Pharmacovigilance and assessment of drug safety reports during COVID 19

• Main Author: Mira K Desai
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2020-01-01
• Series: Perspectives in Clinical Research
• Subjects: causality assessment; covid-19; pharmacovigilance
• Online Access: http://www.picronline.org/article.asp?issn=2229-3485;year=2020;volume=11;issue=3;spage=128;epage=131;aulast=Desai

The speed and volume of clinical research to discover effective drug against novel corona virus has been remarkable. To address the unmet medical need, the regulations are made flexible and convenient without any relaxation in drug safety reporting. The pharmacovigilance activities, especially adverse event reporting regardless of clinical trials or clinical practice should continue as usual because patient safety is the priority. The exposure to experimental drugs with limited evidence of risk - benefit makes it more crucial to adapt robust safety monitoring, accuracy in adverse event reporting, and timely assessment. With the current restriction on physical contact, travel and free movements, isolation, quarantine, and huge clinical workload during pandemic, causality assessment will be more challenging. It may not be possible to capture details of all adverse events, thereby affecting completeness and quality of safety reports. A substantial number of COVID 19 patients will receive investigational drugs along with multiple other medications for clinical manifestations and drug therapy for lifestyle diseases. Causality assessment will be a challenge due to overlapping toxicities, multiple confounding, contributory factors, and insufficient data on safety and risk profile of combining drugs. Assessment will be unable to precisely determine the causality as certain or unlikely, although, it will be valuable in categorizing the causal association as “possible” adverse drug reactions and their scientific basis. Several of these detailed reports, when collated, can identify risk factors for possibilities of prevention or avoid harm. In the current situation of pandemic and uncertainty of experimental new and old repurposed drugs, causation needs to be viewed for the study drug with a public health perspective. After all, this is the best time tested approach to generate evidence and drug evaluation to prevent damage to prospective patients.