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Pharmacovigilance in Public Health Protection
The National Authority of Medicines and Health Products, IP (Infarmed IP) is the entity responsible for the implementation, monitoring and coordination of the National Pharmacovigilance System (SNF). Created in 1992, the SNF aims to prevent, detect and assess adverse reactions to drugs, in constant collaboration with health professionals, the pharmaceutical industry and the health services.
The SNF has developed over time and currently is a structured and integrated network of partners that contribute to the ultimate aim of improving knowledge about the safety profile of drugs available in the market, and thus ensure their increasingly safer consumption. The active role of health professionals and of the pharmaceutical industry has been crucial in the pursuit of this objective by reporting adverse drug reactions, in addition to the role played by the Regional Pharmacovigilance Units, which were set up in our country in 1999 for this purpose.
The constant evolution of the pharmaceutical sector, both in terms of research and scientific and technological advancement - particularly relevant with the introduction of innovative drugs – and in terms of early access to new products, imposed new requirements for risk monitoring and surveillance of adverse reactions to the use of drugs. In this sense, the medicine authorities of the Member States of the European Union and the European Medicines Agency have recently developed new regulatory tools to strengthen pharmacovigilance activities, namely Directive 2010/84/EU and Regulation No. 1235/2010, published in the Official Journal of the European Union on 31 December 2010.
Expected to come into force in July 2012, the new European Pharmacovigilance System (EUPS) will impose agreed and supranational changes in the systems currently in existence in the Member States. These changes include, among others, broadening the definition of adverse reaction, the reorganization of the structure and procedures of the actual surveillance system and the direct involvement of citizens as notifiers.
The new EUPS should also, in an active and integrated manner, be prepared to collect information on suspected adverse reactions resulting from the use of a drug pursuant to permission to be put on the market, as well as from its use outside the terms of the permission to be put on the market, including, in particular, cases of overdose, misuse and abuse, medication errors, and also suspected adverse reactions associated with professional exposure.
The development of the new Pharmacovigilance System in Portugal and in Europe is a challenge that requires the coordinated participation of all stakeholders (consumers, health professionals, researchers, pharmaceutical industry, regulators and governments) to allow a faster and better detection and characterization of the safety problems associated with the use of drugs, and thus help support the subsequent decision-making with regard to the protection of public health.
Cristina Furtado
Guest Auxiliary Lecturer at the Institute of Preventive Medicine of the Faculty of Medicine of the University of Lisbon
Voting Member of the Board of Directors of Infarmed I.P.
cristina.furtado@infarmed.pt
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