How restrictive should the rules be for e-prescribing strong drugs?

Despite advances in modern medicine, when you go to a doctor's office, it's likely that the physician updates your file with a pen and gives you a prescription written on paper. Efforts to move those record-keeping systems into the 21st century have long been under way, particularly at larger hospitals and medical centers. But the push to prescribe controlled substances electronically is caught in an interagency tug-of-war between the Health and Human Services Department and the Drug Enforcement Administration.

Comment on this article in The Forum.In his 2004 State of the Union address, President Bush declared that electronic health records should follow most Americans within 10 years and said that such documents would help physicians "avoid dangerous medical mistakes, reduce costs, and improve care." But last week, the New England Journal of Medicine reported that fewer than 20 percent of doctors have moved to electronic record-keeping. One reason for the slow progress, advocates say, may be that doctors are reluctant to adopt one of the simplest forms of health technology: electronic prescribing.

Many physicians point out that the DEA forbids prescribing controlled substances electronically because hackers might be able to co-opt orders for such substances as OxyContin. Under the Controlled Substances Act, doctors can prescribe most drugs using computer systems that encrypt the information to safeguard it. But for controlled substances--from cough syrups containing codeine and antidepressants to powerful painkillers--a physician must sign a prescription slip that includes his or her DEA registration number. For the most highly regulated drugs, doctors must personally fill out the prescription form, and they cannot authorize refills.

Controlled substances account for about 10 percent of all prescriptions, and many doctors don't want to switch back and forth between pads and computers.

"If I want to write a scrip for Lipitor, I can do it through a completely encrypted process; but if I want to write a scrip for OxyContin, I pick up a pen. How insane is that?" asked John Halamka, chief information officer for Beth Israel Deaconess Medical Center in Boston, chairman of the U.S. Healthcare Information Technology Standards Panel, and a practicing emergency room physician. "It's crazy, and one of the biggest impediments to rolling out e-prescribing."

After Bush's 2004 speech, the DEA submitted a proposed rule to allow e-prescribing of controlled substances to the Office of Management and Budget for review. But OMB asked the Justice Department, which oversees the DEA, to withdraw the request, for unknown reasons, and HHS and the Justice Department have been negotiating on the issue ever since. DEA spokeswoman Rogene Waite said that there has been progress lately, and that the agency planned to publish a proposed rule in the Federal Register on Friday, which will allow public examination and comment. The DEA declined to comment for this article, but at a December Senate hearing, Joseph Rannazzisi, deputy assistant administrator of the DEA's Office of Diversion Control, laid out some of the agency's worries. "Technology, when used appropriately, can increase efficiency and reduce costs," he said. "However, DEA knows all too well that individuals are more than willing to exploit weaknesses in technology for financial gain. A small number of individuals can wreak havoc in a very short period of time." Abuse of prescription medicine is the nation's second-biggest drug problem, he said.

But e-prescribing can protect the public by reducing errors that lead to adverse drug reactions, advocates say. At the 2007 Senate hearing, Tony Trenkle, director of the Office of E-Health Standards and Services at the Centers for Medicare and Medicaid Services, cited estimates of 530,000 adverse drug reactions annually among Medicare patients. In 2006, the Institute of Medicine reported that drug errors affect 1.5 million Americans each year.

"Every day we don't extend e-prescribing, people lose their lives or are affected by an adverse drug event," Trenkle said in an interview.

At the December hearing, lawmakers on both sides of the aisle expressed impatience with the DEA's pace.

"We ought to have a timeframe," said Sen. Tom Coburn, R-Okla. "My fear is, we're going to be sitting here two years from now, doing the same thing, because the pilot didn't go as you wanted."

The hearing was organized by freshman Sen. Sheldon Whitehouse, D-R.I., who is pushing a bill that would require the government to establish a national policy on health information technology and charter a nonprofit corporation to administer a health IT system. When he was Rhode Island's attorney general, Whitehouse helped found the Rhode Island Quality Institute to foster health modernization. He says that helping doctors get comfortable with new technology is essential.

"It really became quite clear that if you fouled up the adoption of e-prescribing, it would have cascading effects into the development of information technology that is essential to repair of our health care system," Whitehouse said. "So to a lot of people, when you see the DEA slow-walking or mishandling the rules for e-prescribing of controlled prescriptions, you think, 'Eh, what's the big deal?' But if you see it in the context of how information technology that the health care system of the future needs has to get deployed, you see that this is a major, major gateway that is being blocked. And it's being blocked by people who I don't think until recently even understood that they were blocking a major gateway."

Some advocates of e-prescribing contend that electronic prescriptions would be easier to monitor for abuse than paper prescriptions.

"I did my residency at Harbor-UCLA Medical Center, and one of my fellow residents left his [prescription] pads and stamp in the physicians lounge. And the next day he got a call saying, 'Did you really write a scrip for 250,000 Tylenol?' " said Halamka, the Boston physician. "You can't audit a piece of paper, but if it's an end-to-end, fully encrypted system, you can see something, say, that's bad, and stop it. Put on a white coat, walk into a hospital system anywhere in America, photocopy a chart, and no one will ever know you did it."

Rannazzisi told senators at the December hearing that he didn't think a single system could handle prescriptions for both controlled substances and other drugs.

"It's critical that we acknowledge and account for the clear and distinct differences between the system for noncontrolled substances and one for powerful and addictive controlled substances," he said. "The technology and standards which are ultimately promulgated for the electronic prescribing of controlled substances cannot simply be plug-and-play."

Trenkle says he is worried that the DEA still wants doctors and hospitals to purchase specific kinds of technology even though systems that the medical profession is already using might do the job.

"Working with us and industry, we should be able to minimize those concerns rather than imposing technical requirements," he said.

Officials from health agencies, while declining to discuss the details of the DEA's draft regulation, described it as a compromise that was far from final. They said that input from the medical community would be sought before any decision is made. "I think the comments will help provide the evidence and factual information we need to have a very constructive dialogue," said Jodi Daniel, director of policy and research in HHS's Office of the National Coordinator for Health Information Technology.

Daniel noted that Berkshire Medical Center in Massachusetts was granted a waiver recently to test e-prescribing of controlled substances under a pilot program, and the results could help shape the final rule.

But no matter what regulations the DEA arrives at for e-prescribing controlled substances, it may be left to the next administration to implement them. White House Chief of Staff Joshua Bolten told agency heads in a May 9 memo that the outgoing Bush administration would not adopt any regulations proposed after June 1 "except in extraordinary circumstances."