DEA ends restrictions on controlled substance e-Rx

Jim Frederick

With a regulatory stroke, the Obama White House has swept away the last serious legal hurdle set by the federal government to the nationwide conversion of the healthcare system to the electronic prescribing and transmission of prescription drugs.

The breakthrough came in June when the U.S. Drug Enforcement Administration struck down legal impediments to the electronic prescribing of controlled substances. The change comes with the agency’s release in June of interim final rules governing prescribing practices, which successfully culminated a 10-year battle by pharmacy and technology interests to modernize all facets of the prescription prescribing and dispensing process.

The federal prohibition against paperless prescribing of controlled substances—a prohibition based on outmoded concerns over the safety of digitally prescribed and stored prescriptions for higher-risk medications—had long bedeviled efforts by pharmacy and industry groups to spur universal adoption of the technology by the nation’s prescribing physicians. The DEA’s decision to eliminate that barrier marked a major victory for those groups.

Chain pharmacy representatives were jubilant. “This is the first time ever that there can be a coordinated e-prescribing system for both controlled and noncontrolled prescription medication,” the National Association of Chain Drug Stores stated. “The prior inability to utilize e-prescribing for controlled substances frequently was reported as a major barrier to physician adoption of e-prescribing.”

NACDS president and CEO Steve Anderson said the DEA’s decision marked “truly a historic day for the healthcare system, as this rule will allow much-needed health information technology solutions to better serve patients.”

NACDS and other groups have worked collaboratively over the past decade with the DEA, the Department of Health and Human Services, pharmacy partners, such intermediaries as Surescripts, technology vendors and others to extend paperless prescribing to controlled substances. In partnership with the National Community Pharmacists Association, the chain pharmacy group created Surescripts in 2001 to foster the nationwide adoption of e-prescribing and provide a network platform for its use.

More than 97% of the nation’s chain community pharmacies now use pharmacy applications that have been tested and certified through Surescripts, according to NACDS, and the number of prescriptions routed electronically grew from 68 million in 2008 to 191 million in 2009.

Despite those gains, however, a large majority of family physicians and their practices—roughly 3-out-of-4 of them—still hand-write prescriptions and rely on their patients to carry them to the pharmacy for dispensing.

Although “electronic health record adoption is picking up rapidly, with an estimated 27% of physicians using some kind of EHR, the vast majority of medical records in the United States are still on paper, with the average appointment taking 13 pages to document,” confirmed Karen Riley, a spokeswoman for the New York eHealth Collaborative and the NYC Regional Electronic Adoption Center for Health.

The adherence problem—whereby many patients simply never even fill a written prescription—also points to the gap that remains between the point of prescribing and the local pharmacy. That gap swallows many written scripts. In one recent study, researchers at Harvard Medical School found the problem of “primary nonadherence” is rampant. Tracking 75,000 patient visits, they found that 22% of first-time patient prescriptions were never filled.

Allowing e-prescribing of tightly controlled pain relievers and other medications likely won’t bridge most of that gap. But it will help simplify the prescribing process for family doctors and specialists.

Opening controlled substances to the world of electronic data storage and communications has long been a top priority for Surescripts. “There’s a high demand for it, both at the state level, where they want to track the use of controlled substances, as well as at the federal level,” former Surescripts CEO Kevin Hutchinson told Drug Store News.

Now, that hurdle has been vaulted. The real transformation of the nation’s healthcare system still depends on how quickly doctors embrace health information technology.

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