The Erice Manifesto: for global reform of the safety of medicines in patient care.

The science of pharmacovigilance--monitoring and evaluating drug safety issues and communicating them effectively--is a vital activity of worldwide significance in the safeguarding of patient welfare and public health. Its clinical, public health and economic importance has been demonstrated, but it needs to be better understood and appreciated by politicians, the media and the public. Pharmacovigilance is evolving from being a largely reactive discipline, concentrating on the discovery of harm caused by marketed drugs, to a proactive study of their safety, effectiveness and associated risk factors in normal medical practice and use by patients. The Erice Manifesto specifies the challenges which must be addressed to ensure the continuing development and usefulness of the science, in particular: The active involvement of patients and the public in the core debate about the risks and benefits of medicines, and in decisions about their own treatment and health . The development of new ways of collecting, analysing and communicating information about the safety and effectiveness of medicines; open discussion about it and the decisions which arise from it . The pursuit of learning from other disciplines about how phamacovigilance methods can be improved, alongside wide-ranging professional, official and public collaboration . The creation of purposeful, coordinated, worldwide support amongst politicians, officials, scientists, clinicians, patients and the general public, based on the demonstrable benefits of pharmacovigilance to public health and patient safety.