hl7:manufacturedProduct
|
|
0 … 1 |
R |
|
(eHD uct) |
@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.
|
(eHD uct) |
@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 |
|
(eHD uct) |
Included |
1 … 1 |
R |
from 2.16.840.1.113883.3.1937.777.11.10.143 eHDSI Material (DYNAMIC)
|
hl7:manufacturedMaterial
|
|
1 … 1 |
R |
|
(eHD uct) |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
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 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.
|
(eHD uct) |
|
|
|
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.
|
(eHD uct) |
|
|
|
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. |
(eHD uct) |
|
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.
|
(eHD uct) |
|
|
|
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> |
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.
|
(eHD uct) |
@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 |
|
(eHD uct) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
|
Example |
<containerPackagedMedicine classCode="CONT" determinerCode="KIND">...</containerPackagedMedicine> |
epsos: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.
|
(eHD uct) |
|
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 |
|
(eHD uct) |
|
CONF |
|
|
Example |
<formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/> |
epsos:capacityQuantity
|
PQ |
1 … 1 |
M |
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.
|
(eHD uct) |
|
|
@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 |
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 "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.
|
(eHD uct) |
@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 |
|
(eHD uct) |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
epsos:code
|
CD.EPSOS |
1 … 1 |
R |
|
(eHD uct) |
|
CONF |
|
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.
|
(eHD uct) |
|
Example |
Acceptable 1 <!-- but in normal situations this should be supplied as a code, not as a name --> <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.
|
(eHD uct) |
@classCode
|
cs |
1 … 1 |
F |
ACTI |
|
Example |
<ingredient classCode="ACTI">...</ingredient> |
epsos: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:
<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.
|
(eHD uct) |
|
|
|
Example |
Strength in normal representation <quantity> <numerator value="5" unit="mg" type="epsos:PQ"/> <denominator value="1" unit="mL" type="epsos:PQ"/></quantity> |
|
Example |
Strength when fractional numerator unit not convertible <quantity> <numerator value="5" unit="mg/mL" type="epsos:PQ"/> <denominator value="1" unit="1" type="epsos:PQ"/></quantity> |
|
Example |
Strength per unit of administration <quantity> <numerator value="500" unit="mg" type="epsos:PQ"/> <denominator value="1" unit="1" type="epsos:PQ"/></quantity> |
|
Example |
Strength per unit of presentation which is not a unit of administration <quantity> <numerator value="2" unit="g" type="epsos:PQ"/> <denominator value="1" unit="{Tube}" type="epsos:PQ"/></quantity> |
epsos:numerator
|
epsos:PQ |
1 … 1 |
R |
|
(eHD uct) |
@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 |
|
(eHD uct) |
@unit
|
cs |
1 … 1 |
R |
|
@value
|
|
1 … 1 |
R |
|
|
Example |
<denominator unit="1" value="1" type="epsos:PQ"/> |
epsos:ingredient
|
|
1 … 1 |
R |
|
(eHD uct) |
@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 |
|
(eHD uct) |
|
|
|
CONF |
|
epsos:originalText
|
ED |
0 … * |
|
|
(eHD uct) |
epsos:reference
|
TEL |
0 … * |
|
|
(eHD uct) |
epsos:translation
|
CD |
0 … * |
|
This element can be used to provide alternative identifications for the described
substance.
|
(eHD uct) |
epsos:name
|
|
0 … 1 |
|
Name of the substance |
(eHD uct) |
|
|
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.
|
(eHD uct) |
@classCode
|
cs |
0 … 1 |
F |
ORG |
@determinerCode
|
cs |
0 … 1 |
F |
INSTANCE |
|
Example |
<marketingAuthorizationHolder classCode="ORG" determinerCode="INSTANCE"> <id root="2.99" extension="XYZ"/> <name>Merck AB</name></marketingAuthorizationHolder> |
|
Schematron assert |
role |
error
|
|
|
test |
@nullFlavor or epsos:id or epsos: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 |
|
(eHD uct) |
|
Example |
<id root="2.99" extension="XYZ"/> |
epsos:name
|
ON |
0 … 1 |
R |
|
(eHD uct) |
|
Example |
<name>Merck AB</name> |