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Gov. Rick Scott on March 19, 2018, imposes a number of legal requirements on healthcare practitioners who prescribe controlled substances, particularly opioids. This new law encompasses 205 pages and imposes new obligations on practitioners that carry penalties for noncompliance. The purpose of this article is to provide a summary of the provisions of HB 21, and provide practitioners with the information they need to comply with the new law. Unless otherwise noted, the provisions of this law will go into effect on July 1, 2018. There are numerous state and federal statutes and regulations that govern the prescribing of controlled substances. HB 21 amended several of the state statutes on controlled substance prescribing. These statutes are briefly discussed below. In 2011, the Florida Legislature passed legislation that regulates the prescribing of controlled substances for chronic nonmalignant pain. Section 456.44, Florida Statutes provides that allopathic physicians, osteopathic physicians, podiatrists, dentists, physician assistants, and advanced registered nurse practitioners who prescribe any controlled substance in Schedules II-IV for the treatment of chronic nonmalignant pain must designate themselves as a controlled substance prescribing practitioner on their practitioner profiles, and must comply with the statutorily established standards of practice. The pill mill epidemic also spawned legislation governing the operation of pain-management clinics. Section 458.3265 and section 459.0137 require “pain clinics” to register with the Department of Health and adhere to a number of regulations established by statute. In 2009, the Florida Legislature responded to the pill mill epidemic by creating the “prescription drug monitoring program (PDMP). This law requires pharmacists and dispensing practitioners to report certain information to the database each time they dispense a controlled substance. As passed in 2009, the law required dispensers of controlled substances to report to the database within seven days. The law did not require physicians to check the database prior to prescribing a controlled substance. E-FORCSE — Electronic-Florida Online Reporting of Controlled Substances Evaluation Program — but referred to throughout this document as the “database”), but makes a number of changes regarding database reporting, checking and access to information. For practitioners, the most important change is the new requirement that a prescriber or dispenser (or the designee of a prescriber or dispenser) must consult the database to review a patient’s controlled substance dispensing history before prescribing or dispensing a controlled substance for a patient who is 16 years of age or older. Note that this requirement applies to all controlled substances, not just opioids. The one concession the Legislature made was to exempt a nonopioid con-trolled substance listed in Schedule V from the mandatory checking requirement. If a medication listed in Schedule V, however, contains any amount of a substance listed as an opioid in s. 893.03 or 21 U.S.C. 812, then the prescriber or dispenser has to consult the database prior to prescribing or dispensing. If the database is not operational or cannot be accessed by the prescriber or dispenser, the practitioner can go ahead and prescribe or dispense the controlled substance, but must document the reason why the database was not consulted and cannot prescribe or dispense more than a three-day supply of the controlled substance. This is of course a significant change from the prior law regarding the operation of the PDMP. Questions naturally arise as to the scope of this change:• Do practitioners have to check the database every time they prescribe a controlled substance for the same patient – even on a prescription that in essence is a refill for a three-day supply?• Same question for an existing patient they are calling in a prescription for: Do they have to check the database before calling in the prescription? Unfortunately, until the DOH or the respective boards provide guidance, all we have to go by is the text of the statute itself. As the law provides that the “prescriber or dispenser must consult the system to review a patient’s controlled substance dispensing history before prescribing or dispensing a controlled substance for a patient age 16 or older,” it appears that practitioners must check the database each time they prescribe or dispense, regardless of whether the patient is an existing patient or not. If the boards interpret this provision differently, the FMA will put out a notice and will update this article accordingly.
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