Prescribing & Dispensing Controlled Substances: Legal Update

By: Michael Silverman

A new law has been passed in Florida that pertains to prescribing and dispensing controlled substances. On March 19, 2018 Governor Scott signed HB21, which becomes effective July 1, 2018. Intended to address the growing nationwide opioid epidemic that has also greatly affected Floridians, among other requirements, the new regulations establish:

• New days’ supply limitations and documentation requirements pertaining to schedule II opioid controlled substance prescribing:
  1. Different limits depending on what being the opioid is prescribed for:
     1. New supply limitations for acute pain (i.e., 3-day supply limit with exception for 7-day supply) versus non-acute pain;
     2. New documentation requirements (e.g., indicating “acute pain exception” or “non-acute pain” on the prescription);
  2. Physicians and pharmacists must both be aware of and abide by these prescribing and dispensing limitations.
• New identification requirements in the dispensing of controlled substances.
• New mandatory continuing education course requirement for prescribers of controlled substances:
  1. Unless exempted (e.g., ARNPs and PAs that have taken the separate 3-hour continuing education requirement for controlled substances), all prescribers registered with the DEA and authorized to prescribe controlled substances must take an approved 2-hour continuing education course by January 31, 2019, and again for each subsequent renewal period.
• Expanded reporting requirements and use of Florida’s Prescription Drug Monitoring Program (“PDMP”), aka “E-FORCSE”:
  1. All practitioners must use the reporting database for prescribing or dispensing of all schedule II-V controlled substances controlled substances unless exemption applies:
     1. Prescriber or dispenser, or their designee, must consult the PDMP to review a patients controlled substance dispensing history before prescribing or dispensing a controlled substance for a patient age 16 or older.

• New registration requirements for Pain Management Clinics that were previously exempt from registration – must register for certificate of exemption by January 1, 2019

The Florida Department of Health offers a very useful online overview of these requirements and also provides a great and concise webinar to sign up for that outlines the new mandates.

With such helpful tools at their disposal and the advance notice being provided, there is little excuse for practitioners who fail to comply with these new requirements, which have unfortunately become necessary to implement. Those that do not adhere to these new regulations risk facing disciplinary actions that range anywhere from warnings and penalties, to loss of licensure and criminal exposure depending on the extent of the violation.

For questions on how these new regulations may affect your practice, contact a health law attorney or the Florida Department of Health at [email protected].