March 17, 2008

All Tied Up
By Selena Chavis
For The Record
Vol. 20 No.6 P. 12

E-prescribing supporters believe easing restrictions on controlled substances would do wonders for adoption rates.

The ineligibility of controlled substances continues to be the bane of e-prescribing supporters who believe an ease in restrictions would do wonders for adoption rates.
There is little dispute among professionals throughout the healthcare industry that the e-prescribing movement brings with it many positives and expected benefits. From reduced errors and costs to improved quality and medication compliance, most insiders agree it’s a vital component to the widespread adoption of a national electronic medical record (EMR) system.

Maria Friedman, director of federal affairs for RxHub, points to statistics suggesting that medication errors account for one of every 131 ambulatory care deaths. Referring to the staggering number of medication errors that occur across the nation each year as “death by decimal,” she suggests that e-prescribing could significantly impact the 150 million calls made annually by pharmacists to clarify manually written prescriptions that cannot be deciphered.

Along with issues of illegible handwriting, she says manual processes make it more difficult for pharmacies to consistently capture important patient information such as drug allergies. And there’s the ongoing issue of what happens to paper prescriptions when they leave a physician’s office. “When you put the prescription in the hands of patients, there’s a possibility of it being altered,” she says.

Like many components of the electronic movement in healthcare, the rationale for e-prescribing seems obvious, but gaining widespread adoption and momentum for the initiative has been daunting. “It’s certainly been a very slow go,” says Mike Burger, director of clinical product management with Sage Software Healthcare, adding that the company’s solutions have offered e-prescribing capabilities for nearly one decade.

Lynne Gilbertson, director of standards development for the National Council for Prescription Drug Programs, speaks positively about the movement, noting that “it’s continuing to evolve,” especially from a standards perspective.

“It’s blazing trails in some instances because it’s the first thing showing up on desktop,” she says, pointing to the information sharing movement at large. Adding that the technological infrastructure is in place for e-prescribing, she says, “Quite a few companies are engaged and showing a lot of progress.”

With statistics pointing to millions of e-prescriptions occurring each year, the momentum of the movement may sound promising, but Anne Canfield, spokesperson for the e-Prescribing Controlled Substances Coalition, is quick to point out that “in the context of the overall prescriptions, it’s only a couple of percent, despite all the hoopla.” In fact, statistics suggest that more than 3 billion prescriptions are written annually in the United States, the large share of which are still manually processed.

Federal regulations prohibiting controlled drug substances from being electronically prescribed have recently taken center stage as an issue needing resolution if e-prescribing is to truly have an effect on the industry.

In a head-to-head battle with the U.S. Drug Enforcement Administration (DEA), many groups suggest that the regulations are a significant impediment to the widespread adoption of e-prescribing. Pointing out that the current regulations would require physicians to continue prescribing controlled substances manually, Canfield says, “Physicians do not want to have to prescribe two different ways.”

Friedman also notes that much of the concern is centered around so-called street drugs such as OxyContin. But in the larger scheme of prescribing, controlled substances cover such widely prescribed medications as Ritalin.

In 2006, the Institute of Medicine estimated that preventable medication errors cost the healthcare system $77 billion annually and called on all physicians to adopt e-prescribing by 2010 to address the problem. In testimony submitted to a December 2007 hearing before the Senate Committee on the Judiciary, the AARP said, “Unfortunately, recent studies indicate that despite the fact that physicians believe that e-prescribing will be good for medicine, only about one in 10 actually use it on a regular basis.”

Burger believes the controlled substance issue is one of many playing a minor role in slowing the overall momentum of the e-prescribing movement. “The single largest roadblock is that there isn’t an obvious and clear benefit to physicians,” he says, adding that controlled substances account for only approximately 10% to 15% of the total number of prescriptions written. “The physicians are challenged because they are not seeing a clear benefit,” he says.

Controlling the Controlled
Clearly defined, e-prescribing is the use of healthcare technology to enable secure, real-time, bidirectional, electronic connectivity between clinicians and pharmacies. This is achieved by providing prescribers with a secure means of electronically accessing health plan data, patient eligibility, and medication history at the point of care and securely transmitting the prescription electronically into the pharmacy’s computer system.

For the DEA, the issue of security and authority are paramount. In a statement made at the December hearings before the judiciary committee, Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control, said that the “DEA supports the use of technology to reduce medical errors, streamline the medical process, and increase efficiency. However, the DEA must balance this objective with its legal responsibility to ensure there is a closed system of distribution for controlled substances in order to minimize the risk that these substances will be diverted and used illegally. Therefore, it is extremely important to understand the need for specific requirements when establishing standards for a system that allows electronic prescribing for controlled substances. It is critical that the technology and standards to be employed include adequate security that incorporates authentication, nonrepudiation, and integrity in the recordkeeping process. These three security-related elements are necessary to ensure that the DEA can fulfill its obligations under the Controlled Substances Act.”

For the DEA, Friedman says the issue centers around an erroneous belief that the current security infrastructure for e-prescribing is inadequate and that they would need a “wet” signature from a physician to prosecute for fraudulent prescribing practices. “One of the misconceptions is that it’s just prescribing over the Internet,” she says, adding that private, secure networks lay the foundation for e-prescribing. “To anyone’s knowledge, there has not been a breach to date.”

