Are you ready to take your drug information game to the next level? Join us for an exciting and informative webinar where we dive into the world of Drug Package Inserts and explore how new technologies and models can enhance the way we access and use this valuable information. With over decades of experience, the Drug Package Insert is a trusted source for healthcare providers, but it's time to bring it into the modern era. Discover the 5 ways Workflow and Decision models can improve patient care and make drug information more accessible than ever before. Don't miss out on this straight-to-the-point presentation, register now!

1. Trisotech.com
Adding Smarts to Drug
Package Inserts
using Clinical Workflows and Decisions
Dr. John Svirbely
Chief Medical Informatics Officer (CMIO)
Denis Gagne
Chief Executive Officer (CEO)

2. Abstract
Are you ready to take your drug information game to the next level? Join us for an exciting and
informative webinar where we dive into the world of Drug Package Inserts and explore how new
technologies and models can enhance the way we access and use this valuable information. With over
decades of experience, the Drug Package Insert is a trusted source for healthcare providers, but it's time
to bring it into the modern era. Discover the 5 ways Workflow and Decision models can improve patient
care and make drug information more accessible than ever before. Don't miss out on this straight-to-the-
point presentation, register now!

3. Outline
1. Discuss the traditional drug package insert and its limitations.
2. Introduce BPM+ Health and standards-based clinical workflow and
decision automation.
3. Demonstrate a "smarter" package insert implemented with clinical
workflow and decision models.
4. Questions and answers as time allows.

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Drug Package Insert
The traditional package insert and its limitations

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What is a drug package insert?
 It is a piece of paper that contains essential information about a medication inserted into
the drug package.
 The format is standardized by the FDA.
 It must meet regulatory approval before the drug can be marketed.
 It is a marvel of knowledge packing that is readily accessible.
Wikimedia Commons. Bepanthen(R) - Bayer.jpg. Mattes. Public domain.

6. Package Insert - Highlights
Components of a Drug Package Insert

7. Package Insert - Full Prescribing Information
Components of a Drug Package Insert

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What are features of package inserts that may
need improvement?
 A package insert contains linear, two-dimensional text that is tightly-
packed (information dense) and passive without functionality.
 It takes time for a novice user to absorb the information.
 The package inserts are often supplemented with outside media for topics
such as drug administration.
 Changes to knowledge about the drug may take years to appear.

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Strategies to Improve Package Insert Usability
Improve
Pervasive
Accessibility
Add Smarts

10. Collected Package Inserts:
The Physicians' Desk Reference (PDR)
 A compendium of most drug package inserts in the US
 It has been available online for quite some time
 It has some messaging tools for adherence and patient saving.

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QR Codes make the information more accessible
 Small footprint.
 Allows for rapid access to web-based resources through
a simple interface.
 Useful to someone computer savvy, less so to the elderly
or someone without a cellphone.
Improve Pervasive Accessibility

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How can workflow and decision models make a
package insert smarter?
 Create microservices that can serve as smart digital assistants.
 Provide access to expanded and cutting-edge evidence, especially for off-
label indications.
 Incorporate multimedia.
 Provide patients with patient educational materials and reminders, while
recording adverse effects.
 Add functionality for secure communications.
Adding Smarts

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BPM+ Health
An introduction

14. Marrying OMG and HL7 standards
www.OMG.org www.HL7.org

15. Some Basic Terminology
Workflow
Automation
Decision
Automation
Open Standards
DMN
(DECISION MODEL AND NOTATION)
Decision tables and logical expressions
BPMN
(BUSINESS PROCESS MODEL AND NOTATION)
Prescriptive sequence of activities
CMMN
(CASE MANAGEMENT MODEL AND NOTATION)
Declarative unstructured event-condition-action
Technology enabled orchestration
of activities, able to react to
business events.
Both may have humans in the loop or not.
(Referred to as Knowledge Workers.)
Technology enabled decisions,
returning answers given some
inputs.

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BPM+
Visual Drag and Drop Paradigm

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BPMN Overview

18. BPM+ Value Add
Data
Intelligent
Healthcare
Automation
Computable Data
Aggregated Data
Data Automation
Information Automation
Orchestration of knowledge
Workflow and Decision Automation
Data in clinical context
• EMR 1
• EMR 2
• Devices
• Wearables
• Diagnostics
• Claims
• Common schema
• Identity resolution
• Medical resources
• Metadata
• Context
• Events awareness
• Tasks and activities
• Roles and responsibilities
• Decisioning
• Case management
• Event orchestration
• AI and ML
• CQL

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Drug Package Insert
Toward a "smarter" package insert

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Demo Drug - Sotalol HCl

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Processing the Package Insert - Terminology

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Processing the Package Insert – Concept Maps

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Business Rules

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Sotalol Dosing

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Patient Resources

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Adverse Drug Effects

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Automation
Demo

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Conclusions
Package inserts are a valuable source of drug information.
The regulations for package inserts were written before newer technologies became available.
Errors in drug therapy can cause serious harm.
Some ways that clinical workflow and decision models can improve package inserts include:
 Improving the reporting of adverse effects during post-marketing surveillance.
 Providing patients with ready access to videos and other media.
 Providing microservices (dose calculation, body surface area, eGFR, etc).
Additional services that can be provided in Gen 2.0:
 Access to the latest evidence.
 Assistance with preauthorization.
 Links to financial assistance programs and enhanced cost saving.

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Any questions?
THANKS!
John Svirbely, MD
Chief Medical Informatics Officer (CMIO),
jsvirbely@Trisotech.com
Denis Gagne
Chief Executive Officer (CEO),
dgagne@Trisotech.com