Agents of the Prescriber

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.

Second, “How is the assignment of agent status accomplished?”

As mentioned, the physician may not sign a blanket agreement granting agency to all nurses at a facility. However, the physician can instead sign an agreement that assigns agency to multiple nurses who are listed by name on a single form, Janeczko reports. The DEA suggested in its statement of policy that all agreements be signed by the practitioner, the agent, and the dispensing pharmacist and they should also be kept on file to protect the long-term care facility in the event that agency status is ever in question.

Third, “What duties are authorized agents able to perform?”

Once an explicit agreement is made, pharmacists can begin accepting oral prescriptions conveyed by an authorized nurse, provided the prescriber has specified to the nurse all required prescription information. On the flipside, any written prescriptions faxed by the nurse must include the prescriber’s signature—even for Schedule III-V substances, Janeczko reports of the DEA’s current interpretation of the law.

With those questions answered in the DEA meeting, Janeczko says the most persistent issue is still that of Schedule II medications. “The DEA really does recognize them as the big problem here, and I do believe it will address them going forward,” she says.

Advice for providers

A few weeks after the DEA’s statement of policy appeared, the law firm Arnall Golden Gregory, LLP, distributed an alert to its clients with a breakdown of the policy and its suggestions to remain compliant. Attorney William Kitchens, one of the client alert’s authors, says the policy is a “good, clarifying statement” of what a nurse agent can and cannot do with regard to controlled substances and how the facility can document these agency relationships.

While the core responsibilities pertaining to prescribing controlled substances may not be delegated to anyone else, an individual practitioner may authorize an agent to perform a limited role in communicating such prescriptions to a pharmacy in order to make the prescription process more efficient.

—DEA statement of policy, Federal Register, October 6, 2010

“Our basic advice is you should have a written agency authorization so that there’s no question and no second guessing so you don’t have a situation where a physician says, ‘I did not give that nurse authorization to do these things,’” Kitchens says.

As previously stated, the DEA is allowing physicians to sign an agreement assigning agency to multiple nurses, listed by name, on one form. Arnall Golden Gregory advises against these types of agreements and has a more “conservative” approach for long-term care providers to follow.

“We’re telling people the best thing to do would be to have an individual agreement or agency documentation between each prescribing physician and each nurse,” Kitchens says. “Sometimes that’s not going to be practical. At a minimum we would say that you ought to have an agreement per doctor—in other words, you want to avoid situations where you have just one form where all the doctors who might be prescribing information for patients sign the same form with 10 nurses on there. Those situations can change and it makes it cumbersome when someone leaves the facility to have their authorization revoked.”

Finally, Kitchens says having individual agreement forms helps in instances where a long-term care facility needs to exercise disciplinary action against an employee who is an authorized agent. “During that period you would not want that person to have authorization to act as an agent, and that may be the facility’s decision,” Kitchens says. The individual’s agreement can easily be revoked without calling into question the other employees’ agreements. “That allows the facility to retain its own best judgment in terms of who should be engaged in acting as agents for physicians,” he says.

A future for Schedule IIs?

With the basic legal requirements that the DEA must abide, Kitchens says he doesn’t see the communication of Schedule II substance prescriptions by nurse agents being made easier any time soon. “I think the DEA is aware of the problems and it is frustrating on occasion, but until they get to the point where they’ve got an electronic prescribing system in place, I think people are just going to have to live through that,” he says sympathetically.

But maybe they won’t have to wait long after all. Janeczko reports in the NCPA newsletter that, with a number of third-party accounting firms already equipped to certify e-prescribing systems, the DEA envisions “e-prescribing for controlled substances actually possible early next year.” This is certainly good news for future long-term care residents who will require such medications to lessen pain, ensuring a more peaceful transition after surgery or through end-of-life care.

Long-Term Living 2010 December;59(12):14-19


Topics: Regulatory Compliance , Risk Management , Uncategorized