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Florida Department of Health New Limits on Schedule II Rx for Pain Medications

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Opiate Prescribing Legislation Passed Florida Legislature
Key Items You Need to Know
Effective Date: July 1, 2018
In an effort to address the opioid crisis impacting communities across the state, the Florida Legislature approved legislation last week that will have an impact on physicians and patients. All physicians practicing in Florida need to be aware of particular measures contained in the legislation that will impact you.
1.        Mandatory Physician Education
2.        Mandatory Review of the Prescription Drug Monitoring Database (E-FORCSE)
3.        Limitations on Prescribing Controlled Substances
4.        Mandatory Emergency Opioid Antagonist
5.        Mandatory Application for a Certificate of Exemption
6.        Board of Medicine to Adopt Standards of Practice for Treatment of Acute Pain
1. Mandatory Physician Education – Prior to January 31, 2019, all physicians registered with the DEA to prescribe controlled substances will have to take a 2-hour Board of Medicine approved CME Course on prescribing controlled substances.  Physicians will have to take the 2-hour course every two years in accordance to your license renewal cycle. The course must be an approved course offered by a statewide association of physicians.
3. Limitations on Prescribing Controlled Substances – Prescriptions of Schedule II Controlled Substances for the treatment of “Acute Pain” are limited to a 3-day supply. If a physician feels that a 3-day supply is insufficient, they can prescribe up to a 7-day supply.
Physicians writing a 7-day supply must include on the prescription “Acute Pain Exemption” to authorize the pharmacist to dispense the higher limits.  The prescriber must adequately document in the patient’s medical records the acute medical condition and lack of alternative treatment options that justify deviation from the 3-day supply limit established in this subsection.
The definition of Acute Pain and thus the 3 and 7 day restriction does not apply for a series of exemptions (see below) to include cancer, terminal conditions, palliative care, or for patients with injuries that have a trauma severity index score of 9 or higher.
Acute Pain is defined as:
(a) “Acute pain” means the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. The term does not include pain related to:
1. Cancer.
2. A terminal condition. As used in this subparagraph, the term “terminal condition” means a progressive disease or medical or surgical condition that causes significant functional impairment; is not considered by a treating physician to be reversible without the administration of life-sustaining procedures; and will result in death within 1 year after diagnosis if the condition runs its normal course.
3. Palliative care to provide relief of symptoms related to an incurable, progressive illness or injury.
4. A traumatic injury with an Injury Severity Score of 9 or higher.
For a prescription for a Schedule II opioid, as defined in s. 893.03 or 21 U.S.C. s. 812, for the treatment of pain, other than acute pain, the practitioner must indicate “NONACUTE PAIN” on the prescription.
The bill makes it clear in Florida Law that controlled substances can be e-prescribed. The DEA has a process for you to register to have e-prescribing capability as long as your EMR enables you to do so. Click here for information on the DEA requirements: https://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/practitioners.htm
4. Mandatory Emergency Opioid Antagonist Prescription– For a prescription for a Schedule II opioid, as defined in s. 893.03 or 21 U.S.C. s. 812, for the treatment of pain related to a traumatic injury with an Injury Severity Score of 9 or higher, the prescriber must concurrently prescribe an emergency opioid antagonist.
5. Mandatory Application for a Certificate of Exemption from the Pain Management Clinic Statutes – The bill requires physician offices that are exempt from the Pain Management Clinic regulations to apply for a Certificate of Exemption on an application form to be provided by the Agency for Health Care Administration.  Physician practices will have to re-apply for this Certificate of Exemption every two years. The Agency will have to develop rules to implement this Certificate of Exemption application and process.
6. Board of Medicine to Adopt Standards of Practice for Treatment of Acute Pain – The Board of Medicine/Department of Health shall adopt rules establishing guidelines for prescribing controlled substances for acute pain, which may include evaluation of the patient, creation and maintenance of a treatment plan, obtaining informed consent and agreement for treatment, periodic review of the treatment plan, consultation, medical record review, and compliance with controlled substance laws and regulations. The rules shall take into account the applicability of the guidelines in different practice settings. Failure of a prescriber to follow such guidelines constitutes grounds for disciplinary action pursuant to s. 456.072(1)(gg), punishable as provided in s. 456.072(2).
Disclaimer: The information on this web site is general information, and not designed to be and should not be relied on as your sole source of information when analyzing.
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