Meet Online at Meeting Number: 196 412 889

/ HL7 RCRIM WG
FHIR AdverseEvent Resource
CALL MINUTES: Friday, November 18, 2016

Meet online at www.webex.com, meeting number: 196 412 889

Phone +1 770-657-9270, passcode 7485962

Attendees: ##

Present / Name / Email / Affiliation
Behnaz Minaei / / FDA
Brian Peck / / EPIC
Claude Nanjo /
x / Daniela Vanco / / FDA
David Pettie / Simon Fraser University
Ed Hammond PhD / / Duke
Edward Helton (NIH/NCI) / / NIH
X / Elaine Ayres (NIH/CC/OD) / / NIH
Gary Saner / Reed Technologies
Hojjat Salamasian / / New York Presbyterian
IonaThraen / / VA/Dept of Health Utah
James Swiger / FDA
Jose Costa Teixeira /
Jose Galvez / NIH
Julie Evans / Samvit Solutions
Julie James / / Blue Wave Informatics
Karen Zimmer /
Konstadinos Kidos / / Baxalta
M’Lynda Owens / / Cognosante
Mary Ann Slack / / FDA
x / Mead Walker / / Mead Walker Consulting
x / Mitra Rocca / / FDA
Pooja Babbrah / / Point of Care Partners
Rashad Hasan / FDA
Raymond Kassekert / / GSK
Rik Smithies / / HL7 UK
Robert Moura
Sheila Connelly / / Technical Talent Resource
Smita Hastak / NCI
Stella Stergiopoulos / / Tufts University
Suranjan De / / FDA
Susan Terrillion (AHRQ/CQuIPS) (CTR) / / AHRQ
Ta Jen Chen / Ta Jen / FDA
Thomas Felix / / AMGEN
Terrie Reed / FDA
Tony Schueth / / Point of Care Partners
Wayne Kubick / / CTO HL7
x / William Friggle / / Sanofi
x / William Gregory / / Pfizer

Project Wiki

http://wiki.hl7.org/index.php?title=FHIR_Adverse_Event_Resource

References

1) Search the FDA Acronyms & Abbreviations Database: http://www.fda.gov/AboutFDA/FDAAcronymsAbbreviations/default.htm

2) FHIR Conformance Rules: http://hl7.org/fhir/conformance-rules.html

a) See 1.12.2 Cardinality

Agenda

1) Approve minutes from October 28

2) Review updated use cases (posted on the wiki)

3) Discuss representation of reaction

4) Review data elements spreadsheet

5) Next call – Friday, December 2 at 10 AM – no call on Friday November 25

Minutes

1) Approve minutes:

a) October 28, 2016 Move: vote deferred

2) The group discussed several key issues related to data elements within the adverse event resource:

a) How to represent an adverse reaction.

i) There are several options available for the representation of an adverse reaction within the context of an adverse event:

(1) Reference the observation resource

(2) Include the data elements for an adverse reaction within the adverse event resource

(3) Support the development of separating the adverse reaction data elements from the current allergy and intolerance resource

(4) The group agreed that is was not appropriate to point to the allergy and intolerance resource for the purpose of using the adverse reaction data elements as they are too constrained.

(5) PLAN: Establish the data elements necessary for capturing the adverse reaction and then determine if the observation resource supports, or if the adverse reaction data elements need to reside within the adverse event resource.

ii) It was noted that the resource must distinguish between the event and the causality associating the event to a specific substance or circumstance. It was noted that an event can be caused by any number of triggers, but teasing out specific causality of an adverse reaction when there may be multiple treatments or conditions is necessary. The group also discussed individual documentation of causality as well as the need for grouping these data across patients. Aggregation is critical for trend analysis. The use of a list was discussed for this purpose.

iii) The group discussed the use of MedDRA as the preferred coding terminology. It was noted that CDISC and ICH use MedDRA. MedDRA is also mandatory for adverse event reporting in the EU and Japan, but not in the US. This group will need to cite MedDRA as the suggested terminology within the AE FHIR resource, and discuss the use of the terminology with the Vocab group as well.

3) Current list of use cases discussed. Mitra Rocca has provided additional use cases related to product quality which will be added to the list. Below is the list of current use case types. Use cases with an asterisk have been addressed.

1. Adverse Event

a. Drug*

b. Biologic

c. Device*

d. Vaccine

e. Medical Food*

f. Dietary Supplement*

g. Herbals

h. Food

i. Cosmetics

j. Reporter variations

i. Healthcare Reported

ii. Patient Reported

iii. Manufacturer Reported

iv. Veterinary Reported

v. Supply Chain

2. Medication Reconciliation*

3. Product Problem (device)*

4. Product Quality (office of pharmaceutical quality)

5. Product Use Error

a. Wrong dose*

b. Package insert error*

c. Wrong technique*

d. Wrong route of administration*

e. Wrong rate*

f. Wrong duration*

g. Wrong time*

h. Expired drug*

6. Problem with use of Medication from Different Manufacturers

7. Protocol Adverse Event with IND

a. Serious Adverse Event

b. Unanticipated Problem* (Consider international terminology)

8. Patient Safety Incident*

9. Patient Safety Near Miss*

10. Patient Safety Unsafe Condition*

The next meeting will be held on Friday, December 2 at 10 AM.

http://hl7-fhir.github.io/event.html

Outstanding Questions from FMG

Questions and comments from the FHIR Management Group (FMG) related to FHIR AdverseEvent Resource:

1) The scope should include events that happen to individual other than patients.

a) Specifically, Practitioners and RelatedPersons

b) Possibly also Devices (e.g. equipment damage)

2) For each of the "related resources", can you define what the nature of the relationship is?

a) Reference by name – links

b) Patient resource

c) Observation resource

d) Medication resources

e) Immunizations

f) Devices

3) Need to correct and update resource proposal and let Lloyd know.

a) http://wiki.hl7.org/index.php?title=AdverseEvent_FHIR_Resource_Proposal

Action Items

1) Any line items that include explicit actions are highlighted in yellow above.

2) Begin writing resource text in the format used for other FHIR Resources. Example: http://hl7.org/fhir/allergyintolerance.html

Next Call

Agenda for Next Call

1) Next call will be on Friday, November 17 at 10 AM.

2) Approve minutes from October 28 meeting

3) Review use case list

4) Discuss use of adverse reaction data

5) Agenda for next meeting – Friday, December 2, 2016

HL7 FHIR AdverseEvent Resource, Call Minutes, Friday, November 18, 2016 Page 4