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draft Template  IPS Manufactured Material

Id 2.16.840.1.113883.10.22.4.3 Effective Date 2024‑08‑04 10:47:30
Status draft Draft Version Label STU2
Name IPSMedMaterial Display Name IPS Manufactured Material
Description
This entry provides details about the medicinal product.
Due to the current absence of global product identifiers the product is described through a set of identification and descriptive attributes (e.g. active substances, strength, unit of presentation,...)  that may be used to integrate jurisdictional product codes.
This shortage will be likely overcome when the ISO IDMP identifiers will be available for concrete usage in the next years, as well as the globally used value sets for products attributes agreed by the ISO IDMP implemention guides. (e.g. GInAs for substances).
Even though there is a quite common consensus about the attributes that should be provided in order to describe a medicine in the context of the international patient summary (e.g. the list of active substances, the strength(s); the administrable pharmaceutical forms;..), this template doesn't require any of them, recommending, above all for cross-borders services, to provide all the available information that could be helpful for the identification of medications
Jurisdictions could specialize this template making some ofthese attributes required.
It is also recognized that in many contexts structured information about the product, might not be available, and only textual information for describing products (e.g. the product scientific name "amoxicillin 400mg/5mL suspension”) or some of their attributes (e.g. textual strength "875 mg + 125 mg" ; "amoxycillin and clavulanic acid") could be used.
This template attempts to provide a solution that takes in account this current complexity being also ready for including the future IDMP-based solution as soon as they will become available for concrete use.
Since the CDA R2.0 model support only a very limited set of information about the products, extensions based on the R_ProductList (Common Product Model) CMET have been used for conveying such information, aiming to align this solution with that that will be likely used for the IDMP implementation Guide.
Classification CDA Entry Level Template
Open/Closed Open (other than defined elements are allowed)
Associated with
Associated with 4 concepts
Id Name Data Set
hl7ips-dataelement-105 draft Product Code draft CEN/TC 251 prEN 17269
hl7ips-dataelement-117 draft Brand Name draft CEN/TC 251 prEN 17269
hl7ips-dataelement-171 draft Product Common Name (and Strength) draft CEN/TC 251 prEN 17269
hl7ips-dataelement-227 draft Pharmaceutical dose form draft CEN/TC 251 prEN 17269
Used by / Uses
Used by 0 transactions and 4 templates, Uses 0 templates
Used by as Name Version
2.16.840.1.113883.10.22.4.2 Include draft IPS Medication Information (detail) (STU2) 2024‑08‑04 10:45:46
2.16.840.1.113883.10.22.4.4 link draft IPS Medication Statement (STU2) 2024‑08‑04 10:41:54
2.16.840.1.113883.10.22.3.1 link pending IPS Medication Summary Section (STU1) 2016‑11‑11
2.16.840.1.113883.10.22.1.1 link draft International Patient Summary (2021) 2020‑07‑14 16:08:21
Relationship Specialization: template 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material (2021‑08‑02 16:52:27)
Adaptation: template 2.16.840.1.113883.10.12.311 CDA Material (2005‑09‑07)
ref
ad1bbr-

Adaptation: template 2.16.840.1.113883.3.1937.777.11.10.147 OpenMed Material (2016‑05‑10 22:43:03)
ref
epsos-
Example
Example
<manufacturedMaterial>
  <!-- Example with all the IDMP Levels (PhPID,MPID, PCID) and other product attributes (e.g. ingredients, ATC Code, strengths) -->
  <templateId root="2.16.840.1.113883.10.22.4.3"/>  <code codeSystem="" code="MPID" displayName="" CodeSystemName="MP EMA">
    <name>Medicinal Product Name</name>    <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="10219000" displayName="tablet" CodeSystemName="EDQM"/>    <asContent>
      <!-- Packaged Medicinal Product (PC) -->
      <containerPackagedProduct>
        <!-- PC ID-->
        <code codeSystem=" " code="PCID" displayName=" ">
          <name>...</name>          <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="" displayName="" CodeSystemName="EDQM"/>        </code>      </containerPackagedProduct>    </asContent>    <asSpecializedKind classCode="GRIC">
      <!-- Pharmaceutical Substance (ATC Code)-->
      <generalizedMaterialKind classCode="MMAT">
        <!-- Pharmaceutical Substance (ATC Code)-->
        <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/>      </generalizedMaterialKind>    </asSpecializedKind>    <asSpecializedKind>
      <!-- Pharmaceutical Product (PhP)-->
      <generalizedMaterialKind classCode="MMAT">
        <code code="PhPID" codeSystem=" " displayName=" " codeSystemName="PhP EMA">
          <name>....</name>        </code>      </generalizedMaterialKind>    </asSpecializedKind>    <!-- list of active ingredients -->
    <ingredient classCode="ACTI" determinerCode="KIND">
      <quantity>
        <!-- strength -->
        <numerator type="PQ" value="20" unit="mg"/>        <denominator type="PQ" value="1" unit="{tablet}"/>      </quantity>      <ingredientSubstance>
        <code codeSystem=" " code="SubstanceID" displayName=" " CodeSystemName="G-SRS">
          <name>...</name>        </code>      </ingredientSubstance>    </ingredient>  </code></manufacturedMaterial>
Example
Example
<manufacturedMaterial classCode="MMAT" determinerCode="KIND">
  <templateId root="2.16.840.1.113883.10.22.4.3"/>  <code code="..." codeSystem="1.2.3.999">
    <name>name</name>    <formCode code="10101000" displayName="Oral drops, solution" codeSystem="0.4.0.127.0.16.1.1.2.1"/>    <asContent classCode="CONT">
      <containerPackagedProduct classCode="CONT" determinerCode="KIND">
        <code>
          <name/>          <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/>          <capacityQuantity value="..." unit="..."/>          <asContent classCode="CONT">
            <containerPackagedProduct classCode="CONT" determinerCode="KIND">
              <code>
                <name/>                <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/>                <asContent classCode="CONT">
                  <containerPackagedProduct classCode="CONT" determinerCode="KIND">
                    <code>
                      <name/>                      <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/>                    </code>                  </containerPackagedProduct>                </asContent>              </code>            </containerPackagedProduct>          </asContent>        </code>      </containerPackagedProduct>    </asContent>    <asSpecializedKind classCode="GRIC">
      <generalizedMaterialKind classCode="MMAT">
        <code code="..." codeSystem="2.16.840.1.113883.6.73">
          <name/>        </code>      </generalizedMaterialKind>    </asSpecializedKind>    <asSpecializedKind classCode="GRIC">
      <generalizedMaterialKind classCode="MMAT">
        <code>
          <name/>        </code>      </generalizedMaterialKind>    </asSpecializedKind>    <ingredient classCode="ACTI" determinerCode="KIND">
      <quantity>
        <numerator value="20" unit="mg"/>        <denominator value="100" unit="mL"/>      </quantity>      <ingredientSubstance>
        <code>
          <name/>        </code>      </ingredientSubstance>    </ingredient>  </code></manufacturedMaterial>
Item DT Card Conf Description Label
hl7:manufacturedMaterial
 		0 … * R (IPSdotsial)
@classCode
 		cs 0 … 1 F MMAT
@determinerCode
 		cs 0 … 1 F KIND
hl7:templateId
 		II 1 … 1 M (IPSdotsial)
@root
 		oid 1 … 1 F 2.16.840.1.113883.10.22.4.3
Choice 0 … 1 Elements to choose from:
  • hl7:code
  • hl7:code[@codeSystem='2.16.840.1.113883.6.96']
hl7:code
 		CE.IPS 0 … 1 R 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. 		(IPSdotsial)
 
target
hl7ips-dataelement-105 draft Product Code draft CEN/TC 251 prEN 17269
hl7:code
 		CE.IPS 0 … 1 R Non IDMP codes from SNOMED CT value set (IPSdotsial)
where [@codeSystem='2.16.840.1.113883.6.96']
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.71 IPS Medications Products (DYNAMIC)
hl7:name
 		EN 0 … 1 R
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.
 (IPSdotsial)
 
target
hl7ips-dataelement-117 draft Brand Name draft CEN/TC 251 prEN 17269
hl7ips-dataelement-171 draft Product Common Name (and Strength) draft CEN/TC 251 prEN 17269
pharm:formCode
 		CE.IPS 0 … 1 R
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.
(IPSdotsial)
 
