Postmarketing Drug Safety and Risk Intervention Studies

3/19/01


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Table of Contents

Postmarketing Drug Safety and Risk Intervention Studies

Topics for Today’s Discussion

Why Post-Marketing Surveillance?

Postmarketing Safety Surveillance

Postmarketing Causality Assessment

Postmarketing Causality Assessment

Use of Cases Identified in AERS

Underreporting: Barriers to Reporting

Underreporting of Adverse Drug Reactions From the Literature

Lotronex

Possible Next Steps

Possible Next Steps

Possible Next Steps

First Drug History

First Case History

Risk Intervention Study Objective

Risk Intervention Study Objective

PPT Slide

LT Monitoring at Baseline after the First Prescription by Cohort

Full Compliance with Monthly LT Monitoring by Cohort among Drug Users

Conclusion

Investigators

Second Drug History

Second Drug History

Second Drug History

Study Objective

Methods

Study Sites

Cohorts Before and After Labeling Changes through 6/98

Results: Contraindicated Drug or Disease

Conclusion

Study Group

Summary / Considerations

Future Directions

Future Directions

Future Directions

Back Up Slides

Sample Size of Study Population, UHG

Criteria for Inclusion in the Study Cohort for LT Monitoring

Study Method for Measuring Liver Transaminase Monitoring in UHG

Cohorts

PPT Slide

Contraindicated Drugs

PPT Slide

Contraindicated Comorbidity

Contraindicated Comorbidity

PPT Slide

Future Directions

Future Directions

Author: david graham