It's been 10 years since the Drug Enforcement Administration briefly mentioned in a Federal Register notice that long-term care nurses are not inherently authorized to communicate controlled substance prescriptions to pharmacies on behalf of DEA-registered practitioners. Since then, providers had directed the complaints of suffering residents toward the DEA as proof that the dispensing of these essential pain medications was inefficient and being delayed, and that its regulation needed to be changed.
Except that in the case of nurses acting as agents of prescribing physicians, the regulation was actually not an issue. While the DEA made it known that nurses are not agents of the prescriber, it never said they could not be, so long as an explicit agency agreement is made to establish a valid relationship between individual practitioners and individual nurses.
Aware that providers did not fully understand this regulation, the DEA published a statement of policy this past October articulating how it interprets the Controlled Substances Act, reiterating its definition of an agency relationship. It clarified that nurses can indeed receive authorization from practitioners to communicate prescriptions for some of these highly addictive substances—the less intense Schedule III through V substances, to be precise.
In the effort to achieve clarity, however, the DEA ultimately inspired ambivalence. Provider organizations and advocates said that while the statement of policy was a “small step forward,” it still did not address some critical concerns, such as excluding nurse agents from orally communicating the higher potency Schedule II painkiller prescriptions (which is in fact federal law not up to DEA discretion). It was also argued that nurse positions, rather than individual nurses, be given agent of the prescriber authority.
“[W]e believe the designation to an individual rather than a position will present significant operational challenges for nursing facilities, physicians, pharmacies, alike,” Evvie Munley, senior health policy analyst at the American Association of Homes and Services for the Aging, wrote on the association's Future of Aging blog right after the statement of policy appeared. As Munley explained, attending physicians will need to sign an agreement with at least one individual on every shift at a facility to ensure a designated agent is available at all hours of the day. With nurses leaving for vacation, holiday, or even termination, it may be impractical to have enough individual agreements signed for a facility to remain compliant.
Unfortunately for providers, it's unknown when these concerns will be addressed. But in the here and now, there are specific compliance issues—and advice—providers should be aware of to keep themselves legal.
Three big questions
This past fall, the National Community Pharmacists Association (NCPA) announced the creation of a new division for “advancing the interests of independent long-term care pharmacy providers.” The division's announcement came just before the DEA's statement of policy on nurse agents, seemingly timed to appear alongside the first big issue it needed to tackle. Susan Janeczko, PharmD, a former lead clinician on the Medicare.gov Web site, was appointed NCPA's director of Long-Term Care Policy and Regulatory Affairs. Janeczko says the DEA released this statement of policy because of confusion from an April 2001 notice in the Federal Register that mentioned long-term care nurses are not agents of the prescriber. “The DEA was just saying [at that time], ‘Listen, the nurses currently do not act that way because there are no agreements, and we see this as a situation where you would need explicit agreements to grant that agency,’” she says.
DEA notes that in a 2001 notice […] DEA briefly discussed the role of nurses in the narrow setting of (long-term care facilities) outside of an employer-employee relationship and where no affirmative actions established an agency relationship between the individual practitioner and the LTCF nurse. This incidental example and other informal discussions have resulted in the need for this published articulation […] DEA regulations on the role of authorized agents in communicating controlled substance prescriptions to pharmacists generally have not changed.
—DEA statement of policy, Federal Register, October 6, 2010
Janeczko also states it is “a bit of a surprise” that the DEA would demand these explicit agreements to grant agency when the Controlled Substances Act itself does not request them. “It is in the DEA's discretion in how it reads the law and what it requires, but it is a little disappointing because it does create burdens on the system that we feel didn't need to exist, that the law does not technically require there to exist,” Janeczko says.
There were other issues with the policy as well. The NCPA met with the DEA in early November for a discussion and received answers to three especially large, lingering questions, Janeczko says.
The first question Janeczko had for the DEA was, “To whom can agency status be assigned?”
“You have that presumption of agency for the nurse or secretary who is an employee of the physician, but who else? Does everyone else need to have an agreement signed?” Janeczko says. The answer is, yes, an agreement must be signed for all other individuals that would communicate controlled substance prescriptions for the physician. This keeps a prescribing physician from signing one blanket agreement that grants agency to all nurses at a facility. Also, pharmacists may not serve as agents of the physician, although they are allowed to send prescribers “reminder letters” for scrips that need to be refilled, Janeczko reports in NCPA's November newsletter, which Long-Term Living was given access.