Magazine article Drug Topics

DEA Issues Interim Final Rule on E-Prescribing of Controlled Drugs

Magazine article Drug Topics

DEA Issues Interim Final Rule on E-Prescribing of Controlled Drugs

Article excerpt


The Drug Enforcement Administration (DEA) has released its long awaited interim final rule for electronic prescribing of controlled substances. The new rule became effective on June 1, 2010, and could be revised later on the basis of public comment. The current rule is based on proposals published in June 2008.

"In general, we are pleased," said Ronna Hauser, vice president of policy and regulatory affairs for the National Community Pharmacists Association (NCPA). "DBA will need to come out with some clarifications to this interim final rule, but they clearly addressed some of our concerns on earlier proposals."

NCPA and other pharmacy organizations have been working with DBA for more than a decade to draft and re fin e rules to apply electronic prescribing to controlled substances. Bpr escribing for controlled substances is not likely to happen for at least another year, cautioned Marcie Bough, director of federal regulatory affairs, American Pharmacists Association (APhA), but the broad outlines appear to be practical for pharmacists, prescribers, and the DBA.

"This rule helps increase the utilization of e-prescribing," Bough said. "There have been real challenges in implementing e-prescribing because DBA was still an open question. This is a step in the right direction, but it is likely that there will be system changes and upgrades needed by some pharmacies before it is up and running. We are still waiting to see the real impact."

The new rule coordinates electronic prescribing for controlled substances and noncontrolled pharmaceutical products. More than 97% of chain pharmacies are equipped to receive and process electronic scripts, according to the National Association of Chain Drug Stores (NACDS). B-prescribing penetration is lower among independents, according to NCPA, but the vast majority of independent pharmacies can also accept e-scripts.

APhA, NCPA, the American Society of Consultant Pharmacists (ASCP), and the American Society of Health-System Pharmacists (ASHP) issued a joint comment on the new rule the day it became effective. The four organizations requested clarification on the way changes and transfers to e-scripts will be made and digital signatures verified, long-term care workflow procedures, standardization of internal codes used to identify individual prescribes working under an institutional DBA registration, options for emergency fills, and additional certification agencies for all practice settings. …

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