Use Of Veterinary Medicinal Products Research Articles

European regulations on the use of antibiotics in veterinary medicine

Antimicrobial resistance endangers the successful combat of bacterial infections in humans and animals. The common use of antibiotic classes including those of high clinical value in human as well as veterinary medicine is a critical factor contributing to or suspected to promote the emergence of antibiotic resistance. New legal provisions laid down in veterinary drug legislations and related guidelines and advice are in force in the European Union to safeguard the effectiveness, accessibility and availability of antibiotics.Categorisation of antibiotics in classes of importance for treatment of infections of humans by the WHO was one of the first steps. This task is also undertaken for antibiotics for treatment of animals by the EMA's Antimicrobial Advice Ad Hoc Expert Group. The new veterinary Regulation (EU) 2019/6 has extended restrictions for use of some antibiotics in animals to a full ban of certain antibiotics. While some (but not all) antibiotic compounds not being authorized in veterinary medicine may still be used in companion animals more strict provisions were already applicable for treatment of food producing animal species. Distinct regulations are in place for the treatment of animals kept in large numbers in flocks. Initial regulations focussed on the protection of consumers from residues of veterinary drugs in food commodities, new regulations address prudent (not routinely) and responsible selection, prescription and use of antibiotics, and have improved the practicality for cascade use outside the terms of marketing authorisation. Mandatory recording of use of veterinary medicinal products for food safety reasons is extended to rules for veterinarians and owners or holders of animals to regularly report the use of antibiotics for the purpose of official surveillance of consumption. National sales data of antibiotic veterinary medicinal products have been collected on a voluntary basis until 2022 by ESVAC, which has created awareness of major differences between EU member states. A significant decline in sales was reported for third and fourth generation cephalosporines, polymyxins (colistin), and (fluoro)quinolones since the initiation in 2011.

Authors\u2019 response on Perkins et al. (2021) \u201cDead in the water: comment on \u201cDevelopment of an aquatic exposure assessment model for imidacloprid in sewage treatment plant discharges arising from use of veterinary medicinal products\u201d

In 2020, Anthe et al. published a newly developed model to predict imidacloprid surface water concentrations stemming from sewage treatment plant (STP) effluent as a consequence of the use of veterinary medicinal products containing imidacloprid in the UK (Anthe in Environ Sci Eur (2020) 32:147, https://doi.org/10.1186/s12302-020–00424-4). The modelled data indicate that these veterinary medicinal products make only a very small contribution to the levels of Imidacloprid observed in the UK water monitoring programme.The commentary by Perkins et al. (Perkins in Environ Sci Eur (2021) 33:88, https://doi.org/10.1186/s12302-021-00533-8) questioned the validity and conclusions of the modelling approach. We believe the modelling approach, which considered what we anticipated to be, the major exposure pathways, gives a realistic picture of the chronic emission via STPs to UK rivers.

Dead in the water: comment on \u201cDevelopment of an aquatic exposure assessment model for imidacloprid in sewage treatment plant discharges arising from use of veterinary medicinal products\u201d

Anthe et al. (Environ Sci Eur 32:147, 2020. https://doi.org/10.1186/s12302-020-00424-4) develop a mathematical model to calculate the contribution of veterinary medicinal products (VMPs) to the levels of imidacloprid observed in the UK water monitoring programme. They find that VMPs make only a very small contribution to measured pollution levels, and that the estimated concentrations do not exceed ecotoxicological thresholds. However, shortcomings in methodology—including the implicit assumption that imidacloprid applied to pets is available for release to the environment for 24 h only and failure to incorporate site-specific sewage effluent data relating to measured levels—raise questions about their conclusions. Adjusting for these and other deficiencies, we find that their model appears consistent with the conclusion that emissions from VMPs may greatly exceed ecotoxicological thresholds and contribute substantially to imidacloprid waterway pollution in the UK. However, the model utilises imidacloprid emissions fractions for animals undergoing the different scenarios (for example, bathing) that are extrapolated from unpublished studies that do not clearly resemble the modelled scenarios, with insufficient evidence provided to support their derivation. As a result, we find that the model presented by Anthe et al. provides no reliable conclusions about the contribution of veterinary medicinal products to the levels of imidacloprid in UK waterways.

