title: Evaluating the effectiveness of risk minimisation measures: the application of a conceptual framework to Danish real-world dabigatran data.
abstract: OBJECTIVE
  For both marketing authorization holders and regulatory authorities, evaluating the effectiveness of risk minimization measures is now an integral part of pharmacovigilance in the European Union. The overall aim of activities in this area is to assess the performance of risk minimization measures implemented in order to ensure a positive benefit-risk balance in patients treated with a medicinal product.
  
  
  METHODS
  Following a review of the relevant literature, we developed a conceptual framework consisting of four domains (data, knowledge, behaviour and outcomes) intended for the evaluation of risk minimization measures put into practice in the Danish health-care system. For the implementation of the framework, four classes of monitoring variables can be named and defined: patient descriptors, performance-related indicators of knowledge, behaviour and outcomes.
  
  
  RESULTS
  We reviewed the features of the framework when applied to historical, real-world data following the introduction of dabigatran in Denmark for the prophylactic treatment of patients with non-valvular atrial fibrillation.
  
  
  CONCLUSIONS
  The application of the framework provided useful graphical displays and an opportunity for a statistical evaluation (interrupted time series analysis) of a regulatory intervention. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd.
authors.affiliation: Danish Medicines Agency, Copenhagen, Denmark.
authors.forename: Martin Erik
authors.initials: ME
authors.lastname: Nyeland
authors.affiliation: Danish Medicines Agency, Copenhagen, Denmark.
authors.forename: Mona Vestergaard
authors.initials: MV
authors.lastname: Laursen
authors.affiliation: Danish Medicines Agency, Copenhagen, Denmark.|Copenhagen Center for Regulatory Science, Copenhagen, Denmark.
authors.forename: Torbjörn
authors.initials: T
authors.lastname: Callréus
mesh_terms: D000991:Antithrombins / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000453:epidemiology; D000069604:Dabigatran / Q000627:therapeutic use*; D016208:Databases, Factual / Q000706:statistics & numerical data*; D003695:Delivery of Health Care / Q000706:statistics & numerical data*; D003718:Denmark / Q000453:epidemiology; D006801:Humans; D060735:Pharmacovigilance; D018570:Risk Assessment
chemical_list: D000991:Antithrombins; D000069604:Dabigatran
keywords: interrupted time series analysis; pharmacoepidemiology; pharmacovigilance; real-world data; risk management