Electronic Prescription Software
Finally, a Prescription Management Software Breakthrough? DEA publishes interim rule on e-prescribing controlled substances
Finally: A Safe and Secure Encrypted e-prescribing System for Controlled Substances— But Will Physicians Be Allowed to Use It? The story of a pilot program that led to the nation’s first DEA-approved, e-prescriptions for controlled substances.
Although there was a 181% increase in the use of e-prescribing across the country from 2008 to 2009 (http://www.surescripts.com/about-e-prescribing/progress-reports/national-progress-reports.aspx), the prohibition on the use of this new technology to prescribe controlled substances (schedule II ‑ schedule V) has been a key barrier holding e-prescribing back from widespread adoption.
Controlled Substances Complicate Practice Adoption Hurdles for E-prescribing
Controlled substances make up roughly 11% of every prescription written, and these prescriptions are written by approximately 90% of all providers (http://www.deadiversion.usdoj.gov). With this said, it is evident that the ban on e-prescribing creates a problem for a majority of providers who wish to use an electronic system. The inability to write a controlled drug electronically creates the need for a provider to implement two office workflows—one for all electronic prescriptions, and one for the controlled substances that must be written by hand. This inconsistency in workflow ultimately defeats the purpose of e-prescribing as a whole. Until now, the Drug Enforcement Agency (DEA) has placed an outright ban on using new technology for the prescribing of any controlled substances, fearing that the systems in place are not secure enough to be trusted with highly abused and addictive medications. Although the DEA issued a proposed rule for the e-prescribing of controlled substances in June of 2008, they are subject to mandates under the Controlled Substances Act that call for a closed system of control for the manufacturing, distributing, and dispensing of controlled substances, making finalization of these rules very difficult without a proven and safe method of secure electronic prescribing.
DEA Realizes the Hurdles and Electronic Workflow Need
Addressing the situation at hand, Michael Blackman, MD, CMIO of Berkshire Health Systems, has stated that, “the lack of approved standards has contributed to a delay in realizing the full patient safety, clinical benefits, and risk reductions that are known to result from e-prescribing, including: better medication management and coordination of care, better decision support, clinician workflow improvement, and reduction of medication errors. Until there’s one process for e-prescribing all drugs, the medical community won’t fully realize the workflow efficiencies that the technology allows” (http://bit.ly/bv8x1B). Acknowledging this pressing issue, industry leaders have known that in order for e-prescribing software and healthcare IT as a whole to become the norm, there must be a cooperative agreement between vendors, users, and the DEA permitting the e-prescribing of controlled substances. Providers who prescribe controlled substances cannot afford to split their practice into two separate workflows. What they need is a solution to this problem that will enable them to reap the benefits of an electronic system without slowing down their entire office.
The first steps toward e-prescribing
Following talks at a 2006 symposium held by the DEA, the spark was lit when DrFirst, Inc., an e-prescribing solutions provider, met with the DEA to discuss a safe and measurable way to overcome the security and accountability issues that have been holding e-prescribing back for so long. This meeting, along with funding from the Agency for Healthcare Research and Quality (AHRQ), spawned the Electronic Prescribing of Controlled Substances (EPCS) pilot program. Right from the start, the DEA identified a set of security elements that must be addressed in a health IT solution for the EPCS.
The First Hurdle Needed to be Crossed - Authentication
Authentication was the first issue mentioned by the DEA, as it is imperative to be able to positively identify the signer of any prescription and be able to correctly identify those who are sending and receiving all prescription data. Non-repudiation was another concern—the system would have to ensure that any and all parties to a prescribing activity could not reasonably deny their participation. The DEA also stressed the necessity for record integrity that would ensure that the prescription’s data and signature have not been altered after it has been signed. Due to the legal ramifications of this project, and the DEA’s concerns with drug abuse, all systems in place had to have the legal sufficiency for the DEA to successfully prosecute if a misuse occurred. All abuses of the system would have to be able to be tracked and proven beyond a reasonable doubt. Signature verification was also a necessity in order to ascertain that an identified signer intended to endorse the writing of a prescription. The final DEA requirement was for all information to be confidential. Only authorized persons were allowed to have access to any of the data from the EPCS project.
Putting it All Together and Creating a System
With these requirements in mind, DrFirst, the e-prescribing provider, collaborated with the Massachusetts Department of Public Health; Berkshire Health Systems, Inc., e-prescribing Network; and Brandeis University’s Heller School for Social Policy and Management to enhance DrFirst’s existing e-prescribing system by adding the security features required for approval by the DEA. The EPCS team chose Berkshire County, MA, as the ideal location to host this pilot due to its relative seclusion, providing a controlled and extremely measurable environment. e-prescribing Network provided a secure and safe connection to pharmacies in the county and was willing t step forward and participate in this unprecedented project.
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