Overview
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
- Co-morbidities
- Concomitant medication use
- Potential off-label use
Case study
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.