CHRB Emergency Rule on Compounded Drugs Geared to Shield Veterinarians

In an attempt to help shield California's backstretch veterinary community from possible further punitive actions by the Veterinary Medical Board (VMB), the California Horse Racing Board (CHRB) has issued proposed emergency regulations designed to clear up discord between these two agencies about the correct use of compounded medications across California's backstretches.

The Food and Drug Administration (FDA) defines the compounding of drugs as “the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more FDA-approved drugs.”

The tranquilizer acepromazine is a prime example of this process, routinely compounded into liquid form to be prescribed and used on fractious dogs and horses. Other commonly used compounded medications across America's backstretches include dantrolene, used on horses that tie-up, and naquasone, for swelling.

Compounded drugs are not FDA-approved, but they are widely used in veterinary medicine provided the compounding process is done according to federal and state guidelines–a dynamic the CHRB has mirrored as a practical regulatory approach for many years, despite the existence of a state statute that essentially forbids drug compounding on CHRB licensed premises.

CHRB's Rule 1867 (b) states that “the possession and/or use on the premises of a facility under the jurisdiction of the Board of any drug, substance or medication that has not been approved by the United States Food and Drug Administration (FDA) for use in the United States.”

The California VMB interprets that rule categorically. Of the roughly 25 backstretch veterinarians currently working in Southern California, nearly all have accusations, are on probation or have record requests pending from the VMB in relation to potential Rule 1867 violations, according to the CHRB.

Last September, the CHRB issued an advisory to its relevant stakeholders stating that the agency's “longstanding interpretation” of rule 1867 “is that lawfully prescribed, compounded medications which are manufactured according to Federal and State guidelines do not violate this regulation.”

But CHRB equine medical director Jeff Blea said that the current Rule 1867 language “falls short of the intention of the rule.” It has been modified “to allow for quality standard care of racehorses by the use of compounded medications provided they are legally manufactured and prescribed in conjunction with a [veterinary client patient relationship].”

The proposed emergency rule making–one along a truncated timeline–appears geared to help shield veterinarians with pending cases by the VMB against them from a potential regulatory trap if they settle with the VMB and return to work under probation: should they then prescribe and administer compounded medications under the current Rule 1867 language, they could face stark professional consequences.

CHRB executive director Scott Chaney explained that the “sole purpose” of the proposed emergency rule making “is to clarify the language both for the vet' med' board but also for the practitioners.”

When asked if Rule 1867 (b)–adopted more than 20 years ago–should have been modified before to avoid the present professional threat that backstretch veterinarians currently face, Chaney pointed to how the CHRB has never cited a veterinarian for a Rule 1867 (b) violation, and that the board wasn't aware of the VMB filing accusations related to the same rule prior to 2020.

“Looking at it today, the easy answer is yes,” said Chaney. “But I think given it's our regulation and we were always purposeful and public about how we interpreted it, there was no reason.”

The proposed new rules modify Rule 1867 with provisions meaning that “possession or use of any compounded drug, substance, or medication, manufactured according to Federal and State laws and regulations, shall not be considered a prohibited veterinary practice” as long as no other human or animal drugs approved by the FDA to do the same job exist and are available, and that the drug is compounded by a California licensed veterinarian or California licensed pharmacy.

The proposed regulations do not differ substantially from any existing comparable federal regulations or statutes, according to the CHRB.

The CHRB has already noticed the proposed emergency regulations, giving interested parties a five-day public comment period. On Feb. 2, the board will submit them to the Office of Administrative Law (OAL). That office then has 10 days to accept or deny the proposed rules.

If the OAL indeed adopts the proposed emergency regulations in this truncated manner, the CHRB has 180 days to formally adopt the rules though its typical rule-making process. If the OAL denies the proposed rules, the CHRB can still adopt them through that normal rule-making process, but they won't go into effect until formally finalized.

The VMB, said Chaney, was involved in the drafting of the proposed regulations.

“We sent them the language we were thinking about, they made some suggestions. We incorporated a few of them but not all,” explained Chaney. “I know they discussed at their last meeting actually commenting, when they had the opportunity, on our regulation.”

The TDN emailed the VMB a series of questions, including whether the agency endorsed the proposed rules, and whether it would urge the OAL to accept or deny it. The VMB has not responded as of publication.

This action is the latest in a regulatory standoff between the CHRB and the VMB, ongoing since the VMB took the unprecedented step of suspending the license of equine medical director Blea at the end of 2021, only to reinstate his license the following September after finding him guilty of only fairly minor record-keeping offenses.

The VMB has complaints currently open against a number of Southern California veterinarians citing them for various alleged offenses beyond Rule 1867 violations, including the alleged misuse of misbranded drugs and of record-keeping offenses.

