Implementierungsleitfaden ISiK-Medikation

Element id

Medication.id

Short description

serverseitige, interne ID des Datensatzes

Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Comments

bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.

Data type

Meta

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

0..1

There are no (further) constraints on this element

Element id

Medication.meta.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Medication.meta.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a

versionId

0..1

Element id

Medication.meta.versionId

Short description

Eindeutiger Name der serverseitigen Version des Datensatzes

Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

Comments

Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine versionID verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine versionIDverfügen.

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

lastUpdated

0..1

instant

Element id

Medication.meta.lastUpdated

Short description

Zeitpunkt der letzten Änderung

Definition

When the resource last changed - e.g. when the version changed.

Comments

Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein lastUpdate verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein lastUpdateverfügen.

Data type

instant

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

source

0..1

There are no (further) constraints on this element

Element id

Medication.meta.source

Short description

Identifies where the resource comes from

Definition

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

Comments

In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

Data type

canonical(StructureDefinition)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

profile

0..*

There are no (further) constraints on this element

Element id

Medication.meta.profile

Short description

Profiles this resource claims to conform to

Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Data type

canonical(StructureDefinition)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

security

0..*

CodingBinding

There are no (further) constraints on this element

Element id

Medication.meta.security

Short description

Security Labels applied to this resource

Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

Comments

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

Data type

All Security Labels (extensible)

Binding

Security Labels from the Healthcare Privacy and Security Classification System.

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

tag

0..*

There are no (further) constraints on this element

Element id

Medication.meta.tag

Short description

Tags applied to this resource

Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

Data type

Binding

Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

CommonTags (example)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

implicitRules

Σ ?!

0..1

There are no (further) constraints on this element

Element id

Medication.implicitRules

Short description

A set of rules under which this content was created

Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

language

0..1

codeBinding

There are no (further) constraints on this element

Element id

Medication.language

Short description

Language of the resource content

Definition

The base language in which the resource is written.

Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Data type

code

Binding

A human language.

CommonLanguages (preferred)

Binding extensions

maxValueSet	AllLanguages

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

text

0..1

Narrative

There are no (further) constraints on this element

Element id

Medication.text

Short description

Text summary of the resource, for human interpretation

Alternate names

narrative, html, xhtml, display

Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Data type

Narrative

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: Act.text?

contained

0..*

Resource

There are no (further) constraints on this element

Element id

Medication.contained

Short description

Contained, inline Resources

Alternate names

inline resources, anonymous resources, contained resources

Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Data type

Resource

Mappings

rim: N/A

extension

0..*

There are no (further) constraints on this element

Element id

Medication.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Comments

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: N/A

modifierExtension

?! C

0..*

There are no (further) constraints on this element

Element id

Medication.modifierExtension

Short description

Extensions that cannot be ignored

Alternate names

extensions, user content

Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Comments

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: N/A

identifier

0..*

There are no (further) constraints on this element

Element id

Medication.identifier

Short description

Business identifier for this medication

Definition

Business identifier for this medication.

Comments

The serial number could be included as an identifier.

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

w5: FiveWs.identifier
rim: .id

code

S Σ

0..1

Element id

Medication.code

Short description

Medikament in codierter Form oder ggf. als Freitext

Definition

A code (or set of codes) that specify this medication, or a textual description if no code is available. Usage note: This could be a standard medication code such as a code from RxNorm, SNOMED CT, IDMP etc. It could also be a national or local formulary code, optionally with translations to other code systems.

Comments

Begründung des Must-Support: grundlegende Information

Data type

SNOMEDCTMedicationCodes (example)

Binding

A coded concept that defines the type of a medication.

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

script10.6: coding.code = //element(*,MedicationType)/DrugCoded/ProductCode coding.system = //element(*,MedicationType)/DrugCoded/ProductCodeQualifier coding.display = //element(*,MedicationType)/DrugDescription
w5: FiveWs.class
v2: RXO-1.1-Requested Give Code.code / RXE-2.1-Give Code.code / RXD-2.1-Dispense/Give Code.code / RXG-4.1-Give Code.code /RXA-5.1-Administered Code.code / RXC-2.1 Component Code
rim: .code

0..1

There are no (further) constraints on this element

Element id

Medication.code.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Medication.code.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a

coding

S Σ

0..*

Element id

Medication.code.coding

Short description

Code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Begründung des Must-Support: Medikamente MÜSSEN kodiert werden, hierfür kann eine PZN, ATC-Code oder SnomedCT Code verwendet werden

Data type

https://gematik.de/fhir/terminology/ValueSet/ti-medication-snomed-ct-vs (extensible)

Slicing

Unordered, Open, by $this(Pattern)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

PZN

S Σ

0..*

ISiKPZNCodingPattern

Element id

Medication.code.coding:PZN

Short description

A reference to a code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Merfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, bspw. existieren für Aspirin 3 verschiedene Packungsgrößen.

Data type

ISiKPZNCoding

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Pattern

{
  "system": "http://fhir.de/CodeSystem/ifa/pzn"
}

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
rim: n/a
v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

ATC-DE

S Σ

0..*

ISiKATCCodingPattern

Element id

Medication.code.coding:ATC-DE

Short description

A reference to a code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Merfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, bspw. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird.

Data type

ISiKATCCoding

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Pattern

{
  "system": "http://fhir.de/CodeSystem/bfarm/atc"
}

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
rim: n/a
v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

SCT

S Σ

0..1

ISiKSnomedCTCodingBindingPattern

Element id

Medication.code.coding:SCT

Short description

A reference to a code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.

Data type

ISiKSnomedCTCoding

Binding

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Pattern

{
  "system": "http://snomed.info/sct"
}

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
rim: n/a
v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

text

S Σ

0..1

Element id

Medication.code.text

Short description

Plain text representation of the concept

Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Begründung des Must-Support: Falls eine Kodierung nicht möglich ist kann das Medikament alternativ per Freitext erfasst werden

Data type

Medication Status Codes (required)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

v2: C*E.9. But note many systems use C*E.2 for this
rim: ./originalText[mediaType/code="text/plain"]/data
orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

status

S Σ ?!

1..1

codeBinding

Element id

Medication.status

Short description

Status der Medikamenteninformation

Definition

A code to indicate if the medication is in active use.

Comments

Begründung des Must-Support: Erforderliche Angabe im FHIR-Standard

Data type

code

Binding

A coded concept defining if the medication is in active use.

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: .statusCode

manufacturer

S Σ

0..1

Reference(Organization)

Element id

Medication.manufacturer

Short description

Hersteller des Medikaments

Definition

Describes the details of the manufacturer of the medication product. This is not intended to represent the distributor of a medication product.

Comments

Begründung des Must-Support: Alignment mit KBV-Profilen

Hinweis: Hier kann der tatsächliche Hersteller des Medikaments benannt werden, vornehmlich im Fall von Wirkstoffmischungen (Rezepturen), beispielsweise die Krankenhausapotheke. Zu beachten ist, dass die zulassende Organisation, wie sie z.B. in den Daten zur PZN benannt ist, nicht als Hersteller gilt.

Data type

Reference(Organization)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

script10.6: no mapping
w5: FiveWs.actor
v2: RXD-20-Substance Manufacturer Name / RXG-21-Substance Manufacturer Name / RXA-17-Substance Manufacturer Name
rim: .player.scopingRole[typeCode=MANU].scoper

0..1

There are no (further) constraints on this element

Element id

Medication.manufacturer.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Medication.manufacturer.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a

reference

Σ C

0..1

There are no (further) constraints on this element

Element id

Medication.manufacturer.reference

Short description

Literal reference, Relative, internal or absolute URL

Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ref-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: N/A

type

0..1

uriBinding

There are no (further) constraints on this element

Element id

Medication.manufacturer.type

Short description

Type the reference refers to (e.g. "Patient")

Definition

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

Comments

This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

Data type

Binding

Aa resource (or, for logical models, the URI of the logical model).

ResourceType (extensible)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: N/A

identifier

0..1

There are no (further) constraints on this element

Element id

Medication.manufacturer.identifier

Short description

Logical reference, when literal reference is not known

Definition

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

Comments

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: .identifier

display

S Σ

1..1

There are no (further) constraints on this element

Element id

Medication.manufacturer.display

Short description

Text alternative for the resource

Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: N/A

form

0..1

Element id

Medication.form

Short description

Abgabeform

Definition

Describes the form of the item. Powder; tablets; capsule.

Comments

Begründung des Must-Support: Basis-Information eines Medikaments

Data type

Binding

A coded concept defining the form of a medication.

SNOMEDCTFormCodes (example)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

script10.6: coding.code = //element(*,DrugCodedType)/FormCode coding.system = //element(*,DrugCodedType)/FormSourceCode
v2: RXO-5-Requested Dosage Form / RXE-6-Give Dosage Form / RXD-6-Actual Dosage Form / RXG-8-Give Dosage Form / RXA-8-Administered Dosage Form
rim: .formCode

0..1

There are no (further) constraints on this element

Element id

Medication.form.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Medication.form.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a

coding

S Σ

0..*

Element id

Medication.form.coding

Short description

Code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Begründung des Must-Support: EDQM definiert eine einheitliche DoseForm auf europäischer Ebene

Data type

http://hl7.org/fhir/uv/ips/ValueSet/medicine-doseform (required)

Slicing

Unordered, Open, by $this(Pattern)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

EDQM

S Σ

0..1

ISiKCodingBinding

Element id

Medication.form.coding:EDQM

Short description

A reference to a code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.

Data type

ISiKCoding

Binding

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
rim: n/a
v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

text

0..1

There are no (further) constraints on this element

Element id

Medication.form.text

Short description

Plain text representation of the concept

Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Requirements

Comments

Very often the text is the same as a displayName of one of the codings.

