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Codesystem-adverse-event-causality-assess.xml

Patient Care Work GroupMaturity Level: N/AStandards Status: Informative

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Definition for Code System AdverseEventCausalityAssessment

<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="adverse-event-causality-assess"/> 
  <meta> 
    <lastUpdated value="2019-09-21T17:23:45.171+00:00"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <h2> AdverseEventCausalityAssessment</h2> 
      <div> 
        <p> Codes for the assessment of whether the entity caused the event.</p> 

      </div> 
      <p> This code system http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess
         defines the following codes:</p> 
      <table class="codes">
        <tr> 
          <td style="white-space:nowrap">
            <b> Code</b> 
          </td> 
          <td> 
            <b> Display</b> 
          </td> 
          <td> 
            <b> Definition</b> 
          </td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">certain
            <a name="adverse-event-causality-assess-certain"> </a> 
          </td> 
          <td> Certain</td> 
          <td> i) Event or laboratory test abnormality, with plausible time relationship to drug intake;
             ii) Cannot be explained by disease or other drugs; iii) Response to withdrawal plausible
             (pharmacologically, pathologically); iv) Event definitive pharmacologically or phenomenologically
             (i.e. an objective and specific medical disorder or a recognized pharmacological phenomenon);
             or v) Re-challenge satisfactory, if necessary.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">probably-likely
            <a name="adverse-event-causality-assess-probably-likely"> </a> 
          </td> 
          <td> Probably/Likely</td> 
          <td> i) Event or laboratory test abnormality, with reasonable time relationship to drug intake;
             ii) Unlikely to be attributed to disease or other drugs; iii) Response to withdrawal clinically
             reasonable; or iv) Re-challenge not required.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">possible
            <a name="adverse-event-causality-assess-possible"> </a> 
          </td> 
          <td> Possible</td> 
          <td> i) Event or laboratory test abnormality, with reasonable time relationship to drug intake;
             ii) Could also be explained by disease or other drugs; or iii) Information on drug withdrawal
             may be lacking or unclear.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">unlikely
            <a name="adverse-event-causality-assess-unlikely"> </a> 
          </td> 
          <td> Unlikely</td> 
          <td> i) Event or laboratory test abnormality, with a time to drug intake that makes a relationship
             improbable (but not impossible); or ii) Disease or other drugs provide plausible explanations.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">conditional-classified
            <a name="adverse-event-causality-assess-conditional-classified"> </a> 
          </td> 
          <td> Conditional/Classified</td> 
          <td> i) Event or laboratory test abnormality; ii) More data for proper assessment needed; or
             iii) Additional data under examination.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">unassessable-unclassifiable
            <a name="adverse-event-causality-assess-unassessable-unclassifiable"> </a> 
          </td> 
          <td> Unassessable/Unclassifiable</td> 
          <td> i) Report suggesting an adverse reaction; ii) Cannot be judged because information is
             insufficient or contradictory; or iii) Data cannot be supplemented or verified.</td> 
        </tr> 
      </table> 
    </div> 
  </text> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="pc"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="draft"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/> 
  </extension> 
  <url value="http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.4.642.1.1254"/> 
  </identifier> 
  <version value="4.1.0"/> 
  <name value="AdverseEventCausalityAssessment"/> 
  <title value="AdverseEventCausalityAssessment"/> 
  <status value="draft"/> 
  <experimental value="false"/> 
  <date value="2019-09-21T17:23:45+00:00"/> 
  <publisher value="HL7 (FHIR Project)"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://hl7.org/fhir"/> 
    </telecom> 
    <telecom> 
      <system value="email"/> 
      <value value="fhir@lists.hl7.org"/> 
    </telecom> 
  </contact> 
  <description value="Codes for the assessment of whether the entity caused the event."/> 
  <caseSensitive value="true"/> 
  <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"/> 
  <content value="complete"/> 
  <concept> 
    <code value="certain"/> 
    <display value="Certain"/> 
    <definition value="i) Event or laboratory test abnormality, with plausible time relationship to drug intake;
     ii) Cannot be explained by disease or other drugs; iii) Response to withdrawal plausible
     (pharmacologically, pathologically); iv) Event definitive pharmacologically or phenomenologically
     (i.e. an objective and specific medical disorder or a recognized pharmacological phenomenon);
     or v) Re-challenge satisfactory, if necessary."/> 
  </concept> 
  <concept> 
    <code value="probably-likely"/> 
    <display value="Probably/Likely"/> 
    <definition value="i) Event or laboratory test abnormality, with reasonable time relationship to drug intake;
     ii) Unlikely to be attributed to disease or other drugs; iii) Response to withdrawal clinically
     reasonable; or iv) Re-challenge not required."/> 
  </concept> 
  <concept> 
    <code value="possible"/> 
    <display value="Possible"/> 
    <definition value="i) Event or laboratory test abnormality, with reasonable time relationship to drug intake;
     ii) Could also be explained by disease or other drugs; or iii) Information on drug withdrawal
     may be lacking or unclear."/> 
  </concept> 
  <concept> 
    <code value="unlikely"/> 
    <display value="Unlikely"/> 
    <definition value="i) Event or laboratory test abnormality, with a time to drug intake that makes a relationship
     improbable (but not impossible); or ii) Disease or other drugs provide plausible explanations."/> 
  </concept> 
  <concept> 
    <code value="conditional-classified"/> 
    <display value="Conditional/Classified"/> 
    <definition value="i) Event or laboratory test abnormality; ii) More data for proper assessment needed; or
     iii) Additional data under examination."/> 
  </concept> 
  <concept> 
    <code value="unassessable-unclassifiable"/> 
    <display value="Unassessable/Unclassifiable"/> 
    <definition value="i) Report suggesting an adverse reaction; ii) Cannot be judged because information is
     insufficient or contradictory; or iii) Data cannot be supplemented or verified."/> 
  </concept> 
</CodeSystem> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.