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ref Template  epSOS CDA substanceAdministration

Id 1.3.6.1.4.1.12559.11.10.1.3.1.3.2 Effective Date valid from 2013‑12‑20
Status draft Draft Version Label
Name epSOSCDASubstanceAdministration Display Name epSOS CDA substanceAdministration
Description
The general model is to record each prescribed medication in a <substanceAdministration> intent (moodCode='INT'). The <substanceAdministration> element may contain subordinate <sub-stanceAdministration> elements in a related component entry to deal with special cases (see the following sections below on Special Cases). These cases include split, tapered, or conditional dosing, or combination medications.

The use of subordinate <substanceAdministration> elements to deal with these cases is optional. The comment field should always be used in these cases to provide the same information as free text in the top level <substanceAdministration> element. There are a variety of special cases for dosing that need to be accounted for. These are described below. Most of these special cases involve changing the dosage or frequency over time, or based on some measurement. When the dosage changes, then additional entries are required for each differing dosage. The last case deals with combination medications.

For the purposes of WP3.5 only the normal, the split dosing and the combination medications are addressed.

- Normal Dosing 1.3.6.1.4.1.19376.1.5.3.1.4.7.1
This template identifier is used to identify medication administration events that do not require any special processing. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. Medications that use this template identifier shall not use subordinate <substanceAdministation> acts.

- Combination Medications 1.3.6.1.4.1.19376.1.5.3.1.4.11
This template identifier is used to identify medication administration events that require special processing to handle combination medications. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. A combination medication is made up of two or more other medications. These may be prepackaged, such as Percocet, which is a combination of Acetaminophen and oxycodone in predefined ratios, or prepared by a pharmacist, such as a GI cocktail.

In the case of the prepackaged combination, it is sufficient to supply the name of the combination drug product, and its strength designation in a single <substanceAdministation> entry. The dosing information should then be recorded as simply a count of administration units.

In the latter case of a prepared mixture, the description of the mixture should be provided as the product name (e.g., "GI Cocktail") , in the <substanceAdministration> entry. That entry may, but is not required, to have subordinate <substanceAdministration> entries included beneath it to record the components of the mixture.

