Pharmacovigilance during a pandemic

John Danese, Industry Director-Life Sciences, Birlasoft and Sreenivas Reddy N, Global Program Director, Life Sciences, Birlasoft explain that legacy pharmacovigilance workflows and systems need a massive overhaul to ensure organisational efficiency and reduce the cost of compliance, especially during a pandemic

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As coronavirus has become the new reality for every health worker and life science company to fight in the front, it is time to relook the approach being taken by the industry towards pharmacovigilance. Health agencies around the world are evaluating the impact of the virus, clinical trials, and pharmacovigilance systems. The rapidly changing situation with the outbreak of the virus has compelled agencies to be more vigilant and proactive in determining the effects of the pandemic for better patient care. Pharmacovigilance is detection, assessment, understanding, and prevention of adverse effects of the therapeutic product on the patient. A thorough pharmacovigilance strategy is essential to ensure patient safety and protect the reputation of pharma and medical device companies. Pharmacovigilance is the report card that helps us identify the successful patient care of the medicine post its clinical trial.

During the preparation of a drug, it goes through different clinical tests to get approved for patients. Pharmacovigilance helps in knowing about the adverse effect of the therapeutic product after it has been launched in the market. It is an important part, like clinical trials, for the product lifecycle. Pharmacovigilance involves the collection of a large amount of data and analysing the same for better patient care and adverse effects.

The increasing number of data sources used to identify adverse events (AE): call centres fielding reports from patients and healthcare practitioners (HCPs); safety databases such as ARGUS, ARISg, electronic health records (EHRs); clinical trial data; medical insurance claims; contract research organisations (CROs); post-marketing safety (PMS) studies; scientific literature; regulatory and NGO databases; and legal cases play a major role in pharmacovigilance.