NCPA Offers DEA Proposed Solution to Balance Patient Needs in Long-Term Care Facilities with Drug Diversion Concerns


Alexandria, VA - August 31, 2010

The National Community Pharmacists Association (NCPA) has proposed that the U.S. Drug Enforcement Administration (DEA) create a new DEA registration sub-category within the "Institutional Practitioner" category in order to break a regulatory logjam that is delaying many seniors who reside in long-term care (LTC) facilities from getting timely access to medication to alleviate severe pain.

"The current system related to the lawful and prompt dispensing of controlled substances in long-term care facilities is broken," NCPA said yesterday in comments submitted to the DEA in response to the agency's request. "Recent changes in interpretation and enforcement of the Controlled Substances Act have made it more difficult to provide needed prescription drugs to LTC patients in a timely manner."

At issue is the DEA's revised interpretation of the Controlled Substances Acts (CSA), which has upended what for years had been accepted practice in long-term care facilities: utilizing nurses to relay information between the physicians and pharmacists, when a direct physician-pharmacist communication was impractical, to ensure the timely administration of critical medications used to treat residents' pain. DEA's current enforcement approach allows such "nurse as agent" exchanges in a hospital setting, but not in long-term care facilities.

In its comments to DEA, NCPA proposed that the agency promulgate a proposed rule to create a new sub-category of DEA registrant known as an "institutional facilitator" that would allow nurses to resume communicating valid prescriptions to the pharmacist so that the appropriate medicine is administered to the patient on a timely basis. NCPA suggested defining an "institutional facilitator" as "a long-term care facility licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which it practices, to facilitate the administration of controlled substances to the end user in the course of professional practice."

"This solution provides for the common goal of ensuring timely medication access to patients in pain while recognizing the DEA's mission to enforce the controlled substances laws and regulations of the United States," NCPA said.

NCPA also told the agency:

  • Joseph Rannazzisi, DEA Deputy Assistant Administrator, Office of Diversion Control, publicly stated that a new class of registrant, such as NCPA proposes, would be a viable option in comments to the Senate Special Committee on Aging on March 24, 2010.
  • "Time is of the essence as current policies have caused needless instances of patient harm. Realizing that a long-term solution may take time, DEA must act quickly to implement interim guidance addressing the 'nurse-as-agent' issue until such time as permanent changes can be achieved."
  • The current requirements strain the physician-pharmacist relationship as pharmacists are forced to either threaten noncompliant prescribers with DEA notification or risk jeopardizing their pharmacy practice if they don't report violations of the short-sighted rules.
  • Pharmacists are presently confronted with the ethical and legal dilemma of either not filling a prescription for patients in pain and violating practice standards or violating DEA's interpretation of the CSA.
  • Approximately 31 percent of all independent community pharmacies service a long-term care facility, with the majority located in areas with a population of less than 20,000.

The National Community Pharmacists Association (NCPA®) represents America's community pharmacists, including the owners of more than 22,700 independent community pharmacies, pharmacy franchises, and chains. Together they represent an $88 billion health-care marketplace, employ over 65,000 pharmacists, and dispense over 40% of all retail prescriptions. To learn more go to www.ncpanet.org or read NCPA's blog, The Dose, at http://ncpanet.wordpress.com.

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