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

v2: C*E.9. But note many systems use C*E.2 for this
rim: ./originalText[mediaType/code="text/plain"]/data
orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

amount

S Σ

0..1

Element id

Medication.amount

Short description

Menge

Definition

Specific amount of the drug in the packaged product. For example, when specifying a product that has the same strength (For example, Insulin glargine 100 unit per mL solution for injection), this attribute provides additional clarification of the package amount (For example, 3 mL, 10mL, etc.).

Comments

Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: .quantity

0..1

There are no (further) constraints on this element

Element id

Medication.amount.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Medication.amount.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a

numerator

S Σ C

1..1

Element id

Medication.amount.numerator

Short description

A fixed quantity (no comparator)

Definition

The comparator is not used on a SimpleQuantity

Comments

Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
qty-3: If a code for the unit is present, the system SHALL also be present
code.empty() or system.exists()
sqty-1: The comparator is not used on a SimpleQuantity
comparator.empty()

Mappings

rim: .numerator
rim: n/a
v2: SN (see also Range) or CQ
rim: PQ, IVL<PQ>, MO, CO, depending on the values

denominator

S Σ C

1..1

Element id

Medication.amount.denominator

Short description

A fixed quantity (no comparator)

Definition

The comparator is not used on a SimpleQuantity

Comments

Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
qty-3: If a code for the unit is present, the system SHALL also be present
code.empty() or system.exists()
sqty-1: The comparator is not used on a SimpleQuantity
comparator.empty()

Mappings

rim: .denominator
rim: n/a
v2: SN (see also Range) or CQ
rim: PQ, IVL<PQ>, MO, CO, depending on the values

ingredient

0..*

Element id

Medication.ingredient

Short description

Informationen zu Bestandteilen (Rezeptur)

Definition

Identifies a particular constituent of interest in the product.

Comments

Begründung des Must-Support: Wirkstoff-Rezepturen müssen dokumentierbar sein

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: .scopesRole[typeCode=INGR]

0..1

There are no (further) constraints on this element

Element id

Medication.ingredient.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

S C

0..*

Element id

Medication.ingredient.extension

Short description

Wirkstofftyp

Alternate names

extensions, user content

Definition

Comments

Begründung des Must-Support: Alignment mit den MII-Profilen

Hinweis: Hiermit kann geklärt werden, ob es sich um eine Angabe zum Wirkstoff oder zum exakten Inhaltsstoff (z.B. Salze) handelt.

Data type

http://fhir.de/StructureDefinition/WirkstofftypEX

Slicing

Unordered, Open, by url(Value)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a

wirkstofftyp

S C

0..1

Extension(Coding)

Element id

Medication.ingredient.extension:wirkstofftyp

Short description

Optional Extensions Element

Alternate names

extensions, user content

Definition

Optional Extension Element - found in all resources.

Comments

Data type

Extension(Coding)

Extension URL

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

modifierExtension

Σ ?! C

0..*

There are no (further) constraints on this element

Element id

Medication.ingredient.modifierExtension

Short description

Extensions that cannot be ignored even if unrecognized

Alternate names

extensions, user content, modifiers

Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Requirements

Comments

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: N/A

item[x]

1..1

Element id

Medication.ingredient.item[x]

Short description

The actual ingredient or content

Definition

The actual ingredient - either a substance (simple ingredient) or another medication of a medication.

Requirements

The ingredient may reference a substance (for example, amoxicillin) or another medication (for example in the case of a compounded product, Glaxal Base).

Slicing

Unordered, Open, by $this(Type)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

script10.6: coding.code = //element(*,MedicationType)/DrugCoded/ProductCode coding.system = //element(*,MedicationType)/DrugCoded/ProductCodeQualifier coding.display = //element(*,MedicationType)/DrugDescription
v2: RXC-2-Component Code if medication: RXO-1-Requested Give Code / RXE-2-Give Code / RXD-2-Dispense/Give Code / RXG-4-Give Code / RXA-5-Administered Code
rim: .player

itemCodeableConcept

0..1

Element id

Medication.ingredient.item[x]:itemCodeableConcept

Short description

Bestandteil in codierter Form oder ggf. als Freitext

Definition

The actual ingredient - either a substance (simple ingredient) or another medication of a medication.

Requirements

The ingredient may reference a substance (for example, amoxicillin) or another medication (for example in the case of a compounded product, Glaxal Base).

Comments

Begründung des Must-Support: Der Bestandteil muss eindeutig benannt sein

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

script10.6: coding.code = //element(*,MedicationType)/DrugCoded/ProductCode coding.system = //element(*,MedicationType)/DrugCoded/ProductCodeQualifier coding.display = //element(*,MedicationType)/DrugDescription
v2: RXC-2-Component Code if medication: RXO-1-Requested Give Code / RXE-2-Give Code / RXD-2-Dispense/Give Code / RXG-4-Give Code / RXA-5-Administered Code
rim: .player

0..1

There are no (further) constraints on this element

Element id

Medication.ingredient.item[x]:itemCodeableConcept.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Medication.ingredient.item[x]:itemCodeableConcept.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a

coding

S Σ

0..*

Element id

Medication.ingredient.item[x]:itemCodeableConcept.coding

Short description

Code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Data type

Slicing

Unordered, Open, by $this(Pattern)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

ASK

S Σ

0..1

ISiKASKCodingPattern

Element id

Medication.ingredient.item[x]:itemCodeableConcept.coding:ASK

Short description

A reference to a code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.

Data type

ISiKASKCoding

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Pattern

{
  "system": "http://fhir.de/CodeSystem/ask"
}

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
rim: n/a
v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

ATC-DE

S Σ

0..1

ISiKATCCodingPattern

Element id

Medication.ingredient.item[x]:itemCodeableConcept.coding:ATC-DE

Short description

A reference to a code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, z. B. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird.

Data type

ISiKATCCoding

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Pattern

{
  "system": "http://fhir.de/CodeSystem/bfarm/atc"
}

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
rim: n/a
v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

PZN

S Σ

0..1

ISiKPZNCodingPattern

Element id

Medication.ingredient.item[x]:itemCodeableConcept.coding:PZN

Short description

A reference to a code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, z. B. existieren für Aspirin 3 verschiedene Packungsgrößen.

Data type

ISiKPZNCoding

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Pattern

{
  "system": "http://fhir.de/CodeSystem/ifa/pzn"
}

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
rim: n/a
v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

SCT

S Σ

0..1

ISiKSnomedCTCodingPattern

Element id

Medication.ingredient.item[x]:itemCodeableConcept.coding:SCT

Short description

A reference to a code defined by a terminology system

Definition

A reference to a code defined by a terminology system.

Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.

Data type

ISiKSnomedCTCoding

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Pattern

{
  "system": "http://snomed.info/sct"
}

Mappings

v2: C*E.1-8, C*E.10-22
rim: union(., ./translation)
orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
rim: n/a
v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

text

S Σ

0..1

There are no (further) constraints on this element

Element id

Medication.ingredient.item[x]:itemCodeableConcept.text

Short description

Plain text representation of the concept

Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Requirements

Comments

Very often the text is the same as a displayName of one of the codings.

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

v2: C*E.9. But note many systems use C*E.2 for this
rim: ./originalText[mediaType/code="text/plain"]/data
orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

itemReference

0..1

Reference(Substance | Medication)

Element id

Medication.ingredient.item[x]:itemReference

Short description

Bestandteil (Referenz auf ein anderes Medikament)

Definition

The actual ingredient - either a substance (simple ingredient) or another medication of a medication.

Requirements

The ingredient may reference a substance (for example, amoxicillin) or another medication (for example in the case of a compounded product, Glaxal Base).

Comments

Begründung des Must-Support: Der Bestandteil muss eindeutig benannt sein

Data type

Reference(Substance | Medication)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

script10.6: coding.code = //element(*,MedicationType)/DrugCoded/ProductCode coding.system = //element(*,MedicationType)/DrugCoded/ProductCodeQualifier coding.display = //element(*,MedicationType)/DrugDescription
v2: RXC-2-Component Code if medication: RXO-1-Requested Give Code / RXE-2-Give Code / RXD-2-Dispense/Give Code / RXG-4-Give Code / RXA-5-Administered Code
rim: .player

0..1

There are no (further) constraints on this element

Element id

Medication.ingredient.item[x]:itemReference.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Medication.ingredient.item[x]:itemReference.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a

reference

S Σ C

1..1

There are no (further) constraints on this element

Element id

Medication.ingredient.item[x]:itemReference.reference

Short description

Literal reference, Relative, internal or absolute URL

Definition

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ref-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: N/A

type

0..1

uriBinding

There are no (further) constraints on this element

Element id

Medication.ingredient.item[x]:itemReference.type

Short description

Type the reference refers to (e.g. "Patient")

Definition

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

Comments

Data type

Binding

Aa resource (or, for logical models, the URI of the logical model).

ResourceType (extensible)

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: N/A

identifier

0..1

There are no (further) constraints on this element

Element id

Medication.ingredient.item[x]:itemReference.identifier

Short description

Logical reference, when literal reference is not known

Definition

Comments

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: .identifier

display

0..1

There are no (further) constraints on this element

Element id

Medication.ingredient.item[x]:itemReference.display

Short description

Text alternative for the resource

Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: N/A

isActive

0..1

boolean

Element id

Medication.ingredient.isActive

Short description

handelt es sich um einen aktiven Bestandteil?

Definition

Indication of whether this ingredient affects the therapeutic action of the drug.

Requirements

True indicates that the ingredient affects the therapeutic action of the drug (i.e. active). False indicates that the ingredient does not affect the therapeutic action of the drug (i.e. inactive).

