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Pharmacovigilance in Europe and North America: divergent approaches.
Soc Sci Med. 2012 Jul; 75(1):165-70.SS

Abstract

Although international medicines regulators adopt a common system to assess the safety and efficacy of new drugs, pre-market evaluation is recognized as incomplete given the much larger post-market experience to follow. Adverse drug reactions contribute to more than 100,000 deaths in the United States annually and are among the top 10 leading causes of death. Regulators are developing active surveillance approaches to assess the risks of medicines in the post-market phase to enhance passive adverse drug reaction reporting systems that capture only one to ten percent of ADRs. The objective of this study is to compare international approaches to active surveillance and the manner in which regulatory agencies access and use post-market evidence in their decisions. A conceptual framework is used to guide the comparative analysis of pharmacovigilance governance and policy in the United Kingdom, France, the European Union, the United States and Canada using data gathered from key informant interviews and document review. While research networks are emerging internationally, we found a greater reliance on industry funding and oversight of post-market research in Europe compared to an emphasis on publicly funded programs in North America.

Authors+Show Affiliations

School of Health Policy and Management, Faculty of Health, York University, Toronto, Canada. mwiktor@yorku.caNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22521677

Citation

Wiktorowicz, Mary, et al. "Pharmacovigilance in Europe and North America: Divergent Approaches." Social Science & Medicine (1982), vol. 75, no. 1, 2012, pp. 165-70.
Wiktorowicz M, Lexchin J, Moscou K. Pharmacovigilance in Europe and North America: divergent approaches. Soc Sci Med. 2012;75(1):165-70.
Wiktorowicz, M., Lexchin, J., & Moscou, K. (2012). Pharmacovigilance in Europe and North America: divergent approaches. Social Science & Medicine (1982), 75(1), 165-70. https://doi.org/10.1016/j.socscimed.2011.11.046
Wiktorowicz M, Lexchin J, Moscou K. Pharmacovigilance in Europe and North America: Divergent Approaches. Soc Sci Med. 2012;75(1):165-70. PubMed PMID: 22521677.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacovigilance in Europe and North America: divergent approaches. AU - Wiktorowicz,Mary, AU - Lexchin,Joel, AU - Moscou,Kathy, Y1 - 2012/04/03/ PY - 2011/04/12/received PY - 2011/10/13/revised PY - 2011/11/29/accepted PY - 2012/4/24/entrez PY - 2012/4/24/pubmed PY - 2012/9/21/medline SP - 165 EP - 70 JF - Social science & medicine (1982) JO - Soc Sci Med VL - 75 IS - 1 N2 - Although international medicines regulators adopt a common system to assess the safety and efficacy of new drugs, pre-market evaluation is recognized as incomplete given the much larger post-market experience to follow. Adverse drug reactions contribute to more than 100,000 deaths in the United States annually and are among the top 10 leading causes of death. Regulators are developing active surveillance approaches to assess the risks of medicines in the post-market phase to enhance passive adverse drug reaction reporting systems that capture only one to ten percent of ADRs. The objective of this study is to compare international approaches to active surveillance and the manner in which regulatory agencies access and use post-market evidence in their decisions. A conceptual framework is used to guide the comparative analysis of pharmacovigilance governance and policy in the United Kingdom, France, the European Union, the United States and Canada using data gathered from key informant interviews and document review. While research networks are emerging internationally, we found a greater reliance on industry funding and oversight of post-market research in Europe compared to an emphasis on publicly funded programs in North America. SN - 1873-5347 UR - https://www.unboundmedicine.com/medline/citation/22521677/Pharmacovigilance_in_Europe_and_North_America:_divergent_approaches_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0277-9536(12)00225-0 DB - PRIME DP - Unbound Medicine ER -