Controlled Medication in Long-Term Care
The Controlled Substances Act (CSA) gives the Drug Enforcement Administration (DEA) the authority to enforce rules that dictate 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.
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 with acknowledgement that the regulations were less practical in a long-term care environment. Starting in 2009, DEA became increasingly strict in its enforcement and began inspecting prescribing and dispensing practices of long-term care providers and pharmacies and issuing large fines, which began in the state of Ohio followed by additional states.
Below is a summary of events and actions that ASCP has taken as well as work done by the multidisciplinary, multi-stakeholder stakeholder Quality Care Coalition for Patients in Pain (QCCPP) with relationship to DEA.
DEA Releases Federal Register Notice on Electronic Prescriptions for Controlled Substances Clarification
October 19, 2011
DEA released a Federal Register notice  (PDF) on clarification on electronic prescriptions for controlled substances. Clarifications from DEA surround third-party audits of electronic prescriptions of controlled substances applications.
Release of Nursing Home Residents Pain Relief Act of 2011
September 14, 2011
Sen. Herb Kohl (D-Wisconsin) introduced the Nursing Home Residents Pain Relief Act of 2011 (S. 1560)  (PDF). The legislation is intended to help ensure that nursing home residents have timely access to Schedule II pain medication in a timely fashion. 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
August 24, 2011
DEA responded in correspondence  (PDF) 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 Submits Comments to the DEA for Development of Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users
January 12, 2011
ASCP provided input  (PDF) in consideration of DEA’s development of procedures for the surrender of unwanted controlled substances by ultimate users on long-term care facilities. ASCP urged DEA to consider the unique practice setting of long-term care facilities with seven items for DEA to consider.
ASCP Submits Comments to EPA Regarding Best Management Practices for Unused Pharmaceuticals
November 9, 2010
The ASCP provided comments to the EPA  (PDF) in response to a solicitation for public comments on the draft guidance document titled “Best Management Practices for Unused Pharmaceuticals at Health Care Facilities.” The comments address various sections of the draft where guidelines are not applicable to long-term care settings or additional guidance is needed.
ASCP Joins with Other Pharmacy Organizations Representing More than 200,000 Pharmacists, Practitioners and Other Patient Caregivers Regarding Constructive Transfers
October 29, 2010
Eight professional organizations including ASCP signed a letter  (PDF) 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
October 6, 2010
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 Submits Comments and Questions to HIT Standards Committee
September 28, 2010
ASCP submitted comments and questions  (PDF) to the HIT Standards Committee regarding DEA interim final rule for electronic prescribing of controlled substances and e-prescribing in the long-term care environment. Questions surrounded the application of DEA IFR in the long-term care setting including: whether the IFR would permit prescribers to use an LTC e-prescribing program for controlled substances prescriptions, whether nursing facilities which can view electronic prescriptions from the practitioner need to send the prescription back to the practitioner for transmission to the pharmacy, what is meant by “as soon as possible” for transmission of a prescription after a signature by a practitioner and whether a long-term care facility EHR can be defined as an intermediary.
ASCP Seeks Changes to DEA Regulations, Responds to June Federal Register Notice
August 30, 2010
ASCP asked the DEA to consider changes to the Controlled Substances Act regulatory framework to improve timely access to controlled medications for residents in long-term care settings. In a letter response  (PDF) to a June 29 DEA Request for Information Notice, “Dispensing of Controlled Substances to Residents at Long-Term Care Facilities ,” (PDF), ASCP requested that DEA clarify through formal rulemaking or policy statement the statutory definition of “agent” in relation to a physician who prescribes controlled medications to patients in long-term care facilities. ASCP recommended that DEA recognize nurses as agents of physicians who prescribe controlled medications to patients in long-term care facilities and patients enrolled in Medicare- or state-certified hospice programs. ASCP also asked DEA to recognize patient charts containing controlled medication orders as valid prescriptions.
ASCP, APhA, ASHP and NCPA Submits Comments Regarding the Interim Final Rule for Electronic Prescribing for Controlled Substances
June 1, 2010
In a joint effort, ASCP, APhA, ASHP and NCPA submitted comments  (PDF) to the interim final rule regarding electronic prescriptions for controlled substances. The comments submitted request additional clarification surrounding changes to electronic prescription orders, the use and responsibilities of digital signatures, standardizing internal code number systems, re-routing/transferring prescriptions, and workflow procedures for long-term care settings. Additionally, the comments also make suggestions for certification/audit entities and emergency fill procedures.