Comments

Begründung des Must-Support: Wird eine vollständige Rezeptur dokumentiert, muss erkennbar sein, welches die Wirkstoffe sind

Data type

boolean

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: NA

strength

0..1

Element id

Medication.ingredient.strength

Short description

Stärke

Definition

Specifies how many (or how much) of the items there are in this Medication. For example, 250 mg per tablet. This is expressed as a ratio where the numerator is 250mg and the denominator is 1 tablet.

Comments

Begründung des Must-Support: Basisinformation in Rezepturen

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

script10.6: //element(*,DrugCodedType)/Strength
v2: RXC-3-Component Amount & RXC-4-Component Units if medication: RXO-2-Requested Give Amount - Minimum & RXO-4-Requested Give Units / RXO-3-Requested Give Amount - Maximum & RXO-4-Requested Give Units / RXO-11-Requested Dispense Amount & RXO-12-Requested Dispense Units / RXE-3-Give Amount - Minimum & RXE-5-Give Units / RXE-4-Give Amount - Maximum & RXE-5-Give Units / RXE-10-Dispense Amount & RXE-10-Dispense Units
rim: .quantity

0..1

There are no (further) constraints on this element

Element id

Medication.ingredient.strength.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Medication.ingredient.strength.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a

numerator

S Σ C

1..1

Element id

Medication.ingredient.strength.numerator

Short description

A fixed quantity (no comparator)

Definition

The comparator is not used on a SimpleQuantity

Comments

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
qty-3: If a code for the unit is present, the system SHALL also be present
code.empty() or system.exists()
sqty-1: The comparator is not used on a SimpleQuantity
comparator.empty()

Mappings

rim: .numerator
rim: n/a
v2: SN (see also Range) or CQ
rim: PQ, IVL<PQ>, MO, CO, depending on the values

denominator

S Σ C

1..1

Element id

Medication.ingredient.strength.denominator

Short description

A fixed quantity (no comparator)

Definition

The comparator is not used on a SimpleQuantity

Comments

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
qty-3: If a code for the unit is present, the system SHALL also be present
code.empty() or system.exists()
sqty-1: The comparator is not used on a SimpleQuantity
comparator.empty()

Mappings

rim: .denominator
rim: n/a
v2: SN (see also Range) or CQ
rim: PQ, IVL<PQ>, MO, CO, depending on the values

batch

0..1

Element id

Medication.batch

Short description

Angaben zur Charge

Definition

Information that only applies to packages (not products).

Comments

Begründung des Must-Support: erforderlich zur Dokumentation der Chargennummer

Hinweis: Bitte beachten Sie gegebenenfalls die Regelungen der zwischen GKV-SV und DAV: https://www.gkv-datenaustausch.de/leistungserbringer/apotheken/apotheken.jsp . Insbesondere den Technischen Anhang 7 (TA7) zur Arzneimittelabrechnungsvereinbarung gemäß § 300 Absatz 3 SGB V in der aktuellsten Fassung.

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

script10.6: no mapping
rim: .player[classCode=CONT]

0..1

There are no (further) constraints on this element

Element id

Medication.batch.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Medication.batch.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a

modifierExtension

Σ ?! C

0..*

There are no (further) constraints on this element

Element id

Medication.batch.modifierExtension

Short description

Extensions that cannot be ignored even if unrecognized

Alternate names

extensions, user content, modifiers

Definition

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Requirements

Comments

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: N/A

lotNumber

0..1

Element id

Medication.batch.lotNumber

Short description

Chargennummer

Definition

The assigned lot number of a batch of the specified product.

Comments

Begründung des Must-Support: Therapiesicherheit und Nachvollziehbarkeit

Hinweis: Gemäß Anlage 1 der TA7 kann hier übergangsweise bis zum 30. Juni 2025 eine Musterchargennummer ("STELLEN") eingetragen werden. Wenn die Übermittlung der Chargenbezeichnung beim Stellen von Arzneimitteln technisch nicht möglich ist, z.B. beim Verblistern, wird von der Verpflichtung zur Chargendokumentation abgesehen. Dementsprechend kann anstatt der tatsächlichen Chargenbezeichnungen "STELLEN" in das hierbeschirebene Datenfeld eingetragen werden.

Data type

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

script10.6: no mapping
v2: RXA-15 Substance Lot Number / RXG-19 Substance Lot Number
rim: .id

expirationDate

0..1

dateTime

There are no (further) constraints on this element

Element id

Medication.batch.expirationDate

Short description

When batch will expire

Definition

When this specific batch of product will expire.

Data type

dateTime

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

script10.6: no mapping
v2: RXA-16 Substance Expiration Date / RXG-20 Substance Expiration Date
rim: participation[typeCode=CSM].role[classCode=INST].scopedRole.scoper[classCode=MMAT].expirationTime

