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Patient Care Work Group | Maturity Level: N/A | Standards 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="2021-03-11T17:06:20.662+11:00"/> <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> </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:2.16.840.1.113883.4.642.4.1254"/> </identifier> <version value="4.1.0"/> <name value="AdverseEventCausalityAssessment"/> <title value="AdverseEventCausalityAssessment"/> <status value="draft"/> <experimental value="false"/> <date value="2021-01-17T07:06:13+11:00"/> <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.