eHDSIePeDManufacturedMaterial

Id 1.3.6.1.4.1.12559.11.10.1.3.1.3.30 Effective Date 2022‑02‑04 17:30:00

Status Draft Version Label

Name eHDSIePeDManufacturedMaterial Display Name eHDSI eP/eD Manufactured Material

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
1.3.6.1.4.1.12559.11.10.1.3.1.3.29	Include	eHDSI eP/eD Medication Information	2022‑02‑03 11:00:00
1.3.6.1.4.1.12559.11.10.1.3.1.3.29	Include	eHDSI eP/eD Medication Information	2022‑09‑12 12:46:37
1.3.6.1.4.1.12559.11.10.1.3.1.3.30	Include	eHDSI eP/eD Manufactured Material	2022‑02‑04 17:30:00
Uses	as	Name	Version
1.3.6.1.4.1.12559.11.10.1.3.1.3.30	Include	eHDSI eP/eD Manufactured Material	DYNAMIC

Relationship Generalization: template 2.16.840.1.113883.10.12.311 (2005‑09‑07)

Item DT Card Conf Description Label

hl7:manufacturedMaterial 0 … * R eHDSrial

@classCode cs 1 … 1 F MMAT

@determinerCode cs 1 … 1 F KIND

hl7:templateId II.EPSOS 1 … 1 M eHDSrial

@root uid 1 … 1 F 1.3.6.1.4.1.12559.11.10.1.3.1.3.30

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 generalizedMaterialKind instead)
PCID code compliant with the IDMP system (see containerPackagedProduct.code instead)

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

1 … 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 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>

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

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

pharm: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 (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>

pharm:asContent 1 … 1 M This structure describes the packaging of the medication.
The <epsos: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 <epsos: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. eHDSrial

@classCode cs 1 … 1 F CONT

pharm:quantity

1 … 1

This element describes how many content items are present in the package.

The preferred way is to provide the 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:

<hl7:translation>
<hl7:originalText>tablets</hl7:originalText>
</hl7: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 eHDSIUnit 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 <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. eHDSrial

@classCode cs 1 … 1 F CONT

@determinerCode cs 1 … 1 F KIND

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

pharm:code

CE.EPSOS

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".

eHDSrial

pharm: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>

pharm:formCode CE.EPSOS 1 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product. 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 (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 (DYNAMIC)

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

pharm:asContent

0 … 1

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.

eHDSrial

@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"/>  </containerPackagedProduct></asContent>

pharm:quantity PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity. eHDSrial

@value 1 … 1 R

Example

unit value is a UCUM annotation

Example

unit value is from the eHDSIUnit value set

pharm:containerPackagedProduct 1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product. eHDSrial

@classCode cs 1 … 1 F CONT

@determinerCode cs 1 … 1 F KIND

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

pharm:code

CE.EPSOS

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".

eHDSrial

pharm:name

0 … *

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.

eHDSrial

pharm:formCode CE.EPSOS 1 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product. 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 (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 (DYNAMIC)

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

pharm:asContent

0 … 1

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.

eHDSrial

@classCode cs 1 … 1 F CONT

pharm:quantity PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity. eHDSrial

@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. eHDSrial

@classCode cs 1 … 1 F CONT

@determinerCode cs 1 … 1 F KIND

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

pharm:code CE.EPSOS 0 … 1 R 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). eHDSrial

pharm:name ST 0 … * R When present, it can be used for the representing the brand name. eHDSrial

pharm:formCode CE.EPSOS 1 … 1 R When present, it encodes the type of the outer package. 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 (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 (DYNAMIC)

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

pharm: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">
<generalizedMaterialKind classCode="MMAT">
<code code=" " codeSystem="2.16.840.1.113883.6.73" codeSystemName="Anatomical Therapeutic Chemical" displayName=" "/> <name/> </generalizedMaterialKind></asSpecializedKind>

pharm:generalizedMaterialKind 1 … 1 M eHDSrial

@classCode cs 1 … 1 F MMAT

pharm:code CD.EPSOS 1 … 1 R The element contains the ATC code of this medicine. 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 (DYNAMIC)

pharm:name

0 … 1

The element SHALL be skipped if the generalizedMaterialKind/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

pharm:part 0 … * R eHDSrial

Included 1 … 1 M from 1.3.6.1.4.1.12559.11.10.1.3.1.3.30 eHDSI eP/eD Manufactured Material (DYNAMIC)

Include Circular reference found with 1.3.6.1.4.1.12559.11.10.1.3.1.3.30.

pharm: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

pharm: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:

<hl7:translation> <hl7:originalText>mg/dose</hl7:originalText> </hl7: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

hl7:numerator PQ 1 … 1 R eHDSrial

@unit cs 1 … 1 R

@value 1 … 1 R

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

hl7:denominator PQ 1 … 1 R eHDSrial

@unit cs 1 … 1 R

@value 1 … 1 R

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

pharm:ingredientSubstance 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>

pharm: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 (DYNAMIC)

hl7:originalText ED 0 … * eHDSrial

hl7:reference TEL 0 … * eHDSrial

hl7:translation CD 0 … * This element can be used to provide alternative identifications for the described substance. eHDSrial

pharm:name 0 … 1 Name of the substance eHDSrial