HIWU's Scollay: New Medication Rules 'Your New Bible'

Despite all the legal jockeying these past few weeks and months, the Horseracing Integrity and Safety Act's (HISA) anti-doping and medication control program still appears set for launch on Jan. 1 in the vast majority of states that conduct pari-mutuel wagering.

This means on the first day of 2023, thousands of trainers, veterinarians and other backstretch workers must grapple with a new set of rules guiding how and when to administer a set of everyday medications–the list of which can be found here–to avoid falling foul of a post-race and out-of-competition positive.

Is there much of a difference between the Association of Racing Commissioners International (ACRI)'s current therapeutic medication schedule and that as outlined by the Horseracing Integrity and Welfare Unit (HIWU)?

Turns out there is–one that, in short, boils down to the differences between the current world of withdrawal guidelines and thresholds, and the looming system of detection times and screening limits.

“There is a substantial difference and if the terms are used interchangeably, there is a profound risk of a medication violation,” warned Mary Scollay, chief of science at HIWU, established by Drug Free Sport International.

Some of the key points as Jan. 1 looms large:

• Detection times do not necessarily provide an accurate medication withdrawal guide;

• New screening limits will require different administration protocols;

• There will be no enforcement “grace period” for stakeholders to adjust.

• This different medication schedule will require adjustments well before Jan. 1;

Withdrawal Guidelines vs. Detection Times

Traditionally, withdrawal guidelines are based on administration studies with a “statistically derived margin of safety built in,” said Scollay.

“The idea is that if you follow the administration protocol described in the study–dose, route of administration–and you comply with the withdrawal guidance,” said Scollay, “you should have a high degree of confidence that you will not have a medication violation.”

In other words, withdrawal guidelines provide a reliable cut-off point to administer a medication to avoid post-race positives.

This is in contrast to detection times under HISA, calculated through studies on a group of horses administered a certain medication.

These horses are then tested to determine the earliest time the drug is eliminated from all the horses' systems–a level below either the lowest concentration identified by the laboratory or below a defined screening limit.

This means that detection times “do not have any margin of safety calculated in,” warned Scollay. “It is the starting point for determining a withdrawal interval. So, the burden for establishing an appropriate withdrawal interval for medication now lies exclusively with the horses' connections.”

In any of these given studies, for example, the horses may metabolize drugs at different speeds–and potentially quicker than a racehorse given the same drug at the same dose.

Studies with a very small cohort of horses–like hydroxyzine, with a detection time of 96 hours from a study with only two horses–provide another reason why detection times can provide a very thin margin of error.

Imagine a study testing a doorframe set at six feet, explained one regulatory veterinarian. If the study participants are all under six foot, no problem. But what about all the six-foot plus individuals not studied?

For practicing veterinarians accustomed to concrete withdrawal times, therefore, this constitutes a sea-change in the way medications can be safely prescribed and administered to avoid costly post-race positives.

“There's no easy answer to this,” admitted Scollay. “I fully understand what a philosophical change this is, and yes, I understand that the vets can feel like they're flying blind right now.”

Aim of Schedule

Aside from a select few substances–like electrolytes, orally administered vitamins and anti-ulcer medications which can be administered up to 24-hours before a race–there is a mandatory 48-hour restricted administration time for all controlled medications.

For a number of these routine controlled medications, the dosage, withdrawal time and stipulated threshold in the current ARCI schedule are the same as the dosage, detection time and screening limits outlined by HIWU.

But where these differ, the differences might be subtle, easily over-looked. The ARCI's phenylbutazone threshold is 0.3 micrograms per millimeter, but is 0.2 micrograms per millimeter under HISA, for example–a small change with significant implications when it comes to its use in the days prior to a race. What's more, Scollay is unable to provide veterinarians and horsemen with specific withdrawal numbers. “HIWU and HISA are not in a position to provide withdrawal guidance,” she said. “I cannot say, 'I think you're going to be fine if you back out to 82 hours.'”

Things can get even trickier when HIWU provides zero dosage, detection time and screening limit guidance on a drug listed on the controlled medication list. But that doesn't necessarily mean veterinarians and trainers are indeed “flying blind.”

The corticosteroid betamethasone has no dosage or detection time listed, but it comes with a Restricted Administration Time (RAT) to race of 14 days (7 days for a work).

The Non-steroidal anti-inflammatory drug (NSAID) diclofenac–commonly found in a topical ointment to treat swelling and inflammation–similarly has no listed dosage and detection time.