Development of an aquatic exposure assessment model for Imidacloprid in sewage treatment plant discharges arising from use of veterinary medicinal products

BackgroundImidacloprid is an active ingredient included in plant protection, biocidal and veterinary medicinal products (VMPs). VMPs containing Imidacloprid are formulated as spot-on products or collars and designed to protect pets, predominantly dogs and cats, from parasite infestation. Monitoring data collected under the Water Framework Directive between 2016 and 2018 showed detectable and varying levels of Imidacloprid in the UK surface water bodies. The aim of the work was to investigate the potential contribution of VMPs by developing a model for predicting the emissions from sewage treatment plants from the use of dog and cat spot-on and collar VMPs. Due to the absence of appropriate exposure models for VMPs, the model was built based on the principles of environmental exposure assessment for biocidal products.ResultsThree emission paths were considered to be the most likely routes for repeated emissions to waterways from the use of spot-on and collar VMPs, i.e., transfer to pet bedding followed by washing, washing/bathing of dogs, and walking dogs in the rain. The developed model was used to calculate the Imidacloprid concentrations in surface water after discharge from wastewater treatment plants. Realistic worst-case input parameters were deduced from sales and survey data and experimental studies. Modelled total concentrations in surface water for each pathway ranged from 0.84 to 4.8 ng/L. The calculated concentrations did not exceed the ecological thresholds for the most sensitive aquatic invertebrate organisms and were found to be much lower than the UK monitoring data for river water. For example, the calculated concentration from the bathing/washing of dogs was < 3% of the highest levels of Imidacloprid measured in surface waters.ConclusionIn conclusion, a model has been successfully built and applied. The modelled data indicate that these VMPs make only a very small contribution to the levels of Imidacloprid observed in the UK water monitoring programme. Further, calculated concentrations do not exceed ecotoxicological threshold values indicating acceptable chronic safety to aquatic organisms.

Occurrence of Veterinary Drug Residues in Poultry and Products Thereof. A Review.

Over the past decades, great efforts in poultry management have led to a tremendous uplift in the productivity of poultry production. This progress, coupled with the intensification of production, has created the potential for diseases in birds as their energy is fully oriented towards productivity but not to resistance. In order to prevent or treat the diseases, biosecurity measures and vaccination are widely applied; nevertheless, medication is still widely practiced worldwide. Information on influencing factors and use of veterinary medicinal products in poultry industry as well as data on detection of residues in poultry products were collected from various sources. The data obtained were analyzed and ranked to represent a likelihood of occurrence of substances to be monitored in poultry and products thereof.

Veterinary Drug Residue in Food of Animal Origin in Switzerland: A Health Concern?

Many drugs are used in livestock farming, particularly antibiotics, with almost 80% of world antibiotic production used for animals. Therefore, veterinary drugs may be present as residues in food of animal origin even if their use is fully regulated to ensure the proper use of veterinary medicinal products, to protect consumers from undesirable residues, and to ensure the supply of quality, safe and effective veterinary medicinal products to safeguard animal health. Analytical techniques for residue analysis have improved significantly with routine use of liquid chromatography coupled with tandem or high-resolution mass spectrometry. This improvement enabled specific searches for several hundred target compounds within minutes in complex matrices such as milk, eggs, honey or meat and organs after slaughter. For many years, a national residue control programme in food has been effective. The rate of non-compliant samples remains low and shows that consumers do not have to worry too much about the presence of drug residues in food of animal origin produced in Switzerland. Despite the significant reduction in antibiotic consumption observed in recent years, the resistance rate and distribution of multidrug-resistant bacteria is steadily increasing, even in countries where drug consumption has decreased significantly. Reducing antimicrobial resistance will undoubtedly be one of the most difficult food safety challenges in the coming years.

Veterinary pharmacovigilance in Europe: a survey of veterinary practitioners

A web-based survey was conducted by the Federation of Veterinarians of Europe with the support of the European Medicines Agency to gain a better insight into the adverse event reporting...

Systematic account of animal poisonings in Germany, 2012–2015

A systematic retrospective study on animal poisonings in Germany (wildlife excluded) between January 2012 and December 2015 was conducted. Data were collected on animal exposure calls to German poison centres,...

Assessment of environmental risks to groundwater ecosystems related to use of veterinary medicinal products

The current EU guidelines for the environmental risk assessment of veterinary pharmaceutical products (VMPs) in groundwater (GW) suggest an approach based on the comparison between the calculated concentration in GW (PECgw) and a threshold concentration of 0.1 μg/L. The latter is the upper limit of the concentration for pesticides in groundwater in the EU. If the calculated PECgw does not exceed the threshold, then the risk is considered acceptable. It is assumed that the concentration of 0.1 μg/L is by default safe for both humans and exposed GW organisms. On this basis, it is not clear whether the GW is recognized as an ecosystem or as a source of drinking water. Largely unrecognized biodiversity in GW is worthy of protection through the adoption of a more scientifically sound risk analysis, which should be based on the consideration of ecological criteria.Based on the evidence of their vulnerability, we propose that risk assessments of GW ecosystems should be a compulsory part of the overall risk assessment of VMPs (as well as pesticides, biocides and feed additives). Furthermore, we suggest the use of a risk quotient approach based on the PEC/PNEC ratio in which the PNEC is calculated including an additional safety factor of 10 to the calculated PNEC for surface water.

