Important News

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

Microchip Regulation Update

On July 1, 2020, the City and County of Honolulu implemented mandatory microchip identification for cats and dogs over the age of four months. This replaces the City and County of Honolulu’s dog license tag requirement, but does not replace the requirement that cats allowed outdoors have visible identification. Any dog or cat without a microchip who is impounded by Hawaiian Humane Society or taken into custody by an animal rescue nonprofit must have a microchip implanted before release. The microchipping obligation does not apply to private individuals returning lost pets or to veterinary clinics, but we hope you will urge your clients to comply with the law. Clients with a new pet who is already microchipped should be informed that they have 30 days to update the pet’s microchip with their owner information.

In addition, the Hawaiian Humane Society will no longer be updating their microchip registry. Instead, they are recommending that veterinarians help pet owners register their information with the microchip manufacturer or with a free online database such as FoundAnimals.org. Pet owners who have microchips implanted by your clinic also have a legal obligation to register their contact information with an online registry within 30 days. Please do not send microchip information to the Hawaiian Humane Society at this time.

Another provision of the new law requires that any intact dog impounded as stray three times in a 12-month period must be spayed/neutered before the dog can be returned to its owner unless a licensed veterinarian finds the dog is medically unfit for sterilization.

Questions or comments may be directed to the Hawaiian Humane Society at info@hawaiianhumane.org or 356-2200.

Update from Hawaiian Humane Society

July 1 marked the implementation of the most significant overhaul of Oahu’s animal welfare ordinance in 25 years. It made changes in three major areas:

Stray animal handling
Pet identification
Routinely stray dogs

The pet identification provisions are expected to affect the greatest number of pet owners.

FAQs

What law has changed?
Revised Ordinance of Honolulu Chapter 7: Animals and Fowl

How did the rules change regarding stray animal holding?
Hawaiian Humane now has legal custody of any stray dog or cat with microchip identification after five days in its care, down from nine. Dogs wearing a current county license tag still must be held for a minimum of nine days. The kenneling fee for stray animals has increased to $10 per day from $2.50. There is still no kenneling charge for animals reclaimed within 24 hours. This is not a legal requirement, but Hawaiian Humane is urging pet owners who travel, particularly if they will not have email or cell phone access, to list their pet sitter or veterinarian as a secondary contact on their microchip registration in the event that their animal gets lost while they are away.

What are the new rules for pet identification?
All dogs and cats are now required to have microchip identification. Pet cats allowed outdoors are still required to have visible identification. That is highly recommended for dogs, as well, but not legally required.

What if you have a current dog license?
Owner information can still be updated with the City and County of Honolulu. No new dog licenses are being sold and licenses can no longer be renewed.

What about microchip registration?
Clinics that wish to upload microchip information should do so with the manufacturer’s database, not Hawaiian Humane. Hawaiian Humane is no longer maintaining a separate microchip database for Oahu and pet owners are no longer legally required to register their microchips with Hawaiian Humane. Under the new ordinance, pet owners who have microchips implanted have 30 days to register their contact information with the microchip manufacturer or a free online database. Similarly, they have 30 days to update any changes to their contact information or to transfer ownership of a pet.

What does the new law say about routine strays, or “frequent fliers”?
Any dog brought to Hawaiian Humane as stray three times in a 12-month period must be spayed/neutered before the dog can be returned to its owner, unless medically contraindicated. Sterilization services will be offered at the Community Spay/Neuter Center, but owners may request that Hawaiian Humane transfer a dog falling under this requirement to a private veterinary clinic upon confirmation of a spay/neuter appointment.

What do we do if someone brings us a lost pet?
Hawaiian Humane remains the official pet lost and found for Oahu. If you need help identifying the owner of a microchipped pet, call the admissions team at 356-2285.