BT04 Comparative safety of remote and in-person isotretinoin initiation: a retrospective analysis of outcomes

Abstract

The significant prevalence of acne, coupled with the COVID-19 pandemic, accelerated the adoption of teledermatology, which remains embedded in routine care. Despite evidence supporting the safety of remote isotretinoin initiation, Medicines and Healthcare products Regulatory Agency (MHRA) requirements suggest in-person initiation, citing concerns in assessing psychological and sexual adverse effects. The aim of this study was to evaluate the safety of remote isotretinoin initiation compared with face-to-face care, by comparing biochemical and psychosexual adverse effects, and pregnancy rates. We assessed the occurrence of each outcome alongside patient-reported measures in a cohort of NHS patients with acne for whom isotretinoin had been initiated remotely or face to face. Data were compared with similar patients from an online teledermatology provider (OTP). In total, 400 NHS patients were initiated remotely (n = 144, 36%) or face-to-face (n = 256, 64%). Blood abnormalities occurred in 11.1% among the remote cohort and 11.7% among the face-to-face cohort, with dose-related change or cessation in 1 and 3 patients, respectively. Mood changes were reported in 8 (5.6%) remote patients and 15 (5.9%) seen face to face, requiring treatment modification in 1 and 3, respectively. Mean PHQ-9 and CADI improved following isotretinoin completion, without pathway difference. Sexual dysfunction occurred in 2 (1.4%) remote patients and 4 (1.6%) seen face to face, without treatment modification. There were no pregnancies. Among 536 OTP patients, biochemical abnormalities necessitating cessation occurred in one. Mood symptoms occurred in 19 patients (3.5%), with 4 requiring treatment modification; sexual dysfunction occurred in 2 (0.4%), without dose change. One terminated pregnancy was recorded (Pregnancy Prevention Programme group C). Rates of biochemical abnormalities, mood changes and sexual dysfunction were overall low and comparable between the remote and face-to-face initiation pathways. The findings align with the NHS’s digital vision and 10-year plan to make digital consultations standard. They provide validated evidence on the safety of remote isotretinoin initiation and solidify the role of teledermatology in enhancing patient access and service efficiency. This largest UK study of its kind should help inform future MHRA regulations.