How to care for iPLEDGE patients during the pandemic
On March 22, 2020 the FDA indicated that “for drugs subject to REMS with laboratory testing or imaging requirements,” which includes isotretinoin under the iPLEDGE program, physicians “prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete these tests or studies during this public health emergency (PHE) and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies. They should also communicate with their patients regarding these judgments including their benefits and risks.”
The iPLEDGE contractor has indicated to AADA that at-home pregnancy tests and telemedicine visits are acceptable for complying with the iPLEDGE requirements during the COVID-19 outbreak. Dermatologists still have to enter pregnancy test information for prescriptions to be filled. The table below indicates what has changed. Note that the updated required are only in effect during an emergency declaration.
Requirement | Changes due to COVID-19 |
|---|---|
Telemedicine | Prescriber to use best medical judgement to manage their patients. Please refer to the March 17, 2020 notice from the Department of Health and Human Services Office for Civil Rights (“Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency”) for guidance. |
Pregnancy testing | Pregnancy test can be “at-home.” The tests can be obtained at drug store, grocery store, or online retailer. The test results and date performed must be communicated to prescriber. Prescriber or designee would enter the date performed (specimen collection date) and test results per usual iPLEDGE program process. |
Prescription window | This requirement will not change. |
Two forms of birth control or abstinence | This requirement will not change. |
All content solely developed by the American Academy of Dermatology
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