Impact of Geographic and Cross-Cultural Differences on Spontaneous Adverse Events Reporting

A study was conducted to explore the potential difference in geographic and cross-cultural variation in safety adverse drug reaction reporting. Attempts were made in the study design to minimize genetic differences, market representation, age, and gender as confounding factors in affecting the findi...

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Bibliographic Details
Published in:Drug information journal 1999, Vol.33 (3), p.921-931
Main Authors: Wu, Hsiao-hui, Fung, Man, Hornbuckle, Ken, Muniz, Edmundo
Format: Article
Language:English
Subjects:
Biological and medical sciences
Clinical trial. Drug monitoring
Cultural factors
Drug development
General pharmacology
Medical sciences
Overdose
Pharmacology. Drug treatments
Safety
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Summary:A study was conducted to explore the potential difference in geographic and cross-cultural variation in safety adverse drug reaction reporting. Attempts were made in the study design to minimize genetic differences, market representation, age, and gender as confounding factors in affecting the findings. Six thousand spontaneous reports from five countries (France, Germany, United Kingdom, United States, and Canada) were randomly generated from our spontaneous safety database which covered a 15-year reporting period (March 1, 1983 to December 31, 1997). The reports were then reviewed and compared against each country for several factors of interest. Despite some limitations, there are interesting observations from the current study that are worth further review. For example, German reports seem more likely to be serious, related to death and life-threatening events, and may warrant more attention. The Canadian and American reports had the highest numbers in the category of lack of drug effect. When further analyzed using continent rather than country as a base, Europe was consistently higher in terms of number of serious reports, death/life-threatening events, and cases of overdose. The current study is limited to our experience and further research by other investigators to confirm these findings is warranted.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286159903300333