Pharmacovigilance Systems: Drug Safety Surveillance

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Presentation transcript:

Pharmacovigilance Systems: Drug Safety Surveillance Electronic Pharmacovigilance Systems: Drug Safety Surveillance Z. Mastaneh, Ph.D

Presentation Overview Pharmaceutical Industry & Pharmacovigilance (PV) Pharmacovigilance (PV) & Information Technologies

Pharmaceutical Industry & Pharmacovigilance (PV)

Thalidomide & Phocomelia

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

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

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)

Pharmacovigilance (PV) & Information Technology (IT)

International ADR Database ADRs Data Collection Assessment of data Accuracy and Completeness, & Analysis Decision making 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

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

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

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

Interesting Conclusion Safer Drugs in the context of IT Insuring Public Confidence Domestic Consumption/ Drug Exports High Profitability and achievement to Dynamic Economy

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