FHIR Adverse Event Resource

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Project Number Project Number 1240

FHIR Resource Proposal AdverseEvent_FHIR_Resource_Proposal

Project Name FHIR Adverse Event Resource

Project Sponsor(s) RCRIM Work Group and Patient Care WG

Description

Project Scope Statement - Project 1240

Objectives / Deliverables

To enhance patient safety, it is noted that many countries have strong needs to exchange product safety information between varieties of stakeholders in the healthcare domain. Currently many regulatory agencies collect safety reports of adverse drug reactions, adverse events, infections, contamination and other incidents from consumers, pharmaceutical companies and healthcare professionals.

The AdverseEvent resource will address the exchange of the following types of information:

1) Individual Case Safety Report (ICSR): Framework for data exchange and information sharing by providing a common messaging format for transmission of Individual Case Safety Reports (ICSR) for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that may occur upon the administration or use of one or more products or substances. The reports can relate to a specific subject or may be used to relay an issue or finding related to a specific substance, product or device.

2) (Not in current standard) – Individual Occurrence Report (IOR): The identification and characterization of exceptional events related to patient care, patient safety, protocol implementation, and service delivery. Examples might be falling out of bed, slipping on a wet floor, inappropriate use of restraints.

Meeting Details

Fridays 10 AM to 11 AM Eastern

Conference Call Information: Phone Number: +1 770-657-9270 Participant Passcode: 7485962

Web Meeting Info (does not include audio connection)

www.webex.com - meeting number 622 569 796 password - Meeting

Direct Meeting Link: Link

Next scheduled meeting: Friday, October 7, 2016 at 10 AM

Meeting Agendas / Minutes / Presentations

Links are to PDF files. Download, or open in a new Tab or Window.

• • • TO COME Call 9 > FHIR AdverseEvent Resource Conf Call on 2016-08-19: Agenda and Minutes

Call 8 > FHIR AdverseEvent Resource Conf Call on 2016-08-12: Agenda and Minutes

Call 7 > FHIR AdverseEvent Resource Conf Call on 2016-07-01: Agenda and Minutes - includes links to data sources

Call 6 > FHIR AdverseEvent Resource Conf Call on 2016-06-24: Agenda and Minutes

Call 5 > FHIR AdverseEvent Resource Conf Call on 2016-06-17: Agenda and Minutes

Call 4 > FHIR AdverseEvent Resource Conf Call on 2016-06-10: Agenda and Minutes

Call 3 > FHIR AdverseEvent Resource Conf Call on 2016-06-03: Agenda and Minutes

Call 2 > FHIR AdverseEvent Resource Conf Call on 2016-05-27: Agenda and Minutes

Call 1 > FHIR AdverseEvent Resource Conf Call on 2016-05-20: Agenda and Minutes

PRESENTATIONS

Call 8 > Presentation, Biosimilar Research, Pooja Babbrah, Senior Consultant, Point of Care Partners, 2016-08-12

Call 6 > Presentation, FDA Adverse Event Reporting, Dr. Mitra Rocca, 2016-06-24

Project Requirements

FHIR AdverseEvent Resource Data Elements Draft as of 2016-06-03

Project References

FHIR Event Resource Pattern

Guidance on standard syntax issued by the FHIR team for any Resource that details event information.

FHIR_Event_Resource_Pattern.pdf, July 5, 2016

Based on TANSI/HL7 V3 ICSRP1, R2-2012

HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report

ICSR Part 1: The Framework for Adverse Event Reporting, R2

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=266

ICSR Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=267 (medicinals only)

AHRQ Patient Safety Common Format Guidelines

https://www.psoppc.org/psoppc_web/publicpages/supportingDocsV1.2

FHIR W5 Guidelines: http://hl7-fhir.github.io/w5.html