Pharmacovigilance in the Era of Covid-19: A Concise Review of the Current Scenario, Implications, and Challenges

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.

Demand of COVID-19 medicines without prescription among community pharmacies in Jodhpur, India: Findings and implications

“…[ 48 49 ] The increased use of various medications without proven benefit can lead to raised risk of adverse drug reactions (ADRs) hence monitoring these and reporting them is crucial for rational drug use. [ 50 51 ] The vaccines have proven to improve immunity against the strains of COVID-19 and seem to be the only option at the current time to end this pandemic, however the safety of these newly developed vaccines needs to be monitored as done by various studies. [ 51 52 53 54 ]…”

“…[ 50 51 ] The vaccines have proven to improve immunity against the strains of COVID-19 and seem to be the only option at the current time to end this pandemic, however the safety of these newly developed vaccines needs to be monitored as done by various studies. [ 51 52 53 54 ]…”

Adverse Drug Reactions Associated With Drugs Prescribed in Psychiatry: A Retrospective Descriptive Analysis in a Tertiary Care Hospital

“…Drugs, which have an indispensable role in treating diseases or ailments, while treating the patients sometimes may have some side effects [1]. Adverse event and adverse effect/adverse drug reaction are the two terms that are frequently used in the world of pharmacovigilance and are misunderstood and confused with each other quite often.…”