The DSRU conducts drug utilisation studies to examine the distribution and use of drugs in the general population.
These studies can be used to establish how drugs are used in a real-world setting and whether they are being prescribed and used as intended.
Our drug utilisation studies include those that form part of risk management plans and use a range of data sources, enabling the following information to be captured from real-world use:
- Characteristics of users
- Indications for use
- Dosing regime
- Concomitant medication use
- Potential off-label use
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.