February 6, 2008

Drug Agency Announces Progress on New E-Prescribing Rules

Senate Hearing Chaired by Whitehouse Pushed DEA for Answers on Lifting Prohibition Against Electronic Prescriptions for Controlled Substance

Washington, D.C. – In the wake of tough questions from U.S. Senator Sheldon Whitehouse (D-R.I.), the Drug Enforcement Administration (DEA) has announced new progress on regulations lifting the federal prohibition against electronic prescriptions for certain medications classified as scheduled drugs. In written responses to questions Whitehouse raised during a Senate Judiciary Committee hearing he chaired in December, the agency said it had “provided the Department of Justice with a proposed rule regarding the electronic prescribing of controlled substances.”

Whitehouse, a former prosecutor and strong advocate for health information technology, called the news “encouraging” but noted that the issue is far from settled. In its written response, DEA said it could not predict how long the approval process would take. Both the Office of Management and Budget (OMB) and the Department of Justice are required to review the proposed rule.

“E-prescribing for controlled substances is long overdue. With millions of Americans securely transmitting credit card and bank account information electronically, there’s no reason a doctor shouldn’t be able to prescribe Vicodin electronically,” Whitehouse said. “I’m glad to see DEA acknowledge the need to move forward with new rules, and I’ll be watching closely over the next several months to make sure this process stays on track.”

Studies show that widespread e-prescribing, used today in about 18 percent of doctors’ practices, could save $20 billion annually, as patients would experience fewer adverse drug events (ADEs) and would be more likely to adhere to a medication regimen. The Center for Information Technology Leadership (CITL) found that a national e-prescribing system could prevent 2.1 million ADEs – 130,000 of which are life-threatening – and 190,000 hospitalizations per year.

Current DEA regulations require that doctors write paper prescriptions for controlled substances, such as pain medications, antidepressants and some drugs used to treat asthma in children. As a result, many doctors resort to writing all their prescriptions by hand rather than maintain a paper system for controlled substances and an electronic system for non-controlled substances.

During the Judiciary Committee hearing, Whitehouse and Senator Tom Coburn (R-Okla.) pressed DEA Deputy Assistant Administrator Joseph T. Rannazzisi, of the Office of Diversion Control, on DEA’s timeframe to revise the existing rules, stressing that further delay could slow the development and implementation of a nationwide, integrated system to support health information technology. “You’ve seen intense bipartisan concern about this. This is not an issue where we’re going to go away,” Whitehouse said at the hearing.

Rannazzisi agreed to inform the Committee, within two months, on when a proposed rule would be issued. Following the hearing, Whitehouse and 18 other senators wrote to Attorney General Michael Mukasey, asking him to review the issue and urging the Drug Enforcement Administration to issue new rules promptly.

Whitehouse served as U.S. Attorney for Rhode Island and the state’s Attorney General. The founder of the Rhode Island Quality Institute, a leader in the state’s efforts to promote electronic prescribing and health information technology utilization, Whitehouse has also introduced Senate legislation to establish a private, non-profit corporation tasked with developing a national, interoperable, secure health IT system (S. 1455).


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