Poultry production in organic system

The consumer market is increasingly concerned with animal foods they consume and especially the conditions in which they are kept during the production period. The posture of poultry is one of the sectors in which these concerns become increasingly demanding, because in industrial poultry farming these animals are kept in cages throughout the production cycle, although the space is considered sufficient for these birds can jogging, that space does not allow the birds to express some characteristics of their natural behavior (taking sand bath up and down perches, have ample room to explore) this behavior is observed in semi-confined system, hillbilly, or organic. Although these systems have certain similarities, they differ in some respects, the organic is certified by bodies, which can be certifying companies, which are in turn supervised by Ministry of Agriculture and Supply, which differs from other . Sanity in the case of organic creation must be made without the use of veterinary medicinal products, and only the mandatory vaccine should be offered to animals, ensuring production within the requirement of the international standards of organic production organization.

Fluoroquinolone Antimicrobials for Chickens

The Food Safety Commission of Japan (FSCJ) conducted a risk assessment on antimicrobial-resistant bacteria resulting from the use of veterinary medicinal products, of which the active ingredient is fluoroquinolone, for the use of chicken growth. The hazards identified are Salmonella spp., Campylobacter spp. and Escherichia coli which acquired antimicrobial resistance as a consequence of using the fluoroquinolone antimicrobial agents in chicken. FSCJ considers that the following possibilities cannot be neglected: 1) selection of hazards as a result of the use of fluoroquinolone antimicrobials in chicken; 2) human exposure to the hazards through consumption of chicken-derived foods; 3) loss or reduction of the efficacy of antimicrobial treatment of human diseases. Particularly regarding Campylobacter spp., the emergence of antimicrobial resistance was a great concern in the release assessment. The food contamination with Campylobacter spp. including the hazard was also the great concern in the exposure assessment. The risk for each hazard was, however, judged to be “Medium” as a result of the overall estimation of the risk. Regarding antimicrobial-resistant bacteria, detailed scientific findings and information are not sufficiently available at this point, and an internationally accepted methodology for the risk assessment has not yet been established. Therefore, it is necessary to keep up with the latest scientific findings and information including the development of discussion in international organizations.

MODELING ENVIRONMENTAL AND HUMAN HEALTH RISKS OF VETERINARY MEDICINAL PRODUCTS APPLIED IN POND AQUACULTURE

A model called ERA-AQUA was developed to assess the risks posed by the use of veterinary medicinal products (VMPs) applied in aquaculture ponds for the targeted produce, surrounding aquatic ecosystems, consumers, and trade of the aquaculture produce. The model calculates risks by following a risk quotient approach, calculating predicted exposure concentrations (exposure assessment) and predicted no-effect concentrations (effect assessment) for the endpoint under study. The exposure assessment is performed by combining information on the environmental characteristics of the aquaculture pond, characteristics of the cultured species, aquaculture management practices, and physicochemical properties of the compound under study. The model predicts concentrations of VMPs in the pond water, pond sediment, cultured species, and watercourse receiving pond effluent discharges by mass balance equations. The effect assessment is performed by combining (eco)toxicological information and food safety threshold concentrations for the studied compound. In the present study, the scientific background, strengths, and limitations of the ERA-AQUA model are presented together with a sensitivity analysis and an example showing its potential applications.

Residues of veterinary medicinal products and coccidiostats in eggs – causes, control and results of surveillance program in Poland

The use of veterinary medicinal products in food producing animals for a variety of purposes causes that their residues may be presented in edible tissues. As a result, in concern of public health, European Union Countries establish each year monitoring plans and they control the levels of harmful substances in food of animal origin. This paper presents survey of residues of veterinary medicinal products and coccidiostats in eggs for Poland and European Union in years 2007-2010. Despite the decrease in reported non-compliant results for coccidiostats, the numbers were still higher than those for veterinary medicines. The most often determined coccidiostats were: nicarbazin, dinitrocarbanilide, salinomycin and lasalocid, and the most often reported non-compliant results for veterinary medicines were: antimicrobials, enrofloxacin and doxycycline.

