J. Yoshicedo, DVM | Hawaii VMA

Legislative Update 2022

The Hawaii Veterinary Medical Association (HVMA) seeks to amend Chapter 471, Hawaii Revised Statutes, to better define the practice and parameters of veterinary medicine and veterinary telemedicine to protect consumers and their pets from inadequate, improper, or unlicensed veterinary care. Further, because there is a shortage of licensed veterinarians in Hawaii, HVMA is proposing to provide for the temporary permitting of out-of-state veterinarians and providing for international veterinary school graduates to qualify for licensure examination in Hawaii.

The COVID-19 pandemic and its associated restrictions brought about consumer demand for telehealth in the field of veterinary medicine. Telemedicine has allowed consumers more access to veterinary services for their pets, particularly in areas where access to veterinary care is limited. However, HVMA is aware that the use of telemedicine may also be abused without an established veterinary-client-patient relationship. Without actual physical examination of a pet, veterinary services rendered through telemedicine alone can be inadequate and below the standard of veterinary care. The addition of telehealth definitions and the telemedicine section will help to clarify the practice of veterinary telemedicine and assist the Hawaii Board of Veterinary Medicine in ensuring consumers in Hawaii receive proper and licensed veterinary telemedicine services.

Additionally, the pandemic highlighted the shortage of veterinarians available to provide specialty and routine veterinary care for Hawaii’s people and their pets. At times, veterinary emergency hospitals were unable to operate 24/7 and surgeon schedules were completely booked for months due to the inability to fill these staffing shortages by temporary permit. In one specific case, there was a veterinary surgeon within the state that could have assisted during this period, but due to her international veterinary school degree, was unable to sit for Hawaii’s state licensing exam due to a technicality in the administrative rules. These amendments are critically important to prevent such veterinary care shortages in the future, and ensure that all qualified veterinarians are allowed to sit for the Hawaii state licensing exam.

This bill has currently been introduced to the House (HB 1598) by Representatives Johanson, Hashem, and Nishimoto; and into the Senate (SB 2798) by Senators Lee, Gabbard, Keith-Agaran, Misalucha, Acasio, Ihara, and San Buenaventura . Please take the time to thank them for their support, and write your local representative to ask for theirs!

Specialty/ER Service Interruption

The Hawaii Board of Veterinary Medicine has recently reinterpreted Hawaii’s veterinary practice law and begun rejecting the practice of veterinary sponsorship. This practice previously allowed many out-of-state specialists to share their services with our clients on a short-term or intermittent basis. All of us have benefited from referring our clients to visiting dermatologists, radiologists, surgeons, as well as our few emergency care centers that operate 24/7. This interruption in veterinary sponsorship has limited service hours at emergency clinics and worsened the backlog of surgery cases in Hawaii.

If your clients are being affected, please encourage them to file a complaint with the DCCA and Board of Veterinary Medicine to insist that they must immediately return to honoring the practice of veterinary sponsorship in Hawaii as clearly allowed by HRS 471(2)-5.

Veterinarians as COVID-19 Vaccinators

Submitted by the American Veterinary Medical Association

The AVMA has been working hard for the past few months, as veterinarians have been increasingly discussed as needing to be among those able to assist in efforts to vaccinate people against COVID, to have veterinarians specifically included in the declarations under the federal Public Readiness and Emergency Preparedness Act (PREP Act), which authorizes the HHS Secretary to issue emergency public health declarations and provides limited immunity from liability to those covered under the act.

As of March 12, 2021, veterinarians and veterinary students are included in the PREP Act:

· It allows veterinarians who are licensed to practice under the law of any state to administer COVID vaccines in any jurisdiction in association with a COVID vaccination effort by a state, local, tribal, or territorial authority or by an institution in which the COVID vaccine is administered.

· This also applies to veterinarians who have held an active license or certification under the law of any state within the last five years which is inactive, expired or lapsed, as well as veterinary students with appropriate training in administering vaccines. The intent is to include recently retired veterinarians who may want to help.

· Today’s amendment preempts any state law that would otherwise prohibit veterinarians or veterinary students who are a “qualified person” under the PREP Act from prescribing, dispensing, or administering COVID vaccines or other covered COVID countermeasures.

· Veterinarians and veterinary students will be afforded liability protections in accordance with the PREP Act and the terms of the amendment. However, specific conditions must be met in order for the authorization to administer the vaccines and the liability protections to apply. These liability protections apply from March 11, 2021, through October 1, 2024.

· In order for the authorization and liability protections to apply, veterinarians and veterinary students must be participating in association with a COVID vaccination effort by a state, local, tribal, or territorial authority, or by an institution in which the COVID vaccine is administered. Additional specific requirements also must be met, such as having basic certification in CPR, completing the CDC COVID vaccination modules, an observation period, etc. There is a separate section of the declaration that applies to those in the uniformed services and for federal employees, contractors and volunteers when authorized to administer COVID vaccine.

· While the liability outlined in the PREP Act is broad, it does not apply to willful misconduct, and the federal government does not provide a legal defense in the event that you are sued. Your state may have separate liability protections, along with separate requirements to qualify, and may or may not provide a legal defense. Veterinary malpractice will not likely respond to claims arising from a veterinarian intentionally vaccinating people against COVID.

