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 Communications Office
 NewsMedia@flhealth.gov
 850-245-4111

Use of Emerging and Off-Label Treatments

COVID-19 prevention and treatments prescribed under the guidance of a licensed health care practitioner can save lives and mitigate the impact of COVID-19 on Floridians. When recommending COVID-19 treatment options for patients’ individualized health care needs, physicians should exercise their individual clinical judgment and expertise based on their patients’ needs and preferences.

These options may include emerging treatments backed by quality evidence, with appropriate patient informed consent, including off-label use or as part of a clinical trial. For example:

• Fluvoxamine
• Inhaled Budesonide

We are committed to protecting the comprehensive practice of health care in an environment where treatments continue to evolve, and expect Florida’s health care providers to stay apprised of the availability of COVID-19 treatment options, including:

• Paxlovid
• Molnupiravir
• Bebtelovimab
• Sotrovimab

As guidance continues to evolve, health care practitioners should sustain and maintain in-depth awareness of the data surrounding COVID-19 treatment options. Some treatments should be closely evaluated before administration for both indication and timing, such as Remdesivir in hospital settings (which recently received FDA approval for out-patient COVID-19 treatment), and lopinavir/ritonavir.

It is the responsibility of health care practitioners to be informed of evolving and emerging patient care options for COVID-19 in order to assess the risks and benefits for individual patients that oftentimes vary on a patient-by-patient basis.

Reporting Noncompliant and Unlicensed Facilities

It is essential to support health care providers at the forefront of health care delivery to our most vulnerable populations, especially our seniors. If you are a health care practitioner who is aware of a hospital that is preventing licensed health care providers from using evidence-based care and exercising clinical judgment in treating patients, please report those instances to the Agency for Health Care Administration.

If you wish to file a complaint against a licensed health care facility regulated by the Agency for Health Care Administration, please contact us at 1-888-419-3456 / 800-955-8771 Florida Relay Service (TDD number) or use our Licensed Health Care Facility Complaint Form.

To file a complaint against an unlicensed health care facility, please contact us at 1-888-419-3456 / 800-955-8771 Florida Relay Service (TDD number) or submit an Unlicensed Health Care Facility Complaint Form.

About the Florida Department of Health

The department, nationally accredited by the Public Health Accreditation Board, works to protect, promote and improve the health of all people in Florida through integrated state, county and community efforts.

Follow us on Twitter at @HealthyFla and on Facebook. For more information about the Florida Department of Health please visit www.FloridaHealth.gov.