DEA publishes regulation permitting e-prescribing of controlled substances

The Drug Enforcement Administration (DEA) released an interim final rule (IFR) outlining the process for practitioners to have the option of electronically writing prescriptions for controlled substances. The IFR provides physician practices, hospitals, and pharmacies with the ability to use modern technology to issue these prescriptions while maintaining a closed system of controls over the dispensing of controlled substances. Key provisions of the IFR include:

  • The requirement that practitioners obtain authentication credentials from federally approved credentialing service providers or certification authorities. (Only DEA registrants may be granted the authority to sign e-prescriptions for controlled substances.)
  • A "two factor authentication" is required for the practitioner to prove his or her identify (i.e., a password and either a hard token, such as a security card, or use of a "biometric," such as retina or fingerprint)
  • No paper duplicates of the prescription are allowed, unless the transmission fails
  • The security system used by the e-prescription software must, to the greatest extent possible, prevent creation or alteration of a prescription for a controlled substance by unauthorized employees of the practice
  • Practice audit logs need to be modified to permit the development of a list of auditable events (i.e., events that indicate a potential security problem)
  • The e-prescription records must be reliable enough to be used in legal actions.

Physicians practices' current e-prescribing software and workflows will most likely need significant modification to comply with the DEA's IFR requirements especially in the area of security.