Veterinary Medicine

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Pet therapy programs have been expanding throughout the country, based largely on the increasing recognition that humans benefit from the human-animal bond.  The human-animal bond is defined by the American Veterinary Medical Association as:

a mutually beneficial and dynamic relationship between people and animals that is influenced by behaviors that are essential to the health and well-being of both. This includes, but is not limited to, emotional, psychological, and physical interactions of people, animals, and the environment.

While the IRS, in (PLR 201719018), has recently ruled “that a charity’s planned pet therapy program, which would bring trained therapy dogs to visit hospital patients and elderly nursing home residents, furthers charitable purposes under Section 501(c)(3),” that ruling does not consider or even mention public health concerns related to such programs.

“In support of its ruling, the IRS cited revenue rulings concluding that providing services to hospital patients and other individuals suffering distress in an effort to east that distress and provide them comfort furthers charitable purposes . . . [and] that activities designed to meet the special needs of the elderly may further charitable purposes.”  See Pet therapy program is a Section 501(c)(3) charitable activity, IRS rules (citations omitted).

However, no matter how well intended and “charitable” these programs are, there are serious potential public health risks from exposure of elderly, sick, immunocompromised patients to zoonotic diseases that pets can carry and transmit.  See, e.g., “Diseases you can share with your pets” previously discussed.

Those in the veterinary community understand these risks, as noted by Dr. Lucas Pantaleon, stating, the “[r]isk of zoonoses also arises with therapy dogs in human hospitals. The dogs go through screening but could bring zoonoses from the hospital back into the community.”  See “Speaker: Animal hospitals must practice infection control” reported by Katie Burns, June 1, 2017.

Researchers at Tufts University recently published the results of a “survey of United States hospitals, eldercare facilities and therapy animal organizations revealed their health and safety policies for therapy animal visits varied widely, with many not following recommended guidelines for animal visitation.”  See, “Could Therapy Animal Visitation Pose Health Risks at Patient Facilities?”, June 19, 2017.

The survey included “responses from 45 eldercare facilities, 45 hospitals, and 27 therapy animal organizations across the country on their existing policies related to animal health and behavioral prerequisites for therapy animals and Animal-assisted intervention (‘AAI’) programs.”

Alarmingly, researchers found that many programs had deficient preventive guidelines to at least minimize the potential exposure of zoonotic pathogens from pets to people, finding:

AAI programs have a potential risk of transmission of zoonotic disease—diseases spread between animals and people. This risk is especially high when health, grooming and handwashing protocols are not carefully used. Another potential risk could come from therapy animals eating raw meat-based diets or treats, which are at high risk of being contaminated with bacteria such as Campylobacter, Salmonella and Cryptosporidium. These pathogens may pose risks to both humans and animals, and especially immunocompromised patients.

Zoonotic disease transmission has also been reported in people contracting salmonella from backyard poultry, where almost one third of the 790 victims confirmed by the Centers for Disease Control and Prevention “are children younger than 5 years old.”  See “Salmonella victims from backyard flocks more than double,” Food Safety News, July 14, 2017.

The human-animal bond benefits both people and animals, especially the elderly and children, and should be encouraged.  However, proper protocols and controls should be in place to keep everyone healthy.

 

A proposed bill “authorizing the provision of health care services through telemedicine and telehealth” (S291) is now on the desk of the Governor of New Jersey for action.

The bill, which authorizes “the provision of health care services through telemedicine and telehealth” governs such services provided by veterinarians, as “[h]ealth care providers,” fails to acknowledge or provide for issues specific to veterinary medicine.  For example, several provisions require the “patient’s request” before providing health care services through telemedicine.  Clearly animal patients cannot request treatment or provide consent.  The bill fails to distinguish a “patient” from a “client” or “animal owner” or to permit such services at the request of a client/owner for the patient which is the fundamental way in which services are provided in a veterinary practice.

