© 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. 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 Do we need to develop a FHIR Adverse Event Resource/Profile? Are there other resources that might be used for this purpose?  What are the key concepts  What is the relationship to the adverse reaction structure in the allergy/intolerance resource? Objectives of this session  To decide if a new resource is needed  Which WG should “own” the resource/profile and other interested WG 6/5/2016 2

© 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. Adverse Events vs Adverse Reactions Adverse Event:  An event that may or may not lead to undesirable/harmful outcome(s) 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) 6/5/2016 3

© 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. 6/5/ Adverse Event Hierrachy (definition: an event that may or may not lead to unwanted or harmful outcomes) Adverse Event Examples: (1) adverse weather event – hail storm/tornado (2) adverse environment event – dioxins spill from a factory) Non-medical Adverse Event Adverse Medical Event Physiological Workflow/Procedure Related Examples: * Removing wrong kidney * Anterior spinal fusion at wrong levels * Patient given a wrong drug * Patient given a right drug at wrong dose Procedural Error Examples: * Patient fell on slippery floor Post-op pneumonia/atelectasis; respiratory failure Patient developed nosocomial infections Complications Example: Patient on clinical trial drug went to bathroom, felt dizzy and had a fall Clinical Trial related Allergy/intolerance adverse reactions Non Allergy/intolerance adverse reactions Includes: * Drug-drug interactions * Toxicity * Overdose (e.g. in case of known allergy/intolerance or drug-drug interaction

© 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. 6/5/ Adverse Events Non-Medical Adverse Events Adverse Medical Events Clinical Trial Related Workflow Related Physiological Allergy/Intolerance Adverse Reactions Non 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. Adverse Event vs Adverse Reaction Adverse Event model and adverse reaction model serve different purposes Adverse event model cannot replace adverse reaction model 6/5/2016 6

© 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. Next step? Do we need a new adverse event resource or profile? Interested WG’s? Next steps 6/5/2016 7