MORGANTOWN, W.Va. (WBOY) – A new Food and Drug Administration draft guidance addresses an animal medicine practice called compounding. Compounding is when a veterinarian or a pharmacy creates a custom drug for a patient. For example, a vet who is treating a smaller patient might crush up a pill meant for a patient with a larger body type, measure it to a precise number of milligrams, put it in syrup, and flavor it to dilute the medication. Currently, states are in charge of regulating compounded animal medications.
“Some days in the clinic, I might see 10 different species of animals. All of varying sizes and all with different requirements of routes of administration of the medicine, flavor of the medication, and so compounding is a necessary part of our daily practice,” explained Jesse Fallon, a veterinarian at Cheat Lake Animal Hospital in Morgantown, “It’s not for us a tiny piece of it, and for our patients, they need it.”
In FDA Draft Guidance #256, Compounding Animal Drugs from Bulk Drug Substances, the FDA takes an interest in specifically compounded medications that are kept in veterinarian offices for emergencies, called office stock, and compounded medications made directly from an active ingredient, called a bulk drug substance. However, according to local veterinarians, keeping office stock is not allowed in West Virginia.
“We can’t keep pre-compounded medications on the shelf to pull out and then divvy up to individual animals, so currently, our regulations are, if we’re going to compound medication, it’s got to be for one specific patient. It has to have that patient’s name on it, and that’s the only one who gets it,” said Fallon.
The big change, for West Virginians, could come from regulations on compounding using a bulk drug substance. A bulk drug substance is an active ingredient in its purest form—without any fillers, dyes, or other things that come in a finished pill. The FDA said in their draft guidance that they believe that compounding using an FDA-approved finished pill should be the first priority for safety and effectiveness.
According to Wedgewood Pharmacy, one of the largest animal compounding pharmacies in the nation, there are several reasons why compounding pharmacies use bulk active ingredients, including avoiding potential harmful inactive ingredients, prevent any variation in potency, cost efficiency, and availability.
Pharmacies and veterinarians can’t remove certain fillers in finished products that patients might be allergic to. Some examples of potentially harmful fillers are certain dyes, a sweetener called Xylitol, which is toxic to dogs, and a preservative called Benzyl Alcohol, which is toxic to cats. According to My Meds Matter, a site sponsored by compounding pharmacies, unnecessary fillers and binders also add volume to the dosage size, making it difficult for them to make smaller dosage sizes for smaller patients.
Also, the site described that a compounding pharmacy looked at how much prices would rise if they had to make the product from a finished product instead of bulk ingredients. The analysis looked at eight of the most frequently prescribed compounded medications that represented 45% of all prescriptions filled by the pharmacy. And they found the average cost increase for those products was 300% because the cost of the active ingredient, as well as the cost of labor, would increase substantially.
“If we’re making a chemotherapy drug for a dog that is available in the human health market except it’s too strong for the dog, and we would have to fractionate that medication, but just starting with a human health chemotherapeutic agents already, the price is set for what a human health insurance pays, not what animal health pet owners pay out of pocket,” explained Bliss, “As an example, Lomustine, which is a very common oncology medication would go from about $40 a tablet to over $700 a tablet. So you can imagine if you’re a pet owner, you might decide you can’t afford to treat your dog for cancer if the price went up that high.”
“There’s a commonly used drug for copper toxicity, Penicillamine, that drug would go from under $80 for a 60 count to over $15,000 for a 60 count. So how could you treat your pet if the medication was 15,000? You couldn’t. So we believe this guidance is potentially going to cause not only unnecessary suffering but unnecessary death because people who could have maintained the health of their animals will be forced to put the animals down because of the cost of medication.”
“This will also impact shelters that take care of animals, it will impact rescue organizations, it will impact zoos, and the treatment of endangered species because they use a lot f compounded medications because the populations of zoo and exotic animals are so small, there really aren’t enough FDA approved drugs to help them so they rely heavily on compounding as well.”
One of the many reasons why a vet might prescribe compounded medications might be that there is a shortage of FDA approved drugs. In fact, according to Bliss, Wedgewood Pharmacy started compounding animal medication when drugs for horses that were FDA approved were discontinued.
