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draft Template  epSOS CDA ManufacturedProduct

Id 1.3.6.1.4.1.12559.11.10.1.3.1.3.1 Effective Date valid from 2013‑12‑20
Status draft Draft Version Label
Name epSOSCDAManufacturedProduct Display Name epSOS CDA ManufacturedProduct
Description
Template CDA ManufacturedProduct (prototype, directly derived from POCD_RM000040 MIF) The medicine entry content module describes a medication used in a <substanceAdministration> or <supply> act. This entry uses the structure of the HL7 V3 R_Medication Universal Common Message Element (CMET), Release 2.

This structure is part of the HL7 V3 2009 Normative Edition (COCT_RM230100UV). The incorporation of this structure is done according to section 1.4 CDA Extensibility of the HL7 CDA standard. Such an extension of the base CDA standard is an accepted practice in IHE (e.g. in the XD* Lab specification).

For the purposes of WP 3.5 this extension is necessary to satisfy the requirements for eP and eD data elements to represent a generic equivalent and ingredients.
The rules of section 1.4 CDA Extensibility require the designation of a new XML namespace for the XML elements in this structure. For the purposes of documentation, the namespace urn:epsos-org:ep:medication shall be used.

The following specification and constraints are applied to the structures of the CMET.

The example uses Pyrimon, Chloramphenicol/ Dexamethasone 1% w/v/ 0.1% w/v 5 ml Eye Drops as the medication. The structure is further explained in the following subsections.
Classification CDA Entry Level Template
Open/Closed Open (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 11 templates, Uses 1 template
Used by as Name Version
1.3.6.1.4.1.12559.11.10.1.3.1.3.2 Containment draft epSOS CDA substanceAdministration 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.2.1 link draft Section Prescription 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.1 link draft epSOS-ePrescription 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.3.3 Containment draft epSOS CDA Supply 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.2.2 link draft Section Dispensation 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.2 link draft epSOS-eDispensation 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.3.4 Containment draft Medication Item 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.2.3 link draft Section Medication Summary 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.3 link draft epSOS-Patient Summary 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.4 link draft epSOS-Health Care Encounter Report 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.5 link draft epSOS-Medication Related Overview 2013‑12‑20
Uses as Name Version
2.16.840.1.113883.3.1937.777.11.10.143 Include draft epSOS CDA Material DYNAMIC
Relationship Specialization: template 2.16.840.1.113883.10.12.312 (2005‑09‑07)
Example
Example
<manufacturedProduct classCode="MANU">
  <templateId root="1.3.6.1.4.1.12559.11.10.1.3.1.3.1"/>  <manufacturedMaterial classCode="MMAT" determinerCode="KIND">
    <!-- National medicinal product code -->
    <code code=" " displayName="Pyrimon" codeSystem=" " codeSystemName=" "/>    <!-- Brand name -->
    <name>Pyrimon</name>    <epsos:formCode code="10604000" displayName="Eye drops, solution" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM"/>    <!-- Container information -->
    <epsos:asContent classCode="CONT">
      <epsos:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
        <epsos:name>Pyrimon 5 ml Eye Drops</epsos:name>        <epsos:formCode code="30008000" displayName="Bottle" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM"/>        <epsos:capacityQuantity value="5" unit="ml"/>        <epsos:capTypeCode code="30022000" codeSystem=" 1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="Dropper applicator" codeSystemName="EDQM"/>      </epsos:containerPackagedMedicine>    </epsos:asContent>    <!-- This is the generic equivalent -->
    <epsos:asSpecializedKind classCode="GRIC">
      <epsos:generalizedMedicineClass classCode="MMAT">
        <epsos:code nullFlavor="NA"/>        <epsos:name>Chloramphenicol/ Dexamethasone</epsos:name>      </epsos:generalizedMedicineClass>    </epsos:asSpecializedKind>    <!-- This is the list of active ingredients -->
    <epsos:ingredient classCode="ACTI">
      <!-- Strength 1% w/v -->
      <epsos:quantity>
        <epsos:numerator xsi:type="epsos:PQ" value="10" unit="mg"/>        <epsos:denominator xsi:type="epsos:PQ" value="1" unit="ml"/>      </epsos:quantity>      <epsos:ingredient classCode="MMAT" determinerCode="KIND">
        <epsos:code code="S01AA01" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="chloramphenicol"/>        <epsos:name>Chloramphenicol</epsos:name>      </epsos:ingredient>    </epsos:ingredient>    <epsos:ingredient classCode="ACTI">
      <!-- Strength 0.1% w/v -->
      <epsos:quantity>
        <epsos:numerator xsi:type="epsos:PQ" value="1" unit="mg"/>        <epsos:denominator xsi:type="epsos:PQ" value="1" unit="ml"/>      </epsos:quantity>      <epsos:ingredient classCode="MMAT" determinerCode="KIND">
        <epsos:code code="D07CB04" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="dexamethasone and antibiotics"/>        <epsos:name>Dexamethasone</epsos:name>      </epsos:ingredient>    </epsos:ingredient>  </manufacturedMaterial></manufacturedProduct>
notice There are open issues with this item:
  • epsos-issue-121: Name of Template Medicine & specialized templates (Open)
  • epsos-issue-124: asSpecializedKind missing in Medication Summary Spec (Open)
  • epsos-issue-126: Add 1.3.6.1.4.1.12559.11.10.1.3.1.3.1 template specializations (Open)
  • epsos-issue-212: cardinality of manufacturedProduct (In Progress)
Item DT Card Conf Description Label
hl7:manufacturedProduct
 0 … 1 R (epSdotsuct)
@classCode
 cs 0 … 1 F MANU
hl7:templateId
 II.EPSOS 1 … 1 R In an epSOS ePrescription or eDispensation document, the name and coding of the medication are specified in the elements under the <manufacturedProduct> element. The templateId element is required and identifies this as a Medicine entry. (epSdotsuct)
@root
 uid 1 … 1 F 1.3.6.1.4.1.12559.11.10.1.3.1.3.1
  Example <templateId root="1.3.6.1.4.1.12559.11.10.1.3.1.3.1">...</templateId>
hl7:templateId
 II.EPSOS 0 … * R (epSdotsuct)
Included 1 … 1 R from 2.16.840.1.113883.3.1937.777.11.10.143 epSOS CDA Material (DYNAMIC)
hl7:manufacturedMaterial
 1 … 1 R (epSdotsuct)
@classCode
 cs 1 … 1 F MMAT
@determinerCode
 cs 1 … 1 F KIND
hl7:code
 CE.EPSOS 0 … 1 R The <code> element of the <manufacturedMaterial> describes the medication.
For the scope of epSOS this is used to convey the “Country A Cross-border/regional/national medicinal product code.