An approach for mapping the vulnerability of European Union soils to antibiotic contamination

Release of antibiotics into the environment through the agricultural reuse of animal manure is considered a cause of chronic environmental exposure that often leads to adverse ecotoxicological effects, as well as to the introduction of antibiotic-resistant bacteria into the environment.The vulnerability of soil to antibiotic contamination plays a major role in determining the extent of the contamination and the likelihood of the emergence of antibiotic resistance and the appearance of ecotoxicological effects. It depends on soil characteristics, which vary across Europe, and antibiotic characteristics, which vary across drug classes. Understanding how soil vulnerability varies geographically for different veterinary medicinal products would be very useful for resource allocation among surveillance programmes.This paper performs risk analysis of the EU region for 12 antimicrobials using a spatial assessment performed in four steps. First, antibiotic release was estimated based on livestock density. Then exposure was estimated based on antimicrobial soil contamination. Third, consequences were modelled based on soil uses. Finally, risk was estimated by combining release, exposure and consequences using spatial multicriteria decision analysis. A final risk value for soil vulnerability was calculated for each antibiotic studied and displayed in chloropletic maps (ArcGIS 9.3). Furthermore, the Getis-Ord Gi statistic was used to identify clusters of areas at high risk for antibiotic soil contamination. Enrofloxacin was the highest-risk antibiotic in the European Union, followed by tetracyclines, tylosin and sulfodiazine. The highest risk values were found in Belgium, Ireland, Netherlands, Switzerland, Denmark, Germany and the UK. The results suggest that this methodology can be used successfully for evaluating the contamination potential of antibiotics over large areas with limited input data. This work is a preliminary step towards prioritising the use of veterinary medicinal products (VMPs), orientating monitoring studies and antimicrobial surveillance programmes, and informing sustainable decision-making for interventions designed to mitigate the risk of VMPs.

Survey on use of veterinary medicinal products in third countries

Survey on use of veterinary medicinal products in third countries

A simulation model for the prediction of tissue:plasma partition coefficients for drug residues in natural casings

Tissue residues arise from the exposure of animals to undesirable substances in animal feed materials and drinking water and to the therapeutic or zootechnical use of veterinary medicinal products. In the framework of this study, an advanced toxicokinetic model was developed to predict the likelihood of residue disposition of licensed veterinary products in natural casings used as envelope for a variety of meat products, such as sausages. The model proved suitable for the calculation of drug concentrations in the muscles of pigs, cattle and sheep, the major species of which intestines are used. On the basis of drug concentrations in muscle tissue, the model allowed a prediction of intestinal concentrations and residues in the intestines that remained equal to or below the concentrations in muscle tissue, the major consumable product of slaughter animals. Subsequently, residues in intestines were found to be below the maximum residue limit value for muscle tissue when drugs were used according to prescribed procedures, including the application of appropriate withdrawal times. Considering the low consumption of natural casings (which represents only about 1-2% of the weight of a normal sausage), it was concluded that the exposure to drug residues from casings is negligible.

The practitioner's role in SAR reporting

SPONTANEOUS reporting of suspected adverse reactions (SARs) is an inexpensive and effective system for ensuring the continued safe and efficacious use of veterinary medicinal products following their introduction to the...

The use of veterinary medicinal products in equine practices in The Netherlands: Balancing between the law and good veterinary practice

SummaryThis study investigates the present situation with respect to the use and abuse of (veterinary) medicinal products (VMPs) by equine practitioners and endeavours to substantiate the perceived discrepancies and friction between the availability of VMPs, legislation in force, code of Good Veterinary Practice and reality of day‐today equine practice. It can be concluded that practising equine medicine in The Netherlands using only authorised equine VMPs is impossible. In most cases the ‘cascade’ or list of essential substances is needed to legitimise the use or, even worse, the use is not legitimised at all. Existing differences between European Union member states in the outcome of procedures for obtaining a marketing authorisation for the same product is seen as an obstacle for the availability and development of equine VMPs needed for safeguarding the future of a professional equine veterinary healthcare.

European legislation governing the use of veterinary medicinal products with particular reference to varroa control

In this article the author guides us through the jungle of European Union regulations and directives that control the marketing and manufacturing authorization of medicinal and veterinary products in Europe, and the limits set for residues in honey. Control of varroa and organic production of agricultural products is also considered.

The exposure assessment for veterinary medicinal products

The proposed methodology for the assessment of the environmental risks of the use of veterinary medicinal products is the hazard quotient approach. This article will elaborate on the exposure assessment with exposure models adapted to the Dutch agricultural situation. Based on the exposure assessment, decisions are made on the acceptability of the environmental risk of a product. Therefore, regulatory authorities have to be careful in choosing exposure scenarios. It will be shown that simple alterations of general models with an eye for common agricultural practice change predicted exposure concentrations by a factor of 2–40. In addition, the current proposals for effect assessment are too diverse, and the triggers that lead to further extensive testing are either useless, or at the least inconsistent with each other. An interdisciplinary approach using knowledge of veterinary and agricultural practice, risk management, and environmental toxicology and chemistry, is needed to determine relevant exposure scenarios.