Burger agrees, adding that the DEA is under the assumption that electronic is less secure, and “clearly, that is 100% ridiculous. What we know for certain is that we have a very detailed and easily accessible audit trail.” He says the DEA has voiced its desire for public key infrastructure encryption as part of the security infrastructure. He says such technology is expensive to implement and would present a logistically challenging proposition to a movement already taxed with issues about cost.

“Docs already don’t want to pay for it. The price pressure is downward,” Burger explains. “The industry premise around controlled substances is that the security currently used is adequate for controlled substances. We’ve occasionally gotten inquiries from state pharmacy boards, but they have always walked away satisfied.”

Explaining the current security infrastructure offered through Sage solutions, Burger says the legitimacy of providers is the starting point. Subscribers to the service—physician and pharmaceutical—have to prove their legitimacy by an enrollment procedure on the company’s secure network.

Once a login and password are approved, physicians are only allowed to send prescriptions from an individual database that Sage provides and then only to a preapproved pharmacy. Burger says the process constitutes an e-signature and follows regulations enacted by federal legislation regarding secure transactions. “The process we are subscribing to is that the electronic signature is there throughout the process,” he says.

Pointing to mounting frustrations to get the DEA to move forward with lifting the regulations, Canfield notes that the issue finally came to a head when e-prescribing was proposed for Medicare. “DEA and CMS [the Centers for Medicare & Medicaid Services] have been working on this for several years,” she says, adding that it was more than industry groups expressing frustration at the December hearings. “The hearing was quite contentious. The senators were quite critical of the DEA.”

And the tides may be changing. The DEA recently announced that it had provided the Department of Justice with a proposed rule regarding the e-prescribing of controlled substances, but it could not predict a timetable for how long the review would last.

An Opportunity in the Making?
Many industry groups believe they have provided a potential opportunity for the DEA and that the benefits go much further than what has been suggested by the medical community. Specifically, many believe that an e-prescribing system could help the DEA with drug enforcement.

The e-Prescribing Controlled Substances Coalition recently published a white paper detailing the inherent opportunities for controlling abuse and fraudulent activity, including the ability to eliminate patient altering of prescriptions and quickly identify patterns pointing to criminal behavior.

“We certainly think there is an opportunity here for the DEA to work with the industry,” Canfield says, citing systems that can be implemented within the medical industry to help direct law enforcement toward potentially unlawful acts. “The industry can certainly work with them to put these systems in place, but so far, it does not appear that they see the value.”

Specifically, the white paper notes that federal and state officials are struggling to keep pace with the diversion of controlled substances, which is further slowed by manual and paper processes that require law enforcement staff to sift through thousands of paper prescriptions in disparate locations, often months after an incident occurs.

Canfield points out that audit trails inherent in e-prescribing offer real-time controlled substance reporting and monitoring capabilities that allow the DEA, as well as state and local law enforcement agencies, the ability to identify potential abuse immediately rather than days or weeks after dispensing.

Also, when prescriptions are submitted electronically, the patient no longer has the capability to alter the prescription, virtually eliminating the opportunity for abuse. “E-prescribing will get paper out of the hands of patients,” Friedman says. “That’s what this is all about—preventing diversion control.”

Inherent audit trails could quickly identify patients who doctor shop and garner multiple prescriptions for controlled substances, according to the e-Prescribing Controlled Substances Coalition. E-prescribing creates an immediate electronic audit trail that is documented and time-stamped through each point in the process, from the physicians’ office to the pharmacy.

Because pharmacies and e-prescriber systems must be registered and certified to access secure networks of vendors, rogue Internet pharmacies will also be eliminated because they would never pass the stringent safeguards, Canfield says.

The Bigger Picture
While many groups believe there won’t be a significant uptake of the e-prescribing movement until the issue over controlled substances has been resolved, others suggest there’s more to the story.

“The physicians are challenged because they are not seeing a clear benefit,” Burger says, adding that while there is an inherent advantage for patient safety, the doctors have to make the investment. “The physicians will tell that the benefits of e-prescribing do not accrue to them but to the pharmacy managers and clients.”

Right off the bat, if a physician implements e-prescribing, the time it takes to complete the submission takes more time than manual processes. “Even with the best systems out there … it still takes an extra minute per patient,” Burger says, adding that the time spent could equate to a couple patient visits per day.

Along with issues stemming from the extra time needed with e-prescribing are the realities that with any new methodology, workflow will initially be disrupted. “Workflow may become uncomfortable at first,” Gilbertson says, even on the pharmacy side. “That’s where we have seen some challenges.”

As an example, Gilbertson points to the change in transactions flowing in real time and how that could impact a small pharmacy. If the manual workflow is adapted to doing refills later in the day or after hours, requests coming in real time could create difficulties at first for some pharmacies.

On the physician side, it’s more about a general “fear of change,” Burger believes, pointing out that it’s going to take more incentive programs to get widespread adoption.

Citing successful incentive initiatives in states such as Massachusetts, he suggests that it doesn’t have to be a big-dollar incentive. “The program there has morphed. You’re not going to retire rich, but at least it compensates them for the effort,” he notes. “Free isn’t good enough; it’s got to be better than that.”

— Selena Chavis is a Florida-based freelance journalist whose writing appears regularly in various trade and consumer publications covering everything from corporate and managerial topics to healthcare and travel.