The bill also requires “[e]ach telemedicine or telehealth organization operating in the State . . . [to] annually register with the Department of Health” and submit an annual report providing

the total number of telemedicine and telehealth encounters conducted; the type of technology utilized to provide services using telemedicine or telehealth; the category of medical condition for which services were sought; the geographic region of the patient and the provider; the patient’s age and sex; and any prescriptions issued.  The commissioner may require the reporting of any additional information as the commissioner deems necessary and appropriate, subject to all applicable State and federal laws, rules, and regulations for recordkeeping and privacy.

Such information would be publicly accessible pursuant to the State’s Open Public Records Act, which may be of concern to biomedical research entities since reported information can reveal confidential information and trade secrets.

That said, the evolution of veterinary medicine necessarily involves telemedicine.  The American Veterinary Medical Association (AVMA ) acknowledges as much in its published “Final Report on Telemedicine” dated Jan. 13, 2017, drafted by the association’s Practice Advisory Panel (AP).

The AP concluded, in part:

Telemedicine is a tool of practice, not a separate discipline within the profession. The AP recognizes that using telemedicine in the delivery of veterinary medical services offers benefits to animal owners, animal patents, and the profession itself. The appropriate application of telemedicine can enhance animal care by facilitating communication, diagnostics, treatments, client education, scheduling, and other tasks within the veterinary profession. Practitioners must apply existing laws and regulations to the provision of telemedicine services in the state they have license to practice veterinary medicine.

The AP recommends that telemedicine shall only be conducted within an existing VCPR [veterinarian client patient relationship], with the exception for advice given in an emergency care situation until that patient(s) can be seen by or transported to a veterinarian. Without a VCPR, telemedicine should not be practiced, and any advice given should remain in general terms, not specific to an individual animal, diagnosis, treatment, etc.

AVMA’s Greg Cima outlined the issues involving telemedicine in “Defining relationships: AVMA considering what medical services can be provided at a distance” posted on May 10, 2017.

At issue is the line between advice and the practice of veterinary medicine, the very issue-in-suit in Hines v. Alldredge, 783 F.3d 197 (5th Cir. 2015) where “a Texas veterinarian . . . was found to have violated the state practice act by performing veterinary medicine without a physical examination or premises visit” when he provided advice via the internet.”

With the decreasing numbers of food animal practitioners across the country, issues of telemedicine will be increasingly important to ensure that livestock receive appropriate and timely medical care.

Companion and other animals will also benefit from the proper use of telemedicine by veterinarians, after the veterinarian-client-patient relationship has been established.

The U.S. Food & Drug Administration (FDA) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so that the FDA can ensure each product is safe and effective for its intended use.

Cancer treatment
Copyright: tashatuvango / 123RF Stock Photo

The FDA is concerned about the marketing and selling of products that have not been approved, particularly because such products may contain dangerous ingredients or may cause harm by negatively impacting beneficial treatments. Often such products are advertised as “natural” or are labeled as a dietary supplement, which may be a tip-off to consumers that the products have not been approved by the FDA.

We invite you to read Fox associate Elizabeth Patton’s post describing the agency’s recent efforts to combat these fraudulent advertising claims. For additional information and guidance regarding FDA-approved drugs for cancer in dogs specifically, see the FDA’s Consumer Update page.

As recently reported by healthypaws® Pet Insurance & Foundation in Cost of Pet Care: 2016, “[v]eterinarians have a greater ability to treat and save sick animals now more than ever before.”

The AVMA offers guidance to both pet owners and veterinarians “recogniz[ing] that viable pet health insurance programs will be important to the future of the veterinary profession’s ability to continue to provide high quality and up-to-date veterinary service.”  The AVMA, while not endorsing any specific pet insurer, includes a list in its guidance to pet owners.  See Do You Need Pet Insurance?