- Split Dosing 1.3.6.1.4.1.19376.1.5.3.1.4.9
This template identifier is used to identify medication administration events that require special processing to handle split dosing. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. A split dose is often used when different dosages are given at different times (e.g., at different times of day, or on different days). This may be to account for different metabolism rates at different times of day, or to simply address drug packaging deficiencies (e.g., and order for Coumadin 2mg on even days, 2.5mg on odd days is used because Coumadin does not come in a 2.25mg dose form).
In this case a subordinate <substanceAdministration> entry is required for each separate dosage
Context Parent nodes of template element with id 1.3.6.1.4.1.12559.11.10.1.3.1.3.2
Classification CDA Entry Level Template
Open/Closed Open (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 2 templates, Uses 6 templates
Used by as Name Version
1.3.6.1.4.1.12559.11.10.1.3.1.2.1 Containment draft Section Prescription 2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.1 link draft epSOS-ePrescription 2013‑12‑20
Uses as Name Version
1.3.6.1.4.1.12559.11.10.1.3.1.3.1 Containment draft epSOS CDA ManufacturedProduct DYNAMIC
2.16.840.1.113883.3.1937.777.11.10.103 Include draft epSOS CDA author prescriber DYNAMIC
2.16.840.1.113883.3.1937.777.11.10.134 Include draft CDA Participant (Body) DYNAMIC
1.3.6.1.4.1.12559.11.10.1.3.1.3.6 Containment draft CDA Number of Packages DYNAMIC
1.3.6.1.4.1.19376.1.5.3.1.4.3.1 Containment draft Entry Medication FulFillment Instructions DYNAMIC
1.3.6.1.4.1.19376.1.5.3.1.4.3 Containment draft epSOS Patient Medication Instructions DYNAMIC
Relationship Specialization: template 2.16.840.1.113883.10.12.308 (2005‑09‑07)
Example
Example
<substanceAdministration classCode="SBADM" moodCode="INT">
  <templateId root="2.16.840.1.113883.10.20.1.24"/>  <templateId root="1.3.6.1.4.1.12559.11.10.1.3.1.3.2"/>  <templateId root=""/>  <!-- Prescription Item ID -->
  <id root="" extension=""/>  <code code="" codeSystem="" displayName="" codeSystemName=""/>  <!-- Reference to narrative text of prescription, e.g.
Pyrimon, Chloramphenicol/ Dexamethasone 1% w/v/ 0.1% w/v 5 ml Eye Drops – three drops -->
  <text>
    <reference value="#med-1"/>  </text>  <statusCode code="active"/>  <effectiveTime xsi:type="IVL_TS">
    <low value=""/>    <high value=""/>  </effectiveTime>  <effectiveTime operator="A" xsi:type="TS|PIVL_TS|EIVL_TS|SXPR_TS">
    <!-- ... -->
  </effectiveTime>  <routeCode code="20051000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="Ocular use" codeSystemName="EDQM"/>  <doseQuantity value="3"/>  <!-- Optional -->
  <approachSiteCode code="" codeSystem="" displayName="" codeSystemName=""/>  <rateQuantity value="" unit=""/>  <consumable>
    <!-- ... -->
  </consumable>  <participant typeCode="AUT">
    <participantRole classCode="LIC">
      <id root=" " extension=" "/>      <scopingEntity classCode="ORG">
        <id root=" " extension=" "/>        <desc>...</desc>      </scopingEntity>    </participantRole>  </participant>  <author>
    <time/>    <assignedAuthor>
      <id/>      <assignedPerson>
        <name/>      </assignedPerson>    </assignedAuthor>  </author>  <!-- 0..* entries describing the components -->
  <entryRelationship typeCode="COMP">
    <sequenceNumber value=""/>  </entryRelationship>  <!-- Optional instructions for Pharmacist -->
  <entryRelationship typeCode="SUBJ">
    <!-- ... -->
  </entryRelationship>  <!--Optional Substitution information -->
  <entryRelationship typeCode="SUBJ">
    <!-- ... -->
  </entryRelationship></substanceAdministration>
notice There are open issues with this item:
Item DT Card Conf Description Label
hl7:substanceAdministration
 R (epSdotsion)
@classCode
 cs 1 … 1 F SBADM
@moodCode
 cs 1 … 1 F INT
hl7:templateId
 II.EPSOS 1 … 1 M CCD templateId (epSdotsion)
@root
 uid 1 … 1 F 2.16.840.1.113883.10.20.1.24
hl7:templateId
 II.EPSOS 1 … 1 M epSOS templateId (epSdotsion)
@root
 uid 1 … 1 F 1.3.6.1.4.1.12559.11.10.1.3.1.3.2
hl7:templateId
 II.EPSOS 1 … 1 R IHE PCC templateId Note: The usage of statusCode values different from “completed” makes this specification not formally compliant with the current IHE PCC specification of the Medication Item Entry Content Module. All the requirements of conformance assertion with these IHE PCC templates cannot therefore be applied until the revision – if any - of the referenced IHE PCC templates. (epSdotsion)
@root
 uid 1 … 1 F 1.3.6.1.4.1.19376.1.5.3.1.4.7
hl7:templateId
 II.EPSOS 0 … 1 R A "normal" act that may not contain any subordinate acts (epSdotsion)
@root
 uid 1 … 1 F 1.3.6.1.4.1.19376.1.5.3.1.4.7.1
hl7:templateId
 II.EPSOS 0 … 1 R A act that records combination medication component information in subordinate acts. (epSdotsion)
@root
 uid 1 … 1 F 1.3.6.1.4.1.19376.1.5.3.1.4.11
hl7:templateId
 II.EPSOS 0 … 1 R A act that records split dose information in subordinate acts. (epSdotsion)
@root
 uid 1 … 1 F 1.3.6.1.4.1.19376.1.5.3.1.4.9
hl7:id
 II.EPSOS 1 … 1 M The following must be true for the prescription item ID:

- The prescription item ID must be globally unique

- In countries where there can be only one item per prescription, the prescription item ID must be the same as the prescription ID

