Veterinary compounding | TSLN.com

Veterinary compounding

Photo by Heather Smith ThomasAn oral medication being given after crushing up pills into a powder and mixing with a palatable fluid like molasses and water - a common example of compounding (changing the formulation of a medication to more easily administer it to the horse).

Illegal compounding received media attention in April 2009 when 19 polo horses in Florida died suddenly – after receiving injections of a compounded vitamin-mineral product that contained excessively high levels of selenium. In 2006, six Louisiana horses died (and approximately 10 more were severely affected) after receiving an illegally compounded clenbuterol product. The offending clenbuterol drug, smuggled into the U.S., was many times more potent than the licensed Ventipulmin and Aeropulmin products, which are used for treating constricted airways.

Horsemen need to understand the difference between legal and illegal drug compounding, to ensure the safety of their animals. Compounding, by definition, is the manipulation of a drug product to produce a dosage or a formulation that is tailored to more adequately meet the needs of a specific patient. This can be done by mixing two drugs together, or creating a more palatable oral product by adding flavoring, creating an oral suspension by crushing tablets and mixing them with fluid, etc. Compounding can be done by a licensed pharmacist on the prescription of a licensed veterinarian, or by the veterinarian.

Scarlet Thomas, director of Pharmacy at Hagyard Equine Medical Institute in Kentucky, says compounding can legally be performed only when there’s no approved animal or human drug available in correct dosage, form or concentration to appropriately treat the patient. It is not legal to create something that merely duplicates an already existing product.

“There are a number of instances in which compounding could be beneficial or necessary,” explains Thomas. “In the equine market, particularly, there are a limited number of drugs commercially available for horses. There are more commercial options for small animals, due to the greater number of cat and dog owners.

“When there is not an appropriate commercially available product, or when a certain medication is discontinued or unavailable from pharmaceutical companies, then compounding becomes necessary. Some medications get dropped by the manufacturer, perhaps due to profitability issues. When products are pulled off the market, for whatever reason (as long as it’s not a safety issue), that might be an appropriate instance to compound that medication. There are still horses with the same illnesses or need for the medication. The horse owner and veterinarian must have some means to continue to obtain these medications, to continue the therapy,” she says.

In some instances equine patients are allergic to certain preservatives, dyes, fillers, carriers, etc. that exist in commercially available products, and something else must be used. Also, certain patients require tailored dosage strengths to meet a unique need.

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“If you’re trying to use a human product or a small animal product for a horse, and it’s geared toward a 25 pound dog or a 150 pound human and you are treating a 1,300 pound horse, this can be challenging,” says Thomas. Compounding the product to more appropriately tailor it for that horse would be a logical solution.

“Also, in some instances the animal may not be able ingest the medication in its commercially available form,” she says. “It may be a human product that is not palatable, or not feasible for a horse to be given 200 tablets of human medication. In those instances it may be necessary to manipulate the drug product into a different formulation or dosage form, or add flavoring. In many instances we add flavoring (such as banana, apple, vanilla) to make it smell and taste better for the animal, so it could be given orally.”

Legal compounding requires a valid veterinarian-client-patient relationship.

“Veterinarians should limit the use of compounded drugs to specific needs in specific patients, when there is no other method or route of drug delivery that is practical for that patient,” says Thomas. “If there’s a commercial product available and it’s reasonable to be given to that particular horse, that’s the first line of treatment.”

The commercial product might be available over the counter or by prescription, but would be the first choice.

Compounded medications would be the next option, but would require a valid prescription from a veterinarian, and it must be patient specific. The veterinarian would have to have seen or know the animal and have diagnosed the condition to be treated. Then he/she must look at what’s available for treating that horse. If there is nothing commercially available to treat that case or there’s something unique about this particular patient that makes it impossible for the commercial product to be appropriate, then a compounded product would be considered.

“Compounding is merely a niche to augment the practice of veterinary medicine,” says Thomas. “It is not an exclusive source of medication, but rather an alternative to be considered when there are no commercially available products that meet the needs of a particular patient/case.”

She advises horse owners to have a good veterinarian they are comfortable with, trusting his or her judgment – a veterinarian that they know well and who knows their animals.

“Talk with the veterinarian if a compounded product will be necessary for a certain animal. Ask about the source of that compound, making sure it’s a reputable pharmacy that your veterinarian has confidence in and trusts,” she says. Ask which FDA approved drug(s) will be used to compound the prescribed medication. You want to know that the ingredients and potency of the compounded product are what they are supposed to be.

Commercial products that are already on the market for the horse should not be compounded.

“An example would be omeprazole, paste, with the same active ingredient and dosage form as Gastrogard (often used for treating or preventing ulcers in horses),” says Thomas. “This has been one of the hugely controversial products.”

If medications are compounded in the same dosage formulation as a patented product and marketed as “look-alikes,” it’s usually not for the health and welfare of the horse, but merely to offer a less expensive product, she explains. The horse owner may choose a compounded substitute because it’s cheaper, but may be getting something less effective (or even dangerous) if obtained illegally.

