Genomics Reporting Implementation Guide
4.0.0-cibuild - CI Build

Genomics Reporting Implementation Guide, published by HL7 International / Clinical Genomics. This guide is not an authorized publication; it is the continuous build for version 4.0.0-cibuild built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/genomics-reporting/ and changes regularly. See the Directory of published versions

## : PharmGKB Evidence Level Example Codes - XML Representation

Page standards status: Informative

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    <CodeSystem xmlns="http://hl7.org/fhir">
      <id value="pharmgkb-evidence-level-custom-cs"/>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem pharmgkb-evidence-level-custom-cs</b></p><a name="pharmgkb-evidence-level-custom-cs"> </a><a name="hcpharmgkb-evidence-level-custom-cs"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/pharmgkb-evidence-level-custom-cs</code> 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">1A<a name="pharmgkb-evidence-level-custom-cs-1A"> </a></td><td>PGKB 1A</td><td>High level of evidence. Supported by a guideline or FDA label with variant specific prescribing guidance. Additionally, supported by at least one publication.</td></tr><tr><td style="white-space:nowrap">1B<a name="pharmgkb-evidence-level-custom-cs-1B"> </a></td><td>PGKB 1B</td><td>High level of evidence. But, NOT supported by a guideline or FDA label with variant specific prescribing guidance. Additionally, supported by at least one publication.</td></tr><tr><td style="white-space:nowrap">2A<a name="pharmgkb-evidence-level-custom-cs-2A"> </a></td><td>PGKB 2A</td><td>Moderate level of evidence. Supported by being a KNOWN pharmacogene on https://www.pharmgkb.org/vips. Also, found in multiple studies but may have a minority of studies that did not support the majority opinion. Supported by at least two indpendent publications.</td></tr><tr><td style="white-space:nowrap">2B<a name="pharmgkb-evidence-level-custom-cs-2B"> </a></td><td>PGKB 2B</td><td>Moderate level of evidence. NOT in the list of very important, KNOWN pharmacogenes. Found in multiple studies but may have a minority of studies that did not support the majority opinion. Supported by at least two indpendent publications.</td></tr><tr><td style="white-space:nowrap">3<a name="pharmgkb-evidence-level-custom-cs-3"> </a></td><td>PGKB 3</td><td>Low-level of evidence. Where either the assocation is based on a single study, failed to be reproduced, or preliminary evidence.</td></tr><tr><td style="white-space:nowrap">4<a name="pharmgkb-evidence-level-custom-cs-4"> </a></td><td>PGKB 4</td><td>The evidence does not support an association between the variant and the drug phenotype. (negative)</td></tr></table></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="cg"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
        <valueCode value="informative">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
            <valueCanonical
                            value="http://hl7.org/fhir/uv/genomics-reporting/ImplementationGuide/genomics-reporting"/>
          </extension>
        </valueCode>
      </extension>
      <url
           value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/pharmgkb-evidence-level-custom-cs"/>
      <version value="4.0.0-cibuild"/>
      <name value="PharmGKBEvidenceLevelCustomCS"/>
      <title value="PharmGKB Evidence Level Example Codes"/>
      <status value="active"/>
      <experimental value="true"/>
      <date value="2025-11-08T00:09:50+00:00"/>
      <publisher value="HL7 International / Clinical Genomics"/>
      <contact>
        <name value="HL7 International / Clinical Genomics"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/clingenomics"/>
        </telecom>
        <telecom>
          <system value="email"/>
          <value value="cg@lists.HL7.org"/>
        </telecom>
      </contact>
      <description
                   value="PharmGKB contains examples of evidence level concepts that are not conflated with clinical significance. These can be found on PharmGKB https://www.pharmgkb.org/page/clinAnnLevels. These examples are informational only, for copyright information contact the relevant source."/>
      <jurisdiction>
        <coding>
          <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
          <display value="World"/>
        </coding>
      </jurisdiction>
      <caseSensitive value="true"/>
      <content value="complete"/>
      <count value="6"/>
      <concept>
        <code value="1A"/>
        <display value="PGKB 1A"/>
        <definition
                    value="High level of evidence. Supported by a guideline or FDA label with variant specific prescribing guidance. Additionally, supported by at least one publication."/>
      </concept>
      <concept>
        <code value="1B"/>
        <display value="PGKB 1B"/>
        <definition
                    value="High level of evidence. But, NOT supported by a guideline or FDA label with variant specific prescribing guidance. Additionally, supported by at least one publication."/>
      </concept>
      <concept>
        <code value="2A"/>
        <display value="PGKB 2A"/>
        <definition
                    value="Moderate level of evidence. Supported by being a KNOWN pharmacogene on https://www.pharmgkb.org/vips. Also, found in multiple studies but may have a minority of studies that did not support the majority opinion. Supported by at least two indpendent publications."/>
      </concept>
      <concept>
        <code value="2B"/>
        <display value="PGKB 2B"/>
        <definition
                    value="Moderate level of evidence. NOT in the list of very important, KNOWN pharmacogenes. Found in multiple studies but may have a minority of studies that did not support the majority opinion. Supported by at least two indpendent publications."/>
      </concept>
      <concept>
        <code value="3"/>
        <display value="PGKB 3"/>
        <definition
                    value="Low-level of evidence. Where either the assocation is based on a single study, failed to be reproduced, or preliminary evidence."/>
      </concept>
      <concept>
        <code value="4"/>
        <display value="PGKB 4"/>
        <definition
                    value="The evidence does not support an association between the variant and the drug phenotype. (negative)"/>
      </concept>
    </CodeSystem>