OPIOIDS: ADEs & ADRs

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•What makes pain the fifth vital sign?

•Where are those 14,600 deaths a year in FAERS?

•Did the reporting systems accurately capture trends in overdose, abuse, and deaths? 

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•Do data from FAERS correspond with information from other sources?

•Is overdose death subject to expedited reporting in PV?

•How are signals detected in pharmacovigilance?

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•How do PV reporting systems detect ADR prevalence, incidence, and frequency?

•How do PV reporting systems detect changes in trends?

•How did the introduction of REMS for ER/LA affect the trends?

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•How the data from FAERS compare to data from DEA?

•For what indications are Rx opioids typically prescribed?

•How do labeled indications compare to actual prescriptions?

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•What will change with package level identifiers imposed by DSCSA?