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THE PHARMA REVIEW (MAY JUNE 2017)

Pharmacovigilance: Past, Present and Future - Moving Ahead in Patient Safety

Kavya H B, Krithi Krishnan I, Neenu Thomas, Vinuth Chikkamath, & Anantha Naik Nagappa*

Introduction: After World War II the great industrial revolution spurred. The development in science and technology herald an era of modern living and management of health and other social needs. Especially in Europe where many industries were setup with actively involved commercial industry practices. The epidemic of diseases started hunting mankind and in order to control the suffering and death, there was need of new drugs. Drug discovery and research became a prominent activity and further in order to sponsor the these activities, commercialization of drugs and health services was developed to support and sustain. Many new molecular entities were synthesized for example Sulpha drugs, arsenic compounds and various antibiotics like streptomycin, tetracycline etc. One of the biggest questions was regarding safety of these drugs in humans when used for treating diseases. The first thought was to establish the safety of new drugs in animals. Various animal models were established to test the safety of these drugs. Ultimately it led to establishment of the therapeutic index with consisted of efficacy and toxicity. There were many Adverse Drug Reactions (ADRs) mandating the necessity of vigilance of long term safety issues of the drugs in the humans. In the course of long term usage it was soon understood that many of these drugs manifested a variety of ADRs not only in the people who use them but also in children bond to them. For example thalidomide induced teratogenicity1-2..

 

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