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October 2, 2006
Are controlled substances ruining any chance of widespread adoption of e-prescribing? The debate continues among federal agencies. Health and Human Services (HHS) is working hard to get physicians to adopt electronic prescribing (e-prescribing). It’s issued standards for the technology. It’s made exceptions to fraud laws to allow private donations of e-prescribing technology, as well as electronic health record (EHR) technology that includes e-prescribing. It’s paying for demonstration programs to test it. Beyond that, the new certification process for EHR software, under a contract with the HHS, includes e-prescribing in the elements those packages must have to get approval. That certification, the HHS has made clear, may eventually be required for receiving payments from Medicare and other federal programs. Anthony Trenkle, director of the Centers for Medicare & Medicaid Office of E-health Standards and Services, points to findings that tens of thousands of people die from medication errors each year and says the HHS sees “e-prescribing as something that saves lives, promotes safety.” But physician adoption of e-prescribing still needs a lot of help. According to SureScripts, one of the major networks for e-prescribing, more than 90% of pharmacists in the United States are enabled for e-prescribing, but the percentage of physicians sending prescriptions electronically is very small. Alan Zuckerman, MD, primary care informatics program director at Georgetown University, says that number contrasts sharply with the situation in some nations where nearly all prescriptions are electronic. One significant fly in the ointment is the question of what to do about controlled substances. The Drug Enforcement Administration (DEA) oversees the systems that keep tabs on the prescribing of controlled substances, including a number of pain medications. Practitioners who prescribe controlled substances and pharmacies who dispense them must have a DEA registration number and pharmacists must retain records of such prescriptions and make them available to law enforcement if necessary. Now, the DEA has some serious concerns about allowing those medications to be electronically prescribed, at least with no further security attached. On the other hand, controlled substances make up approximately 11% of prescriptions and HHS officials say if physicians are forced to have a separate prescribing system for those medications, it will be a big disincentive for adopting e-prescribing at all. The issue is so difficult that two agencies held joint hearings this summer to get the views of a range of experts. Pharmacy, medicine, and IT representatives urged the agencies to allow controlled substance e-prescribing to start now at current security levels. They contended that the current system would keep most diversion from happening—or help detect it if it did occur—and that e-prescribing technology can certainly perform that work better than paper prescriptions. But law enforcement officials argued that the electronic flow of millions of controlled substance prescriptions with no further security measures will induce new types and levels of diversion that may be impossible to catch up with. Providers Say the Need Is Now Kelly Cronin of the Office of the National Coordinator for Health Information, describing the intense work happening under President George W. Bush’s mandate to make health information interoperable, said that although controlled substances present special challenges, “we don’t want to be creating too many special circumstances that may be overly burdensome to clinicians or may not be feasible to implement on a broad scale.” Pharmacists’ representatives unanimously called for allowing e-prescribing of controlled substances immediately. Lynne Gilbertson, director of standards development for the National Council of Prescription Drug Programs, noted the industry’s stance that additional security measures had not been well-tested with prescribing and could encumber the process. Pointing out that there are already a number of security layers in e-prescribing, Gilbertson said pharmacists “are using user registration and verification processes with trusted partners. There [are] sign-on and authentication processes, there [are] secure transmissions going across these wires. There [are] a lot of auditing processes and logging processes. “And when it comes right down to it, it is the pharmacist who is responsible for using his or her professional judgment on whether [he or she] should proceed with that prescription,” she said. Colleen Brennan, RPh, director of professional and educational affairs at the National Community Pharmacists Association, said pharmacists believe e-prescribing can help control drug diversion by providing better inventory controls and possibly even allowing pharmacies to cut controlled substance inventories; allowing prescriptions to be directed to a specific pharmacy; and providing the aid of secure networks in tracking prescriptions and information on whether a patient has picked up an order. Calvin Knowlton, RPh, MDiv, PhD, head of ExcelleRx and a past president of the American Pharmacists Association, agreed: “These technologies in use today must be secure and they are all HIPAA-compliant, providing for transmission security, integrity of information transmitted, access control, and authentication.” Zuckerman, who represented the AAP, asserted that the prescribing should be allowed now but with ongoing assessment of security needs. “One must constantly go back to reassess threats and risks because five years from now, whatever we do on an interim basis today, is going to change as the new threats arise from experience and level of use,” he said. Zuckerman argued that the few thousand physicians currently using e-prescribing won’t create incentive for large-scale criminal activity. But in five years, if there are hundreds of thousands of doctors using it, more definitive regulations may be necessary. Michael Burger, who is e-prescribing product manager for Emdeon Practice Services, which, he said, is the largest of the practice management vendors, warned that the cost of adding new levels of encryption to e-prescribing would be significant at a time when competition is already pushing the price of systems down and physicians still have a low adoption rate. He also warned against making e-prescribing more difficult for physicians. Although there are benefits to physicians, such as fewer call-backs from pharmacists, doctors often focus on the extra time required to log on to a computer and check drug warnings, as compared with just writing on a prescription pad. “So layer on more complication and the business case becomes even less obvious,” Burger said. Indeed, he asserted, at this point, e-prescribing vendors are competing much more with the prescription pad than with each other. “We are very concerned about slowing the adoption of electronic prescribing.