Developments and Future Directions of Prescription-Based Observational Cohort Pharmacovigilance

  • Deborah Layton
Part of the Methods in Pharmacology and Toxicology book series (MIPT)


Lessons learnt from recent examples of drug safety hazards include the acknowledgment of discordance in learning about safety of new medicines during development as compared to during use within routine clinical practice, post marketing. Changes in pharmacovigilance regulations and legislation have given greater weight to the importance of post-marketing observational research and understanding more regarding natural variation in patients and their responses to treatment. In this chapter the origin and evolution of prescription-based event monitoring is described, with examples of real-life studies presented to offer some insight into the contributions and challenges of these post marketing systems in relation to monitoring the safety and use of new medicines.

Key words

Prescription-based event monitoring Post authorization safety studies Observational research Drug utilization 


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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Deborah Layton
    • 1
    • 2
  1. 1.Drug Safety Research UnitSouthamptonUK
  2. 2.IQVIALondonUK

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