Document Detail

Quality and completeness of utilisation data on biological agents across European countries: tumour necrosis factor alpha inhibitors as a case study.
MedLine Citation:
PMID:  21351308     Owner:  NLM     Status:  MEDLINE    
PURPOSE: For optimal decision making on access to and regulations around biologicals availability of national utilisation data is a prerequisite. This study characterises the main categories of critical issues in collecting available national utilisation data on tumour necrosis factor alpha (TNFalpha) inhibitors in different European countries.
METHODS: Data were collected on characteristics of the nature of TNFalpha usage data and on usage of TNFalpha itself (2003-2007). Utilisation rates were expressed as defined daily doses (DDDs)/1000 inhabitants/day. Data from Denmark, Finland, Ireland, the Netherlands, Norway and Portugal were included.
RESULTS: Characteristics of TNFalpha (usage settings and ways of distribution to patients) and databases (type of data collected, public availability and data sources) influenced the way data were collected and determined the type of research and policy questions that can validly be addressed. The prevailing differences in the structure of national databases are prohibitive for critical aspects of medicines utilisation studies. An increase in TNFalpha usage over time was observed in all countries and varied widely from 0.32 (Portugal) to 1.89 (Norway) DDDs/1000 inhabitants/day (2007).
CONCLUSIONS: In the European countries studied data on national TNFalpha usage is not easily, if at all accessible. Intercountry collaboration and sharing of technical resources will facilitate harmonisation of data collection allowing independent, population based, health and outcomes research.
Joëlle M Hoebert; Aukje K Mantel-Teeuwisse; Liset van Dijk; Richard O Laing; Hubert G M Leufkens
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Publication Detail:
Type:  Journal Article     Date:  2011-01-10
Journal Detail:
Title:  Pharmacoepidemiology and drug safety     Volume:  20     ISSN:  1099-1557     ISO Abbreviation:  Pharmacoepidemiol Drug Saf     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-02-25     Completed Date:  2011-06-24     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  9208369     Medline TA:  Pharmacoepidemiol Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  265-71     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 John Wiley & Sons, Ltd.
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
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MeSH Terms
Antibodies, Monoclonal / administration & dosage*,  pharmacology,  therapeutic use
Antibodies, Monoclonal, Humanized
Drug Utilization Review / methods,  standards*
Immunoglobulin G / administration & dosage*,  pharmacology,  therapeutic use
Product Surveillance, Postmarketing
Receptors, Tumor Necrosis Factor / administration & dosage*,  therapeutic use
Research Design / standards*
Tumor Necrosis Factor-alpha / antagonists & inhibitors*
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Antibodies, Monoclonal, Humanized; 0/Immunoglobulin G; 0/Receptors, Tumor Necrosis Factor; 0/Tumor Necrosis Factor-alpha; 0/infliximab; 185243-69-0/TNFR-Fc fusion protein; FYS6T7F842/adalimumab

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