… We are finally getting to the point where we are on an upward trend and physicians are really beginning to adopt this, and we don’t want to throw a barrier in there,” Burger said. James Chen, head of DrFirst, an e-prescribing company, argued that e-prescribing of controlled substances will improve law enforcement’s ability to track fraud “almost instantaneously.” Law Says It Could Fuel Diversion She said large-scale drug diversions have “involved doctors, pharmacists, employees of doctors, offices in the pharmacies. It deals with wholesalers; it deals with the transportation of the product from one end to the other. It is not all about the prescription end. But the prescription end is a significant end, is a significant feature.” Leaving the hard-copy prescription system for controlled substances at this point, McElhaney asserted, “would significantly fuel the diversionary process.” With her office already dealing with the “nightmare” of diversion investigations that involve Internet pharmacies or the computer systems of doctors and pharmacies, the idea of starting e-prescribing now and adding more security later is a concern, McElhaney said. “Law enforcement is not set up forensically to take that taxing work in.… We need to have extremely strict standards from the get-go,” she said. The DEA points out that e-prescribing systems should not only protect against the risk of diversion, but they must also allow for adequate information to be gathered for prosecution when diversion does occur. It also noted that “in criminal cases, evidence used in the prosecution must meet the highest evidentiary standard, that of beyond a reasonable doubt.” McElhaney explained, “The integrity of the evidentiary information is paramount.… If we go to an electronic format, I lose handwriting, I lose fingerprints, I lose half of my identification process. It’s gone.” Addressing the IT vendors at the meeting, McElhaney said, “You scare me to death.” She said, “The vendors, their companies, their employers: I don’t know who any of these people are.” These companies, she said, hold a wealth of information on personal health and controlled substances and there is no system for licensing them. McElhaney noted, for example, that some vendors’ contracts for services with pharmacists and physicians will be terminated, leaving the vendor with a lot of information. Steve Bruck, head of BruckEdwards, a company that works with federal computer security, said he is optimistic that an acceptable solution can be found, but a lot of groundwork is needed. He suggested a survey be done of e-prescription vendors to determine current security levels. “How is identity verified? Is it done in person? What type of credential is used for the authentication? When does the credential expire? Is the same registration process applied to the office staff? Once issued, how are the credentials safeguarded?” he queried. Bruck pointed out there have been incidents of computerized medical devices being compromised although they were upgraded on closed networks. “A common thread between closed networks and open networks: They are all managed by human beings. And we all make mistakes,” he said. Private practice systems may be secured behind closed doors, but, he asked, if they are connected to the Internet, how often will they be updated with operating system patches or virus definitions? “Who is responsible for doing that? Is this handled by the practice? Is it a priority? Things get hectic,” Bruck said. “Acknowledging that the Internet is a hostile place, the question becomes how can we prevent users from accidentally having malware or spyware installed on their computer?” Bruck asked. Recommending a number of measures to enhance security, he pointed out that as EHR use continues to increase, so will the number of “insiders,” such as vendor employees, who could, in turn, place systems more at risk. Bruck also urged the DEA and the industry to educate each other, noting that such collaboration resulted last year in the DEA-approved standard for electronic distribution (not prescription) of controlled substances, such as from distributor to pharmacist. One recurring discussion during the hearings was whether the government should require public key infrastructure (PKI) for controlled substances e-prescribing. PKI systems, as explained by the Government Accountability Office, are based on cryptography and require digital keys and digital certificates created by third-party authorities, which are also responsible for ensuring that the certificates remain valid. Zuckerman said although e-prescribing of controlled substances should go forward as soon as possible, additional security requirements could be evaluated as its use expands, and that pilot studies should be done immediately to test PKI in large-scale use and in small practices. As of mid-August, Karen Trudel, deputy director of the HHS Office of E-health Standards and Services, said the agencies are still sifting through the mounds of information from the hearing and plan to meet soon. There was no predicted date for a resolution of the issue. — Kathryn Foxhall is a freelance writer in the Washington, D.C., area. She covers health informatics, public health, health policy, reimbursement, mental health, and other issues. More information on the issue of electronic prescribing
is available at www.deadiversion.usdoj.gov, under
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