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draft Template  epSOS CDA ManufacturedProduct

Template (internal) 1.3.6.1.4.1.12559.11.10.1.3.1.3.1 - epSOSCDAManufacturedProduct
Id 1.3.6.1.4.1.12559.11.10.1.3.1.3.1
Version valid from 2013‑12‑20 status draft Under develeopment
Classification CDA Entry Level Template
Open/Closed Open (other than defined elements are allowed)
Description Template CDA ManufacturedProduct (prototype, directly derived from POCD_RM000040 MIF) The medicine entry content module describes a medication used in a <substanceAdministratio> 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.
Used by / Uses
Used by / Uses 12 templates
Used by Template id as Name Version
1.3.6.1.4.1.12559.11.10.1.3.1.3.2 Containment epSOSCDASubstanceAdministration epSOS CDA substanceAdministration 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.2.1 link SectionPrescription Section Prescription 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.1 link epSOS-eP epSOS-ePrescription 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.3.3 Containment epSOSCDASupply epSOS CDA Supply 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.2.2 link SectionDispensation Section Dispensation 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.2 link epSOS-eD epSOS-eDispensation 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.3.4 Containment EntryMedicationSummary Entry Medication Summary 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.2.3 link SectionMedicationSummary Section Medication Summary 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.3 link epSOS-PS epSOS-Patient Summary 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.4 link epSOS-HCER epSOS-Health Care Encounter Report 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.5 link epSOS-MRO epSOS-Medication Related Overview 2013‑12‑20
Uses Template id as Name Version
2.16.840.1.113883.3.1937.777.10.10.143 Include epSOSCDAMaterial DYNAMIC
Relationship Specialization: template 2.16.840.1.113883.10.12.312 (2005‑09‑07)
Item DT Card Conf Description Label
hl7:manufacturedProduct
0 .. * R (epSOSCDAManufacturedProduct)
treetree @classCode
0 .. 1 F MANU
  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>    <XXX: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 -->
    <XXX:asContent classCode="CONT">
      <XXX:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
        <XXX:name>Pyrimon 5 ml Eye Drops</XXX:name>        <XXX:formCode code="30008000" displayName="Bottle" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM"/>
        <XXX:capacityQuantity value="5" unit="ml"/>
        <XXX:capTypeCode code="30022000" codeSystem=" 1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="Dropper applicator" codeSystemName="EDQM"/>
      </XXX:containerPackagedMedicine>    </XXX:asContent>    <!-- This is the generic equivalent -->
    <XXX:asSpecializedKind classCode="GRIC">
      <XXX:generalizedMedicineClass classCode="MMAT">
        <XXX:code nullFlavor="NA"/>
        <XXX:name>Chloramphenicol/ Dexamethasone</XXX:name>      </XXX:generalizedMedicineClass>    </XXX:asSpecializedKind>    <!-- This is the list of active ingredients -->
    <XXX:ingredient classCode="ACTI">
      <!-- Strength 1% w/v -->
      <XXX:quantity>
        <XXX:numerator xsi:type="epsos:PQ" value="10" unit="mg"/>
        <XXX:denominator xsi:type="epsos:PQ" value="1" unit="ml"/>
      </XXX:quantity>      <XXX:ingredient classCode="MMAT" determinerCode="KIND">
        <XXX:code code="S01AA01" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="chloramphenicol"/>
        <XXX:name>Chloramphenicol</XXX:name>      </XXX:ingredient>    </XXX:ingredient>    <XXX:ingredient classCode="ACTI">
      <!-- Strength 0.1% w/v -->
      <XXX:quantity>
        <XXX:numerator xsi:type="epsos:PQ" value="1" unit="mg"/>
        <XXX:denominator xsi:type="epsos:PQ" value="1" unit="ml"/>
      </XXX:quantity>      <XXX:ingredient classCode="MMAT" determinerCode="KIND">
        <XXX:code code="D07CB04" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="dexamethasone and antibiotics"/>
        <XXX:name>Dexamethasone</XXX:name>      </XXX:ingredient>    </XXX:ingredient>  </manufacturedMaterial></manufacturedProduct>
treetree 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. (epSOSCDAManufacturedProduct)
treeblank treetree @root
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>
treetree hl7:templateId
II.EPSOS 0 .. * R (epSOSCDAManufacturedProduct)
Included from 2.16.840.1.113883.3.1937.777.10.10.143 epSOS CDA Material (DYNAMIC) 0..*
treetree hl7:manufacturedMaterial
0 .. * R (epSOSCDAManufacturedProduct)
treeblank treetree @classCode
1 .. 1 F MMAT
treeblank treetree @determinerCode
1 .. 1 F KIND
treeblank treetree 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.
(epSOSCDAManufacturedProduct)
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.16041 MaterialEntityClassType (DYNAMIC)
treeblank treetree hl7:name
EN 0 .. 1 R In an epSOS ePrescriprion or eDispensation document, the <name> element should contain the brand name of the medication. (epSOSCDAManufacturedProduct)
treeblank treetree 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.
(epSOSCDAManufacturedProduct)
  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>
treeblank treetree 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. (epSOSCDAManufacturedProduct)
treeblank treeblank treetree @classCode
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>
treeblank treeblank treetree epsos:containerPackagedMedicine
1 .. * R (epSOSCDAManufacturedProduct)
treeblank treeblank treeblank treetree @classCode
1 .. 1 F CONT
treeblank treeblank treeblank treetree @determinerCode
1 .. 1 F INSTANCE
  Example <epsos:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">...</epsos:containerPackagedMedicine>
treeblank treeblank treeblank treetree epsos:name
ST 0 .. * R (epSOSCDAManufacturedProduct)
  Example <epsos:name>...</epsos:name>
treeblank treeblank treeblank treetree epsos:formCode
CE.EPSOS 1 .. 1 R (epSOSCDAManufacturedProduct)
  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>
treeblank treeblank treeblank treetree epsos:capacityQuantity
PQ 1 .. 1 M (epSOSCDAManufacturedProduct)
treeblank treeblank treeblank treeblank treetree @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)
treeblank treeblank treeblank treeblank treetree @value
1 .. 1 R
  Example <epsos:capacityQuantity unit="1" value="700">...</epsos:capacityQuantity>
treeblank treetree epsos:asSpecializedKind
0 .. 1 R The classCode of "GRIC" 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 coded representation of the generic medicine, and the <epsos:name> element may be used for the plain text representation. (epSOSCDAManufacturedProduct)
treeblank treeblank treetree @classCode
1 .. 1 F GRIC
  Example <epsos:asSpecializedKind classCode="GRIC">
  <epsos:generalizedMedicineClass classCode="MMAT">
    <epsos:code code=" " codeSystem=" " displayName=" " codeSystemName=" "/>
    <epsos:name/>
  </epsos:generalizedMedicineClass></epsos:asSpecializedKind>
treeblank treeblank treetree epsos:generalizedMedicineClass
R (epSOSCDAManufacturedProduct)
treeblank treeblank treeblank treetree @classCode
1 .. 1 F MMAT
treeblank treeblank treeblank treetree epsos:code
R (epSOSCDAManufacturedProduct)
treeblank treetree 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.