- The prescription item ID can be used by the prescribing system or provider to identify the prescription to which it belongs. This provides the link from the dispensed medicine to the prescription.
(epSdotsion)
  Example <id extension="23" root="1.2.246.556.12001.4.93.1.1"/>
hl7:code
 CD.EPSOS 0 … 1 R The <code> element is used to supply a code that describes the <substanceAdminstration> act, not the medication being administered or prescribed. This may be a procedure code, such as those found in ICD-10, or may describe the method of medication administration, such as by intravenous injection. The type of medication is coded in the consumable; do not supply the code for the medication in this element. This element is optional.
Note: One of the values from the Value Set epSOSCodeNoMedication shall be used in the <code> element to record that a patient is either not on medications, or that medications are not known. 		(epSdotsion)
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19708 ActSubstanceAdministrationCode (DYNAMIC)
or
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.22 epSOSCodeNoMedication (DYNAMIC)
hl7:text
 ED 0 … 1 R (epSdotsion)
  Example <text>...</text>
hl7:reference
 0 … 1 R The URI given in the value attribute of the element points to an element in the narrative content that contains the complete text describing the medication. In a CDA document, the URI given in the value attribute of the element points to an element in the narrative content that contains the complete text describing the medication. (epSdotsion)
  Example <reference value="#eP_as_text"/>
hl7:statusCode
 CS 1 … 1 M The status of all <substanceAdministration> elements must be either "active" or "completed" and track the progress of the Act in its specified mood.
For example, statusCode="completed" when moodCode is "RQO" doesn't mean that the substance has been administrated, but that the request (e.g. the prescription) has been completed. 		(epSdotsion)
  CONF
@code shall be "active"
or
@code shall be "completed"
  Example <statusCode code="active"/>
hl7:effectiveTime
 IVL_TS 1 … * R The first <effectiveTime> element encodes the start and stop time of the medication regimen. This an interval of time (xsi:type='IVL_TS'), and must be specified as shown. This is an additional constraint placed upon CDA Release 2.0 by this profile, and simplifies the exchange of start/stop and frequency information between EMR systems.
The <low> and <high> values of the first <effectiveTime> element represent the start and stop times for the medication. The <low> value represents the start time, and the <high> value represents the stop time. If either the <low> or the <high> value is unknown, this shall be recorded by setting the nullFlavor attribute to UNK.

The <high> value records the end of the medication regime according to the information provided in the prescription or order. For example, if the prescription is for enough medication to last 30 days, then the high value should contain a date that is 30 days later then the <low> value. The rationale is that a provider, seeing an un-refilled prescription would normally assume that the medication is no longer being taken, even if the intent of the treatment plan is to continue the medication indefinitely.
(epSdotsion)
  Example <effectiveTime xsi:type="IVL_TS">
  <low value="20130321"/>  <high value="20140321"/></effectiveTime>
hl7:effectiveTime
 1 … * R The second <effectiveTime> element records the frequency of administration.
This <effectiveTime> element must be intersected with the previous time specification (operator='A'), producing the bounded set containing only those time specifications that fall within the start and stop time of the medication regimen. Several common frequency expressions appear in the table below, along with their XML representations.
This effectiveTime has a xsi:type of either TS, PIVL_TS, EIVL_TS, or SXPR_TS.
Frequency Description XML Representation
b.i.d. Twice a day <effectiveTime xsi:type='PIVL_TS' institutionSpecified='true' operator='A'> <period value='12' unit='h' /></effectiveTime>
q12h Every 12 hours <effectiveTime xsi:type='PIVL_TS' institutionSpecified='false' operator='A'> <period value='12' unit='h' /></effectiveTime>
Once Once, on 2005-09-01 at 1:18am. <effectiveTime xsi:type='TS' value='200509010118'/>
t.i.d. Three times a day, at times determined by the person administering the medication . <effectiveTime xsi:type='PIVL_TS' institutionSpecified='true' operator='A'> <period value='8' unit='h' /></effectiveTime>
q8h Every 8 hours <effectiveTime xsi:type='PIVL_TS' institutionSpecified='false' operator='A'> <period value='8' unit='h' /></effectiveTime>
qam In the morning <effectiveTime xsi:type='EIVL' operator='A'> <event code='ACM'/></effectiveTime>
  Every day at 8 in the morning for 10 minutes <effectiveTime xsi:type='PIVL_TS' operator='A'> <phase> <low value="198701010800" inclusive="true"/> <width value="10" unit="min"/> </phase> <period value='1' unit='d'/></effectiveTime>
q4-6h Every 4 to 6 hours. <effectiveTime xsi:type="PIVL_TS" institutionSpecified="false" operator="A"> <period xsi:type="PPD_PQ" value="5" unit="h"> <standardDeviation value="1" unit="h"/> </period></effectiveTime>

