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

Abstract

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.

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Correspondence to Dr. Man Fung MD, MBA, FACP.

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Wu, HH., Fung, M., Hornbuckle, K. et al. Impact of Geographic and Cross-Cultural Differences on Spontaneous Adverse Events Reporting. Ther Innov Regul Sci 33, 921–931 (1999). https://doi.org/10.1177/009286159903300333

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Key Words

  • Spontaneous reporting system
  • Pharmacovigilance
  • Cross-cultural differences
  • Safety adverse event reporting