Sept 1, 2000 - Dr. John Lengel, the Administrator of the Drugs and Medications Program, answers questions about recently adopted amendments to the Drugs and Medications Rule in the following interview. The AHSA issued a news release dated August 30, 2000 about these two rule changes. The news release has prompted many questions from AHSA members. News releases are by their nature brief and to the point. It is clear that more background information regarding the rule changes would be helpful.

Q: When were these amendments first proposed and by whom?
A: The Drugs and Medications Committee proposed them after its July 10, 2000 meeting, however, they resulted from research, discussions, and dialogue that began more than 20 years ago and which has been pretty intense in recent years.

Q: What has happened in recent years?
A: In mid 1997 the Veterinary Committee expressed its concerns about the overuse of NSAIDs (nonsteroidal anti-inflammatory drugs) in connection with horses competing at AHSA recognized shows and events. In late 1997 the Drugs and Medications Committee conducted several administration studies, and based upon them proposed a set of rule changes to address this issue. These rule change proposals were controversial and became the focus of discussions at the Annual Meeting held in Hilton Head, South Carolina in January 1998. The only change to the NSAID rule that was adopted that year was the prohibition of using more than two NSAIDs simultaneously, effective June 1, 1998. The vote on all other proposals to restrict or forbid NSAIDs was postponed to the next Annual Meeting. At the 1999 Annual Meeting held in St. Louis, Missouri the current NSAID rule was adopted with little controversy, effective April 1, 1999. Since then the only changes, which have been relatively minor, have been attempts to clarify or fine-tune the existing rule.

Q: What needed to be fine-tuned?
A: Two main issues arose as a result of all the dialogue that took place about the NSAID rule in recent years. One was whether the dose and time recommendations that help trainers achieve compliance with the quantitative restrictions of the rule could be made more flexible and therefore easier to live with. In other words, does the recommended daily dose have to be administered at a particular time prior to competition, or would it be possible to decrease the recommended dose while shortening or eliminating the requirement to withdraw the horse prior to competition? This had been done with Bute (phenylbutazone) following the Hilton Head Annual Meeting.

Q: What was the other issue?
A: It was the requirement to file a medication report in connection with the use of two NSAIDs. There were a lot of questions about when and how, which were unsuccessfully addressed by minor amendments to the rule in July 1999 and January 2000. The main question was, why was it necessary to file the form in the first place? The Drugs and Medications Committee and the Veterinary Committee had thought a lot of useful information regarding the practical use of NSAIDs could be gleaned from the medication report forms. In the end, this proved not to be the case.

Q: So what happened next?
A: To address the first issue, the AHSA conducted administration studies involving Arquel (meclofenamic acid) and naproxen, to determine whether the dose and time recommendations could be made more flexible, without causing excessive analgesia, and without interfering with the detection of other substances in the samples. The Drugs and Medications Committee had decided to undertake these studies at its January 2000 meeting held in Las Vegas. The studies were conducted this past spring, and the results of the studies were discussed at the Drugs and Medications Committee's meeting of July 10, 2000.

Q: What did the studies show?
A: Several things. First, they showed that making the dose and time recommendations for naproxen more flexible caused significant "masking" problems in the laboratory. In other words, the resulting plasma concentrations interfered with the detection of other drugs in the samples. This precluded any changes in connection with naproxen.

Q: What about Arquel?
A: The opposite was true. If the recommended daily dose was divided, and half administered each 12 hours, there resulted neither masking properties nor excessive analgesia. All that had to be done to eliminate the recommendation to refrain from competition for a certain number of hours, given the divided dose, was to increase the maximum permitted plasma concentration from 1.0 to 2.5 micrograms per ml, a relatively insignificant change.

Q: So this is what the Drugs and Medications Committee proposed?
A: Yes.

Q: What happened to address the second issue, the requirement to file a medication report in connection with the use of two NSAIDs?
A: Prior to its July 10th meeting the Drugs and Medications Committee undertook a study of the medication reports filed since April 1, 1999, the date the NSAID rule became effective. A review of more than 1,400 NSAID medication reports showed several things. First, many if not most were either incomplete or improperly completed. Second and more importantly, there was little information about the practical use of NSAIDs to be gleaned from them. As a result, at its July 10th meeting the Committee realized it either had to enforce this rule more strictly or eliminate it. Since little practical information was being gleaned, it opted for the latter.

Q: In other words, the Committee proposed to eliminate the requirement to file a medication report in connection with the use of two NSAIDs?
A: Yes.

Q: When these two proposals were forwarded for consideration, what was the proposed effective date?
A: The Drugs and Medications Committee wanted to see them adopted as soon as possible.

Q: Why?
A: In a general sense, each of the proposals more easily facilitates the treatment of illness or injury in horses, thereby protecting their health and well-being. In a specific sense, each makes it easier for trainers to comply with the rules. Also, the Committee was no doubt aware that these changes would be welcomed by many.

Q: Why would others not welcome them?
A: On the two ends of the spectrum are those who believe the AHSA Drugs and Medications Rule is either too conservative or too liberal. The majority of those who compete under it believe that it strikes an appropriate balance between protecting the fairness of competition and protecting the health and well-being of the equine athlete, by accommodating the legitimate treatment of illness and injury. It would be impossible to adopt a rule that makes everyone happy. The Committee's goal is to maintain the proper balance.

Q: So what happened next?
A: Prior to the August 7, 2000, meeting of the Executive Committee, the Officers reviewed the proposals to determine whether they met the requirements for being deemed matters of extraordinary circumstance. The Officers determined that they did, for the reasons stated above. This authorized and enabled the Executive Committee to consider and vote upon them at its August 7th meeting, which it did, and adopted them.

Q: Why wasn't the vote postponed to the Annual Meeting in January 2001?
A: The Drugs and Medications Committee saw no reason for such a delay. It would have meant that these changes, which facilitate the easier treatment of illness and injury and make the Drugs and Medications Rule more user friendly, would have to be delayed at least six months. The Officers and the Executive Committee concurred with the Drugs and Medications Committee. Neither of these changes was perceived as potentially controversial.

Q: Doesn't the Drugs and Medications Committee think it's better for AHSA members to express their opinions before adopting new rules?
A: Of course it does. Opinions about these two issues have been expressed to the Drugs and Medications Committee many times in recent years, in particular at the Annual Meetings at which the NSAID rule has been discussed. These very discussions were what prompted the studies that led to these changes. The Drugs and Medications Committee has been studying these issues for years and it has a long memory of the opinions that have been expressed.

Q: So what, pertaining the Drugs and Medications Rule, will AHSA members have a chance to discuss and vote upon in January?
A: There are a number of amendments to the Drugs and Medications Rule that have been proposed by the National Hunter/Jumper Council, pertaining to six important aspects of the rule. The Drugs and Medications Committee will publish a two-part report about them in the September and October 2000 issues of Horse Show Magazine. These proposals will be discussed and voted upon by the members who attend the Annual Meeting in Colorado Springs.

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