1. Pharmacovigilance Systems: Drug Safety Surveillance
Electronic
Pharmacovigilance Systems:
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. Pharmaceutical Industry & Pharmacovigilance (PV)
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
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

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

14. غروب زیبا ی ساحل خلیج فارس