“This is the only CHRB regulation that the vet' med' board was using in its accusations,” said Chaney, when asked if the CHRB was planning on issuing other similar proposed emergency regulations.

“There are other causes of action, this just eliminated one of them,” he added. “The others the CHRB can't address, like problems with the Veterinary Medicine Practice Act and prosecutorial philosophy.”

The post CHRB Emergency Rule on Compounded Drugs Geared to Shield Veterinarians appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

Source of original post

Travelogue: Southeast Asia, Day 2

Editor's note: Jockey and veterinarian Ferrin Peterson is traveling in Southeast Asia to help refugee groups with the veterinary care their animals need, helping humans to survive the refugee crisis in a war-torn area. Click here to read yesterday's blog post.

Once we reach the village, we set up camp which means successfully tying up your hammock between two sturdy trees to sleep in overnight. We bathe and wash our clothes in the river, and the pack animal team roams freely like a herd of wild horses. They always return at feed time, of course. The villagers cook for us, which consists of a rice dish with meat from one of their village animals and a vegetable. My past two trips were during my Christmas breaks from school, and on Christmas Day the villagers offered us their delicacy: cooked chicken feet. Thankfully there were always enough people around that I could nonchalantly pass that dish on to the next person.

I have an exciting, yet testing journey ahead of me. Veterinary medicine is challenging enough, working with patients who do not speak and amongst species that are so different from one another. A sedative that can relax one species can cause euphoria in another species. Each species has their unique Achilles heel: it is not always their feet and gut.

The pack team currently consists of seven mules and nine Mongolian ponies. I plan to vaccinate the pack animal team against rabies and Japanese encephalitis. I attempted this on my last trip, but when we reached our destination and I retrieved the vaccines from the transport cooler, I saw they had frozen, which ruined their efficacy. That was disheartening after packing them all that way and wondering when the next opportunity would arise for someone to vaccinate the herd. Hopefully I improve with temperature regulation this go-around.

Some of the training sessions I have planned for the pack animal handlers include: basic observations of a healthy versus a sick animal, checking vital parameters, body condition scoring, hoof care, wound care and bandaging, medication routes, nasogastric intubation for choke, and fecal flotation to detect parasites (the medical facility is equipped with a microscope).

Another important aspect I wish to address is selecting for their pack team. One or two of the village leaders travel to the city to select the Mongolian ponies and mules. In the past, they had introduced a gray mare with very poor conformation who could not stand up to the demands of her new job, and as a result she slowed down the entire team. They told me that in the city there is a Monkhood ceremony where the young monk rides in on a “white” horse. When the village leader saw this gray mare for sale, he assumed she must be a good deal. I just spent weeks looking at top Thoroughbreds going through the sales ring in Kentucky. I will have to readjust my lens for the type of horses best equipped to trek through mountains and thrive in jungles.

I also plan to teach the villagers to pass an orogastric tube down a water buffalo's esophagus and into its stomach to relieve bloat. I taught a village this technique on a past trip despite only learning it from a YouTube video. The entire village came to watch me do this crazy “magic trick.” To my relief, I successfully passed it into the rumen and then watched several villagers do it, too!

I have learned to go in with a plan but to be adaptable and always ready to rise to the occasion. I believe it is important to give back and share the knowledge a person has acquired, but to never underestimate the importance of local understanding about someone's culture and environment. Most importantly, I am going in with an open mind to see how the villagers and I can learn from and help each other.

The post Travelogue: Southeast Asia, Day 2 appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

Source of original post

InCompass Launches EquiTAPS

InCompass Solutions has launched EquiTAPS, a free service that enables users to submit veterinary treatment and procedure records to racing authorities for horses in their care and to give authorized parties in other jurisdictions access to those records.

EquiTAPS satisfies reporting requirements as set forth by the Horseracing Integrity and Safety Authority (HISA) and will accept records submitted by covered persons as defined by HISA, including trainers and veterinarians. When required by HISA's regulations, treatment and procedure information entered into EquiTAPS will be automatically forwarded to HISA.

“We are excited to offer EquiTAPS, which will assist horsemen and veterinarians of all racing breeds to keep track of horses in their care while working in compliance with HISA, which has jurisdiction over Thoroughbreds,” said Chris Dobbins, senior vice president of InCompass. “We believe this service provides a bridge between horsemen, racetracks, and HISA for the welfare of the racehorse.”

The post InCompass Launches EquiTAPS appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

Source of original post

Honoring 50 Years of Vigilance Against Equine Disease

It must have become rather irritating for virologists, over the past couple of years, to hear so many of us appointing ourselves overnight experts on the best ways to tackle a pandemic. But that was a familiar enough experience for Dr. Peter Timoney, thinking back 20 years to the harrowing time when the Bluegrass was gripped by panic over Mare Reproductive Loss Syndrome (MRLS).