In a CDA document, the <originalText> shall contain a <reference> whose URI value points to the generic name and strength of the medication in the narrative, or just the generic name alone if strength is not relevant.

Note: When the text is supplied from the narrative, the implication is that if the components of a combination medication are supplied in an entry, these must also be displayed in narrative text; the combination medication will not be able to be broken down into its component parts. This is entirely consistent with the CDA Release 2.0 requirements that the narrative supply the necessary and relevant human readable information content.
(epSdotsuct)
 
target
epsos-dataelement-135 draft Medicinal product code draft epSOS Data Set
hl7:name
 EN 0 … 1 R In an epSOS ePrescriprion or eDispensation document, the <name> element should contain the brand name of the medication. (epSdotsuct)
 
target
epsos-dataelement-137 draft Brand name draft epSOS Data Set
epsos:desc
 EN 0 … 1 R Free-text representation of the strength. (epSdotsuct)
  Example <cda:desc>20/12,5 mg</cda:desc>
epsos:formCode
 CE.EPSOS 1 … 1 R <epsos:formCode code='' displayName='' codeSystem='' codeSystemName=''/>
This code represents the form of the medication (e.g. tablet, capsule, liquid). The value of this code affects the units used in the substance administration quantity element – if the form is a tablet, for example, the unit is 1; if the form is a liquid, the unit will be part of UCUM. The value set is epSOSDoseForm, OID: 1.3.6.1.4.1.12559.11.10.1.3.1.42.2.
(epSdotsuct)
 