<id value="ISiKMedikament" />
<url value="https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament" />
<version value="5.1.0" />
<name value="ISiKMedikament" />
<status value="active" />
<experimental value="false" />
<date value="2025-10-23" />
<publisher value="gematik GmbH" />
<description value="Dieses Profil ermöglicht die Abbildung von patientenunabhängigen Informationen zu Medikamenten in ISiK Szenarien." />
<fhirVersion value="4.0.1" />
<kind value="resource" />
<abstract value="false" />
<type value="Medication" />
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/Medication" />
<derivation value="constraint" />
<differential>
<element id="Medication">
<path value="Medication" />
<constraint>
<key value="isik-med-1" />
<severity value="error" />
<human value="Medikamenten-Code, -Bezeichnung oder Inhaltsstoffe müssen angegeben werden." />
<expression value="code.exists() or ingredient.exists()" />
<source value="https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament" />
</constraint>
</element>
<element id="Medication.id">
<path value="Medication.id" />
<short value="serverseitige, interne ID des Datensatzes" />
<comment value="**bedingtes Pflichtfeld/bedingtes MS:** Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine `id` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `id`verfügen." />
<mustSupport value="true" />
</element>
<element id="Medication.meta.versionId">
<path value="Medication.meta.versionId" />
<short value="Eindeutiger Name der serverseitigen Version des Datensatzes" />
<comment value="Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine `versionID` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `versionID`verfügen." />
</element>
<element id="Medication.meta.lastUpdated">
<path value="Medication.meta.lastUpdated" />
<short value="Zeitpunkt der letzten Änderung" />
<comment value="Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein `lastUpdate` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein `lastUpdate`verfügen." />
</element>
<element id="Medication.code">
<path value="Medication.code" />
<short value="Medikament in codierter Form oder ggf. als Freitext" />
<comment value="Begründung des Must-Support: grundlegende Information" />
<mustSupport value="true" />
</element>
<element id="Medication.code.coding">
<path value="Medication.code.coding" />
<slicing>
<discriminator>
<type value="pattern" />
<path value="$this" />
</discriminator>
<rules value="open" />
</slicing>
<comment value="Begründung des Must-Support: Medikamente MÜSSEN kodiert werden, hierfür kann eine PZN, ATC-Code oder SnomedCT Code verwendet werden" />
<mustSupport value="true" />
</element>
<element id="Medication.code.coding:PZN">
<path value="Medication.code.coding" />
<sliceName value="PZN" />
<comment value="Merfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, bspw. existieren für Aspirin 3 verschiedene Packungsgrößen." />
<min value="0" />
<max value="*" />
<type>
<code value="Coding" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/ISiKPZNCoding" />
</type>
<patternCoding>
<system value="http://fhir.de/CodeSystem/ifa/pzn" />
</patternCoding>
<mustSupport value="true" />
</element>
<element id="Medication.code.coding:ATC-DE">
<path value="Medication.code.coding" />
<sliceName value="ATC-DE" />
<comment value="Merfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, bspw. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird." />
<min value="0" />
<max value="*" />
<type>
<code value="Coding" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/ISiKATCCoding" />
</type>
<patternCoding>
<system value="http://fhir.de/CodeSystem/bfarm/atc" />
</patternCoding>
<mustSupport value="true" />
</element>
<element id="Medication.code.coding:SCT">
<path value="Medication.code.coding" />
<sliceName value="SCT" />
<min value="0" />
<max value="1" />
<type>
<code value="Coding" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/ISiKSnomedCTCoding" />
</type>
<patternCoding>
<system value="http://snomed.info/sct" />
</patternCoding>
<mustSupport value="true" />
<binding>
<strength value="extensible" />
<valueSet value="https://gematik.de/fhir/terminology/ValueSet/ti-medication-snomed-ct-vs" />
</binding>
</element>
<element id="Medication.code.text">
<path value="Medication.code.text" />
<comment value="Begründung des Must-Support: Falls eine Kodierung nicht möglich ist kann das Medikament alternativ per Freitext erfasst werden" />
<mustSupport value="true" />
</element>
<element id="Medication.status">
<path value="Medication.status" />
<short value="Status der Medikamenteninformation" />
<comment value="Begründung des Must-Support: Erforderliche Angabe im FHIR-Standard" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="Medication.manufacturer">
<path value="Medication.manufacturer" />
<short value="Hersteller des Medikaments" />
<comment value="Begründung des Must-Support: Alignment mit KBV-Profilen\n\n  Hinweis: Hier kann der tatsächliche Hersteller des Medikaments benannt werden, vornehmlich im Fall von Wirkstoffmischungen (Rezepturen), beispielsweise die Krankenhausapotheke. Zu beachten ist, dass die zulassende Organisation, wie sie z.B. in den Daten zur PZN benannt ist, nicht als Hersteller gilt." />
<mustSupport value="true" />
</element>
<element id="Medication.manufacturer.display">
<path value="Medication.manufacturer.display" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="Medication.form">
<path value="Medication.form" />
<short value="Abgabeform" />
<comment value="Begründung des Must-Support: Basis-Information eines Medikaments" />
<mustSupport value="true" />
</element>
<element id="Medication.form.coding">
<path value="Medication.form.coding" />
<slicing>
<discriminator>
<type value="pattern" />
<path value="$this" />
</discriminator>
<rules value="open" />
</slicing>
<comment value="Begründung des Must-Support: EDQM definiert eine einheitliche DoseForm auf europäischer Ebene" />
<mustSupport value="true" />
</element>
<element id="Medication.form.coding:EDQM">
<path value="Medication.form.coding" />
<sliceName value="EDQM" />
<min value="0" />
<max value="1" />
<type>
<code value="Coding" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/ISiKCoding" />
</type>
<mustSupport value="true" />
<binding>
<strength value="required" />
<valueSet value="http://hl7.org/fhir/uv/ips/ValueSet/medicine-doseform" />
</binding>
</element>
<element id="Medication.amount">
<path value="Medication.amount" />
<short value="Menge" />
<comment value="Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein" />
<mustSupport value="true" />
</element>
<element id="Medication.amount.numerator">
<path value="Medication.amount.numerator" />
<comment value="Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein" />
<min value="1" />
<type>
<code value="Quantity" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/MedicationQuantity" />
</type>
<mustSupport value="true" />
</element>
<element id="Medication.amount.denominator">
<path value="Medication.amount.denominator" />
<comment value="Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein" />
<min value="1" />
<type>
<code value="Quantity" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/MedicationQuantity" />
</type>
<mustSupport value="true" />
</element>
<element id="Medication.ingredient">
<path value="Medication.ingredient" />
<short value="Informationen zu Bestandteilen (Rezeptur)" />
<comment value="Begründung des Must-Support: Wirkstoff-Rezepturen müssen dokumentierbar sein" />
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.extension">
<path value="Medication.ingredient.extension" />
<short value="Wirkstofftyp" />
<comment value="Begründung des Must-Support: Alignment mit den MII-Profilen\n\n    Hinweis: Hiermit kann geklärt werden, ob es sich um eine Angabe zum Wirkstoff oder zum exakten Inhaltsstoff (z.B. Salze) handelt." />
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.extension:wirkstofftyp">
<path value="Medication.ingredient.extension" />
<sliceName value="wirkstofftyp" />
<min value="0" />
<max value="1" />
<type>
<code value="Extension" />
<profile value="http://fhir.de/StructureDefinition/WirkstofftypEX" />
</type>
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.item[x]">
<path value="Medication.ingredient.item[x]" />
<slicing>
<discriminator>
<type value="type" />
<path value="$this" />
</discriminator>
<ordered value="false" />
<rules value="open" />
</slicing>
</element>
<element id="Medication.ingredient.item[x]:itemCodeableConcept">
<path value="Medication.ingredient.item[x]" />
<sliceName value="itemCodeableConcept" />
<short value="Bestandteil in codierter Form oder ggf. als Freitext" />
<comment value="Begründung des Must-Support: Der Bestandteil muss eindeutig benannt sein" />
<min value="0" />
<max value="1" />
<type>
<code value="CodeableConcept" />
</type>
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.item[x]:itemCodeableConcept.coding">
<path value="Medication.ingredient.item[x].coding" />
<slicing>
<discriminator>
<type value="pattern" />
<path value="$this" />
</discriminator>
<rules value="open" />
</slicing>
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.item[x]:itemCodeableConcept.coding:ASK">
<path value="Medication.ingredient.item[x].coding" />
<sliceName value="ASK" />
<min value="0" />
<max value="1" />
<type>
<code value="Coding" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/ISiKASKCoding" />
</type>
<patternCoding>
<system value="http://fhir.de/CodeSystem/ask" />
</patternCoding>
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.item[x]:itemCodeableConcept.coding:ATC-DE">
<path value="Medication.ingredient.item[x].coding" />
<sliceName value="ATC-DE" />
<comment value="Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, z. B. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird." />
<min value="0" />
<max value="1" />
<type>
<code value="Coding" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/ISiKATCCoding" />
</type>
<patternCoding>
<system value="http://fhir.de/CodeSystem/bfarm/atc" />
</patternCoding>
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.item[x]:itemCodeableConcept.coding:PZN">
<path value="Medication.ingredient.item[x].coding" />
<sliceName value="PZN" />
<comment value="Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, z. B. existieren für Aspirin 3 verschiedene Packungsgrößen." />
<min value="0" />
<max value="1" />
<type>
<code value="Coding" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/ISiKPZNCoding" />
</type>
<patternCoding>
<system value="http://fhir.de/CodeSystem/ifa/pzn" />
</patternCoding>
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.item[x]:itemCodeableConcept.coding:SCT">
<path value="Medication.ingredient.item[x].coding" />
<sliceName value="SCT" />
<min value="0" />
<max value="1" />
<type>
<code value="Coding" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/ISiKSnomedCTCoding" />
</type>
<patternCoding>
<system value="http://snomed.info/sct" />
</patternCoding>
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.item[x]:itemCodeableConcept.text">
<path value="Medication.ingredient.item[x].text" />
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.item[x]:itemReference">
<path value="Medication.ingredient.item[x]" />
<sliceName value="itemReference" />
<short value="Bestandteil (Referenz auf ein anderes Medikament)" />
<comment value="Begründung des Must-Support: Der Bestandteil muss eindeutig benannt sein" />
<min value="0" />
<max value="1" />
<type>
<code value="Reference" />
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Substance" />
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Medication" />
</type>
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.item[x]:itemReference.reference">
<path value="Medication.ingredient.item[x].reference" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.isActive">
<path value="Medication.ingredient.isActive" />
<short value="handelt es sich um einen aktiven Bestandteil?" />
<comment value="Begründung des Must-Support: Wird eine vollständige Rezeptur dokumentiert, muss erkennbar sein, welches die Wirkstoffe sind" />
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.strength">
<path value="Medication.ingredient.strength" />
<short value="Stärke" />
<comment value="Begründung des Must-Support: Basisinformation in Rezepturen" />
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.strength.numerator">
<path value="Medication.ingredient.strength.numerator" />
<min value="1" />
<type>
<code value="Quantity" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/MedicationQuantity" />
</type>
<mustSupport value="true" />
</element>
<element id="Medication.ingredient.strength.denominator">
<path value="Medication.ingredient.strength.denominator" />
<min value="1" />
<type>
<code value="Quantity" />
<profile value="https://gematik.de/fhir/isik/StructureDefinition/MedicationQuantity" />
</type>
<mustSupport value="true" />
</element>
<element id="Medication.batch">
<path value="Medication.batch" />
<short value="Angaben zur Charge" />
<comment value="Begründung des Must-Support: erforderlich zur Dokumentation der Chargennummer\n\n  Hinweis: Bitte beachten Sie gegebenenfalls die Regelungen der zwischen GKV-SV und DAV: https://www.gkv-datenaustausch.de/leistungserbringer/apotheken/apotheken.jsp . Insbesondere den Technischen Anhang 7 (TA7) zur Arzneimittelabrechnungsvereinbarung gemäß § 300 Absatz 3 SGB V in der aktuellsten Fassung." />
<mustSupport value="true" />
</element>
<element id="Medication.batch.lotNumber">
<path value="Medication.batch.lotNumber" />
<short value="Chargennummer" />
<comment value="Begründung des Must-Support: Therapiesicherheit und Nachvollziehbarkeit\n\n    Hinweis: Gemäß Anlage 1 der TA7 kann hier übergangsweise bis zum 30. Juni 2025 eine Musterchargennummer ("STELLEN") eingetragen werden. Wenn die Übermittlung der Chargenbezeichnung beim Stellen von Arzneimitteln technisch nicht möglich ist, z.B. beim Verblistern, wird von der Verpflichtung zur Chargendokumentation abgesehen. Dementsprechend kann anstatt der tatsächlichen Chargenbezeichnungen "STELLEN" in das hierbeschirebene Datenfeld eingetragen werden." />
<mustSupport value="true" />
</element>
</differential>

