Beginning July 1, 2018, new laws place additional requirements on prescribers when prescribing controlled substances. Failure to comply with these additional laws may result in disciplinary and criminal actions.
Prescribers and dispensers must check E-FORCSE prior to prescribing a controlled substance to a patient over 16 years of age. The checking requirement applies to all schedules and classes of controlled substances prescribed for any purpose. Prescribers and dispensers must consult the database regardless of whether the patient was recently seen or whether the prescription is called-in or refilled. It has always been good practice to check E-FORCSE prior to prescribing; however, it was not previously required.
Acute Pain Requirements
Effective July 1, 2018 schedule II opioids prescribed for the treatment of acute pain must not exceed a three-day supply. Acute pain is defined as:
[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:
2. A terminal condition…“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 greater.
456.44(1)(a), Fla. Stat. (2018)
[However,] a 7-day supply may be prescribed if:
1. The prescriber, in his or her professional judgment, believes that more than a 3-day supply of such an opioid is medically necessary to treat the patient’s pain as an acute medical condition;
2. The prescriber indicates “ACUTE PAIN EXCEPTION” on the prescription; and
3. The prescriber adequately documents 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.
456.44(5)(a), Fla. Stat. (2018)
When prescribing schedule II opioids for non-acute pain (e.g. chronic nonmalignant pain), prescribers must indicate on the prescription “NONACUTE PAIN.” Chronic nonmalignant pain is not subject to the 3 day/7 day prescribing limitation.
Mandatory Controlled Substance CE Course
Before January 31, 2019, all Florida licensed health professionals registered with the DEA (physicians, optometrists, podiatrists, and dentists) must complete a 2-hour continuing education course on prescribing controlled substances. For a list of approved courses, see http://www.flhealthsource.gov/FloridaTakeControl/. Following the initial course, these health professionals must complete 2-hours of CE training on controlled substances prior to each biannual license renewal.
Exempt Pain Clinics Required to Register
Previously, certain pain clinics were not required to register with the Department of Health (DOH). These previously exempt clinics will now be required to register with DOH and obtain a Certificate of Exemption. See 458.3265 and 459.0137, F.S. for a list of exempt entities.
Additional Board Rules
The licensing Boards will establish additional rules regulating the prescribing of controlled substances for the treatment of acute pain. Rules will include guidelines on patient evaluation, treatment plans, informed consent, controlled substance agreements, consultation, and medical record review. Chapman Law Group will provide a copy of these additional rule to clients once the rules are available.