Evidence-Enhanced Product Labeling

(EPLs)

Jon DukeApril 15, 2014

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

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)

The EPL Big Picture

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Adverse Reactions

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Adverse Reactions

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Adverse Reactions

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StructuredProduct Label

EnhancedProduct Label

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

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)

JSLibrary

OHDSIAPIs

Other Evidence Sources

OHDSIKB

OHDSIPLATO

Services

SPL

Potential OHDSI KB Content

What’s in an SPL?Part 1: XML (the content)

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XML/XSL/CSS HTML

What’s in an SPL?Part 2: XSLT (the format)

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What’s in an SPL?Part 3: CSS (the style)

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What’s in an SPL?Roll them together HTML

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What’s in an SPL?HTML

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What’s in an SPL?HTML

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EPL Javascript

SPLXML/XSL/CSS HTML

EPL / OHDSIAPIs

Other Evidence Sources

OHDSIKB

OHDSIPLATO

Services

Web App

EPL.js

Structured Product

Label

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Tell me all the known ADRs for this drug

From SPL to EPL

EPL / OHDSIAPIs

EPL / OHDSIAPIs

Web App

EPL.js

Structured Product

Label

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From SPL to EPL

Web App

EPL.js

From SPL to EPL

Adverse Reactions

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Web App

EPL.js

From SPL to EPL

Adverse Reactions

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Web App

EPL.js

From SPL to EPL

Adverse Reactions

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Web App

EPL.js

From SPL to EPL

Adverse Reactions

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Web App

EPL.js

Tell me the specific evidence for this HOIDOI_HOI_id=234515

Detail On-Demand

Adverse Reactions

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EPL / OHDSIAPIs

EPL / OHDSIAPIs

Web App

EPL.js

Structured Product

Label

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From SPL to EPL

Adverse Reactions

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~~~ ~~ ~~ ~~Advanced Jquery Tooltips supportAJAX calls, visualzations, full HTML5

Example EPL Prototype

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Example EPL Prototype

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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

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Thanks!

Questions?

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