2.16.840.1.113883.10.22.4.3/static-2021-08-02T165227

Id	2.16.840.1.113883.10.22.4.3	Effective Date	2021‑08‑02 16:52:27 Other versions this id: IPSMedMaterial as of 2016‑11‑10
Status	Draft	Version Label	2021
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 7 concepts Id Name Data Set hl7ips-data​element-105  Product Code  CEN/TC 251 prEN 17269 hl7ips-data​element-117  Brand Name  CEN/TC 251 prEN 17269 hl7ips-data​element-132  Substance code  CEN/TC 251 prEN 17269 hl7ips-data​element-133  Strength  CEN/TC 251 prEN 17269 hl7ips-data​element-170  Active ingredient List  CEN/TC 251 prEN 17269 hl7ips-data​element-171  Product Common Name (and Strength)  CEN/TC 251 prEN 17269 hl7ips-data​element-227  Pharmaceutical dose form  CEN/TC 251 prEN 17269
Relationship	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"/>    </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>    </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>    </ingredientSubstance>  </ingredient></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"/>            </containerPackagedProduct>          </asContent>        </containerPackagedProduct>      </asContent>    </containerPackagedProduct>  </asContent>  <asSpecializedKind classCode="GRIC">     <generalizedMaterialKind classCode="MMAT">       <code code="..." codeSystem="2.16.840.1.113883.6.73"/>      <name/>    </generalizedMaterialKind>  </asSpecializedKind>  <asSpecializedKind classCode="GRIC">     <generalizedMaterialKind classCode="MMAT">       <code/>      <name/>    </generalizedMaterialKind>  </asSpecializedKind>  <ingredient classCode="ACTI" determinerCode="KIND">     <quantity>       <numerator value="20" unit="mg"/>      <denominator value="100" unit="mL"/>    </quantity>    <ingredientSubstance>       <code/>      <name/>    </ingredientSubstance>  </ingredient></manufacturedMaterial>
Item DT Card Conf Description Label hl7:manufactured​Material 0 … * R (IPS...ial) @classCode cs 0 … 1 F MMAT @determiner​Code cs 0 … 1 F KIND hl7:templateId II 1 … 1 M (IPS...ial) @root oid 1 … 1 F 2.16.840.1.113883.10.22.4.3 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. (IPS...ial)   hl7ips-data​element-105  Product Code  CEN/TC 251 prEN 17269 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. (IPS...ial)   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.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. (IPS...ial)   hl7ips-data​element-227  Pharmaceutical dose form  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.25 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:capacity​Quantity> element described the capacity of the packaging. For example, to represent 30 tablets, the <pharm:formCode> element at the <manufacturedMaterial> level must indicate tablets as the form, value attribute of the <pharm:capacity​Quantity> element must have the value of 30, and the unit attribute can be 1 or {tablet} or omitted. In the cases where the unit attribute is not 1, UCUM units shall be used.  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. (IPS...ial) @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>  </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"/>  </containerPackagedProduct></asContent> pharm:quantity PQ 0 … 1 (IPS...ial) @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:containerPackagedProduct 1 … 1 R It represents the most inner Package Item or the Packaged Medicinal Product. (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code 0 … 1 If this is 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". (IPS...ial) pharm:name ST 0 … 1 It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is the most inner  <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial)   hl7ips-data​element-117  Brand Name  CEN/TC 251 prEN 17269   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. (IPS...ial)   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:capacity​Quantity PQ 0 … 1 R It represents the functional capacity of the container: e.g. blister containing 20 tablets or ampule of 10 ml. (IPS...ial) @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 <capacityQuantity value="20" unit="{tablet}"/>   Example <capacityQuantity value="10" unit="mL"/> 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.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 (IPS...ial) @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:containerPackagedProduct 1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD.IPS 0 … 1 If this is 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". (IPS...ial) pharm:name ST 0 … 1 R It represents the Name of the Package Item or of the Packaged Medicinal Product If this is the most inner  <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial)   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. (IPS...ial)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) pharm:capacity​Quantity PQ 0 … 1 R It represents the functional capacity of the container: e.g. blister containing 20 tablets or ampule of 10 ml. (IPS...ial) @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 <capacityQuantity value="20" unit="{tablet}"/>   Example <capacityQuantity value="10" unit="mL"/> 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.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 (IPS...ial) @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:containerPackagedProduct 1 … 1 R When present, it represents the the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code 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). (IPS...ial) pharm:name ST 0 … * R When present, it can be used for the representing the brand name. (IPS...ial) 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. (IPS...ial)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) pharm:capacity​Quantity PQ 0 … 1 R It represents the functional capacity of the container: e.g. blister containing 20 tablets or ampule of 10 ml. (IPS...ial) @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 <capacityQuantity value="20" unit="{tablet}"/>   Example <capacityQuantity value="10" unit="mL"/> 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. (IPS...ial) 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 (IPS...ial) @classCode cs 1 … 1 F MMAT pharm:code CD.IPS 1 … 1 R The element contains the ATC code of this medicine. (IPS...ial)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.29 WHO ATC (DYNAMIC)   Example <code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> pharm:name 0 … * (IPS...ial) 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. (IPS...ial) @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/>  </generalizedMaterialKind></asSpecializedKind> pharm:generalizedMaterialKind R (IPS...ial) @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. (IPS...ial) pharm:name 0 … * R (IPS...ial)   hl7ips-data​element-171  Product Common Name (and Strength)  CEN/TC 251 prEN 17269 pharm:ingredient 0 … * R This module provides the list of the active substances used for this product; one or more substances may be present. The classCode of "ACTI" indicates that this is an active ingredient. (IPS...ial)   hl7ips-data​element-170  Active ingredient List  CEN/TC 251 prEN 17269 @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 <quantity> element contains the numerator and denominator of the strength ratio.</quantity> (IPS...ial)   hl7ips-data​element-133  Strength  CEN/TC 251 prEN 17269   Example <quantity>...</quantity> hl7:numerator PQ 1 … 1 R (IPS...ial) @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 (IPS...ial) @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 The active substance 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.  (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code 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. (IPS...ial)   hl7ips-data​element-132  Substance code  CEN/TC 251 prEN 17269   CONF The value of @code should be drawn from value set 2.16.840.1.113883.11.22.32 Medicine Active Substances (DYNAMIC) hl7:originalText ED 0 … * (IPS...ial) hl7:reference TEL 0 … * (IPS...ial) hl7:translation CD 0 … * This element can be used to provide alternative identifications for the described substance. (IPS...ial) pharm:name 0 … 1 C Name of the substance (IPS...ial)   Schematron assert role  error     test pharm:code or pharm:name     Message Either the name or the code of the substance (or both) shall be provided