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Veterinary pharmacovigilance, how and why

The surveillance of patients’ and consumers’ safety concerns products that are very different one from the other: medicines, medical devices, cosmetics and others. In the field of medicinal products, the collection and evaluation of safety information, including adverse events recorded after the launch in the market, concerns not only medicines for human use, but also veterinary drugs.

The basic principle of veterinary pharmacovigilance is the same applied to that regarding drugs used in humans, that is ensuring a safe use of drugs, updating information and taking all measures required so that this never fails.

However, there are several differences between the surveillance expected for a veterinary drug and the one expected for a drug for human use.

First of all, the reference authority is different: it is not the Italian Medicine Agency, but the Ministry of Health, namely Office 4 for Veterinary Medicines of the Direction General of Animal Health and Veterinary Drugs (DGSAF), taking care of its management. The national pharmacovigilance system depends on the Ministry, that is part of it together with the regional Pharmacovigilance Centres.

On the other hand, at European level, the Competent Authority is the European Medicines Agency (EMA), that coordinates the veterinary pharmacovigilance activities of the Member States through guidelines approved by the Committee for Medicinal Products for Veterinary Use (CVMP). Thanks to a pharmacovigilance information network, where EU veterinary authorities upload all their available information, Member States exchange information allowing the monitoring of veterinary medicines safety.

Another important aspect is that veterinary pharmacovigilance ensures not only a safe use of veterinary medicines in animals, but also the safety for humans getting in contact with them, as well as the safety for the environment. Again, it is a task of the veterinary pharmacovigilance to monitor the safety of animal feed and vaccines.

Finally, the procedure to report suspected adverse reactions also differs. As for medicinal products for human use, a suspected event regarding veterinary medicines can be reported by a veterinary surgeon or by a pharmacist, but also by anyone having reason to believe that the use of a veterinary medicines caused a suspected adverse reaction. The report will be forwarded to the Ministry or to the reference pharmacovigilance centre, filling in a dedicated form in all its parts and including all available details, also enclosing any laboratory data and post-mortem outcomes, pictures and any other information that could be important. The reporting form can be submitted either via ordinary mail, or e-mail, or certified e-mail (PEC) or delivered by hand.

No fee is to be paid for the sending of reports, nor is a feedback expected from the Ministry. However, there are specific deadlines to be met: no later than 6 days from the adverse event for veterinary surgeons and pharmacists; no later than 15 days for all other subjects.

Written by: Maria Pia Felici

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