Targeting antimicrobials in food animals (part 1) (Proceedings)


Targeting antimicrobials in food animals (part 1) (Proceedings)

Aug 01, 2010

This checklist serves as a starting point for evaluating your applications of antimicrobials in food animals.

1. Do I understand the difference that will be made in clinical outcome from my application of a drug to this animal or in this system?

     • See Number Needed to Treat below
     • How much of the observed clinical response rate is due to the drug and how much is due to spontaneous recovery?
     • Is appropriate clinical trial data available to drive my decision process?
          o Prospective?
          o Randomized?
          o Masked?
          o Controlled?
          o Appropriate statistical treatment?
          o Applicable to this production system?
               1. Animal type and production stage
               2. Case definitions for illness and success/failure
     • Are the trial outcome parameters an actual clinical response or a substitution variable?
          o Fever reduction vs. change in clinical outcome
          o Titers vs. disease protection
     • How can I address my observational bias in interpreting the outcome of drug applications in production systems?
          o Historical controls?
          o True case success and case fatality rates?
2. For antimicrobials, do I understand the application of antimicrobial susceptibility testing?
     • Clinical and Laboratory Standards Institute (CLSI) approved breakpoints
     • Correct methods for in-house testing
     • Kirby-Bauer vs. microwell dilution methods
3. Is it legal?
     • AMDUCA regulations
          o Prohibited ELDU drugs
          o Avoidance of illegal residues
     • Compliance policy guideline for compounding
4. Have I thought through the disposition of animals after receiving this drug?
     • Withdrawal time or extended withdrawal time?
     • Are they able to enter the food chain in any manner?
5. Could there be untoward food safety effects?
     • Residues?
     • Antimicrobial effects on prevalence or susceptibility of foodborne pathogens?
6. Have I actually searched for and considered evidence?
     • Am I being authoritarian or authoritative?