Date:  

Time: 2-4pm Eastern

Agenda Topics

  • Attendance

  • Review of agenda

  • MedicationKnowledge

    • value sets for type attributes
    • FHIR-24651 - BOSS and PAI (invite Julie)

Supporting Documents

Minutes/Conclusions Reached

  • Agenda review
    • no additions or changes
  • Introductions
    • quick round
  • Approval of WGM minutes from Sydney
    • moved to approve Peter Sergent/Jean Duteau  8-0-2
  • MedicationKnowledge
    • FHIR-24651 BOSS and PAI
      • (ask Julie for Ingredient Roles and Strength)
      • product is dexamethasone sodium phosphate at 4.3 mg/ml, but is dosed as dexamethasone base 3.3. mg/ml
        • Precise ingredient is what is actually in the product
        • Basis of Strength substance what the noted strength is based upon
      • MedicationKnowledge
        • change isActive to an ingredient role valueset. 
        • BR&R Ingredient.role is similar, but not bound to a valueset.  
        • probably an exemplar valueset, e.g., active ingredient, excipient.  would need to work with BR&R
        • MedicationKnowledge.referenceStrength can be used for BOSS, but doesn't work for all cases.
        • Discussion of possible sources for ingredient role valueset.  V3, SPOR, SNOMED, etc.  None are perfect. 
      • Where do we go from here
    • value sets for type attributes
      • will postpone to another session

Action Items

Date:  

Time: 6-8pm Eastern

Agenda Topics

  • Pharmacy Overview (if new attendees)

  • Discussion of FHIR Resource maturity and plans for R5

Supporting Documents

Minutes/Conclusions Reached

  • Reminder to log in and add your attendance for this session - add a new row if you were here in an earlier session
  • Introductions
  • Review of resources - no new attendees
  • Maturity Level of Resources
    • MedicationRequest - current = 3
      • plan for R5 - maturity = 5 and normative
      • 21st Century Cures Act will push implementation of this
      • Canada, US, Australia, NZ (R4)
    • MedicationDispense - current = 2
      • plan for R5 - maturity = 5 
      • Cerner - not implemented
      • Australia - R4; Canada
    • MedicationAdministration - current = 2
      • plan for R5 - maturity = 3
      • Cerner - implemented but read only - confusing about how to implement across all medications
        • looking for implementation guidance
      • Epic - not supported
      • Australia - plan to add when charting has been implemented - future
      • ? NL implementation
    • MedicationUsage - current = 3
      • plan for R5 - maturity = 4 
      • Epic - mostly querying an EHR to get MedicationStatements rather than creating
      • Cerner - read/write since DSTU2 - understand better
        • feels like most mature
        • most implementation experience
        • skipped STU3
        • will not be implementing for R4 - moving to MedRequest
      • Australia - STU3 create and query
    • Medication - current = 3
      • plan for R5 - maturity = 5 and Normative
      • Cerner - has implemented contained resource and code
      • Epic - has implemented contained resource and code
      • Australia - contained and code
    • MedicationKnowledge - current = 1
      • plan for R5 - maturity = 3
      • CSIRO in Australia looking at MedKnowledge
      • Phast in France will be doing a project
      • 2 projects - CARIN Drug Formulary the DaVinci PDEX Formulary projects have included MedKnowledge
  • Question
    • FMM 5 - is it implemented in 5 systems in at least 2 countries - ie at least 5 in each of multiple countries or can the 5 be split across countries?
      • FHIR I answer:  split across countries is accurate
    • does it have to be read/write?
      • FHIR I answer:  'depends' - it could be fine depending on the use, but if we feel that the resource has not been exercised in one form (read or write), then we may decide it is not mature
    • does it matter if it is only in DSTU? or STU3?
      • FHIR I answer:  No.  And if you have a resource that substantially is good to move to a higher maturity, but one element/attribute is not there, then we can identify that the element/attribute that still be listed as STU, while the over all resource can be moved up in maturity level. 
  • There is quality work that is needed across all of the resources
  • What are the mobile apps uses to track medication recording by patients?  MedUsage or MedAdministration?
  • Value Sets on MedicationKnowledge
    • Need to determine the process for getting changes made to codesystems and valuesets and also to get new codesystem/value sets added
    • Missing bindings
      • relatedMedicationKnowledge.type
      • productType - reach out to Hans to see if there is something in Product resource that can be used
      • monograph.type - look at FDB files; reach out to Wolters Kluwer
      • item.itemCodeableConcept
      • cost.type
      • monitoringProgram.type
      • administrationGuidelines.dosage.type
      • indication.indicationCodeableConcept