</StructureDefinition>

{

"resourceType": "StructureDefinition",
"id": "ISiKMedikament",
"url": "https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament",
"version": "5.1.0",
"name": "ISiKMedikament",
"status": "active",
"experimental": false,
"date": "2025-10-23",
"publisher": "gematik GmbH",
"description": "Dieses Profil ermöglicht die Abbildung von patientenunabhängigen Informationen zu Medikamenten in ISiK Szenarien.",
"fhirVersion": "4.0.1",
"kind": "resource",
"abstract": false,
"type": "Medication",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Medication",
"derivation": "constraint",
"differential": {
"element": [
{
"id": "Medication",
"path": "Medication",
"constraint": [
{
"key": "isik-med-1",
"severity": "error",
"human": "Medikamenten-Code, -Bezeichnung oder Inhaltsstoffe müssen angegeben werden.",
"expression": "code.exists() or ingredient.exists()",
"source": "https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament"
}
]
},
{
"id": "Medication.id",
"path": "Medication.id",
"short": "serverseitige, interne ID des Datensatzes",
"comment": "**bedingtes Pflichtfeld/bedingtes MS:** Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine `id` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `id`verfügen.",
"mustSupport": true
},
{
"id": "Medication.meta.versionId",
"path": "Medication.meta.versionId",
"short": "Eindeutiger Name der serverseitigen Version des Datensatzes",
"comment": "Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine `versionID` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `versionID`verfügen."
},
{
"id": "Medication.meta.lastUpdated",
"path": "Medication.meta.lastUpdated",
"short": "Zeitpunkt der letzten Änderung",
"comment": "Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein `lastUpdate` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein `lastUpdate`verfügen."
},
{
"id": "Medication.code",
"path": "Medication.code",
"short": "Medikament in codierter Form oder ggf. als Freitext",
"comment": "Begründung des Must-Support: grundlegende Information",
"mustSupport": true
},
{
"id": "Medication.code.coding",
"path": "Medication.code.coding",
"slicing": {
"discriminator": [
{
"type": "pattern",
"path": "$this"
}
],
"rules": "open"
},
"comment": "Begründung des Must-Support: Medikamente MÜSSEN kodiert werden, hierfür kann eine PZN, ATC-Code oder SnomedCT Code verwendet werden",
"mustSupport": true
},
{
"id": "Medication.code.coding:PZN",
"path": "Medication.code.coding",
"sliceName": "PZN",
"comment": "Merfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, bspw. existieren für Aspirin 3 verschiedene Packungsgrößen.",
"min": 0,
"max": "*",
"type": [
{
"code": "Coding",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/ISiKPZNCoding"
]
}
],
"patternCoding": {
"system": "http://fhir.de/CodeSystem/ifa/pzn"
},
"mustSupport": true
},
{
"id": "Medication.code.coding:ATC-DE",
"path": "Medication.code.coding",
"sliceName": "ATC-DE",
"comment": "Merfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, bspw. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird.",
"min": 0,
"max": "*",
"type": [
{
"code": "Coding",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/ISiKATCCoding"
]
}
],
"patternCoding": {
"system": "http://fhir.de/CodeSystem/bfarm/atc"
},
"mustSupport": true
},
{
"id": "Medication.code.coding:SCT",
"path": "Medication.code.coding",
"sliceName": "SCT",
"min": 0,
"max": "1",
"type": [
{
"code": "Coding",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/ISiKSnomedCTCoding"
]
}
],
"patternCoding": {
"system": "http://snomed.info/sct"
},
"mustSupport": true,
"binding": {
"strength": "extensible",
"valueSet": "https://gematik.de/fhir/terminology/ValueSet/ti-medication-snomed-ct-vs"
}
},
{
"id": "Medication.code.text",
"path": "Medication.code.text",
"comment": "Begründung des Must-Support: Falls eine Kodierung nicht möglich ist kann das Medikament alternativ per Freitext erfasst werden",
"mustSupport": true
},
{
"id": "Medication.status",
"path": "Medication.status",
"short": "Status der Medikamenteninformation",
"comment": "Begründung des Must-Support: Erforderliche Angabe im FHIR-Standard",
"min": 1,
"mustSupport": true
},
{
"id": "Medication.manufacturer",
"path": "Medication.manufacturer",
"short": "Hersteller des Medikaments",
"comment": "Begründung des Must-Support: Alignment mit KBV-Profilen\n\n  Hinweis: Hier kann der tatsächliche Hersteller des Medikaments benannt werden, vornehmlich im Fall von Wirkstoffmischungen (Rezepturen), beispielsweise die Krankenhausapotheke. Zu beachten ist, dass die zulassende Organisation, wie sie z.B. in den Daten zur PZN benannt ist, nicht als Hersteller gilt.",
"mustSupport": true
},
{
"id": "Medication.manufacturer.display",
"path": "Medication.manufacturer.display",
"min": 1,
"mustSupport": true
},
{
"id": "Medication.form",
"path": "Medication.form",
"short": "Abgabeform",
"comment": "Begründung des Must-Support: Basis-Information eines Medikaments",
"mustSupport": true
},
{
"id": "Medication.form.coding",
"path": "Medication.form.coding",
"slicing": {
"discriminator": [
{
"type": "pattern",
"path": "$this"
}
],
"rules": "open"
},
"comment": "Begründung des Must-Support: EDQM definiert eine einheitliche DoseForm auf europäischer Ebene",
"mustSupport": true
},
{
"id": "Medication.form.coding:EDQM",
"path": "Medication.form.coding",
"sliceName": "EDQM",
"min": 0,
"max": "1",
"type": [
{
"code": "Coding",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/ISiKCoding"
]
}
],
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/ips/ValueSet/medicine-doseform"
}
},
{
"id": "Medication.amount",
"path": "Medication.amount",
"short": "Menge",
"comment": "Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein",
"mustSupport": true
},
{
"id": "Medication.amount.numerator",
"path": "Medication.amount.numerator",
"comment": "Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein",
"min": 1,
"type": [
{
"code": "Quantity",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/MedicationQuantity"
]
}
],
"mustSupport": true
},
{
"id": "Medication.amount.denominator",
"path": "Medication.amount.denominator",
"comment": "Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein",
"min": 1,
"type": [
{
"code": "Quantity",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/MedicationQuantity"
]
}
],
"mustSupport": true
},
{
"id": "Medication.ingredient",
"path": "Medication.ingredient",
"short": "Informationen zu Bestandteilen (Rezeptur)",
"comment": "Begründung des Must-Support: Wirkstoff-Rezepturen müssen dokumentierbar sein",
"mustSupport": true
},
{
"id": "Medication.ingredient.extension",
"path": "Medication.ingredient.extension",
"short": "Wirkstofftyp",
"comment": "Begründung des Must-Support: Alignment mit den MII-Profilen\n\n    Hinweis: Hiermit kann geklärt werden, ob es sich um eine Angabe zum Wirkstoff oder zum exakten Inhaltsstoff (z.B. Salze) handelt.",
"mustSupport": true
},
{
"id": "Medication.ingredient.extension:wirkstofftyp",
"path": "Medication.ingredient.extension",
"sliceName": "wirkstofftyp",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"http://fhir.de/StructureDefinition/WirkstofftypEX"
]
}
],
"mustSupport": true
},
{
"id": "Medication.ingredient.item[x]",
"path": "Medication.ingredient.item[x]",
"slicing": {
"discriminator": [
{
"type": "type",
"path": "$this"
}
],
"ordered": false,
"rules": "open"
}
},
{
"id": "Medication.ingredient.item[x]:itemCodeableConcept",
"path": "Medication.ingredient.item[x]",
"sliceName": "itemCodeableConcept",
"short": "Bestandteil in codierter Form oder ggf. als Freitext",
"comment": "Begründung des Must-Support: Der Bestandteil muss eindeutig benannt sein",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"mustSupport": true
},
{
"id": "Medication.ingredient.item[x]:itemCodeableConcept.coding",
"path": "Medication.ingredient.item[x].coding",
"slicing": {
"discriminator": [
{
"type": "pattern",
"path": "$this"
}
],
"rules": "open"
},
"mustSupport": true
},
{
"id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ASK",
"path": "Medication.ingredient.item[x].coding",
"sliceName": "ASK",
"min": 0,
"max": "1",
"type": [
{
"code": "Coding",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/ISiKASKCoding"
]
}
],
"patternCoding": {
"system": "http://fhir.de/CodeSystem/ask"
},
"mustSupport": true
},
{
"id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ATC-DE",
"path": "Medication.ingredient.item[x].coding",
"sliceName": "ATC-DE",
"comment": "Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, z. B. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird.",
"min": 0,
"max": "1",
"type": [
{
"code": "Coding",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/ISiKATCCoding"
]
}
],
"patternCoding": {
"system": "http://fhir.de/CodeSystem/bfarm/atc"
},
"mustSupport": true
},
{
"id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:PZN",
"path": "Medication.ingredient.item[x].coding",
"sliceName": "PZN",
"comment": "Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, z. B. existieren für Aspirin 3 verschiedene Packungsgrößen.",
"min": 0,
"max": "1",
"type": [
{
"code": "Coding",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/ISiKPZNCoding"
]
}
],
"patternCoding": {
"system": "http://fhir.de/CodeSystem/ifa/pzn"
},
"mustSupport": true
},
{
"id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:SCT",
"path": "Medication.ingredient.item[x].coding",
"sliceName": "SCT",
"min": 0,
"max": "1",
"type": [
{
"code": "Coding",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/ISiKSnomedCTCoding"
]
}
],
"patternCoding": {
"system": "http://snomed.info/sct"
},
"mustSupport": true
},
{
"id": "Medication.ingredient.item[x]:itemCodeableConcept.text",
"path": "Medication.ingredient.item[x].text",
"mustSupport": true
},
{
"id": "Medication.ingredient.item[x]:itemReference",
"path": "Medication.ingredient.item[x]",
"sliceName": "itemReference",
"short": "Bestandteil (Referenz auf ein anderes Medikament)",
"comment": "Begründung des Must-Support: Der Bestandteil muss eindeutig benannt sein",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Substance",
"http://hl7.org/fhir/StructureDefinition/Medication"
]
}
],
"mustSupport": true
},
{
"id": "Medication.ingredient.item[x]:itemReference.reference",
"path": "Medication.ingredient.item[x].reference",
"min": 1,
"mustSupport": true
},
{
"id": "Medication.ingredient.isActive",
"path": "Medication.ingredient.isActive",
"short": "handelt es sich um einen aktiven Bestandteil?",
"comment": "Begründung des Must-Support: Wird eine vollständige Rezeptur dokumentiert, muss erkennbar sein, welches die Wirkstoffe sind",
"mustSupport": true
},
{
"id": "Medication.ingredient.strength",
"path": "Medication.ingredient.strength",
"short": "Stärke",
"comment": "Begründung des Must-Support: Basisinformation in Rezepturen",
"mustSupport": true
},
{
"id": "Medication.ingredient.strength.numerator",
"path": "Medication.ingredient.strength.numerator",
"min": 1,
"type": [
{
"code": "Quantity",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/MedicationQuantity"
]
}
],
"mustSupport": true
},
{
"id": "Medication.ingredient.strength.denominator",
"path": "Medication.ingredient.strength.denominator",
"min": 1,
"type": [
{
"code": "Quantity",
"profile": [
"https://gematik.de/fhir/isik/StructureDefinition/MedicationQuantity"
]
}
],
"mustSupport": true
},
{
"id": "Medication.batch",
"path": "Medication.batch",
"short": "Angaben zur Charge",
"comment": "Begründung des Must-Support: erforderlich zur Dokumentation der Chargennummer\n\n  Hinweis: Bitte beachten Sie gegebenenfalls die Regelungen der zwischen GKV-SV und DAV: https://www.gkv-datenaustausch.de/leistungserbringer/apotheken/apotheken.jsp . Insbesondere den Technischen Anhang 7 (TA7) zur Arzneimittelabrechnungsvereinbarung gemäß § 300 Absatz 3 SGB V in der aktuellsten Fassung.",
"mustSupport": true
},
{
"id": "Medication.batch.lotNumber",
"path": "Medication.batch.lotNumber",
"short": "Chargennummer",
"comment": "Begründung des Must-Support: Therapiesicherheit und Nachvollziehbarkeit\n\n    Hinweis: Gemäß Anlage 1 der TA7 kann hier übergangsweise bis zum 30. Juni 2025 eine Musterchargennummer (\"STELLEN\") eingetragen werden. Wenn die Übermittlung der Chargenbezeichnung beim Stellen von Arzneimitteln technisch nicht möglich ist, z.B. beim Verblistern, wird von der Verpflichtung zur Chargendokumentation abgesehen. Dementsprechend kann anstatt der tatsächlichen Chargenbezeichnungen \"STELLEN\" in das hierbeschirebene Datenfeld eingetragen werden.",
"mustSupport": true
}
]
}