The mean (average) of the low and high values is specified for the period. The mean of 4 and 6 is 5. The standard deviation is recorded as one half the differences between the high and low values, with an unspecified distribution. The type attribute of the <effectiveTime> element describes the kind of frequency specification it contains. More detail is given for each type in the table below.
xsi:type Description
TS An xsi:type of TS represents a single point in time, and is the simplest of all to represent. The value attribute of the <effectiveTime> element specifies the point in time in HL7 date-time format (CCYYMMDDHHMMSS)
PIVL_TS An xsi:type of PIVL_TS is the most commonly used, representing a periodic interval of time. The <low> element of <phase> may be present. If so it specifies the starting point, and only the lower order components of this value are relevant with respect to the <period>. The <width> element represents the duration of the dose administration (e.g., for IV administration). The <period> indicates how often the dose is given. Legal values for the unit attribute of <period> are s, min, h, d, wk and mo representing seconds, minutes, hours, days, weeks, and months respectively.
EIVL_TS An xsi:type of EIVL_TS represents an event based time interval, where the event is not a precise time, but is often used for timing purposes (e.g. with meals, between meals, before breakfast, before sleep). Refer to the HL7 TimingEvent vocabulary for the codes to use for the <event> element. This interval may specify an <offset> which provides information about the time offset from the specified event (e.g., <offset><low value='-1' unit='h'/><width value='10' unit='min'/></offset> means 1 hour before the event. In that same example, the <width> element indicates the duration for the dose to be given.
SXPR_TS An xsi:type of SXPR_TS represents a parenthetical set of time expressions. This type is used when the frequency varies over time (e.g., for some cases of tapered dosing, or to handle split dosing). The <comp> elements of this <effectiveTime> element are themselves time expressions (using any of the types listed above). Each <comp> element may specify an operator (e.g. to intersect or form the union of two sets).
(epSdotsion)
hl7:routeCode
 CE.EPSOS 0 … 1 R The element specifies the route of administration using the EDQM route of administration vocabulary. A code must be specified if the route is known, and the displayName attribute should be specified. If the route is unknown, this element shall not be sent. (epSdotsion)
  CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.12 epSOSRouteofAdministration (DYNAMIC)
hl7:doseQuantity
 IVL_PQ 0 … 1 R The dose is specified in the <doseQuantity> element. If a dose range is given (e.g., 1-2 tablets, or 325-750mg), then the <low> and <high> bounds are specified in their respective elements, otherwise both <low> and <high> have the same value. If the dose is in countable units (tablets, caplets, "eaches"), then the unit should be valorized = ‘1’The unit attribute – when expresses measureable units - shall be derived from the Value Sets epSOSUnits, 1.3.6.1.4.1.12559.11.10.1.3.1.42.16 based on the UCUM code system. The countable units attribute shall be derived from the value set epSOSDoseForm, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.2.
Any <low> and <high> elements used for <doseQuantity> or <rateQuantity> should contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document.

In a CDA document, any <low> and <high> elements used for <doseQuantity> or <rateQuantity> SHOULD contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document.
(epSdotsion)
@unit
 cs 1 … 1 R
  CONF
The value of @unit shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.16 epSOSUnits (DYNAMIC)
  Example <doseQuantity nullFlavor="UNK">...</doseQuantity>
hl7:rateQuantity
 IVL_PQ 0 … 1 R The rate is specified in the <rateQuantity> element. The rate is given in units that have measure over time. In this case, the units should be specified as a string made up of a unit of measure (see doseQuantity above), followed by a slash (/), followed by a time unit (s, min, h or d).
Again, if a range is given, then the <low> and <high> elements contain the lower and upper bound of the range, otherwise, they contain the same value.
Any <low> and <high> elements used for <doseQuantity> or <rateQuantity> should contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document.

