Id1.3.182.11.10.3.12Effective Date2018‑08‑17 08:53:25
Statusdraft DraftVersion Label
NameMedicationItemeHDSIDisplay NameeHDSI Medication Item Entry
ContextPathname /
ClassificationCDA Entry Level Template
Open/ClosedClosed (only defined elements are allowed)
Used by / Uses
Used by 0 transactions and 1 template, Uses 1 template
Used by as NameVersion
1.3.182.11.10.2.7Containmentdraft eHDSI Medication Summary Section 2018‑08‑17 15:54:59
Uses as NameVersion
1.3.182.11.10.3.3Containmentdraft eHDSI Comment EntryDYNAMIC
ItemDTCardConfDescriptionLabel
hl7:substanceAdministration
R
The general model is to record each prescribed medication in a <substanceAdministration>
intent (moodCode='INT'). To record medications which were taken in the past, the moodCode shall be set to 'EVN'.  
MedidotsHDSI
@classCode
cs1 … 1FSBADM
@moodCode
cs1 … 1R
hl7:templateId
II1 … 1MMedidotsHDSI
@root
uid1 … 1F1.3.182.11.10.3.12
hl7:id
1 … 1RAn UUID representing the lineMedidotsHDSI
@root
uuid1 … 1R
@extension
cs0NPNP/not present
hl7:code
CD0 … 1R
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 arenot known.
MedidotsHDSI
hl7:text
ED1 … 1MMedidotsHDSI
hl7:reference
1 … 1M 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. MedidotsHDSI
@value
cs1 … 1R
 Example<reference value="#eP_as_text"/>
hl7:statusCode
CS1 … 1M The status of all elements must be either "active" or"completed". Status of "active" indicates a currently valid prescription, status of completedi ndicates a previously taken medication. MedidotsHDSI
 CONF
@code shall be "active"
or
@code shall be "completed"
 Example<statusCode code="active"/>
hl7:effectiveTime
IVL_TS1 … 1M<low> represents the start date of the medication.
<high> represents the end date of the medication, shall be set to nullFlavor = "UNK" if not known.

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. 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.
MedidotsHDSI
where [1]
 Example<effectiveTime xsi:type="IVL_TS">
  <low value="20130321"/>  <high nullFlavor="UNK"/></effectiveTime>
hl7:low
TS.DATE1 … 1RMedidotsHDSI
@nullFlavor
cs0 … 1FUNK
hl7:high
TS.DATE1 … 1RMedidotsHDSI
@nullFlavor
cs0 … 1FUNK
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.

FrequencyDescriptionXML Representation
b.i.d.Twice a day<effectiveTime xsi:type='PIVL_TS' institutionSpecified='true' operator='A'> <period value='12' unit='h' /></effectiveTime>
q12hEvery 12 hours<effectiveTime xsi:type='PIVL_TS' institutionSpecified='false' operator='A'> <period value='12' unit='h' /></effectiveTime>
OnceOnce, 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>
q8hEvery 8 hours<effectiveTime xsi:type='PIVL_TS' institutionSpecified='false' operator='A'> <period value='8' unit='h' /></effectiveTime>
qamIn 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>
q4-6hEvery 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:typeDescription
TSAn 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_TSAn 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_TSAn 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_TSAn 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).
MedidotsHDSI
hl7:routeCode
CE0 … 1RThe 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. 
MedidotsHDSI
hl7:doseQuantity
IVL_PQ0 … 1R

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...

If the dose is in countable items (tablets, caplets, "eaches"), then the unit should be valorized  = ‘1’. In this case it is allowed to used the UCUM annotations for describing the type of countable items (e.g. .{tablet}, {puff},..).

The unit attribute – when expresses unit of measures- 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 is derived from the value set epSOSDoseForm, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.2

MedidotsHDSI
hl7:rateQuantity
IVL_PQ0 … 1RThe 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.
MedidotsHDSI
hl7:consumable
1 … 1MThe <consumable> element shall be present, and shall contain a <manufacturedProduct>element, conforming to the Medicine Entry Content module template
MedidotsHDSI
hl7:manufacturedProduct
1 … 1MMedidotsHDSI
@classCode
cs1 … 1FMANU
hl7:manufacturedMaterial
1 … 1MMedidotsHDSI
@classCode
cs1 … 1FMMAT
@determinerCode
cs0 … 1FINSTANCE
hl7:code
CE.EPSOS1 … 1RThis element is generally used to identify a medicinal product.
Containing Luxembourg medicinal product identifiers from ValueSet with OID 1.3.182.4.16.

In case where there is information "No information" or "Known absence" then the eSanté NullFlavorValues value set shall be used.

MedidotsHDSI
 CONF
The value of @code shall be drawn from value set 1.3.182.10.63.1 eSante_NullValueRepresentation (DYNAMIC)
or
The value of @code shall be drawn from value set 1.3.182.10.68.1 eSante_Prescriptable_DrugItems (DYNAMIC)
hl7:originalText
ED0 … 1RMedidotsHDSI
hl7:name
EN1 … 1R
This element is supposed to be valorized with the complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction.
MedidotsHDSI
epsos:formCode
CE1 … 1RThis 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 eSante_PharmaceuticalDoseForm, OID: 1.3.182.10.55.1  
MedidotsHDSI
 CONF
The value of @code shall be drawn from value set 1.3.182.10.55.1 eSante_PharmaceuticalDoseForm (DYNAMIC)
epsos:asSpecializedKind
0 … 1RThis 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.

MedidotsHDSI
@classCode
cs1 … 1FGEN
epsos:generalizedMedicineClass
RMedidotsHDSI
@classCode
cs1 … 1FMMAT
epsos:code
CD1 … 1RMedidotsHDSI
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.
MedidotsHDSI
epsos:ingredient
0 … *ROne 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.
MedidotsHDSI
@classCode
cs1 … 1FACTI
epsos:quantity
1 … 1RThe 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.             
MedidotsHDSI
epsos:numerator
ANY1 … 1RMedidotsHDSI
@unit
cs0 … 1 
@value
0 … 1 
 Constraint@nullFlavor or (@unit and @value)
epsos:denominator
ANY1 … 1RMedidotsHDSI
@unit
cs0 … 1 
@value
0 … 1 
 Constraint@nullFlavor or (@unit and @value)
epsos:ingredient
1 … 1RMedidotsHDSI
@classCode
cs1 … 1FMMAT
@determinerCode
cs1 … 1FKIND
epsos:code
CD1 … 1RMedidotsHDSI
 CONF
The value of @code shall be drawn from value set 1.3.182.10.56.1 eSante_ActiveIngredients (DYNAMIC)
epsos:originalText
ED0 … 1MedidotsHDSI
epsos:reference
TEL0 … 1MedidotsHDSI
epsos:name
ST0 … 1MedidotsHDSI
hl7:reference
0 … 1MedidotsHDSI
@typeCode
cs1 … 1FREFR
hl7:externalObservation
1 … 1MReference which lead to Observation which caused this Medication being prescribed/dispensed forMedidotsHDSI
hl7:id
II1 … 1MMedidotsHDSI
@root
uuid1 … 1R
@extension
st0NPNP/not present
hl7:entryRelationship
0 … 1Contains 1.3.182.11.10.3.3 eHDSI Comment Entry (DYNAMIC)MedidotsHDSI
@typeCode
cs1 … 1FSUBJ
@inversionInd
bl1 … 1Ftrue