The Erice Declaration
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COMMENTARY
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The Erice Declaration The Critical Role of Communication in Drug Safety Bruce Hugman The Uppsala Monitoring Centre, Uppsala, Sweden
Abstract
The Erice Declaration on Communicating Drug Safety Information, first published in September 1997, provides a vision of vigorous, open, ethical, patient-centred communications in drug safety that the world has yet to achieve. The Declaration is reprinted here as a further stimulus to all parties to renew their commitment and to add new momentum to the improvements which have undoubtedly taken place in the past few years. The content of the Declaration is briefly reviewed, and some of the continuing communications challenges and problems are outlined.
The publication of The Erice Declaration on Communicating Drug Safety Information in September 1997 coincided with, and was probably significantly instrumental in achieving, a worldwide movement to include communications high on the core agenda of pharmacovigilance. The topic has remained firmly on that agenda and has shown increasing prominence in the literature, at workshops and conferences, and in almost all drug safety debates.[1-8] The Declaration itself is often cited. The international group, which met in Erice (see Appendix) and drafted the Declaration, represented most stake holders in the drug safety arena: patients, clinicians, lawyers, regulators, industry, researchers and campaigners, journalists and communications experts, academics and international health organisations. It was this unique assembly of interests and skills that led to the radical and comprehensive sweep of the document’s content – concluding above all that the primary goals of patient safety and public health could be achieved only through open, transparent, ethical and effective communication of drug safety issues involving all players and tailored to their needs. The fundamental shift implied was from the processing and distribution of information to the active engagement of all parties and to the under-
standing and meeting of their wishes and needs: from an essentially bureaucratic, distributive model to an interactive, patient-centred model. The Declaration asserts the right of patients and the public to good information about the safety of drugs “ethically and effectively communicated”. It deals particularly with that problematic area, lack of certainty: “Facts, hypotheses and conclusions should be distinguished, uncertainty acknowledged…”. It insists that all the information relating to benefit and harm, effectiveness and risk about medicines should be openly available and debated. The Declaration is a very short document (one A4 page), but the challenges it raises are profound and they are still far from being met. We know that much regulatory communication is ineffective;[9,10] we know that large numbers of patients experience serious or fatal damage from their medicines;[11] we know that flawed behaviour by doctors and patients is widespread;[12] we know that drug crises
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