“[Another reason people use compounded medications is if] there’s a manufacturing backorder, and there’s a drug that patients are maintained on with a chronic condition, and say the drug goes on backorder and they need that medication,” explained Bliss.
In those instances, a finished product might not be available to the pharmacy to compound for a patient. Also, according to My Meds Matter, many pharmaceutical manufacturers won’t sell their products to compounding pharmacies because they worry it might negatively affect sales of their product.
We reached out to FDA officials, who explained that if a patient needs to use a bulk drug substance for some reason and an FDA-approved product is not available, compounding using a bulk drug substance would be allowed under this draft so long as the drug is not a copy of an approved product. Officials also explain that the draft is an attempt to recognize that there might not always be approved products for each specific patient, but the intention here is to encourage people to use a product that has been evaluated for safety and effectiveness.
We believe this guidance is potentially going to cause not only unnecessary suffering but unnecessary death because people who could have maintained the health of their animals will be forced to put the animals down because of the cost of medication.Marcy Bliss, CEO of Wedgewood Pharmacy
An FDA spokesperson offered this statement:
When compounding a drug for a specific animal, veterinarians and pharmacists can begin with either an FDA-approved drug or a bulk drug substance. When starting with an FDA-approved product, veterinarians and pharmacists can make changes like adding a flavor to make the medicine more palatable, grinding up tablets into a liquid, diluting the concentration to the suitable dose, and more. This is already legal under Federal law and is not addressed by the FDA’s draft guidance 256.
The FDA also understands that sometimes it’s not possible to start with an FDA-approved product when compounding for a particular patient. Maybe the pet has an allergy to an inactive ingredient in the FDA-approved product, or it’s not available in the concentration needed. Perhaps the veterinarian believes that the compounded product would make a clinical difference in the pet’s treatment. Under the policies described in the draft guidance, FDA would ask that the veterinarian document in the pet’s record the reason why they chose to prescribe the product compounded from a bulk drug substance.
It’s important to understand that FDA-approved products have been evaluated for safety, effectiveness and quality, while animal drugs compounded from bulk drug substances have not.
The bottom line is that veterinarians and pet owners in West Virginia will still be able to access medications that are compounded from patient specific prescriptions for pets if the draft guidance is finalized.
“The process if you go to the store, or your doctor gives you a prescription and you go buy a prepared tablet, that does go through a different set of safety mechanisms and there was a concern in the past over injectable medications that were contaminated with fungal contaminates and were given to humans. And so those without some regulation, you could get to a point where you could get in trouble,” said Fallon, “However, the current regulations are pretty tight and the high quality pharmacies—if you just try to get the cheapest one—the high quality pharmacies that have proper contamination control and quality assurance mechanisms then you can get it very safely. It’s a matter of oversight over at the laboratory that makes sure that they have appropriate quality control and quality assurance steps in place rather than a nationwide restriction on availability”
According to My Meds Matter, compounding pharmacies get bulk substances from FDA registered and inspected facilities, and receive a certificate of analysis verifying the purity and quality of the ingredients. Also, standards for state licensing and accreditation for compounding pharmacies are often rigorous, involving lots of tests and inspections.
Aside from all of these controversial points to the draft guidance, there are some parts that Bliss even agrees with.
“I think some of the early parts of the guidance is workable. A veterinarian should have a veterinarian patient relationship before prescribing medicine and I absolutely agree with that. This guidance also indicates that compounded medicine should not be used in food chain animals. I also agree with that because it hasn’t been tested for withdrawal time so you wouldn’t want to be eating dinner and have compounded medicine in your chicken because they haven’t been studied for that reason,” said Bliss, “I’m in support of those two aspects of the guidance and other than that, I think that it should be left up to the states to regulate because they’ve proven that they can regulate this at the state board pharmacy level and at the state veterinarian medical board level and I think that they’ve demonstrated that they have a proven track record of doing that very well.”
The FDA is accepting comments on the guidance until October 15. After that, officials explained they will review the comments and make changes if necessary, and then put it out as final guidance or re-issue it for comments again.
- FDA Draft Guidance #256 – Full Text
- Submit comments to the FDA on the draft guidance
- My Meds Matter
- FDA’s Q&A on Draft Guidance #256