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  1. FHIR Specification Feedback
  2. FHIR-32064

ClinicalUseIssue should have at least minimal support of warnings

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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • R5
    • Biomedical Research & Regulation
    • ClinicalUseDefinition (was ClinicalUseIssue)
    • 15.7.4
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      Agreement to the following:
      1. Create a new element in ClinicalUse – "Warning" - with CodeableConcept; Definition will be – Critical information about the environmental or health or physical risks or hazards, that serve as caution to the user or consumer. (0..1)
      2. Delete the description element
      3. Add 5th bullet to the Boundaries & Relationships section – Warning – Critical information about the environmental or health or physical risks or hazards, that serve as caution to the user or consumer.
      4. Update Scope section – Add the following – ClinicalUseIssue is to record an instance of facts about a particular medication, device or procedure in relation to its intended use (indication), situations where it should not normally be used (contraindication), known side effects (undesirable effects), clashes with other substances - medications, foods etc. (interactions) and critical information about risks or hazards to caution the user or consumer (warnings). The resource is used to record one such instance, and all its details.
      5. Add constraint – can use only of of the five ClinicalUse.type

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      Agreement to the following: 1. Create a new element in ClinicalUse – "Warning" - with CodeableConcept; Definition will be – Critical information about the environmental or health or physical risks or hazards, that serve as caution to the user or consumer. (0..1) 2. Delete the description element 3. Add 5th bullet to the Boundaries & Relationships section – Warning – Critical information about the environmental or health or physical risks or hazards, that serve as caution to the user or consumer. 4. Update Scope section – Add the following – ClinicalUseIssue is to record an instance of facts about a particular medication, device or procedure in relation to its intended use (indication), situations where it should not normally be used (contraindication), known side effects (undesirable effects), clashes with other substances - medications, foods etc. (interactions) and critical information about risks or hazards to caution the user or consumer (warnings). The resource is used to record one such instance, and all its details. 5. Add constraint – can use only of of the five ClinicalUse.type
    • Francois Macary / Peter Bomberg : 18-0-1
    • Enhancement
    • Non-compatible
    • R5

    Description

      ClinicalUseIssue may convey information of 5 distinct types, as announced by the value set ClinicalUseIssueType attached to the "type" element.

      However, only 4 of these 5 are explicitly supported by a dedicated backbone: indication, contraindication, interaction and undesirableEffect. The fith one "warning" is not represented in the resource. At the minimum, it should  be possible to convey a warning as a CodeableConcept (either one or more coding, or only the text).

      Hence this suggested change:

      1) Add this element to the resource:

      warning

      • CodeableConcept
      • summary
      • 0..1 
      • Definition: "Specifics for when this is a warning"

      2) In the Boundaries & Relationships section, add one fith bullet to the bullet list:

      • Warning: A warning or precaution for use of a medicinal product, medical device or procedure.

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            Unassigned Unassigned
            fmacary Francois Macary
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              Created:
              Updated:
              Resolved: