In accordance with the definition established by the World Health Organization (WHO), Pharmacovigilance is the science that collects, monitors, investigates and evaluates the information on the effects of drugs, biological products, medicinal plants, and traditional medicines, in order to identify new adverse reactions, to determine their frequency and prevent danger to patients. To achieve this, WHO established the International Pharmacovigilance Program in 1968 with the idea of pooling all the existing data on adverse drug reactions1.
Arising from this initiative the Health Authorities of each country have drawn up precise guidelines to protect patients from possible damages from drugs. The Spanish Pharmacovigilance System (SEFV) comprises the Pharmacovigilance Centres of each Autonomous Community, the Spanish Medicines Agency (AEMPS) and health professionals. Royal Decree 711/2002, of 19 July, is the law that regulates the pharmacovigilance of drugs for human use in Spain2.
One new aspect of European legislation on Pharmacovigilance is the encouragement of direct notification by the public of suspected adverse reactions that they detect3; for this reason, notification by patients and users will be of great importance in the future.
In Spain, notification of an adverse reaction is made using a yellow card system communicating this fact to the pharmaceutical industry or to Regional Pharmacovigilance Centres, with the current possibility of on-line notification4.
The interest of the scientific community on the problems arising from adverse reactions is obvious by the increased number of publications observed in the last few years. Thus, the publication of suspected adverse drug reactions, which include those found in phytotherapy, alternative medicines, vaccines or other biological or health products is important for post-marketing surveillance. For this reason, it is recommended to follow the directives supported by the International Society for Pharmacoepidemiology (ISPE)1 and the International Society of Pharmacovigilance (IFoP)6.
Another important facet are the activities or projects associated with the teaching and learning of skills by students or health personnel on the subject of Pharmacovigilance, highlighting, within this training dimension, the existence of courses enabling the student to widen these skills by studying for a Master's Degree7.
Pharmacovigilance also has a research aspect related to the use of drugs and their impact on the population; this has led to Pharmacovigilance Centres participating in different projects, such as pharmacoepidemiological studies, studies to stimulate notifications, and observational studies on this aspect, and cost-effectiveness studies, where the results would subsequently be communicated in literature sessions, presentations at conferences, and publications.
Among the research projects, highlighted for its relevance, is the "EUDRAGENE project" on the influence of genetic polymorphisms in serious adverse drug reactions8; an international project funded by the European Commission, and which attempts to genetically identify populations at risk of developing serious adverse drug reactions; a new working hypothesis that has generated a sense of great expectancy among the scientific community9.
1.- Organización Mundial de la Salud. Perspectivas políticas de la OMS sobre medicamentosLa farmacovigilancia: garantía de seguridad en el uso de los medicamentos. Ginebra. Octubre de 2004.
2.- Boletín Oficial del Estado. Real Decreto 711/2002, de 19 de julio, por el que se regula la farmacovigilancia de medicamentos de uso humano.
3. Directiva 2010/84/ue del Parlamento europeo y del Consejo de 15 de diciembre de 2010,
que modifica, en lo que respecta a la farmacovigilancia, la Directiva 2001/83/CE por la que se
establece un código comunitario sobre medicamentos para uso humano. Diario Oficial de la Unión Europea 31.12.2011
4.- Instituto de Farmacoepidemiología. Universidad de Valladolid
5.- International Society for Pharmacoepidemiology.
6.- International Society of Pharmacovigilance (ISoP)
7.- Máster en Farmacovigilancia. Universitat de Barcelona.
8.- European collaboration to establish a case-control DNA collection for studying the genetic basis of adverse drug reactions. London School of Hygiene and Tropical Medicine Keppel Street, London. UK
9- Giacomini KM, Krauss RM, Roden DM, Eichelbaum M, Hayden MR, Nakamura Y. When good drugs go bad. Nature 2007; 446: 975-977
Beatriz Cuevas Ruiz PhD.
Servicio de Hematología y Hemoterapia. Complejo Asistencial Universitario de Burgos.
Mail: bcuevas @ hgy.es