The North American Pet Health Insurance Association, “a freestanding body comprised of reputable and experienced pet health insurance companies and pet health professionals” describes it purpose in North America is to:

  • Collectively drive growth for, and acceptance of, the pet health insurance (PHI) industry, its members, and its products through public and industry awareness initiatives, shared resources, and industry transparency
  • Be a neutral voice for the reporting and dissemination of information about the benefits of PHI, and the industry, while promoting competitive choice for consumers about how pet insurance functions as well as the spectrum of coverage options available
  • Explore and develop partnerships with other insurance, industry, animal welfare organizations and professionals who share complimentary aspects of our work and mandate
  • Provide support to individual NAPHIA member companies in educating, marketing, and disseminating information on the industry across a wide variety of audiences and markets.  See About NAPHIA.

NAPHIA currently has 13 “industry members,” and describes its members as “collectively represent[ing] more than 20 different pet insurance brands currently marketed across the US and Canada.”  See The Pet Health Insurance Industry in North America.

NAPHIA reports that ‘over 1.6 million of the 179 million pets in North America are insured by NAPHIA members.’

Many businesses have begun offering pet insurance to their employees as part of their benefit packages.  Like any other insurance plan, a careful review of the policy is essential before deciding to sign on.

Plans may include the following options: (1) Accident only plans; (2) Accident & Illness; (3) Insurance with Embedded Wellness; and (4) Endorsements.  According to NAPHIA 97% of insured pets in the U.S. “were covered either through an Accident & Illness plan or an Insurance with Embedded Wellness plan.”  See State of the Industry Report 2016 Highlights.

Since diagnostic and treatment options for pets will continue to expand, it may make sense to obtain coverage to ensure that owners are best equipped financially to provide care needed, as determined in consultation with your veterinarian-of-choice.

New Jersey Senate Bill No. 2847,  introduced on December 12, 2016 would make some important beneficial changes to the laws governing animal rescue organizations and shelters in New Jersey, but would also require the unnecessary and harmful premature spay and neuter of cats and dogs before sale from pet shops, kennels, shelters, pounds, and animal rescue organizations.

Considering the positive amendments first, the bill would require registration of all animal rescue organizations with the State Department of Health.  Registration is currently voluntary.

Pursuant to Public Law 2011, Chapter 142, the New Jersey Department of Health shall establish a voluntary registry of animal rescue organizations and their facilities.

As of November 3, 2016 there were 70 in-state and out-of-state animal rescue organizations voluntarily registered in New Jersey, as listed on the DOH website.

Registration and oversight of animal rescue organizations is sorely needed.

Another positive amendment in S2847 is the ability of shelters or pounds to euthanize an animal surrendered by its owner before the current seven-day waiting period, and the ability to euthanize a stray or an animal surrendered by someone other its owner if a veterinarian determines “that the animal is in extreme pain and cannot recover from the illness or condition that is causing the pain.”

A veterinarian should make this determination for animals surrendered by their owners or other individuals for at least 2 reasons: (1) proper animal ownership can be difficult to determine; and (2) the irreversible decision whether or not to euthanize an owned pet should be decided by a veterinarian, trained and licensed to make such determinations.

As for the requirement to spay or neuter a dog or cat before sale, so long as the animal is merely two months old, for reasons previously discussed, this premature, unnecessary elective surgery at so young an age exposes each animal to short and long-term injury and harm.  Increasingly, scientific evidence proves that the early removal of endocrine glands, such as testes and ovaries, increases the incidence of certain metabolic disorders, including some forms of cancer, and can decrease the lifespan of certain pets.  The decision about when to spay or neuter an individual pet should be determined by the owner in consultation with their veterinarian, after learning about the risks and benefits of such procedures.  Veterinarians are increasingly advising dog owners to wait until at least after the pet’s first reproductive cycle to sterilize their dog.  The requirement remains with each owner to ensure that their pet is not irresponsibly bred until it is spayed or neutered.

Finally, the requirement for shelters and pounds to pay owners up to $250.00 for any pet released before it is spayed or neutered could have a devastating impact on these organizations who are already struggling to compete with animal rescue organizations.

