DEA enforces written order requirement for schedule II drugs

A coalition of physicians, nurses and pharmacists argues that the agency is delaying some patients' access to pain relief.

By Kevin B. O’Reilly — Posted Nov. 18, 2009

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Concerned about the diversion of controlled substances in nursing homes, hospice care organizations and long-term-care facilities, the U.S. Drug Enforcement Administration no longer is allowing pharmacies to dispense schedule II drugs based on chart orders.

The DEA has taken actions against long-term-care pharmacies in Ohio, Virginia and Wisconsin for violating the Controlled Substances Act. The agency says the federal law requires that, except in emergencies, doctors provide written orders directly to pharmacists. Following an emergency, a written order authorizing the prescription is required within seven days. Pharmacists who fill schedule II orders without a written prescription could face fines or criminal prosecution from the DEA.

A letter from the DEA about these requirements is available online (link).

Traditionally, physicians have given orders for schedule II drugs verbally to nurses who enter them as chart orders and send them to pharmacies for dispensing.

The AMA House of Delegates at its 2009 Annual Meeting asked the Association to urge the DEA to recognize "nursing staff as agents of the prescriber/physician in long-term-care facilities." The AMA has met with the DEA and says it will follow-up with the organization and affected physicians "until this issue is satisfactorily resolved."

The agency's change has put law enforcement and patient care at loggerheads, said Claudia Schlosberg, director of policy and advocacy at the American Society of Consultant Pharmacists.

One potential drawback is that about 40% of doctors working as medical directors for U.S. facilities do not have an office, making it difficult for them to fax orders.

"The DEA has put health care professionals in a very difficult position where they have a professional obligation to treat their patients in an adequate and timely fashion, but if you do that, you're violating the Controlled Substances Act," Schlosberg said. "It's a real dilemma."

The society has convened a group of organizations representing medical directors, palliative care physicians, nurses, pharmacists and others to protest the DEA's actions. The group is known as the Quality Care Coalition for Patients in Pain (link).

In meetings with Schlosberg, the AMA and others, the DEA has said it has no choice but to enforce the law as written in the Controlled Substances Act.

On Oct. 19, Sen. Herb Kohl (D, Wis.), chair of the Senate Special Committee on Aging, and committee member Sen. Sheldon Whitehouse (D, R.I.) sent a letter to Attorney General Eric Holder asking him to back a legislative fix in the law. The DEA is working with the Justice Dept. on a response to the letter, a DEA spokeswoman said.

"The DEA's requirements impose extraordinary additional burdens on not just the physician but on the pharmacist and the nurse as well," Schlosberg said. "Everyone's struggling now to comply with these rules that, essentially, don't work."

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