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Databases Used in Pharmacovigilance Across the Globe

  • Vipin Bhati,
  • Mukesh Nandave,
  • Anoop Kumar,
  • Deepti Pandita

摘要

Different pharmacovigilance (PV) systems and databases are used worldwide in the field of PV. These databases play a vital role in the vigilance of the safety of medications and medical products after their approval and distribution. Collecting and analysing adverse event reports enables early detection of potential safety concerns, facilitates regulatory actions, and contributes to public health protection. This chapter emphasizes the advantages of these databases, such as their ability to conduct signal detection, post-market surveillance, and support research endeavours. Furthermore, the limitations of these databases such as underreporting, reporting bias, and the need for careful causality assessment were also discussed.