New Rule Allows for Electronic Transmission of Controlled Substance Prescriptions - July 5, 2010
Orlando Florida
A new Drug Enforcement Agency (DEA) rule could substantially impact the way prescriptions for controlled substances can be transmitted from a physician to a pharmacy. As physicians and pharmacies seek to cut costs and maximize efficiency, electronic record keeping and prescription filing has become more commonplace. In response, the DEA has relaxed previous restrictions on electronically filing controlled substance prescriptions. However, recognizing the high risks posed by abusing or forging controlled substance prescriptions, the DEA has created a system of requirements which must be met before a physician is able to take advantage of the new rule.
The DEA defines controlled substances as drugs and other substances that have a potential for abuse and psychological and physical dependence; these include opioids, stimulants, depressants, hallucinogens, anabolic steroids, and drugs that are immediate precursors of these classes of substances. Once classified as a controlled substance, drugs are then broken down into one of five categories depending on the potential for abuse and risk of dependance. Today, controlled substances account for between 11% and 12% of prescriptions written in the United States.
Under the previous rule, physicians were prohibited from electronically sending prescriptions for schedule II-V controlled substances to pharmacies. However, under the current rule, which was published March 31, 2010 in the Federal Register, physicians who meet certain requirements will be permitted to e-file those prescriptions beginning June 1, 2010. To be eligible to e-file controlled substance prescriptions, physicians must meet two of three factors. The “two-factor authentication protocol,” which seek to guard against fraudulent prescription filings by confirming the prescribers true identity includes:
1.A password or PIN number,
2.biometric data- either a fingerprint or iris scan, or
3.a “hard token”- a secured device separate from a computer that can provide a password to a physician at the time of e-filing.
To be eligible to e-file controlled substance prescriptions, physicians must validate their identity with a designated agency. When applying for the proper credentials to utilize e-filing programs, physicians must supply verifiable information such as government issued identification or financial account information.
Currently, Michigan laws vaguely address the current state of e-filing prescriptions for controlled substances. MCL 333.7333(7) states that physicians may electronically transmit prescriptions as long as they do not conflict with federal law. The law does not differentiate between controlled substance and non-controlled substance prescriptions. As a result, we may see future clarification from the Michigan legislature or the Board of Pharmacy regarding this issue. Importantly, physicians and pharmacies that currently possess the technology to e-file prescriptions must ensure that their systems comply with the new DEA “two-factor authentication protocol” requirements for controlled substances. Licensed physicians who cannot afford to implement the required technology or simply wish to opt out of the program are still able to produce physical prescriptions which can be presented at a pharmacy.
Smith Haughey Rice & Roegge will continue to monitor developments in this area and distribute updated information as it becomes available.
Summer clerk Brian Shekell contributed to this post.
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