Id2.16.840.1.113883.3.1937.777.11.10.146Effective Date2016‑05‑10 22:32:31
Statusretired RetiredVersion Label
NameopenMedManufacturedProductDisplay NameOpenMed ManufacturedProduct
Description
< this template is currently used for demonstration purposes for the OpenMedicine preoject>

Template CDA ManufacturedProduct (prototype, directly derived from POCP_RM010100UV ) 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_ProductListed Common Message Element (CMET), Release 2.

This structure is part of the HL7 V3 2015 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).

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. < change the namespace > 

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.
ClassificationCDA Entry Level Template
Open/ClosedOpen (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 0 templates, Uses 1 template
Uses as NameVersion
2.16.840.1.113883.3.1937.777.11.10.147Includeretired OpenMed MaterialDYNAMIC
RelationshipSpecialization: template 2.16.840.1.113883.10.12.312 CDA ManufacturedProduct (2005‑09‑07)
ref
ad1bbr-
Example
Example
<hl7:manufacturedProduct classCode="MANU">
  <!-- OpenMedicine experimental template -->
  <hl7:templateId root="2.16.840.1.113883.3.1937.777.11.10.146"/>  <!-- Medicinal Product -->
  <hl7:manufacturedMaterial classCode="MMAT" determinerCode="KIND">
    <!-- MP ID -->
    <!-- The values and the OID used are not real and used only for exemplification purposes -->
    <hl7:code codeSystem="2.16.840.1.113883.3.1937.777.11.10.146.99.99.1" code="MPID_123" displayName="Pyrimon" CodeSystemName="MP EMA"/>    <hl7:name>Pyrimon</hl7:name>    <cpm:formCode codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" code="10604000" displayName="Eye drops, solution" CodeSystemName="EDQM"/>    <cpm:asContent>
      <!-- this is the way SPL provide the quantity ... TO BE CHECKED -->
      <cpm:quantity xsi:type="PQ" value="5" unit="ml"/>      <!-- Packaged Medicinal Product (PC) -->
      <cpm:containerPackagedProduct>
        <!-- PC ID-->
        <!-- The values and the OID used are not real and used only for exemplification purposes -->
        <cpm:code codeSystem="2.16.840.1.113883.3.1937.777.11.10.146.99.99.2" code="PCID_123" displayName="Pyrimon Eye Drops (Dexamethasone/Chloramphenicol) - 0.1%/1% (5ml)" CodeSystemName="PC EMA"/>        <cpm:name>Pyrimon Eye Drops (Dexamethasone/Chloramphenicol) - 0.1%/1% (5ml)</cpm:name>        <cpm:formCode codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" code="30008000" displayName="Bottle" CodeSystemName="EDQM"/>      </cpm:containerPackagedProduct>    </cpm:asContent>    <cpm:asSpecializedKind classCode="GRIC">
      <!-- Pharmaceutical Substance (ATC Code)-->
      <cpm:generalizedMaterialKind classCode="MMAT">
        <!-- Pharmaceutical Substance (ATC Code)-->
        <cpm:code code="S01CA01" codeSystem="2.16.840.1.113883.6.73" displayName="Dexamethasone and antiinfectives" codeSystemName="WHO ATC"/>      </cpm:generalizedMaterialKind>    </cpm:asSpecializedKind>    <cpm:asSpecializedKind>
      <!-- Pharmaceutical Product (PhP)-->
      <cpm:generalizedMaterialKind classCode="MMAT">
        <!-- PC ID (in this example PhPID level 3) -->
        <!-- The values and the OID used are not real and used only for exemplification purposes -->
        <cpm:code code="PhPID_123" codeSystem="2.16.840.1.113883.3.1937.777.11.10.146.99.99.3" displayName="Dexamethasone and Chloramphenicol eye drop" codeSystemName="PhP EMA"/>        <cpm:name>Dexamethasone and Chloramphenicol eye drop</cpm:name>      </cpm:generalizedMaterialKind>    </cpm:asSpecializedKind>    <!-- List of active ingredients -->
    <!-- Ingredient 1 : CHLORAMPHENICOL1% w/v -->
    <cpm:ingredient classCode="ACTI" determinerCode="KIND">
      <cpm:quantity>
        <!-- Strength 1% w/v -->
