Regional Reference Center for Pharmacovigilance
TAG: pharmacovigilance, adverse reactions, reporting, EMA, reference center, veterinary electronic prescription
Pharmacovigilance, is defined by the World Health Organisation (WHO) as the science and activity relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The aim of regulatory pharmacovigilance is to provide drugs with a positive risk-benefit profile to the patients. Spontaneous reporting system (SRS) is created, and this become the primary method for collecting post-marketing information on drug safety. The main function of SRS is the early detection of signals of new, rare and serious adverse drug reactions (ADRs), lack of expected efficacy, problems related with withdrawal periods and environmental impact. A spontaneous reporting system enables physicians and, increasingly more often, veterinarians, pharmacists and patients to report suspected ADRs to a pharmacovigilance centre. Spontaneous reporting is also used by the pharmaceutical industry to collect information about their drugs. By SRS is possible to monitor all drugs on the market throughout their entire life cycle at a relatively low cost. The primary goal of the Regional Centre for Veterinary Pharmacovigilance (RCP) is to collect data regarding the post-marketing ADRs caused by drugs in veterinary practice and to report them to the competent Authorities. The Piedmont Region, as stated by the current Italian legislation (D.Lvo n. 193/2006, 2001/82/CE and 2004/28/CE), established the Regional Centre for Veterinary Pharmacovigilance at the Department of Veterinary Sciences, University of Turin. Veterinarians, physicians, pharmacists, animal owners and breeders operating in the territory should refer to the RCP using a computer format, whenever they record any adverse reaction related to the use of a medicine in animals. They can obtain from the RCP a scientific support in the management of the case or in the choice of analysis, if necessary. The RCP send in real-time the report to the Italian Ministry of Health.
- Piedmont Region
- Barbero R., Dezzutto D., Vercelli C., Barbarino G., Fea G., Mina G., Gennero M.S. - Veterinary Pharmacovigilance: drugs traceability and antimicrobial consumption - A Pilot Study in Piedmont Region”, IV International Conference on Antimicrobial Research, Torremolinos - Malaga, Spain, 29 June - 1 July 2016
- Vercelli C., Re G., Barbarino M., Gennero S., Dezzutto D., Fea G., Mina G., Barbero R. - Veterinary pharmacovigilance: drugs traceability and antimicrobial consumption. A pilot study in Piedmont Region - (2015) Journal Of Veterinary Pharmacology And Therapeutics, vol. 38, supl.1, p.24.
- Cell lab – Division of Veterinary Pharmacology and Toxicology
- Dr. Raffaella Barbero - Director DMV - ASL TO 4 (Pubblic Health Service)
Team
Prof. Giovanni Re (Coordinator)
Dr. Cristina Vercelli
Dr. Graziana Gambino
Contacts
giovanni.re@unito.it
cristina.vercelli@unito.it
graziana.gambino@unito.it