      • patientCharacteristics.characteristicCodeableConcept

      • medicationClassification.type
      • packaging.type
      • drugCharacteristic.type
      • regulation.substitution.type
      • schedule.schedule

Action Items

Date:  

Time: 10am to 12noon Eastern

Agenda Topics

  • Joint Meeting with BR&R - Unicom Project - BR&R Hosting

Supporting Documents

Minutes/Conclusions Reached

  • No notes - See BR&R minutes for this session

Action Items

Date:  

Time: 2-4pm Eastern

Agenda Topics

  • MedicationUsage Issues - invite Cerner/Epic

    • Taken/ not take attribute
    • Compliance Attribute

Supporting Documents

Minutes/Conclusions Reached

  • Jean is chairing - welcomed the attendees!
  • Discussing the Compliance issues
    • One view is that:  
      • EHR view of what the patient should be doing is found in Medication Request
      • Patient view of what the patient is doing is found in Medication Usage
  • Melva was recounting the relevant information from the minutes from Sydney WGM on this topic. 
  • Discussion about how the current MedicationUsage.status is defined:

    On 2020-05-06, I asserted that I didn't take Drug X from 2000-01-01 to 2019-12-30

MedicationUsage.status = ??completed??
MedicationUsage.medication = Drug X
MedicationUsage.effectivePeriod.start = 2000-01-01
MedicationUsage.effectivePeriod.end = 2019-12-31
MedicationUsage.dateAsserted = 2020-05-06
MedicationUsage.compliance = Not Taken

On 2020-05-06, I asserted that I never took Drug X

MedicationUsage.status = ??completed??
MedicationUsage.medication = Drug X
MedicationUsage.effectivePeriod.start = <null>
MedicationUsage.effectivePeriod.end = <null>
MedicationUsage.dateAsserted = 2020-05-06
MedicationUsage.compliance = Not Taken

Today, I tell you that I started taking Drug X on 2020-09-08 and am still taking it.

MedicationUsage.status = ??active??
MedicationUsage.medication = Drug X
MedicationUsage.effectivePeriod.start = 2020-09-08
MedicationUsage.effectivePeriod.end = <null>
MedicationUsage.dateAsserted = 2020-09-22
MedicationUsage.compliance = Taken (or a sub-code of Taken)

  • Decisions:
    • Remove not-taken from MedicationUsage.status
    • Change MedicationUsage.takenAsOrdered to a CodeableConcept (example binding) that has the following values:
      • Taking
      • Taking as directed
      • Taking not as directed
      • Not Taking
      • Unknown (unable to obtain)
    • Change MedicationUsage.takenAsOrdered to MedicationUsage.adherence
  • Do we need MedicationUsage.status?  What does status actually mean?
    • If we keep it, are the statuses just 'active?', 'completed', 'entered-in-error', 'unknown'?
    • Options:
      • keep status as-is
      • change status to be 'completed', 'entered-in-error', 'unknown'
      • remove status and have a enteredInError boolean attribute
  • FHIR-19470 - Melva Peters/John Hatem: 14-0-0 Add an adherence attribute
  • FHIR-19468 - Scott Robertson/Melva Peters: 14-0-0 Remove not-taken attribute

Action Items

Date:  

Time: 4-6pm Eastern

Agenda Topics

  • Joint Meeting with FHIR-I (FHIR-I hosting) - FHIR-I hosting

Supporting Documents

Minutes/Conclusions Reached

Timeline assuming tooling and funding in place:

