Fentanyl buccal tablets

• We were approached by a company which requested a drug utilisation and safety study for fentanyl buccal tablets
• One of the aims of this study was to describe the utilisation characteristics of patients prescribed fentanyl buccal and to assess how the product was being used
• An observational post-marketing cohort study was conducted
• Exposure data were collected from dispensed prescriptions issued by general practitioners (GPs)
• Outcome data (indication, patient demographic and selected clinical characteristics) were collected from GPs via bespoke data collection forms
• The final study results indicated that fentanyl buccal was largely being prescribed according to the terms of the license, but off-label use was also reported
• The DSRU was responsible for study design, data collection, analysis, interpretation and writing the final study report and paper

Full details are provided in this publication (see below):

Utilization of fentanyl buccal tablets in England: Exploring off-label use reported in a cohort study. Osborne V, Layton D, Fogg C, Al-Shukri M, Shakir SA. Eur J Pain. 2014 Apr;18(4):506-12.