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The Drug Enforcement Agency recently released its much-anticipated Interim Final Rule (IFR) on electronic prescribing of controlled substances. While additional clarification is needed from DEA, the rule opens the door for electronic transmission of controlled-substance prescriptions to pharmacies and removes a significant barrier to the overall use of electronic prescribing.
However, until industry transaction standards that fully accommodate the requirements identified by the rule are available, industry stakeholders as well as the Food & Drug Administration must work collaboratively to develop interim solutions.
Electronic prescribing systems in various forms have been around for at least two decades. In recent years, as regulatory, financial and other barriers have been eliminated, use of these systems has increased significantly. In 2009 more than 12 percent of eligible prescriptions were delivered electronically to a pharmacy, and this rate is expected to increase to almost 20 percent in 2010.
As a result of the IFR, doctors will be able to automate the prescribing process. However, not all physicians are expected to fully implement e-prescribing. Therefore, pharmacies will be required to develop new systems for electronically transmitted controlled-substance prescriptions, and to continue to maintain and support existing paper-based systems.
The prescription drug industry has historically led the healthcare services industry in the innovative use of technology to deliver cost-effective and safer patient care. As other types of medical claims continue to be processed by cumbersome, paper-based systems, the pharmacy industry has evolved into a highly efficient and coordinated model for secure electronic information exchange.
On a daily basis, millions of prescriptions are electronically reviewed for potential clinical issues, such as drug-drug interactions, and prescription benefit claims are processed in real-time through intermediaries to myriad payers by pharmacies across the nation.
This level of automation would not be possible without nationally recognized transaction standards. Regarding prescription drug delivery, standards have been developed and maintained through broadly supported, collaborative and consensus-based processes.
Over the last 30 years, the National Council for Prescription Drug Programs (NCPDP), a non-profit standards development organization, has fostered collaboration within this complex, heavily regulated and highly competitive industry, bringing together participants from the retail, mail and institutional pharmacy sectors as well as payers, manufacturers and technology vendors.
Government agencies such as FDA and the Centers for Medicare and Medicaid Services (CMS) have also joined NCPDP to develop and maintain a wide range of pharmacy transaction standards that have enabled the successful automation of prescription drug delivery.
CMS worked collaboratively with NCDPD in the seamless process of Medicare Part D, as did the FDA in developing the Structured Product Labeling (SPL). The rule will make more prescriptions eligible for electronic transmission and should contribute to an even more rapid adoption of e-prescribing.
However the requirements defined by the DEA Rule cannot be seamlessly implemented. Existing national electronic prescription transaction standards – SCRIPT Version 8.1 and Version 10.6 (currently under HHS regulatory review) – were developed without benefit of the IFR or input from the DEA. As a result, they are not perfectly aligned.
For example, neither SCRIPT 8.1 nor 10.6 has mandatory fields required by the DEA rule for the prescriber's first name or patient address. Fortunately, both versions include built-in flexibility and alternative, and potential interim solutions exist that could balance regulatory goals and operational reality.
NCPDP has also identified issues that require clarification that have implications in long term and post acute care settings. The Council has also called for clarification of the digital signature option and references to the SCRIPT Standard, versions and data fields.
The prescription drug delivery system, especially in emerging functions such as e-prescribing, will continue to drive innovation and automation across healthcare. We look forward to working collaboratively with the DEA and other stakeholders to more efficiently and effectively address the immediate need for interim solutions as well as in the ongoing standards development process.
-- John Klimek is senior vice president for industry information technology for the National Council for Prescription Drug Programs.