Allowing e-Rx for Controlled SubstancesInterim Final Rule spells out guidelines
The rule is slated to be officially published in the Federal Register on March 31 and become effective 60 days later.
DEA is soliciting comments during the 60-day period, especially on its anti-fraud provisions. These include identity proofing; access control; authentication; biometric subsystems and testing of those subsystems; internal audit trails for electronic prescription applications; and third-party auditors and certification organizations.
The regulation requires those submitting e-prescriptions to use two-factor authentication. "However, while DEA is requiring in this interim final rule that the authentication credential be two-factor, DEA is seeking further comments on this issue," the rule notes.
The rule also permits the use of biometric technology as a substitute for a hard token or password.
To view the interim final rule, click here. The 334-page rule will permit pharmacies to receive, dispense and archive electronic prescriptions for controlled substances.
"The regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing," the DEA states in opening comments to the rule.
"Additionally, the regulations will reduce paperwork for DEA registrants who dispense controlled substances and have the potential to reduce prescription forgery. The regulations will also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions.
"Moreover, they will help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which may increase efficiency, and potentially reduce the amount of time patients spend waiting to have their prescriptions filled."