Compounding: Stay afloat in the muddy regulatory waters
What is compounding?
Veterinary drug compounding is a useful and commonly employed technique for treating patients with specific requirements. Flavor, dosage and route of delivery can be altered to suit the needs of the patient.
Compounding drugs for animal patients is regulated by 50 different state boards of pharmacy and murky federal laws. Although compounded drugs are not approved by the
Food and Drug Administration (FDA), they are allowed when approved drugs are not available or suitable for the intended use.
But determining exactly what is best for the patient – while remaining within the bounds of the law – can be confusing. In order to protect yourself, it is important keep a few things in mind.
Gigi Davidson, RPh, DICVP, is director of clinical pharmacy services at North Carolina State University. She is also a member of the Veterinary Drugs Committee of Experts and the Compounding Pharmacy Committee of Experts for the United States Pharmacopeia.
“In my opinion the most important thing is for veterinarians to realize that there is no guarantee of potency, stability, bioavailability, safety or efficacy with a compounded preparation like veterinarians can expect from FDA-approved products,” Davidson said.
Different compounders may use different methods or bases for their products, and very few have done tests on the stability of their compounds, she said.
One way to help ensure quality is to use trustworthy and credentialed pharmacies. Davidson urges veterinarians to do business – when possible – with pharmacies that are accredited by the Pharmacy Compounding Accreditation Board (PCAB).
Formed in 2004 by eight national pharmacy organizations, the nonprofit PCAB runs a voluntary accreditation program to ensure quality standards for compounding pharmacies.
“PCAB represents the only unified set of professional and ethical standards for compounding pharmacy,” Davidson said. “All 50 states regulate compounding pharmacies differently and hold them all to different standards. … If a pharmacy meets the incredibly rigorous accreditation standards, then a veterinarian can be assured that the pharmacy is legally and ethically impeccable and that its compounds are of the highest possible quality.”
The board has accredited 46 pharmacies in 40 states, and 40 more pharmacies are awaiting accreditation. PCAB maintains a list of accredited compounding pharmacies on their website, or veterinarians can contact PCAB’s Executive Director Tom Murry at (919) 824-5753 to find an accredited pharmacy.
What you should know:
You are responsible
Ultimately, the veterinarian is accountable for what happens to the patient.
“The other very critical factor that veterinarians must realize is that even if evidence abounds regarding the safety and efficacy of a compound, that they are responsible for determining whether or not the compound is achieving the desired therapeutic effect,” Davidson said.
Veterinarians should keep track of the results for their patients who have been prescribed compounds, and make sure they know what exactly is going into each prescription.
Davidson gave the example of a dog that was being treated with pyridostigmine (Mestinon) solution for myasthenia gravis at N.C. State College of Veterinary Medicine’s teaching hospital. The dog was doing well on the treatment, but then returned several months later weak and unable to stand.
“Apparently the owner had taken her prescription for pyridostigmine solution to a compounding pharmacy and the well-intentioned pharmacist had offered to compound a more dog-friendly flavor of the pyridostigmine,” Davidson said. “Unfortunately, the pharmacist included methylcellulose in the vehicle which completely bound the pyridostigmine making it unavailable for absorption. Luckily, we realized the mistake before the dog was euthanized.”
On the legal fringe
Animal drug compounding is covered, albeit loosely, in the Animal Medicinal Drug Use Clarification Act (AMDUCA). AMDUCA permits veterinary drug compounding if:
- The compounder is using FDA-approved human and animal drugs on the order of a licensed veterinarian,
- There is a valid veterinarian-client-patient relationship in place, and
- There is not a comparable approved drug available in the same dosage form and concentration. (Duplicating an existing FDA-approved drug is considered piracy.)
However, AMDUCA stops short of addressing the legality of using bulk, or raw chemicals to compound drugs.
“So therapies such as potassium bromide or cisapride or diethylstilbestrol that can only be prepared from bulk chemicals are still in a regulatory void,” Davidson said.
In addition to AMDUCA, the FDA has a published document called the Compliance Policy Guide (CPG) for Compounding of Drugs for Use in Animals. This document lays out guidelines for FDA inspectors to help them decide when to take any enforcement action relating to veterinary compounding. The focus of the CPG is to prevent veterinarians or pharmacies from making and distributing non-FDA-approved new animal drugs in violation of the Food, Drug and Cosmetic Act.
“This CPG was originally developed in 1996 and revised in 2003 and has been again recently revised by FDA, but the most recent revision is not yet available for public view,” Davidson said.
FDA spokeswoman Laura Alvey said the revision of the CPG is ongoing, but offered little information about its future.
“The FDA continues to review and revise the CPG,” Alvey said. “There is no estimated date as to when a revision will be issued. The current CPG remains in effect.”
Know the boundaries
Despite the murky laws, there are some clear boundaries in what is allowed in terms of dispensing compounded drugs to clients. The general rule is that if the prescription is for a specific client, a compounded drug must be sent home with only that client. If a prescription is for office use, that compounded drug must be used only in the office.
