Get access

Utilization of fentanyl buccal tablets in England: Exploring off-label use reported in a cohort study


  • Funding sources

    The Drug Safety Research Unit (DSRU) is an independent charity (No. 327206) that works in association with the University of Portsmouth. It receives unconditional donations from pharmaceutical companies. The companies have no control on the conduct or the publication of the studies conducted by the DSRU. The unit has received such funds from the manufacturer of fentanyl buccal tablets (Cephalon). The DSRU retained its academic independence with respect to the conduct of the study and external communications of the results of the study.

  • Conflicts of interest

    Saad Shakir has received money for providing training and advice in pharmacovigilance to pharmaceutical companies. Deborah Layton has received money for the development of an educational module on ADR reporting for the Royal Pharmaceutical Society and as a guest lecturer to undergraduate pharmacy students. Mohammad Al-Shukri is now an employee of GlaxoSmithKline. Vicki Osborne and Carole Fogg have no conflicts of interest to declare.



Fentanyl citrate buccal tablets are indicated for the treatment of breakthrough pain (BTP) in cancer, in adults who are receiving maintenance opioid therapy for chronic cancer pain.


One of the objectives of this study was to describe the utilization characteristics of patients prescribed fentanyl buccal and to assess how the product is being used in relation to the terms of license of marketing approval.


An observational post-marketing cohort study was conducted. For the analysis of this study, exposure data were collected from dispensed prescriptions issued by general practitioners (GPs) between March 2009 and June 2011. Outcome data (indication, event, patient demographic and selected clinical characteristics) were collected by sending questionnaires to GPs at least 6 months after the drug was first prescribed. Summary descriptive statistics were calculated.


The cohort consisted of 551 patients, of which 54.8% (n = 302 patients) were female. The median age for the cohort was 62 years (interquartile range: 50–72 years), with one patient (0.2%) aged less than 18 years. A primary indication of BTP in cancer was reported for 61.9% (n = 341) patients. Regular opioid therapy was reported upon starting the treatment for 383 patients (69.5% of cohort). In total, 69 patients (12.5%) had one or more contraindications for use. The most frequent initial titration dose was 100 μg/day (n = 247).


The final study results show that fentanyl buccal is largely being prescribed according to the terms of the license in general practice in England, but off-licence use and use in the presence of contraindications and warnings have been reported.