}

ISiKMedikament

Constraints/Invarianten

Name	Schweregrad	Beschreibung	Ausdruck
isik-med-1	error	Medikamenten-Code, -Bezeichnung oder Inhaltsstoffe müssen angegeben werden.	code.exists() or ingredient.exists()

Terminology-Bindings

Element	Staerke	ValueSet
Medication.code.coding:SCT	extensible	https://gematik.de/fhir/terminology/ValueSet/ti-medication-snomed-ct-vs
Medication.form.coding:EDQM	required	http://hl7.org/fhir/uv/ips/ValueSet/medicine-doseform

Anmerkungen zu Must-Support-Feldern

Feldname	Kurzbeschreibung	Hinweise
Medication.id	serverseitige, interne ID des Datensatzes	bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine `id` verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `id`verfügen.
Medication.code	Medikament in codierter Form oder ggf. als Freitext	Begründung des Must-Support: grundlegende Information
Medication.code.coding		Begründung des Must-Support: Medikamente MÜSSEN kodiert werden, hierfür kann eine PZN, ATC-Code oder SnomedCT Code verwendet werden
Medication.code.coding:PZN		Merfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, bspw. existieren für Aspirin 3 verschiedene Packungsgrößen.
Medication.code.coding:ATC-DE		Merfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, bspw. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird.
Medication.code.coding:SCT
Medication.code.text		Begründung des Must-Support: Falls eine Kodierung nicht möglich ist kann das Medikament alternativ per Freitext erfasst werden
Medication.status	Status der Medikamenteninformation	Begründung des Must-Support: Erforderliche Angabe im FHIR-Standard
Medication.manufacturer	Hersteller des Medikaments	Begründung des Must-Support: Alignment mit KBV-Profilen Hinweis: Hier kann der tatsächliche Hersteller des Medikaments benannt werden, vornehmlich im Fall von Wirkstoffmischungen (Rezepturen), beispielsweise die Krankenhausapotheke. Zu beachten ist, dass die zulassende Organisation, wie sie z.B. in den Daten zur PZN benannt ist, nicht als Hersteller gilt.
Medication.manufacturer.display
Medication.form	Abgabeform	Begründung des Must-Support: Basis-Information eines Medikaments
Medication.form.coding		Begründung des Must-Support: EDQM definiert eine einheitliche DoseForm auf europäischer Ebene
Medication.form.coding:EDQM
Medication.amount	Menge	Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein
Medication.amount.numerator		Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein
Medication.amount.denominator		Begründung des Must-Support: Bei einer Medikation MUSS die Menge dokumentierbar sein
Medication.ingredient	Informationen zu Bestandteilen (Rezeptur)	Begründung des Must-Support: Wirkstoff-Rezepturen müssen dokumentierbar sein
Medication.ingredient.extension	Wirkstofftyp	Begründung des Must-Support: Alignment mit den MII-Profilen `Hinweis: Hiermit kann geklärt werden, ob es sich um eine Angabe zum Wirkstoff oder zum exakten Inhaltsstoff (z.B. Salze) handelt.`
Medication.ingredient.extension:wirkstofftyp
Medication.ingredient.item[x]:itemCodeableConcept	Bestandteil in codierter Form oder ggf. als Freitext	Begründung des Must-Support: Der Bestandteil muss eindeutig benannt sein
Medication.ingredient.item[x]:itemCodeableConcept.coding
Medication.ingredient.item[x]:itemCodeableConcept.coding:ASK
Medication.ingredient.item[x]:itemCodeableConcept.coding:ATC-DE		Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, z. B. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird.
Medication.ingredient.item[x]:itemCodeableConcept.coding:PZN		Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, z. B. existieren für Aspirin 3 verschiedene Packungsgrößen.
Medication.ingredient.item[x]:itemCodeableConcept.coding:SCT
Medication.ingredient.item[x]:itemCodeableConcept.text
Medication.ingredient.item[x]:itemReference	Bestandteil (Referenz auf ein anderes Medikament)	Begründung des Must-Support: Der Bestandteil muss eindeutig benannt sein
Medication.ingredient.item[x]:itemReference.reference
Medication.ingredient.isActive	handelt es sich um einen aktiven Bestandteil?	Begründung des Must-Support: Wird eine vollständige Rezeptur dokumentiert, muss erkennbar sein, welches die Wirkstoffe sind
Medication.ingredient.strength	Stärke	Begründung des Must-Support: Basisinformation in Rezepturen
Medication.ingredient.strength.numerator
Medication.ingredient.strength.denominator
Medication.batch	Angaben zur Charge	Begründung des Must-Support: erforderlich zur Dokumentation der Chargennummer Hinweis: Bitte beachten Sie gegebenenfalls die Regelungen der zwischen GKV-SV und DAV: https://www.gkv-datenaustausch.de/leistungserbringer/apotheken/apotheken.jsp . Insbesondere den Technischen Anhang 7 (TA7) zur Arzneimittelabrechnungsvereinbarung gemäß § 300 Absatz 3 SGB V in der aktuellsten Fassung.
Medication.batch.lotNumber	Chargennummer	Begründung des Must-Support: Therapiesicherheit und Nachvollziehbarkeit `Hinweis: Gemäß Anlage 1 der TA7 kann hier übergangsweise bis zum 30. Juni 2025 eine Musterchargennummer ("STELLEN") eingetragen werden. Wenn die Übermittlung der Chargenbezeichnung beim Stellen von Arzneimitteln technisch nicht möglich ist, z.B. beim Verblistern, wird von der Verpflichtung zur Chargendokumentation abgesehen. Dementsprechend kann anstatt der tatsächlichen Chargenbezeichnungen "STELLEN" in das hierbeschirebene Datenfeld eingetragen werden.`

Übergangslösung für die Chargendokumentation beim Verblistern

Für eine Einführung in den Sachverhalt, siehe Chargendokumentation: Lösung für Verblisterer gefunden. Die dort angesprochene Lösung kann gegebenenfalls auch auf den stationären Sektor übertragen werden und im Modul ISiK Medikation Anwendung finden.

`Medication.lot-number`

Bedeutung: Chargennummer

Hinweise: Bitte beachten Sie gegebenenfalls die Regelungen der zwischen GKV-SV und DAV für den Bereich der Apotheken. Insbesondere den Technischen Anhang 7 (TA7) zur Arzneimittelabrechnungsvereinbarung gemäß § 300 Absatz 3 SGB V in der aktuellsten Fassung, Erste Änderungsvereinbarung.

Relevanter Passus: Soweit die Übermittlung der Chargenbezeichnung beim „Stellen“ von Arzneimitteln technisch nicht möglich ist, wird bis zur Schaffung entsprechender technischer Möglichkeiten analog § 312 Absatz 1 Nummer 3 SGB V ausnahmsweise bis zum 30. Juni 2025 von der Verpflichtung zur Chargendokumentation abgesehen. Anstelle der tatsächlichen Chargenbezeichnungen ist „STELLEN“ in das entsprechende Datenfeld einzutragen. Dabei sind die Abrechnungs- und rahmenvertraglichen Regelungen im Übrigen einzuhalten, insbesondere ist sicherzustellen, dass die in Anlage 9 § 2 Satz 1 des Rahmenvertrages nach § 129 Absatz 2 SGB V beschriebenen Mitwirkungspflichten auf Nachfrage erfüllt werden. Siehe auch, Ergänzung in der Anlage 1 zur Arzneimittelabrechnungsvereinbarung gemäß § 300 Abs. 3 SGB V in der FAQ-Liste zur TA7.

