The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals

Purpose To describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of biopharmaceuticals. Methods A cross-sectional analysis was performed of follow-up requirements of PSURs submitted for centrally approved biopharmaceuticals in the European Union between 1 July 2008 and...

Full description

Saved in:
Bibliographic Details
Published in:European journal of clinical pharmacology 2013-02, Vol.69 (2), p.217-226
Main Authors: Ebbers, Hans C., Mantel-Teeuwisse, Aukje K., Sayed-Tabatabaei, Fakhredin A., Moors, Ellen H. M., Schellekens, Huub, Leufkens, Hubert G. M.
Format: Article
Language:English
Subjects:
Adverse Drug Reaction Reporting Systems
Biological and medical sciences
Biological Products - adverse effects
Biomedical and Life Sciences
Biomedicine
Communication
Drug Labeling
Humans
Medical sciences
Pharmaceuticals
Pharmacoepidemiology and Prescription
Pharmacology. Drug treatments
Pharmacology/Toxicology
Product Surveillance, Postmarketing
Safety management
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Purpose To describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of biopharmaceuticals. Methods A cross-sectional analysis was performed of follow-up requirements of PSURs submitted for centrally approved biopharmaceuticals in the European Union between 1 July 2008 and 30 June 2010. A follow-up analysis on a subset of products that submitted multiple PSURs within the study period was also performed. Results The cross-sectional analysis included 70 PSURs. Potential safety concerns occurred in 57 (83 %) of all PSURs, and 26 (37 %) concluded a need to change the Summary of Product Characteristics (SPC). In comparison to newer products, products authorized for more than 10 years contained significantly fewer potential safety concerns (60 vs. 92 %; p  
ISSN:0031-6970
1432-1041
DOI:10.1007/s00228-012-1317-3