Pharmacovigilance Risk Management



The modern age has seen the appearance of many life saving, miraculous and lifestyle drugs that promise to revolutionize the health and wellness industry that’s worth billions of dollar in revenue annually. This is one reason why drug companies lavish billions of dollars in research and development. But since drugs can save and also kill if something goes horribly wrong, the concept of pharmacovigilance is of utmost importance as one really needs to be mindful of and vigilant about drugs and their effects or after effects as the case may be. Risk management as a concept has also gained prominence in the world of business and commerce. Every business enterprise encompasses and confronts risk as a result of the business operations. It looks at the ways and means of analyzing, assessing and prioritizing risks so that the company’s best interests are well preserved.

Pharmacovigilance risk management is the happy marriage between the concepts of Pharmacovigilance and Risk Management. Pharmaceutical companies now have to face huge and costly risky propositions in the form of drug recalls and also litigation on account of drug related problems as well as hazards to the human life. Take for example the drug giant Merck, which had to withdraw Vioxx from the market which led to huge revenue losses to the extent of $2.5 billion annually. Vioxx is said to have caused many heart attacks and it was pharmacovigilance that led to its withdrawal. Now risk management in the realm of Pharmacovigilance will help drug companies adopt specific strategies to analyze and take steps to reduce the impact due to risks that are pharmacological in nature.

In brief, Pharmacovigilance risk management helps to promote the utilization of expertise and supports collaborative working, with the objective of assessment, detection, understanding and avoidance of the adverse effects of various drugs and medicines.







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