Some states allow a veterinarian to order compounded drugs “for office use.” If a veterinarian writes a legal prescription for an “office use” compound, the compounding pharmacy can send the prescription to the veterinarian and he/she can administer it in the office only. Such prescriptions cannot be sent home with the client.
“This is probably the largest area of abuse of compounded preparations,” Davidson said. “Many veterinarians do not realize that it is they who are breaking the law if they send home an ‘office use’ compound.”
If a compound is prescribed for a specific client, the veterinarian may dispense the drug to that client, but not anyone else. Davidson said some veterinarians try to get around compounding laws – for example by acquiring prescription compounds in their own pets’ names and then dispensing them to clients. But this is also illegal, and responsible pharmacies will catch on to it.
It is important to remember that any legal repercussions relating to compounded drug violations will fall squarely on the shoulders of the veterinarian – not the pharmacy. This is another good reason to be careful in choosing your providers.
“PCAB surveyors are very much aware of what constitutes legitimate volumes of drugs for individual patients,” she said. “So if they inspect a pharmacy and find that a veterinarian has written prescriptions for 1,000 diethylstilbestrol capsules for one dog in a year, then the PCAB surveyors know that this volume is inappropriate for a single patient and will become quite suspicious of the pharmacys dispensing patterns.”
How confusing can it get?
A recent court case highlights the confusion on the topic. The court’s decision – which relates to human drug compounding – makes the practice semi-legal in some states, while not legal in others.
In July, the Fifth Circuit U.S. Court of Appeals ruled that a part of Section 503A of the Food, Drug and Cosmetic Act regarding advertising for compounding pharmacies was severable from the other parts of the section, which implicitly tolerates compounding (for human drugs).
However, a Ninth Circuit court decision in 2001 said the advertising restrictions were unconstitutional and invalidated the entire section. This effectively made compounding illegal in the Ninth Circuit (Washington, Oregon, California, Nevada, Arizona, Idaho, Montana, Alaska and Hawaii, Guam and the Northern Mariana Islands), while in the Fifth Circuit (Texas, Louisiana, Mississippi) it is allowed.
Contrary to some perceptions, none of these rulings affect compounding for veterinary use, since AMDUCA and the CPG are still valid.
Due to the legal ups and downs with the human side of things, Davidson thinks the human compounding issue is destined for the highest levels of government. And when it gets there, hopefully there will be some clarification on the animal side, too.
“What we still need is a ruling on using bulk chemicals to compound for animals,” Davidson said. “Only the Supreme Court or Congress can fix this one for us.”
‘High level of interest’
Most respondents took time to add comments on their survey forms, which Albers saw as a sign that people are at least watching the economy closely.
“To me, it indicated a high level of interest in the issue,” he said.
Of the nearly 500 practices that left comments, 25 percent said they had, or were planning to, increase prices to help get through the downturn. More than 12 percent said they were cutting staff, and 26 percent said they were increasing marketing. Nearly 10 percent were planning to add services or facilities, and 15 percent said they were not making any changes at all.
Margaret Rucker, DVM, said that her practice in rural southwestern Virginia is adding 3,800 square feet in the next eight months, and they are planning to add one veterinarian and a licensed technician. She said the practice’s revenue is up 14 percent so far this year.
“The average driving time for our clients is almost an hour,” Rucker said. “Our area has been blessed lately with growth due to new manufacturing and two new IT companies, which have moved into our county. Our new client numbers are increasing each month.”
Other practices were not feeling so fortunate. Brent Cook, DVM, of Kingsbrook Animal Hospital in Frederick, Md., reported a 20 percent drop in revenue from January to June.
“We had always been taught that veterinary medicine was safe no matter what the national economy might be doing because people are always going to pay to get things done for their pets – Baloney!” Cook said.
“Perhaps veterinary medicine was economy-proof when the average doctor transaction was $60, but now there is a lot of technology available to allow us to practice better medicine,” Cook continued. “We are much better at care for pets and people, but everything has a cost and the change in the economy seems to have proven that pets are a luxury these days and the cost of their care comes from expendable income, which no one has.”
Cathy Smith, DVM, owner of Oak Park Veterinary Clinic in Grover Beach, Calif., said revenue is down 20 percent compared with last year. She said this year’s gross income is the lowest her practice has had since 1995.
“I am not replacing my doctor on leave, and will operate as a solo practitioner for the first time in 14 years,” Smith said. “Dismal times! Efforts to increase marketing have not had a noticeable impact based on customer feedback.”
Julie Wahl, support staff member at Highland Animal Clinic in Anchorage, Alaska, commented that while her practice is increasing prices slightly, Alaska is not as affected by the economic woes of the rest of the country.
“We are a 36-year-old family practice with third-generation clients using and recommending our practice,” Wahl said. “Our area demographics are on the high end of the economic scale, and our area of Anchorage is still growing, bringing in more potential clients.”
The e-mail survey was sent out in July to AAHA-member directors of both accredited and non-accredited practices.