epSOSCDAManufacturedProduct

1.3.6.1.4.1.12559.11.10.1.3.1.3.1

ref

epsos-

Effective Date

2018‑10‑25 10:12:04

Status Retired Version Label

Name epSOSCDAManufacturedProduct Display Name epSOS CDA ManufacturedProduct

Description

Template CDA ManufacturedProduct (prototype, directly derived from POCD_RM000040 MIF) The medicine entry content module describes a medication used in a <substanceAdministration> or <supply> act. This entry uses the structure of the HL7 V3 R_Medication Universal Common Message Element (CMET), Release 2.

This structure is part of the HL7 V3 2009 Normative Edition (COCT_RM230100UV). The incorporation of this structure is done according to section 1.4 CDA Extensibility of the HL7 CDA standard. Such an extension of the base CDA standard is an accepted practice in IHE (e.g. in the XD* Lab specification).

For the purposes of WP 3.5 this extension is necessary to satisfy the requirements for eP and eD data elements to represent a generic equivalent and ingredients.
The rules of section 1.4 CDA Extensibility require the designation of a new XML namespace for the XML elements in this structure. For the purposes of documentation, the namespace urn:epsos-org:ep:medication shall be used.

The following specification and constraints are applied to the structures of the CMET.

The example uses Pyrimon, Chloramphenicol/ Dexamethasone 1% w/v/ 0.1% w/v 5 ml Eye Drops as the medication. The structure is further explained in the following subsections.

Classification CDA Entry Level Template

Open/Closed Open (other than defined elements are allowed)

Used by / Uses

Used by 0 transactions and 0 templates, Uses 1 template

Uses	as	Name	Version
2.16.840.1.113883.3.1937.777.11.10.143	Include	eHDSI Material	DYNAMIC

Relationship

Version: template 1.3.6.1.4.1.12559.11.10.1.3.1.3.1 epSOS CDA ManufacturedProduct (2013‑12‑20)

ref

epsos-

Specialization: template 2.16.840.1.113883.10.12.312 CDA ManufacturedProduct (2005‑09‑07)

ref

ad1bbr-

Example

<manufacturedProduct classCode="MANU">
  <templateId root="1.3.6.1.4.1.12559.11.10.1.3.1.3.1"/>  <manufacturedMaterial classCode="MMAT" determinerCode="KIND">
    
    <code code=" " displayName="Pyrimon" codeSystem=" " codeSystemName=" "/>    
    <name>Pyrimon</name>    <epsos:formCode code="10604000" displayName="Eye drops, solution" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM"/>    
    <epsos:asContent classCode="CONT">
      <epsos:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
        <epsos:name>Pyrimon 5 ml Eye Drops</epsos:name>        <epsos:formCode code="30008000" displayName="Bottle" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM"/>        <epsos:capacityQuantity value="5" unit="ml"/>        <epsos:capTypeCode code="30022000" codeSystem=" 1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="Dropper applicator" codeSystemName="EDQM"/>      </epsos:containerPackagedMedicine>    </epsos:asContent>    
    <epsos:asSpecializedKind classCode="GRIC">
      <epsos:generalizedMedicineClass classCode="MMAT">
        <epsos:code nullFlavor="NA"/>        <epsos:name>Chloramphenicol/ Dexamethasone</epsos:name>      </epsos:generalizedMedicineClass>    </epsos:asSpecializedKind>    
    <epsos:ingredient classCode="ACTI">
      
      <epsos:quantity>
        <epsos:numerator xsi:type="epsos:PQ" value="10" unit="mg"/>        <epsos:denominator xsi:type="epsos:PQ" value="1" unit="ml"/>      </epsos:quantity>      <epsos:ingredient classCode="MMAT" determinerCode="KIND">
        <epsos:code code="S01AA01" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="chloramphenicol"/>        <epsos:name>Chloramphenicol</epsos:name>      </epsos:ingredient>    </epsos:ingredient>    <epsos:ingredient classCode="ACTI">
      
