Presentation Description: Adverse drug reactions (ADRs) are a growing cause of morbidities across the globe which poses 15% to 20% of their hospital budgets occupied on health-care resources. In order to achieve real-life data about the features, diagnosis, and controlling of an adverse effect related to the use of the commonly used drugs, we performed a comparative analysis of Pharmacovigilance and off the label usage of drugs. Sufficient scientific evidence for supporting Off the label usage of drugs better as compared to FDA approved medication to treat a medical condition layout the basis to promote this drug for clinical trials. As an example, Since 1998 Sildenafil was approved to treat erectile dysfunction in the United States; earlier to this, in 1989, Sildenafil was introduced by Pfizer for the treatment of angina pectoris and hypertension. Though commonly used analgesic drug Asprin was discovered in 1890 to treat rheumatism; in 2015 Aspirin treatment got approved for the treatment of acute cardiac events in high-risk patients. Applicability of off the label usage of drugs has shown potential for the treatment of a medical condition that has never established the Food and Drug Administration (FDA) approval. Nowadays, this may be understood by the growing concerns about antimalarial drug Hydroxychloroquine and steroidal drug Dexamethasone for the treatment of the Covid-19 pandemic. Hence, off the label usage of drugs serves as a safety tool applied to drugs already in the market through the signal detection transformation in pharmacovigilance studies.
Consciously monitoring and reporting of Adverse drug events and other effects may simultaneously generate information regarding off the label use of drugs.
Off the label usage of selected drugs would enhance generating sets of probabilities to delineate drug adverse events.
Demonstrate and correlate the importance of optimization of drug therapy in patients with comorbidities involves the ongoing assessment of the alternative effects of a marketed medicine
Helpful to understand how pharmacovigilance effectively contributes to learning off the label usage of drugs.
Clinical trials of Off the label usage of drugs would minimize the risk and cost of the drug discovery process by providing an efficient screening of the existing drugs for their unintended use.