        <cpm:numerator unit="mg" value="10" xsi:type="PQ"/>        <cpm:denominator unit="ml" value="1" xsi:type="PQ"/>      </cpm:quantity>      <!-- chloramphenicol -->
      <cpm:ingredientSubstance>
        <cpm:code codeSystem="2.16.840.1.113883.4.9" code="66974FR9Q1" displayName="CHLORAMPHENICOL" CodeSystemName="SRS"/>        <cpm:name>CHLORAMPHENICOL</cpm:name>      </cpm:ingredientSubstance>    </cpm:ingredient>    <!-- Ingredient 2 : DEXAMETHASONE 0.1% w/v -->
    <cpm:ingredient classCode="ACTI" determinerCode="KIND">
      <cpm:quantity>
        <!-- Strength 0.1% w/v -->
        <cpm:numerator unit="%" value="0.1" xsi:type="PQ"/>        <cpm:denominator unit="ml" value="1" xsi:type="PQ"/>      </cpm:quantity>      <!-- chloramphenicol -->
      <cpm:ingredientSubstance>
        <cpm:code codeSystem="2.16.840.1.113883.4.9" code="7S5I7G3JQL" displayName="DEXAMETHASONE" CodeSystemName="SRS"/>        <cpm:name>DEXAMETHASONE</cpm:name>      </cpm:ingredientSubstance>    </cpm:ingredient>    <!-- This is the list of active ingredients -->
  </hl7:manufacturedMaterial></hl7:manufacturedProduct>
ItemDTCardConfDescriptionLabel
hl7:manufacturedProduct
0 … *Ropendotsduct
hl7:templateId
II.EPSOS1 … 1Mopendotsduct
@root
uid1 … 1F2.16.840.1.113883.3.1937.777.11.10.146
Included0 … 1 from 2.16.840.1.113883.3.1937.777.11.10.147 OpenMed Material (DYNAMIC)
hl7:manufacturedMaterial
0 … 1RThis element describes the IDMP Medicinal Product. 
opendotsrial
@classCode
cs1 … 1FMMAT
@determinerCode
cs1 … 1FKIND
 Example<hl7:manufacturedMaterial>
  <!-- Example with all the IDMP Levels (PhPID,MPID, PCID) and other attributes used in epSOS (e.g. ingredients, ATC, strengths) -->
  <hl7:code codeSystem="" code="MPID" displayName="" CodeSystemName="MP EMA"/>  <hl7:name>Medicinal Product Name</hl7:name>  <cpm:formCode codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" code="10219000" displayName="tablet" CodeSystemName="EDQM"/>  <cpm:asContent>
    <!-- Packaged Medicinal Product (PC) -->
    <cpm:containerPackagedProduct>
      <!-- PC ID-->
      <cpm:code codeSystem=" " code="PCID" displayName=" "/>      <cpm:name>...</cpm:name>      <cpm:formCode codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" code="" displayName="" CodeSystemName="EDQM"/>    </cpm:containerPackagedProduct>  </cpm:asContent>  <cpm:asSpecializedKind classCode="GRIC">
    <!-- Pharmaceutical Substance (ATC Code)-->
    <cpm:generalizedMaterialKind classCode="MMAT">
      <!-- Pharmaceutical Substance (ATC Code)-->
      <cpm:code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/>    </cpm:generalizedMaterialKind>  </cpm:asSpecializedKind>  <cpm:asSpecializedKind>
    <!-- Pharmaceutical Product (PhP)-->
    <cpm:generalizedMaterialKind classCode="MMAT">
      <cpm:code code="PhPID" codeSystem=" " displayName=" " codeSystemName="PhP EMA"/>      <cpm:name>....</cpm:name>    </cpm:generalizedMaterialKind>  </cpm:asSpecializedKind>  <!-- list of active ingredients -->
  <cpm:ingredient classCode="ACTI" determinerCode="KIND">
    <cpm:quantity>
      <!-- strength -->
      <cpm:numerator unit="mg" value="20" xsi:type="PQ"/>      <cpm:denominator unit="1" value="{tablet}" xsi:type="PQ"/>    </cpm:quantity>    <cpm:ingredientSubstance>
      <cpm:code codeSystem=" " code="SubstanceID" displayName=" " CodeSystemName="G-SRS"/>      <cpm:name>...</cpm:name>    </cpm:ingredientSubstance>  </cpm:ingredient></hl7:manufacturedMaterial>
hl7:code
CE.EPSOS0 … 1RIDMP Medicinal Product ID (MPID)

< used in of epSOS to convey the “Country A Cross-border/regional/national medicinal product code. >

< REMOVE ? => 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. >

< ADD binding with the EMA MPID > 		opendotsrial
hl7:name
EN0 … 1R
IDMP Medicinal Product Name.
The complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction.
The name may be applicable in one or more country/language combinations.

