Clinical Pharmacology Laboratory 2

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Clinical Information "Scavenger Hunt"

Exercise 1. Animal Medical Drug Use Clarification Act (AMDUCA)

FDA regulation of veterinary medicine under AMDUCA is specified in the Code of Federal Regulations (CFR) Chapter 21, Part 530. (21CFR530) This sepecific part of the CFR is available on my teaching website. The CFR is the most DIRECT description of these regulations. Please use the CFR to answer the following:

Question 1. List 5 pieces of information (on an individual, group, herd, flock or "per client basis") that must be retained in records by a veterinarian must be maintained when you use a drug in an extra-label fashion in animal patients.

Question 2. List 3 items that must be on the "label" of a drug prescribed in an extra-label manner. Remember that "label" does not necessarily mean a "sticky thing attached to the bottle of pills." (the exact wording is "shall bear or be accompanied by labeling information").

Exercise 2. FOI

This link will provide you with the freedom of information summary (FOI) for the "Metaphylaxis" indication for Micotil: NADA 140-929. Use this FOI to answer the following questions:
The first "Pivotal" Field Trial of Micotil Metaphylaxis listed in the FOI is labeled T5C489405. Use this study to answer questions 3 - 7.

Question 3. In this study, approximately how many cattle were in each study group (there are three study groups)?

Question 4. Considering the same field trial (T5C489405) and using ONLY table 4.1, was morbidity statistically different between the Metaphylaxis ("Early treatment") Group and the Control Group?

Question 5. Considering the same field trial (T5C489405) and using ONLY table 4.1, was morbidity statistically different between the Treatment ("Temperature-based") Group and the Control Group?

Question 6. Considering the same field trial (T5C489405) and using ONLY table 4.1, was morbidity statistically different between the Metaphylaxis ("Early treatment") Group and the Treatment ("Temperature-based") Group?

Question 7. Micotil is labeled for: "treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica." Can you tell whether the cattle that died during the study actually died from this specific indication?

Exercise 3. Online Resources

Question 8. According to the "FDA Approved Animal Drug Products Online Database System," How many approved NADAs exist for the ingredient "Ceftiofur?"

Question 9. Compare Naxcel Sterile Powder (NADA# = 140-338) to Excenel Sterile Suspension (NADA# = 140-890). List two fundemental differences between the two products.

Question 10. If you use Excenel Sterile Suspension to treat pneumonia in Sheep, is the use extra-label?