This is often where controversy over compounding comes into the picture. It is not legal to compound something just to save money. Compounding should only be done for the health and welfare of the horse, not to pirate a manufacturer’s patent – and produce something cheaper because the horseman or veterinarian does not want to purchase an approved product.

Illegal compounding received media attention in April 2009 when 19 polo horses in Florida died suddenly – after receiving injections of a compounded vitamin-mineral product that contained excessively high levels of selenium. In 2006, six Louisiana horses died (and approximately 10 more were severely affected) after receiving an illegally compounded clenbuterol product. The offending clenbuterol drug, smuggled into the U.S., was many times more potent than the licensed Ventipulmin and Aeropulmin products, which are used for treating constricted airways.

Horsemen need to understand the difference between legal and illegal drug compounding, to ensure the safety of their animals. Compounding, by definition, is the manipulation of a drug product to produce a dosage or a formulation that is tailored to more adequately meet the needs of a specific patient. This can be done by mixing two drugs together, or creating a more palatable oral product by adding flavoring, creating an oral suspension by crushing tablets and mixing them with fluid, etc. Compounding can be done by a licensed pharmacist on the prescription of a licensed veterinarian, or by the veterinarian.

Scarlet Thomas, director of Pharmacy at Hagyard Equine Medical Institute in Kentucky, says compounding can legally be performed only when there’s no approved animal or human drug available in correct dosage, form or concentration to appropriately treat the patient. It is not legal to create something that merely duplicates an already existing product.

“There are a number of instances in which compounding could be beneficial or necessary,” explains Thomas. “In the equine market, particularly, there are a limited number of drugs commercially available for horses. There are more commercial options for small animals, due to the greater number of cat and dog owners.

“When there is not an appropriate commercially available product, or when a certain medication is discontinued or unavailable from pharmaceutical companies, then compounding becomes necessary. Some medications get dropped by the manufacturer, perhaps due to profitability issues. When products are pulled off the market, for whatever reason (as long as it’s not a safety issue), that might be an appropriate instance to compound that medication. There are still horses with the same illnesses or need for the medication. The horse owner and veterinarian must have some means to continue to obtain these medications, to continue the therapy,” she says.

In some instances equine patients are allergic to certain preservatives, dyes, fillers, carriers, etc. that exist in commercially available products, and something else must be used. Also, certain patients require tailored dosage strengths to meet a unique need.

“If you’re trying to use a human product or a small animal product for a horse, and it’s geared toward a 25 pound dog or a 150 pound human and you are treating a 1,300 pound horse, this can be challenging,” says Thomas. Compounding the product to more appropriately tailor it for that horse would be a logical solution.

“Also, in some instances the animal may not be able ingest the medication in its commercially available form,” she says. “It may be a human product that is not palatable, or not feasible for a horse to be given 200 tablets of human medication. In those instances it may be necessary to manipulate the drug product into a different formulation or dosage form, or add flavoring. In many instances we add flavoring (such as banana, apple, vanilla) to make it smell and taste better for the animal, so it could be given orally.”

Legal compounding requires a valid veterinarian-client-patient relationship.

“Veterinarians should limit the use of compounded drugs to specific needs in specific patients, when there is no other method or route of drug delivery that is practical for that patient,” says Thomas. “If there’s a commercial product available and it’s reasonable to be given to that particular horse, that’s the first line of treatment.”

The commercial product might be available over the counter or by prescription, but would be the first choice.

Compounded medications would be the next option, but would require a valid prescription from a veterinarian, and it must be patient specific. The veterinarian would have to have seen or know the animal and have diagnosed the condition to be treated. Then he/she must look at what’s available for treating that horse. If there is nothing commercially available to treat that case or there’s something unique about this particular patient that makes it impossible for the commercial product to be appropriate, then a compounded product would be considered.

“Compounding is merely a niche to augment the practice of veterinary medicine,” says Thomas. “It is not an exclusive source of medication, but rather an alternative to be considered when there are no commercially available products that meet the needs of a particular patient/case.”

She advises horse owners to have a good veterinarian they are comfortable with, trusting his or her judgment – a veterinarian that they know well and who knows their animals.

“Talk with the veterinarian if a compounded product will be necessary for a certain animal. Ask about the source of that compound, making sure it’s a reputable pharmacy that your veterinarian has confidence in and trusts,” she says. Ask which FDA approved drug(s) will be used to compound the prescribed medication. You want to know that the ingredients and potency of the compounded product are what they are supposed to be.

Commercial products that are already on the market for the horse should not be compounded.

“An example would be omeprazole, paste, with the same active ingredient and dosage form as Gastrogard (often used for treating or preventing ulcers in horses),” says Thomas. “This has been one of the hugely controversial products.”

If medications are compounded in the same dosage formulation as a patented product and marketed as “look-alikes,” it’s usually not for the health and welfare of the horse, but merely to offer a less expensive product, she explains. The horse owner may choose a compounded substitute because it’s cheaper, but may be getting something less effective (or even dangerous) if obtained illegally.

This is often where controversy over compounding comes into the picture. It is not legal to compound something just to save money. Compounding should only be done for the health and welfare of the horse, not to pirate a manufacturer’s patent – and produce something cheaper because the horseman or veterinarian does not want to purchase an approved product.

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