Dynamic Product Labeling Overview
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This document discusses dynamic product labeling, which customizes drug label information to be more patient-specific and relevant to providers. It proposes augmenting standard drug labels with additional data layers that can include observational data, literature evidence, adverse event reports, malpractice cases, provider historical data, and ontologies. This customized information would be overlaid on the standard drug label when a specific drug and patient are entered. The goal is to make drug safety information more useful for patients and providers by targeting it based on the individual drug and patient. It notes that such a system would require significant medical knowledge but that the technical framework could be lightweight using web technologies.
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.