Frequently Asked Questions

No. This is not a requirement of the new controlled substances law. After the passing of CS/CS/HB 21, only the section numbering and title for Section 456.44, Controlled Substance Prescribing, changed to: Section 456.44(3) Standards of Practice for Treatment of Chronic Nonmalignant Pain.

The language did not change and reads:

S. 456.44(3)(d) states, in part, “The patient shall be seen by the registrant at regular intervals, not to exceed 3 months, to assess the efficacy of treatment, ensure that controlled substance therapy remains indicated, evaluate the patient’s progress toward treatment objectives, consider adverse drug effects, and to review the etiology of the pain. Continuation or modification of therapy shall depend on the registrant’s evaluation of the patient’s progress. If treatment goals are not being achieved, despite medication adjustments, the registrant shall reevaluate the appropriateness of continued treatment. The registrant shall monitor patient compliance in medication usage, related treatment plans, controlled substance agreements, and indications of substance abuse or diversion at a minimum of 3-month intervals.

No. The legislature did not carve out an exemption for prescribers in pain management clinics who prescribe Schedule II opioid controlled substances for the treatment of acute pain. They are subject to the 3 and up to 7-day supply limits and to the labeling requirements for “ACUTE PAIN EXCEPTION” (for 4-7 day supply) and “NONACUTE PAIN” (for greater than 7-day supply).

The law is silent and does not reference the filling of out-of-state prescriptions (which may or may not comply with Florida’s new requirements). The law does not set forth a prohibition on filling them.

Yes. If the “note” is transmitted with or considered to be part of the actual electronic prescription to be transmitted to the pharmacist, then the annotation of “Acute Pain Exception” or “Non-Acute Pain” would be acceptable.

If a prescription for a Schedule II opioid does not meet the requirements as specified in the law, the pharmacist should follow their current standard policy and procedures by contacting the prescribing practitioner to verify written information contained within the prescription. Any change in the prescription should be promptly reduced to writing and properly annotated based on your current pharmacy practice.

‘No. The 3 and up-to-7 day supply limits apply to Schedule II opioids prescribed for the treatment of acute pain.

No. For example, the day supply limits do not apply to Hycodan® Cough Syrup for a patient who is being treated for an unrelenting cough or to Ritalin® for a patient being treated for ADHD. The 3-day and up to 7-day limits apply to Schedule II opioids prescribed for the treatment of acute pain.

When prescribing opioids to a patient with an Injury Severity Score of 9 or higher, the prescriber must:

1. Prescribe an emergency opioid antagonist AND
2. Indicate “nonacute pain” on the prescription

“Acute pain” is the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. It does not include pain related to cancer, terminal conditions, pain treated with palliative care, or traumatic injuries with an Injury Severity Score of 9 or greater.

Exceptions to acute pain limits:

1. cancer,
2. a terminal condition (a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by the 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. pain treated with palliative care (the provision of relief for symptoms related to an incurable, progressive illness or injury), and
4. a traumatic injury with an Injury Severity Score of 9 or higher. See Trauma.org for more information.

**The law did not change prescribing of controlled substances for treatment of nonacute pain or chronic nonmalignant pain.

Yes. If the prescription is for a greater than a 7-day supply, the prescriber must indicate “Non-Acute Pain.”

No. The law provides that for the treatment of acute pain, a prescription for an opioid drug listed as a Schedule II controlled substance in s. 893.03 or 21 U.S.C. s. 812 may not exceed a 3-day supply, except that up to a 7-day supply may be prescribed if certain conditions are met. The “3-day” and “7-day” applies to the supply of the opioid drug listed as a Schedule II controlled substance, not the number of days after the prescription is written for which it is still valid.