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anses

French Agency for Food, Environmental and Occupational Health & Safety

ANSES publishes for the first time a detailed report of the adverse effects of veterinary medicinal products (2011 drug monitoring report)9 November 2012

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News of 09/11/2012

Through its French Agency for Veterinary Medicinal Products, ANSES is tasked with the assessment and management of veterinary drug risks in France. One of its main missions is the implementation of the veterinary drug monitoring plan, which aims to gather notifications of adverse effects linked to veterinary drug use. In addition to data supplied in support of marketing authorisation (MA) applications, this post-MA monitoring data is essential for adapting risk management measures for the safe use of medicinal products.
The 2011 report on the veterinary drug monitoring plan shows that the system that has been set up provides effective transmission of adverse effect notifications, ranking France among the EU countries with the highest rates of notification. In addition, several management measures were taken based on these notifications to reduce the risks linked to the veterinary medicinal products under scrutiny.
Lastly, due to the low notification rate in certain sectors (the pig and avian sectors in particular) and of the importance of maintaining respondent motivation, two areas will now be the subject of special campaigns: veterinary drug monitoring information targeting veterinarians and notification promotion in the enclosed breeding sectors.

Through its French Agency for Veterinary Medicinal Products (ANSES-ANMV), ANSES is tasked with the assessment and management of veterinary drug risks in France. One of its main tasks is the implementation of the veterinary drug monitoring plan. In 2011, ANSES-ANMV registered 2836 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 caused permanent or long-term symptoms resulting in congenital malformations or abnormalities, or causing a handicap or major disability in the treated animal which could put the animal's life in danger or cause death.

Over 90% of the notifications received come from veterinary practitioners. Those sent in by animal owners or breeders represent close to 9%. The vast majority of the adverse effects reported in 2011 concerned house pets, with cats and dogs representing 81% of all notifications. The adverse effects concerning cattle represented 11% of all notifications. Notifications for other species represented less than 3% per species.

The percentage of each drug class involved varied depending on species. In house pets, antiparisitics were the drug class cited in the highest number of notifications (36% for dogs and 43% for cats). In cattle, vaccines were the most commonly cited drug class (33%, excluding vaccines for bluetongue disease). This observation reflects the heightened exposure of these animal populations to these types of products as well as heightened responsiveness when reactions are due to individual treatments, for the most part preventive.

Analysis of the results

A thorough analysis was conducted of the products which received the most "serious case" notifications. Thus, among the 28 medicinal products involved in at least 10 “serious case” notifications, 20 are exclusively authorised for use on pets. In terms of the drug classes involved, 14 were vaccines, 5 were sedatives or anesthetics and 4 were antiparasitics.

The number of notifications of adverse effects is only one of the aspects used to evaluate the potential risk posed by a given medicinal product. The overall number of cases must also be compared with the total number of animals treated over a given period (incidence) and the severity of the adverse effects observed must also be considered. The calculated incidence of the adverse effects for these 28 medicinal products shows that for 25 of them, incidence is low (less than one case per 10 000) and no cases show an incidence of one case per 100 animals treated or more. Since incidence is a relative factor, due to its methods of calculation, surveillance of a veterinary medicinal product also takes into account other factors such as the type of clinical signs observed with regard to the pharmaco-toxicological profile of the active substances present in the product, and the severity of the adverse effects compared to how they evolve over time (persistence in particular).

Consequences vis-à-vis risk management

Drug monitoring data may lead to modifications in veterinary medicinal product authorisations, or even to the suspension or withdrawl of MAs if the benefit\risk ratio is considered to be negative. Depending on whether MAs are delivered within the frame of a national procedure or a European one, such management decisions may be taken either by the European Commission or by ANSES-ANMV.

In 2011 following a rise in the incidence of anaphylactic effects in cattle after administration of the HIPRABOVIS PNEUMOS vaccine, ANSES-ANMV suspended the MA for this vaccine in April of that year. This country-based decision then brought about a harmonised EU-wide suspension decision.

Furthermore, following suspicions of a lack of effectiveness in rabbit haemorrhagic disease virus (RHDV) vaccines, scientific research conducted in conjunction with the ANSES Ploufragan laboratory brought to light a new genetic variant of the virus, therefore requiring changes in the existing vaccines and\or development a new vaccine for this disease.

Accidents in cats linked to the use of permethrin (an antiparasitic for dogs), continue to occur despite the warnings which have been added to package leaflets and product labels since 2007. ANSES therefore reminds pet owners to be vigilant in this area.

The 2011 report on the veterinary drug monitoring plan shows that the French system is effective in revealing new evidence which, once assessed, adds to the available information on authorised veterinary medicines and accordingly provides post-MA drug monitoring. However, these results also have highlighted low notification rates in certain sectors, especially the avian and pig sectors. Therefore, two areas will now be developed by ANSES-ANMV as a top priority: the promotion of notifications in the enclosed breeding sectors and veterinary drug monitoring information campaigns. An example of the latter, informing veterinarians when unexpected adverse effects occur, was conducted in the summer of 2012 following notification of several cases of adverse effects linked to two drugs used in cattle and in cats and dogs respectively).

Pour en savoir plus

> 2011 veterinary drug monitoring report (in french only)

· What is drug monitoring?

Veterinary drugs only receive marketing authorisation if assessment of the data concerning their quality, safety and efficacy make it possible to conclude that the benefits linked to their use is greater than the risks incurred. The clinical trials conducted in the framework of applications for MAs make it possible to highlight a certain number of adverse effects which may occur when using medicinal products. However, these trials are conducted on a limited number of animals and under controlled conditions of use. The large-scale use of a medicinal product in real-life conditions once an MA has been granted makes it possible to precisely pinpoint a product's adverse effects and to identify any potential risk factors (species, breed, age, pre-existing conditions, etc.). Drug monitoring therefore aims to detect all emerging signs as quickly as possible, both unexpected adverse effects and known adverse effects with unexpected frequency or severity. These post-MA monitoring initiatives can sometimes necessitate adjustments to risk management measures, which may include the issuing of precautions for use, and in certain cases may engender withdrawal of the product's MA.
Monitoring of reactions to veterinary medicinal products is conducted through the veterinary drug monitoring plan, which has been in full operation since 2002. The effectiveness of this plan is based on spontaneous notifications, 90% of which are currently submitted by veterinary practitioners. These notifications are then registered and evaluated both by the MA holder and the Veterinary Pharmacovigilance Centre in Lyon (CPVL). Potential signs are identified through this system and then undergo collective expert assessment, which may take place on a European level with experts from the competent authorities of the other EU States and\or on a country-wide level, with involvement of experts from the National Commission for Veterinary Medicinal Products.