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THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2010)

Global Drug Safety Monitoring Systems: Marching Forward to Minimize
Drug Related Health Hazards

D. Sreedhar, Manthan D Janodia, Virendra S Ligade, Ajay G Pise, N. Udupa

Introduction
Newer drugs are very much needed to fight emerging diseases. These new drugs undoubtedly have the ability to treat the diseases effectively but a few may cause unwanted effects. We have enough examples of drugs which had side effects apart from their excellent disease treatment potential. Although the thalidomide disaster is now over 50 years, still it triggers fear in the minds of people, the government and the regulatory authorities. There are even recent examples such as Vioxx, which had resulted in death of a few patients. Such events would compel drug regulatory authorities to propose even more stringent regulations to approve the newer drugs. Such events would also trigger the government authorities to establish appropriate systems to tackle such menace. Pharmacovigilance is one such system which has emerged to address issues related adverse effects of drugs. The definition of pharmacovigilance provided by World Health Organization (WHO) is universally accepted and widely used. It defines pharmacovigilance as “the Science and activities relating to the detection, assessment, understanding and prevention of adverse drug reactions”.1 Recently it covered even biologics, blood products, herbal and other complementary medicines, medical devices and vaccines. In simple terms pharmacovigilance refers to post-marketing monitoring of drug safety.

 

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