prescriber FAQ

No. In response to the Novel Coronavirus Disease (COVID-19) pandemic, the Food and Drug Administration (FDA) has issued guidance on a temporary policy for non-enforcement of certain risk evaluation and mitigation strategies (REMS) requirements such as laboratory testing. This includes laboratory testing REMS requirements for clozapine.

The FDA recognizes that during the COVID-19 outbreak, completion of REMS-required laboratory testing or imaging studies may be difficult because patients may need to avoid public places and patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine. Under these circumstances, undergoing laboratory testing or imaging studies in order to obtain a drug subject to a REMS can put patients and others at risk for transmission of the coronavirus.

For drugs subject to these REMS with laboratory testing requirements, health care providers prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete these tests the outbreak, and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies. Health care providers should also communicate with their patients regarding these judgments, including the risks associated with it.

Although all REMS requirements remain in effect, the FDA does not intend to take enforcement action against sponsors or others for accommodations made regarding laboratory testing requirements provided that such accommodations were made based on the judgment of a health care professional.

Yes. The Division of Medicaid and Medical Services continues to allow medications to be prescribed through telehealth. The preferred order of prescribing medications is:

• Secure e-prescribe

• Fax

• Phone

• Hard Copy