| Welcome to ASCP's DEA Resource Center Welcome to the new and improved DEA Resource Center! Please contact us if there's something you'd like to see listed here. Please choose one of the following areas: DEA Issues Coalition  New DVD Available: Navigating DEA Rules in the Long-Term Care Setting  This new informational video explains DEA rules and provides guidance on common scenarios and questions that long-term care professionals will likely encounter, such as dealing with hospital discharge orders that contain controlled medications and accessing controlled medications from the emergency kit. Preview of Video Available by clicking here. Educational objectives of the video:
Latest DEA News August 10, 2010 Senate Aging Committee Releases Discussion Draft Bill for LTCF Registration In yet another twist in the long-running issue with DEA, the Senate Special Committee on Aging under the direction of Senator Herb Kohl (D-WI), in conjunction with the Senate Judiciary Committee, has released a discussion draft of an untitled bill proposing to amend the Controlled Substances Act (CSA), which would create a registration category for nursing homes. The objective of the proposed new CSA authority is to promote the timely administration of controlled substances in nursing home settings. The draft discussion bill was released publicly following a meeting between Aging Committee staff and officials from the DEA and the Department of Justice (DOJ). July 29, 2010 Ohio Board of Pharmacy Registration and Waiver Proposal Sent to DEA ASCP has received the final draft of of the proposed long-term care facility registration category description developed by the ad hoc pharmacists group under Ohio’s Board of Pharmacy, which was submitted to DEA this week. (Download the proposal here.) Other stakeholders have not had an opportunity to review and provide formal comments on this proposal. However in the weeks preceding the release of this draft, feedback provided by members, including the ASCP Advocacy Council, helped us to develop a set of criteria required for ASCP to support any solution being considered as a fix for patient access to controlled pain medications. In general, an appropriate solution would incorporate:
June 29, 2010 DEA Issues Request for Comment in Consideration of Possible CSA Revisions to Accommodate LTCF Residents The Drug Enforcement Administration (DEA) issued a notice today in the Federal Register requesting the public's feedback on whether the agency should revise existing regulations in order to make it easier for residents in long-term care facilities (LTCFs) to gain access to controlled substance medications. DEA is specifically seeking comments from practitioners, pharmacists, LTCFs, nurses, residents and families of residents in long-term care. This request for comment appears to be directly related to the decades-long advocacy efforts of ASCP, as well as the work done by the multidisciplinary, multi-stakeholder Quality Care Coalition for Patients in Pain (QCCPP). Representatives from all aspects of long-term care have long requested relief from the wait experienced by patients denied timely access to narcotic pain medications due to DEA regulations that are not compatible with the long-term care practice model. DEA's request for comment presents stakeholders with another opportunity to seek changes to the Controlled Substances Act (CSA) that would allow for the LTCF nurse to be recognized as the agent of the prescribing physician and to allow chart orders to be recognized as valid prescriptions for controlled substance medications. The request for comments concludes with a list of 56 questions for which DEA would like comments. Some of these questions are fairly basic and reflect a need for more information and better understanding by DEA about fundamental aspects of LTCF operations. In other cases, the questions are attempting to solicit anecdotes or evaluate the scope or frequency of problems in LTCFs that result from DEA regulations. ASCP's comments will be managed through the Policy & Advocacy department with support from our leadership committees including the Advocacy Council, the Executive Committee and the Board of Directors. Members working on this issue at the local chapter level may get involved by joining our Grassroots Network. To join ASCP's Grassroots Network, click here: http://bit.ly/grsignup May 24, 2010 ASCP Files Comments on DEA Interim Final Rule on E-Prescribing of Controlled Substances In March, the Drug Enforcement Administration (DEA) released an interim final rule for the electronic prescribing of controlled substances. The rule provides practitioners with the option of writing prescriptions for controlled substances electronically and also permits pharmacies to receive, dispense, and archive these electronic prescriptions. However, the system and process requirements are unclear for the unique pharmaceutical care management requirements and workflows pertinent to long-term care and other post acute providers (collectively referred to as “LTPAC” providers) such as nursing facilities, hospice, home health care and assisted living communities. Although the interim final rule went into effect June 1, 2010, the DEA did accept public comments on the rule. ASCP sent an individual comment letter in addition to a joint letter with the American Society of Health-System Pharmacists, American Pharmacists Association, and National Community Pharmacists Association. Our individual letter focused on four major issue areas:
May 10, 2010 1995 DEA Letter on Nurse as Agent A recent newsletter from McDonald Hopkins, LLC contains an article on a 15-year-old letter from the Drug Enforcement Administration (DEA) to the Missouri Department of Health explicitly “permit[s] a physician or other practitioner to designate, in writing, a responsible individual at a LTCF 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." The letter, dated September 7, 1995, also explains how a long-term care facility and prescribing practitioner can create this relationship through a written document. Specifically, DEA states that a document should be created and signed by the prescribing practitioner and that copies should be retained by both the practitioner and the long-term care facility. DEA also recognizes the different staffing patterns in long-term care and therefore suggests that “authority be granted to a specific position (e.g., head nurse) rather than a specific individual.” However, DEA states that authorization “may not be granted to the multiple positions to the long term care facility or its staff as a group." Importantly, the DEA’s 15-year-old letter contradicts what the DEA has stated to ASCP in meetings – that the only way that an agency relationship can be established is through employment. However, the guidance does suggest that DEA may have greater leeway based upon its legal authorities to recognize the LTC facility nurse as an agent of the practitioner even when no employment relationship exists. As announced after the Senate listening session on controlled substance dispensing barriers, ASCP is actively working with DEA and NABP to address: (1) the nurse-as-agent issue and (2) the recognition of chart orders as valid prescription orders in the LTC setting. We anticipate receiving revised policy from DEA on these practice issues in the near future. Until then, we recommend that pharmacies and long-term care facilities consult with their legal counsel regarding the implications of this letter. ASCP would like to acknowledge Ned Milenkovich, PharmD, JD of McDonald Hopkins, LLC for sharing this letter. - Click here to download the letter May 3, 2010 ASCP Sends Letter To DEA Requesting Guidance On How To Annotate Tamper Resistant Prescriptions Faxed To LTC Pharmacies ASCP members have raised concerns about dispensing controlled substances based upon prescriptions written on tamper resistant prescription pads that have been faxed to the pharmacy. By design, these prescriptions appear in the pharmacy with a prominent watermark identifying the prescription as "void," or "illegal," while the original prescription that is not sent to the pharmacy appears valid. The situation creates an increased risk of diversion and potentially exposes long-term care pharmacies to risk upon audit or inspection. ASCP has asked DEA for guidance on how to handles these prescriptions to minimize both of these concerns. April 13, 2010 ASCP Issues Summary of DEA e-Prescribing Rule ASCP has prepared a summary of DEA’s Interim Final Rule for Electronic Prescribing of Controlled Drugs which was published in the Federal Register on March 31, 2010.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. Although the regulations go into effect on June 1, 2010, DEA is seeking further comments on a number of key issues. Further, the rule is not self-implementing. In fact, it may take many months before the infrastructure is in place to support the full implementation of these rules in ambulatory and long-term care settings. ASCP has prepared a summary of the Interim Final Rule that is designed to provide you with a top line understanding of its key requirements. ASCP is working with the National Council of Prescription Drug Plan Programs (NCPDP), other long-term care providers, and other pharmacy associations to develop additional technical analysis of the rule. We will also be preparing comments. Please note, if you would like to comment on the IFR, comments must be filed no later than June 1, 2010. All comments must reference "docket no. DEA-218." Written comments sent via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrisette Drive, Springfield, VA 22152. Electronic comments may be sent through http://www.regulations.gov using the electronic comment form provided on the site. For questions regarding the IFR, please contact ASCP at govaff@ascp.com. March 30, 2010 DEA Releases Long Awaited e-Prescribing Interim Final Rule The long-awaited Drug Enforcement Administration (DEA) interim final rule (IFR) was released last week. Almost 2 years earlier, on June 27, 2008, DEA published a Notice of Proposed Rulemaking (NPRM) to revise its regulations to allow the creation, signature, transmission, and processing of electronic controlled substance (CS) prescriptions. Many in the industry felt that the inability to process CS prescriptions electronically has hindered prescriber adoption of electronic prescribing (e-prescribing). DEA's IFR is classified as a major rule subject to Congressional review. The effective date will be 60 days after publication in the Federal Register (proposed date March 31, 2010). DEA is requiring a two-factor authentication for practitioners prescribing electronic CS prescriptions. The DEA is specifically asking: "Is there an alternative to two-factor authentication that would provide an equally safe, secure, and closed system for electronic prescribing of controlled substances while better encouraging adoption of electronic prescriptions for controlled substances? (page 28)" In a major change from the proposed rule, the IFR would allow the CS prescription to be reviewed by the LTC facility nurse after being digitally signed by the prescriber and before it is transmitted to the pharmacy as long as the practitioner authenticated electronic prescription is not modified before or during transmission (page 30). In preparation for the release of the DEA rule, ASCP members have been working with the National Council for Prescription Drug Plans (NCPDP) LTC Work Group 14 on possible solutions to assure this DEA rule will work in the Long Term and Post Acute Care (LTPAC) setting. The NCPDP LTC Work Group EHR HL7 Task Group will be meeting on April 7th to begin evaluating the e-prescribing SCRIPT standard to assure the DEA IFR and two factor authentication works in the LTPAC environment. NCPDP formed a special task group to review and formulate the DEA IFR comments as it relates to the SCRIPT. This task group will be co-chaired by ASCP President Spiro (representing NCPDP WG14) and will begin meeting on April 14th in time to meet the 60 day comment period. March 25, 2010 ASCP Leaders Testify at "Listening Session" Before US Senate On March 24, ASCP leaders Ross Brickley and Robert Warnock, both certified geriatric pharmacists, testified before a Senate Special Committee on Aging "listening session" entitled, "The War on Drugs Meets the War on Pain: Nursing Home Patients Caught in the Crossfire." Senator Herb Kohl (D-WI), Chairman of the Senate Special Committee on Aging, presided. The purpose of the session was to examine the challenges associated with dispensing of pain medication in nursing homes across our country, an issue Senator Kohl termed "very serious -- one that impacts the daily well-being and comfort of millions of elderly Americans."
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