If amended to address these concerns, S2847 could be supportable.

 

The City Law includes mandatory sterilization requirements for 8 week-old puppies and kittens who weigh at least 2 pounds.

The question is not “can the surgery be performed on a 2 pound 8 week old puppy” but rather, based on the totality of the circumstances, can the veterinarian recommend the procedure for a puppy or dog housed before and after surgery in a pet store and obtain informed consent from the animal’s owner.

For the following reasons, as NYPWA experts and NYC veterinarians testified, the answer is no—not without violating the standards of veterinary practice the State requires.

The State considers it unprofessional conduct if a veterinarian fails to obtain informed consent before proceeding with any medical care or surgery, and has disciplined veterinarians who have failed to obtain informed consent.

The State requires each pet store to designate a veterinarian to provide care to pets in the store, and to provide accepted veterinary standards of care to all pets in pet stores both pre- and post-operative.  This cannot be accomplished if a veterinarian performs the mandatory surgery because, no matter the age, there are environmental stressors in a pet store that, when added to the stress of anesthesia and surgery, will harm animals.  This is most serious for puppies whose immune systems are still developing.

The Law prohibits the transfer of ownership until after the pet is sterilized.  Therefore, the pet must return to the pet store after the surgery for post-operative care, which according to veterinarians is substandard care.

“A pet store is not a suitable environment for post-surgical recovery of baby animals.”  “Post-operative care typically provided by pet owners in their home cannot be performed in a pet store.”

Recently scientists have discovered that early gonadectomy is harmful to pets.  “Gonadectomy prior to puberty or sexual maturity may make the risks of some diseases higher in certain breeds and individuals.”

The American Veterinary Medical Association, the Society for Theriogenology and the American College of Theriogenology are opposed to mandatory sterilization laws for privately-owned pets.  Based on scientific evidence, veterinarians and specialists now recommend delaying sterilization until the first heat to prevent the harm from premature removal of endocrine glands needed for proper growth and certain metabolic disorders and cancer.

According to the Association of Shelter Veterinarians, “A veterinarian should make the final decision regarding acceptance of any patient for surgery . . . [t]he surgeon should use discretion regarding minimum and maximum patient age and body weight taking into account the availability of staff expertise and necessary equipment to care for patients.  Owned pets may be best served by scheduling surgery at 4 months of age or older . . . [i]n situations involving animals that will be placed for adoption, neutering is best performed prior to adoption . . . to ensure compliance.”

The interstate pet market is based on sales of puppies between 8-14 weeks of age, the time for optimal socialization with their owners.  The City’s response to professional objections to early sterilization is that the pet stores should hold onto these puppies for a longer period of time.  According to animal behavior experts “[d]elaying sales as the City has suggested traumatizes the animals [and] increases undesirable behavioral traits that are detrimental to successful lifelong pet ownership.”

For all these reasons, the City Law creates an insurmountable obstacle for pet stores and veterinarians to comply with both the State and City Law, and should be considered preempted by State law.

 

Effective client communications is the key to success in many professions, including the practice of veterinary medicine. While serving on the New Jersey State Board of Veterinary Medicine for nearly a decade, I was continuously surprised by the number of complaints filed against veterinarians for what amounted to a failure to adequately communicate with client.  The care provided by the veterinarian usually met or exceeded the required standard of care, so the complaint could have been avoided if the veterinarian had ensured that what they had intended to communicate with the client was the information that was actually received.

Of course, in many cases it is difficult to obtain that goal, particularly when a beloved pet is critically sick or injured.

That is why a recently published study on topic was of interest to me.

Jane R. Shaw, et al. recently published “Outcomes assessment of on-site communication skills education in a companion animal practice” see J. Am. Vet. Med. Assoc. 2016:249:419-432.

The objective of the assessment was

“to evaluate veterinarian-client communication and veterinarian and client satisfaction with veterinary visits before and after veterinarians underwent a 6-month communication skills training program in a practice setting.”

