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?
