2.16.840.1.113883.10.22.4.2

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1 Template IPSManufacturedProduct

1.1 Aktuelle Version

Id2.16.840.1.113883.10.22.4.2Gültigkeit ab2024‑08‑04 10:45:46
Status  EntwurfVersions-LabelSTU2
NameIPSManufacturedProductBezeichnungIPS Medication Information (detail)
Beschreibung  This entry describes the consumable subject of the medication statement.
All the information about the  medication is provided in the included IPS Manufactured Material template.
KlassifikationCDA Entry Level Template
Offen/GeschlossenOffen (auch andere als die definierten Elemente sind erlaubt)
Assoziiert mit
Assoziiert mit 1 Konzept
IdNameDatensatz
hl7ips-data​element-2  Medicinal Product   CEN/TC 251 prEN 17269
Benutzt
Benutzt 1 Template
Benutzt als NameVersion
2.16.840.1.113883.10.22.4.3Inklusion  IPS Manufactured Material (STU2)DYNAMIC
BeziehungSpezialisierung: Template 2.16.840.1.113883.10.22.4.2 IPS Medication Information (detail) (2016‑11‑10)
ref
hl7ips-

Adaptation: Template 2.16.840.1.113883.10.12.312 CDA ManufacturedProduct (2005‑09‑07)
ref
ad1bbr-

Spezialisierung: Template 2.16.840.1.113883.10.21.4.11 UV Medication Information (detail) (DYNAMIC)
ref
pharmcda-
Beispiel
Beispiel
<manufacturedProduct classCode="MANU">
  <templateId root="2.16.840.1.113883.10.22.4.2"/>  <!-- include template 2.16.840.1.113883.10.22.4.3 'IPS Manufactured Material' (dynamic) 1..1 R -->
</manufacturedProduct>
ItemDTKardKonfBeschreibungLabel
hl7:manufacturedProduct
0 … *R
 
 
hl7ips-data​element-2  Medicinal Product   CEN/TC 251 prEN 17269
 @classCode
cs0 … 1FMANU
 hl7:templateId
II1 … 1M
  @root
uid1 … 1F2.16.840.1.113883.10.22.4.2
Eingefügt1 … 1R von 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material (DYNAMIC)
 hl7:manufactured​Material
1 … 1R
  @classCode
cs0 … 1FMMAT
  @determiner​Code
cs0 … 1FKIND
  hl7:templateId
II1 … 1M
   @root
oid1 … 1F2.16.840.1.113883.10.22.4.3
Auswahl0 … 1Elemente in der Auswahl:
  • hl7:code
  • hl7:code[@codeSystem='2.16.840.1.113883.6.96']
   hl7:code
CE.IPS0 … 1R  This element is generally used to identify a medicinal product.
When the IDMP identifiers will be concretely available for usage this element will be used for conveying the Medicinal Product Identifier (MPID).
For the time being, it could be optionally used for conveying jurisdictional or agreed cross jurisdictional medicinal product code.
 
 
hl7ips-data​element-105  Product Code   CEN/TC 251 prEN 17269
   hl7:code
CE.IPS0 … 1R  Non IDMP codes from SNOMED CT value set
wo [@codeSystem='2.16.840.1.113883.6.96']
 CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.71 IPS Medications Products (DYNAMIC)
  hl7:name
EN0 … 1R 
This element is supposed to be valorized with 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.
 
 
hl7ips-data​element-117  Brand Name   CEN/TC 251 prEN 17269
hl7ips-data​element-171  Product Common Name (and Strength)   CEN/TC 251 prEN 17269
  pharm:formCode
CE.IPS0 … 1R 
Administrable Pharmaceutical Dose Form.
This code represents the form of the medication (e.g. tablet, capsule, liquid)
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration.
It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT.
 
 
hl7ips-data​element-227  Pharmaceutical dose form   CEN/TC 251 prEN 17269
 CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.25 IPS Medicine Doseform (DYNAMIC)
 Beispiel<formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" displayName="Capsule, soft">...</formCode>
  pharm:asContent
0 … * 
This structure describes the packaging of the medication.
The <pharm:formCode> element provides the code for the particular package.
If the package has a brand name, it can be described in the <pharm:name> element.
The <pharm:capacity​Quantity> element describes the capacity of the packaging, while the <pharm:quantity> the actual quantity of inner packaged items in the outer packaging container.
The product might have a single (30 pills bottle) or multiple (5 vials 10 ml; box with 2 blisters of 20 tablets) layers of packaging.
In the latter case, the most inner (nested) item represents the most outer package item.
For example the case 
  \--Box 
  \-----2 blisters 
  \--------20 tablets 
is described as "20 tablets" contained by "a blister"; "2 blisters" contained by one box.


