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draft Template  OpenMed ManufacturedProduct

Id 2.16.840.1.113883.3.1937.777.11.10.146 Effective Date valid from 2016‑05‑10 22:32:31
Status draft Draft Version Label
Name openMedManufacturedProduct Display Name OpenMed 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.
Classification CDA Entry Level Template
Open/Closed Open (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 0 templates, Uses 1 template
Uses as Name Version
2.16.840.1.113883.3.1937.777.11.10.147 Include draft OpenMed Material DYNAMIC
Relationship Specialization: template 2.16.840.1.113883.10.12.312 (2005‑09‑07)
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>
Item DT Card Conf Description Label
hl7:manufacturedProduct
 0 … * R (opedotsuct)
hl7:templateId
 II.EPSOS 1 … 1 M (opedotsuct)
@root
 uid 1 … 1 F 2.16.840.1.113883.3.1937.777.11.10.146
Included 0 … 1 from 2.16.840.1.113883.3.1937.777.11.10.147 OpenMed Material (DYNAMIC)
hl7:manufacturedMaterial
 0 … 1 R This element describes the IDMP Medicinal Product. 
(opedotsuct)
@classCode
 cs 1 … 1 F MMAT
@determinerCode
 cs 1 … 1 F KIND
  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.EPSOS 0 … 1 R IDMP 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 > 		(opedotsuct)
hl7:name
 EN 0 … 1 R
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.. ]> 		(opedotsuct)
cpm:formCode
 CE.EPSOS 1 … 1 R Pharmaceutical dose form.
This code represents the form of the medication (e.g. tablet, capsule, liquid)
 (opedotsuct)
  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 <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 … * R This structure describes the packaging of the product. (opedotsuct)
@classCode
 cs 1 … 1 F CONT
  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 .... ] 
 (opedotsuct)
@classCode
 cs 1 … 1 F CONT
@determinerCode
 cs 1 … 1 F INSTANCE
cpm:code
 0 … 1 (opedotsuct)
cpm:name
 ST 0 … 1 Name of the Packaged Medicinal Product / Package Item (opedotsuct)
  Example <cpm:name>...</cpm:name>
cpm:formCode
 CE.EPSOS 0 … 1 R (opedotsuct)
  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 <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
 PQ 1 … 1 M (opedotsuct)
@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 <cpm:capacityQuantity unit="1" value="700">...</cpm:capacityQuantity>
cpm:asContent
 0 … * R (opedotsuct)
@classCode
 cs 1 … 1 F CONT
  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 … * R Used in this context for describing the Packaged Medicinal Product and or the Packaged Medicinal Product Item (opedotsuct)
@classCode
 cs 1 … 1 F CONT
@determinerCode
 cs 1 … 1 F INSTANCE
  Example <cpm:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">...</cpm:containerPackagedMedicine>
cpm:code
 0 … * (opedotsuct)
cpm:name
 ST 0 … * R (opedotsuct)
  Example <cpm:name>...</cpm:name>
cpm:formCode
 CE.EPSOS 1 … 1 R (opedotsuct)
  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 <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. (opedotsuct)
@classCode
 cs 1 … 1 F CONT
  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 … * R Used in this context for describing the Packaged Medicinal Product and or the Packaged Medicinal Product Item (opedotsuct)
@classCode
 cs 1 … 1 F CONT
@determinerCode
 cs 1 … 1 F INSTANCE
  Example <cpm:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">...</cpm:containerPackagedMedicine>
cpm:code
 0 … * (opedotsuct)
cpm:name
 ST 0 … * R (opedotsuct)
  Example <cpm:name>...</cpm:name>
cpm:formCode
 CE.EPSOS 1 … 1 R (opedotsuct)
  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 <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
 PQ 0 … * (opedotsuct)
cpm:asSpecializedKind
 1 … 1 R This 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. 		(opedotsuct)
@classCode
 cs 1 … 1 F GRIC
  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
 R (opedotsuct)
@classCode
 cs 1 … 1 F MMAT
cpm:code
 CD.EPSOS 1 … 1 R (opedotsuct)
@codeSystem
 CONF 0 … 1 F 2.16.840.1.113883.6.73 (WHO ATC)
  Example <cpm:code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/>
cpm:name
 0 … 1 R (opedotsuct)
cpm:asSpecializedKind
 0 … * R This 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. 		(opedotsuct)
@classCode
 cs 1 … 1 F GRIC
  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
 R (opedotsuct)
@classCode
 cs 1 … 1 F MMAT
cpm:code
 CD.EPSOS 1 … 1 R IDMP PhP Id. The level and the startum of the PhPID is distiguished by the codeSystem OID <to be verified> (opedotsuct)
cpm:name
 0 … 1 R (opedotsuct)
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).

(opedotsuct)
@classCode
 cs 1 … 1 F ACTI
@determinerCode
 cs 1 … 1 F KIND
  Example <cpm:ingredient classCode="ACTI">...</cpm:ingredient>
cpm:quantity
 1 … 1 M 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. (opedotsuct)
  Example <cpm:quantity>...</cpm:quantity>
cpm:numerator
 PQ 1 … 1 R (opedotsuct)
@unit
 cs 1 … 1 R
@value
 1 … 1 R
  Example <cpm:numerator unit="mg" value="20" xsi:type="PQ">...</cpm:numerator>
cpm:denominator
 PQ 1 … 1 R (opedotsuct)
@unit
 cs 1 … 1 R
@value
 1 … 1 R
  Example <cpm:denominator unit="1" value="1" xsi:type="PQ">...</cpm:denominator>
cpm:ingredientSubstance
 1 … 1 R Active 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. 
(opedotsuct)
cpm:code
 1 … 1 R Identifier of the substance. <binding with the vocabulary to be added likely the G-SRS (2.16.840.1.113883.4.9 SRS OID>
(opedotsuct)
cpm:name
 0 … 1 Name of the substance
(opedotsuct)