Interaktionen

ISiKCapabilityStatementMedikamentRolle

Name	Interaktion	Verbindlichkeit
ISiKCapabilityStatementMedikamentRolle	create	SHALL
ISiKCapabilityStatementMedikamentRolle	read	SHALL
ISiKCapabilityStatementMedikamentRolle	update	SHALL
ISiKCapabilityStatementMedikamentRolle	search-type	SHALL

Name	Parameter	Typ	Verbindlichkeit	Hinweise
ISiKCapabilityStatementMedikamentRolle	_id	token	SHALL	Beispiel: `GET [base]/Medication?_id=103270` `Anwendungshinweise: Weitere Informationen zur Suche nach '_id' finden sich in der [FHIR-Basisspezifikation - Abschnitt 'Parameters for all resources'](https://hl7.org/fhir/R4/search.html#all).`
ISiKCapabilityStatementMedikamentRolle	code	token	SHALL	Beispiel: `GET [base]/Medication?code=http://fhir.de/CodeSystem/bfarm/atc\|V03AB23` `Anwendungshinweise: Weitere Informationen zur Suche nach Token-type Parametern finden sich in der [FHIR-Basisspezifikation - Abschnitt 'Token Search'](https://hl7.org/fhir/R4/search.html#token).`
ISiKCapabilityStatementMedikamentRolle	form	token	SHALL	Beispiel: `GET [base]/Medication?form=http://standardterms.edqm.eu\|11210000` `Anwendungshinweise: Weitere Informationen zur Suche nach Token-type Parametern finden sich in der [FHIR-Basisspezifikation - Abschnitt 'Token Search'](https://hl7.org/fhir/R4/search.html#token).`
ISiKCapabilityStatementMedikamentRolle	ingredient	reference	SHALL	Beispiel: `GET [base]/Medication?ingredient=Medication/123` `Anwendungshinweise: Weitere Informationen zur Suche nach Reference-type Parametern finden sich in der [FHIR-Basisspezifikation - Abschnitt 'Reference Search'](https://www.hl7.org/fhir/R4/search.html#reference).`
ISiKCapabilityStatementMedikamentRolle	ingredient-code	token	SHALL	Beispiel: `GET [base]/Medication?ingredient-code=http://fhir.de/CodeSystem/bfarm/atc\|L01DB01` `Anwendungshinweise: Weitere Informationen zur Suche nach Token-type Parametern finden sich in der [FHIR-Basisspezifikation - Abschnitt 'Token Search'](https://hl7.org/fhir/R4/search.html#token).`
ISiKCapabilityStatementMedikamentRolle	status	token	SHALL	Beispiel: `GET [base]/Medication?status=active` `Anwendungshinweise: Weitere Informationen zur Suche nach Token-type Parametern finden sich in der [FHIR-Basisspezifikation - Abschnitt 'Token Search'](https://hl7.org/fhir/R4/search.html#token).`
ISiKCapabilityStatementMedikamentRolle	ingredient.code	reference	SHALL	Beispiel: `GET [base]/Medication?ingredient.code=http://fhir.de/CodeSystem/bfarm/atc\|V03AB23` `Anwendungshinweise: Weitere Informationen zur Suche nach Token-type Parametern finden sich in der [FHIR-Basisspezifikation - Abschnitt 'Token Search'](https://hl7.org/fhir/R4/search.html#token). Weitere Informationen zur Suche nach verketteten Parametern finden sich in der [FHIR-Basisspezifikation - Abschnitt 'Chained Parameters'](https://hl7.org/fhir/R4/search.html#chaining).`
ISiKCapabilityStatementMedikamentRolle	lot-number	token	SHALL	Beispiel: `GET [base]/Medication?lot-number=X123456` `Anwendungshinweise: Weitere Informationen zur Suche nach Token-type Parametern finden sich in der [FHIR-Basisspezifikation - Abschnitt 'Token Search'](https://hl7.org/fhir/R4/search.html#token).`

(Reverse-)Include

Name	Include
ISiKCapabilityStatementMedikamentRolle	Medication:ingredient

Beispiele

ExampleISiKMedikament1

Medikament codiert (Wirkstoff):

Medikament codiert (Wirkstoff)

<meta>

</meta>

<text>

--- We have skipped the narrative for better readability of the resource ---

</text>

<code>

<system value="http://fhir.de/CodeSystem/bfarm/atc" />
<version value="2024" />
<code value="V03AB23" />
<display value="Acetylcystein" />

</coding>

</code>

</Medication>

{

"resourceType": "Medication",

"id": "ExampleISiKMedikament1",

"meta": {

"profile": [

"https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament"

]

"text": {

"status": "additional",

--- We have skipped the narrative for better readability of the resource ---

"code": {

"coding": [

{

"system": "http://fhir.de/CodeSystem/bfarm/atc",
"code": "V03AB23",
"display": "Acetylcystein",
"version": "2024"

}

]

"status": "active"

}

Acetylcystein

ExampleISiKMedikament2

Infusionslösung:

Beispiel für eine Infusionslösung

<meta>

</meta>

<text>

--- We have skipped the narrative for better readability of the resource ---

</text>

<code>

</code>

<form>

<system value="http://standardterms.edqm.eu" />
<code value="11210000" />
<display value="Solution for infusion" />

</coding>

</form>

</valueCoding>

</extension>

<system value="http://fhir.de/CodeSystem/bfarm/atc" />
<version value="2024" />
<code value="L01DB01" />
<display value="Doxorubicin" />

</coding>

</itemCodeableConcept>

<value value="85" />
<unit value="mg" />
<system value="http://unitsofmeasure.org" />
<code value="mg" />

</numerator>

<value value="250" />
<unit value="Milliliter" />
<system value="http://unitsofmeasure.org" />
<code value="mL" />

</denominator>

</strength>

</ingredient>

</itemReference>

</ingredient>

</Medication>

{

"resourceType": "Medication",

"id": "ExampleISiKMedikament2",

"meta": {

"profile": [

"https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament"

]

"ingredient": [

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 85,
"unit": "mg",
"code": "mg"

"denominator": {

"system": "http://unitsofmeasure.org",
"value": 250,
"unit": "Milliliter",
"code": "mL"

}

"extension": [

{

"url": "http://fhir.de/StructureDefinition/WirkstofftypEX",

"valueCoding": {

"system": "http://fhir.de/CodeSystem/WirkstofftypCS",

"code": "IN"

}

Infusion bestehend aus 85mg Doxorubicin aufgelöst zur Verabreichung in 250ml 5-%iger (50 mg/ml) Glucose-Infusionslösung

"coding": [

{

"system": "http://fhir.de/CodeSystem/bfarm/atc",
"code": "L01DB01",
"version": "2024",
"display": "Doxorubicin"

}

]

"isActive": true

{

"itemReference": {

"reference": "Medication/7f27cb8d-940b-43fd-ab8b-fee5b7a9b060"

"isActive": true

}

"text": {

"status": "additional",

--- We have skipped the narrative for better readability of the resource ---

"code": {

"text": "Infusion bestehend aus 85mg Doxorubicin aufgelöst zur Verabreichung in 250ml 5-%iger (50 mg/ml) Glucose-Infusionslösung"

"status": "active",

"form": {

"coding": [

{

"system": "http://standardterms.edqm.eu",
"code": "11210000",
"display": "Solution for infusion"

}

]

}

ExampleISiKMedikament3

Medikament codiert (PZN):

Medikament codiert (mit PZN)

<meta>

</meta>

<text>

--- We have skipped the narrative for better readability of the resource ---

</text>

<code>

<system value="http://fhir.de/CodeSystem/ifa/pzn" />
<code value="07265233" />
<display value="Pantozol® 40 mg 98 St." />

</coding>

</code>

</Medication>

{

"resourceType": "Medication",

"id": "ExampleISiKMedikament3",

"meta": {

"profile": [

"https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament"

]

"text": {

"status": "additional",

--- We have skipped the narrative for better readability of the resource ---

"code": {

"coding": [

{

"system": "http://fhir.de/CodeSystem/ifa/pzn",
"code": "07265233",
"display": "Pantozol® 40 mg 98 St."

}

]

"status": "active"

}

Pantozol® 40 mg 98 St.

ExampleISiKMedikament4

Medikamentenrezeptur aus Fertigarzneimitteln:

Medikamentenrezeptur aus Fertigarzneimitteln

<meta>

</meta>

<text>

--- We have skipped the narrative for better readability of the resource ---

</text>

<form>

</form>

<system value="http://fhir.de/CodeSystem/ifa/pzn" />
<code value="00266040" />
<display value="IBU-ratiopharm® 400 mg akut Schmerztabletten 20 St." />

</coding>

</itemCodeableConcept>

<value value="400" />
<unit value="mg" />
<system value="http://unitsofmeasure.org" />
<code value="mg" />

</numerator>

<value value="1" />
<unit value="Tablette" />
<system value="http://unitsofmeasure.org" />
<code value="1" />

</denominator>

</strength>

</ingredient>

<system value="http://fhir.de/CodeSystem/ifa/pzn" />
<code value="01126111" />
<display value="Paracetamol-ratiopharm® 500 mg 20 St." />

</coding>

</itemCodeableConcept>

<value value="500" />
<unit value="mg" />
<system value="http://unitsofmeasure.org" />
<code value="mg" />

</numerator>

<value value="1" />
<unit value="Tablette" />
<system value="http://unitsofmeasure.org" />
<code value="1" />

</denominator>

</strength>

</ingredient>

</Medication>

{

"resourceType": "Medication",

"id": "ExampleISiKMedikament4",

"meta": {

"profile": [

"https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament"

]

"ingredient": [

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 400,
"unit": "mg",
"code": "mg"

"denominator": {

"system": "http://unitsofmeasure.org",
"unit": "Tablette",
"value": 1,
"code": "1"

}

"coding": [

{

"system": "http://fhir.de/CodeSystem/ifa/pzn",
"code": "00266040",
"display": "IBU-ratiopharm® 400 mg akut Schmerztabletten 20 St."

