Controlled substances, LTC nurses, and verbal drug orders

July 15, 2010

The relationship between prescribing practitioners and nurses working in a long-term-care (LTC) facility is of significant concern to the LTC facility when controlled substances are needed.

Key Points

According to Drug Enforcement Administration (DEA) regulations, it is clear that a prescribing practitioner may engage an authorized "agent" to prepare and transmit drug orders to a dispensing pharmacy on the prescribing practitioner's behalf. Nevertheless, by means of an April 25, 2001, notice in the Federal Register (66 Fed. Reg. 20834), DEA enforcement activity, and informal discussions with DEA, DEA has made it known that it will not recognize an "agency" relationship between a prescribing practitioner and an LTC nurse.

This current DEA position represents a departure from DEA's 1995 letter to the Missouri Department of Health. That letter was drafted by G. Thomas Gitchel, chief, Liaison and Policy Section of the Office of Diversion Control at DEA on September 7, 1995. The letter expressly stated that "DEA will permit a physician or other practitioner to designate, in writing, a responsible individual at an LTC facility to act as his or her agent for the purpose of communicating oral prescriptions for controlled substances in Schedule III and IV to a pharmacy servicing the facility."

In this regard, DEA stated that "[b]ecause of different shifts and staff turnover, it is suggested that authority be granted to a specific position (e.g. head nurse) rather than a specific individual. Such authorization may not be granted to the multiple positions at the long-term-care facility or its staff as a group."

DEA did caution interested parties that a prescribing practitioner who delegated authorization would be responsible for the activities of the "employee or employees acting as his or her agent, just as he or she would if the agent were an employee under the direct control and supervision of the practitioner."

In this regard, DEA ensured that a registrant, i.e., the physician, would be held responsible in the case of any drug diversion.

At the time, DEA voiced its concern about expediting the delivery of prescription medication to patients in the LTC sector. DEA's view was balanced, in that it considered patient care and sought to prevent any drug diversion. Although it was at all times concerned with the possibility of drug diversion, DEA responsibly determined that patient care should not be undermined.

Regrettably, DEA has departed from its 1995 position and currently will not recognize an employee nurse at an LTC facility as the authorized agent of a prescriber. This leaves many pharmacies scrambling as they try to track down an unavailable physician at the expense of timely patient care.

NED MILENKOVICH is a member at McDonald Hopkins LLC and chairs its Drug and Pharmacy Practice Group. He is also a member of the Illinois State Board of Pharmacy. Ned can be reached at 312-642-1480 or at nmilenkovich@mcdonaldhopkins.com
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