Drug Utilisation Studies
Drug utilisation studies examine the marketing, distribution, prescription and use of drugs in a society, with special emphasis on the resulting medical, social and economic consequences (WHO).
Drug utilisation studies can form an important part of the risk management plan for a product, enabling the following information to be captured from real life clinical practice:
- Characteristics of users
- Indications for use
- Dosing regime
- Concomitant medication use
- Potential off-label use
Drug utilisation studies are frequently included in Risk Management Plans. The DSRU has extensive experience in advising on and conducting such studies. Our capabilities include:
- Production of a protocol considering regulatory requirements for study
- Management of the study and analysis of data
- Interpretation of study results
- Production of interim and final study reports
- Publication of study results in peer reviewed journals
Compared to other pharmacoepidemiological methods, generally drug utilisation studies are relatively easier to conduct and deliver results earlier.