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1 Template IPSMedicationStatement
1.1 Aktuelle Version
Id
2.16.840.1.113883.10.22.4.4
Gültigkeit ab
2024‑08‑04 10:41:54
Status
Entwurf
Versions-Label
STU2
Name
IPSMedicationStatement
Bezeichnung
IPS Medication Statement
Beschreibung
An IPS Medication entry describes a medication statement, that is a substance administration that has actually occurred (e.g., pills ingested or injections given) or are intended to occur (e.g., "take 2 tablets twice a day for the next 10 days"). Medication activities in "INT" mood are reflections of what a clinician
intends a patient to be taking. For example, a clinician may intend that a patient to be administered Lisinopril 20 mg PO for blood pressure control. If what was actually administered was Lisinopril 10 mg., then the Medication activities in the "EVN" mood would reflect actual use.
The source of this information can be the patient, significant other (such as a family member or spouse), or a clinician. A common scenario where this information is captured is during the history taking process during a patient visit or stay, but it could be derived from the medications information recorded into a GP's EHR-system, in form of prescribed medication, or
administration statements.
The medication information may come from sources such as the patient's memory, from a prescription bottle, or from a list of medications the patient, clinician or other party maintains.
A medication statement is usually less specific than an a prescription or a medication administration record.
This entry is composed by a main substanceAdministration act and a subordinate substanceAdministration act, unless it is asserted that there are no medications data.
The first conveys information as the product, the period of administration and the route of administration; the latter is used to provide dosage information as the frequency of intakes or the amount of the medication given.
Kontext
Elternknoten des Template-Element mit Id 2.16.840.1.113883.10.22.4.4
Klassifikation
CDA Entry Level Template
Offen/Geschlossen
Offen (auch andere als die definierten Elemente sind erlaubt)
<substanceAdministrationclassCode="SBADM"moodCode="INT"> <templateIdroot="2.16.840.1.113883.10.22.4.4"/><codecode="no-medication-info"codeSystem="2.16.840.1.113883.5.1150.1"displayName="No information about medications"> <statusCodecode="completed"/><effectiveTimenullFlavor="NA"xsi:type="IVL_TS"/><consumable> <manufacturedProduct> <manufacturedMaterialnullFlavor="NA"/></manufacturedProduct></consumable></code></substanceAdministration>
Item
DT
Kard
Konf
Beschreibung
Label
hl7:substanceAdministration
0 … 1
R
hl7ips-dataelement-104
Medication
CEN/TC 251 prEN 17269
@classCode
cs
1 … 1
F
SBADM
@moodCode
cs
1 … 1
R
If the statement refers to a prescribed medication then a <substanceAdministration> intent (moodCode='INT') is used; otherwise, to record medications which are stated to have taken, the moodCode shall be set to 'EVN'.</substanceAdministration>
CONF
Der Wert von @moodCode MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.20.9.18 MoodCodeEvnInt (DYNAMIC)
hl7:templateId
II
1 … 1
M
@root
uid
1 … 1
F
2.16.840.1.113883.10.22.4.4
hl7:id
II
0 … *
R
hl7:code
CD.IPS
1 … 1
R
The <code> element is valorized with the Substance Administration ACT code "DRUG" unless it is used for asserting the known absence of medication treatments or no information about them.
hl7ips-dataelement-220
Medication Summary content status
CEN/TC 251 prEN 17269
CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.14 DRUGActCode (DYNAMIC)
oder
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.79 IPS No Medications (DYNAMIC)
hl7:text
ED
0 … 1
R
The URI given in the value attribute of the <reference> 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 <reference> element points to an element in the narrative content that contains the complete text describing the medication.
hl7:reference
TEL
1 … 1
M
@value
url
1 … 1
R
Reference pointing to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1
hl7:statusCode
CS
1 … 1
M
CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.12 ActStatusActiveCompletedAbortedSuspended (DYNAMIC)
Beispiel
<statusCodecode="active"/>
Eingefügt
1 … 1
R
von 2.16.840.1.113883.10.21.9.1 UV Use Period (DYNAMIC)
Auswahl
1 … 1
The effectiveTime element encodes the use period of the medication, it is always expressed as an interval of time. It may be expressed using the low and high OR with the width element. The first is used to indicate a specified interval (e.g. from march 15th, 2017); the latter for indicating a 'floating' period (e.g. 2 weeks).
