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


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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.