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. This article discusses that proposed rule.
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 or she would sign any other legal document. Pharmacies must ensure the accuracy and authenticity of the prescription and archive the paper prescription.
The DEA cited several considerations supporting the modernization of controlled substance regulation. According to the 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, the 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 record (EHR) and electronic medical record (EMR) systems approved by SureScripts and the Certification Commission for Healthcare Information Technology (CCHIT) are of primary interest.
Additionally, the DEA would like updated statistics regarding physicians' ability to send noncontrolled substance prescriptions electronically via EHR and EMR systems, and the functionality of such systems. The DEA also seeks to analyze the present state of multifactor tokens, such as a username and password, plus a one-time-use password sent to a device in possession of a registered user. The DEA hopes that comments will give insight into how current systems affect noncontrolled 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.
Frederick R. Ball is a trial lawyer focusing his practice in areas in which companies or individuals are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, DEA, CMS and other regulatory agencies. Mr. Ball also regularly deals with enforcement of noncompetition agreements, protection of trade secrets and regulatory compliance.