hl7:manufacturedProduct
|
|
0 … 1 |
R |
|
(eHDion) |
@classCode
|
cs |
0 … 1 |
F |
MANU |
hl7:templateId
|
II.EPSOS |
1 … 1 |
R |
|
(eHDion) |
@root
|
uid |
1 … 1 |
F |
1.3.6.1.4.1.12559.11.10.1.3.1.3.31 |
Included |
1 … 1 |
R |
from 1.3.6.1.4.1.12559.11.10.1.3.1.3.32 eHDSI PS Manufactured Material (DYNAMIC)
|
hl7:manufacturedMaterial
|
|
1 … 1 |
R |
|
(eHDion) |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
hl7:templateId
|
II.EPSOS |
1 … 1 |
M |
|
(eHDion) |
@root
|
uid |
1 … 1 |
F |
1.3.6.1.4.1.12559.11.10.1.3.1.3.32 |
hl7:code
|
CE.EPSOS |
0 … 1 |
R |
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)
- Package code (national or 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.
|
(eHDion) |
|
Example |
Acceptable 1 <code code="036772010" codeSystem="2.16.840.1.113883.2.9.6.1.5" codeSystemName="AIC" displayName="TIARTAN*28CPR RIV 600+12,5MG"/> |
|
Example |
Acceptable 2 <code code="014094" codeSystem="1.2.246.537.6.55" codeSystemName="VNR" codeSystemVersion="2017.012" displayName="FORSTEO"/> |
|
Example |
Acceptable 3 <code code="1008368" codeSystem="1.3.6.1.4.1.28284.6.2.4.44" codeSystemName="Ravimipreparaadi kood" displayName="MAREVAN FORTE"> <originalText> <reference value="#ORIGNAME"/> </originalText></code> |
|
Example |
Unacceptable <code code="C09BX01" codeSystem="2.16.840.1.113883.6.88" displayName="Triplixam, perindopril + indapamid + amlodipin / tbl. film obl. 30x(5 mg+1,25 mg+5
mg), C09BX01161"/> |
hl7:name
|
EN |
0 … 1 |
R |
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.
|
(eHDion) |
|
|
|
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> |
pharm:desc
|
EN |
0 … 1 |
R |
Free-text representation of the strength. |
(eHDion) |
|
Example |
<desc>20/12,5 mg</desc> |
pharm:formCode
|
CE.EPSOS |
0 … 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.
|
(eHDion) |
|
|
|
CONF |
|
|
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
|
|
0 … 1 |
R |
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:quantity> represents 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.
|
(eHDion) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
pharm:quantity
|
PQ |
1 … 1 |
M |
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>Tablet</hl7:originalText>
</hl7:translation>
To improve understanding for the receiver, the additional information has to be provided
in English.
3 possible uses for the @unit attribute are allowed:
- The preferred situation where value of the unit attibute comes from the eHDSIUnit
value set.
- A UCUM annotation can be used in the unit attribute. In the case of countable items,
the content between curly brackets must be a concept from the eHDSIQuantityUnit value
set.
- For countable units, the unit attribute can also be set to '1', and the translation
element can be used to convey the type of content item.
|
(eHDion) |
|
|
@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.
|
(eHDion) |
@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 |
If this is also the most outer <pharm:containerPackagedProduct> then the <code> element
is used to convey the national package identification code or the IDMP Packaged Medicinal
Product Identifier (PCID) when it will become actually available for usage.
|
(eHDion) |
pharm:name
|
ST |
0 … * |
R |
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.
|
(eHDion) |
|
|
|
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.
|
(eHDion) |
|
CONF |
|
|
Example |
<formCode code="30009000" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Box"/> |
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.
|
(eHDion) |
@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 |
1 … 1 |
M |
The quantity which specified how many inner packaged content entities are in an outer
packaging container entity.
|
(eHDion) |
@unit
|
cs |
0 … 1 |
|
3 possible uses for the @unit attribute are allowed:
- The preferred situation where value of the unit attibute comes from the eHDSIUnit
value set.
- A UCUM annotation can be used in the unit attribute. In the case of countable items,
the content between curly brackets must be a concept from the eHDSIQuantityUnit value
set.
- For countable units, the unit attribute can also be set to '1', and the translation
element can be used to convey the type of content item.
If the @unit attribute is not provided, it is considered to have the default value
'1'.
|
@value
|
|
1 … 1 |
R |
|
|
Example |
unit value is a UCUM annotation <quantity value="20" unit="{tablet}"/> |
|
Example |
unit value is from the eHDSIUnit value set <quantity value="10" unit="mL"/> |
pharm:containerPackagedProduct
|
|
1 … 1 |
R |
It represents the intermediate Package Item or the Packaged Medicinal Product.
|
(eHDion) |
@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 |
If this is also the most outer <pharm:containerPackagedProduct> then the <code> element
is used to convey the national package identification code or the IDMP Packaged Medicinal
Product Identifier (PCID) when it will become actually available for usage.
|
(eHDion) |
pharm:name
|
ST |
0 … * |
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.
|
(eHDion) |
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.
|
(eHDion) |
|
CONF |
|
|
Example |
<formCode code="30009000" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Box"/> |
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.
|
(eHDion) |
@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.
|
(eHDion) |
@unit
|
cs |
0 … 1 |
|
3 possible uses for the @unit attribute are allowed:
- The preferred situation where value of the unit attibute comes from the eHDSIUnit
value set.
- A UCUM annotation can be used in the unit attribute. In the case of countable items,
the content between curly brackets must be a concept from the eHDSIQuantityUnit value
set.
- For countable units, the unit attribute can also be set to '1', and the translation
element can be used to convey the type of content item.
