Id1.3.182.11.5.2.3.1Effective Date2017‑12‑27 11:30:45
Statusdraft DraftVersion Label
NameMedPrescriptionItemEntryDisplay NameMed Prescription Item Entry
Description
A Prescription Item belongs to one prescription and represents one prescribed medication. It may be associated with one or more observations. Prescription Item is the atomic entity for logistics, distribution and billing. It contains the prescribed medicine and dosage information as well as other information to the prescribed item such as patient- and fulfillment instructions and substitution handling.
ContextPathname /
ClassificationCDA Entry Level Template
Open/ClosedClosed (only defined elements are allowed)
Used by / Uses
Used by 0 transactions and 1 template, Uses 3 templates
Used by as NameVersion
1.3.182.11.5.2.2.1Containmentdraft Prescription Meds Section2017‑12‑15 16:02:24
Uses as NameVersion
1.3.182.11.5.2.3.2Includedraft Medicine EntryDYNAMIC
1.3.182.11.9.3.2Containmentdraft Patient InstructionDYNAMIC
1.3.182.11.9.3.3Containmentdraft Fulfiller InstructionDYNAMIC
Example
Example
<substanceAdministration moodCode="INT" classCode="SBADM">
  <templateId root="1.3.182.11.5.2.3.1"/>  <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.7.1"/>  <id root="ab625fd5-2ea9-433c-af17-71f0a1484443"/>  <text>
    <reference value="#line1"/>  </text>
  <statusCode code="completed"/>  <effectiveTime xsi:type="IVL_TS">
    <low value="20171229"/>    <high value="20180102"/>  </effectiveTime>
  <effectiveTime operator="A" xsi:type="PIVL_TS">
    <period value="8" unit="h"/>  </effectiveTime>
  <repeatNumber value="0"/>  <doseQuantity value="1"/>  <consumable>
    <manufacturedProduct classCode="MANU">
      <!-- See entry definition -->
    </manufacturedProduct>
  </consumable>
</substanceAdministration>
ItemDTCardConfDescriptionLabel
hl7:substanceAdministration
1 … 1MMedPdotsntry
@classCode
cs1 … 1FSBADM
@moodCode
cs1 … 1FINT
hl7:templateId
II1 … 1MThis templateId identifies a in the context of ePrescription in Luxembourg.
In addition to the templateId 1.3.182.11.5.3.1, one of the following templateId shall be present to represent the type of dosing instructions
MedPdotsntry
@root
uid1 … 1F1.3.182.11.5.2.3.1
Choice1 … 1Elements to choose from:
  • hl7:templateId
  • hl7:templateId
  • hl7:templateId
  • hl7:templateId
  • hl7:templateId
hl7:templateId
II0 … 1RThis templateId is used to identify medication administration events that do not require any special processing.
In case (structured) dosage instructions are not provided (e.g., because they are only provided as narrative text), this specific templateId SHALL be used. 
MedPdotsntry
@root
uid1 … 1F1.3.6.1.4.1.19376.1.5.3.1.4.7.1
 Schematron assertrolered error 
 test(not(../hl7:consumable/hl7:manufacturedProduct/hl7:manufacturedMaterial/hl7:code/@nullFlavor) and not(../hl7:effectiveTime[1]/@nullFlavor) and not(../hl7:effectiveTime[2]/@nullFlavor) and ((../hl7:doseQuantity and not(../hl7:doseQuantity/@nullFlavor)) or (../hl7:rateQuantity and not(../hl7:rateQuantity/@nullFlavor))) and not(../hl7:entryRelationship[@typeCode="COMP"])) or (../hl7:consumable/hl7:manufacturedProduct/hl7:manufacturedMaterial/hl7:code/@nullFlavor) 
 MessageIf Normal Dosing is used, and the medication is in the referential, the 2 effectiveTime and one of doseQuantity or rateQuantity shall be present and not nullFlavor. No related compononent shall be present. If the medication is not in the referential, the effectiveTimes can be nullFlavored. It is possible not to provide doseQuantity nor rateQuantity 
hl7:templateId
II0 … 1RThis templateId is used to identify medication administration events that require special processing to handle tapered dosing.
A tapered dose is often used for certain medications where abrupt termination of the medication can have negative consequences. Tapered dosages may be done by adjusting the dose frequency, the dose amount, or both.
When merely the dose frequency is adjusted, (e.g., Prednisone 5mg b.i.d. for three days, then 5mg. daily for three days, and then 5mg every other day), then only one medication entry is needed, multiple frequency specifications recorded in <effectiveTime> elements. When the dose varies (e.g., Prednisone 15mg daily for three days, then 10 mg daily for three days, the 5 mg daily for three days), subordinate medication entries should be created for each distinct dosage.
MedPdotsntry
@root
uid1 … 1F1.3.6.1.4.1.19376.1.5.3.1.4.8
hl7:templateId
II0 … 1R
This templateId is used to identify medication administration events that require special processing to handle split dosing.
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.
MedPdotsntry
@root
uid1 … 1F1.3.6.1.4.1.19376.1.5.3.1.4.9
hl7:templateId
II0 … 1RThis templateId is used to identify medication administration events that require special processing to handle conditional dosing.
A conditional dose is often used when the dose amount differs based on some measurement (e.g., an insulin sliding scale dose based on blood sugar level). In this case a subordinate <substanceAdministration> entry is required for each different dose, and the condition should be recorded.
MedPdotsntry
@root
uid1 … 1F1.3.6.1.4.1.19376.1.5.3.1.4.10
hl7:templateId
II0 … 1R
This template identifier is used to identify medication administration events that require special processing to handle combination medications.
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.
MedPdotsntry
@root
uid1 … 1F1.3.6.1.4.1.19376.1.5.3.1.4.11
hl7:id
II1 … 1MThis ID represent the prescription line ID and shall be present and unique, using an UUID in @root. @extension shall not be present.MedPdotsntry
@root
uuid1 … 1R
@extension
st0NPNP/not present
hl7:statusCode
CS1 … 1MThis element does NOT represent the status of the Prescription Item (e.g. whether the item has been dispensed or not) but represent the status of the act of prescribing. At the time when the document is generated, the act of prescribing is considered as being done.
Thus, if present, it shall always be "completed"
MedPdotsntry
@code
cs1 … 1Fcompleted
hl7:effectiveTime
2 … 2RThis element encodes the start and stop time of the medication regimen.

