Pharmacovigilance on the turn? Adverse reactions methods in 2012

On 31 December 2011 a new European Directive on pharmacovigilance1 signalled a very important change. It amended Directive 2001/83/EC on the community code relating to human medicines, and said that Union rules on pharmacovigilance: > ‘… should be based on the crucial role of healthcare professionals in monitoring the safety of medicines, and should take account of the fact that patients are also well placed to report suspected adverse reactions to medical products. It is therefore appropriate to facilitate the reporting of suspected adverse reactions by both healthcare professionals and patients, and to make methods for such reporting available to them.’?1 Views in the pharmacovigilance community had been divided, many for various reasons doubting the value or practicality of …