Dynamic Product Labeling Overview
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Customizing Drug Product Labeling with Evidence Layers and Personalization
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Dynamic Product Labeling Overview
- 1. Rapid fire talk Dynamic Product Labeling Jon Duke MD, MS Regenstrief Institute
- 3. 3258 3391 3841 5317 7458 8160 0 1000 2000 3000 4000 5000 6000 7000 8000 9000 Pre-1960 1960-1969 1970-1979 1980-1989 1990-1999 2000-2009 WordCount Date of Drug Approval Drug Labels are Growing Longer
- 4. 70 103 111 118 121 127 165 185 227 241 384 0 50 100 150 200 250 300 350 400 All Drugs Bisphosphonates Beta Blockers Benzodiazepines NSAIDs Statins ACE-Inhibitors Proton Pump Inhibitors 5-HT1 Agonists (Triptans) Atypical Antipsychotics SSRI's Mean Number of ADE's per label DrugClass 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.
- 5. Rapid fire talk 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.
- 6. Drug labels have become more relevant to industry, regulators, researchers, and lawyers than they are to patients and providers
- 7. Dynamic Product Labeling refers to customizing the user experience of a drug label to make it - More patient-specific - More provider-relevant
- 8. Zaxyza
- 11. Rapid fire talk
- 12. Augmenting the User Experience with Layers
- 13. Rapid fire talk Evidence Layers Observational Data Literature Evidence Adverse Event Reporting Malpractice / Tort Cases Provider Historical Data Ontologies + Patient Data Zaxyza
- 14. Rapid fire talk 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
- 15. Rapid fire talk Enter drug name Additional Data Layers Observational Data Literature Evidence Adverse Event Reporting Malpractice / Tort Cases Provider Historical Data Ontologies Literature Evidence on Abnormal Hepatic Function with Zaxyza 3 Randomized Controlled Studies 5 Observational Studies 11 Case Reports 2 Review Papers + Patient Data
- 16. Rapid fire talk Enter drug name Additional Data Layers Observational Data Literature Evidence Adverse Event Reporting Malpractice / Tort Cases Provider Historical Data Ontologies + Patient Data
- 17. Rapid fire talk Enter drug name Additional Data Layers Observational Data Literature Evidence Adverse Event Reporting Malpractice / Tort Cases Provider Historical Data Ontologies Malpractice Cases involving Seizure and Zaxyza 127 cases on Lexis-Nexis 135 cases on Westlaw 87 cases on PACER + Patient Data
- 18. Rapid fire talk 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
- 19. Rapid fire talk Dynamic Product Labeling requires a lot knowledge - Knowledge of the evidence (literature, observational data) - Knowledge of the patient (manual entry, EHR)
- 20. Rapid fire talk - The label customization framework itself is lightweight (Javascript, CSS, HTML5) - Initially targeting SPLs but ultimately extensible to SPCs and other drug safety content
- 21. Rapid fire talk Thank you.