More information on vaccination volunteer requirements

PREP Fact Sheet that Includes Veterinarians as Qualified Health Professionals

Federal Requirements for the Veterinarian-Client-Patient Relationship

The following guidance information has been provided by the AVMA

THE BASICS

The federal government regulates veterinary medicine and animal drugs very differently than it does human health care and drugs intended for human use. This is, in part, because veterinarians are key to maintaining a healthy, safe, and wholesome food supply and because they also play an important role in overseeing the judicious use of antimicrobials in animals. One important difference between human and veterinary medicine is that the U.S. Food and Drug Administration (FDA) has authority under the federal Food, Drug and Cosmetic Act (FDCA) over the use of animal drugs and human drugs by veterinarians, and the authority to define how a veterinarian-client-patient relationship (VCPR) is established for certain uses of animal and human drugs. [1]

For these uses, FDA has authority to require the keeping of veterinary medical records and to access them at any reasonable time to verify and copy them. [2] Use of animal and human drugs by veterinarians that violates the federal VCPR parameters set forth in the FDCA and its implementing regulations results in the drug being statutorily deemed unsafe for the use and, if in animal feed, the feed is statutorily deemed adulterated. [3] The USDA, which regulates veterinary biological products, also has promulgated rules defining a VCPR using the same language as the FDA. [4]

APPLICATION OF THE FEDERAL VCPR

The federal VCPR applies to any use of an FDA-approved human drug in animals, including over-the-counter (OTC) human drugs. [5] It applies to any use of an FDA-approved animal drug in any manner that differs from its approved labeling (Extra Label Drug Use [6]), such as a different frequency of administration, different dose, different medical indication for its use, different route of administration, or use in a different species. [7] It also applies to the use of compounded drugs by veterinarians [8] and a veterinarian’s authorization of a veterinary feed directive (VFD). [9] All of these are very common occurrences in the day-to-day practice of veterinary medicine.

Establishing the federal VCPR requires a physical examination of the animal or timely and medically appropriate visits to the premises where animals are kept. The FDA does not allow the VCPR to be established through electronic means. [10] FDA does allow the VCPR to be maintained electronically through telemedicine. [11] Veterinarians must comply with the federal VCPR in each of the circumstances in which it applies, irrespective of whether state law defines it differently.

The federal VCPR also applies in two important, but more limited, circumstances under USDA authorities. Veterinarians who manufacture biological products for use in their patients must do so within the context of the federal VCPR. [12] Veterinarians also must have established a federal VCPR when using prescription platform product biologics, which are a new category of biotechnology vaccines. [13]

CONFLICTING STATE AND FEDERAL VCPR DEFINITIONS AND TELEMEDICINE

• Conflicting state and federal VCPR definitions (e.g., states allowing the VCPR to be established electronically) would cause significant confusion. The FDA and USDA have used the same regulatory definition to avoid such confusion.
• Veterinarians must comply with the federal VCPR requirements where they apply, regardless whether state laws are more lax. Activities where the federal VCPR applies are extremely common in day-to-day veterinary practice.
• State law and regulations relating to the establishment of a VCPR that conflict with federal law would also cause telemedicine encounters to be frustrating for many veterinary clients. A veterinarian who has not already established a VCPR that complies with federal requirements (i.e., by conducting an in-person examination/visit) could not even recommend the use of an FDA-approved human OTC product for an animal without violating federal law.
• There are many valuable uses of telemedicine within the parameters of a federal VCPR.

21 USC 360b; 21 CFR Part 530
21 CFR 530.5
21 USC 360b(a)(1), (2), (4) & (5); 21 USC 342(a)
9 CFR 107.1(a)(1)
21 USC 360b(a)(5); 21 CFR 530.2; 21 CFR 530.3(a)
https://www.fda.gov/animal-veterinary/resources-you/ins-and-outs-extra-label-drug-use-animals-resource-veterinarians
21 USC 360b(a)(4); 21 CFR 530.2; 21 CFR 530.3(a)
https://www.fda.gov/animal-veterinary/resources-you/ins-and-outs-extra-label-drug-use-animals-resource-veterinarians#compounding; FDA Draft Guidance for Industry #256
21 CFR 558.6(b)
FDA letter to the American Veterinary Medical Association, April 6, 2017 – “Therefore, for the purposes of the federal definition, a VCPR cannot be established solely through telemedicine (e.g., photos, videos, or other electronic means that do not involve examination of the animal(s) or timely visits to the premises).”; During the pandemic FDA announced they will temporarily suspend enforcement of the federal VCPR physical exam and premises visit requirements. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-269-enforcement-policy-regarding-federal-vcpr-requirements-facilitate-veterinary. In this announcement FDA reiterated that under normal circumstances – “Given that the Federal VCPR definition requires animal examination and/or medically appropriate and timely visits to the premises where the animal(s) are kept, the Federal VCPR definition cannot be met solely through telemedicine.”
Id. “The regulations do not specifically address the use of telemedicine to maintain an established VCPR. However, based upon the language of the VCPR definition provided above, nothing would prohibit the use of telemedicine (e.g., use of photos, videos, or other electronic means that may be considered virtual) to allow the veterinarian to keep informed and able to make medical judgments regarding the health of the animal(s) and the need for medical treatment between periodic examinations of the animal(s) and/or timely visits to the premises where the animal(s) are being kept.”
9 CFR 107.1(a)
USDA Veterinary Services Memorandum 800.214

THE BASICS

APPLICATION OF THE FEDERAL VCPR

CONFLICTING STATE AND FEDERAL VCPR DEFINITIONS AND TELEMEDICINE

Veterinary Leadership Conference 2021

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