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Clearing Up Equine Medication Confusion:

ArticleClearing Up Equine Medication Confusion: | Midwest Veterinary Supply

Clearing Up Equine Medication Confusion:

An Interview with Attorney Denise C. Farris

Q: Please introduce yourself and explain your background with compounded drugs.

A: Sure. My name is Denise Farris and I'm the Managing Member of the Farris Law Firm LLC in Kansas City. As an equine/agriculture law attorney, I was asked back in 2006 to write an article for Equine Veterinary Management magazine on new AAEP guidelines governing authorized and illegal use of compounded products. That in turn led to over seven years of reviewing and analyzing case law, federal regulations and public education articles and lectures on the "do's and don'ts" of compounding.


Q: What is compounding?

A: In its simplest context, "compounding" refers to any manipulation of a drug which changes its intended form, delivery, dosage, or end use or patient. In the human context, an example might be making a pill into a liquid for a child. In the animal industry, compounded products are much more prevalent and are frequently used without an animal owner or trainer even being aware that the product they are getting is not an FDA-approved/analyzed drug, or of any issues that may create. Many times, an animal owner, trainer, or even a veterinarian will refer to compounded products as "generics"; however, these products have not undergone the scrutiny that true "generics" have to go through.


Q: What would be an example of a compounded product in animals?

A: There are two primary categories; unapproved drugs and off-label drugs. "Unapproved drugs" refers to pharmaceutical creation of a specific treatment for a specific animal where no other FDA approved product exists. These unapproved drugs are not FDA reviewed or tested in any manner for potency, shelf life, efficacy, consistency, and adverse effects. Manufacturing processes are not subject to FDA oversight for sterility or adherence to Good Manufacturing Practices. An example of an unapproved drug for animals is "methimazole" to treat hyperthyroidism in cats. While available as an FDA approved product for humans, there is no FDA approved equivalent for animal use but the compounded product is the only product available to treat this condition.

In contrast, "off label" refers to compounding which starts with an FDA approved drug modified for its end use in manners not contemplated by the original manufacturers, and not FDA tested or approved. An example would be modifying a feline pill from tablet to liquid by dissolving in tuna juice so your cat will take the medication. While this may be the only alternative for a finicky cat, what could be unknown is if the change of the form, from pill to liquid, may have potential repercussions in how the drug is metabolized by your cat. Again, compounded products are not "generic" versions of approved drugs. They have not undergone the same type of testing that FDA-approved versions have.


Q: Can you give me an example of potential concerns with compounded products?

A: Sure. Most of you will remember the twenty one polo ponies that died in Florida several years ago? That resulted from a non-regulated, compounded batch of supplements given to the horses immediately before their death. The product batch miscalculated the amount of a potentially toxic ingredient, selenium, which was included in an amount proving toxic to the horses. In the human context, a recent example was the outbreak of fungal meningitis linked to contaminated MPA steroid injections formulated by a compounding pharmacy. Unfortunately this resulted in a number of highly publicized human deaths. Both incidents led to a vigorous dialogue on pros and cons of compounding and efforts to achieve more balance in public education, and statutory review of FDA oversight and sanction powers. Unfortunately, much of that has focused on human medicine and not on compounding for animals.


Q: Based on that, is compounding even legal?

A:Compounding is legal within a very specific context. The FDA recognizes that compounding represents the original practice of pharmacology, before the FDA was created. It also recognizes that given the number of unique allergies and sensitivities, there may always be certain patients who are unable to take a drug in the FDA approved format or dosage. Compounding is the answer to finding appropriate treatment for these unique individuals. In the animal world, compounding is even more prevalent given the obvious challenges to a vet attempting to treat patients ranging from elephants to horses and cows to small dogs, cats, lizards and birds. If no FDA approved product exists to treat a specific condition in a specific species, compounding is the only avenue available. Thus the FDA has developed a rule of thumb, which permits issue specific context under what we call the VCPR parameters: One Vet, to a Specific Client with a unique need, under a Patient Relationship where the vet examines, administers, and monitors the use of the compounded product and most importantly, where there is no FDA approved product available that the animal can use. Compounding under these parameters is permissible. Compounding outside these parameters is suspect and typically illegal.


Q: So why is compounding even an issue?

A: The issue arises in the context of large compounding facilities creating and mass marketing compounded products which appear as knock-offs or equal substitutes to FDA approved drugs, where they are anything but. The manufacture and mass marketing violates a number of FDA regulations, violates the fundamental principles of the VCPR parameters, and essentially provides what the public mistakenly believes are cheaper but effective "generic" drugs As these products are typically provided with very poor labeling, the end user is typically ill-informed about the product being used to treat their animal.


Q: Can you give me an example in the horse world?

