Pharmacies, dispensing prescribers, and certain healthcare facilities in Florida will soon have an easier time complying with controlled-substance reporting requirements.
Florida established its Prescription Drug Monitoring Program (“PDMP”) in 2009 amid a proliferation of pain clinics and rising prescription drug abuse. State law requires pharmacies and dispensing prescribers to submit a report to the PDMP database each time they dispense controlled substances to a patient. Prescribers and pharmacists can use the centralized database to identify patients who have duplicate prescriptions or other risk factors for the abuse or diversion of medications.
Last month, the Florida Legislature passed Senate Bill 964, which changes who may access the database. Currently only pharmacists and prescribers, such as physicians, dentists, and nurse practitioners, are authorized to access and submit reports to the database. Beginning July 1, 2016 the new law will specifically allow designees working on behalf of pharmacists and prescribers to check the database and submit reports. This change is intended to improve compliance by making it easier for busy pharmacists and prescribers to delegate reporting activities to their staff.
Pharmacists and practitioners enjoy immunity from criminal, civil, and administrative liability for the good faith use of the PDMP (or failure to use the PDMP). Unfortunately, the legislature did not extend the civil, criminal, and administrative statutory immunity from liability granted to pharmacists and practitioners to their agents. We hope that this does not deter its use.
We recommend that the pharmacies and practitioners provide additional training to these designees on the use of the database. There has already been one case before the Board of pharmacy where a pharmacist was disciplined for improperly accessing (bad faith) the PDMP, and the law already provides for criminal prosecution of violations. Given the lack of immunity for even good faith use of the database, training for these persons becomes even more important.
Impaired practitioner consultants may also now request access to the PDMP to review the database information of a participant or referral under certain circumstances if agreed to by the participant.
Additionally, the new law provides that rehabilitation hospitals, assisted living facilities, and nursing homes that dispense controlled substances to their patients no longer need to submit reports to the database. The new exemption eases an administrative burden on those facilities, which are generally seen as low risk because the facility staff controls the administration of medications.
The following events are already exempt from the reporting requirements:
- A health care practitioner when administering a controlled substance directly to a patient if the amount of the controlled substance is adequate to treat the patient during that particular treatment session.
- A pharmacist or health care practitioner when administering a controlled substance to a patient or resident receiving care as a patient at a hospital, nursing home, ambulatory surgical center, hospice, or intermediate care facility for the developmentally disabled which is licensed in this state.
- A practitioner when administering or dispensing a controlled substance in the health care system of the Department of Corrections.
- A practitioner when administering a controlled substance in the emergency room of a licensed hospital.
- A health care practitioner when administering or dispensing a controlled substance to a person under the age of 16.
- A pharmacist or a dispensing practitioner when dispensing a one-time, 72-hour emergency resupply of a controlled substance to a patient.
Governor Rick Scott signed Senate Bill 964 on April 1, 2016. The law takes effect on July 1, 2016.