The rule is available at the Federal Register's public inspection site at federalregister.gov/inspection.aspx, and will be officially published on March 31, effective 60 days later. The DEA will accept public comments during the 60-day interval.
Controlled substances are drugs that have the potential for abuse or dependence, including opiates, stimulants, depressants, hallucinogens and anabolic steroids. These drugs account for up to 20 percent of all prescriptions, according to various studies, which has forced providers that have adopted electronic prescribing to still maintain paper processes.
The rule will permit pharmacies to receive, dispense and archive electronic prescriptions for controlled substances. The regulations, according to DEA, are an addition to, not a replacement of, existing rules governing 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; additionally, the regulations will reduce paperwork for DEA registrants who dispense controlled substances and have the potential to reduce prescription forgery," according to the interim final rule. "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."
It's these expected benefits that industry stakeholders, and a growing number of members of Congress, have been trying to convince DEA to appreciate for nearly a decade. The agency has considered such a rule since at least May 2001 when it issued an advanced notice of proposed rulemaking on the topic. But it wasn't until four years later than the DEA began to examine how to revise its rules to permit electronic prescriptions.
In December 2007, a 50-member coalition of stakeholders sent President Bush a letter asking for movement on the issue. "The country can no longer afford to have a two-tiered prescribing system," the letter stated. Nineteen U.S. Senators soon followed with their own letter. The agency finally published a proposed rule in June 2008, and 11 senators sent another letter in May 2009 asking for the final rule.
--Joseph Goedert
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