A: Let me try. A good example in the animal context are drugs for treatment of equine ulcers. The bulk pharmaceutical ingredient typically used for this treatment is Omeprazole. There are two FDA approved omeprazole-based products on the market, GASTROGARD® (omeprazole) and ULCERGARD® (omeprazole), which are products that have undergone extensive FDA testing and can be relied upon to obtain measurable results when used as directed in horses. But in many instances trainers or vets are recommending the use of knockoffs containing Omeprazole—some sold as compounded "generics" and others which may bear "brand" names and are being sold directly to horse owners —but NONE of which have been reviewed or approved by the FDA.

In side by side tests performed by University of California – Davis between the FDA approved product and a compounded version, the effectiveness differences are dramatic. The compounded product is proven to be largely ineffective when compared to GASTROGARD. In other studies at UC-Davis, the amount of omeprazole in multiple compounded versions was tested versus the amounts their labels claimed on Day 0 through Day 60. In this study, actual concentrations of the compounded formulations were as low as 63% on day 0 and as low as 17% on day 60.

Thus, you might be paying less for the compounded product, but A) Is it working, and B) is it actually doing more harm by allowing your horse to continue to suffer? In addition, FDA regulations strictly prohibit the use of compounded products to treat a specific condition in a specific animal, where an FDA approved product is marketed for the same condition / animal treatment. Thus the prescribing vet or trainer recommending the use of the compounded knock-off is legally exposed to both civil and administration sanctions.


Q: If its FDA prohibited, why does anyone do it?

A: Often cost is a driver in the use of these products, but in my experience, it's a combination of several things in addition to that. One, many vets are not aware of the regulations given their complexity. The AVMA and AAEP go to great lengths to provide adequate treatises and presentations clarifying the issues, but vets still remain confused about actual applications of the law to the facts within their practices. This isn't a legal defense, though. Two, the FDA has limited resources which it divides between monitoring human and animal drug infractions. The majority of its attention and resources are directed towards protecting the human consumers, although FDA sanctions in the animal context occur frequently and may increase under proposed changes strengthening FDA oversight and regulatory authority over both the human and animal compounding industries. Three, the drug companies need to be more aggressive in filing civil and administrative enforcement actions enjoining these situations when they occur. The more developed the case law, the easier it is to understand what is – and is not – permissible. Four, and perhaps most importantly, the trainers of the animals, and their owners, simply do not understand the difference between using compounded and FDA approved drugs and in most instances may not even know they are being asked to use a compounded drug or the risks involved in that use. Thus there's a total lack of "informed consent" which is supposed to be the fundamental aspect of the Vet/Client/Patient Relationship parameter. As trainers and owners become more educated, they will know to ask more detailed questions and this will in large part help to regulate the market.

IMPORTANT SAFETY INFORMATION: CAUTION: Safety of GASTROGARD in pregnant or lactating mares has not been determined. ULCERGARD can be used in horses that weigh at least 600 pounds. Safety in pregnant mares has not been determined.


Q: Are there any other concerns with drugs I may be using for horses in my care?

A: Another thing to be aware of is "off-label" use of drugs. An example would be the use of a drug intended to treat a disease in dogs, given to a horse. Given the vast differences in the digestive systems of a dog and horse, as well as the size differences, you can see the potential for unintended negative consequences. A comparison example is the use of a common flea product, K9 ADVANTIX®, which is intended for use in dogs only. This same product is neurologically toxic and potentially fatal if used on cats. The use of the EPA approved ADVANTIX for dogs is standard EPA approved use; the same product's use on cats is not EPA approved, is use for a different species, and thus would be deemed "off label" use.


Q: What do you mean, "off label"?
A: Under the FDA regulations, which include the Food, Drug and Cosmetic Act of 1938, and subsequent regulatory programs under AMDUCA and FDAMA, any drug intended for a wide universe of patients – animal or human – requires strict adherence to a costly and lengthy "New Drug Approval" process defined by statute. The process ensures things such as:
  • The product's purity, safety, efficacy, stability, and proven shelf life
  • Requires significant testing to identify and guard against negative adverse effects on potential users.
  • Manufacturers are required to report Suspected Adverse Events and Lack of Efficacy to the FDA immediately
  • Accurate labeling identifying active ingredient, dosage requirements, shelf life, and potential adverse effects
All of this guarantees the product will perform as expected in the anticipated wide universe of patients needing it. When a new product hits the shelves as FDA approved, you know it's been tested extensively and subsequently labeled to meet these standards. "Off label" use means the product is not being used in the manner or in the type of patient for which it was developed and tested, which in turn means that the protections of the FDA new drug approval process are no longer applicable.

Q: Does a prescribing vet or trainer have any liability exposure for using a compounded product or using a product off-label on an animal?

