2.16.840.1.113883.10.22.4.2/static-2016-11-10T000000

Id	2.16.840.1.113883.10.22.4.2	Effective Date	valid from 2016‑11‑10
Status	Draft	Version Label
Name	IPSManufacturedProduct	Display Name	IPS ManufacturedProduct
Description This entry describes a medication used in a <substanceAdministration> act indicated in a medication statement. 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). 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 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)
Used by / Uses	Used by 0 transactions and 3 templates, Uses 1 template Used by as Name Version 2.16.840.1.113883.10.22.4.4 Containment IPS Medication Entry 2016‑11‑11 2.16.840.1.113883.10.22.3.1 IPS Medication Summary Section 2016‑11‑11 2.16.840.1.113883.10.22.1.1 International Patient Summary 2017‑04‑11 Uses as Name Version 2.16.840.1.113883.10.22.4.3 Include IPS Manufactured Material DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.312 (2005‑09‑07) Adaptation: template 2.16.840.1.113883.3.1937.777.11.10.146 (2016‑05‑10 22:32:31)
Example	Example <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>
Item DT Card Conf Description Label hl7:manufacturedProduct 0 … * R (IPS…uct) @classCode cs 0 … 1 F MANU hl7:templateId II 1 … 1 M (IPS…uct) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.2 Included 1 … 1 R from 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material (DYNAMIC) hl7:manufactured​Material 1 … 1 R (IPS…uct) @classCode cs 0 … 1 F MMAT @determiner​Code cs 0 … 1 F KIND hl7:templateId II 1 … 1 R (IPS…uct) @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…uct) 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…uct) cpm: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…uct)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.25 Medicine Doseform (DYNAMIC)   Example <cpm:formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" displayName="Capsule, soft">...</cpm:formCode> cpm:asContent 0 … * 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 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…uct) @classCode cs 1 … 1 F CONT   Example Packaged Medicinal Product with multiple layers packaging <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 Packaged Medicinal Product with formCode <cpm:asContent>   <cpm:containerPackagedProduct>     <!-- Packaged Medicinal Product -->     <cpm:code codeSystem="1.999.999" code="PC_ID" displayName="Packaged Product Name"/>    <cpm:name>100 MIRACLE PILLS(TM)</cpm:name>    <cpm:formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="30009000" displayName="Box" CodeSystemName="EDQM"/>  </cpm:containerPackagedProduct></cpm:asContent> cpm:containerPackagedProduct 1 … * R It represents the most inner Package Item or the Packaged Medicinal Product. (IPS…uct) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F INSTANCE cpm:code 0 … 1 If this is the most inner  <cpm: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…uct) cpm:name ST 0 … 1 It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is the most inner  <cpm:containerPackagedProduct> than this element can be used for the brand name. (IPS…uct)   Example <cpm:name>AMOXIFEN(R) 20 compresse 20 mg</cpm:name> cpm: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…uct)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)   Example <cpm:formCode code="30007000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</cpm:formCode> cpm:capacityQuantity PQ 0 … 1 R It represents the functional capacity of the container: e.g. blister containing 20 tablets or ampule of 10 ml. (IPS…uct) @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 <cpm:capacityQuantity value="20" unit="{tablet}"/>   Example <cpm:capacityQuantity value="10" unit="mL"/> cpm: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…uct) @classCode cs 1 … 1 F CONT cpm:containerPackagedProduct 1 … * R It represents the intermediate Package Item or the Packaged Medicinal Product (IPS…uct) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F INSTANCE cpm:code 0 … 1 If this is the most inner  <cpm: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…uct) cpm: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  <cpm:containerPackagedProduct> than this element can be used for the brand name. (IPS…uct)   Example <cpm:name>...</cpm:name> cpm: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 referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. (IPS…uct)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) cpm: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…uct) @classCode cs 1 … 1 F CONT cpm:containerPackagedProduct 1 … * R When present, it represents the the Packaged Medicinal Product (IPS…uct) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F INSTANCE cpm:code 0 … * 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…uct) cpm:name ST 0 … * R When present, it can be used for the representing the brand name. (IPS…uct) cpm: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…uct)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) cpm:quantity PQ 0 … * (IPS…uct) cpm: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…uct) where [1] @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 1 … 1 M (IPS…uct) @classCode cs 1 … 1 F MMAT cpm:code CD.IPS 1 … 1 R The <code> element contains the ATC code of this medicine. (IPS…uct)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.29 WHO ATC (DYNAMIC)   Example <cpm:code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> cpm:name 0 … 1 (IPS…uct) cpm: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…uct) where [2] @classCode cs 1 … 1 F GRIC   Example <cpm:asSpecializedKind classCode="GRIC">   <cpm:generalizedMaterialKind classCode="MMAT">     <cpm:code code="PhPID_Lvl1" codeSystem="1.999.999" displayName="Pharmaceutical Product Name" codeSystemName="PhPID Level 1"/>    <cpm:name/>  </cpm:generalizedMaterialKind></cpm:asSpecializedKind> cpm:generalizedMaterialKind R (IPS…uct) @classCode cs 1 … 1 F MMAT cpm: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…uct) cpm:name 0 … 1 R (IPS…uct) cpm: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…uct) @classCode cs 1 … 1 F ACTI @determiner​Code cs 1 … 1 F KIND 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. (IPS…uct)   Example <cpm:quantity>...</cpm:quantity> cpm:numerator PQ 1 … 1 R (IPS…uct) @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 cpm:denominator PQ 1 … 1 R (IPS…uct) @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 cpm: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…uct) cpm:code CD.IPS CWE 0 … 1 R 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…uct)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.32 Medicine Active Substances (DYNAMIC) hl7:originalText ED 0 … * (IPS…uct) hl7:reference TEL 0 … * (IPS…uct) hl7:translation CD 0 … * This element can be used to provide alternative identifications for the described substance. (IPS…uct) cpm:name 0 … 1 Name of the substance (IPS…uct)