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

Abstract

A study was conducted to explore the potenticil diflerence in geographic' mid cross-culturul variution in safee udverse drug reuction reporting. Attempts n'ere made in the study design to minimize genetic dflerences, market representution. age. and gender CIS confounding fiictors in affecting the findings. Six thousand spontaneous reports from five countries ( Frunce, Germany, United Kingdom, United Stutes, and Canudu) were randomly generated from our spontaneous safety dutabase which covered u 15-year reporting period (March 1. I983 to December 31, 1997). The reports were then reviewed and compared ugainst each cvuntrv for severul factors of interest. Despite some limitations, there are interesting observations from the current study that are worth further review. For example, German reporis seem more likely to be serious. related to death und lifethreatenin.? events. and muy nrirrrmt more attention. The Cunudirm and American reports hod the highest numbers in the catego? of luck of drug eflect. When .further analyzed using continent ruther than coutitty u s a base. Europe was consistently higher in terms of number qf serious reports. deatidlife-threatening events. and cases qf overdose. The current study is limited to our experience and ,further research by other investigators to confirm these findings is wurranted.

Post‐licensure safety surveillance for human papillomavirus‐16/18‐AS04‐adjuvanted vaccine: more than 4 years of experience

“…The 10 most frequent AEs (presented as MedDRA Preferred Terms [PTs]) reported after vaccination with HPV‐16/18 vaccine are consistently reported across countries worldwide and are dominated by cases from five countries with longstanding national immunisation programmes, representing 80% (8916/11 145) of all reports since launch (Table ). Varying frequencies of each event in individual countries reflect the known different local reporting awareness and reporting practices . Overall, the results shown in Table are comparable to post‐marketing safety surveillance conducted in the UK, Italy and the Netherlands .…”