< clarify if we should provide only the full name or also the parts >
 
< In an epSOS ePrescriprion or eDispensation document, the <name> element should contain the brand name of the medication. [NB: check if this still applies.. ]>		opendotsrial
cpm:formCode
CE.EPSOS1 … 1RPharmaceutical dose form.
This code represents the form of the medication (e.g. tablet, capsule, liquid)
opendotsrial
 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 eHDSIDoseForm (DYNAMIC)
 Example<cpm:formCode code="10211000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM" codeSystemVersion="2015" displayName="Capsule, soft">...</cpm:formCode>
cpm:asContent
0 … *RThis structure describes the packaging of the product.opendotsrial
@classCode
cs1 … 1FCONT
 Example<cpm:asContent>
  <cpm:containerPackagedProduct>
    <!-- Inner Package -->
    <cpm:code codeSystem=" " code="" displayName=""/>    <cpm:asContent>
      <cpm:containerPackagedProduct>
        <!-- Intermediate Package -->
        <cpm:asContent>
          <cpm:containerPackagedProduct>
            <!-- Outer Package / Packaged Medicinal Product -->
          </cpm:containerPackagedProduct>        </cpm:asContent>      </cpm:containerPackagedProduct>    </cpm:asContent>  </cpm:containerPackagedProduct></cpm:asContent>
 Example<cpm:asContent>
  <cpm:containerPackagedProduct>
    <!-- Packaged Medicinal Product -->
    <cpm:code codeSystem=" " code="MPID" displayName="MP name"/>    <cpm:name>..</cpm:name>    <cpm:formCode codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" code=".." displayName="MP name" CodeSystemName="EDQM"/>  </cpm:containerPackagedProduct></cpm:asContent>
cpm:containerPackagedProduct
1 … *R
It shall be used for describing the IDMP Packaged Medicinal Product and - when needed - the Package Items.
       
The most inner (nested) item represent the most outer package item.
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
If the package has a brand name, it can be described in the <name> element. [TO BE CHECKED] 

[ To be evaluated what to use or not the capacityQuantity the SPL uses the quantity element .... ] 
opendotsrial
@classCode
cs1 … 1FCONT
@determinerCode
cs1 … 1FINSTANCE
cpm:code
0 … 1opendotsrial
cpm:name
ST0 … 1Name of the Packaged Medicinal Product / Package Itemopendotsrial
 Example<cpm:name>...</cpm:name>
cpm:formCode
CE.EPSOS0 … 1Ropendotsrial
 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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
 Example<cpm:formCode code="30007000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</cpm:formCode>
cpm:capacityQuantity
PQ1 … 1Mopendotsrial
@unit
cs1 … 1R
 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 eHDSIUnit (DYNAMIC)
@value
1 … 1R
 Example<cpm:capacityQuantity unit="1" value="700">...</cpm:capacityQuantity>
cpm:asContent
0 … *Ropendotsrial
@classCode
cs1 … 1FCONT
 Example<cpm:asContent classCode="CONT">
  <cpm:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
    <cpm:name/>    <cpm:formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/>    <cpm:capacityQuantity value=" " unit=" "/>  </cpm:containerPackagedMedicine></cpm:asContent>
cpm:containerPackagedProduct
1 … *RUsed in this context for describing the Packaged Medicinal Product and or the Packaged Medicinal Product Itemopendotsrial
@classCode
cs1 … 1FCONT
@determinerCode
cs1 … 1FINSTANCE
 Example<cpm:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">...</cpm:containerPackagedMedicine>
cpm:code
0 … *opendotsrial
cpm:name
ST0 … *Ropendotsrial
 Example<cpm:name>...</cpm:name>
cpm:formCode
CE.EPSOS1 … 1Ropendotsrial
 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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
 Example<cpm:formCode code="30007000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</cpm:formCode>
cpm:asContent
0 … *R This structure describes the packaging of the medication. The <cpm:formCode> element provides the code for the particular package. If the package has a brand name, it can be described in the <cpm:name> element.. The <cpm:capacityQuantity> element described the capacity of the packaging. For example, to represent 30 tablets, the <cpm:formCode> element at the <manufacturedMaterial> level must indicate tablets as the form, value attribute of the <cpm: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. opendotsrial
@classCode
cs1 … 1FCONT
 Example<cpm:asContent classCode="CONT">
  <cpm:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
    <cpm:name/>    <cpm:formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/>    <cpm:capacityQuantity value=" " unit=" "/>  </cpm:containerPackagedMedicine></cpm:asContent>
cpm:containerPackagedProduct
1 … *RUsed in this context for describing the Packaged Medicinal Product and or the Packaged Medicinal Product Itemopendotsrial
@classCode
cs1 … 1FCONT
@determinerCode
cs1 … 1FINSTANCE
 Example<cpm:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">...</cpm:containerPackagedMedicine>
cpm:code
0 … *opendotsrial
cpm:name
ST0 … *Ropendotsrial
 Example<cpm:name>...</cpm:name>
cpm:formCode
CE.EPSOS1 … 1Ropendotsrial
 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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
 Example<cpm:formCode code="30007000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</cpm:formCode>
cpm:quantity
PQ0 … *opendotsrial
cpm:asSpecializedKind
1 … 1RThis module is used for Representing the Pharmaceutical Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System.

