Recent signals in pharmacovigilance

Abstract

Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem of already marketed drugs. The main goal of this is to promote safe and effective use of health products by providing timely information about the safety of health products to patients, health-care professional s, and the public. There are several bodies involved in this process. The World Health Organisation (WHO) established its Programme for International Drug Monitoring, in response to the thalidomide disaster detected in 1961. World Health Organization (WHO) Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC), promotes pharmacovigilance of the WHO member countries. At the end of 201 0, 134 countries were part of the WHO Pharmacovigilance Programme. The WHO defines a safety signal as a "Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously". Information received from patients and healthcare providers via pharmacovigilance agreements as well as other sources such as medical literature is considered in signal detection. Once it is decided that there is a plausible association between an adverse effect and a drug, U MC signals those to national pharmacovigilance centres via "VigiLyze" and the signals will be published in the publicly-available WHO Pharmaceuticals Newsletter (online) and the individual signals are sent to the appropriate pharmaceutical company when they can be identified as uniquely responsible for the drug concerned. Regulators in individual countries may investigate these further and will decide on continued use of the medicine. Confirmed associations will lead to changing the information for patients, providing a public warning or in the most serious situations, withdrawing a drug from the market. For example, pharmacovigilance finding of "Roficoxib" causing increased risk of heart attack and stroke on long term use in high doses Jed to voluntary withdrawal of the drug by manufacturer from the US market in 2004.