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The Controlled Substances Act (CSA) gives the Drug Enforcement Administration (DEA) the authority to enforce rules that dictate the prescribing and dispensing of controlled substances to patients. The CSA was designed to protect public health and safety by preventing diversion and improper use while upholding the legitimate use of controlled substances, focusing on community and ambulatory settings.
Unfortunately, current DEA regulations are not appropriate for the long-term care environment, particularly as this setting has evolved over time. The implementation of the CSA has been a barrier to nursing home facilities in fulfilling the Centers for Medicare and Medicaid Services’ (CMS) requirement to provide appropriate routine and emergency pharmaceutical care in a timely manner under a prescriber’s order.
For many years, DEA did not strictly enforce its regulations on long-term care facilities, because of the acknowledgement that the regulations were less practical in a long-term care environment. Starting in 2009, DEA became increasingly stringent in its enforcement and began inspecting the prescribing and dispensing practices of long-term care providers and pharmacies, often issuing large fines.
The American Society of Consultant Pharmacists (ASCP) supports recognizing nurses as agents of the prescriber in long-term care and hospice settings and supports permitting pharmacists to dispense controlled substances based upon chart orders for residents in a long-term care facility. Such changes to current policy would remove the barriers currently standing between patients in these facilities and the medications they so desperately need. Minimizing the risk of diversion of controlled substances is a critical task, however ASCP believes that this mission should never put in jeopardy the care of our frail and dying patients.
This page contains information and resources pertaining to the Controlled Substances Act and potential new policies for consultant pharmacists and LTC facilities.
Release of Nursing Home Residents Pain Relief Act of 2011
Sen. Herb Kohl (D-Wisconsin) introduced the Nursing Home Residents Pain Relief Act of 2011 (S. 1560). The legislation is intended to help ensure that nursing home residents have timely access to Schedule II pain medications. It provides an additional method of transmitting Schedule II prescriptions to pharmacies in emergency situations by allowing participating skilled nursing facilities to appoint “facility designees,” which, with physician approval, can reduce oral orders to writing and transmit them to pharmacies. Prescribing physicians would then be required to sign a copy of the order within seven business days to continue using non-written prescriptions with that pharmacy. The proposed new method of prescription transmission would require additional record keeping by facilities, pharmacies, and physicians. Among other requirements, facilities would be obligated to maintain updated lists of facility designees, physicians would be obligated to maintain personal lists of orally transmitted prescriptions, and pharmacies would be required to maintain original and signed copies of orally transmitted prescriptions. It would also permanently prohibit the use of "fax-back forms."
DEA Writes a Letter to National Association of Boards of Pharmacy to Provide Guidelines on Information a Pharmacist May Provide When It Is Missing from a Schedule II Prescription
The DEA responded in correspondence to the National Association of Boards of Pharmacy letter to request guidelines on what pharmacists should do if schedule II prescriptions are missing information. In the letter, DEA wrote that it “expects that when information is missing from or needs to be changed on a schedule II controlled substance prescription, pharmacists use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.”
ASCP Joins with Other Pharmacy Organizations Representing More than 200,000 Pharmacists, Practitioners and Other Patient Caregivers Regarding Constructive Transfers
Eight professional organizations including ASCP signed a letter to DEA regarding DEA’s regulations on constructive transfer of intrathecal drugs. The letter supports constructive delivery of intrathecal drugs from pharmacies to treating physicians to ensure the sterility, efficacy and safety of the drug.
DEA Publishes Statement of Policy on Authorized Agents
DEA published a statement of policy (PDF) in the October 6 edition of the Federal Register clarifying the role of an authorized agent of a prescriber under existing law. The statement clarifies what authority an agent of a prescriber has, as well as specific applications of the law in long-term care with regards to how a valid prescription may be transmitted to a pharmacy. The statement also defines which persons may be designated the agent of a prescriber and provides recommended wording for a written authorization.
ASCP publishes official talking points on eliminating barriers to controlled medication access in the long-term care setting
ASCP’s talking points on eliminating barriers to controlled medication access in the long-term care setting outline ways in which the Controlled Substances Act may have adverse affects on patients in long-term care facilities. The talking points also outline ASCP’s recommendations to Congress for amending the Act.
For more news and information about prescribing and dispensing controlled substances in the long-term care setting, please visit the full News Archive.