In a CDA document, any <low> and <high> elements used for <doseQuantity> or <rateQuantity> SHOULD contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document.
(epSdotsion)
hl7:consumable
 1 … 1 R Contains 1.3.6.1.4.1.12559.11.10.1.3.1.3.1 epSOS CDA ManufacturedProduct (DYNAMIC) (epSdotsion)
treeblank where [@typeCode='CSM'] [hl7:manufacturedProduct [hl7:templateId [@root='1.3.6.1.4.1.12559.11.10.1.3.1.3.1']]]
@typeCode
 cs 1 … 1 F CSM
Included 0 … * R from 2.16.840.1.113883.3.1937.777.11.10.103 epSOS CDA author prescriber (DYNAMIC)
In the unlikely case where the prescriber of a prescription item is different from the author of the prescription, the prescription item prescriber shall be represented by the element of the entry. When the Prescription Item Entry is part of a Dispensed Medicine Entry as a Related Prescription Item (see subsection 12.1.3.4.8), the author element shall be present, and shall contain the prescription item author (or author of the prescription if the prescription item has no separate author). See the 2.4.3.3 Prescriber description for the structure of the element.
hl7:author
 0 … * R (epSdotsion)
@typeCode
 cs 0 … 1 F AUT
@contextControlCode
 cs 0 … 1 F OP
hl7:functionCode
 CE.EPSOS 1 … 1 M R1.10.6
  CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.1 epSOSHealthcareProfessionalRoles (DYNAMIC)
hl7:time
 TS.EPSOS.TZ 1 … 1 R The author/time element represents the start time of the author’s participation in the creation of the clinical document. The author/time element SHALL be present. (epSdotsion)
hl7:assignedAuthor
 1 … 1 R (epSdotsion)
@classCode
 cs 0 … 1 F ASSIGNED
  Schematron assert role red error  
  test @nullFlavor or hl7:assignedPerson or hl7:assignedAuthoringDevice  
  Message If assignedAuthor has an associated representedOrganization with no assignedPerson or assignedAuthoringDevice, then the value for "ClinicalDocument/author/assignedAuthor/id/@NullFlavor" SHALL be "NA" "Not applicable" 2.16.840.1.113883.5.1008 NullFlavor STATIC.  
hl7:id
 II.EPSOS 1 … * R HP ID number R1.10.5
@nullFlavor
 cs 0 … 1 F NA
hl7:code
 CE.EPSOS 0 … 1 R HP Specialty R1.10.7
hl7:addr
 AD.EPSOS 1 … * R IHE PCC
hl7:telecom
 TEL.EPSOS 1 … * R Attribute @value SHALL contain a URI if element telecom is used. The URI scheme SHALL be one of URLScheme IHE PCC / R1.10.8 / R1.10.8.1 / R1.10.8.2
@use
 set_cs 0 … 1  
  CONF
The value of @use shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.40 epSOSTelecomAddress (DYNAMIC)
hl7:assignedPerson
 1 … 1 M (epSdotsion)
@classCode
 cs 0 … 1 F PSN
@determinerCode
 cs 0 … 1 F INSTANCE
hl7:name
 PN 1 … 1 R HP Name IHE PCC
  Example <name>
  <given>John</given>  <family>Español Smith</family></name>
hl7:family
 1 … * R HP Family Name/Surname R1.10.1
hl7:given
 1 … * R HP Given Name R1.10.2
hl7:prefix
 0 … * R HP Prefix R1.10.3
hl7:suffix
 0 … * R HP Suffix R1.10.4
hl7:representedOrganization
 1 … 1 R Contains 2.16.840.1.113883.3.1937.777.11.10.111 epSOS CDA Organization (DYNAMIC) R1.10.9
Included 0 … * R from 2.16.840.1.113883.3.1937.777.11.10.134 CDA Participant (Body) (DYNAMIC)
The organization which provided the credentialing for the prescriber needs to be expressed via a <participant> structure, which is in addition to the <author> element specified earlier. The type code of the <participant> element shall be "AUT", and the class code of the <participantRole> element shall be "LIC".

The ID of the participation role is optional, and when present it shall be the prescriber ID as specified in the <author> structure at the section or entry level.

