News Archive: Prescribing and Dispensing Controlled Substances in LTCs

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News Archive

September 2010
ASCP Submits Comments and Questions to HIT Standards Committee

September 28, 2010
ASCP submitted comments and questions to the HIT Standards Committee regarding the 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.

August 2010
ASCP Seeks Changes to DEA Regulations, Responds to June Federal Register Notice

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 to a June 29 DEA Request for Information Notice, “Dispensing of Controlled Substances to Residents at Long-Term Care Facilities,” ASCP requested that DEA clarify through formal rulemaking or a 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.

June 2010
ASCP, APhA, ASHP and NCPA Submits Comments Regarding the Interim Final Rule for Electronic Prescribing for Controlled Substances

In a joint effort, ASCP, APhA, ASHP and NCPA submitted comments 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.

May 2010
ASCP Submits Comments to DEA Regarding the Interim Final Rule for Electronic Prescribing of Controlled Substances

ASCP submitted comments 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.

April 2010
ASCP Releases Summary of DEA’s Interim Final Rule for Electronic Prescribing of Controlled Drugs
ASCP released a full summary 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:

  • Identify Proofing and Logical Access Controls
  • Two Factor Authentication
  • Authorization of Controlled Substance Prescriptions
  • Monthly Logs
  • Transmission to the Pharmacy
  • Changes to the Prescription Paper Copies
  • Audit Trails and Audit Requirements
  • Record Keeping
  • Pharmacy Responsibilities
  • Pharmacy System Requirements

March 2010
Senate Special Committee on Aging Hold Hearing

Joseph Rannazzisi of DEA submitted testimony 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 before the Senate Special Aging Committee focusing on four key points:

  1. How strict compliance with DEA rules delays patient access to needed controlled medications as revealed in the ACPP nationwide survey of clinicians.
  2. The conflicts between DEA rules and standards of practice in long-term care.
  3. How ASCP and others have worked with DEA over many decades to try to resolve these conflicts.
  4. Recommendations to move toward a more balanced regulatory approach with ensures that patients’ needs come first but also recognizes the need for effective controls to reduce diversion risk.

December 2009
Assistant Attorney General Ronald Weich Submits a Letter to The Honorable Herb Kohl

Assistant Attorney General Ronald Weich submitted a letter 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.

October 2009
QCCPP Releases Issue Brief Regarding DEA Regulations and Access to Medications for Seniors in Nursing Home and Terminally-Ill Patients

QCCPP released an Issue Brief 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
U.S. Senators Herb Kohl and Sheldon Whitehouse submitted a letter 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.

September 2009
ASCP Partners with Organizations and Individuals in Long-Term Care Submit a Letter in Response to August 6, 2009 "Dear Practitioner" Letter

ASCP partnered with various individuals and organizations to submit a response 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.

August 2008
DEA Releases a "Dear Practitioner" Letter to Provide Guidelines

The DEA released a "Dear Practitioner" Letter 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.

March 2009
DEA Issues Request for Comment in the Advance Notice of Proposed Rulemaking on the Disposal of Controlled Substances by Persons Not Registered with DEA

ASCP submitted comments 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:

  • The Food and Drug Administration (FDA), CMS, EPA and DEA work together to develop a comprehensive, coordinated set of national guidelines for the disposal of all unused medications, both controlled and non-controlled.
  • Encouragement for outreach to and education of health care providers on the national disposal guidelines.
  • Strong encouragement to consider operational efficiency and both direct and indirect business costs for any disposal method that the Agency recommends or mandates.

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