The results as reported were impressive:

“After the intervention, appointments were 5.4 minutes longer and veterinarians asked 60% fewer closed-ended lifestyle-social questions, provided 1.4 times as much biomedically related client education, and used 1.5 and 1.24 times as much facilitative and emotional rapport communication, respectively, compared with before the intervention.”

By altering the quality of the communication, the veterinarians received more medically-relevant information from their clients, and both veterinarians and clients felt that enhanced communications benefited the pet being treated.

Adequate communication between veterinarians and their clients is not only considered a “core clinical skill” by the AVMA Council on Education while evaluating colleges of veterinary medicine for accreditation purposes, it forms the basis of requirements by most States for veterinarians to obtain informed consent from clients before providing veterinary services to their patients.

The AVMA approved a policy on informed consent[1] in 2007.

“Informed consent better protects the public by ensuring that veterinarians provide sufficient information in a manner so that clients may reach appropriate decisions regarding the care of their animals.”

“Veterinarians, to the best of their ability, should inform the client or authorized agent, in a manner that would be understood by a reasonable person, of the diagnostic and treatment options, risk assessment, and prognosis, and should provide the client or authorized agent with an estimate of the charges for veterinary services to be rendered. The client or authorized agent should indicate that the information is understood and consents to the recommended treatment or procedure.”

“Documentation of verbal or written informed consent and the client’s understanding is recommended.”

States, including New York have disciplined veterinarians for failure to obtain informed consent.

 

Also, cases in several states have discussed the requirements for veterinarians to obtain informed consent from their clients.

 

In Lawrence v. Big Creek Veterinary Hosp., L.L.C., No. 6-2737, 2007 WL 2579436 (Ohio App. 11 Dist. Sept. 7, 2007), the court stated that the informed consent doctrine required for other medical professionals “is clearly indicative of the veterinarian’s duty of care.”

 

In Hines v. Alldredge, 783 F.3d 197 (5th Cir. 2015), the court cited Tex. Med. Providers Performing Abortion Servs. v. Lakey, 667 F.3d 570, 584–85 (5th Cir.2012) (Higginbotham, J., concurring) for the conclusion that “[t]he doctor-patient relationship has long been conducted within the constraints of informed consent to the risks of medical procedures, as demanded by the common law, legislation, and professional norms.”

 

In Emes Stable v. University of Pennsylvania, 1988 WL 33893 (E.D.Pa. April 4, 1988) the court discussed the requirement for veterinarian to obtain informed consent from clients which includes informing their clients of the “alternatives that a reasonable man such as the owner would deem significant in making a decision whether to undergo the recommended treatment.”

 

Whether to comply with state veterinary practice acts, or to prevent unwarranted complaints, veterinarians (and their clients) are best served when their communication skills remain a priority in their practice.

 

[1] As of November 2007, the AVMA discontinued use of the term “informed consent” in matters relating to veterinary medicine replacing it with the term “owner consent”.

FDA, gearing up for the implementation of the Veterinary Feed Directive (VFD), recently “issued a letter reminding retail establishments that sell medically important antimicrobials for use in feed or water for food animals that the marketing status of those products will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016.”

As reported in the Daily Herald, those servicing livestock producers in Utah have also been trying to spread the word:

“Local veterinarians, feed suppliers and livestock producers gathered in Lehi on Thursday to learn how the federal feed directive, which goes into effect on Jan. 1, will affect their operations.

The meeting is just one of a series of meetings being held across the state to make sure livestock producers aren’t taken by surprise when the new directive takes effect. It is expected to affect almost everyone who raises animals for human consumption — from 4-Hers to turkey farmers to bee keepers.”

The VFD sets forth “the process for authorizing use of VFD drugs and provides a framework for veterinarians to authorize the use of medically important antimicrobials in feed when needed for specific animal health purposes” as reported by Lydia Zuraw on JUNE 3, 2015 at Food Safety News.

