Pharmacovigilance | Anses - Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail

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French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 01/12/2017

Pharmacovigilance

ANSES publishes for the second time a detailed report of the adverse effects of veterinary medicinal products

Keywords : Pharmacovigilance, Adverse effects

A surveillance scheme for the adverse effects of veterinary medicinal products has been in operation since 2002, and has provided an on-line declaration service since 2010.

This drug monitoring plan makes it possible to detect adverse effects and to more effectively describe them in animals. Declaring adverse effects provides continuous monitoring of the risks and benefits of veterinary medicinal products after they have been placed on the market, and therefore promotes their safe use. 

Through your declarations, you help expand our knowledge of veterinary medicinal products, which in turn is of benefit to animals, their owners and all those involved in animal health.  

ANSES’s mission via the French Agency for Veterinary Medicinal Products (ANSES-ANMV) involves the assessment and risk management of veterinary medicinal products in France. One of its main tasks is the implementation of the veterinary drug monitoring plan.

In 2012, ANSES-ANMV registered 3058 cases of adverse effects in animals in its national database, including 43% which were considered to be "serious" adverse effects, in other words reactions which induced permanent or long-term symptoms resulting in a congenital malformation or abnormality, or causing a handicap or major disability in the treated animal which could put the animal's life in danger or bring about its death.

The 2012 report shows that the total number of these declarations is continuously on the rise. The results are generally comparable to those obtained in 2011 and confirm that the national scheme that has been set up effectively enables detection of new signals and therefore makes it possible to add to the available knowledge of veterinary drugs.

Analysis of the results

Over 90% of the declarations submitted to institutional entities are sent in by veterinarians. Those sent in by animal owners or breeders represent 7.57%.

As in 2011, the vast majority of the adverse effects reported in 2012 involved domestic carnivores, with cats and dogs representing 82% of all declarations. Declarations concerning cattle represented 9.3 % of all declarations. Declarations for other species represented less than 2% per species.

The percentage of each drug class involved varied depending on species. For domestic carnivores, antiparasitics were the most often-cited drug class. For cattle, vaccines were the group most commonly mentioned.

More than a specific risk profile, these figures reflect the heightened exposure of various animal populations to certain types of products as well as better responsiveness by respondents with regard to effects in healthy animals.

However, the number of declarations of adverse effects is only one of the aspects used to evaluate the potential risk posed by a given medicinal product. It is imperative that the overall number of cases be compared with the total number of animals exposed over a given period in order to evaluate incidence.

The calculated incidence of the adverse effects for these 35 medicinal products implicated in at least 10 "serious case" declarations in 2012 shows that for 27 of them, the incidence remains very low (less than one case per 10 000) and that no cases show an incidence reaching even one case per 100 animals treated.

One should keep also keep in mind that while incidence is an important factor in drug surveillance, because of the calculation methods used, it remains a relative indicator. For this reason, in addition to the statistic results obtained, veterinary drug surveillance also takes into account other factors such as the clinical signs profile observed compared to the pharmaco-toxicological profile of the implicated compounds, their severity and also the evolution over time (epiphenomena or persistence over time).

Consequences vis-a-vis risk management

The data gathered by the national pharmacovigilance plan have led to MA modifications, to the publication of press releases and have also been used in the context of revisions in regulations and in the supply circuit for certain medicinal products.

Nonetheless, the observation made in 2011 showing a low rate of declaration in certain sectors has been confirmed. Because of this, in addition to its assessment activities per se, ANSES-ANMV decided to closely examine the issue in order to develop a certain number of initiatives both for communication purposes and for the promotion of pharmacovigilance in the industrial sectors.

With regard to communication, various initiatives have been conducted in conjunction with the National Commission for Veterinary Medicinal Products (CNMV). Promotional activities undertaken in the industrial sectors have also been initiated, and thanks to reinforced staff in the pharmacovigilance department, these will continue (with the setting up of networks in particular).

 

For 2013, the main topics selected by ANSES-ANMV in the area of pharmacovigilance and efforts to further develop it involve pursuing communications initiatives, as well as promoting declaration submission in the industrial sectors, with special initiatives in the areas of both initial and continuing veterinary training.
In addition to pharmacovigilance, special efforts have been made for the monitoring of the various impacts of veterinary drug use subsequent to their marketing (post-MA in general). The reorganisation of the ANMV, with the creation of a market surveillance unit, founded in July 2013, should also make it possible to optimise initiatives in this area.