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Enhancing Drug Safety through Electronic Pharmacovigilance Systems

Discover the vital role of Information Technologies in Pharmaceutical Industry & Pharmacovigilance (PV) for monitoring drug safety. Explore how IT supports surveillance, evaluation, and prevention of Adverse Drug Reactions (ADRs). Learn about the benefits of IT in PV like safer medication use and cost reduction. Unveil the significance of a National ADR Database and the prerequisites for its implementation. Gain insights into the global efforts to ensure drug safety and build public confidence in pharmaceutical products.

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Enhancing Drug Safety through Electronic Pharmacovigilance Systems

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  1. Electronic PharmacovigilanceSystems: Drug Safety Surveillance Z. Mastaneh, Ph.D

  2. Presentation Overview • Pharmaceutical Industry & Pharmacovigilance (PV) • Pharmacovigilance (PV) & Information Technologies

  3. Pharmaceutical Industry & Pharmacovigilance (PV)

  4. Thalidomide & Phocomelia

  5. Drug Safety Assessment • Two main phases: • Pre – marketing • Post - marketing Limited Size Narrow Population (age and sex specific) Narrow Indication (only specific disease) Short Duration

  6. Drug Safety Assessment Pharmaceutical Industry & Pharmacovigilance (PV)

  7. Pharmacovigilance (PV) Pharmakon ----- in Greece ------ drug Vigilare ---------- in Latin ------- to keep watch Activities relating to detection, assessment, understanding and prevention of Adverse Drug Reactions (ADRs). (WHO)

  8. Pharmacovigilance (PV) & Information Technology (IT)

  9. International ADR Database Spontaneous Case Reports Case Series Reports National ADR Database Electronic Health Records Data Data from Patient Registries • Case Reviews • Data Mining • … Cohort Studies Results

  10. Prerequisites of National ADR Database • A common reporting form (Electronic form with specific data elements) • Agreed guidelines for data formulating and entering • Common terminologies and classifications • Compatible systems for transmitting, storing, retrieving and disseminating information

  11. Benefits of IT for PV • Safer use of medicines • Quick and timely decision making and taking necessary actions • Reduce costs of ADRs • Observe ethical considerations • Insuring public confidence

  12. Pharmaceutical industry ranking in top 10 profitable industries Furtune Journal, 2010

  13. Interesting Conclusion

  14. غروب زیبا ی ساحل خلیج فارس

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