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retired Template  epSOS CDA Material

Id 2.16.840.1.113883.3.1937.777.11.10.143 Effective Date 2018‑09‑20 14:46:04
Other versions this id:
Status retired Retired Version Label
Name epSOSCDAMaterial Display Name epSOS CDA Material
Classification CDA Entry Level Template
Open/Closed Open (other than defined elements are allowed)
Associated with
Associated with 7 concepts
Id Name Data Set
epsos-dataelement-105 draft Strength draft epSOS Data Set
epsos-dataelement-137 draft Brand name draft epSOS Data Set
epsos-dataelement-135 draft Medicinal product code draft epSOS Data Set
epsos-dataelement-106 draft Pharmaceutical dose form draft epSOS Data Set
epsos-dataelement-104 draft Active ingredient code draft epSOS Data Set
epsos-dataelement-103 draft Active ingredient draft epSOS Data Set
epsos-dataelement-138 draft Medicinal product package size draft epSOS Data Set
Relationship Version: template 2.16.840.1.113883.3.1937.777.11.10.143 epSOS CDA Material (2013‑12‑20)
Generalization: template 2.16.840.1.113883.10.12.311 CDA Material (2005‑09‑07)
ref
ad1bbr-
Item DT Card Conf Description Label
hl7:manufacturedMaterial
0 … * R (epSdotsial)
@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.
(epSdotsial)
 
target
epsos-dataelement-135 draft Medicinal product code draft epSOS Data Set
  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.
(epSdotsial)
 
target
epsos-dataelement-137 draft Brand name draft epSOS Data Set
  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. (epSdotsial)
  Example <epsos:desc>20/12,5 mg</epsos: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 epSOSDoseForm, OID: 1.3.6.1.4.1.12559.11.10.1.3.1.42.2.
(epSdotsial)
 
target
epsos-dataelement-106 draft Pharmaceutical dose form draft epSOS Data Set
  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 <epsos:formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2017-04-14" displayName="Capsule, soft">...</epsos:formCode>
epsos:asContent
0 … * 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 epSOSUnits, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.16 and epSOSDoseForm, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.2. (epSdotsial)
@classCode
cs 1 … 1 F CONT
  Example <epsos:asContent classCode="CONT">
  <epsos:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
    <epsos:name/>    <epsos:formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/>    <epsos:capacityQuantity value=" " unit=" "/>  </epsos:containerPackagedMedicine>
</epsos:asContent>
epsos:containerPackagedMedicine
1 … * R (epSdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F INSTANCE
  Example <epsos:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">...</epsos: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.
(epSdotsial)
  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 (epSdotsial)
  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)
or
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 <epsos: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.
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>packets each containing 21 tables of A and 7 tables of B</epsos:originalText>
</epsos:translation>
To improve understanding for the receiver, the additional information has to be provided in English.
(epSdotsial)
 
target
epsos-dataelement-138 draft Medicinal product package size draft epSOS Data Set
@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 <epsos: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.

(epSdotsial)
@classCode
cs 1 … 1 F GEN
  Example <epsos:asSpecializedKind classCode="GEN">
  <epsos:generalizedMedicineClass classCode="MMAT">
    <epsos:code code=" " codeSystem="2.16.840.1.113883.6.73" codeSystemName="Anatomical Therapeutic Chemical" displayName=" "/>    <epsos:name/>  </epsos:generalizedMedicineClass>
</epsos:asSpecializedKind>
epsos:generalizedMedicineClass
R (epSdotsial)
@classCode
cs 1 … 1 F MMAT
epsos:code
CD.EPSOS 1 … 1 R (epSdotsial)
  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.
(epSdotsial)
  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. (epSdotsial)
@classCode
cs 1 … 1 F ACTI
  Example <epsos:ingredient classCode="ACTI">...</epsos: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 epSOSUnits 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.
(epSdotsial)
 
target
epsos-dataelement-105 draft Strength draft epSOS Data Set
  Example
Strength in normal representation
<epsos:quantity>
  <epsos:numerator value="5" unit="mg" xsi:type="epsos:PQ"/>  <epsos:denominator value="1" unit="mL" xsi:type="epsos:PQ"/></epsos:quantity>
  Example
Strength when fractional numerator unit not convertible
<epsos:quantity>
  <epsos:numerator value="5" unit="mg/mL" xsi:type="epsos:PQ"/>  <epsos:denominator value="1" unit="1" xsi:type="epsos:PQ"/></epsos:quantity>
  Example
Strength per unit of administration
<epsos:quantity>
  <epsos:numerator value="500" unit="mg" xsi:type="epsos:PQ"/>  <epsos:denominator value="1" unit="1" xsi:type="epsos:PQ"/></epsos:quantity>
  Example
Strength per unit of presentation which is not a unit of administration
<epsos:quantity>
  <epsos:numerator value="2" unit="g" xsi:type="epsos:PQ"/>  <epsos:denominator value="1" unit="{Tube}" xsi:type="epsos:PQ"/></epsos:quantity>
epsos:numerator
epsos:PQ 1 … 1 R (epSdotsial)
@unit
cs 1 … 1 R
@value
1 … 1 R
  Example <epsos:numerator unit="mg" value="20" xsi:type="epsos:PQ"/>
epsos:denominator
epsos:PQ 1 … 1 R (epSdotsial)
@unit
cs 1 … 1 R
@value
1 … 1 R
  Example <epsos:denominator unit="1" value="1" xsi:type="epsos:PQ"/>
epsos:ingredient
1 … 1 R (epSdotsial)
@classCode
cs 1 … 1 F MMAT
@determinerCode
cs 1 … 1 F KIND
  Example <epsos:ingredient classCode="MMAT" determinerCode="KIND">
  <epsos:code code="C09CA02" codeSystem="2.16.840.1.113883.6.73" codeSystemName="Anatomical Therapeutic Chemical" displayName="Eprosartan"/>  <epsos:name>EPROSARTAN</epsos:name></epsos:ingredient>
epsos:code
CD.EPSOS 1 … 1 R (epSdotsial)
 
target
epsos-dataelement-104 draft Active ingredient code draft epSOS Data Set
  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 … * (epSdotsial)
epsos:reference
TEL 0 … * (epSdotsial)
epsos:translation
CD 0 … * This element can be used to provide alternative identifications for the described substance. (epSdotsial)
epsos:name
0 … 1 Name of the substance (epSdotsial)
 
target
epsos-dataelement-103 draft Active ingredient draft epSOS Data Set