title: Animal health pharmaceutical industry.
abstract: The animal health pharmaceutical industry has proactively reported on the volumes of member company antimicrobial active ingredients sold in the U.S. At the individual company level, reporting of finished product distribution data to the FDA is a regulatory requirement, with applications to surveillance and pharmacovigilance. An accounting of product manufactured is done for purposes of good business practices, as well as marketing analyses. Additional applications of antimicrobial usage data might include use in risk assessments, such as for the FDA's Center for Veterinary Medicine Guidance for Industry #152 for the evaluation of the microbiological safety of antimicrobials intended for use in food animals. Compilation of national usage data will be a complex undertaking, hindered by issues such as confidentiality, auditing, field use practice variations, population dynamics (e.g. disease incidence, market conditions for poultry and livestock production), and generic usage. The amounts or volumes in pounds should be considered relative to the large number of animals under husbandry in the United States. Large volumes might seem impressive unless put into proper context. Until such time as a clearly defined application of national usage data is agreed, it is recommended that local usage programs will provide more useful information to perpetuate prudent antimicrobial use in animals.
authors.affiliation: Animal Health Institute, 1325 G Street Suite 700, Washington, DC 20005, USA. rcarnevale@ahi.org
authors.forename: Richard A
authors.initials: RA
authors.lastname: Carnevale
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Shryock
mesh_terms: D000827:Animal Welfare; D000818:Animals; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004345:Drug Industry / Q000592:standards*; D004346:Drug Information Services / Q000706:statistics & numerical data*; D024881:Drug Resistance, Bacterial; D006801:Humans; D014481:United States; D019155:Veterinary Drugs / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000900:Anti-Bacterial Agents; D019155:Veterinary Drugs