Newsletter

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

Conservation Medicine Spotlight: Avian Translocations with Pacific Rim Conservation

by Adrien Pesque, DVM

Pacific Rim Conservation, a nonprofit organization, has the mission of maintaining and restoring native bird diversity, populations, and ecosystems in Hawaii and the Pacific Region. In an effort to combat the threats to seabird populations including climate change and non-native predators (feral cats, pigs, rats, etc), chicks are translocated to predator proof fenced refuges on the main Hawaiian islands where they will fledge and return to breed. On Oahu, black-footed albatross, Bonin petrel, and Tristram’s storm-petrel chicks were translocated from Midway and Tern Island to James Campbell National Wildlife Refuge. On Kauai, endangered Hawaiian petrels and Newell’s shearwater face similar threats of habitat degradation and non-native predators, but also collisions with power lines and structures exacerbated by light attraction. Individuals of these two species were translocated from the Kauai mountaintops to a predator proof fenced area within the Kīlauea Point National Wildlife Refuge. These new breeding colonies will provide a safe haven for new generations to come.

Dr. Adrien Pesqué, the staff wildlife veterinarian, joined the team this year and created a mobile veterinary clinic to oversee the health of the chicks. Clinical cases included avian pox lesions, osteomyelitis of the beak, a non-healing corneal ulcer, and aspiration pneumonia secondary to gastric foreign bodies. Plastics and fishing material in the GI tract were present in our chicks and continue to cause life threatening problems for ocean wildlife.

Dr. Suzanne Pluskat, the staff wildlife veterinarian stationed on Midway Atoll, worked with partners to ensure the safety of the endangered Laysan duck for the anticipated rodent eradication on the island. Laysan duck cases involved pododermatitis, complicated corneal ulcers, femoral fracture repair and physical therapy. During the “construction season” (July-September when there are no albatross), many white tern chicks and the first ever black noddy chick were salvaged and fledged successfully.

Pacific Rim Conservation partners with multiple government and non-profit groups to make this work possible. To learn more about these translocations and other research projects, please visit www.pacificrimconservation.org.

HVMA Supports PAWS Across the Pacific

When the pandemic reduced flights to and from Hawaii last spring one little-known impact was that on our local animal shelters. Many island shelters and rescues rely on transport of dogs and cats to the continental US for placement options when no adopters are found locally. The cancellation of flights reduced the availability of space for pets to catch a ride. Shelters across the state made every effort to foster and house the increasing number of animals but many reported this was reducing their capacity to help other animals in need.

Greater Good Charities (GGC) stepped in to assist and coordinate an unprecedented rescue flight in this time of emergency. GGC had previously supported the Hawaii community by donating thousands of pounds of pet food since the pandemic began. A multi-organization effort supported by HIEMA and HVMA resulted in the safe transport of nearly 600 dogs and cats from Hawaii to Seattle. On October 28 a charter Hercules C-130 cargo plane flew from Oakland, CA to Lihue, then Honolulu, Kahului and Hilo picking up animals along the way. All pets were examined by a veterinarian and given a health certificate prior to the flight and a large team including veterinarians were available at Boeing Field in Seattle to ensure the animals were comfortable and healthy on arrival. Many pets were adopted within days of arrival. For more information and photos and video on the largest ever pet rescue flight visit GGC Paws Across the Pacific Page.

This is the first part of an emergency support effort from GGC that will include providing emergency sheltering supplies, disaster sheltering training and more to area animal welfare organizations.

Mahalo to the sponsors who helped make it happen: The Animal Rescue Site, Banfield Foundation, Royal Canin, VCA Animal Hospitals, PEDIGREE Foundation, Petco Foundation, Tito’s Handmade Vodka, Healthy Paws Pet Insurance & Foundation, MuttNation Foundation, Kamaka Air Inc, Air Charter Service, and Jackson Galaxy.