Abstract
Context
The abuse of opioids and opioid-related harms, including deaths, in the United States
are well documented. In the European Union, opioid use has also been increasing, particularly
of fentanyl.
Objective
We assessed the prevalence of off-label prescribing of transmucosal immediate-release
fentanyl (TIRF), in France, in 2019. We looked at the patients’ and prescribers’ characteristics
and compared the population of patients who received TIRF in off-label prescriptions
with those taking it on-label. We also examined the differences between the patients
with and without cancer in the off-label use population.
Methods
This was a population-based cross-sectional study conducted in 2019, using the French
national insurance claims database Système National d'Informations Inter-Régimes de
l'Assurance Maladie, covering 98.8% of the French population, or 66 million people.
Results
We selected 224,000 patients with fentanyl prescriptions. Among them, 23,209 had at
least one TIRF delivered. The median age was 71 years (59-85) and most patients were
female (55.8%). The prevalence of off-label prescribing of TIRF was 51.8% (n = 12,031), corresponding to 9827 patients not diagnosed with cancer. The three main
pharmaceutical TIRF specialties prescribed in two groups were Abstral, Pecfent, and
Instanyl. Overall, TIRF was mainly prescribed by private general practitioners (64.8%).
Conclusion
The prevalence of off-label prescribing of TIRF in France is extremely high. A field
survey is now needed 1) to better understand why TIRF is used in conditions not indicated
in its marketing authorization, and in what clinical situations, and 2) to determine
whether the benefit/risk ratio of such use is favorable.
Key Words
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Article info
Publication history
Published online: February 18, 2022
Accepted:
February 16,
2022
Identification
Copyright
© 2022 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.
