BACKGROUND: Drug Utilization Studies (DUS) describe prescribing, dispensing and use of medicines in defined populations. DUS can be used to track off-label use of drugs and can form the basis for numerous aspects of evaluating the safe and effective use of medicines. The ability of DUS to identify prescribing patterns, to provide denominator data for rates of adverse reactions in special populations, to characterize baseline risk profile in patients, to estimate potential drug abuse, and to assess the effectiveness of routine and additional risk minimization activities, are only some of their potential applications in the EU-RMP/REMS. Nonetheless, the value of DUS often remains unrecognized.
OBJECTIVES: To share the experience across sectors on the value and limitations of DUS in the context of EU-RMP/ REMS, including methodological challenges and limitations, and unexplored opportunities. Target audience: Individuals involved in EU-RMP/REMS development and evaluation will find this symposium useful.
DESCRIPTION: The symposium will include six panelists from US- and EU-based organizations, who will describe their experience with DUS in the context of EU RMP/ REMS, including methodological challenges, lesson learned and recommendations for future efforts. After an introduction to the format, including an overview of DUS in the EU RMP repository (A. Rubino, EMA, Chair), the symposium will include the following four speakers and topics: M-AWallander (Bayer HealthCare Pharmaceuticals) - DUS in support of EU-RMP: Case studies from the perspective of EU-based industry T Callreus (Danish Medicines Agency) - Regulatory Drug Utilisation Studies: some experiences from the Danish Medicines Agency P Saddier (Merck and Co) - DUS in the evaluation of use and safety profile of vaccines from the perspective of USbased industry MB Ritchey (FDA) - Device Utilization Studies: Use and safety from a FDA perspective Closing remarks by S. Perez-Gutthann (RTI-HS, Co-chair) will summarize current experience and will highlight potential applications of DUS in EU-RMP/REMS. Each presentation will be 15 minutes. All panelists will participate in general discussion (15–20 min) with the audience led by Chair and Cochair.