  • Goes to ballot Jan 2nd 2021 (End of Nov content deadline) publication in Q2 2021
  • R4B as a base with specific resources:  Medication Definition and Evidence-Based Medicine. No real room for additional scope
  • R5 for comment ballot may 2021 (based on readiness and acceptance of normative scope)
    2nd normative ballot only for substantive changes Nov/Dec 2021
  • R5 for publication Q2 2022
  • Pharmacy Q - new attribute changes proposed MedUsage resource and new vocab. Could wait for R5 release but considered significant enough to consider for R4B. Changes for Argonaut
    • Argonaut will ignore R4B changes as new resources added not relevant. If prescription changes go in then may be valid, but unlikely to happen
  • BR&R pharmacy resources included in R4B include medicinal product. Other resource changes for in use resources is being avoided if possible and should be delayed to R5
  • No current freeze date but prefer details of any proposed changes for R4B by end of next week (4th oct)
  • R4B is intended only for changes that must be available prior to R5 eg. major projects, regulatory requirements
  • Request for Adverse event resource (Hugh - IBM use in FDA implementation?) FMG needs to understand the criticality of project (is it a regulatory requirement and what are the current issues with using existing R4 resource. Hugh to touch base with Jean and get back to FMG with additional information (eg. Rollout)
  • If maturity level changes are included in R4B all resources will be included. FMG to decide.

Resources that would like to be normative in R5 and/or increasing maturity for R5 that are not ready for normative

  • BR&R concerns on balloting timelines. Can't meet R4B, but too long to R5 for draft vs non draft. Won't be able to go normative till R7=9 years before it can go normative. To be discussed.

Pharmacy Questions:

  • FMM 5 - is it implemented in 5 systems in at least 2 countries - eg at least 5 in each of multiple countries or can the 5 be split across countries?
    • 5 spread across at least 2 countries
  • does it have to be read/write?
    • not dictated depends on what is reasonable for the resource. expectation for both unless unreasonable for the resource - then raise and chat with FMG. discuss why its ok
  • does it matter if it is only in DSTU? or STU3?
    • you can count any implementation from any release as long as the release content is similar to the content of the resource now
    • If you have net new elements that haven't had much implementation experience, flag them at STU level. Not all elements have to go normative.


Action Items

  • John Hatem  to follow up on why Medication and MedicationUsage not taking normative 

Date:  

Time: 6-8pm Eastern

Agenda Topics

  • Medication List IG

Supporting Documents

Minutes/Conclusions Reached

Overview by Melva

  • Comes out of USCore Medication List and the inconsistent definition of what a medication list is
  • oriented around Context of use.  different use cases have different requirements and potentially definitions
  • Target is Jan 2021 ballot, will need to get material together mid- or late November.  Still considerable work to do
  • questions
    • Stephen Chu: concept of "active" medication list".  Some medications can have effects long after they are discontinued.  In the long term, these medications would not be included in an "active" list.  Suggesting a "relevant" medication list is more appropriate to be inclusive of these medications.  
      • seems to be another Context
      • Pharmacy has avoided the term "active" in this work
      • Can we "define" what a "relevant" list would contain.  
        • it is a clinical determination

Related work

  • (scott - lost a bit.  need to review what Daniel said) 
  • NCPDP Medication History standard
  • other work which was reviewed/referenced:  Background Material

Open issues

  • what data elements would be necessary for a given context
    • is this out of scope for this document?  data elements may be implementation dependent
  • Is a "profile" synonymous with "list"
    • can be synonyms or not. 
    • some regulations use profile for list. 
    • some implementations have a data-rich "profile" and a simpler "list".
    • also Standardized Medication Profile (NCPDP/HL7) is on the data-rich side
    • suggesting adding a discussion of profile vs list in Scope and Boundaries
    • IPS call it a Medication Summary
  • what queries are necessary for a given context

In addition to the work on confluence (Patient Medication List Guidance), Jean has started moving the content to FHIR (http://build.fhir.org/ig/HL7/fhir-med-list-guidance/)

Working on Prescribing context.  See Prescribing Lists on Confluence

Discussion on Medication Reconciliation. 