“In case of multi active ingredients medicinal product the first ingredient element is used for describing the the ATC code associated to the medicinal product, each single active ingredients and related strengths are instead conveyed using the subIngredient elements

(epSOSCDAManufacturedProduct)
treeblank treeblank treetree @classCode
1 .. 1 F ACTI
treeblank treeblank treetree @determinerCode
1 .. 1 F KIND
  Example <epsos:ingredient classCode="ACTI">...</epsos:ingredient>
treeblank treeblank treetree 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. (epSOSCDAManufacturedProduct)
  Example <epsos:quantity>...</epsos:quantity>
treeblank treeblank treeblank treetree epsos:numerator
epsos:PQ 1 .. 1 R (epSOSCDAManufacturedProduct)
treeblank treeblank treeblank treeblank treetree @unit
1 .. 1 R
treeblank treeblank treeblank treeblank treetree @value
1 .. 1 R
  Example <epsos:numerator unit="mg" value="20" xsi:type="epsos:PQ">...</epsos:numerator>
treeblank treeblank treeblank treetree epsos:denominator
epsos:PQ 1 .. 1 R (epSOSCDAManufacturedProduct)
treeblank treeblank treeblank treeblank treetree @unit
1 .. 1 R
treeblank treeblank treeblank treeblank treetree @value
1 .. 1 R
  Example <epsos:denominator unit="1" value="1" xsi:type="epsos:PQ">...</epsos:denominator>