|September 22, 2011|
Previously published on September 20, 2011
Last week Senator Herb Kohl (D-WI) introduced a bill (S. 1560) to facilitate controlled substance access for residents of residential long-term care facilities. The proposed bill, which would amend the federal Controlled Substances Act (“CSA”), specifically 21 U.S.C. §§ 802 and 829, is a long-awaited resolution for long-term care patients’ inability to obtain much-needed, faster access to controlled pain medication. As Senator Kohl stated, “The law should prevent suffering, not make it worse .... Unfortunately, DEA’s [controlled substance] crackdown has left elderly nursing home residents waiting for hours or even days for relief from excruciating pain. This legislation would help end these needless and avoidable delays.”
The 2011 bill traces its origins back to at least October 2009 when Senator Kohl, who is Chairman of the Special Committee on Aging and a Member of the Judiciary and Appropriations Committees, corresponded with Department of Justice ("DOJ") concerning long-term care patients’ lack of access to controlled substances in emergency situations (and attached proposed legislation along with that correspondence). Because of DOJ’s perceived delay in taking action, and then-acting DEA Administrator Michelle Leonhart’s delay in addressing this serious issue, Senator Kohl placed a senatorial hold on Leohnart’s pending nomination as DEA Administrator, preventing the nomination from proceeding to the full senate until the DEA made “more progress towards our goal of ensuring that nursing home residents get timely access to the prescription drug care they need.” Kohl added, “[e]very day nursing home patients continue to suffer from agonizing pain and we need an interim solution as soon as possible.”
Senator Kohl lifted his hold on Leonhart’s nomination, however, only after the Department of Justice (and Attorney General Eric Holder personally) provided assurances in December 2010 that DOJ would deliver draft legislation in the beginning of 2011 outlining certain changes to the CSA. This proposed bill appears to make good on this promise.
The amendments to the CSA would permit nurses or licensed health care professionals (i.e., designated agents) to transmit a practitioner’s oral prescription for a schedule II-IV controlled substance to DEA-licensed pharmacies. In exchange, nursing homes, practitioners, and pharmacies would have to account for the controlled substances in a rigorous manner. Senator Kohl stated that the changes are necessary to permit long-term care patients in chronic and debilitating pain access to schedule II substances much faster than waiting for the written prescription of a practitioner: Waiting serves only to deny the patient more immediate access to much needed pain medication.
Note that DEA had issued a policy statement in October 2010 to permit nursing home residents to more quickly access certain controlled substances, but not schedule II drugs. Under that policy, a nursing home’s licensed health care professionals can, acting as an authorized agent of a physician, transcribe the physician’s oral prescription for schedule III, IV or V medications to a pharmacy for dispensing. However, the policy statement did not go far enough; it does not permit the oral transcription from a practitioner to an agent for a schedule II drug, many of which are those that are most urgently needed to treat pain in a long-term care environment.
Senator Kohl’s proposed legislation would amend the CSA to give DEA statutory authority, unlike the DEA October 2010 policy statement, to allow licensed health care professionals to transmit prescriptions for schedule II controlled substances. Titled the “Nursing Home Resident Pain Relief Act of 2011,” a physician will be able to authorize the administrator of the long-term care facility to designate nurses and other appropriately licensed health professionals to act as “facility designees,” or agents. The facility designee will be able to transmit a prescription and administer pain-relieving controlled substances to residents whose medical conditions warrant immediate pain relief, based on the transmission of a valid oral prescription from the registered practitioner to the facility designee. Under the proposed law, an administrator of a long-term care facility will be able to designate one or more qualified individuals to serve as a designee for the administration of controlled substances, and the practitioner will similarly authorize in writing the scope of the authorization, i.e., for none, some or all controlled substances regardless of their schedule.
The proposed law also allows for a facility designee to transmit an oral prescription for a schedule II medication during an emergency in limited situations. The proposed law requires detailed pharmacy verification of oral prescriptions transmitted by facility designees, including a requirement that, not later than 72 hours after dispensing the controlled substances pursuant to an oral prescription, the pharmacy will be required to transmit a copy of the prescription document that it received from the facility designee to the prescribing practitioner. The practitioner must then endorse and return within 5 days to the dispensing pharmacy the copy of the prescription that it received from the pharmacy. The dispensing pharmacy must attach the practitioner-endorsed prescription to the document that the pharmacy received from the facility designee. If the pharmacy does not receive an endorsed prescription from the practitioner within the 5-day period, the pharmacy is prohibited from dispensing other controlled substances for the long-term care facility until endorsements are received. The pharmacy is required to notify DEA if the physician endorsement is not received within a 10-day period of time -- beginning on the date on which the pharmacy transmitted notice to the prescribing practitioner. The proposed bill invites the Attorney General to define by regulation the term “oral prescription.” In addition to permitting a facility designee to transmit and dispense a controlled substance prescription, the bill also modifies and codifies regulations for dispensing in emergency situations, which are currently set forth at 21 C.F.R. § 1306.11(d).
The bill would also require that all parties to the transaction keep and maintain written records documenting each step in the prescribing and dispensing process. The requirements include a written attestation by the facility designee verifying that the designee has spoken personally with the prescribing practitioner and that all the required information provided by the practitioner was completely and accurately recorded. If the facility designee transmits the prescription to a pharmacy by facsimile, that facsimile will serve as the original written prescription and must be maintained by the pharmacy in accordance with the CSA and its regulations.
The legislation provides strong criminal and civil penalties under the CSA, including individual or personal liability for long-term care administrators for the wrongful acts of facility designees, for diverting drugs or violating recordkeeping requirements.