The <code> element contains the ATC code, the <name> element may be used for the plain text representation. The classCode of "GRIC" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry. 		opendotsrial
@classCode
cs1 … 1FGRIC
 Example<cpm:asSpecializedKind classCode="GRIC">
  <cpm:generalizedMaterialKind classCode="MMAT">
    <!-- Pharmaceutical Substance (ATC Code)-->
    <cpm:code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/>  </cpm:generalizedMaterialKind></cpm:asSpecializedKind>
cpm:generalizedMaterialKind
Ropendotsrial
@classCode
cs1 … 1FMMAT
cpm:code
CD.EPSOS1 … 1Ropendotsrial
@codeSystem
CONF0 … 1F2.16.840.1.113883.6.73
 Example<cpm:code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/>
cpm:name
0 … 1Ropendotsrial
cpm:asSpecializedKind
0 … *RThis module can be used to represent the Pharmaceutical Product (Ids Set)
The Medicinal Product can be classified according to various classification systems, which may be jurisdictional or international. The classification system itself is specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. 		opendotsrial
@classCode
cs1 … 1FGRIC
 Example<cpm:asSpecializedKind classCode="GRIC">
  <cpm:generalizedMaterialKind classCode="MMAT">
    <cpm:code code=" " codeSystem=" " displayName=" " codeSystemName="WHO ATC"/>    <cpm:name/>  </cpm:generalizedMaterialKind></cpm:asSpecializedKind>
cpm:generalizedMaterialKind
Ropendotsrial
@classCode
cs1 … 1FMMAT
cpm:code
CD.EPSOS1 … 1RIDMP PhP Id. The level and the startum of the PhPID is distiguished by the codeSystem OID <to be verified>opendotsrial
cpm:name
0 … 1Ropendotsrial
cpm:ingredient
0 … *R

This module proivdes the list of active ingredients used for this product. One or more active ingredients may be present.
The classCode of "ACTI" indicates that this is an active ingredient. 

Note: In this version the Pharmaceutical Substance ATC is no more provided as an ingredient but as a class of products (asSpecializedKind.generalizedMaterialKind.code element).

opendotsrial
@classCode
cs1 … 1FACTI
@determinerCode
cs1 … 1FKIND
 Example<cpm:ingredient classCode="ACTI">...</cpm:ingredient>
cpm:quantity
1 … 1M The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The <quantity> element contains the numerator and denominator of the strength ratio.opendotsrial
 Example<cpm:quantity>...</cpm:quantity>
cpm:numerator
PQ1 … 1Ropendotsrial
@unit
cs1 … 1R
@value
1 … 1R
 Example<cpm:numerator unit="mg" value="20" xsi:type="PQ">...</cpm:numerator>
cpm:denominator
PQ1 … 1Ropendotsrial
@unit
cs1 … 1R
@value
1 … 1R
 Example<cpm:denominator unit="1" value="1" xsi:type="PQ">...</cpm:denominator>
cpm:ingredientSubstance
1 … 1RActive ingredient used for this product. The <code> element contains the coded representation of the ingredient and the <name> element may be used for the plain text representation. 
opendotsrial
cpm:code
1 … 1RIdentifier of the substance. <binding with the vocabulary to be added likely the G-SRS (2.16.840.1.113883.4.9 SRS OID>
opendotsrial
cpm:name
0 … 1Name of the substance
opendotsrial