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Legal considerations

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  • Veterinarians have considerable ability to use biologics in a discretionary manner.
  • Continuous medical decision-making is an inherent aspect of veterinary medicine. There is no reason to believe that decisions regarding vaccine selection and use will carry any greater legal risk than the myriad of other medical decisions made in daily practice. Relative risk for utilizing these guidelines in developing patient vaccination protocols is considered low, particularly as the U.S. Department of Agriculture (USDA) is removing the standard annual revaccination recommendation from vaccine labels.
  • The best method for insulating a practitioner from legal liability relative to vaccination or anything else is effective client communication. Client communication of risk and/or benefit information, and documentation of that communication in the medical record, should be in direct and simple terms.

Do veterinarians have professional discretion in the use of vaccines in their practice?

Yes, with a few limitations. The recommendations contained in the Guidelines may differ in some parts from statements on product labels. However, veterinarians in small animal practice in the United States have considerable discretion in exercising their judgment relative to the use of veterinary biologic products licensed by the USDA within their professional practice.1 The same is true for veterinarians in Canada using biologic products approved under the Canadian Food and Drug Act. As such, practitioners have the ability to incorporate the use of the Guidelines into their practices. This is particularly true with respect to revaccination intervals under new USDA labeling rules finalized in 2016 and that will be implemented over the next several years.2 Unless there is data that establish the need for revaccination recommendations the new labeling will state: “The need for annual booster vaccinations has not been established for this product; consultation with a veterinarian is recommended.”

The USDA Center for Veterinary Biologics (CVB) regulates the licensure and preparation of most veterinary biologics, including all material on their labeling. CVB does not regulate the practice of veterinary medicine. Although CVB does have the statutory authority to stop the sale, barter, or exchange of “any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product,” they would only take action against a small animal practitioner under extraordinary circumstances. Before initiating such action, CVB would most likely contact the veterinarian and/or undertake a profession-wide educational initiative.3

Vaccines licensed by the USDA and prepared in establishments licensed by the USDA are not directly subject to the Animal Medicinal Drug Use Clarification Act (AMDUCA) or the Food and Drug Administration’s (FDA) implementing regulations. However, it is possible for the FDA’s Center for Veterinary Medicine to regulate some products that most practitioners would consider biologicals. Products that are approved by the FDA are subject to AMDUCA’s and FDA’s established specific rules for “extra-label” drug use. Products regulated by the USDA may be identified by the “USDA Establishment Number” that appears on labeling.

States may also regulate the discretionary use of biologic products by veterinarians. This can be confusing, as the state and federal terminology may be similar but applied differently. The state’s definition of “drug” may include biologic products, and the state may use the term “extra-label” differently than the federal application.4 Veterinarians should be aware of any state-specific restrictions in their state’s veterinary practice act or implementing regulations. However, it is the authors’ belief that such restrictions are sufficiently general that they should not interfere with the ability to use these Guidelines. In Canada, the provinces have the legal authority to regulate the veterinary profession, but they have no authority whatsoever relating to trade in drugs, medications, and biologics. In this context, the provincial veterinary legislation may, for instance, require that a veterinarian obtain the informed consent of the client before using a substance in a manner that differs from its labeled indications.

Rabies vaccination

Rabies vaccine represents a unique class of products due to the public health concern. The USDA places restrictions on the licenses for rabies products, such that their distribution in each state is limited to authorized recipients as designated by proper state officials (e.g., state public health veterinarian) and under such additional conditions as these authorities may require. Each state or jurisdiction, in turn, has its own rabies control program. The substance of this law varies among jurisdictions and can encompass state, provincial, and/or local requirements. A common theme to this regulation is compulsory vaccination, irrespective of the label statements that the products are for use in healthy animals. Sometimes veterinarians and/or clients desire to forego rabies vaccination, believing it to be contraindicated due to the health or age of the dog. Veterinarians must be very careful in such circumstances. Veterinarians must not assume they have the discretion to recommend against vaccination in the face of mandatory state vaccination laws. Therefore, it is imperative that veterinarians investigate, understand, and follow the legal requirements for rabies vaccination in the areas in which they practice . The same approach is prudent in Canada.

Potential for liability associated with vaccine administration

Potential liability for medical decision-making is a fact of life for any health care provider including veterinarians. This potential professional liability encompasses all aspects of veterinary practice, including the selection and use of vaccines and other biologic products. The best deterrent to legal action in this context is effective communication with clients.

When recommendations to extend revaccination intervals were initially discussed within the veterinary profession, many veterinarians were concerned they could face significant liability if revaccination intervals were extended beyond the annual revaccination recommendation contained on many vaccine labels at the time. However, any such significant liability concerns have not materialized within the profession in the years since the AAHA Canine Vaccination Guidelines were first published. This concern should be even less now that the USDA is removing most annual revaccination recommendation statements from vaccine labeling.

1 Any relevant state law (e.g., for rabies administration) should be followed. It is also possible for vaccines, such as those used in official USDA disease eradication programs or to combat foreign diseases, to carry specific labeled restrictions on their use. Veterinarians should adhere to any such restrictions.
2 81 Fed. Reg. 59427 (2016)
3 It does not appear that CVB has taken an enforcement action against a small animal veterinarian relative to their exercise of professional judgment in the discretionary use of a vaccine for at least 30 yr. It is believed they have never done so. The most likely reason for any such action would be a significant safety issue.
4 See 811 IAC 12.2(2) (IA—a board rule titled “extra-label use of veterinary drugs, medications and immunization products” specifies that for animals not intended for food, one of the permissible criteria for extra label us is that “there are no marketed drugs, medications and immunization products specifically labeled for the condition(s) diagnosed”; or in the veterinarian’s clinical judgment the labeled dosage is inappropriate for the condition or the extra-label use should result in a better outcome for the patient.); Ala Admin Code r. 420-4-4.01(8) (AL—rabies control program defines “extra label use of vaccine” as “use of an animal vaccine in a species that is not specified on the product label or product insert.”)

These guidelines are supported by a generous educational grant from
Boehringer Ingelheim USA Inc., Merck Animal Health, and Zoetis.