E-drug: 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.
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 30 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
Further information from: Prof I Ralph Edwards, +46 18 65 60 60
or Bruce Hugman, EQUUS, +44 171 274 8724
Wilbert Bannenberg, SADAP Coordinator
Hallmark 938, P/Bag X 828, Pretoria 0001, South Africa
Tel work +27-12-3120374/5 Fax +27-12-3244525 Cellphone +27-82-5756249
Email 73377.3055@compuserve.com or bannew@hltrsa.pwv.gov.za
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