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.

In case the (structured) dosage instructions include a dose regime ("dose regime" groups the data elements Medication Frequency, Dose Quantity and Rate Quantity, provided in a certain type of dosing ("Normal dosing", "Split dosing", etc.)) this element SHALL be present and specify the entire duration of the medication treatment. In case the Duration of Treatment is unknown the <low> and <high> sub-elements of this element SHALL be set to nullFlavor "UNK".

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.
The type is either TS, PIVL_TS, EIVL_TS, PIVL_PPD_TS or SXPR_TS.

In case the (structured) dosage instructions include a dose regime using “Normal Dosing”, this element SHALL be present and SHALL NOT be null flavor.
If dosage instructions are provided narrative only, this element SHALL NOT be present.
In all other cases this element MAY be present.

Several common frequency expressions appear in the table below, along with their XML representations.


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.
PIVL_PPD_TSAn xsi:type of PIVL_PPD_TS represents a probabilistic time interval and is used to represent dosing frequencies like q4-6h. This profile requires that the distributionType of this interval be left unspecified. The <period> element specifies the average of the time interval, and the value of the <standardDeviation> shall be computed as half the width of the interval. The unit attributes of the <period> and <standardDeviation> elements shall be the same
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).


MedPdotsntry
hl7:repeatNumber
1 … 1MMedPdotsntry
@value
1 … 1F0
hl7:routeCode
CE0 … 1MedPdotsntry
 CONF
The value of @code shall be drawn from value set 1.3.182.10.52.1 eSante_RoutesOfAdministration (DYNAMIC)
hl7:doseQuantity
IVL_PQ0 … 1CThe dose is specified if 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 attribute is not sent. Otherwise the units are sent. The unit attribute should be derived from the HL7 UnitsOfMeasureCaseSensitive vocabulary.

In case the (structured) dosage instructions include a dose regime using “Normal Dosing”, this element SHALL be present and SHALL NOT be null flavor.
If dosage instructions are provided narrative only, this element SHALL NOT be present.
In all other cases this element MAY be present.

Any <low> and <high> elements used for <doseQuantity> should contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document
MedPdotsntry
hl7:rateQuantity
IVL_PQ0 … 1CThe 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).

In case the (structured) dosage instructions include a dose regime using “Normal Dosing”, this element SHALL be present and SHALL NOT be null flavor.
If dosage instructions are provided narrative only, this element SHALL NOT be present.
In all other cases this element MAY be present.

