Genomics Reporting Implementation Guide
3.0.0 - STU3
Genomics Reporting Implementation Guide
3.0.0 - STU3
This page is part of the Genetic Reporting Implementation Guide (v3.0.0: STU3) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions
| Active as of 2024-12-12 |
<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><a name="pharmgkb-evidence-level-custom-cs-en-US"> </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>
<url
value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/pharmgkb-evidence-level-custom-cs"/>
<version value="3.0.0"/>
<name value="PharmGKBEvidenceLevelCustomCS"/>
<title value="PharmGKB Evidence Level Example Codes"/>
<status value="active"/>
<experimental value="true"/>
<date value="2024-12-12T21:16:09+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>
IG © 2022+ HL7 International / Clinical Genomics. Package hl7.fhir.uv.genomics-reporting#3.0.0 based on FHIR 4.0.1. Generated 2024-12-12
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