Some Other Ideas About the Future of Pharmacovigilance
It is perceived that, during this century, pharmacovigilance has evolved to a more complex discipline: new technological developments, a refinement in its methods, new tasks and, overall, new legislations have been the most remarkable landmarks. A big cor
- PDF / 73,482 Bytes
- 3 Pages / 439.37 x 666.14 pts Page_size
- 47 Downloads / 242 Views
Some Other Ideas About the Future of Pharmacovigilance Alfonso Carvajal, Teresa Falomir, and Carmelo Aguirre
It is perceived that, during this century, pharmacovigilance has evolved to a more complex discipline: new technological developments, a refinement in its methods, new tasks and, overall, new legislations have been the most remarkable landmarks. A big corpus of legislation has been implemented in the last few years, particularly those coming from the main regulatory agencies―the Food and Drug Administration and the European Medicines Agency. Particularly remarkable have been the 16 volumes of legislation released by the European Medicines Agency, intended to regulate these activities. While legislation tries to control activities, we do not know the exact amount of normative control that is necessary to improve these activities; in fact, we do not really know if a new legislation is able by itself to improve these activities. What is certain is that the workload in the pharmacovigilance centres has been considerably increased along these last years; a substantial part of this workload is devoted to paperwork. On the other hand, agencies are claiming for independence and transparency. Independence is one of the most used words in the headquarters of big agencies. However, in addition to the official national pharmacovigilance systems, they are in parallel and sometimes interconnected, the corresponding systems set up by each pharmaceutical company. Through these systems, pharmaceutical companies collect safety information upon their products and are able to conduct pharmacoepidemiological studies. It is notoriously known that studies conducted by the industry systematically favour the industry itself.
A. Carvajal Centro de Farmacovigilancia de Castilla y León, Valladolid, Spain T. Falomir Centro de Farmacovigilancia de las Islas Baleares, Palma de Mallorca, Spain C. Aguirre (*) Unidad de Farmacovigilancia del País Vasco, Galdakao, Spain e-mail: [email protected] © Springer International Publishing Switzerland 2017 I.R. Edwards, M. Lindquist (eds.), Pharmacovigilance, DOI 10.1007/978-3-319-40400-4_4
31
32
A. Carvajal et al.
In order to improve pharmacovigilance activities for the coming years—regardless of other technological or methodological improvements—we suggest the following proposals: 1. Global regulation for a global market. For a global community which has access to learn through the Internet the new developments in medicine, it is nonsense a local or regional (i.e. European) regulation. For what matters to us, and as a general rule, it is not for the best that in a country or zone, a particular medicine is to be withdrawn and in other countries to remain on the market or just to insert different safety information, as it currently happens, in the summary of product characteristics. In addition, a global regulation might account for, though not necessarily, more independence from local powers and, overall, for more efficiency in terms of time and money. 2. To diminish bureaucracy. There is du
Data Loading...