At the very time when his skills were most precious, as a world authority on equine virology based right there at the University of Kentucky, so his toil became most literally thankless.

“Oh yes, you feel like you're in the stocks,” he recalls. “And of course the expectation is that you should have had 20-20 hindsight. 'Why didn't you do this, why didn't you do that?' It all became very fast and furious, human nature being what it is…”

He permits himself one of the wry chuckles seldom far away in conversation with this immaculate figure, dapper and courteous, whose true standing in our community can be more accurately judged by the Lifetime Contribution Award he has just received from the Kentucky Thoroughbred Association/Kentucky Thoroughbred Owners and Breeders. As their citation declared: “There is no one more respected or admired on the topic of infectious diseases, either locally or internationally, than Dr. Peter J. Timoney, MVB, MS, PhD, FRCVS, professor and Frederick Van Lennep Chair at the Gluck Equine Research Center.”

But the alphabet soup and formal distinctions, which could be infinitely extended, feel almost incidental to the still greater status implied by the first half of that sentence—nourished, as it is, by a tireless spirit of inquiry and service. In the words of one of Kentucky's leading farm managers, Timoney is “on speed-dial for any equine laboratory in the world where they stumble across something that makes them uneasy.”
While grateful that his community had sought to ease the wrench of retirement, Timoney reflects on his award with resolute modesty.

“It was very thoughtful of them and I was deeply honored in that I didn't deserve it, frankly,” he says. “Not that I haven't been involved in the industry, on both sides of the Atlantic, for a very significant number of years. In fact, it's 50 years since I became species-specialized. But for me there was no greater pleasure or distinction to the day than the presence of Mr. Bassett.”

A significant span even of Ted Bassett's years measures their friendship. They recently shared a meal in the Keeneland track kitchen. John Williams was sitting on the adjacent table and the next thing Timoney knew the pair had broken into song. “Oh, it was choice!” he exclaims—an expression that quaintly captures the Irish lilt, light and precise, he retains after all these years.

And suddenly, no less typically, you realize that we're no longer talking about the latest of Timoney's many awards.

It turns out that he prefers to discuss his own limitations, and those of his field. These latter, of course, diminish all the time–which goes a long way to explaining Timoney's reluctance to take things easier now. But like a general who learns to read the mind of his opponent, through a long siege, he will never lose his awe for the way Nature, in her most aggressive garb, is always one step ahead.

“How many viruses have we truly eradicated?” he asks. “Two, smallpox and rinderpest. That's it. It would be counter-productive for a virus to eliminate the host species it infects. You take African Horse Sickness. In Equus caballus, the domesticated horse, certain forms of the disease can kill 90 to 95 percent of infected individuals within a week of exposure. What about mules? Yes, they become sick but the mortality rate is less, maybe 50%. As for donkeys, it depends on the type under discussion: in European donkeys, the virus can kill 40 to 50%. But this doesn't occur in the case of African donkeys that survive the infection. They've been around for a considerable period of time. Given time, agents and their hosts learn to adapt.

“Nature is amazing. Take bats, the single largest class of Mammalia: an estimated 6,000 different species. Sources of rabies, SARS-1, SARS-CoV-2 viruses: none of which clinically affect them. But by golly, look what they're capable of causing in humans.”

Timoney will always cherish insights obtained as a graduate student in the 1960s, when privileged to sit in on meetings between then prominent pioneers in arbovirology (i.e. studying arthopod vectors like mosquitoes). “Endowed by instinct and very strong observational skills, they had worked out how certain viruses spread to humans and persisted in nature,” he says. “A forerunner to what was subsequently expanded upon in the era of molecular diagnostics. I'll never forgetting listening to Karl Johnson describing what he had discovered in relation to Bolivian hemorrhagic fever, caused by Machupo virus which can give rise to fatal infections in humans. At the time there was no idea how people became exposed to the virus. He investigated a range of species of rodents and found that one, a small mouse, Calomys callosus, was susceptible to the virus and became persistently infected with it–but that the virus didn't kill it. The virus localised in the kidneys and was shed in the urine. Individuals unfortunate to come in contact with contaminated food or any fomite [material carrying infection] ran the risk of being exposed to the virus and many developed the disease.”

One of Timoney's early mentors was “one of the true virus hunters”, a Texan who had spent many years working in Africa and South America and identified a number of arboviruses; and had previously worked under Dr. Kenneth Smithburn, who discovered West Nile virus in Uganda in 1937. Timoney embraces that sense of the baton being passed, from one generation to the next; the perseverance and accretion of science. In that vein, he urges graduate students today to go back and see how remarkable was some of the deductive work published in 19th Century medical journals, when laboratory diagnostics was still in its infancy.