  • this could have multiple lists as input and a reconciled med list output
  • the "trigger" for the MedRec needs to be broadened.  Admission, Discharge, Transfer, periodic management of patient (e.g., in US, CMS requires periodic Medication Management, including medication reconciliation),

Discussion on Blister Packing Lists

  • initial list is for all meds for the patient
  • then culled to a list of only medications to be packaged (may be more than one package)
  • the ultimate package will include a list a all meds for the patient, but not all of those will be in the blister pack cells

Wrapping up

  • much work remains
  • working calls on Thursdays at 4 pm ET.  will skip next week.  Need more participants

Next session: Wednesday 9/23 at 10 am ET

Motion to adjourn (Melva Peters/Danielle Bancroft)  no opposition 9/22/2020 1923 ET

Action Items

  • Scott M. Robertson to draft text regarding profile vs list to include in Scope, Definitions, both, or more.  

Date:  

Time: 10am to 12noon Eastern

Agenda Topics

  • Catalogue Project  postponed to October 5th Teleconference

  • FHIR Resource maturity clean up

  • Work on FHIR issues

  • MedicationKnowledge QA 

  • Value Sets for MedicationKnowledge

Supporting Documents

Minutes/Conclusions Reached

  • Pharmacy resources maturity levels updated in Pharmacy WGM Sept 21, 6-8PM Eastern minutes
  • Medication Knowledge QA - Melva led the team through known issues discussion - see tracker 24098
    • Reviewed Administration Guidelines and Indication areas of MedicationKnowledge resource
      • Created JIRA 28597 tracker - see tracker for details
    • Continued discussion about other codeableConcept attributes that need a value set.  The following list is just a subset of the attributes that we discussed in today's call. 
      • monograph.type - suggested exemplar value set proposed from Pan Canadian content
      • patientCharacteristic.type - e.g. height, weight, gender
      • medicine.classification.type - e.g. AHFS
      • medicine.classification - e.g. analgesics, opiates, hallucinogens
      • packaging.material
      • packaging.type
      • productType
      • substitution.type

Action Items

Date:  

Time: 2-4pm Eastern

Agenda Topics

  • FHIR Issues

Supporting Documents

Minutes/Conclusions Reached

  • Discussing FHIR tracker items.  For resolutions for tracker items please see JIRA
    • 26614 discussed - see JIRA
    • As a result of today's discussions - new trackers were being created
      • Blister Plack support in Medication Request
      • Update wording in Dosage Instruction on how to deal with two orders
      • Create new examples e.g. for orders that can be given oral or IV  
    • 28599 item discussed - changes to MedicationRequest to support communicating drugs needs to be included in a blister pack see tracker item for details.  Passed
    • 28601 item discussed - passed
    • 28597 item discussed - administration.guideline and indication in MedicationKnowledge - Passed
    • 28412 see tracker - question answered 
    • 28575 see tracker - passed

Date:  

Time: 10am to 12 noon Eastern


Agenda Topics

  • Review of Pharmacy Projects

  • Review Pharmacy Standards to determine status

Supporting Documents

Minutes/Conclusions Reached

  • Brett - PDMP received lots of comments

    • will come to a Pharmacy teleconference

    • loading ballot comments into JIRA - reach out to Lloyd if there are issues

    • discussion of the use of spreadsheet for ballot comments

  • Review of Pharmacy Projects

    • Project 1483

      • Motion by Jean - seconded by Scott - to close 1483 Pharmacy DAM 3 year plan item

        • 13-0-0 Carried

  • Review of standards

    • Standards for Review - updated
    • NCPDP Electronic Prescribing Coordination Mapping Document
    • This is an old version and should retired
    • 457 - when we publish the latest version of PDMP, it will replace this one
      • need to merge 1291 and 1393 projects
      • talk to Lynn to determine how to go forward with this
    • 414 - Scott to check on MTM Templates to see if it should be active or stable
    • All other have a status that is correct

  • FHIR Issues - see updates in JIRA

    • FHIR 28602

    • FHIR-28593

Action Items

  • Melva Peters to update projects in Project Insight based on discussion
  • Melva Peters to talk to Lynn/Brett about 1393 and 1291 - and how to get down to 1 project
  • Scott M. Robertson to check on status of MTM Templates standards - should it be active or stable

Date:  