Any <low> and <high> elements used for <rateQuantity> should contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document
MedPdotsntry
hl7:consumable
1 … 1MMedPdotsntry
hl7:manufacturedProduct
1 … 1MMedPdotsntry
@classCode
cs1 … 1FMANU
Included from 1.3.182.11.5.2.3.2 Medicine Entry (DYNAMIC)
hl7:manufacturedMaterial
1 … 1MMedidotsntry
@classCode
cs1 … 1FMMAT
@determinerCode
cs1 … 1FKIND
hl7:templateId
II1 … 1MMedidotsntry
@root
uid1 … 1F1.3.182.11.5.2.3.2
hl7:code
CE1 … 1R
The <code> element of the <manufacturedMaterial> element SHALL be present and describes the code of the medication. 
@codeSystem shall be 1.3.182.5.47 if it's a prescribed item
@codeSystem shall be 1.3.182.5.48 if it's a dispensed item
If the medication is not coded in the list, nullFlavor NA shall be used.
Medidotsntry
@nullFlavor
cs0 … 1FNA
 CONF
The value of @code shall be drawn from value set 1.3.182.10.68.1 eSante_Prescriptable_DrugItems (DYNAMIC)
or
The value of @code shall be drawn from value set 1.3.182.10.69.1 eSante_Dipensable_DrugItems (DYNAMIC)
 Schematron assertrolered error 
 test@nullFlavor="NA" or (@codeSystem="1.3.182.5.47" and ../../../../../../hl7:templateId/@root="1.3.182.11.5.2.2.1") or (@codeSystem="1.3.182.5.48" and ../../../../../../hl7:templateId/@root="1.3.182.11.6.2.2.1") 
 Message@codeSystem shall be 1.3.182.5.47 or 1.3.182.5.48 If the medication is not coded in the list, nullFlavor NA shall be used. 
hl7:name
ST1 … 1R
The element SHALL contain the name of the medication from the list (to be provided)

If the medicine has no brand name (e.g., magistral preparations, compound medicine, …) nullFlavor="NA" SHALL be used.
Medidotsntry
@nullFlavor
cs0 … 1FNA
pharm:formCode
CD0 … 1This code represents the pharmaceutical dose form (e.g., tablet, capsule, liquid) and SHOULD be present, if not implied by the product. It MAY be present if implied by the product. The value of this code affects the units used in the substance administration quantity element.

Medidotsntry
 CONF
The value of @code shall be drawn from value set 1.3.182.10.55.1 eSante_PharmaceuticalDoseForm (DYNAMIC)
pharm:ingredient
0 … *
One or more active ingredients SHOULD be represented with this structure. The classCode of "ACTI" indicates that this is an active ingredient.

Careful, there may be several active ingredients. Take care to include here only active ingredients, not excipient
Medidotsntry
@classCode
cs1 … 1FACTI
pharm:quantity
RTO_QTY_QTY0 … 1The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The <pharm:quantity> element SHOULD be present and represents the strength of the active ingredient(s) as the ratio of the active ingredient(s) to a unit of medication. The <pharm:quantity> element contains the numerator and denominator of the strength ratio.

Medidotsntry
 Example
Strength of 10 mg of the ingredient per ml of the medication
<XXX:quantity>
  <numerator xsi:type="PQ" value="10" unit="mg"/>  <denominator xsi:type="PQ" value="1" unit="ml"/></XXX:quantity>
 Example
Strength of the ingredient in 1 unit of the given medication. 2% of the ingredient (e.g., XYLOPHIL 2% GEL)
<XXX:quantity>
  <numerator xsi:type="PQ" value="2" unit="%"/>  <denominator xsi:type="PQ" value="1"/></XXX:quantity>
 Example
5mg of the ingredient (e.g., XYZAL 5MG F.C.TABLET)
<XXX:quantity>
  <numerator xsi:type="PQ" value="5" unit="mg"/>  <denominator xsi:type="PQ" value="1"/></XXX:quantity>
pharm:ingredient
Medidotsntry
@classCode
cs1 … 1FMMAT
@determinerCode
cs1 … 1FKIND
pharm:code
CE0 … 1Medidotsntry
 CONF
The value of @code shall be drawn from value set 1.3.182.10.56.1 eSante_ActiveIngredients (DYNAMIC)
pharm:name
ST1 … 1MThe name of the active ingredient, comes from the displayName of pharm:code Medidotsntry
hl7:entryRelationship
0 … *C
Related components
A top level <substanceAdministration> element may contain one or more related components, either to handle split, tapered or conditional dosing, or to support combination medications.
In the first three cases, the subordinate components shall specify only the changed <frequency> and/or <doseAmount> elements. For conditional dosing, each subordinate component shall have a <precondition> element that specifies the <observation> that must be obtained before administration of the dose. The value of the <sequenceNumber> shall be an ordinal number, starting at 1 for the first component, and increasing by 1 for each subsequent component. Components shall be sent in <sequenceNumber> order.

