Establishing defined daily and course doses for antimicrobials used in Pakistani broilers to enable farm-level quantification and comparison of antimicrobial use.

Monitoring antimicrobial use (AMU) is crucial, as it plays a key role in driving antimicrobial resistance (AMR). Animals account for a significant share of AMU, making it essential to accurately quantify AMU exposure at the species, farm, and country levels. In Pakistan, prophylactic use of antimicrobials remains common alongside therapeutic use. This study aimed to establish defined daily and course doses for both therapeutic and prophylactic use of antimicrobials in commercial broiler production in Pakistan. A list of antimicrobial products was compiled from the daily treatment records from 100 commercial broiler farms in Punjab, Pakistan. For each active substance (AS), a defined daily dose (DDD) was assigned for treatment, prevention or both, by averaging the recommended doses of all similar AS with the same administration route. A defined course dose (DCD) was calculated by multiplying the average recommended dose by the average treatment duration for each AS, based on the Summary of Product Characteristics (SmPC). A total of 41 AS, categorized into 17 antimicrobial classes, were identified from 139 antimicrobial products. The most frequently reported AS were colistin (polymyxins) at 15.9 %, amoxicillin (aminopenicillins) at 7.5 %, neomycin (aminoglycosides) at 7.3 %, enrofloxacin (fluoroquinolones) at 6.7 %, and tylosin (macrolides) at 6.4 % of the total treatments (n = 358) reported at farms. Notably, 51 % of AS were classified as critically important for human medicine by WHO. Among AS indicated for treatment in SmPC, the defined daily doses for Pakistan (DDD) varied substantially from the European Medicines Agency (EMA) values (DDD), with the top deviations being Tiamulin (+147.8 %), Sulfadimidine_TMP (+111.2 %), Flumequine (+88.6 %), Spiramycin (-87.8 %), and Tylosin (-84.3 %). This study presents a list of defined daily doses and defined course doses for AMU quantification in Pakistani broilers using dose-based indicators. The observed differences between Pakistani and EMA doses, and lack of EMA doses for preventive antimicrobials, suggest using Pakistani DDD values to quantify antimicrobial usage in Pakistan. A huge variation in recommended doses was reported in SmPC. There is an urgent need to establish a list of approved veterinary antimicrobials used in Pakistan, along with harmonization in recommended doses and maintenance of standardized SmPC by the drug regulatory authorities. Setting up a national-level list of defined daily doses is crucial to accurately monitor and quantify AMU.