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.
In case of unbounded period (continuous therapy) the high element will be valued with the nullFlavor attribute to NA.
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 a prescription that has not been refilled 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.
Case 2: 'floating' period: The width element is used to specify a period of (actual or intended) administration that is not anchored to any specific date (e.g. a two weeks therapy)
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.21.1 Medication Time Units (UCUM) (DYNAMIC)
hl7:effectiveTime
IVL_TS
0 … 1
C
Case 3: anchored period: The width element is used to specify a period of (actual or intended) administration anchored to a specific date (e.g. a two weeks therapy starting today)
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.21.1 Medication Time Units (UCUM) (DYNAMIC)
hl7:routeCode
CE.IPS
0 … 1
R
The <routeCode> element specifies the route of administration using the EDQM route of administration vocabulary.
A code must be specified if the route is known.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration.
It is known that also alternative jurisdictional and international terminologies are also used for this concept domain, as NCI or SNOMED CT.
Official NCI and EDQM maps for the route of administration are available from the EDQM site.
hl7ips-dataelement-102
Route of administration
CEN/TC 251 prEN 17269
CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.33 IPS Medicine Route of Administration (DYNAMIC)
hl7:doseQuantity
IVL_PQ
NP
hl7:rateQuantity
IVL_PQ
NP
hl7:administrationUnitCode
CE
NP
hl7:consumable
1 … 1
M
@typeCode
cs
1 … 1
F
CSM
Eingefügt
von 2.16.840.1.113883.10.22.4.2 IPS Medication Information (detail) (DYNAMIC)
hl7:manufacturedProduct
0 … *
R
hl7ips-dataelement-2
Medicinal Product
CEN/TC 251 prEN 17269
@classCode
cs
0 … 1
F
MANU
hl7:templateId
II
1 … 1
M
@root
uid
1 … 1
F
2.16.840.1.113883.10.22.4.2
Eingefügt
1 … 1
R
von 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material (DYNAMIC)
hl7:manufacturedMaterial
1 … 1
R
@classCode
cs
0 … 1
F
MMAT
@determinerCode
cs
0 … 1
F
KIND
hl7:templateId
II
1 … 1
M
@root
oid
1 … 1
F
2.16.840.1.113883.10.22.4.3
Auswahl
0 … 1
Elemente in der Auswahl:
hl7:code
hl7:code[@codeSystem='2.16.840.1.113883.6.96']
hl7:code
CE.IPS
0 … 1
R
This element is generally used to identify a medicinal product. When the IDMP identifiers will be concretely available for usage this element will be used for conveying the Medicinal Product Identifier (MPID). For the time being, it could be optionally used for conveying jurisdictional or agreed cross jurisdictional medicinal product code.
hl7ips-dataelement-105
Product Code
CEN/TC 251 prEN 17269
hl7:code
CE.IPS
0 … 1
R
Non IDMP codes from SNOMED CT value set
wo [@codeSystem='2.16.840.1.113883.6.96']
CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.71 IPS Medications Products (DYNAMIC)
hl7:name
EN
0 … 1
R
This element is supposed to be valorized with the complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction.
The name may be applicable in one or more country/language combinations.
hl7ips-dataelement-117
Brand Name
CEN/TC 251 prEN 17269
hl7ips-dataelement-171
Product Common Name (and Strength)
CEN/TC 251 prEN 17269
pharm:formCode
CE.IPS
0 … 1
R
Administrable Pharmaceutical Dose Form.
This code represents the form of the medication (e.g. tablet, capsule, liquid)
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration.
