DEA Issues Proposed Rule On E-Prescribing

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...