28. Leveraging Routinely Collected Healthcare Data to Scale Up Drug Safety Surveillance: The EU-ADR Experience

  1. Elizabeth B. Andrews PhD, MPH, FISPE3 and
  2. Nicholas Moore MD, PhD, FRCP(Edin), FISPE4
  1. Gianluca Trifirò1 and
  2. Preciosa Coloma2

Published Online: 4 APR 2014

DOI: 10.1002/9781118820186.ch28

Mann's Pharmacovigilance

Mann's Pharmacovigilance

How to Cite

Trifirò, G. and Coloma, P. (2014) Leveraging Routinely Collected Healthcare Data to Scale Up Drug Safety Surveillance: The EU-ADR Experience, in Mann's Pharmacovigilance (eds E. B. Andrews and N. Moore), John Wiley & Sons, Ltd, Oxford, UK. doi: 10.1002/9781118820186.ch28

Editor Information

  1. 3

    Vice President, Pharmacoepidemiology and Risk Management, RTI Health Solutions, Research Triangle Park, NC, USA

  2. 4

    Professor of Clinical Pharmacology, Service Hospitalo-Universitaire de Pharmacologie, Bordeaux, France

Author Information

  1. 1

    Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy and Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands

  2. 2

    Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands

Publication History

  1. Published Online: 4 APR 2014
  2. Published Print: 1 APR 2014

ISBN Information

Print ISBN: 9780470671047

Online ISBN: 9781118820186

SEARCH

Keywords:

  • drug safety surveillance;
  • electronic healthcare records (EHRs).;
  • EU-ADR;
  • healthcare data;
  • pharmacovigilance

Summary

Safety-related warnings and market withdrawal of prominent drugs in recent years have fueled efforts to consider other data sources for surveillance and to develop new methodologies in order to supplement existing pharmacovigilance systems. One of the important resources posited to have enormous potential for proactive safety surveillance are electronic healthcare records (EHRs). Linking of healthcare databases for active drug safety surveillance is feasible in Europe, and yet the leverage to do so may be too low for very rare events and for drugs that are infrequently used, or captured, in the databases, and a system such as exploring and understanding adverse drug reactions (EU-ADR) may be better at detecting signals with lower strength of association for events that have a relatively high background frequency.