The credentialing organization (College) is represented by the <scopingEntity> element with a class code of "ORG". The name is represented by the <desc> element, and the credentialing organization (College) ID is represented by the <id> element of the scoping entity
hl7:participant
 0 … * R (epSdotsion)
@typeCode
 cs 1 … 1 R
  CONF
The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.10901 ParticipationType (DYNAMIC)
@contextControlCode
 1 … 1 F OP
hl7:time
 IVL_TS 0 … 1 R (epSdotsion)
hl7:awarenessCode
 CE.EPSOS 0 … 1 R (epSdotsion)
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.10310 TargetAwareness (DYNAMIC)
hl7:participantRole
 1 … 1 R (epSdotsion)
@classCode
 0 … 1 F ROL
hl7:id
 II.EPSOS 0 … * R (epSdotsion)
hl7:code
 CE.EPSOS 0 … 1 R (epSdotsion)
@codeSystem
 CONF 0 … 1 F 2.16.840.1.113883.5.111 (RoleCode)
hl7:addr
 AD 0 … * R (epSdotsion)
hl7:telecom
 TEL 0 … * R (epSdotsion)
Choice 0 … 1 Elements to choose from:
hl7:playingDevice
 R Contains 2.16.840.1.113883.3.1937.777.11.10.129 CDA Device (DYNAMIC) (epSdotsion)
hl7:playingEntity
 R Contains 2.16.840.1.113883.3.1937.777.11.10.128 CDA PlayingEntity (DYNAMIC) (epSdotsion)
hl7:scopingEntity
 0 … 1 R (epSdotsion)
@classCode
 0 … 1 F ENT
@determinerCode
 0 … 1 F INSTANCE
hl7:id
 II.EPSOS 0 … * R (epSdotsion)
hl7:code
 CE.EPSOS 0 … 1 R (epSdotsion)
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.16040 EntityCode (DYNAMIC)
hl7:desc
 ED 0 … 1 R (epSdotsion)
hl7:entryRelationship
 1 … 1 R
Contains 1.3.6.1.4.1.12559.11.10.1.3.1.3.6 CDA Number of Packages (DYNAMIC) 		(epSdotsion)
treeblank where [@typeCode='COMP']
@typeCode
 cs 1 … 1 F COMP
hl7:entryRelationship
 0 … * R An entry relationship may be present to provide the fulfillment instructions. When present, this entry relationship shall contain a Medication Fulfillment Instructions entry content module.

Again, a related statement is made about the medication or immunization. In CDA, this observation is recorded inside an <entryRelationship> element occurring at the end of the substance administration or supply entry. The containing <act> is the subject (typeCode='SUBJ') of this new observation, which is the inverse of the normal containment structure, thus inversionInd='true'.


Contains 1.3.6.1.4.1.19376.1.5.3.1.4.3.1 Entry Medication FulFillment Instructions (DYNAMIC) 		(epSdotsion)
treeblank where [@typeCode='SUBJ'] [hl7:act [hl7:templateId [@root='2.16.840.1.113883.10.20.1.43'] and hl7:templateId [@root='1.3.6.1.4.1.19376.1.5.3.1.4.3.1']]]
@typeCode
 cs 1 … 1 F SUBJ
@inversionInd
 bl 1 … 1 F true
hl7:entryRelationship
 0 … 1 R An entry relationship may be present to provide the substitution instructions. When present, this entry relationship SHALL contain one and only one observation.

This observation SHALL have :

  • the code element valorized with @code=‟SUBST' and @codeSystem='2.16.840.1.113883.5.6'
  • the value element valorized with one of the value of the epSOSSubstitutionCode Value Set (Vaue Set OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.7). Nullflavor is not allowed.

NOTE:
Within the epSOS-I scope the “N” code shall be interpreted as No substitution allowed excepting for the Package Size.

The presence of any other code that is not “N”, or the absence of the substitution instructions, means that also the brand name (as well as the Package Size) can be changed.

(epSdotsion)
@typeCode
 cs 1 … 1 F SUBJ
hl7:observation
 (epSdotsion)
@classCode
 cs 0 … 1 F OBS
@moodCode
 cs 0 … 1 F EVN
hl7:code
 1 … 1 M (epSdotsion)
@code
 CONF 1 … 1 F SUBST
@codeSystem
 1 … 1 F 2.16.840.1.113883.5.6 (ActClass)
hl7:value
 1 … 1 M (epSdotsion)
  CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.7 epSOSSubstitutionCode (DYNAMIC)
hl7:entryRelationship
 0 … * R An entry relationship may be present to provide the patient medication instructions. When present, this entry relationship shall contain a Patient Medications Instructions entry content module.

Again, a related statement is made about the medication or immunization. In CDA, this observation is recorded inside an <entryRelationship> element occurring at the end of the substance administration or supply entry. The containing <act> is the subject (typeCode='SUBJ') of this new observation, which is the inverse of the normal containment structure, thus inversionInd='true'.


Contains 1.3.6.1.4.1.19376.1.5.3.1.4.3 epSOS Patient Medication Instructions (DYNAMIC) 		(epSdotsion)
treeblank where [@typeCode='SUBJ'] [hl7:act [hl7:templateId [@root='2.16.840.1.113883.10.20.1.49'] and hl7:templateId [@root='1.3.6.1.4.1.19376.1.5.3.1.4.3']]]
@typeCode
 cs 1 … 1 F SUBJ
@inversionInd
 bl 1 … 1 F true