It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT.
hl7ips-dataelement-227
Pharmaceutical dose form
CEN/TC 251 prEN 17269
CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.25 IPS Medicine Doseform (DYNAMIC)
This structure describes the packaging of the medication.
The <pharm:formCode> element provides the code for the particular package.
If the package has a brand name, it can be described in the <pharm:name> element.
The <pharm:capacityQuantity> element describes the capacity of the packaging, while the <pharm:quantity> the actual quantity of inner packaged items in the outer packaging container. The product might have a single (30 pills bottle) or multiple (5 vials 10 ml; box with 2 blisters of 20 tablets) layers of packaging.
In the latter case, the most inner (nested) item represents the most outer package item.
For example the case
\--Box
\-----2 blisters
\--------20 tablets
is described as "20 tablets" contained by "a blister"; "2 blisters" contained by one box.
The most inner package represents the Packaged Medicinal Product.
When the IDMP Packaged Medicinal Product ID (PCID) will become actually available for usage, the most inner package <code> element will be used to convey the IDMP PCID.
@classCode
cs
1 … 1
F
CONT
Beispiel
Packaged Medicinal Product with multiple layers packaging
The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
@unit
cs
0 … 1
CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
1 … 1
R
Beispiel
<quantityvalue="20"unit="{tablet}"/>
Beispiel
<quantityvalue="10"unit="mL"/>
pharm:containerPackagedProduct
1 … 1
R
It represents the most inner Package Item or the Packaged Medicinal Product.
@classCode
cs
1 … 1
F
CONT
@determinerCode
cs
1 … 1
F
KIND
pharm:code
0 … 1
If this is also the most outer <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
pharm:name
ST
0 … 1
It represents the Name of the Package Item or of the Packaged Medicinal Product.
If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name.
Beispiel
<name>AMOXIFEN(R) 20 compresse 20 mg</name>
pharm:formCode
CE.IPS
0 … 1
R
This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration.
CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)
It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml.
@unit
cs
0 … 1
CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
1 … 1
R
pharm:asContent
0 … *
R
In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the "2 blisters"
In the case of
\--Box
\-----5 vials
it represents the Packaged Medicinal Product.
@classCode
cs
1 … 1
F
CONT
pharm:quantity
PQ
0 … 1
R
The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
@unit
cs
0 … 1
CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
1 … 1
R
Beispiel
<quantityvalue="20"unit="{tablet}"/>
Beispiel
<quantityvalue="10"unit="mL"/>
pharm:containerPackagedProduct
1 … 1
R
It represents the intermediate Package Item or the Packaged Medicinal Product
@classCode
cs
1 … 1
F
CONT
@determinerCode
cs
1 … 1
F
KIND
pharm:code
CD.IPS
0 … 1
If this is also the most inner <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
pharm:name
ST
0 … 1
R
It represents the Name of the Package Item or of the Packaged Medicinal Product
If this is also the most inner <pharm:containerPackagedProduct> than this element can be used for the brand name.
Beispiel
<name>...</name>
pharm:formCode
CE.IPS
1 … 1
R
This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as reference terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration.
CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)
pharm:capacityQuantity
PQ
0 … 1
It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml.
@unit
cs
0 … 1
CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
1 … 1
R
pharm:asContent
0 … *
R
In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the Packaged Medicinal Product.
@classCode
cs
1 … 1
F
CONT
pharm:quantity
PQ
0 … 1
R
The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
@unit
cs
0 … 1
CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
1 … 1
R
Beispiel
<quantityvalue="20"unit="{tablet}"/>
Beispiel
<quantityvalue="10"unit="mL"/>
pharm:containerPackagedProduct
1 … 1
R
When present, it represents the Packaged Medicinal Product
@classCode
cs
1 … 1
F
CONT
@determinerCode
cs
1 … 1
F
KIND
pharm:code
CD.IPS
0 … 1
When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
pharm:name
ST
0 … 1
R
When present, it can be used for the representing the brand name.
pharm:formCode
CE.IPS
1 … 1
R
When present, it encodes the type of the outer package.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration.
