Veterinary antibiotic consumption in Ireland Gavin Ryan HPRA 2018 Veterinary Medicines Information Day 13 June 2018

Introduction Veterinary antibiotics are authorised by the HPRA or the EMA. All veterinary antibiotics are subject to prescription. Antibiotics are not permitted for use as growth promoters. They are an essential tool in treating animals. Many antibiotics for veterinary use are also used in humans. Antimicrobial resistance is of major concern for both animal and human health. Reporting of sales data is one of the steps in encouraging responsible use. 25/04/2019

Introduction Veterinary antibiotic sales data have been collected annually by the HPRA since 2009. Each MAH is requested to provide all sales data on centrally and nationally authorised antibiotics marketed in IE. Data is currently collected from 71 MAHs, >500 authorisations. Data from 2016 onwards are shared with the Department of Agriculture, Food and the Marine (DAFM) as part of the national action plan to address antimicrobial resistance (AMR). Note: antibiotics under special licence and human use under the cascade are not included. 25/04/2019

Data collection Data collection is conducted in accordance with the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project. Allows for harmonised collection and reporting of the sales of veterinary antibiotic data across Member States. Report on sales of veterinary antibiotics published annually on EMA website. 25/04/2019

Methodology Sales data on each product presentation requested from each MAH. Data provided are not audited or subject to independent verification. Data captured in harmonised ESVAC data collection template. Quantity of each active substance determined. Data reviewed for discrepancies. Submitted to ESVAC. Sales data reported by antibiotic class to protect confidentiality. 51 active substances, 71 MAHs, 373 presentations marketed. 548 authorisations of which 322 marketed. 25/04/2019

Distribution of sales (tonnes) of veterinary antibiotics in IE 2016 25/04/2019

Pharmaceutical form breakdown of veterinary antibiotics sold in IE 2016 Oral remedy: oral pastes, powders, solutions and boluses 25/04/2019

Population correction unit (PCU) Animal demographics change over time. In order to account for this the PCU has been established as a denominator for the sales data. PCU for each animal category is calculated by multiplying numbers of livestock animals and slaughtered animals by the theoretical weight at the most likely time for treatment. Exported and imported animals are also taken into account. 1 PCU = 1 kg of animal biomass. Sales data can be reported as mg active substance/PCU. PCU is a technical unit of measurement and not a real value. 25/04/2019

Sales of veterinary antibiotics, 2012-2016   2012 2013 2014 2015 2016 Tonnes sold 97.4 99.1 89.4 96.9 103.4 Difference of 200,000 tonnes in biomass between 2012 and 2016. PCU (1,000 tonnes) 1725 1762 1866 1892 1963 mg/PCU 56 48 51 53 25/04/2019

Sales of veterinary antibiotics, 2012-2016 25/04/2019

Sales of 3rd & 4th gen. cephalosporins, fluoroquinolones   2012 2013 2014 2015 2016 3rd & 4th gen. cephalosporins (t) 0.21 0.17 0.24 0.22 0.25 Fluoroquinolones (t) 1.00 0.89 0.69 0.79 0.94 25/04/2019

Stratification of sales data by species Estimate the antibiotic consumption per species based on an allocation of the proportion of total sales for a VMP to each indicated target species. An interim approach until more detailed data on each animal category is available. The focus is on cattle, pigs and poultry. MAHs will be asked to provide a distribution (as percentage %) of antibiotic use according to the categories of species for which an individual VMP presentation has presumably been used. 25/04/2019

Stratification of sales data by species Additional columns added to the ESVAC template for the collection of data for stratification of sales data by species 25/04/2019

Conclusions Sales of antibiotics in IE fluctuate on a yearly basis. Factors such as disease prevalence, change in the national herd, or product held in the supply chain between years can contribute to these changes. The data provides a general indication on sales trends. Stratification by species may better estimate how the products are used. Management priorities should not be based on this data alone. 25/04/2019

HPRA website http://www.hpra.ie/homepage/veterinary/special-topics/antibiotic-resistance 25/04/2019

ESVAC website 25/04/2019

25/04/2019

National action plan on AMR 2017-2020 https://health.gov.ie/wp-content/uploads/2017/10/iNAP_web-1.pdf 25/04/2019