target
epsos-dataelement-106 draft Pharmaceutical dose form draft epSOS Data Set
  CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.2 epSOSDoseForm (DYNAMIC)
  Example <epsos:formCode code="10211000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Capsule, soft">...</epsos:formCode>
epsos:asContent
 0 … * R This structure describes the packaging of the medication. The <epsos:formCode> element provides the code for the particular package. If the package has a brand name, it can be described in the <epsos:name> element.. The <epsos:capacityQuantity> element described the capacity of the packaging. For example, to represent 30 tablets, the <epsos:formCode> element at the <manufacturedMaterial> level must indicate tablets as the form, value attribute of the <epsos:capacityQuantity> element must have the value of 30, and the unit attribute must be 1. In the cases where the unit attribute is not 1, UCUM units shall be used. The value set is epSOSUnits, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.16 and epSOSDoseForm, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.2. (epSdotsuct)
@classCode
 cs 1 … 1 F CONT
  Example <epsos:asContent classCode="CONT">
  <epsos:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
    <epsos:name/>    <epsos:formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/>    <epsos:capacityQuantity value=" " unit=" "/>  </epsos:containerPackagedMedicine></epsos:asContent>
epsos:containerPackagedMedicine
 1 … * R (epSdotsuct)
@classCode
 cs 1 … 1 F CONT
@determinerCode
 cs 1 … 1 F INSTANCE
  Example <epsos:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">...</epsos:containerPackagedMedicine>
epsos:name
 ST 0 … * R (epSdotsuct)
  Example <epsos:name>...</epsos:name>
epsos:formCode
 CE.EPSOS 1 … 1 R (epSdotsuct)
  CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.2 epSOSDoseForm (DYNAMIC)
or
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.3 epSOSPackage (DYNAMIC)
  Example <epsos:formCode code="30007000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</epsos:formCode>
epsos:capacityQuantity
 PQ 1 … 1 M (epSdotsuct)
 
target
epsos-dataelement-138 draft Medicinal product package size draft epSOS Data Set
@unit
 cs 1 … 1 R
  CONF
The value of @unit shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.16 epSOSUnits (DYNAMIC)
@value
 1 … 1 R
  Example <epsos:capacityQuantity unit="1" value="700">...</epsos:capacityQuantity>
epsos:asSpecializedKind
 0 … 1 R This module is used for representing the classification of the Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System. 

The classCode of "GEN" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry.

The <epsos:code> element contains the ATC code, and the <epsos:name> element may be used for the plain text representation.

(epSdotsuct)
@classCode
 cs 1 … 1 F GEN
  Example <epsos:asSpecializedKind classCode="GEN">
  <epsos:generalizedMedicineClass classCode="MMAT">
    <epsos:code code=" " codeSystem="2.16.840.1.113883.6.73" codeSystemName="Anatomical Therapeutic Chemical" displayName=" "/>    <epsos:name/>  </epsos:generalizedMedicineClass></epsos:asSpecializedKind>
epsos:generalizedMedicineClass
 R (epSdotsuct)
@classCode
 cs 1 … 1 F MMAT
epsos:code
 CD.EPSOS 1 … 1 R (epSdotsuct)
  CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 epSOSActiveIngredient (DYNAMIC)
epsos:name
 0 … 1 (epSdotsuct)
epsos:ingredient
 0 … * R

One or more active ingredients may be represented with this structure. The classCode of "ACTI" indicates that this is an active ingredient. The <epsos:code> element contains the coded representation of the ingredient and the <epsos:name> element may be used for the plain text representation.

(epSdotsuct)
@classCode
 cs 1 … 1 F ACTI
@determinerCode
 cs 1 … 1 F KIND
  Example <epsos:ingredient classCode="ACTI">...</epsos:ingredient>
epsos:quantity
 1 … 1 M The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The <epsos:quantity> element contains the numerator and denominator of the strength ratio. (epSdotsuct)
 
target
epsos-dataelement-105 draft Strength draft epSOS Data Set
  Example <epsos:quantity>...</epsos:quantity>
epsos:numerator
 epsos:PQ 1 … 1 R (epSdotsuct)
@unit
 cs 1 … 1 R
@value
 1 … 1 R
  Example <epsos:numerator unit="mg" value="20" xsi:type="epsos:PQ">...</epsos:numerator>
epsos:denominator
 epsos:PQ 1 … 1 R (epSdotsuct)
@unit
 cs 1 … 1 R
@value
 1 … 1 R
  Example <epsos:denominator unit="1" value="1" xsi:type="epsos:PQ">...</epsos:denominator>
epsos:ingredient
 CD.EPSOS 1 … 1 R (epSdotsuct)
epsos:code
 CD.EPSOS 1 … 1 R (epSdotsuct)
 
target
epsos-dataelement-104 draft Active ingredient code draft epSOS Data Set
  CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 epSOSActiveIngredient (DYNAMIC)
epsos:originalText
 ED 0 … * (epSdotsuct)
epsos:reference
 TEL 0 … * (epSdotsuct)
epsos:translation
 CD 0 … * This element can be used to provide alternative identifications for the described substance. (epSdotsuct)
epsos:name
 0 … 1 Name of the substance
(epSdotsuct)
 
target
epsos-dataelement-103 draft Active ingredient draft epSOS Data Set