tertiary care teaching hospital in India

Abstract

Background: WHO has declared Coronavirus 2019 (COVID-19) as pandemic on 11th March 2020. Hydroxychloroquine (HCQ) chemoprophylaxis has been approved by the Indian Council of Medical Research (ICMR) for asymptomatic healthcare workers treating suspected or confirmed COVID-19 cases and asymptomatic household contacts of confirmed patients. However, there is a scarcity of data regarding the efficacy and safety of HCQ for COVID-19 prophylaxis and treatment. Objective: The present study was designed to evaluate the adverse drug reaction (ADR) profile of HCQ prophylaxis among healthcare workers in a tertiary care teaching hospital in India. Methods: A Descriptive cross-sectional study was conducted in Kalpana Chawla Medical College and Hospital, Karnal for duration of 3 months (April-June 2020). The study was performed on the reported ADRs due to HCQ prophylaxis by the healthcare workers to the ADR monitoring centre of the institute during this period. Results: Gastrointestinal disturbance such as loose stool (16.4%) and hyperacidity (14.9%) were the most commonly reported ADRs during the study period. The incident rate of adverse drug reactions was 23.7%. The number of ADRs was found to be significantly (p<0.01) more in female as compared to male. We have observed that most of the reactions were reported following the 1st day loading dose. Conclusions: Our results showed that gastrointestinal system was most commonly affected. Loose stool and hyperacidity were most frequently reported ADRs due to HCQ prophylaxis. Larger studies are required to ensure the safety of the use of HCQ as prophylaxis for COVID 19.