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Medical Licensing Board clarifies schedule II prescribing rule
The Dec. 10, 2007, issue of ISMA Reports announced a new Drug Enforcement Administration (DEA) rule that took effect Dec. 19, 2007. It allows physicians to provide individual patients with multiple prescriptions for the same schedule II controlled substance, to be filled sequentially, with the combined effect of allowing patients to receive up to a 90-day supply of that controlled substance over time.
However, the article reminded physicians that Indiana's law prohibiting "refills" of schedule II drugs had not changed. And it was not clear whether state regulators would view the new DEA rule as being in conflict with Indiana law.
ISMA staff has sought clarification in recent months. At its January meeting, the Indiana Medical Licensing Board (MLB) discussed the DEA rule.
Michael Rinebold, director of the MLB, reported, "The Board pointed out that current law prohibits the practice of writing refills for scheduled II drugs; however, the DEA rule now clarifies the DEA's position on the practice of writing multiple scripts for schedule IIs over a 90-day period.
Following the discussion, the Board did not feel there was a conflict between state law prohibiting schedule II refills and federal law allowing multiple scripts for schedule IIs within a 90-day period."
The Board noted the following five criteria must be followed in order to comply with the new rule:
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Each separate prescription must be issued for a legitimate medical purpose by a physician acting in the usual course of professional practice.
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The physician must provide written instructions on each prescription indicating the earliest date on which a pharmacy may fill each prescription.
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The physician must conclude that providing a patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.
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The issuance of multiple prescriptions must be permissible under the applicable state laws.
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The physician must comply fully with all applicable requirements under the Controlled Substances Act and federal regulations, as well as any additional requirements under state law.
Further, the rule clarifies:
"Nothing in this [Final Rule] shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so."
Under state and federal law, each prescription must be dated as of – and signed on – the day issued. Practitioners must ensure adequate safeguards to prevent diversion and abuse.
Find a copy of the MLB's minutes>>
See the DEA final rule>>
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