DEA issues rule on e-prescribing for controlled drugs

The Drug Enforcement Administration has released a long-awaited regulation on e-prescribing of controlled substances that is expected to remove a major barrier to use of the application.

The rule is similar to the DEA’s 2008 proposed regulation for e-prescribing, but it adds the option of using a biometric identifier, such as a fingerprint or iris scan, to authenticate the identity of the user of the e-prescribing system.

Under the rule, doctors would be able to electronically prescribe controlled substances such as morphine and other painkillers. Currently, doctors must use paperwork and fax machines for those substances. If they choose to prescribe other drugs electronically, the physicians have to maintain separate paper and electronic record systems, which many choose not to do.

The DEA on March 24 issued the 334-page Interim Final Rule on Electronic Prescriptions for Controlled Substances. It is expected to be officially published in the Federal Register on March 31, followed by a 60-day comment period.

“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 interim final rule states. “Additionally, the regulations will reduce paperwork for DEA registrants who dispense controlled substances and have the potential to reduce prescription forgery.”

The e-prescribing regulations also have the potential to reduce errors and help doctors and hospitals integrate their records, the document said.

The rule covers drugs and other substances that have a potential for abuse and street use, including opioids, stimulants, depressants, hallucinogens, and anabolic steroids. At the same time, the drugs have legitimate usages in medical care and in some practices make up a significant percentage of prescriptions, the DEA said.

The DEA in 2008 published a Notice of Proposed Rulemaking for e-prescribing of controlled substances that described a two-factor authentication rule. The new interim final rule maintains two factors while adding the possibility of a biometric.

In the new regulation, users of e-prescribing systems for controlled substances would have prove their identities with two of the following three factors: something you know (password); something you have (token) or something you are (biometric).

“Authentication based only on knowledge factors is easily subverted because they can be observed, guessed, or hacked and used without the practitioner’s knowledge. In the interim final rule DEA is allowing the use of a biometric as a substitute for a hard token or a password,” the IFR states.

The DEA said it is seeking further comments on alternatives to two-factor authentication while also encouraging e-prescribing.