Free-text Allergy to clinical trial drug

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Approval Status

  • Approval Status: Approved
  • Example Task Force: 4/26/2018
  • SDWG: 10/1/2018

C-CDA 2.1 Example:

  • 2.16.840.1.113883.10.20.22.2.6.1:2015-08-01

  • Allergy Concern Act 2.16.840.1.113883.10.20.22.4.30:2015-08-01

  • Allergy Intolerance Observation 2.16.840.1.113883.10.20.22.4.7:2014-06-09

  • Reaction Observation 2.16.840.1.113883.10.20.22.4.9:2014-06-09
  • Severity Observation 2.16.840.1.113883.10.20.22.4.8:2014-06-09

Reference to full CDA sample:

  • Allergies in empty CCD

Validation location

Comments

  • This example illustrates an example of allergy to a new drug ingredient which is in a clinical trial phase and not approved by the FDA. As a result, there is no RxNorm, NDF-RT, SNOMED or UNII code. An NCI thesaurus code is in turn used as a translation code since NCI tracks new chemotherapy drugs in clinical trial phases.

Additional Notes and Assumptions: * The example drug, talazoparib, was in clinical trial phase at the time of this example. It is possible for this drug to be approved at some point in the future after this C-CDA example is approved.

Custodian

  • May Terry (GitHub: mayterry88)

Keywords

  • substance, allergies, allergy

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Example: download example view on GitHub 

