Pros And Cons Of Pharmacovigiliance

Pharmacovigiliance is defined by the World Health Organisation as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” [1]. In other words, pharmacovigilance can be simply defined as drug safety. Adverse reactions can be explained as when medicines affect the body in a harmful and unintended manner. Prior to obtaining marketing authorisation for a new drug, the drug has to be tested and the corresponding data has to be gathered. These tests are known as clinical trials, and the relevant regulatory bodies must use this data to decide whether the drugs benefits outweigh the associated risks. If the benefits are seen to be greater than the risks marketing

Each member state has a competent regulatory authority, which are responsible for ensuring drug safety. In Ireland the Health Products Regulatory Authority (HPRA) is the competent body. Some member states may also have regional centres that are coordinated through the national body. There is the European Commission, which is the responsible competent authority for centrally authorised products within the EU. Finally the European Medicines Agency (EMA) is also responsible for centrally authorised products. The EMA however has the important responsibility to organise the overall system coordination for pharmacovigilance.

There was a desire to improve drug safety Europe wide as adverse side effects of medicines amassed a death toll of around 197,000 patients per year in the EU. These unintended side effects also accounted for 5% of hospital admissions and unfortunately were the fifth most common cause of death in hospitals. As result in 2005 an independent study and review of medicine safety monitoring was undertaken. The study found that the new pharmacovigilance legislation could save up to 5910 lives per year across the year. A significant amount of public consultation was also included as part of the study. This directly led to several significant changes to the safety monitoring of medicines across the EU. In 2010 the European Parliament adopted a new directive (Directive: 2010/84/EU) and regulation (Regulation (EU) No. 1235/2010). This directive and legislation improved upon the existing Directive (2001/83/EC) and Regulation (EC No. 726/2004) at the time. In order to ensure these new pieces of legislation became legally binding at an operational; the Commission Implementing Regulation was passed in June 2012. There were further amendments made to this legislation in 2012, following the withdrawal of a medicine sold under the name Mediator. The amendments were intended to strengthen the protection of patients. The new Directive (2012/26/EU) and Regulation (EU 1027/2012) became law in October and June 2013 respectively.