As Scollay explains, that's because the process of calculating elimination times in an ointment–and therefore, one routinely applied in wildly different amounts to different parts of the body–is extremely difficult.

But this underscores, she said, the overarching aim of the new medication schedule–to foster a more conservative approach to veterinary medicine.

If diclofenac is used to treat a problematic joint, said Scollay, “from my perspective, once you've got that joint quieted down, I think you'd still want to assess that horse's response to treatment and assess the horse's recovery by breezing him.

“And so, you're not talking about ceasing treatment on a specific joint that has been inflamed and problematic going into a race in three days.”

In other words, if a topical diclofenac ointment is being used to treat certain musculoskeletal problems, then racing probably shouldn't be on the horse's imminent agenda, said Scollay.

Clearance Testing

More broadly, there's a very rough rule-of-thumb when it comes to calculating withdrawal times. One is that a short detection time is typically indicative of fast elimination from the system, said Scollay.

“But if something takes 96 hours to clear, I would be more conservative because I know it clears slowly,” said Scollay, speculating that “if I add just 24 hours onto that, I may not have allowed enough time for it to clear.”

But perhaps the most accurate guide for veterinarians and trainers concerned about a positive test, said Scollay, would be to conduct “clearance testing” well before race-day–a service provided through HIWU.

“We'll collect the sample from the horse, and then send it to the laboratory that's doing the testing. The trainer would have to provide information about the treatment, the drug, the dose, the frequency–when it was halted,” said Scollay.

It's not a free service, however.

“I don't know what that fee is yet,” Scollay added. “That would be paid for by the horse's connections.”

Importantly, the new controlled medication rules are primarily germane to post-race testing, not HISA's out-of-competition testing program, which is largely focused on banned substances.

That said, the new rules prohibit the presence of more than one NSAID or corticosteroid in both post-race and post-work samples–a prohibition designed to nix the practice of “stacking.”

HIWU's new common controlled medication list provides secondary detection times for three common NSAIDS, to help avoid a stacking offense.

Enforcement

Though the new drug rules might prove a marked change from the current status-quo, don't expect an enforcement grace period for stakeholders to acclimatize to their new regulatory expectations.

“The regulations don't provide for it,” said Scollay, categorically.

So, what are some of the implications for a positive of a controlled substance? An outline of the sanctions can be found here.

The majority of post-race positives are for everyday therapeutic medications–like phenylbutazone, a class C controlled drug, a first time positive for which would result in a fine of up to $500 and the automatic disqualification of the horse.

Which leads to another question: Who will be held responsible in the event of a positive?

The ultimate-insurer rule places the burden of responsibility on the shoulders of the trainer. But in the language of the law, there appears to be room for the veterinarian (and perhaps others) to be similarly held culpable.

As Scollay describes it, such a scenario would be case-specific. “The facts of the case would have to determine who else might be complicit,” she said. “To be fair, if it's an overage of a medication one would say, 'well, the vet didn't administer that without the trainer's knowledge and consent.'”

And so, when should veterinarians, trainers and others start applying these new controlled medication rules?

Given the 14-day stand down on all intra-articular injections–along with a 15-day detection time for the NSAID firocoxib–Scollay recommends familiarization with, and application of, the new rules as soon as possible, to avoid regulatory consequences come Jan. 1.

In other words, if trainers and veterinarians are deciding on withdrawal decisions after a horse is entered to race after Jan. 1, “they've waited too long,” said Scollay.

“I think more important is for veterinarians and trainers to review the document together and develop a shared approach to interpreting detection times,” she said. “And there is no time like the present for that.”

Education

Between now and Jan. 1, HIWU will apparently be releasing educational materials aimed towards regulatory and practicing veterinarians, and the trainers themselves.

Another intended event, said Scollay, is a webinar with a noted European veterinarian to explain how detection times and screening limits translate in Europe, where they've been in effect for much longer. Scollay was unable to provide details about then that might be, however.

The Racing Medication and Testing Consortium (RMTC) can act as an information intermediary, said Scollay, who added that industry stakeholders can contact her directly with any drug-related questions.

She also recommends printing off HIWU's controlled medication list—once again linked to here–before laminating and pinning it to the barn wall.

“I've been using the 'L' word every chance I can get. Laminate it, put it on your clipboard. Give them to your staff. That's your new bible,” Scollay said.

“There's no easy answer to this other than be more conservative and be more cautious of medication than you have been,” she said. “And ask yourself, 'does this horse really need it?'”