Rapid fire talk
Dynamic Product Labeling
Jon Duke MD, MS Regenstrief Institute
3258 3391
3841
5317
7458
8160
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
Pre-1960 1960-1969 1970-1979 1980-1989 1990-1...
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
Benzod...
Rapid fire talk
We’ve Got a Global Problem
Kesselheim AS, Franklin JM, Avorn J, Duke J. Speaking the same language? Intern...
Drug labels have become more relevant to
industry, regulators, researchers, and lawyers
than they are to patients and prov...
Dynamic Product Labeling refers to customizing the
user experience of a drug label to make it
- More patient-specific
- Mo...
Zaxyza
Rapid fire talk
Rapid fire talk
Augmenting the User Experience with Layers
Rapid fire talk
Evidence Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malpractice / Tort Cases
Pr...
Rapid fire talk
Enter drug name
Additional Data Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malp...
Rapid fire talk
Enter drug name
Additional Data Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malp...
Rapid fire talk
Enter drug name
Additional Data Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malp...
Rapid fire talk
Enter drug name
Additional Data Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malp...
Rapid fire talk
Enter drug name
Additional Data Layers
Observational Data
Literature Evidence
Adverse Event Reporting
Malp...
Rapid fire talk
Dynamic Product Labeling requires a lot knowledge
- Knowledge of the evidence (literature,
observational d...
Rapid fire talk
- The label customization framework itself is
lightweight (Javascript, CSS, HTML5)
- Initially targeting S...
Rapid fire talk
Thank you.
Dynamic Product Labeling Overview
Dynamic Product Labeling Overview
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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. 1. Rapid fire talk Dynamic Product Labeling Jon Duke MD, MS Regenstrief Institute
  2. 2. 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
  3. 3. 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.
  4. 4. 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.
  5. 5. Drug labels have become more relevant to industry, regulators, researchers, and lawyers than they are to patients and providers
  6. 6. Dynamic Product Labeling refers to customizing the user experience of a drug label to make it - More patient-specific - More provider-relevant
  7. 7. Zaxyza
  8. 8. Rapid fire talk
  9. 9. Rapid fire talk
  10. 10. Augmenting the User Experience with Layers
  11. 11. Rapid fire talk Evidence Layers Observational Data Literature Evidence Adverse Event Reporting Malpractice / Tort Cases Provider Historical Data Ontologies + Patient Data Zaxyza
  12. 12. 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
  13. 13. 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
  14. 14. 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
  15. 15. 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
  16. 16. 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
  17. 17. Rapid fire talk Dynamic Product Labeling requires a lot knowledge - Knowledge of the evidence (literature, observational data) - Knowledge of the patient (manual entry, EHR)
  18. 18. 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
  19. 19. Rapid fire talk Thank you.
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