FDA announced that the final rule is:

“an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health.”

Notably, as previously discussed here, the rule memorializes the concept that veterinarian may only prescribe antibiotics to animals “within the context of a veterinarian-client-patient relationship (VCPR), which includes sufficient knowledge of the animal, visits to the farm, and follow-up evaluation or care.”

While many states include that requirement in state veterinary medical practice acts, not all states include a definition of or specifications for the “veterinarian-client-patient relationship.”  (See table of state laws compiled by AVMA).

The VFD will require veterinarians to follow state-defined VCPR requirements as long as the state requirements include the key elements in the final VFD.

FDA requires:

“the veterinarian engage with the client (i.e., animal producer or caretaker) to assume responsibility for making clinical judgments about patient (i.e., animal) health, have sufficient knowledge of the animal by conducting examinations and/or visits to the facility where the animal is managed, and provide for any necessary follow-up evaluation or care.”

However, “where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements.”

FDA issued a draft revised guidance for industry, “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” in July 2016 that “described the type of information that the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends sponsors provide [the agency] to address the human food safety of new animal drugs used in food-producing animals.”

In addition to proving that drugs are safe and efficacious in the targeted livestock species, drug companies (sponsors) face increasing hurdles to prove that “food derived from treated animals is safe for human consumption.”

FDA has already begun implementing other changes to “the way medically important antibiotics have been used in animal agriculture for decades.” See FDA’s Guidance #213.

As reported on its website, FDA explains:

“[o]nce the changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, and animal producers will need to obtain authorization from a licensed veterinarian to use them for prevention, control or treatment of a specifically identified disease.”

Food animal veterinarians and livestock farmers are concerned about their ability to treat animals with antibiotics appropriately when needed. In response,

“[t]he FDA acknowledges the important role medically important antimicrobials play in treating, controlling, and preventing disease in food-producing animals. However, the agency has been actively engaging veterinary organizations, animal producer organizations and other stakeholders to express our position that medically important antibiotics labeled for continuous or undefined durations of use is not consistent with judicious use principles, as outlined in previously-released guidance documents.”

In “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” FDA “provides, in one document, an overview of the overall process for the human food safety evaluation of new animal drugs used in food-producing animals, including:

  • Determining an acceptable daily intake (ADI);
  • Calculating safe concentrations;
  • Assignment of a tolerance;
  • Calculation of a withdrawal period and a milk discard time; and
  • Evaluation of carcinogenic compounds.”

In addition to analyzing the appropriate withdrawal times for meat, milk, and eggs, the agency evaluates the proposed drugs for their potential to create additional pressures on antibiotic resistance in humans.

However, FDA has identified drugs that may not have to undergo this analysis if it (and its metabolites and excipients) are not:

  • “regularly considered to have properties that would exert pressure towards the emergence or selection of bacteria of public health concern;
  • used to treat zoonotic gastroenteritis or other bacterial diseases in humans;
  • under development to treat bacterial diseases in humans; or
  • indicated for a bacterial disease in food-producing animals (i.e., indication is instead antifungal, antiprotozoal, anthelminthic, etc.).”

With the emergence of new methods of disease treatment and  prevention (using, for example, genetically immune livestock) hopefully veterinarians and farmers will not have to rely on antibiotics to treat animals and keep them healthy, since it will be increasingly difficult to obtain and retain the ability to use these drugs in livestock.

Attorney Talk - Veterinary Law with Nancy Halpern

I’m pleased to have been able to participate in Attorney Talk, a podcast centered on casual conversations about the law. Hosted by Kenneth W. Thayer, a partner at Gaylord Popp, LLC, each episode features discussions with individual lawyers about themselves, their practices, and what they love about the law and legal profession.

I invite you to visit the episode page on the Attorney Talk website to hear my wide-ranging interview. You can also visit the show’s iTunes page to listen to full episodes, subscribe and provide a rating (5 stars, of course.)

Thanks to Ken for the wonderful conversation!