Supplemental Material for The Impact of the COVID-19 Pandemic and the iPLEDGE REMS Update on Isotretinoin Prescription Delays and Interruptions: An Interrupted Time Series Analysis
Description
eMethod 1: Cohort determination, data collection, definitions of outcomes, and analysis. eTable I. Patient demographics, isotretinoin treatment information, and reasons for iPLEDGE-related delays and interruptions for patients with acne on isotretinoin stratified by time period. eTable II. ITSA results for the monthly percentage of prescriptions with either iPLEDGE-Related Delays or Interruptions for all patients with acne on isotretinoin, stratified by iPLEDGE Category, and the difference between iPLEDGE Category. eFigure 1. Interrupted Time Series Analysis (ITSA) for the monthly percentage of isotretinoin prescriptions with iPLEDGE-related delays for all patients with acne on isotretinoin from January 2018 to October 2023. The first vertical dashed line (March 16, 2020) indicates the onset of the COVID-19 Pandemic, with a 2.6% immediate increase in iPLEDGE-related delays (p<0.001) (shown by the orange vertical line) which had a stable trend during the pandemic time period (a 0.08% decrease per month, p=0.397). The second vertical dashed line (December 13, 2021) marks the transition to the new iPLEDGE system, showing a 5.0% immediate increase in monthly iPLEDGE-related delays (p<0.001) represented by the vertical blue dashed line which was sustained through the post-update period as shown by the post-iPLEDGE Update trend line in red (a 0.07% decrease per month, p=0.476). eFigure 2. ITSA for the monthly percentage of isotretinoin prescriptions with iPLEDGE-related delays stratified by iPLEDGE category from January 2018 to October 2023. The first vertical dashed line (March 16, 2020) indicates the start of the COVID-19 pandemic, with a 4.0% immediate increase in monthly iPLEDGE-related delays for patients who can become pregnant (p<0.001) followed by a 0.1% per month decrease in iPLEDGE-related delays over the pandemic time period (p=0.027). For patients who cannot become pregnant, there was a 1.3% immediate increase in monthly iPLEDGE-related delays at the start of the pandemic (p=0.024) followed by a 0.1% decrease per month (p=0.024) throughout the pandemic time period. The second vertical dashed line (December 13, 2021) marks the iPLEDGE update, with patients who can become pregnant having a 6.0% immediate increase in monthly iPLEDGE-related delays (p<0.001) which persisted through the end of the post-update period as shown by the red trend line (a 0.1% decrease per month, p=0.133). Patients who cannot become pregnant had a 3.9% immediate increase in monthly iPLEDGE-related delays after the iPLEDGE update (p<0.001) without a significant change in the trend through the end of the post-update period, shown by the dashed blue trend line (a 0.12% per month decrease, p=0.053).