Transcript PCWG - HL7 Wiki

PCWG – October 2015
Adverse Event FHIR
Profile???
Tuesday – Q Lunch
Stephen Chu
Russ Leftwich
Elaine Ayres
© 2015 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Introduction
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Do we need to develop a FHIR Adverse Event
Resource/Profile?
Are there other resources that might be used for
this purpose?
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

What are the key concepts
What is the relationship to the adverse reaction structure
in the allergy/intolerance resource?
Objectives of this session
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
To decide if a new resource is needed
Which WG should “own” the resource/profile and other
interested WG
© 2015 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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Adverse Events vs Adverse Reactions
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Adverse Event:

An event that may or may not lead to
undesirable/harmful outcome(s)
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
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Examples of event: a fall, a wrong procedure
Reporting adverse event in healthcare is a
regulatory and patient safety requirement
Adverse Reaction:

Uncomfortable, unwanted, or dangerous effects
resulting from exposure to substances (drug, food,
environmental materials, chemicals, etc)
© 2015 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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Adverse Event Hierrachy
Adverse Event
(definition: an event that may or may not
lead to unwanted or harmful outcomes)
Adverse Medical Event
Clinical
Trial related
Examples:
* Patient fell on slippery floor
• Post-op pneumonia/atelectasis;
respiratory failure
• Patient developed nosocomial
infections
Examples: (1) adverse weather event – hail storm/tornado
(2) adverse environment event – dioxins spill from a factory)
Workflow/Procedure
Related
Example:
Patient on clinical trial drug
went to bathroom, felt dizzy
and had a fall
Complications
Non-medical Adverse Event
(e.g. in case of
known allergy/intolerance
or drug-drug interaction
Procedural Error
Allergy/intolerance
adverse reactions
Examples:
* Removing wrong kidney
* Anterior spinal fusion at wrong levels
* Patient given a wrong drug
* Patient given a right drug at wrong dose
© 2015 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Physiological
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Non
Allergy/intolerance
adverse reactions
Includes:
* Drug-drug interactions
* Toxicity
* Overdose
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Adverse Events
Adverse Medical
Events
Workflow
Related
Clinical
Trial
Related
Non-Medical
Adverse
Events
Physiological
Allergy/Intolerance
Non
Adverse Reactions Allergy/Intolerance
Adverse Reactions
© 2015 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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Adverse Event vs Adverse Reaction


Adverse Event model and adverse reaction
model serve different purposes
Adverse event model cannot replace
adverse reaction model
© 2015 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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3/29/2016
Next step?
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

Do we need a new adverse event resource
or profile?
Interested WG’s?
Next steps
© 2015 Health Level Seven ® International. All Rights Reserved.
HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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