      <epsos:quantity>
        <epsos:numerator xsi:type="epsos:PQ" value="1" unit="mg"/>        <epsos:denominator xsi:type="epsos:PQ" value="1" unit="ml"/>      </epsos:quantity>      <epsos:ingredient classCode="MMAT" determinerCode="KIND">
        <epsos:code code="D07CB04" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="dexamethasone and antibiotics"/>        <epsos:name>Dexamethasone</epsos:name>      </epsos:ingredient>    </epsos:ingredient>  </manufacturedMaterial></manufacturedProduct>

Item DT Card Conf Description Label

hl7:manufacturedProduct 0 … 1 R epSOduct

@classCode cs 0 … 1 F MANU

hl7:templateId II.EPSOS 1 … 1 R In an epSOS ePrescription or eDispensation document, the name and coding of the medication are specified in the elements under the element. The templateId element is required and identifies this as a Medicine entry. epSOduct

@root uid 1 … 1 F 1.3.6.1.4.1.12559.11.10.1.3.1.3.1

Example <templateId root="1.3.6.1.4.1.12559.11.10.1.3.1.3.1">...</templateId>

hl7:templateId II.EPSOS 0 … * R epSOduct

Included 1 … 1 R from 2.16.840.1.113883.3.1937.777.11.10.143 eHDSI Material (DYNAMIC)

hl7:manufacturedMaterial 1 … 1 R eHDSrial

@classCode cs 1 … 1 F MMAT

@determinerCode cs 1 … 1 F KIND

hl7:code

CE.EPSOS

0 … 1

The element is used to convey a regional/national medicinal product code or MPID compliant with the IDMP system.

The element MUST NOT be used to convey:

ATC code (see generalizedMedicineClass instead)

PCID code compliant with the IDMP system (containerPackagedMedicine.code to be added later for this use)

The <originalText> under the code MAY be included, but is not expected to be processed by the recipient of the document. If included, it SHALL contain a <reference> whose URI value points to the generic name and strength of the medication in the narrative, or just the generic name alone if strength is not relevant.

If the code is not available, the whole field SHOULD be skipped.

eHDSrial

Example

Acceptable 1

Example

Acceptable 2

Example

Acceptable 3

Example

Unacceptable

hl7:name

0 … 1

If present in the document, the element SHALL contain the brand name (invented name) of the medicinal product according to its marketing authorization. No additional information about the product (such as strength, dose form, package type, etc) is normally permitted, unless it is an inseparable part of the brand name, as authorized by a Medicines Agency.

If the information about the brand name is not available (for example it cannot be extracted from the long textual description of the medicinal product or the prescription is active ingredient based), the whole field SHOULD be skipped.

eHDSrial

Example

Acceptable 1

<name>TIARTAN</name>

Example

Acceptable 2

<name>HUMALOG MIX25 KWIKPEN</name>

Example

Acceptable 3

<name>FUROSEMIDA APOTEX 40 mg COMPRIMIDOS EFG</name>

Example

Unacceptable 1

<name>LIPITOR F.C.TAB 20MG/TAB ΒTx 14 (BLIST 2x 7)</name>

Example

Unacceptable 2

<name>TIARTAN*28CPR RIV 600+12,5MG</name>

Example

Unacceptable 3

<name>Triplixam, perindopril + indapamid + amlodipin / tbl. film obl. 30x(5 mg+1,25 mg+5 mg), C09BX01161</name>

Example

Unacceptable 4

<name>amoxicillin</name>

Example

Unacceptable 5

<name>FUROSEMIDA APOTEX 40 mg COMPRIMIDOS EFG, 10 comprimidos</name>

epsos:desc EN 0 … 1 R Free-text representation of the strength. eHDSrial

Example <desc>20/12,5 mg</desc>

epsos:formCode CE.EPSOS 1 … 1 R This code represents the form of the medication (e.g. tablet, capsule, liquid). The value of this code affects the units used in the substance administration quantity element – if the form is a tablet, for example, the unit is 1; if the form is a liquid, the unit will be part of UCUM. The value set is eHDSIDoseForm, OID: 1.3.6.1.4.1.12559.11.10.1.3.1.42.2. eHDSrial

CONF

The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.2 eHDSIDoseForm (DYNAMIC)