CONF
Der Wert von @code MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)
pharm:capacityQuantity
PQ
0 … 1
It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml.
@unit
cs
0 … 1
CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC)
@value
1 … 1
R
pharm: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 "GRIC" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry.
wo [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73']
The Medicinal Product can be classified according to various classification systems, which may be jurisdictional or international. The classification system itself is specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified.
When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, the PhPID will be represented by the generalizedMaterialKind/code element.
When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, this element will be used for representing the IDMP PhP Id.
The level and the stratum of the PhPID will be distiguished by the OID of the code system.
pharm:name
0 … *
R
pharm:ingredient
0 … *
R
This module provides the list of the ingredients (substances with a role) used for this product; one or more ingredients may be present.
The classCode of "ACTI" indicates that this is an active ingredient.
@classCode
cs
1 … 1
R
CONF
Der Wert von @classCode MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC)
pharm:quantity
1 … 1
M
The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The <quantity> element contains the numerator and denominator of the strength ratio.</quantity>
Beispiel
<quantity>...</quantity>
hl7:numerator
PQ
1 … 1
R
@unit
cs
1 … 1
R
CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.30 Medicine Strength Numerator (DYNAMIC)
@value
1 … 1
R
hl7:denominator
PQ
1 … 1
R
@unit
cs
1 … 1
R
CONF
Der Wert von @unit MUSS gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.31 Medicine Strength Denominator (DYNAMIC)
@value
1 … 1
R
pharm:ingredientSubstance
1 … 1
R
@classCode
cs
1 … 1
F
MMAT
@determinerCode
cs
1 … 1
F
KIND
pharm:code
CD.IPS (extensible)
0 … 1
C
The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances. The Global Ingredient Archival System (GInAS) will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard. Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances. This choice will be revised based on the availability and the maturity of GInAS.
CONF
Der Wert von @code SOLLTE gewählt werden aus dem Value Set 2.16.840.1.113883.11.22.32 IPS Medicine Active Substances (DYNAMIC)
hl7:originalText
ED
0 … *
hl7:reference
TEL
0 … *
hl7:translation
CD
0 … *
This element can be used to provide alternative identifications for the described substance.
pharm:name
0 … 1
C
Name of the substance
Schematron assert
role
error
test
pharm:code or pharm:name
Meldung
Either the name or the code of the substance (or both) shall be provided
Eingefügt
0 … *
von 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC)
hl7:author
0 … *
hl7:templateId
II
1 … 1
M
@root
uid
1 … 1
F
2.16.840.1.113883.10.22.4.14
hl7:time
TS.IPS.TZ
1 … 1
R
hl7:assignedAuthor
1 … 1
M
hl7:id
II
1 … *
R
hl7:code
0 … 1
R
Auswahl
0 … 1
Elemente in der Auswahl:
hl7:assignedPerson
hl7:assignedAuthoringDevice
hl7:assignedPerson
0 … 1
C
@classCode
cs
0 … 1
F
PSN
@determinerCode
cs
0 … 1
F
INSTANCE
hl7:name
PN
1 … *
R
Name of the person (e.g. the Healthcare Professional) authoring this document
von 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC)
@classCode
cs
0 … 1
F
DEV
@determinerCode
cs
0 … 1
F
INSTANCE
hl7:code
CE
0 … 1
hl7:manufacturerModelName
SC
0 … 1
hl7:softwareName
SC
0 … 1
hl7:representedOrganization
0 … 1
hl7:id
II
0 … *
hl7:name
0 … *
hl7:telecom
TEL
0 … *
hl7:addr
AD
0 … *
hl7:entryRelationship
0 … *
C
Subordinate Substance Administration Statement as a component of the overall medication statement.
Unless medications are unknown or known absent, at least one subordinated <substanceAdministration> has to be present to convey information about dosages (dose, frequency of intakes,..).
Subordinated <substanceAdministration> elements can be also used either to handle split dosing, or to support combination medications.
Entwurf