<?xml version="1.0" encoding="UTF-8"?>
<section>
    <templateId root="2.16.840.1.113883.10.20.22.2.6.1"/>
    <templateId root="2.16.840.1.113883.10.20.22.2.6.1" extension="2015-08-01"/>
    <!-- Allergies (entries required) section template -->
    <code code="48765-2" codeSystem="2.16.840.1.113883.6.1"/>
    <title>Allergies, Adverse Reactions and Alerts</title>
    <text>
        <table>
            <thead>
                <tr>
                    <th>Allergen</th>
                    <th>Reaction</th>
                    <th>Reaction Severity</th>
                    <th>Documentation Date</th>
                    <th>Onset Date</th> <!-- Date from observation/effectiveTime-->
                </tr>
            </thead>
            <tbody>
                <tr ID="allergy1">
                    <td ID="allergy1allergen">talazoparib</td>
                    <td>
                        <content ID="allergy1reaction">Dyspnea</content>
                    </td>
                    <td>
                        <content ID="allergy1reactionseverity">Moderate</content>
                    </td>
                    <td>April 1 2018</td>
                    <td>April 1 2018</td>
                </tr>
            </tbody>
        </table>
    </text>
    <entry typeCode="DRIV">
        <act classCode="ACT" moodCode="EVN">
            <!-- ** Allergy problem act ** -->
            <templateId root="2.16.840.1.113883.10.20.22.4.30"/>
            <templateId root="2.16.840.1.113883.10.20.22.4.30" extension="2015-08-01"/>
            <id root="4a2ac5fc-0c85-4223-baee-c2e254803974"/>
            <code code="CONC" codeSystem="2.16.840.1.113883.5.6"/>
            <text>
			  <reference value="#allergy1"/>
			</text>
            <statusCode code="active"/>
            <!-- This is the time stamp for when the allergy was first documented as a concern-->
            <effectiveTime value="20180401103001-0500"/> <!-- Apr 1, 2018 at 10:30a ET -->
            <author>
                <templateId root="2.16.840.1.113883.10.20.22.4.119"/>
                <time value="20180401"/>
                <assignedAuthor>
                    <id extension="12345" root="2.16.840.1.113883.4.6"/>
                    <code code="207RX0202X" codeSystem="2.16.840.1.113883.6.101"
                        codeSystemName="Health Care Provider Taxonomy" displayName="Allopathic &amp; Osteopathic Physicians; Internal Medicine, Medical Oncology"/>
                    <telecom use="WP" value="tel:555-555-1234"/>
                    <assignedPerson>
                        <name>
                            <given>Adam</given>
                            <family>Anydoc</family>
                        </name>
                    </assignedPerson>
                </assignedAuthor>
            </author>
            <entryRelationship typeCode="SUBJ">
                <observation classCode="OBS" moodCode="EVN">
                    <!-- allergy observation template -->
                    <templateId root="2.16.840.1.113883.10.20.22.4.7"/>
                    <templateId root="2.16.840.1.113883.10.20.22.4.7" extension="2014-06-09"/>
                    <id root="4d3ac7ac-0c32-8712-b3fe-c2b268808259"/>
                    <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/>
                    <text>
                        <reference value="#allergy1"/>
                    </text>
                    <statusCode code="completed"/>
                    <!-- This is the time stamp for the biological onset of the allergy. -->
                    <!-- Just the year is shown since a specific month and date was not reported -->
                    <effectiveTime>
                        <low value="20180401"/>
                        <high value="20180401"/>
                    </effectiveTime>
                    <!-- This specifies that the allergy is to a medication in contrast to other allergies (substance) -->
                    <value xsi:type="CD" code="59037007" displayName="Intolerance to drug (finding)"
                        codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" />
                    <author>
                        <templateId root="2.16.840.1.113883.10.20.22.4.119"/>
                        <time value="20180401"/>
                        <assignedAuthor>
                            <id extension="99999999" root="2.16.840.1.113883.4.6"/>
                            <code code="207RX0202X" codeSystem="2.16.840.1.113883.6.101"
                                codeSystemName="Health Care Provider Taxonomy"
                                displayName="Allopathic &amp; Osteopathic Physicians; Internal Medicine, Medical Oncology"/>
                            <telecom use="WP" value="tel:555-555-1234"/>
                            <assignedPerson>
                                <name>
                                    <given>Adam</given>
                                    <family>Anydoc</family>
                                </name>
                            </assignedPerson>
                        </assignedAuthor>
                    </author>
                    <participant typeCode="CSM">
                        <participantRole classCode="MANU">
                            <playingEntity classCode="MMAT">
                                <!-- This drug is a clinical trial drug not approved by FDA so there is no RxNorm code -->
                                <!-- For non-drug substances that don't have a concept you may omit codeSystem -->
                                <!-- Use OTH and originalText -->
                                <code nullFlavor="OTH" codeSystem="2.16.840.1.113883.6.88" codeSystemName="RxNorm"> 
                                    <originalText>
                                        <reference value="#allergy1allergen"/>
                                    </originalText>
                                    <!-- Include clinical trial code or local code and codeSystem in translation-->
                                   <translation code="C95733" displayName="talazoparib" 
                                                codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI"/>
                                </code>
                            </playingEntity>
                        </participantRole>
                    </participant>
                    <!-- Only one reaction recorded here, although multiple reactions may be recorded to the same substance ([0..*] -->
                    <entryRelationship typeCode="MFST" inversionInd="true">
                        <observation classCode="OBS" moodCode="EVN">
                            <!-- Reaction Observation template -->
                            <templateId root="2.16.840.1.113883.10.20.22.4.9"/>
                            <templateId root="2.16.840.1.113883.10.20.22.4.9" extension="2014-06-09"/>
                            <id root="fea0b775-f3fe-4e0a-9c4f-4a5c235c2af0"/>
                            <code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/>
                            
                            <statusCode code="completed"/>
                            <effectiveTime value = "20180401"/>
                            <value xsi:type="CD" code="267036007" codeSystem="2.16.840.1.113883.6.96"
                                codeSystemName="SNOMED CT" displayName="Dyspnea">
                                <originalText>
                                    <reference value="#allergy1reaction"/>
                                </originalText>
                            </value>
                            <entryRelationship typeCode="SUBJ" inversionInd="true">
                                <observation classCode="OBS" moodCode="EVN">
                                    <!-- Severity Observation template -->
                                    <templateId root="2.16.840.1.113883.10.20.22.4.8"/>
                                    <templateId root="2.16.840.1.113883.10.20.22.4.8" extension="2014-06-09"/>
                                    <code code="SEV" codeSystem="2.16.840.1.113883.5.4"
                                        codeSystemName="ActCode"/>
                                    <text>
                                        <reference value="#allergy1reactionseverity"/>
                                    </text>
                                    <statusCode code="completed"/>
                                    <value xsi:type="CD" code="6736007" codeSystem="2.16.840.1.113883.6.96"
                                        codeSystemName="SNOMED CT" displayName="Moderate"/>
                                </observation>
                            </entryRelationship>
                        </observation>
                    </entryRelationship>
                   </observation>
            </entryRelationship>
        </act>
    </entry>
</section>

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