Example <formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2017-04-14" displayName="Capsule, soft">...</formCode>

epsos:asContent 0 … 1 R This structure describes the packaging of the medication. The element provides the code for the particular package. If the package has a brand name, it can be described in the element. The element described the capacity of the packaging. For example, to represent 30 tablets, the element at the level must indicate tablets as the form, value attribute of the element must have the value of 30, and the unit attribute must be 1. In the cases where the unit attribute is not 1, UCUM units shall be used. The value set is eHDSIUnit, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.16 and eHDSIDoseForm, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.2. eHDSrial

@classCode cs 1 … 1 F CONT

Example <asContent classCode="CONT">
<containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
<name/> <formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/> <capacityQuantity value=" " unit=" "/> </containerPackagedMedicine></asContent>

epsos:containerPackagedMedicine 1 … 1 R eHDSrial

@classCode cs 1 … 1 F CONT

@determinerCode cs 1 … 1 F KIND

Example <containerPackagedMedicine classCode="CONT" determinerCode="KIND">...</containerPackagedMedicine>

epsos:name

0 … *

If present, the element SHALL contain a sufficiently detailed description of the prescribed medicinal product/package. The description may contain information on the brand name, dose form, package (including its type or brand name), strength, etc.

If the detailed description of the product is not available, the element SHALL be skipped.

eHDSrial

Example

Acceptable 1

<name>LIPITOR F.C.TAB 20MG/TAB ΒTx 14 (BLIST 2x 7)</name>

Example

Acceptable 2

<name>TIARTAN*28CPR RIV 600+12,5MG</name>

Example

Acceptable 3

<name>Triplixam, perindopril + indapamid + amlodipin / tbl. film obl. 30x(5 mg+1,25 mg+5 mg), C09BX01161</name>

Example

Unacceptable 1

<name>EASYHALER</name>

Example

Unacceptable 2

<name>amoxicillin</name>

Example

Unacceptable 3

<name>TIARTAN</name>

epsos:formCode CE.EPSOS 1 … 1 R eHDSrial

CONF

The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.2 eHDSIDoseForm (DYNAMIC)

The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.3 eHDSIPackage (DYNAMIC)

Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>

epsos:capacityQuantity

1 … 1

This element describes the capacity of the packaging.
For sending an overall amount prescription, set the whole quantity here in combination with one package in the supply element.

The preferred way is to provide the capacity quantity in a coded form using the @unit and @value attributes.
If no coded information is available and even the use of UCUM annotations is not sufficient and more information is available within the national infrastructure, the originalText element can be used to add additional information:

<epsos:translation>
<epsos:originalText>tablets</epsos:originalText>
</epsos:translation>

To improve understanding for the receiver, the additional information has to be provided in English.

eHDSrial

@unit cs 1 … 1 R The value of the unit attibute should come from the epSOSUnits value set. There is no constraint since we also want to enable the use of UCUM annotations, that are not part of the value set.

@value 1 … 1 R

Example <capacityQuantity unit="1" value="700"/>

epsos:asSpecializedKind

0 … 1

This module is used for representing the classification of the Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System.

The classCode of "GEN" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry.

The <epsos:code> element contains the ATC code, and the <epsos:name> element may be used for the plain text representation.

eHDSrial

@classCode cs 1 … 1 F GEN

Example <asSpecializedKind classCode="GEN">
<generalizedMedicineClass classCode="MMAT">
<code code=" " codeSystem="2.16.840.1.113883.6.73" codeSystemName="Anatomical Therapeutic Chemical" displayName=" "/> <name/> </generalizedMedicineClass></asSpecializedKind>

epsos:generalizedMedicineClass R eHDSrial

@classCode cs 1 … 1 F MMAT

epsos:code CD.EPSOS 1 … 1 R eHDSrial

CONF

The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 eHDSIActiveIngredient (DYNAMIC)

epsos:name

0 … 1

The element SHALL be skipped if the generalizedMedicineClass/code element is present and contains a valid value (not a nullFlavor).

If present, the element SHALL contain a textual description of the generic equivalent of the medication described in the current Medicine entry.

