The results indicate that the BCPNN can be used in the detection of significant signals from the data set of the WHO Programme on International Drug Monitoring. The BCPNN will be an extremely useful adjunct to the expert assessment of very large numbers of spontaneously reported ADRs.
The WHO global individual case safety report (ICSR) database system, VigiBase, now holds more than 3,800,000 ICSRs contributed by the national centers (as of March 2007). VigiBase is used directly by the national centers and is accessed indirectly by other regulatory bodies, the pharmaceutical industry, and academia through data requests to the UMC.
Overall, only one report in eight provides the desired level of information, but much higher proportions are observed for individual countries. Physicians and e-reporting tools also generate greater proportions of well-documented reports overall. Reports from consumers/non-health professionals in specific regions have excellent quality, which illustrates their potential for the future. vigiGrade has already provided valuable information by highlighting data quality issues both in Italy and the USA.
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