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THE PHARMA REVIEW (MAY 2009)

Pharmacovigilance and Clinical Trials

Aarti Sharma, Himanshu Gupta

Abstract: Clinical and preclinical studies cannot guarantee absolute safety of a drug. Therefore pharmacovigilance has been introduced to identify and respond to drug safety issues. It is related to the surveillance of drugs once they are released for use in the community (post marketing surveillance) and relies on voluntary reporting, prescription monitoring, medical records and statistical studies in the population. It is important that adequate Pharmacovigilance standards are introduced to monitor adverse reactions of drugs, before they are launched in a country like India. In this article we have tried to give an insight view on different aspect of pharmacovigilance.
 
Introduction
Modern medicines have changed the way to control and manage diseases. Despite all these benefits adverse drug reactions continue to be the common, often preventable, cause of illness, disability and sometimes death also. Clinical and preclinical studies cannot guarantee absolute safety of a drug. Therefore pharmacovigilance has been introduced to identify and respond to drug safety issues. The term pharmacovigilance originates from the Greek words Pharmacon (=Drug) and Vigilare (= to keep watch). It is related to evaluation, understanding and prevention of possible adverse drug reactions related to any medication or treatment. Pharmacovigilance has grown to a considerable extent over the past 10-15 years. Pharmacovigilance works the same way as regulatory agencies to protect the patients from unnecessary drug hazards.
 
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of long term and short term side effects of medicines.4 It is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbal and traditional medicines with a view to:

  • Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.

  • Improve public health and safety in relation to the use of medicines.

  • Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.

  • Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.

 

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