*Anjali Kadam, Rushikesh Ghule, Prof. S. A. Waghmare and Dr. Hemant Kamble


Drug safety and pharmacovigilance remains a dynamic clinical and scientific discipline. Pharmacovigilance is defined by the World Health Organization (WHO) as ’the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. No drug which is pharmacologically effective is without hazard. Further more not all hazards can be known before a drug is marketed. This was the clear conclusion of the first chairman of the UK’s Committee on Safety of Drugs, Derrick Dunlop, in the mid1970s, and it remains as true today. Pharmacovigilance, which encompasses the processes involved in identifying, assessing and minimising the risks associated with medicines in clinical use, is now accepted as a vital public health function. As a direct result of the thalidomide tragedy in the 1960s, notification systems for reporting information on adverse drug reactions to the authorities were put in place in most countries. Since then, the science, methodologies and tools of pharmacovigilance have evolved, largely in response to the growing complexity of drug safety issues. Examples of this complexity include drug-related harms which may be similar to those of the background pathologies in the population treated; harms which may be apparent only in very long-term use; and harms which may be difficult to distinguish from the condition itself being treated. Evaluating risks as complex as these requires a range of approaches and data sources, and sound judgement in applying them. It is no longer appropriate to talk about moving up a hierarchy of evidence away from less robust forms of data such as single case adverse reaction reports, but of an integrated approach potentially involving a plurality of evidence. Public expectations have grown too, and delays in acting on drug safety issues are not accepted. Medicines regulators have shifted from a largely reactive response to drug safety issues, to a more proactive approach. Companies and regulators plan safety studies and implement active surveillance to fill in the knowledge gaps that inevitably exist at the time of market authorisation, which is still based on clinical trials designed principally to show a drug’s efficacy.

Keywords: pharmacovigilance, drug safety, clinical trails.

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