Dynamic Product Labeling Technical

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Customizing Drug Labeling

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Dynamic Product Labeling Technical

  1. 1. Evidence-Enhanced Product Labeling (EPLs) Jon Duke April 15, 2014
  2. 2. What Are We Trying to Solve? A Problem with Labeling • While considered the official source of drug safety information – Labels are infrequently read by patient or providers – The evidence for a given ADR is often scant – They are one-size-fits-all and do not support personalized decision-making
  3. 3. What Are We Trying to Solve? A Problem with OHDSI • While we are developing superb methods and brilliant tools to convey evidence on drug safety – Driving use of external tools requires significant activation energy – Awareness of the evidence being generated by OHDSI may diffuse slowly even to those who would be extremely interested (e.g., drug knowledge vendors) – Users will generally need to know what they are looking for (e.g., what drug-outcome pairs)
  4. 4. The EPL Big Picture 4 Adverse Reactions ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~~ ~~ ~~ ~~ Adverse Reactions ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ Adverse Reactions ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ Structured Product Label Enhanced Product Label
  5. 5. Evidence-Enhanced Product Labeling • EPL is a platform for injecting approved product labeling with evidence from external sources • Evidence may manifest as – visual emphasis / de-emphasis of label content – on-demand display of data and visualizations • EPL is a trojan horse for getting people to see the incredible work of OHDSI while using a standard reference
  6. 6. Enhanced Product Labeling: Framework vs App • EPL is fundamentally a framework that can work with any web application • Two Reference Apps – Embedding of HOMER-like content within SPL (DOI_HOI evidence base) – Embedding of PLATO-like content within SPL (requires mechanism to capture patient data- manual inputs, CCD, blue button, etc)
  7. 7. JS Library OHDSI APIs Other Evidence Sources OHDSI KB OHDSI PLATO Services SPL
  8. 8. Potential OHDSI KB Content
  9. 9. What’s in an SPL? Part 1: XML (the content) 9 XML/XSL/CSS  HTML
  10. 10. What’s in an SPL? Part 2: XSLT (the format) 10
  11. 11. What’s in an SPL? Part 3: CSS (the style) 11
  12. 12. What’s in an SPL? Roll them together  HTML 12
  13. 13. What’s in an SPL? HTML 13
  14. 14. What’s in an SPL? HTML 14
  15. 15. EPL Javascript SPL XML/XSL/CSS  HTML EPL / OHDSI APIs Other Evidence Sources OHDSI KB OHDSI PLATO Services
  16. 16. Web App EPL.js Structured Product Label ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ Tell me all the known ADRs for this drug From SPL to EPL EPL / OHDSI APIs
  17. 17. EPL / OHDSI APIs Web App EPL.js Structured Product Label ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ From SPL to EPL
  18. 18. Web App EPL.js From SPL to EPL Adverse Reactions ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~
  19. 19. Web App EPL.js From SPL to EPL Adverse Reactions ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~
  20. 20. Web App EPL.js From SPL to EPL Adverse Reactions ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~
  21. 21. Web App EPL.js From SPL to EPL Adverse Reactions ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~
  22. 22. Web App EPL.js Tell me the specific evidence for this HOI DOI_HOI_id=234515 Detail On-Demand Adverse Reactions ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ EPL / OHDSI APIs
  23. 23. EPL / OHDSI APIs Web App EPL.js Structured Product Label ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ From SPL to EPL
  24. 24. Adverse Reactions ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ns ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~ ~~~ ~~ ~~ ~~ Advanced Jquery Tooltips support AJAX calls, visualzations, full HTML5
  25. 25. Example EPL Prototype 25
  26. 26. Example EPL Prototype 26
  27. 27. Final Thoughts • Evidence-enhancement not limited to SPLs, could be applied to SPCs or any other web content with identifiable drugs and outcomes • Designed to be flexible in terms of novel evidence sources and presentation layers • Will develop in parallel with OHDSI KB and APIs 27
  28. 28. Thanks! Questions? 28

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