Opioid misuse and opioid-related consequences, including fatalities, are extensively established in the United States. Opioid consumption, particularly fentanyl, has been growing throughout the European Union. In 2019, researchers sought to determine the incidence of off-label prescribing of transmucosal immediate-release fentanyl (TIRF) in France. They examined the characteristics of patients and prescribers who got TIRF in off-label prescriptions with those who received it on-label. In the off-label usage group, They also looked at the differences between patients with and without cancer.

The French national insurance claims database Système National d’Informations Inter-Régimes de l’Assurance Maladie was used in this population-based cross-sectional analysis, which included 98.8% of the French population, or 66 million individuals. 

They chose 224,000 people who had fentanyl prescriptions. Among them, 23,209 received at least one TIRF. The median age was 71 years (59-85), with most patients female (55.8%). The prevalence of TIRF off-label medication was 51.8% (n=12,031), equating to 9,827 individuals who were not cancer patients. Abstral, Pecfent, and Instant were the three major pharmacological TIRF specialties administered in two groups. Overall, private general practitioners were the most likely to prescribe TIRF (64.8%).

In France, off-label prescribing of TIRF is highly common. A field survey is now required to better understand why TIRF is used in conditions not included in its marketing authorization, in what clinical scenarios, and if the benefit/risk ratio of such use is good.