Abstract
INTRODUCTION: Prescriptions of transmucosal immediate-release fentanyl (TIRF) have increased in recent years, driven by their rapid onset and ease of administration compared to other opioids like morphine and oxycodone, especially for breakthrough pain. A 2022 study reported high rates of off-label TIRF use, particularly among general practitioners (GPs). This study aimed to assess the prevalence and patterns of off-label TIRF use by GPs, and perceived efficacy for predictable pain associated with medical procedures. Secondary objectives included evaluating its use in other specific contexts such as swallowing or alertness disorders, acute pain, and overall tolerability. METHODS: A mixed-methods study was designed to combine qualitative interviews exploring clinical contexts with a quantitative cross-sectional survey assessing the prevalence of off-label use of TIRF among French GPs. Data were collected through a national online survey. RESULTS: A total of 682 completed questionnaires were analyzed. The study focused exclusively on off-label prescribing of TIRFs. Off-label use was reported by 46% of GPs across a variety of clinical indications. Specifically, 244 GPs (36%; 95% CI 32-40) reported prescribing TIRFs for procedural pain. Other off-label indications were also reported, including use for alertness disorders (24%; 95% CI 21-27), swallowing disorders (32%; 95% CI 28-35), and acute rheumatological pain (12%; 95% CI 9-14). These findings highlight a substantial level of off-label prescribing, with varying perceptions of efficacy and tolerability across different clinical contexts. CONCLUSIONS: This study confirms widespread off-label TIRF use in well-defined clinical situations. While many GPs report positive outcomes, important concerns remain, including limited training, difficulty with dose titration, and the risk of use disorder. Targeted education and clearer prescribing guidelines could help ensure a safer and more appropriate use of TIRF in GPs practice.