PHARMACOVIGILANCE IN THE ERA OF COVID-19: A CONCISE REVIEW OF THE CURRENT SCENARIO, IMPLICATIONS, AND CHALLENGES

Siddhartha Dutta,Hina Lal,Sneha Ambwani,Tarun Kumar,Kishna Ram,G C Mishra

doi:10.22159/ijap.2021v13i3.41063

Abstract

The pandemic of Coronavirus Disease 2019 (COVID-19) has now affected the entire globe which was first surfaced in China in December 2019. In absence of effective therapy to manage COVID-19, repurposed therapies were being used to manage the condition. In view of an urgent need for definitive therapy, multiple repurposed drugs, and investigational drug candidates are being tried in clinical trials which may lead to the emergence of unknown short term and long term adverse drug reactions (ADRs), and hence it is crucial to assess the safety of the tried therapeutic interventions. The lag in the pharmacovigilance activities in the midst of this pandemic fosters under-reporting of ADRs. Difficulty in causality assessment due to factors like wide variations in clinical presentation, concomitant use of multiple drugs, associated comorbidities, drug-drug and drug-disease interaction which forestalls the appropriate causality assessment. Hydroxychloroquine, a repurposed antimalarial drug has been a part of hue and cry at present because of its in-question safety in patients with cardiac disorders. National and International Drug monitoring centers have stressed upon reporting of ADRs and to boost up the process and come up with various recommendations. We can overcome these issues by working cohesively, motivating HCPs and patients to report ADRs electronically, and by setting up dedicated pharmacovigilance rapid response team to tackle the issues at the earliest.

Highlights

In current times of pandemic of Coronavirus Disease 2019 (COVID19), the entire globe is fighting a war against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [1]
The COVID19 started in the Wuhan district of China with few cases of pneumonia having unfamiliar etiology and later it got spread to other countries of the world following which on March 11, 2020, it was declared as a global pandemic by the World Health Organization (WHO) [1,2,3]
In view of the dire need for an effective drug or vaccine against COVID-19, if we primarily focus the weight on the efficacy of the particular investigational candidate it would be difficult to ensure the short and long-term safety of these agents

Summary

INTRODUCTION

In current times of pandemic of Coronavirus Disease 2019 (COVID19), the entire globe is fighting a war against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [1]. Apart from the usual information to be shared in the ADR form this new version has few newly added features to be reported like status on pregnancy, lactation, relevant tests/laboratory data with dates like chest X-Ray, ECG, biochemical examination, ophthalmological examination, test for COVID-19 (RT-PCR test or rapid antibody test), recent travel information, relevant medical/medication history, drug interaction, concomitant medication including a drug used for co-morbidities, and complementary medicines with therapy dates [26] This additional information and knowledge regarding COVID-19 patients can help assist in the causality assessment in a better way. Dedicated pharmacovigilance rapid response team to collect, assess, and report the ADRs

CONCLUSION

39. American College of Cardiology

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