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Notice

Electronic Prescriptions for Controlled Substances; Notice of Meeting

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Notice of meeting.

SUMMARY:

The Drug Enforcement Administration (DEA), in conjunction with the Department of Health and Human Services (HHS), is conducting a public meeting to discuss electronic prescriptions for controlled substances. Specifically, this meeting is intended to allow industry—prescribers, pharmacies, software/hardware vendors, and other interested third parties—to address how electronic prescribing systems can meet DEA's prescription requirements under the Controlled Substances Act, without unduly burdening the parties to electronic prescribing transactions.

DATES:

This meeting will be held Tuesday, July 11, 2006, and Wednesday, July 12, 2006, 8:30 a.m. until 5:30 p.m. Registration will begin at 7:30 a.m. This meeting will be held at the Marriott Crystal City at Reagan National Airport, 1999 Jefferson-Davis Highway, Arlington, VA 22202; (703) 413-5500. The meeting will take place in the Crystal Forum amphitheatre, adjacent to the hotel.

Meeting Attendance: To ensure proper handling, please reference “Docket No. DEA-218N” on all written and electronic correspondence regarding this meeting. Persons wishing to attend this meeting, space permitting, must provide attendee information to the Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, via e-mail to dea.diversion.policy@usdoj.gov, or via facsimile, (202) 353-1079, as specified below. Persons wishing to attend the meeting must provide this information to the Liaison and Policy Section no later than June 26, 2006.

Comments: All written comments will be made available at the Diversion Control Program Web site, http://www.deadiversion.usdoj.gov prior to the public meeting. Therefore, as this is a public meeting, confidential business information or other proprietary information SHOULD NOT be presented at this meeting.

Persons wishing to provide written comments must do so no later than June 26, 2006. To ensure proper handling of Start Printed Page 28053comments, please reference “Docket No. DEA-218N” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. Comments may be directly sent to DEA electronically by sending an electronic message to dea.diversion.policy@usdoj.gov. DEA will accept attachments to electronic comments in Microsoft word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here.

This meeting will consist of panel presentations. There will be limited opportunities for attendees to make oral comments at the meeting.

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FOR FURTHER INFORMATION, CONTACT:

Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, telephone: (202) 307-7297.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Many within the health care industry are encouraging the adoption of electronic prescriptions because such prescriptions would improve patient safety by eliminating medical errors that arise from misread or misunderstood handwritten prescriptions. These parties also focus on the potential cost savings, both to industry and the public, realized from, among other benefits: fewer medical errors and adverse drug events; fewer callbacks from pharmacies to practitioners to clarify handwritten prescription information; and reduced ability and opportunity to commit fraud and diversion of prescription medications. The focus of these parties is to facilitate adoption of electronic prescribing as quickly as possible to obtain the benefits that are expected to follow.

Both the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have an interest in electronic prescribing. DEA is responsible for enforcing the Controlled Substances Act, including the prescribing and dispensing of controlled substances to the public by DEA-registered practitioners and pharmacies. Such enforcement includes the writing and signature of prescriptions and retention of prescription records.

The Department of Health and Human Services has a statutory mandate to facilitate adoption of electronic prescribing. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires that “prescriptions * * * for covered Part D drugs prescribed for Part D eligible individuals that are transmitted electronically shall be transmitted only in accordance with such standards under an electronic prescription drug program” that meets the requirements of the MMA (Pub. L. 108-173). HHS is required to promulgate transmission standards for the Medicare electronic prescription drug program. HHS adopted foundation standards regarding transmission of electronic prescriptions for covered Part D drugs prescribed for Part D eligible individuals by publication of a Final Rule which became effective January 1, 2006 (70 FR 67567, November 7, 2005).

HHS also has a statutory mandate under the Health Insurance Portability and Accountability Act (HIPAA), the Administrative Simplification provisions of which require HHS to adopt standards for the electronic transmission of health information contained in certain financial and administrative transactions. HIPAA also requires HHS to adopt standards for the security of electronic health information, and, in consultation with the Department of Commerce, to adopt standards for electronic signatures for certain HIPAA transactions. These regulations and standards are applicable to all health plans (including federal health programs), healthcare clearinghouses, and all health care providers who conduct electronic transactions.

Therefore, DEA, in conjunction with HHS, is conducting a public meeting to allow the public, including prescribers, pharmacies, software/hardware vendors, and other interested third parties, to identify electronic signature solutions for electronic prescribing which mitigate, to the greatest extent possible, any cost and burdens associated with adoption of the new technology while addressing the security and accountability requirements under the Controlled Substances Act of 1970 as they relate to controlled substances. Specific questions which persons are encouraged to address are as follows:

  • What is your perception of the current risks associated with electronic prescribing?
  • How did you identify those risks?
  • How does your electronic prescribing system address those risks?
  • Are risks pertaining to prescriptions for controlled substances different from prescriptions for non-controlled substances? Please explain.
  • What additional modifications would be necessary for your system to be used for electronic prescribing of controlled substances? Please be specific as to how this would be done, and the burden (cost or otherwise) this would entail.
  • How does your system authenticate the person signing the prescription?
  • How does your system ensure the integrity of the prescription records?
  • What current and future threats (e.g., eavesdropping, man-in-the-middle attack, hijacking, impersonation) to system-wide security have you considered during your design, development, and implementation?
  • If smart cards, open networks or other methods of transmission are used to facilitate electronic prescribing, can your system work within those environments? Please specifically explain how it can or why it cannot.

Meeting Participation

This meeting is open to the public. Persons and organizations representing prescribers, pharmacies, and vendors who design, develop, or market electronic prescribing software or hardware/software used to permit electronic prescribing [authenticate individuals or used to sign or secure electronic documents] may be particularly interested in this meeting.

Persons wishing to attend this meeting, space permitting, must provide the following information to the Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, no later than June 26, 2006 via e-mail or facsimile using the contact information listed above:

Name:

Title:

Company/Organization:

Address:

Telephone:

E-mail address:

Persons needing accommodations (e.g., sign language interpreter) are requested to notify DEA with their accommodation request no later than June 26, 2006.

This meeting will consist of panel presentations. There will be limited opportunities for attendees to make oral comments at the meeting.

Persons wishing to provide written comments may do so no later than June 26, 2006. All written comments will be made available at the Diversion Control Program Web site, http://Start Printed Page 28054www.deadiversion.usdoj.gov prior to the public meeting. Therefore, as this is a public meeting, confidential business information or other proprietary information SHOULD NOT be presented at this meeting. Please see the “Comments” section above for further information regarding providing written comments.

Start Signature

Dated: May 9, 2006.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control.

End Signature End Supplemental Information

[FR Doc. E6-7302 Filed 5-12-06; 8:45 am]

BILLING CODE 4410-09-P