ASCP Submits Comments to DEA Regarding the Interim Final Rule for Electronic Prescribing of Controlled Substances
May 24, 2010
ASCP submitted comments  (PDF) to DEA on the Interim Final Rule for Electronic Prescribing of Controlled Substances  published in the Federal Register on March 31, 2010. The comments focused on the following topics: compatibility with LTPAC pharmaceutical management workflow, changes to the prescription, compatibility with current and emerging transaction and certification standards, and physician adoption in LTPAC settings.
ASCP Releases Summary of DEA’s Interim Final Rule for Electronic Prescribing of Controlled Drugs
ASCP released a full summary  (PDF) of DEA’s interim final rule regarding electronic prescribing of controlled substances. The regulations provide practitioners with the option of writing prescriptions for controlled substances electronically and also permit pharmacies to receive, dispense, and archive these electronic prescriptions.
The major features of the IFR include:
Senate Special Committee on Aging Hold Hearing
March 24, 2010
Joseph Rannazzisi of DEA submitted testimony  (PDF) before the Senate Special Committee on Aging entitled “The War on Drugs Meets the War on Pain: Nursing Home Patients Caught in the Crossfire.” DEA maintains that it has and continues to implement regulations that allow for proper prescribing and dispensing of controlled substances currently and with evolving technologies in long-term care settings.
Ross Brickley RPh, MBA, CGP, Past President of ASCP, submitted testimony  (PDF) before the Senate Special Aging Committee focusing on four key points:
Assistant Attorney General Ronald Weich Submits a Letter to The Honorable Herb Kohl
December 2, 2009
Assistant Attorney General Ronald Weich submitted a letter  (PDF) to the Honorable Herb Kohl in response to the Senator’s letter concerning the issue of prescribing controlled substances at Long-Term Care Facilities. In the letter, the Assistant Attorney General supports the current DEA rules and regulations and argues that relying on nurses to submit chart orders of controlled substances and or independently submitting an order without a prescriber’s knowledge “trivialize the doctor-patient relationship and weaken the quality of care for the frail and infirm.”
QCCPP Releases Issue Brief Regarding DEA Regulations and Access to Medications for Seniors in Nursing Home and Terminally-Ill Patients
October 28, 2009
QCCPP released an Issue Brief  (PDF) to highlight pharmacists, physicians, nurse practitioners, and nurses concern over DEA’s rules and regulations being applied in long-term care settings including the critical role of nurses in long-term care and hospice and chart orders.
U.S. Senators Herb Kohl and Sheldon Whitehouse Submit a Letter to Attorney General Eric Holder
October 19, 2009
U.S. Senators Herb Kohl and Sheldon Whitehouse submitted a letter  (PDF) to Attorney General Holder regarding the CSA as a barrier to providing pain relief and other medications in a timely manner in long-term care and hospice settings.
ASCP Partners with Organizations and Individuals in Long-Term Care Submit a Letter in Response to August 6, 2009 "Dear Practitioner" Letter
September 3, 2009
ASCP partnered with various individuals and organizations to submit a response  (PDF) to the August 6. 2009 "Dear Practitioner" Letter. This letter was endorsed by 50 state and national associations and companies that represented every sector and discipline within long-term care and hospice. In addition, over 100 clinicians signed-on to the letter. The letter asked DEA to explain their policies, provide guidance and to ask DEA to work with stakeholder groups to develop a workable framework for prescribing and dispensing controlled drugs for long-term care residents and hospice patients.
DEA Releases a "Dear Practitioner" Letter to Provide Guidelines
August 6, 2009
The DEA released a "Dear Practitioner" Letter  (PDF) to provide guidelines for whether a pharmacists can prepare a written version of a physician’s verbal order and fax back the order for the physician to sign. The letter also addresses what elements of a prescription that a pharmacist can correct.
DEA Issues Request for Comment in the Advance Notice of Proposed Rulemaking on the Disposal of Controlled Substances by Persons Not Registered with DEA
March 23, 2009
ASCP submitted comments  (PDF) to DEA in response to an advanced notice of rulemaking  on disposal of controlled substances by persons not registered with the DEA issued January 21, 2009. The comments addressed questions that DEA had put forth to the public and made the following recommendations: