Session delves into state, federal laws on compounding, prescriptions
The ever-changing state and federal rules governing pharmacy within veterinary medicine were the subject of a wide-ranging session during the 2014 AVMA Public Policy Symposium, Sept. 5-6 in Rosemont, Illinois, a forum for leaders of state VMAs and other veterinary associations.
Speakers described developments in the rules for veterinary compounding, how Virginia veterinarians gained latitude to dispense a 72-hour supply of compounded drugs from office stock for home use, how Maine veterinarians defeated a proposal to mandate that veterinarians always provide a prescription in writing, and how Wisconsin veterinarians secured an exemption from the state’s prescription monitoring program for controlled substances.
Dr. Frank G. Vice, who is in the practice of human pharmacy as well as veterinary medicine in Kentucky, offered an overview of the legalities of veterinary compounding.
“It seems that mixing drugs together shouldn’t be that big of an issue,” Dr. Vice said. “However, it’s become a very controversial issue.”
Dr. Vice recommended veterinarians be very careful about compounding their own drugs and take advantage of compounding pharmacies. He noted that the Food and Drug Administration takes exception to compounding from raw bulk ingredients and prohibits extralabel use of certain drugs in food animals.
||Dr. Frank G. Vice is in the practice of human pharmacy as well as veterinary medicine in Kentucky. During the AVMA Public Policy Symposium, he offered an overview of the legalities of veterinary compounding. (Photo by Verna Barnett)
The states supervise compounding, Dr. Vice said. Veterinarians who deal with compounded drugs need to keep prescriptions on file; maintain a veterinarian-client-patient relationship in each case; and realize that safety, efficacy, and labeling concerns carry forward to compounded drugs.
Dr. Ashley Morgan, an assistant director of the AVMA Governmental Relations Division, summarized current activity on veterinary compounding by the federal government and the AVMA.
The Government Accountability Office is preparing a report for Congress on the compounding of drugs for use in animals, while the Food and Drug Administration plans to revise the existing compliance policy guide on the subject.
The AVMA Task Force on Veterinary Compounding Legislation is developing a proposal for federal legislation to explicitly allow compounding from bulk substances in certain circumstances, anticipatory compounding, and dispensing from office stock for home use. In July, the AVMA participated in a roundtable discussion on veterinary compounding with the FDA and other stakeholders.
Dr. Jeff Newman, president of the Virginia VMA, spoke about the passage of Virginia legislation, effective July 1, to allow veterinarians to dispense from office stock for home use in certain circumstances.
In 2013, the Virginia Board of Pharmacy stated that it would start sanctioning veterinarians who dispensed commercially prepared compounded drugs for home use, a violation of state law.
The VVMA recruited support from legislators and other organizations to pass legislation that allows a veterinarian “to dispense a compounded drug, distributed from a pharmacy, when (i) the animal is his own patient, (ii) the animal is a companion animal as defined in the regulations of the Board of Veterinary Medicine, (iii) the quantity dispensed is no more than a 72-hour supply, (iv) the compounded drug is for the treatment of an emergency condition, and (v) timely access to a compounding pharmacy is not available, as determined by the prescribing veterinarian.”
Many states require veterinarians to write a prescription on request, rather than dispensing the drug. The Fairness to Pet Owners Act pending in Congress would mandate that veterinarians always write a prescription, regardless of whether the client wants one.
Several years ago, a similar proposal arose in Maine. Bill Bell, executive director of the Maine VMA, said the measure was “so bad that had we done nothing, it would have died anyway of its own weight.” He said veterinarians could not leave defeat of the bill to chance, however.
The MVMA mobilized members to contact their legislators in opposition. Later, the MVMA came up with key points for members to share. One point was that veterinarians already advise clients when it makes sense to go to a pharmacy, Bell said.
Members of the MVMA attended a hearing on the proposal wearing lapel stickers saying “My Veterinary Practice is a Small Business.” Also making a big impression was a letter from the AVMA stating that Maine would be the first state to pass this sort of law.
The proposal died in committee soon afterward.
|| Bill Bell
|| Kim Brown Pokorny
Another requirement in many states is for veterinarians to participate in prescription monitoring programs for controlled substances, but other states exempt veterinarians. Kim Brown Pokorny, executive director of the Wisconsin VMA, spoke about the strategy behind Wisconsin veterinarians securing an exemption from their state program.
The law creating Wisconsin’s new prescription monitoring program required health care “practitioners” to participate. The WVMA discovered the inclusion of veterinarians when regulators began implementing the program.
“This law was meant for humans, and we got swept into it,” Brown Pokorny said.
The WVMA pursued several strategies in response. The association appealed to a state board that reviews regulations of small businesses, which determined the rule was overly burdensome for veterinarians and asked for legislation to provide an exemption. The WVMA worked with the pharmacy board to create more flexible reporting provisions in case the rule could not be repealed. The association also approached legislators directly for an exemption. The bill granting the exemption was signed into law three days before veterinarians would have had to start reporting.
A key argument by the WVMA was that requiring veterinarians to participate in the prescription monitoring program would not further public policy because drug diversion is rare in veterinary medicine.
The session on pharmaceutical issues concluded with information on drug disposal and answers to frequently asked questions. Dr. Kristi Henderson, acting director of the AVMA Scientific Activities Division, spoke briefly about drug disposal. Answering the FAQs were Dr. Colleen Currigan, a feline practitioner on the AVMA Task Force on Veterinary Compounding Legislation, and Dr. Lynne White-Shim, an assistant director of the AVMA Scientific Activities Division.
The AVMA provides resources on drug disposal at www.avma.org/wastedisposal and www.avma.org/unwantedmeds. The Association provides resources on prescriptions and compounding at www.avma.org/pharmacy.
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