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). “DEA 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 DEA for more than a decade to draft and refine rules to apply electronic prescribing to controlled substances. E-prescribing 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 DEA.

“This rule helps increase the utilization of e-prescribing,” Bough said. “There have been real challenges in implementing e-prescribing because DEA 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). E-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 prescribers working under an institutional DEA registration, options for emergency fills, and additional certification agencies for all practice settings.

NACDS expressed similar concerns in a separate comment.

NCPA is happy with the new 2-year electronic record-keeping requirement. The proposed rule had called for retaining electronic prescription records for 5 years. DEA also relaxed verification procedures.

“They were very concerned with keeping the closed distribution system closed,” Hauser said. “Now we can all start moving forward.”

One of the biggest hurdles is verification of electronic signatures, she continued. Not every prescriber or pharmacy is equipped to send or accept verified digital signatures.

Pharmacy groups are pushing DEA to make intermediaries responsible for verifying digital signatures just as they now verify other prescription details. One solution that has been suggested is to dedicate an existing field to digital signature verification.

APhA is focusing on ways to change and transfer electronic prescriptions for controlled substances. There are established procedures to change strength or other elements on a paper script, Bough noted, and to transfer a paper prescription between pharmacies. Similar changes will be needed once prescribers begin writing electronic prescriptions.

Hospitals face another problem. Many residents and other prescribers write for controlled substances using an institutional DEA number and add a numeric code for personal identification. DEA has not yet told prescribers or pharmacies how, or whether, these individual identifiers will be standardized.

“Pharmacies would like to standardize the suffixes added by some worksites, particularly institutions,” she said. “This is an opportunity for DEA and pharmacies and vendors to standardize internal code numbers to provide a greater margin of safety.”

Detailed information on the new rule is available online athttp://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html