Dispensing Controlled Substances
The Nursing Home Resident Pain Relief Act of 2011
Long term care (LTC) and hospice providers in several states are experiencing significant delays in obtaining controlled substances prescriptions for their residents due to enforcement actions by the Drug Enforcement Administration (DEA) against LTC pharmacies pursuant to the Controlled Substances Act (CSA) and its implementing regulations. These enforcement actions, designed to reduce theft and diversion of Schedule II-V controlled substances, are instead resulting in residents being left for hours - and even days - without adequate relief to treat pain, seizures, psychiatric and end of life symptoms.
The DEA has taken the position that nurses in LTC facilities are not "agents of the practitioner", requiring that physicians fax prescriptions for Schedule II controlled drugs directly to LTC pharmacies. Each fax must be dated and signed on the date it is issued and contain the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed and directions for use and the name, address and registration number of the practitioner.
The only time that a pharmacist can dispense a Schedule II upon the verbal order of a practitioner is in an emergency situation, defined as (1) that immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user; (2) that no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II, and (3) that it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to dispensing. If a practitioner calls in a verbal order for a Schedule II in an emergency, the practitioner must deliver a valid, written prescription to the dispensing pharmacist within seven days. Reports of strict enforcement and fines emerged in Ohio in March 2009.
LTCPA and industry stakeholders are very concerned about the impact of strict enforcement of these DEA rules on resident care. LTCPA supports the ability of LTC and hospice providers in obtaining all necessary medications, including controlled substances, as medically prescribed, for their residents.
The Nursing Home Resident Pain Relief Act of 2011 | September 2011
The Nursing Home Resident Pain Relief Act of 2011 (S.1560) allows an individual practitioner who is providing medical care to a resident of an institutional LTC facility to enter into an authorizing agreement with a LTC facility administrator through which the administrator may designate qualified individuals to act as the practitioner's agent. Oral prescriptions may be communicated for a limited quantity of Schedule II controlled substances in emergency situations through this agency relationship.
Senate Judiciary Committee Hearing for DEA Administrator | November 2010
The Senate Judiciary Committee met to consider the confirmation of Michelle Leonhart as Administrator of the DEA. Senator Herb Kohl (D-WI) expressed his disappointment to Leonhart that the DEA had not resolved how to ensure that patients in nursing homes are not in pain due to the DEA’s interpretation of regulations around prescribing of controlled substances.
View Hearing (forward to minute 107:00 of the webcast)
DEA Broadens "Authorized Agent" Prescription Rules | October 2010
The DEA issued a Statement of Policy to provide guidance under existing law regarding authorized agents. The policy relates to the proper role of a duly authorized agent of a DEA-registered individual practitioner in connection with the communication of a controlled substance prescription to a pharmacy. The policy statement would allow the DEA to recognize a nurse working in a LTC facility to act as an agent of the practitioner when prescribing Schedule III-V medications.
DEA Requests Public Comment | June 2010
The DEA issued a Notice Requesting Public Comment in order to analyze ongoing issues related to the dispensing of controlled substances to residents residing at LTC facilities. The DEA is exploring whether possible revisions to regulations ensure residents of LTC facilities to receive controlled substance medications within the framework of the CSA.
Senate Special Committee on Aging Hearing | March 2010
The Senate Special Committee on Aging held a hearing entitled "The War on Drugs Meets the War of Pain: Nursing Home Residents Caught in the Crossfire". The hearing was called to examine the DEA's recent enforcement of long-standing rules under the Controlled Substances Act.
Asst. Attorney General Responds to Sens. Kohn and Whitehouse | December 2009
Assistant Attorney General Ronald Weich replied to Sens. Herb Kohl (D-WI) and Sheldon Whitehouse (D-RI) on behalf of the U.S. Department of Justice (DOJ) citing that recent enforcement activity is in direct response to complaints made by pharmacists and others who reported violations of the Controlled Substances Act and its implementing regulations. The DOJ further stated their concerns with business practices that increased the risk of diversion and “trivialize the doctor-patient relationship and weaken the quality of care”. The letter points out that the DEA’s licensing relationship is with the physician.
Sens. Kohl and Whitehouse Issue Letter to Attorney General Holder Jr. | October 2009
Sens. Herb Kohl (D-WI) and Sheldon Whitehouse (D-RI) wrote a letter to Attorney General Eric Holder, urging the Obama administration to issue new directives to the DEA and support a possible legislative fix for this issue which has concerned nursing home administrators and geriatric experts for years.
DEA Sends Out 'Dear Practitioner' Letter | August 2009
The DEA issued a "Dear Practitioner" letter based on LTC stakeholder requests to explain the DEA's interpretation and enforcement of a ruling that does not recognize the LTC nurse as an agent for the prescribing physician in a LTC setting in relation to Schedule II-V drugs. Unfortunately, the letter did not address "nurse-as-an-agent" designation or Schedule III-V drugs.
DEA Requests Public Comment | April 2001
The DEA issued a Notice Requesting Public Comment on preventing the accumulation of controlled substances at LTC facilities. Within this context, the DEA restates their position on the nurse-physician agent relationship by stating that, "no legal agency relationship exists between the LTCF nurse and the physician, this widely-used system is not in compliance with legal requirements."
1995 Thomas Gitchel Letter to Missouri DOH | September 1995
On September 7, 1995, G. Thomas Glitchel, chief, Liaison and Policy Section of the Office of Diversion Control at the DEA wrote a letter to the Missouri Department of Health expressly stating 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 the letter, DEA advised how a LTC facility and prescribing practitioner should handle such a relationship - stating that a document be created and signed by the prescribing practitioner with copies retained by both practitioner and LTC facility.