If the prescription is generic (based on one or more active ingredients), the element, if present, SHALL contain the INN or a similar description of the prescribed medicine.

eHDSrial

Example

Acceptable 1

<name>amoxicillin</name>

Example

Acceptable 2

<name>emollient cream</name>

Example

Acceptable 3

<name>clinical nutrition preparation</name>

Example

Acceptable 4

<name>FUROSEMIDA 40 mg 10 comprimidos</name>

Example

Unacceptable 1

<name>Ácido cromoglícico [Opticrom], 20 mg/ml, Colírio, solução, Recipiente unidose - 20 unidade(s) - 0.3 ml</name>

Example

Unacceptable 2

<name>TIARTAN</name>

Example

Unacceptable 3

<name>TIARTAN*28CPR RIV 600+12,5MG</name>

epsos:ingredient 0 … * R One or more active ingredients may be represented with this structure. The classCode of "ACTI" indicates that this is an active ingredient. The element contains the coded representation of the ingredient and the element may be used for the plain text representation. eHDSrial

@classCode cs 1 … 1 F ACTI

Example <ingredient classCode="ACTI">...</ingredient>

epsos:quantity

1 … 1

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.

The denominator element should contain an amount with its corresponding unit. Only when the numerator comes in a fractional form and cannot be separated into the numerator and denominator form, or is related to a unit of administration, a unit of '1' in the denominator is allowed.

The units used must come from the eHDSIUnit Value Set.

The preferred way is to provide the medication strength in a coded form using the @numerator and @denominator attributes. If no coded information is available and even the use of UCUM annotations is not sufficient and more information is available within the national infrastructure, the originalText element can be used to add additional information:

<epsos:translation> <epsos:originalText>mg/dose</epsos:originalText> </epsos:translation>

To improve understanding for the receiver, the additional information has to be provided in English.

eHDSrial

Example

Strength in normal representation

Example

Strength when fractional numerator unit not convertible

Example

Strength per unit of administration

Example

Strength per unit of presentation which is not a unit of administration

epsos:numerator epsos:PQ 1 … 1 R eHDSrial

@unit cs 1 … 1 R

@value 1 … 1 R

Example <numerator unit="mg" value="20" type="epsos:PQ"/>

epsos:denominator epsos:PQ 1 … 1 R eHDSrial

@unit cs 1 … 1 R

@value 1 … 1 R

Example <denominator unit="1" value="1" type="epsos:PQ"/>

epsos:ingredient 1 … 1 R eHDSrial

@classCode cs 1 … 1 F MMAT

@determinerCode cs 1 … 1 F KIND

Example <ingredient classCode="MMAT" determinerCode="KIND">
<code code="C09CA02" codeSystem="2.16.840.1.113883.6.73" codeSystemName="Anatomical Therapeutic Chemical" displayName="Eprosartan"/> <name>EPROSARTAN</name></ingredient>

epsos:code CD.EPSOS 1 … 1 R eHDSrial

CONF

The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 eHDSIActiveIngredient (DYNAMIC)

epsos:originalText ED 0 … * eHDSrial

epsos:reference TEL 0 … * eHDSrial

epsos:translation CD 0 … * This element can be used to provide alternative identifications for the described substance. eHDSrial

epsos:name 0 … 1 Name of the substance eHDSrial

epsos:marketingAuthorizationHolder 0 … 1 Companies or other legal entities, including non profit-making organisations, who are granted the marketing authorization of a medicinal product and are responsible for it throughout its lifetime. epSOduct

@classCode cs 0 … 1 F ORG

@determinerCode cs 0 … 1 F INSTANCE

Example <epsos:marketingAuthorizationHolder classCode="ORG" determinerCode="INSTANCE">
<epsos:id root="2.99" extension="XYZ"/> <epsos:name>Merck AB</epsos:name></epsos:marketingAuthorizationHolder>

Schematron assert role error

test @nullFlavor or hl7:id or hl7:name

Message If the MarketingAuthorizationHolder element is specified and doesn't have a nullFlavor value, an id or name element has to present.

epsos:id II.EPSOS 0 … * R epSOduct

Example <epsos:id root="2.99" extension="XYZ"/>

epsos:name ON 0 … 1 R epSOduct

Example <epsos:name>Merck AB</epsos:name>