A: Absolutely, if the prescription of the compounded product is outside of the very narrow VCPR definition, and if it's done without specifically advising and obtaining the animal owner's "knowing consent". "Knowing consent" means you would need to disclose the differences between compounded and FDA approved products; why the compounded product is suggested in this instance as the only viable means of treatment, and whether an FDA approved product is available, but is not being used, and why. I am not aware of very many vets or trainers who are in compliance with this element of "knowing consent". If an adverse reaction occurred, the animal owner or Plaintiff could potentially assert legal actions against both the vet and the trainer, including professional and ordinary negligence, misrepresentation, fraud, and/or breach of contract and warranty and product liability claims. If the product given is a substitute for an FDA approved product for that condition, in that species of animal, the use of the compounded product is both a civil and administrative violation justifying an additional count of "negligence per se," which is proven simply by demonstrating the existence of the statute and the violator's non-compliance with same. In all of these instances, where the use of the compounded product is deemed "an intentional act", the defendant vet or trainer using or recommending the use of the compounded product will most likely be denied coverage under the professional liability policy. So the entire proposition is very risky for the person recommending the use of the compounded product, and escalates dramatically if a compounded product is being used where an FDA approved product is available.


Q: I've heard that many vets recommend compounded products to try to save their clients' money. Isn't that a valid defense?

A: First, case law specifically states that use of a compounded product merely for cost savings is prohibited and illegal. So no defense there. Second, consumers need to understand the reason FDA– approved products are more expensive. Factors such as the high cost related to the extensive New Drug Approval testing and approval steps required to ensure potency, stability, efficacy and shelf life of the product, as well as the additional manufacturing requirements for Good Manufacturing Procedure (GMP) processes required, all contribute to costs. These include inspection of the bulk ingredients, quality control mechanisms and oversight over each batch preparation, detailed record keeping, sterile production and packaging requirements, and detailed product labeling. Where a compounded product has none of these elements, of course it can be sold cheaper. The comparison is like asking me if I want surgery with a dull scalpel to save money. What would YOUR answer be?


Q: What if the horse that is given an off-label or compounded product is insured? Does that change anything?

A: Potentially. All insurance policies typically exclude coverage for "intentional acts" that proximately cause the "occurrence". If a trainer or owner intentionally elects to use an off-label product, outside FDA manufacturer recommendations, they could not only be liable for comparative fault or contributory negligence blocking any claim against the manufacturer, but also find a corresponding insurance claim denied on the basis of the owner or trainer's "intentional act" in using that product. Similarly, there is no veterinarian liability coverage for claims arising out of the use of compounded products. Practitioners and owners need to understand these rules and where possible, use FDA approved products. If not possible, work closely with your veterinarian and an accredited compounding pharmacy to create a highly monitored product with personal oversight of the animal being treated with that product.


Q: In summary, how would you recommend our readers understand the compounding/off-label "do's and don'ts", to use your phrase?
A: I'd recommend your readers be aware of the following guidelines:
  1. Valid compounding under existing FDA regulations requires:
    1. A Vet/Client/Patient relationship, with informed consent by the pet owner
    2. Where the use of the compounded product is limited:
      1. to unique needs of a specific patient or group of patients
      2. to situations where a physiological response to therapy or systemic drug concentrations can be monitored; or
      3. to situations where no other method or type of drug delivery is practical
  1. Horse owners need to remember that even then, compounded/unapproved versions of products are NOT FDA evaluated for:
    1. Safety
    2. Efficacy
    3. Stability
    4. Purity
    5. Consistency of manufacturing
    6. onsistency one batch to the other
    7. Adherence to the correct amount of active ingredient needed for treatment
  1. Horse owners and trainers need to ask:
    1. Is this a compounded/unapproved product and if so, why are we using it? Get this in writing!
    2. Is there an FDA approved product available and if so, why AREN'T we using it? Get this in writing!
    3. Is the providing compounding pharmacy licensed in the state where the animal resides? If not, be wary!
    4. Is the provision of this product in compliance with your applicable state laws on compounding?
    5. Is the product provided with a detailed label including, at a minimum, the product name, active ingredient(s), dosage instructions, and minimum storage and shelf life instructions? If not, ask for this information before you accept it!
    6. Is the prescribing vet providing monitoring services to determine if the product is working as anticipated, or alternatively to spot potential adverse effects?
    7. Is the product a product which is being mass produced, marketed and advertised by a compounding pharmacy or other manufacturer in a magazine? If so, review Section 3(l) thru (Vl) above and then determine if you're willing to chance using it.

©Denise E. Farris, Esq., Farris Law Firm LLC (September 2013). This article may not be reprinted or reproduced in any manner without the consent of the author. Contact: Denise Farris, Farris Law Firm LLC. (913) 766 1262 or This email address is being protected from spambots. You need JavaScript enabled to view it.. Denise is a nationally recognized equine and business attorney, "AV" rated with Martindale Hubbell and recipient of numerous business law awards at the local and national level. She was recognized in the March 2013 issue of EQUUS Magazine as among the national "2013 Leaders in Equine Law". The firm also offers dispute resolution services for the equine and agricultural law industry. www.farrislawfirm.com.

DISCLAIMER
This article provides general coverage of its subject area. It is provided free, with the understanding that the author, publisher and/ or publication does not intend this article to be viewed as rendering legal advice or service. If legal advice is sought or required, the services of a competent professional should be sought. The publisher shall not be responsible for any damages resulting from any error, inaccuracy or omission contained in this publication.
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