A ranking of European veterinary medicines based on environmental risks

Abstract

The most likely entry pathways of veterinary pharmaceuticals to the environment are via slurry or manure from intensively reared animals to soil and via dung or urine from animals grazing on pasture. These pathways may result in contamination of surface water via runoff or leaching and drainage. Direct entry into water may occur by defecation by pasture animals or by Scompanion animals. In addition, application of medicines for aquaculture is important for a limited number of veterinary medicinal products. For a large number of veterinary medicinal products, consistent data on the environmental risk have never been generated. In this project, a simple risk-based ranking procedure was developed that should allow assessing the potential for environmental risks of active substances of veterinary medicinal products. In the European Union approximately 2000 products containing 741 active substances were identified. In the prescreening step and in agreement with the technical guidelines released by the European Medicines Agency, 294 natural substances, complex mixtures, and substances with low expected exposure were exempted from the ranking procedure. For 233 active substances, sufficient information was collated on 4 exposure scenarios: Intensively reared animals, pasture animals, companion animals, and aquaculture. The ranking approach was performed in 4 phases: (1) usage estimation; (2) characterization of exposure to soil, dung, surface water, and aquatic organisms depending on exposure scenarios; (3) characterization of effects based on therapeutical doses; and (4) risk characterization, which is the ratio of exposure to effects (risk index), and ranking. Generally, the top-ranked substances were from the antibiotic and parasiticide groups of veterinary medicines. Differences occurred in the ranking of substances in soil via application to either intensively reared or pasture animals. In intensive rearing, anticoccidia, for example, are used as feed-administered medicines (feed additives) in comparatively large doses over a long time. For pasture animals, these substances are used less, if at all, and therefore receive lower ranks. Besides that, the risk indices for the aquatic compartment are large for substances used in aquaculture or applied to companion animals. In conclusion, the ranking scheme developed for this project provided a scientifically based and pragmatic means of assessing the relative priority of veterinary medicines for further detailed risk assessment. The outcome of this project will support pharmaceutical industries and competent authorities when seeking authorization for market applications of veterinary pharmaceutical products.

One Health approach to use of veterinary pharmaceuticals

“…Environmental risk assessment for new VPs is necessary for national licensing in EU countries. But there are approximately 2000 VPs in use in the EU, most of which have never been fully tested (14). VPs are exempt from assessment if they are used in a nonfood species, in a minor food species (i.e., all species except cattle, pigs, chickens, sheep for meat, and Atlantic salmon) if reared the same way as a major species for which an assessment already exists, or belong to certain product types (considered to be used for "a small number of animals in a herd or flock"): anesthetics; sedatives; injectable antibiotics (except those used for pigs, respiratory disease in cattle, or foot rot in sheep); injectable corticosteroids; hormones (except those that have a zootechnical use); and injectable NSAIDs (15).…”

Pharmaceuticals in the environment: scientific evidence of risks and its regulation

“…Within the past few years, the UBA has funded different projects on prioritization approaches for human and veterinary pharmaceuticals. Those projects investigated prioritizing pharmaceuticals via general risk assessment together with MOA approaches and the use and extrapolation of toxicological data (for details and results, see [25][26][27]). In addition, publicly available prioritization data and results have been screened.…”

Potential impacts of climate change on veterinary medicinal residues in livestock produce: An island of Ireland perspective††This paper is one of a series of reviews on “Climate Change and Food Safety – an Island of Ireland perspective”.

“…Veterinary drugs which combat coccidiosis in livestock (a protozoal disease caused by parasites of the genus Eimeria) are used most heavily in intensive indoor rearing systems (Kools et al, 2008), particularly the poultry and pig industries. Indoor rearing systems are expected to be largely insulated from the effects of climate change due to their biosecurity measures (Gale et al, 2009) and should see little appreciable change in veterinary drug use as a result of this driver.…”

“…Antibiotics and parasiticides (including anthelmintics) have been ranked as the European veterinary medicines most likely to pose risks to the environment (although anticoccidial drugs pose a high risk within intensive rearing systems) and worthy of further risk assessment (Kools et al, 2008). Concentrations of residues in the environment are not regulated despite estimates that the shedding of antibiotics via manure may be up to kilograms per hectare (Kemper, 2008).…”