Skip to site navigation Skip to main content Skip to footer content Skip to Site Search page Skip to People Search page

Alerts and Updates

DEA Issues Proposed Rule on E-Prescribing

July 10, 2008

DEA Issues Proposed Rule on E-Prescribing

July 10, 2008

Read below

Physicians and Pharmacists Be Aware

On June 27, 2008, the Drug Enforcement Administration (DEA) released a Notice of Proposed Rulemaking. In an effort to modernize the regulation of controlled substances, the DEA is proposing an amendment to its regulations that would permit practitioners to write and pharmacies to dispense and archive prescriptions of controlled substances electronically. The new regulations aim to promote accuracy and efficiency. The DEA seeks public comment.

Current regulations require a practitioner to sign a prescription for a controlled substance by hand in the same fashion he would sign any other legal document. Pharmacies must ensure the accuracy and authenticity of the prescription, and archive the paper prescription.

DEA cited several considerations supporting the modernization of controlled substance regulation. According to DEA, illegible handwriting, misunderstood oral prescriptions and similarly named drugs often lead to inaccurate prescription dispensation. Also, electronic prescriptions capable of being automatically linked to medical records can quickly alert pharmacists to potentially dangerous drug interaction and patient allergies prior to dispensing the drug. However, any medical record linking must conform to HIPAA guidelines ensuring confidentiality.

The DEA is seeking comment on specific issues related to modernizing the regulation of controlled substances. First, DEA solicits feedback highlighting protections currently in use in electronic submission services, including but not limited to safeguards against intermediary interference with prescriptions and current practitioner enrollment processes. Electronic services such as Electronic Health Records (EHR) and Electronic Medical Records (EMR) systems approved by SureScripts and Certification Commission for Healthcare Information Technology (CCHIT) are of primary interest.

Additionally, DEA would like updated statistics regarding physicians' ability to send non-controlled substance prescriptions electronically via EHR and EMR, and the functionality of such systems. The DEA also seeks to analyze the present state of multi-factor tokens, such as a username and password, plus a one-time use password sent to a device in possession of a registered user. DEA hopes that comments will give insight into how current systems affect non-controlled substance prescription diversion and fraud, which would in turn assist in improving the proposed DEA regulations related to electronically prescribing controlled substances.

In addition to comments regarding the current state of electronic prescription practices, the DEA seeks alternative solutions for electronic prescribing of controlled substances that meet DEA standards for regulating controlled substances. The suggestions should also be as effective as the National Institute of Standards and Technology guidelines for Level 4.

Written comments must be postmarked and electronic comments must be sent on or before September 25, 2008.

For Further Information

If you have any questions about this Alert or would like more information, please contact Frederick R. Ball, any of the other lawyers in the Pharmaceutical, Medical Device, Pharmacy & Food industry group, or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.