target
hl7ips-dataelement-227 draft Pharmaceutical dose form draft CEN/TC 251 prEN 17269
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.25 IPS Medicine Doseform (DYNAMIC)
  Example <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:capacityQuantity> 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.
(IPSdotsial)
@classCode
 		cs 1 … 1 F CONT
  Example
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>
  Example
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
 		PQ 0 … 1 The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
 		(IPSdotsial)
@unit
 		cs 0 … 1  
  CONF
The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
 		1 … 1 R
  Example <quantity value="20" unit="{tablet}"/>
  Example <quantity value="10" unit="mL"/>
pharm:containerPackagedProduct
 		1 … 1 R It represents the most inner Package Item or the Packaged Medicinal Product. (IPSdotsial)
@classCode
 		cs 1 … 1 F CONT
@determinerCode
 		cs 1 … 1 F KIND
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".
 (IPSdotsial)
pharm:name
 		ST 0 … 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.
(IPSdotsial)
  Example <name>AMOXIFEN(R) 20 compresse 20 mg</name>
pharm:formCode
 		CE.IPS 0 … 1 R 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. 		(IPSdotsial)
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)
  Example <formCode code="30007000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</formCode>
pharm:capacityQuantity
 		PQ 0 … 1 It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. (IPSdotsial)
@unit
 		cs 0 … 1  
  CONF
The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
 		1 … 1 R
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. 
 (IPSdotsial)
@classCode
 		cs 1 … 1 F CONT
pharm:quantity
 		PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
 		(IPSdotsial)
@unit
 		cs 0 … 1  
  CONF
The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
 		1 … 1 R
  Example <quantity value="20" unit="{tablet}"/>
  Example <quantity value="10" unit="mL"/>
pharm:containerPackagedProduct
 		1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product (IPSdotsial)
@classCode
 		cs 1 … 1 F CONT
@determinerCode
 		cs 1 … 1 F KIND
pharm:code
 		CD.IPS 0 … 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".
(IPSdotsial)
pharm:name
 		ST 0 … 1 R
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.
(IPSdotsial)
  Example <name>...</name>
pharm:formCode
 		CE.IPS 1 … 1 R 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. 		(IPSdotsial)
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)
pharm:capacityQuantity
 		PQ 0 … 1 It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. (IPSdotsial)
@unit
 		cs 0 … 1  
  CONF
The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
 		1 … 1 R
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. 
 (IPSdotsial)
@classCode
 		cs 1 … 1 F CONT
pharm:quantity
 		PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
 		(IPSdotsial)
@unit
 		cs 0 … 1  
  CONF
The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
 		1 … 1 R
  Example <quantity value="20" unit="{tablet}"/>
  Example <quantity value="10" unit="mL"/>
pharm:containerPackagedProduct
 		1 … 1 R When present, it represents the Packaged Medicinal Product (IPSdotsial)
@classCode
 		cs 1 … 1 F CONT
@determinerCode
 		cs 1 … 1 F KIND
pharm:code
 		CD.IPS 0 … 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). (IPSdotsial)
pharm:name
 		ST 0 … 1 R When present, it can be used for the representing the brand name. (IPSdotsial)
pharm:formCode
 		CE.IPS 1 … 1 R 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. 		(IPSdotsial)
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)
pharm:capacityQuantity
 		PQ 0 … 1 It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. (IPSdotsial)
@unit
 		cs 0 … 1  
  CONF
The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
 		1 … 1 R
pharm: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 "GRIC" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry.
(IPSdotsial)
where [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73']
@classCode
 		cs 1 … 1 F GRIC
  Example <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 … 1 M (IPSdotsial)
@classCode
 		cs 1 … 1 F MMAT
pharm:code
 		CD.IPS 1 … 1 R The <code> element contains the ATC code of this medicine. (IPSdotsial)
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.29 IPS WHO ATC (DYNAMIC)
  Example <code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/>
pharm:name
 		0 … * (IPSdotsial)
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. 		(IPSdotsial)
@classCode
 		cs 1 … 1 F GRIC
  Example <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 (IPSdotsial)
@classCode
 		cs 1 … 1 F MMAT
pharm:code
 		CD.IPS 1 … 1 R
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.
(IPSdotsial)
pharm:name
 		0 … * R (IPSdotsial)
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.
 (IPSdotsial)
@classCode
 		cs 1 … 1 R
  CONF
The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC)
pharm:quantity
 		1 … 1 M The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The element contains the numerator and denominator of the strength ratio. (IPSdotsial)
  Example <quantity>...</quantity>
hl7:numerator
 		PQ 1 … 1 R (IPSdotsial)
@unit
 		cs 1 … 1 R
  CONF
The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.30 Medicine Strength Numerator (DYNAMIC)
@value
 		1 … 1 R
hl7:denominator
 		PQ 1 … 1 R (IPSdotsial)
@unit
 		cs 1 … 1 R
  CONF
The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.31 Medicine Strength Denominator (DYNAMIC)
@value
 		1 … 1 R
pharm:ingredientSubstance
 		1 … 1 R (IPSdotsial)
@classCode
 		cs 1 … 1 F MMAT
@determinerCode
 		cs 1 … 1 F KIND
pharm:code
 		CD.IPS (extensible) 0 … 1 C 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. 		(IPSdotsial)
  CONF
The value of @code should be drawn from value set 2.16.840.1.113883.11.22.32 IPS Medicine Active Substances (DYNAMIC)
hl7:originalText
 		ED 0 … * (IPSdotsial)
hl7:reference
 		TEL 0 … * (IPSdotsial)
hl7:translation
 		CD 0 … * This element can be used to provide alternative identifications for the described substance. (IPSdotsial)
pharm:name
 		0 … 1 C Name of the substance (IPSdotsial)
  Schematron assert role red error  
  test pharm:code or pharm:name  
  Message Either the name or the code of the substance (or both) shall be provided