“Some of those papers are tremendous introductions,” he says. “I think our powers of observation and reasoning are not perhaps as finely tuned as they were in early investigators. We're spoilt today by the wealth of advanced diagnostics available to us.”

Now that technology has made deep sequencing far more affordable and rapid than even five years ago, it is possible to identify additional agents that have never been recognised or that used to be described as “orphans” because they couldn't be linked to a specific disease.
Such efficiencies are critical whenever science finds itself in a race against the clock to trace the cause of new disease. It's hard to imagine the sinking feeling that Timoney must have experienced when MRLS hit. While hindsight, as he has already remarked, is all very well, he reflects wistfully on the time, a couple of decades previously, when one of the biggest breeding farms in Kentucky sent expelled foetuses for analysis that could well have represented cases of MRLS.

“A species of streptococcus was being isolated that we felt at the time wasn't the cause of the problem,” he recalls. “But what we didn't know was there was a background surge that year in the population of tent caterpillars. In 2001, the latter were everywhere, they were to be found in the suburbs of Lexington. One couldn't walk outside without scrunching them underfoot. The horses were ingesting them in the course of grazing, and the setae on the integument of the caterpillars were piercing the wall of the small intestine. Bacteria from the alimentary tract were carried via the bloodstream to the pregnant uterus. It was terrible, upwards of a third of all pregnancies being lost that breeding season. A terrible consequence for the industry to bear.”

By the following year, farms were adapting. They cut down cherry trees, and either kept mares indoors or muzzled them at pasture. Timoney's vocation certainly calls for a thick skin. He remembers, as a young vet in rural England seconded to the British Ministry of Agriculture to assist in an outbreak of foot and mouth disease in the late 1960s, how the associated depression in some instances led farmers to take their own lives.

“The first cases I saw of this dreaded disease involved the No. 3 Ayrshire herd in England,'” Timoney recalls. “And all I could do was share in the misery and grief of the farmers affected. The images of the resulting desolation never leave you.”

Timoney had actually been drawn into the horse world in the slipstream of another crisis. He was still working with cattle and sheep diseases when a number of prominent Thoroughbred studs in the south of Ireland were struck by the neurologic form of Equine Herpesvirus 1 in 1972. That prompted the Department of Agriculture to re-assign him to head up a new equine diseases section at the Central Veterinary Research Laboratory.

After an extensive training period in the U.S. and Canada, he established and headed up the new section for six years until in 1979 accepting an associate professorship in virology at Cornell, where he supervised a high volume multi-species diagnostic service. After a couple of years or so, he returned to Ireland to assist in planning and developing an Irish Equine Centre before in 1983 taking a full-time research position in the University of Kentucky Department of Veterinary Science. He served as department chair from 1989 to 2008, and director of the Maxwell H. Gluck Equine Research Center from 1989 to 2006.

Those years encompassed immense changes in racing and breeding, above all in the frequency and range of international horse travel. The challenge today is to facilitate that movement while mitigating the risk of disease transfer to an acceptable level. Timoney is confident that it's possible to achieve this goal using the High Health, High Performance framework and, when indicated, the Equine Disease-Free Zone concept.

“While I'm a very strong proponent of the facilitation of international horse movement, my greatest worry is the risk of introducing a disease into the U.S. that might have catastrophic repercussions,” he says. “At the end of the day, containment of risk is dependent on the actions, or lack thereof, of human beings. The greatest consequences for the equine industry in the U.S. would be if either African horse sickness or Venezuelan equine encephalitis were introduced or re-introduced into the country. Were even one case to occur, it would result in a trade embargo on all horse exports for a minimum of two years. We all know what this industry is worth, not least as one of the few labor-intensive ones that remain. Sometimes one has to err on the side of conservatism. What's at stake is too great.”

First and foremost, Timoney remains animated by a deep respect for the species that has captivated him for decades. After all, there is no more privileged insight into the inner spirit of the Thoroughbred than the relationship of physician and patient. While he has a pragmatic wariness of their unpredictability on occasion, having taken the odd kick in his time, he marvels at their beauty, spirit and performance potential. “The intensely competitive spirit they can have is unequalled among domestic species,” he says. “Horses are such noble creatures. It's easy to see how over millennia, the horse has been the subject of magnificent masterpieces of art and sculpture.”

That this mystique has drawn five decades of diligence and inspiration from Dr. Peter J. Timoney is a profound benediction to our community, though typically he sees it the other way round. “I feel very fortunate,” he stresses. “Both to have been given the opportunity to work in the field I found myself in for the past 50 years, and with an animal species that is a continuing source of wonderment, and an industry that has been so supportive over the years.”

The post Honoring 50 Years of Vigilance Against Equine Disease appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

Source of original post

Verified by MonsterInsights