In case the (structured) dosage instructions include a dose regime using “Normal Dosing”, subordinate <substanceAdministration> entries SHALL NOT be present.
If dosage instructions are provided narrative only, subordinate <substanceAdministration> entries SHALL NOT be present.
In case the (structured) dosage instructions include a dose regime using other types than “Normal Dosing”, one or more subordinate <substanceAdministration> entries SHALL be present.
In case subordinate <substanceAdministration> entries are present, the <consumable> element of subordinate <substanceAdministration> entries SHALL NOT contain a medicine, but the <manufacturedProduct/manufacturedMaterial> element SHALL be set to nullFlavor=’NA’.
MedPdotsntry
@typeCode
cs1 … 1FCOMP
hl7:sequenceNumber
INT1 … 1MMedPdotsntry
hl7:entryRelationship
0 … 1Patient Medication Instructions
At most one instruction MAY be provided for each <substanceAdministration> entry.
Patient Medication Instructions (used in a Prescription Item) are comments from "prescriber to patient" and may contain the following information:
  • Human readable dosage instructions (e.g., a representation of the structured dosage instructions as narrative text, any special dosage instructions which could not have been represented in structured way, etc.)
  • General comments by the prescriber to the patient (e.g., "take with food", etc.)

Contains 1.3.182.11.9.3.2 Patient Instruction (DYNAMIC)
MedPdotsntry
@typeCode
cs1 … 1FSUBJ
@inversionInd
bl1 … 1Ftrue
hl7:entryRelationship
0 … 1
Fulfillment Instructions
At most one instruction MAY be provided for each <substanceAdministration> entry.
Fulfillment Instructions (used in a Prescription Item) are comments from “prescriber to dispenser” and may contain the following information:
  • A proposal of a product/brand including information about substitution in case of prescribing Generic/Scientific names (e.g., Prescriber prescribes the generic "Paracetamol" but proposes the product "Adol 500mg Caplet" to be dispensed because the patient is used to that medicine)
  • Information to the preparation of compound medicine (e.g., "20 capsules of phenytoin, 20 ml glycerin, 2ml alcohol, Q.S. Syrup to 200ml")
  • General comments by the prescriber to the dispenser (e.g., if the patient is very old: "Patient is instructed about the dosing, but please repeat the instruction to ensure that the patient understood how to intake the medicine")

Contains 1.3.182.11.9.3.3 Fulfiller Instruction (DYNAMIC)
MedPdotsntry
@typeCode
cs1 … 1FSUBJ
@inversionInd
bl1 … 1Ftrue
hl7:precondition
0 … *MedPdotsntry
hl7:criterion
ANY1 … 1MMedPdotsntry
hl7:text
ANY1 … 1MMedPdotsntry
hl7:reference
ANY1 … 1MMedPdotsntry
@value
1 … 1R
 Schematron assertrolered error 
 testhl7:effectiveTime[1]/@nullFlavor or (not(hl7:effectiveTime[1]/hl7:center) and not(hl7:effectiveTime[1]/hl7:width) and (hl7:effectiveTime[1]/hl7:low/@value or hl7:effectiveTime[1]/hl7:low/@nullFlavor="UNK") and (hl7:effectiveTime[1]/hl7:high/@value or hl7:effectiveTime[1]/hl7:high/@nullFlavor="UNK")) 
 MessageIf the first effectiveTime is present, low and high shall be present, and the only nullFlavor allowed is "UNK" 
 Schematron assertrolered error 
 testhl7:effectiveTime[2]/@nullFlavor or hl7:effectiveTime[2]/@operator="A" 
 MessageIf the second effectiveTime is not nullFlavor, it shall have @operator="A" 
 Schematron assertrolered error 
 testhl7:effectiveTime[2]/@nullFlavor or hl7:effectiveTime[2]/@xsi:type="TS" or hl7:effectiveTime[2]/@xsi:type="PIVL_TS" or hl7:effectiveTime[2]/@xsi:type="EIVL_TS" or hl7:effectiveTime[2]/@xsi:type="PIVL_PPD_TS" or hl7:effectiveTime[2]/@xsi:type="SXPR_TS" 
 MessageIf the second effectiveTime is not nullFlavor, its type is either TS, PIVL_TS, EIVL_TS, PIVL_PPD_TS or SXPR_TS.