The most inner package represents the Packaged Medicinal Product.

When the IDMP Packaged Medicinal Product ID (PCID) will become actually available for usage, the most inner package <code> element will be used to convey the IDMP PCID.
   @classCode
cs1 … 1FCONT
 Beispiel
Packaged Medicinal Product with multiple layers packaging
<asContent>
  <containerPackagedProduct>
    <!-- Inner Package -->
    <code codeSystem="..." code="..." displayName="...">
      <asContent>
        <containerPackagedProduct>
          <!-- Intermediate Package -->
          <asContent>
            <containerPackagedProduct>
              <!-- Outer Package / Packaged Medicinal Product -->
            </containerPackagedProduct>          </asContent>        </containerPackagedProduct>      </asContent>    </code>  </containerPackagedProduct></asContent>
 Beispiel
Packaged Medicinal Product with formCode
<asContent>
  <containerPackagedProduct>
    <!-- Packaged Medicinal Product -->
    <code codeSystem="1.999.999" code="PC_ID" displayName="Packaged Product Name">
      <name>100 MIRACLE PILLS(TM)</name>      <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="30009000" displayName="Box" CodeSystemName="EDQM"/>    </code>  </containerPackagedProduct></asContent>
   pharm:quantity
PQ0 … 1  The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
    @unit
cs0 … 1 
 CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
    @value
1 … 1R
 Beispiel<quantity value="20" unit="{tablet}"/>
 Beispiel<quantity value="10" unit="mL"/>
   pharm:containerPackagedProduct
1 … 1R  It represents the most inner Package Item or the Packaged Medicinal Product.
    @classCode
cs1 … 1FCONT
    @determiner​Code
cs1 … 1FKIND
    pharm:code
0 … 1 
If this is also the most outer <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
 
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
    pharm:name
ST0 … 1 
It represents the Name of the Package Item or of the Packaged Medicinal Product.
If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name.
 Beispiel<name>AMOXIFEN(R) 20 compresse 20 mg</name>
    pharm:formCode
CE.IPS0 … 1R  This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.

Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration.
 CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)
 Beispiel<formCode code="30007000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</formCode>
    pharm:capacity​Quantity
PQ0 … 1  It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml.
     @unit
cs0 … 1 
 CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
     @value
1 … 1R
    pharm:asContent
0 … *R 
In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case 
  \--Box 
  \-----2 blisters 
  \--------20 tablets 
it describes the "2 blisters" 
In the case of 
  \--Box 
  \-----5 vials
it represents the Packaged Medicinal Product. 
     @classCode
cs1 … 1FCONT
     pharm:quantity
PQ0 … 1R  The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
      @unit
cs0 … 1 
 CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
      @value
1 … 1R
 Beispiel<quantity value="20" unit="{tablet}"/>
 Beispiel<quantity value="10" unit="mL"/>
     pharm:containerPackagedProduct
1 … 1R  It represents the intermediate Package Item or the Packaged Medicinal Product
      @classCode
cs1 … 1FCONT
      @determiner​Code
cs1 … 1FKIND
      pharm:code
CD.IPS0 … 1 
If this is also the most inner  <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
 
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
      pharm:name
ST0 … 1R 
It represents the Name of the Package Item or of the Packaged Medicinal Product
If this is also the most inner  <pharm:containerPackagedProduct> than this element can be used for the brand name.
 Beispiel<name>...</name>
      pharm:formCode
CE.IPS1 … 1R  This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.

Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as reference terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration.
 CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)
      pharm:capacity​Quantity
PQ0 … 1  It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml.
       @unit
cs0 … 1 
 CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
       @value
1 … 1R
      pharm:asContent
0 … *R 
In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case 
  \--Box 
  \-----2 blisters 
  \--------20 tablets 
it describes the Packaged Medicinal Product. 
       @classCode
cs1 … 1FCONT
       pharm:quantity
PQ0 … 1R  The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
        @unit
cs0 … 1 
 CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
        @value
1 … 1R
 Beispiel<quantity value="20" unit="{tablet}"/>
 Beispiel<quantity value="10" unit="mL"/>
       pharm:containerPackagedProduct
1 … 1R  When present, it represents the Packaged Medicinal Product
        @classCode
cs1 … 1FCONT
        @determiner​Code
cs1 … 1FKIND
        pharm:code
CD.IPS0 … 1  When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
        pharm:name
ST0 … 1R  When present, it can be used for the representing the brand name.
        pharm:formCode
CE.IPS1 … 1R  When present, it encodes the type of the outer package.

Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration.
 CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)
        pharm:capacity​Quantity
PQ0 … 1  It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml.
         @unit
cs0 … 1 
 CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
         @value
1 … 1R
  pharm:asSpecializedKind
0 … 1R 
This module is used for representing the classification of the Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System.
The classCode of "GRIC" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry.
wo [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73']
   @classCode
cs1 … 1FGRIC
 Beispiel<asSpecializedKind classCode="GRIC">
  <generalizedMaterialKind classCode="MMAT">
    <!-- Pharmaceutical Substance (ATC Code)-->
    <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/>  </generalizedMaterialKind></asSpecializedKind>
   pharm:generalizedMaterialKind
1 … 1M
    @classCode
cs1 … 1FMMAT
    pharm:code
CD.IPS1 … 1R  The <code> element contains the ATC code of this medicine.
 CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.29 IPS WHO ATC (DYNAMIC)
 Beispiel<code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/>
    pharm:name
0 … *
  pharm:asSpecializedKind
0 … *R  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.

When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, the PhPID will be represented by the generalizedMaterialKind/code element.
   @classCode
cs1 … 1FGRIC
 Beispiel<asSpecializedKind classCode="GRIC">
  <generalizedMaterialKind classCode="MMAT">
    <code code="PhPID_Lvl1" codeSystem="1.999.999" displayName="Pharmaceutical Product Name" codeSystemName="PhPID Level 1">
      <name/>    </code>  </generalizedMaterialKind></asSpecializedKind>
   pharm:generalizedMaterialKind
R
    @classCode
cs1 … 1FMMAT
    pharm:code
CD.IPS1 … 1R 
When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, this element will be used for representing the IDMP PhP Id.
The level and the stratum of the PhPID will be distiguished by the OID of the code system.
    pharm:name
0 … *R
  pharm:ingredient
0 … *R 
This module provides the list of the ingredients (substances with a role) used for this product; one or more ingredients may be present.
The classCode of "ACTI" indicates that this is an active ingredient.
   @classCode
cs1 … 1R
 CONF
Der Wert von @classCode MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC)
   pharm: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.</quantity>
 Beispiel<quantity>...</quantity>
    hl7:numerator
PQ1 … 1R
     @unit
cs1 … 1R
 CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.30 Medicine Strength Numerator (DYNAMIC)
     @value
1 … 1R
    hl7:denominator
PQ1 … 1R
     @unit
cs1 … 1R
 CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.31 Medicine Strength Denominator (DYNAMIC)
     @value
1 … 1R
   pharm:ingredientSubstance
1 … 1R
    @classCode
cs1 … 1FMMAT
    @determiner​Code
cs1 … 1FKIND
    pharm:code
CD.IPS (extensible)0 … 1C  The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances. 
The Global Ingredient Archival System (GInAS)  will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard.
Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances.
This choice will be revised based on the availability and the maturity of GInAS.
 CONF
Der Wert von @code SOLLTE gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.32 IPS Medicine Active Substances (DYNAMIC)
     hl7:originalText
ED0 … *
      hl7:reference
TEL0 … *
     hl7:translation
CD0 … *  This element can be used to provide alternative identifications for the described substance.
    pharm:name
0 … 1C  Name of the substance
 Schematron assertrole error 
 testpharm:code or pharm:name 
 MeldungEither the name or the code of the substance (or both) shall be provided 


1.2 Zusammenstellung aller Versionen dieses Templates

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