MedicineSociology

K. Sharman

2006.12.1Alternative Law Journal

DOI: 10.1177/1037969x0603100410

tlooto Summary

Pharmacovigilance is instrumental in helping to ensure patient safety for both newly released drugs and those that are well established in the market, as well as meeting the challenges posed by the ever increasing range and potency of medicines.

Abstract

: Pharmacovigilance is instrumental in helping to ensure patient safety for both newly released drugs and those that are well established in the market. It is an important and integral part of clinical research. Pharmacovigilance is “defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines. Despite its 40 years history, Pharmacovigilance remains a dynamic clinical and scientific discipline. It continues to play a crucial role in meeting the challenges posed by the ever increasing range and potency of medicines. When adverse effects and toxicity do appear especially, when previously unknown, it is essential that these are reported, analysed and their significance communicated effectively to an audience that has the knowledge to interpret the information, which carry an inevitable and some for all medicines there is a trade-off between the benefits and the potential for harm. The harm can be minimized by ensuring that medicines of good quality, safety and efficacy are used rationally and that the expectations and concerns of the patient are taken into account when therapeutic decisions are made.

Citation format

SHARMAN, K. An emerging field. Alternative Law Journal, 2006, 31: 227–229.