An opportunity for improvement:
            <scp>iPLEDGE</scp>
            policy changes during the coronavirus pandemic

Farah, Ronda S.; Fiessinger, Lori; Mansh, Matthew

doi:10.1111/dth.14411

Cited by 6 publications

(7 citation statements)

References 8 publications

(2 reference statements)

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“…Prior to the pandemic, iPLEDGE, a computer-based risk management program approved by the Food and Drug Administration (FDA) to decrease fetal exposure to isotretinoin, required use of Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories for human chorionic gonadotropin (β-hCG) measurements for women taking isotretinoin, 3 so the majority of visits were inperson. iPLEDGE recently allowed for telemedicine with home urine pregnancy tests, 3 with a noticeable shift from in-person to virtual visits and from use of laboratory testing to home urine pregnancy tests. Dermatologists should be cautioned that home urine pregnancy tests have variable sensitivity and require accurate user interpretation.…”

mentioning

confidence: 99%

“…Dermatologists should be cautioned that home urine pregnancy tests have variable sensitivity and require accurate user interpretation. 3 Discrepancies may exist between manufactureradvertised accuracy and laboratory-determined accuracy of home pregnancy tests, with one study reporting the agreement in accuracy ranging from less than 50% to greater than 90%, depending on the brand. 4 Hyperkalemia is extremely uncommon in women ≤ 45 years old taking spironolactone, 5 and serum potassium monitoring may not be necessary.…”

mentioning

confidence: 99%

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Retrospective study of acne telemedicine and in‐person visits at an academic center during the COVID‐19 pandemic

Diaz

Lipner

2021

J of Cosmetic Dermatology

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confidence: 99%

mentioning

confidence: 99%

Retrospective study of acne telemedicine and in‐person visits at an academic center during the COVID‐19 pandemic

Diaz

Lipner

2021

J of Cosmetic Dermatology

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“…According to this statement, if there is no risk of pregnancy, the prescriptions for several months could be given taking into account the need to monitor blood test and side effects with remote consultations. In situations where it is not possible to perform monthly pregnancy tests, home pregnancy tests are recommended as a suitable alternative [11]. With the rapid growth of teledermatology, these recommendations have been practiced and the patients were able get their prescriptions instead of in-person visits [2].…”

Section: Discussionmentioning

confidence: 99%

Isotretinoin Treatment Practices and Outcomes in Acne Patients During the COVID-10 Pandemic: A Single Center, Retrospective, Comparative Study

Atak

Mendi

Yıldızhan

et al. 2022

Dermatol Pract Concept

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Introduction: The COVID-19 pandemic drastically changed the priorities in healthcare services; outpatient management of acne has changed during this period. Objectives: We aimed to investigate treatment practices, outcomes and identify modified follow-up schedules applied during the pandemic. Methods: The patients who were admitted to dermatology outpatient clinic between March 13 and July 13, 2020, were included. Patients who were admitted between March 13 and July 13, 2019, were served as controls for the study. For each patient, age, gender, treatment protocols, treatment intervals, compliance with the treatment, treatment modifications, and adverse events were recorded. Results: The total number of acne patients admitted to dermatology outpatient clinics during the pandemic period was 278 and consisted of 12.3% (278) of all admissions. Isotretinoin treatment was started in only 16 (5.8%) of the patients. The proportion of patients who were under follow-up was significantly higher during the pandemic period (P < 0.005). There was no difference between the pandemic period and the non-pandemic period in terms of starting isotretinoin treatment (P > 0.05). During pandemic period, 79% of the patients who used isotretinoin were followed-up every two or more months. Extended follow-up intervals showed no difference for detecting side effects (P > 0.05). Conclusions: Acne patients constitute an important part of dermatology outpatient clinics. During the pandemic period, the majority of acne patients came for follow-up. Extended follow-up periods were adopted by physicians and were found safe and effective in the current study. Thus, isotretinoin treatment seems efficacious and safe during pandemic period.

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“…Furthermore, provider preference may also explain gender differences in isotretinoin prescription during the pandemic. There may be greater reluctance among providers to prescribe isotretinoin to female patients over telehealth due to concerns about the accuracy of home pregnancy tests [ 7 ] or, in the case of initiation of treatment, challenges in completion of the iPLEDGE enrollment process.…”

Section: Discussionmentioning

confidence: 99%

“…The coronavirus disease 2019 (COVID-19) pandemic catalyzed the adoption of telehealth across specialties including dermatology, not only in the United States but all over the world [ 1 ]. In response, guidance on FDA Risk Evaluation and Mitigation Strategy (REMS)-required testing was updated [ 9 ], permitting patients on isotretinoin to complete monthly visits via telehealth and undergo pregnancy testing at home instead of at the provider’s office [ 7 ]. We hypothesized that these changes could potentially reduce iPLEDGE-related barriers and improve the accessibility of isotretinoin for female patients during the pandemic.…”

Section: Introductionmentioning

confidence: 99%

Gender differences in isotretinoin prescriptions during the COVID-19 pandemic at a U.S. academic medical center

Duan

Luzuriaga

2022

Arch Dermatol Res

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Systemic isotretinoin is a highly effective treatment for severe and refractory acne but carries risk for serious adverse effects such as teratogenicity. The risk mitigation system used in the United States, iPLEDGE, requires all patients on isotretinoin therapy to complete monthly tasks including follow-up visits with their prescriber, and patients with childbearing potential must additionally undergo monthly pregnancy testing. Female patients seeking isotretinoin are disproportionately affected by iPLEDGE-related barriers and have historically been prescribed isotretinoin less than male patients. The onset of the COVID-19 pandemic and updated regulations permitting at-home pregnancy testing and telehealth for monthly follow-up visits presented an opportunity to study the impact of these changes on the isotretinoin gender gap. We performed a single-center analysis to determine whether gender differences in isotretinoin prescription changed at our institution at the beginning of the pandemic. We found that male predominance of isotretinoin prescriptions was greater during the pandemic compared to pre-pandemic (odds ratios: 4.13 vs. 2.86). Furthermore, male patients were more likely to utilize telehealth compared to in-person visits for isotretinoin follow-up relative to female patients (odds ratios: 6.00 vs. 3.62). Despite the newly introduced flexibilities of telehealth and remote pregnancy testing, gender inequity in receiving isotretinoin treatment persists.

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An opportunity for improvement: iPLEDGE policy changes during the coronavirus pandemic

Cited by 6 publications

References 8 publications

Retrospective study of acne telemedicine and in‐person visits at an academic center during the COVID‐19 pandemic

Retrospective study of acne telemedicine and in‐person visits at an academic center during the COVID‐19 pandemic

Isotretinoin Treatment Practices and Outcomes in Acne Patients During the COVID-10 Pandemic: A Single Center, Retrospective, Comparative Study

Gender differences in isotretinoin prescriptions during the COVID-19 pandemic at a U.S. academic medical center

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