If the @unit attribute is not provided, it is considered to have the default value
'1'.
|
@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.
|
(eHDion) |
@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 |
If this is also the most outer <pharm:containerPackagedProduct> then the <code> element
is used to convey the national package identification code or the IDMP Packaged Medicinal
Product Identifier (PCID) when it will become actually available for usage.
|
(eHDion) |
pharm:name
|
ST |
0 … * |
R |
When present, it can be used for the representing the brand name.
|
(eHDion) |
pharm:formCode
|
CE.EPSOS |
1 … 1 |
R |
When present, it encodes the type of the outer package.
|
(eHDion) |
|
CONF |
|
|
Example |
<formCode code="30009000" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Box"/> |
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.
The <pharm:code> element contains the ATC code, and the <pharm:name> element may be
used for the plain text representation.
|
(eHDion) |
where [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73'] |
|
@classCode
|
cs |
1 … 1 |
F |
GRIC |
|
Example |
<asSpecializedKind classCode="GRIC"> <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 |
|
(eHDion) |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
pharm:code
|
CD.EPSOS |
1 … 1 |
R |
The element contains the ATC code of this medicine.
|
(eHDion) |
|
CONF |
|
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.
|
(eHDion) |
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.
|
(eHDion) |
@classCode
|
cs |
1 … 1 |
F |
GEN |
|
Example |
<asSpecializedKind classCode="GEN"> <generalizedMaterialKind classCode="MMAT"> <code code="PhPID_Lvl1" codeSystem="1.999.999" displayName="Pharmaceutical Product Name" codeSystemName="PhPID Level 1"/> <name/> </generalizedMaterialKind></asSpecializedKind> |
pharm:generalizedMaterialKind
|
|
1 … 1 |
M |
|
(eHDion) |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
pharm:code
|
CD.EPSOS |
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.
|
(eHDion) |
pharm:name
|
|
0 … * |
|
|
(eHDion) |
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.
|
(eHDion) |
|
|
@classCode
|
cs |
1 … 1 |
F |
ACTI |
|
Example |
<ingredient classCode="ACTI">...</ingredient> |
pharm:quantity
|
|
1 … 1 |
M |
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.
|
(eHDion) |
|
|
|
Example |
Strength in normal representation <quantity> <numerator value="5" unit="mg" type="PQ"/> <denominator value="1" unit="mL" type="PQ"/></quantity> |
|
Example |
Strength when fractional numerator unit not convertible <quantity> <numerator value="5" unit="mg/mL" type="PQ"/> <denominator value="1" unit="1" type="PQ"/></quantity> |
|
Example |
Strength per unit of administration <quantity> <numerator value="500" unit="mg" type="PQ"/> <denominator value="1" unit="1" type="PQ"/></quantity> |
|
Example |
Strength per unit of presentation which is not a unit of administration <quantity> <numerator value="2" unit="g" type="PQ"/> <denominator value="1" unit="{Tube}" type="PQ"/></quantity> |
hl7:numerator
|
PQ |
1 … 1 |
R |
|
(eHDion) |
@unit
|
cs |
1 … 1 |
R |
|
@value
|
|
1 … 1 |
R |
|
|
Example |
<numerator unit="mg" value="20" type="PQ"/> |
hl7:denominator
|
PQ |
1 … 1 |
R |
|
(eHDion) |
@unit
|
cs |
1 … 1 |
R |
3 possible uses for the @unit attribute are allowed:
- The preferred situation where value of the unit attibute comes from the eHDSIUnit
value set.
- A UCUM annotation can be used in the unit attribute. In the case of countable items,
the content between curly brackets must be a concept from the eHDSIQuantityUnit value
set.
- For countable units, the unit attribute can also be set to '1', and the translation
element can be used to convey the type of content item.
|
@value
|
|
1 … 1 |
R |
|
|
Example |
<denominator unit="1" value="1" type="PQ"/> |
pharm:ingredientSubstance
|
|
1 … 1 |
R |
|
(eHDion) |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
|
Example |
<ingredientSubstance classCode="MMAT" determinerCode="KIND"> <code code="C09CA02" codeSystem="2.16.840.1.113883.6.73" codeSystemName="Anatomical Therapeutic Chemical" displayName="Eprosartan"/> <name>EPROSARTAN</name></ingredientSubstance> |
pharm:code
|
CD.EPSOS |
1 … 1 |
R |
|
(eHDion) |
|
CONF |
|
hl7:originalText
|
ED |
0 … * |
|
|
(eHDion) |
hl7:reference
|
TEL |
0 … * |
|
|
(eHDion) |
hl7:translation
|
CD |
0 … * |
|
This element can be used to provide alternative identifications for the described
substance.
|
(eHDion) |
pharm:name
|
|
0 … 1 |
|
Name of the substance |
(eHDion) |
hl7:manufacturerOrganization
|
|
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.
|
(eHDion) |
@classCode
|
cs |
0 … 1 |
F |
ORG |
@determinerCode
|
cs |
0 … 1 |
F |
INSTANCE |
|
Example |
<manufacturerOrganization classCode="ORG" determinerCode="INSTANCE"> <id root="2.99" extension="XYZ"/> <name>Merck AB</name></manufacturerOrganization> |
|
Schematron assert |
role |
error
|
|
|
test |
@nullFlavor or hl7:id or hl7:name |
|
|
Message |
If the Marketing Authorization Holder or Manufacturer Organization element is specified
and doesn't have a nullFlavor value, an id or name element has to present. |
|
hl7:id
|
II.EPSOS |
0 … * |
R |
|
(eHDion) |
|
Example |
<id root="2.99" extension="XYZ"/> |
hl7:name
|
ON |
0 … 1 |
R |
|
(eHDion) |
|
Example |
<name>Merck AB</name> |