BETHESDA, MD 26 October 2012—Utah this year passed a law that allows physicians to dispense oncology drugs under an exemption from the state's pharmacy practice act. But the law includes some pharmacist-supported provisions to make office-based dispensing safer for patients.
These provisions include a requirement that physicians follow the same labeling, record-keeping, storage, patient counseling, and quality-of-care regulations as pharmacists and adhere to United States Pharmacopeia chapter 797 standards for sterile compounding.
In addition, the law requires the Division of Occupational and Professional Licensing, which includes the Utah Pharmacy Board, to conduct a study of "prescribing practitioner exemptions" and dispensing and report the findings to the legislature.
The law specifies that physicians may dispense oral, i.v., rectal, and dermal cancer chemotherapy formulations as well as supportive therapy, except for Schedule I, II, or III controlled substances.
Dispensing physicians are not permitted to make a profit on cancer chemotherapy but are allowed to recoup "expenses and services related to providing the cancer drug regimen," according to the law.
In addition, patients must be informed that they may instead purchase their medications from a pharmacy and must be given an opportunity to consult with a pharmacist if they wish to do so.
Objections. Melissa Skelton Duke, president-elect of the Utah Society of Health-System Pharmacists, said she is resigned to the new law, which was passed over the Society's objections.
"Rather than incorporating physician dispensing rules into the pharmacy practice act, the law created an exemption that would allow [oncologists] to dispense medications outside of the pharmacy practice act," Duke said. "This is very much an exception in Utah compared to how dispensing is regulated in other states."
"I think we are making the best of the situation, [but] we still are very much opposed to removing pharmacy from the process," she said.
As the original bill was making its way through the state legislature, ASHP and the Institute for Safe Medication Practices likewise stated their opposition to the law.
"We tried to rally as many different stakeholders as we could to fight this," Duke said. "A lot of support is available if you know how to ask for it."
In a letter to state legislators, ASHP noted that physician dispensing is "carefully regulated" throughout the country, with some states requiring special licensing or registration of physicians who engage in dispensing.
The final version of Utah's law requires physicians to notify the Division of Occupational and Professional Licensing of their intent to dispense cancer medications but does not require a license or other certification.
Mission creep. This year's law had its roots in 2010, when ophthalmologists and weight-loss specialists in Utah lobbied for office-based dispensing of certain drugs. In response, the state passed its first physician-dispensing law, which exempted physicians from the state's pharmacy practice act for the purpose of dispensing bimatoprost ophthalmic solution and human chorionic gonadotropin injection.
"That was the first crack in the door of physician dispensing in our state," said David Young, associate professor at the University of Utah College of Pharmacy in Salt Lake City and chair of the Utah Pharmacy Board.
Oncology specialists followed suit this past year, raising the specter of different physician specialties advocating in succession for their own exemptions from the pharmacy practice act. Young called this process "a very inefficient way to do physician dispensing."
According to meeting minutes from the board of pharmacy, Utah State Representative Evan Vickers, one of the bill's two cosponsors, has indicated there will be a moratorium on exempting other specialty groups until more is known about physicians' dispensing practices.
"What came out of this past year's legislative session really was, 'Yes, this is doable for these folks, but let's all take a collective breath and maybe take a bigger look at the issue,'" Young said.
Pharmacy board records state that Vickers, a pharmacist, decided to cosponsor the bill and work to improve it instead of letting it pass as originally written.
"He was able to get a bunch of language in there saying that if you are going to do this, you're going to be held to the same standards as pharmacies," Young said. "If you're going to allow folks to dispense but have no standards, that makes no sense at all."
The study. A fiscal note that was attached to the law authorizes $26,200 in total funding during fiscal years 2013 and 2014 to support a study of physicians' dispensing practices, which will be conducted by the University of Utah College of Pharmacy.
According to the board of pharmacy, the study will examine state laws that allow practitioners to dispense and will review information about dispensing from the National Association of Boards of Pharmacy, state boards of pharmacy, and legal databases. If funding permits, the study will also allow pharmacists to visit Utah physician practices where dispensing occurs and determine whether it conforms to the state pharmacy board's rules.
Young believes the study will be the largest in the country to examine physician dispensing.
"The idea was to get a better scope of what's going on in our state and, potentially, nationally" he said. "It's not just an issue here; it's an issue that multiple states are grappling with."
What's next. Young said a preliminary report on dispensing practices will be presented to legislators in November. As of late September, he said, no physicians had notified the professional licensing division about their intent to dispense cancer medications.
Nationally, about 5% of oncology medications are dispensed from physicians' offices, according to a recent report from the Zitter Group, a managed-care consulting company.
Young expects that physician dispensing will occur in Utah, but he said it may not unfold the way oncologists expected when they proposed the law.
"I'm not sure that all of these places and providers that would be doing this fully understood all of the other stuff that they have to follow that we have to follow as pharmacists," he said.