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Customizing Drug Product Labeling with Evidence Layers and Personalization
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Dynamic Product LabelingJon Duke MD, MS Regenstrief Institute
Pre-1960 1960-1969 1970-1979 1980-1989 1990-1999 2000-20090
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Drug Labels are Growing Longer
All Drugs
Bisphosphonates
Beta Blockers
Benzodiazepines
NSAIDs
Statins
ACE-Inhibitors
Proton Pump Inhibitors
5-HT1 Agonists (Triptans)
Atypical Antipsychotics
SSRI's
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Mean Number of ADE's per label
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Drug Labels are Packed with Warnings
Duke J, Friedlin J, Ryan P. A Quantitative Analysis of Adverse Events and ‘Overwarning’ in Drug Labeling. Archives of Internal Medicine. May 2011;171(10):944-6.
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We’ve Got a Global Problem
Kesselheim AS, Franklin JM, Avorn J, Duke J. Speaking the same language? International variations in the safety information accompanying top-selling prescription drugs. BMJ Journal of Quality and Safety. 2013 22(9):727-734.
Drug labels have become more relevant toindustry, regulators, researchers, and lawyersthan they are to patients and providers
Dynamic Product Labeling refers to customizing the user experience of a drug label to make it
- More patient-specific- More provider-relevant
Zaxyza
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Augmenting the User Experience with Layers
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Evidence Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malpractice / Tort Cases
Provider Historical Data
Ontologies
+ Patient Data
Zaxyza
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Enter drug name
Additional Data Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malpractice / Tort Cases
Provider Historical Data
Ontologies
Observational Data Analysis
Abnormal Hepatic Function
with Zaxyza
+ Patient Data
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Enter drug name
Additional Data Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malpractice / Tort Cases
Provider Historical Data
Ontologies
Literature Evidence onAbnormal Hepatic Function with Zaxyza
3 Randomized Controlled Studies5 Observational Studies11 Case Reports2 Review Papers
+ Patient Data
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Enter drug name
Additional Data Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malpractice / Tort Cases
Provider Historical Data
Ontologies
+ Patient Data
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Enter drug name
Additional Data Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malpractice / Tort Cases
Provider Historical Data
Ontologies
Malpractice Cases involvingSeizure and Zaxyza
127 cases on Lexis-Nexis135 cases on Westlaw
87 cases on PACER
+ Patient Data
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Enter drug name
Additional Data Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malpractice / Tort Cases
Provider Historical Data
Ontologies In your patients on Zaxyza
Myalgia has occurred in 4 of 86 patients
+ Patient Data
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Dynamic Product Labeling requires a lot knowledge- Knowledge of the evidence (literature, observational data)
- Knowledge of the patient (manual entry, EHR)
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- The label customization framework itself is lightweight (Javascript, CSS, HTML5)- Initially targeting SPLs but ultimately extensible
to SPCs and other drug safety content
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Thank you.
