Commentary on intentional falsification of at-home pregnancy tests.

To the Editor: The article by Johnson et al emphasizes a potential problem in the wake of the US Food and Drug Administration’s change in the rules for Risk Evaluation and Mitigation Strategy (REMS) programs allowing for home pregnancy tests (HPTs) to be performed during the COVID-19 pandemic. Some patients undergoing treatment with isotretinoin have falsified HPT results. In another study of 89 patients at Massachusetts General Hospital who submitted HPTs, Smith and Machavariani found that 14 patients (15.7%) used either images downloaded from the internet or edited copies of previously uploaded HPTs. Although the motivation for this is more likely due to convenience and avoiding additional costs of HPTs rather than falsification to hide a pregnancy, it is a very concerning development. The iPLEDGE REMS program exists to decrease fetal exposure to isotretinoin. Falsification is completely unacceptable because it goes directly against the program’s goals. At the same time, these actions by what is likely a small minority of patients should not lead to abandonment of HPTs as a form of verification.

Telemedicine as a form of delivering care is here to stay: telemedicine has become a routine and highly useful part of health care in many specialties, including dermatology, and follow-up visits for isotretinoin are particularly well suited to telemedicine visits.3, 4, 5 In a survey of American Acne and Rosacea Society members, 75% of the members agreed that they would like to continue to use telehealth and home pregnancy testing to care for patients with acne treated with isotretinoin. In addition, >75% agreed that telehealth has increased access for patients, and >70% agreed that home pregnancy testing was important to ensure access to isotretinoin. In response to their findings, the Department of Dermatology, Massachusetts General Hospital, changed their policy so that the photographs of pregnancy tests are submitted with the current date with the patient’s name written using a dark marker to easily screen for images obtained from the internet.

Our goal is to ensure safe and equitable use of isotretinoin. The misdeeds of a few individuals should not be allowed to penalize the clear benefits of telemedicine in the management of isotretinoin to literally thousands of patients. The authors of this small case series point out that changes in the iPLEDGE REMS program during the pandemic have allowed increased access to this medication for many patients and have offered their protocol for handling HPTs. We call on the Food and Drug Administration and the iPLEDGE REMS program to continue collecting data on the optimal approach for implementing HPTs while also affirming the use of laboratory and in-office pregnancy tests as options. In the interim, prescribers may consider common-sense approaches to mitigate risk, such as date verification of testing by having patients write their name and the date on HPT photographs prior to uploading them or requesting in-office or laboratory pregnancy tests in patients in whom falsification is a concern.

Conflicts of interest

None disclosed.