The Drug Enforcement Agency (DEA) is posting in the Federal Register on Wednesday an interim final rule that would permit hospitals, healthcare providers, and pharmacies to use electronic prescriptions in the dispensing of controlled drugs. Comments on the rule will be open for 60 days.
The rule is similar to a regulation proposed by DEA in June 2008 for e-prescribing. That provision ran into trouble when federal healthcare providers told DEA that the approach proposed for the private sector was inconsistent with their existing practices and did not meet the security requirements for federal systems.
Under current regulations, while providers can create prescriptions electronically for controlled substances, those prescriptions are either printed out for signatures or faxed to a pharmacy. "True electronic prescriptions are transmitted as electronic data files to the pharmacy, whose applications import the data file into its database," the rule noted.
The new interim rule adds the option of using of biometric identifiers—such as a fingerprints, iris scans, or handprints—to help authenticate the identity of the e prescribing user. In the new regulation, users of e prescribing systems for controlled substances would have to prove their identities by using two out of three factors: something you know (passwords), something you have (tokens), or something you are (biometrics).
In the new rule, DEA said it is allowing the use of a biometric as a substitute for a hard token or a password. If a hard token is used, it must meet specified security standards for cryptographic devices or one time password devices, and it must be stored on a device that is separate from the computer in use.
"Allowing for electronic prescribing of controlled substances—while maintaining rigorous controls to prevent illegal diversion and protect privacy—is key to unleashing the vast cost saving and quality improvement potential of health information technology," said Sen. Sheldon Whitehouse (D-RI), a member of the Senate Judiciary Committee, in a statement. "This new interim rule from the DEA and DOJ brings us one step closer to that goal."
The rule addresses the use of controlled substances that "have a potential for abuse and psychological and physical dependence" such as opioids, stimulants, depressants, hallucinogens, and anabolic steroids. Controlled substances constitute between 10% and 11% of all prescriptions written in the U.S.