Board debates policy points on medicinal products

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Thorny issues surrounding the appropriate use of medicinal products—and how to handle adverse events—prompted discussion during the Executive Board meeting.

Board members postponed revising the policy on Human-Labeled Drug Products, Sale to Veterinarians. On recommendation of the Council on Biologic and Therapeutic Agents, the board adopted a new policy on Adverse Event Reporting, and revised the Guidelines for Veterinary Prescription Drugs and the Guidelines for Use of Autogenous Biologics.

In postponing revisions to the policy on Human-Labeled Drug Products, the board requested input on liability issues on a proposed new point in the revision: "Veterinarians bear full responsibility when using human-labeled prescription products in the treatment of animals."

Dr. Bonnie V. Beaver, immediate past president of the AVMA, raised legal concerns about the word "full" in front of the word "responsibility." She gave an example of a bad batch of drugs being outside a veterinarian's control.

In reference committee deliberations, AVMA President Henry E. Childers had said veterinarians bear full responsibility for all actions under their licensure.

But Dr. Larry Kornegay, District VIII representative, said product problems are always possible with prescriptions. Dr. Guy Pidgeon, District I representative, added that extralabel use always carries some risk. The Food and Drug Administration has not substantiated the safety and efficacy of using human-labeled drugs in animals.

Following discussion, Dr. Childers said the new point about full responsibility does make him a little nervous. The board asked the staff to seek advice on the wording.

Other revisions to the policy on Human-Labeled Drug Products would describe why veterinarians need access to human-labeled prescription drugs, note that veterinarians usually seek human-labeled medications from distributors or suppliers rather than manufacturers, and acknowledge the passage of the Animal Medicinal Drug Use Clarification Act and the need to comply with AMDUCA regulations.

The board went ahead with a new policy advocating stronger systems for reporting adverse events from use of medicinal products. The Council on Biologic and Therapeutic Agents wants to reduce the potential to falsely flag spurious events as cause for concern and reduce the potential to fail to detect unique subgroups at increased risk.

The council has been discussing pharmacovigilance with the FDA Center for Veterinary Medicine and the Department of Agriculture's Center for Veterinary Biologics. The Animal Health Institute has working groups addressing the subject. At the council's recommendation, the board also adopted the following policy:

Adverse Event Reporting

Being committed to the continuing availability of medicinal products that are pure, safe, potent and efficacious for animals, the AVMA encourages continued development and strengthening of adverse event reporting systems. This includes continued collaboration with constituent professional organizations, industry organizations, government entities and other stakeholders.

The board approved revising the Guidelines for Veterinary Prescription Drugs, with one alteration to the council's suggestions.

The revisions clarify that, according to federal regulations, a drug container must bear certain minimum information so people administering the drug have adequate directions in their hands when treating animals. But the board removed a sentence regarding additional instructions: "The animal owner must keep the additional instructions with the original drug container that has the attached label."

Dr. Beaver said the requirement would be unrealistic, and it would mandate action by owners rather than veterinarians. Dr. James O. Cook, District V representative, said a requirement for veterinarians to tell owners to keep instructions may be appropriate—but would be another burden for veterinarians. The board voted to strike the sentence.

The board also revised the policy on Guidelines for Use of Autogenous Biologics, which formerly bore the title Guidelines for Good Veterinary Practice in the Use of Autogenous Biologics.

The document now informs veterinarians how to find relevant USDA regulations and memos, de-emphasizes clinical practices that the Clinical Practitioners Advisory Committee believes are understood, and summarizes dating of autogenous products.