Revision as of 20:05, 27 March 2018

Comments on this page

Template IPSMedMaterial

Description

Keine Beschreibung in Deutsch (de-DE) verfügbar
en-US:

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 of
                               these 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.

Actual version

Id

2.16.840.1.113883.10.22.4.3

Effective Date

2024‑08‑04 10:47:30

Other versions this id:

IPSMedMaterial as of 2021‑08‑02 16:52:27
IPSMedMaterial as of 2016‑11‑10

Status

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	Product Code	CEN/TC 251 prEN 17269
hl7ips-dataelement-117	Brand Name	CEN/TC 251 prEN 17269
hl7ips-dataelement-171	Product Common Name (and Strength)	CEN/TC 251 prEN 17269
hl7ips-dataelement-227	Pharmaceutical dose form	CEN/TC 251 prEN 17269

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

<manufacturedMaterial>
  
  <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>
      
      <containerPackagedProduct>
        
        <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">
      
      <generalizedMaterialKind classCode="MMAT">
        
        <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/>      </generalizedMaterialKind>    </asSpecializedKind>    <asSpecializedKind>
      
      <generalizedMaterialKind classCode="MMAT">
        <code code="PhPID" codeSystem=" " displayName=" " codeSystemName="PhP EMA">
          <name>....</name>        </code>      </generalizedMaterialKind>    </asSpecializedKind>    
    <ingredient classCode="ACTI" determinerCode="KIND">
      <quantity>
        
        <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

Item

DT

Card

Conf

Description

Label

hl7:manufacturedMaterial

0 … *

R

(IPS...ial)

@classCode

cs

0 … 1

F

MMAT

@determinerCode

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

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.

(IPS...ial)


	hl7ips-dataelement-105	Product Code	CEN/TC 251 prEN 17269

hl7:code

CE.IPS

0 … 1

R

Non IDMP codes from SNOMED CT value set

(IPS...ial)

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.

(IPS...ial)


hl7ips-dataelement-117	Brand Name	CEN/TC 251 prEN 17269
hl7ips-dataelement-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-dataelement-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 IPS Medicine Doseform (DYNAMIC)

Example

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.

(IPS...ial)

@classCode

cs

1 … 1

F

CONT

Example

Packaged Medicinal Product with multiple layers packaging

Example

Packaged Medicinal Product with formCode

<asContent>
  <containerPackagedProduct>
    
    <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.

(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

Example

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

@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".

(IPS...ial)

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.

(IPS...ial)

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

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.

(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: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

R

The quantity which specified how many inner packaged content entities are in an outer packaging container entity.

(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

Example

pharm:containerPackagedProduct

1 … 1

R

It represents the intermediate Package Item or the Packaged Medicinal Product

(IPS...ial)

@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".

(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 also the most inner <pharm:containerPackagedProduct> than this element can be used for the brand name.

(IPS...ial)

Example

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: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.

(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: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

R

The quantity which specified how many inner packaged content entities are in an outer packaging container entity.

(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

Example

pharm:containerPackagedProduct

1 … 1

R

When present, it represents the Packaged Medicinal Product

(IPS...ial)

@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).

(IPS...ial)

pharm:name

ST

0 … 1

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: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.

(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: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

pharm:generalizedMaterialKind

1 … 1

M

(IPS...ial)

@classCode

cs

1 … 1

F

MMAT

pharm:code

CD.IPS

1 … 1

R

The <code> 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 IPS WHO ATC (DYNAMIC)

Example

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

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)

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.

(IPS...ial)

@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)

Example

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

(IPS...ial)

@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.

(IPS...ial)

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 … *

(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

List of all versions of this template

2016-11-10 (Under develeopment)

@@ Line 4: / Line 4: @@
 [[Category:Template]]
 =Template ''IPSMedMaterial''=
+==Description==
+<p><span style="color: grey;">Keine Beschreibung in Deutsch (de-DE) verfügbar<br/>en-US: <div class="yui-wk-div">
+        <div class="yui-wk-div">
+            <div class="yui-wk-div" style="margin: 0px 0px 4px; vertical-align: top;">This entry provides details about the medicinal product.<br clear="none"/>
+                <div class="yui-wk-div" style="margin: 0px 0px 4px; vertical-align: top;">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,...) &#160;that may be used to integrate jurisdictional product codes.<br clear="none"/>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).<br clear="none"/>
+                    <br clear="none"/>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<br clear="none"/>Jurisdictions could specialize this template making some of
+                                these attributes required.<br clear="none"/>
+                    <br clear="none"/>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. </div>
+                <div class="yui-wk-div" style="margin: 0px 0px 4px; vertical-align: top;">
+                    <br clear="none"/>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&#160;concrete&#160;use.<br clear="none"/>
+                    <br clear="none"/>Since the CDA R2.0 model support only a very limited set of information about the products, extensions based on the&#160;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.</div>
+            </div>
+        </div>
+        <div class="yui-wk-div">
+            <br clear="none"/>
+        </div>
+    </div>
+</span></p>
 ==Actual version==
 {{:{{BASEPAGENAME}}/dynamic}}

Difference between revisions of "2.16.840.1.113883.10.22.4.3"

Revision as of 20:05, 27 March 2018

Template IPSMedMaterial

Description

Actual version

List of all versions of this template

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