Time: 2-4pm Eastern


Agenda Topics

  • Medication List IG

  • MCC e-Care Project Presentation - Gay Dolin

  • 3:30 - 4pm - PQ/CMC Project Leads joining

    • Discussion of requirements for Medication for medication from Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ/CMC) or Pharmaceutical Quality Project.  Our PSS is here https://confluence.hl7.org/display/BRR/Pharmaceutical+Quality+%28PQ%29+PSS

    • We have multiple use cases in relation to a drug product –

      • Need to define a drug product – for which we are leveraging the BR&R resources – MedicinalProductDefinition, PackagedProductDefinition, etc.  (DEFINITIONAL)

      • Need to make batches of the drug product – we are looking at leveraging the Medication resource from Pharmacy for this use case  (INSTANCE)

Supporting Documents

Minutes/Conclusions Reached

  • New names - introductions


  • Medication List (until Gay is available)
    • Question on contexts: they are mostly narrative - rationale, settings, descriptions, etc.  When we get to types of queries, is this to be example queries with specific parameters (and explanation of the parameters).  Agreement that is the intent.
    • Do architectures need to be included.  We have tried to be architecture/implementation agnostic, but may be an issue in some jurisdictions.  Also, this IG is not about how to do MedLists, it is about best practices and recommendations.
      • We should at least consider architecture implications.
      • Suggestion to have a section on assumptions, e.g., centralized data vs distributed/federated.


  • MCC e-Care Plan
    • Gay Dolin presenting: HL7-Virtual-WGM-MCC overview.pptx
    • Multiple Chronic Conditions (MCC) eCare Plan
    • eCare Plan for People with Multiple Chronic Conditions
      • pulling care plan data from multiple sources
    • Ballot target is Sept 2022
      • most of the "difficult" items have been resolved
      • still work to refine, add data elements/constraints, etc
      • planning for 4 Connectathons
    • officially R4 but with some CI content
      • mostly referencing US Core Profiles
      • mostly constraints, no new extensions
      • A library of profiles, not one massive profile
    • Bi-weekly meetings 5pm ET every other week, next is Sept 30
    • Walk-through of IG on Trifolia
      • MedicationStatement is referenced
      • USCoreMedicationRequest is referenced
      • no specific questions on pharmacy resources
      • Question if MedList Guidance may be useful to MCC eCare Plan
        • we will consider this as we continue work on MedList Guidance
    • Pharmacy's relationship to MCC eCare:
      • motion to add Pharmacy as an interested party Melva Peters/John Hatem 19-0-1 - passed


  • PQ/CMC Project Leads joining

    • Pharmaceutical Quality (PQ) PSS

    • Pharmaceutical Quality (PQ) - Regulatory Use Case
    • FHIR  pharmaceutical quality data for submission to FDA
    • Looking at Medication for specific instances of manufactured products (with batch id and exp date)
      • okay for batch id, exp date
      • but manufacturer vs license holder (Pfizer holds the name but the product is manufactured )
      • other requested additions to Medication for their
        • batch.production manufacturer (assigned manufacturer)
        • batch.production date
        • batch.release date
        • allow multiple batches 
        • change medication.code to allow reference to PackagedProductDefinition (CodeableReference)
          • pushback: not clinical relevant.  clinical systems normally would not support the information in MedicinalProductDefinition
      • running out of time
        • Asked PQ/ to create Jira tickets 
        • Pharmacy will follow up and coordinate discussion with PQ/CMC group

Action Items

Date:  

Time: 6-8pm Eastern

Agenda Topics

  • Medication List IG

Supporting Documents

Minutes/Conclusions Reached

  • Discussion of Medication List IG
    • Review of Administration Administration Section
      • Will have a definitions section at the top level of the IG
      • discussion of list vs record
      • John will continue to work on this section
    • may need to consider adding Morphine Equivalents - not sure which resource

Action Items

Date:  

Time: 10am to 12 noon Eastern

Agenda Topics

  • Joint Meeting with CDS/CQI - CQI hosting

Supporting Documents

Minutes/Conclusions Reached

  • discussion of Medication Knowledge
  • Review of PDDI ballot and work
  • discussion of Medication List project
  • Bryn has some work on a MME calculation that may be of interest 

Action Items