Pharmocovigilance Essay

Pharmocovigilance

Pharmocovigilance as define by the oxford dictionary is "the practice of monitoring the effects of medical drugs after they have been licensed for use especially in order to identify and evaluate previously unreported adverse reactions"[1]. In the EU all medicine is strictly analysed and tested for their quality , efficacy and safety before it is authorised for market. Even as these drugs are on the market they are continuously monitored to ensure any particulate which could affect the safety of the drug is identified and assessed and the necessary measures are taken .The Pharmocovigilance legislation was put into place to reduce the risks and increase the benefit of medicine and was "developed based on the observation that adverse drug reactions caused roughly 197,000 deaths in the EU"[2].

Since 1995 there have not been any major changes in the EU regulations of human medicine until the new Pharmocovigilance legislation came into effect during the month of July 2012. The aims of the Pharmocovigilance Legislation is to lessen the count of adverse drug reactions in the EU, through the following:

• Compiling and maintain data on the safety of medicines

• Analyzing data to identify the ADR's

• Assessing the data to determine safety issues

• Following effective regulatory action to deliver

An example of an adverse drug reaction is pathological addiction, like gambling ,shopping, sexual and other intense urges caused by dopamine agonists or hair loss and anaemia caused by chemotherapy. Adverse drug reactions should not be mistaken with an adverse effect which is the unwanted event experienced by a patient whilst on a medicine, regardless of whether or not the medicine is believed to be related to the event. An example of an adverse event would be drowning while the patient is on specific