DEA Proposes Rules for e-Prescribing Controlled Substances

Proponents of electronic prescribing were encouraged recently when the DEA proposed regulations that would allow e-prescribing of controlled substances. If adopted, the new regulations would give physicians and other prescribers the option of adding Schedule II drugs to the other medications they routinely prescribe electronically.

Steven Waldren, M.D., director of AAFP's Center for Health Information Technology, called the DEA action long overdue. "Our stance has always been that physicians should have the freedom to e-prescribe, regardless of the medication," he said.

Although controlled substances are not the most often prescribed drugs in the country, they represent a significant proportion of prescriptions, says the DEA. In December 2007 testimony before Congress, the agency noted that prescriptions for pharmaceutical controlled substances make up about 10 percent to 11 percent of all prescriptions written in the United States.

That's significant, said Waldren, because "until there's one process for e-prescribing all drugs, the medical community won't fully realize the workflow efficiencies that the technology allows.

"This action should have been taken several years ago," he added.

A June 27 DEA press release about the action said the proposal could potentially reduce prescription errors due to illegible handwriting and misunderstood verbal prescriptions. The proposed rule, which was published in the June 27 Federal Register (at the Federal Register main page, type "electronic prescribing, controlled substances" in the "2008 [Volume 73] Only" search field), also would permit pharmacies to receive, dispense and archive electronic prescriptions.

Security issues have long clouded the issue of e-prescribing controlled substances. The DEA is subject to mandates under the Controlled Substances Act that call for a closed system of control for manufacturing, distributing and dispensing controlled substances.

Waldren said it's the mandated "level-four security" that the AAFP intends to investigate further and comment on during the DEA's public comment period, which ends Sept. 25.

The Academy is concerned about security "overkill" with multiple safeguards, such as user names, passwords, personal identification numbers and so-called crypto keys -- a thumb drive-like device that plugs into the physician's computer, said Waldren. He added that too many federal barriers hamper family physicians' ability to realize the increases in safety and efficiency afforded by e-prescribing.

Waldren said he doesn't expect much, if any, opposition to the proposed e-prescribing regulations. "This is something that's being pushed at all levels; the AAFP had a meeting many months ago at the White House and talked to key staffers. We've talked to members of Congress about this, as well," he said.

Both the U.S. House and Senate have introduced bills promoting e-prescribing for Medicare beneficiaries. And late in 2007, the American Health Information Community submitted a list of recommendations regarding mandatory e-prescribing to HHS Secretary Michael Leavitt. Near the top of the list was a call to enable e-prescribing of controlled substances before any federal mandates on e-prescribing for Medicare beneficiaries go into effect.