Impact of Geographic and Cross-Cultural Differences on Spontaneous Adverse Events Reporting
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IMPACT OF GEOGRAPHIC AND CROSS-CULTURAL DIFFERENCES ON SPONTANEOUS ADVERSE EVENTS REPORTING HSIAO-HUI Wu, MS Eli I.illy Taiwan. Taipei, Taiwan
MANFUNG,MD, MBA, FACP, KEN HORNBUCKLE, DVM, MPH, PHD, AND EDMUNDO MUNIZ,MD PHD Worldwide Pharmacovigilance and Epidemiology, I d y Research Lab, Indianapolis. Indiana
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 f o r 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. Key Words: Spontaneous reporting system; Pharmacovigilance; Cross-cultural differences: Safety adverse event reporting
INTRODUCTION THE SPoNTANEoUS ADVERSE event reporting system is a widely used and costeffective method to detect adverse drug reactions in the postmarketing phase of a drug's
Reprint address: Dr. Man Fung. Worldwide P h m a c o vigilance & Epidemiology, I,illy Research Laboratories. DC 2531, Indianapolis. IN 46285. E-mail: fung_rn@ liIly.com.
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development (1-9). Since its inception about three decades ago, the system has gained y is now a standard in wide p o p u ~ a ~ t and the pharmaceutical industry for detecting and monitoring potential drug safety issues (1013). Many of the regulatory agencies in the world have statutory requirements for such a system and at times require postmarketing surveillance as a criterion for approval of certain products in the market (196). Although the system has great potential.
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Hsicro-hui Wu,Mcrn FunK. Ken Hornbuckle. and Edmundo Muniz
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there are some factors that may limit its usefulness. For example, the type of the reports received as well as the quality of these reports are important (2.1417). In addition to small variations in regional regulatory requirements in data collection, there are
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