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The Erice DeclarationIn September, I was invited to attend an international workshop to review the Erice Declaration in Sicily. I was one of many pharmacovigilance professionals to attend the event. Our pharmacovigilance backgrounds were varied and many different countries participated.
The workshop was held at the Ettore Majorana Foundation and Centre for Scientific Culture, which is situated in a remarkable and memorable medieval town of Erice (which has Phoenician and Greek roots) seated 750m above sea-level atop a mountain overlooking the city of Trapani. The International School of Pharmacology was founded here in 1976 and many courses and workshops related to drugs and drug use are held here. For more information about the Foundation, visit: http://www.ccsem.infn.it.
The Erice Declaration was conceived and published in 1997. The full title of the original document was: The Erice Declaration on Communicating Drug Safety Information (available at http://who-umc.org/graphics/24752.pdf). It was a visionary statement setting out ideals for drug safety communication. It was translated into many different languages and is still cited today. The original declaration mentioned the need for all players in the field to be involved and engaged in drug safety activities.
The statement set about delivering 5 pharmacovigilance principles, as follows:
1. Drug safety information should always serve the needs of the public, providing factual information,
acknowledging uncertainties and delivered in a format that meets the needs of all users.
2. Educational information required special attention and a commitment to provide to patients and healthcare
providers guidance on the safe use of medicinal products together with a balanced view of the benefits and
3. Evidence used to assess the benefits and risks of medicines should be freely accessible and openly available.
4. Every country should ensure they have a pharmacovigilance system in place to collect and evaluate safety
information. The use of this reporting system should be actively supported by governments.
5. Emerging safety problems should be intercepted early and promptly dealt with. Information regarding safety
issues should be effectively communicated.
The aims of the workshop were to engage members in the review of the Erice Declaration and discuss the need for changes to current and future pharmacovigilance, and whether or not it is perhaps time for a new Erice Declaration. The workshops extended over 3 days and active discussion took place on topics such as, PV in low-income countries, new web-technologies, the patient perspective and new approaches for therapeutic outcomes.
Overall, the group felt that pharmacovigilance had made good progress in the 20 years since the original declaration was published in 1997 and that a newer visionary approach was needed to capture a sense of direction for the future of pharmacovigilance.
The points raised for future development in the area of pharmacovigilance included:
1. Patient’s front and centre: By actively promoting patient engagement and viewing patients as valuable contributors,
advisors and partners in the healthcare decision making process;
2. Pharmacovigilance integration: Pharmacovigilance should extend throughout healthcare from regulators, to
companies, prescribers and patients to ensure that safety is at the forefront of all clinical decisions;
3. Pharmacovigilance collaboration: Active engagement with educational institutions and collaboration with
independent bodies to promote the science and activities of pharmacovigilance;
4. Pharmacovigilance methodologies: To work with research institutes to further develop methodology and tools used
for pharmacovigilance to improve the safety assessment of medicines and risk minimisation;
5. Pharmacovigilance transparency: Pharmacovigilance should work towards ensuring that all stakeholders remain
patient centred and work towards the promotion of improving the quality and health of all patients, irrespective of
ethnicity or origin;
6. Monitoring clinical outcomes: Pharmacovigilance must become the leading science to ensure clinical care results in
beneficial treatment outcomes by taking an active role in monitoring how drug therapies are used in practice, how
they are prescribed and how such actions affect treatment outcomes;
7. Measuring pharmacovigilance outcomes: Pharmacovigilance needs to pursue the investigation and quantification
of value-added outcomes and cost-savings related to pharmacovigilance activities.
A number of concerns, some of which have long plagued the world of healthcare, were raised such as, inadequate access to basic medicines in low-income countries, the need for healthcare systems to be structured in ways that support regional and cultural differences and; for appropriate measures to be implemented to address corruption and manipulation within the healthcare and pharmaceutical industries.
Whilst the scope of pharmacovigilance is evolving to encompass a broader framework that includes a wide range of issues around the safe and effective use of medicines, I feel these concerns fell somewhat out of the scope of what pharmacovigilance as a scientific discipline can realistically achieve or be wholly responsible for.
The essence of my time in Erice really helped me to see that the role of the PV specialist has evolved tremendously in the last decade. Colleagues viewed the pharmacovigilance specialist as valuable contributors to patient safety, supporting clinicians through the provision of technical information to ensure therapeutic care is delivered safely and effectively.
So, the workshop concluded having debated these issues at length and we now wait in anticipation of the outcome of our hard work and deliberation.
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