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Effective Communications in Pharmacovigilance - The Erice Declaration

The following declaration was drawn up at the International Conference on Developing Effective Communications in Pharmacovigilance, Erice, Sicily, 24-27 September 1997. It was attended by health professionals, researchers, academics, media writers, representatives of the pharmaceutical industry, drug regulators, patients, lawyers, consumers and international health organisations.

Preamble:

Monitoring, evaluating and communicating drug safety is a public-health activity with profound implications that depend on the integrity and collective responsibility of all parties - consumers, health professionals, researchers, academia, media, pharmaceutical industry, drug regulators, governments and international organisations - working together. High scientific, ethical and professional standards and a moral code should govern this activity. The inherent uncertainty of the risks and benefits of drugs needs to be acknowledged and explained. Decisions and actions that are based on this uncertainty should be informed by scientific and clinical considerations and should take into account social realities and circumstances.

Declaration:

Flaws in drug safety communication at all levels of society can lead to mistrust, misinformation and misguided actions resulting in harm and the creation of a climate where drug safety data may be hidden, withheld, or ignored.

Fact should be distinguished from speculation and hypothesis, and actions taken should reflect the needs of those affected and the care they require. These actions call for systems and legislation, nationally and internationally, that ensure full and open exchange of information, and effective standards of evaluation. These standards will ensure that risks and benefits can be assessed, explained and acted upon openly and in a spirit that promotes general confidence and trust.

The following statements set forth the basic requirements for this to happen, and were agreed upon by all participants from 34 countries at Erice:

  1. Drug safety information must serve the health of the public. Such information should be ethically and effectively communicated in terms of both content and method. Facts, hypotheses and conclusions should be distinguished, uncertainty acknowledged, and information provided in ways that meet both general and individual needs.
  2. Education in the appropriate use of drugs, including interpretation of safety information, is essential for the public at large, as well as for patients and health-care providers. Such education requires special commitment and resources. Drug information directed to the public in whatever form should be balanced with respect to risks and benefits.
  3. All the evidence needed to assess and understand risks and benefits must be openly available. Constraints on communication parties, which hinder their ability to meet this goal must be recognised and overcome.
  4. Every country needs a system with independent expertise to ensure that safety information on all available drugs is adequately collected, impartially evaluated, and made accessible to all. Adequate nonpartisan financing must be available to support the system. Exchange of data and evaluations among countries must be encouraged and supported.
  5. A strong basis for drug safety monitoring has been laid over a long period, although sometimes in response to disasters. Innovation in this field now needs to ensure that emergent problems are promptly recognised and efficiently dealt with, and that information and solutions are effectively communicated.

These ideals are achievable and the participants at the conference commit themselves accordingly. Details of what might be done to give effect to this declaration have been considered at the conference and form the substance of the conference report.

Erice, September 27 1997

The Conference was organised by:
the Uppsala Monitoring Centre; the Clinical Pharmacology Unit, Institute of Pharmacology of Verona University; the Ettore Majorana Centre for Scientific Culture, International School of Pharmacology; the World Health Organisation and supported by EQUUS Communications, London

The full report from the conference is available from the UMC. Please contact the Sales Department at the UMC to order your own copy of the Erice Report.