}

]

"isActive": true

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 500,
"unit": "mg",
"code": "mg"

"denominator": {

"system": "http://unitsofmeasure.org",
"unit": "Tablette",
"value": 1,
"code": "1"

}

"coding": [

{

"system": "http://fhir.de/CodeSystem/ifa/pzn",
"code": "01126111",
"display": "Paracetamol-ratiopharm® 500 mg 20 St."

}

]

"isActive": true

}

"text": {

"status": "additional",

--- We have skipped the narrative for better readability of the resource ---

"status": "active",

"form": {

"text": "Tabletten"

}

ExampleISiKMedikament4

ExampleISiKMedikament5

Medikamentenrezeptur aus Wirkstoffen:

Medikamentenrezeptur aus Wirkstoffen

<meta>

</meta>

<text>

--- We have skipped the narrative for better readability of the resource ---

</text>

<form>

</form>

<system value="http://fhir.de/CodeSystem/bfarm/atc" />
<version value="2024" />
<code value="M02AA13" />
<display value="Ibuprofen" />

</coding>

</itemCodeableConcept>

<value value="400" />
<unit value="mg" />
<system value="http://unitsofmeasure.org" />
<code value="mg" />

</numerator>

<value value="1" />
<unit value="Tablette" />
<system value="http://unitsofmeasure.org" />
<code value="1" />

</denominator>

</strength>

</ingredient>

<system value="http://fhir.de/CodeSystem/bfarm/atc" />
<version value="2024" />
<code value="N02BE01" />
<display value="Paracetamol" />

</coding>

</itemCodeableConcept>

<value value="500" />
<unit value="mg" />
<system value="http://unitsofmeasure.org" />
<code value="mg" />

</numerator>

<value value="1" />
<unit value="Tablette" />
<system value="http://unitsofmeasure.org" />
<code value="1" />

</denominator>

</strength>

</ingredient>

</Medication>

{

"resourceType": "Medication",

"id": "ExampleISiKMedikament5",

"meta": {

"profile": [

"https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament"

]

"ingredient": [

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 400,
"unit": "mg",
"code": "mg"

"denominator": {

"system": "http://unitsofmeasure.org",
"unit": "Tablette",
"value": 1,
"code": "1"

}

"coding": [

{

"system": "http://fhir.de/CodeSystem/bfarm/atc",
"code": "M02AA13",
"display": "Ibuprofen",
"version": "2024"

}

]

"isActive": true

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 500,
"unit": "mg",
"code": "mg"

"denominator": {

"system": "http://unitsofmeasure.org",
"unit": "Tablette",
"value": 1,
"code": "1"

}

"coding": [

{

"system": "http://fhir.de/CodeSystem/bfarm/atc",
"code": "N02BE01",
"display": "Paracetamol",
"version": "2024"

}

]

"isActive": true

}

"text": {

"status": "additional",

--- We have skipped the narrative for better readability of the resource ---

"status": "active",

"form": {

"text": "Tabletten"

}

ExampleISiKMedikament5

ExampleISiKMedikament6

Medikament als Freitext:

Medikament als Freitext

<meta>

</meta>

<text>

--- We have skipped the narrative for better readability of the resource ---

</text>

<code>

</code>

</Medication>

{

"resourceType": "Medication",

"id": "ExampleISiKMedikament6",

"meta": {

"profile": [

"https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament"

]

"text": {

"status": "additional",

--- We have skipped the narrative for better readability of the resource ---

"code": {

"text": "Enoxaparin-Natrium 40 mg"

"status": "active"

}

Enoxaparin-Natrium 40 mg

ExampleISiKMedikament7

Medikament (hier: Paracetamol) in Wasser aufgelöst:

Medikament (hier: Paracetamol) in Wasser aufgelöst

<meta>

</meta>

<text>

--- We have skipped the narrative for better readability of the resource ---

</text>

<code>

</code>

<system value="http://fhir.de/CodeSystem/bfarm/atc" />
<version value="2024" />
<code value="N02BE01" />
<display value="Paracetamol" />

</coding>

</itemCodeableConcept>

<value value="500" />
<unit value="mg" />
<system value="http://unitsofmeasure.org" />
<code value="mg" />

</numerator>

<value value="1" />
<system value="http://unitsofmeasure.org" />
<code value="1" />

</denominator>

</strength>

</ingredient>

</itemCodeableConcept>

<value value="1" />
<unit value="Esslöffel" />
<system value="http://unitsofmeasure.org" />
<code value="1" />

</numerator>

<value value="1" />
<system value="http://unitsofmeasure.org" />
<code value="1" />

</denominator>

</strength>

</ingredient>

</Medication>

{

"resourceType": "Medication",

"id": "ExampleISiKMedikament7",

"meta": {

"profile": [

"https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament"

]

"ingredient": [

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 500,
"unit": "mg",
"code": "mg"

"denominator": {

"system": "http://unitsofmeasure.org",
"value": 1,
"code": "1"

}

"coding": [

{

"system": "http://fhir.de/CodeSystem/bfarm/atc",
"code": "N02BE01",
"display": "Paracetamol",
"version": "2024"

}

]

"isActive": true

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 1,
"unit": "Esslöffel",
"code": "1"

"denominator": {

"system": "http://unitsofmeasure.org",
"value": 1,
"code": "1"

}

"text": "Wasser"

"isActive": false

}

"text": {

"status": "additional",

--- We have skipped the narrative for better readability of the resource ---

"code": {

"text": "Paracetamol gelöst in Wasser"

"status": "active"

}

Paracetamol gelöst in Wasser

ExampleISiKMedikament8

Zytostatikum mit relativer Wirkstärken-Angabe (mg/kg Körpergewicht):

Zytostatikum mit absoluter Wirkstärken-Angabe:

<meta>

</meta>

<text>

--- We have skipped the narrative for better readability of the resource ---

</text>

<code>

</code>

<form>

<system value="http://standardterms.edqm.eu" />
<code value="11210000" />
<display value="Solution for infusion" />

</coding>

</form>

<system value="http://fhir.de/CodeSystem/bfarm/atc" />
<version value="2024" />
<code value="L01CD01" />
<display value="Paclitaxel" />

</coding>

</itemCodeableConcept>

<value value="80" />
<unit value="mg" />
<system value="http://unitsofmeasure.org" />
<code value="mg" />

</numerator>

<value value="1" />
<unit value="m² KOF" />
<system value="http://unitsofmeasure.org" />
<code value="m2" />

</denominator>

</strength>

</ingredient>

<system value="http://fhir.de/CodeSystem/bfarm/atc" />
<version value="2024" />
<code value="B05BA11" />
<display value="Glucose" />

</coding>

</itemCodeableConcept>

<value value="50" />
<unit value="mg" />
<system value="http://unitsofmeasure.org" />
<code value="mg" />

</numerator>

<value value="1" />
<unit value="Milliliter" />
<system value="http://unitsofmeasure.org" />
<code value="mL" />

</denominator>

</strength>

</ingredient>

</Medication>

{

"resourceType": "Medication",

"id": "ExampleISiKMedikament8",

"meta": {

"profile": [

"https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament"

]

"ingredient": [

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 80,
"unit": "mg",
"code": "mg"

"denominator": {

"system": "http://unitsofmeasure.org",
"value": 1,
"unit": "m² KOF",
"code": "m2"

}

"coding": [

{

"system": "http://fhir.de/CodeSystem/bfarm/atc",
"code": "L01CD01",
"display": "Paclitaxel",
"version": "2024"

}

]

"isActive": true

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 50,
"unit": "mg",
"code": "mg"

"denominator": {

"system": "http://unitsofmeasure.org",
"value": 1,
"unit": "Milliliter",
"code": "mL"

}

Infusion bestehend aus 80 mg/m² KOF Paclitaxel aufgelöst zur Verabreichung in 5-%iger (50 mg/ml) Glucose-Infusionslösung

"coding": [

{

"system": "http://fhir.de/CodeSystem/bfarm/atc",
"code": "B05BA11",
"display": "Glucose",
"version": "2024"

}

]

"isActive": false

}

"text": {

"status": "additional",

--- We have skipped the narrative for better readability of the resource ---

"code": {

"text": "Infusion bestehend aus 80 mg/m² KOF Paclitaxel aufgelöst zur Verabreichung in 5-%iger (50 mg/ml) Glucose-Infusionslösung"

"status": "active",

"form": {

"coding": [

{

"system": "http://standardterms.edqm.eu",
"code": "11210000",
"display": "Solution for infusion"

}

]

}

ExampleISiKMedikament9

Zytostatikum mit absoluter Wirkstärken-Angabe:

<meta>

</meta>

<text>

--- We have skipped the narrative for better readability of the resource ---

</text>

<code>

</code>

<form>

<system value="http://standardterms.edqm.eu" />
<code value="11210000" />
<display value="Solution for infusion" />

</coding>

</form>

<system value="http://fhir.de/CodeSystem/bfarm/atc" />
<version value="2024" />
<code value="L01CD01" />
<display value="Paclitaxel" />

</coding>

</itemCodeableConcept>

<value value="142" />
<unit value="mg" />
<system value="http://unitsofmeasure.org" />
<code value="mg" />

</numerator>

<value value="500" />
<unit value="Milliliter" />
<system value="http://unitsofmeasure.org" />
<code value="mL" />

</denominator>

</strength>

</ingredient>

<system value="http://fhir.de/CodeSystem/bfarm/atc" />
<version value="2024" />
<code value="B05BA11" />
<display value="Glucose" />

</coding>

</itemCodeableConcept>

<value value="50" />
<unit value="mg" />
<system value="http://unitsofmeasure.org" />
<code value="mg" />

</numerator>

<value value="1" />
<unit value="Milliliter" />
<system value="http://unitsofmeasure.org" />
<code value="mL" />

</denominator>

</strength>

</ingredient>

</Medication>

{

"resourceType": "Medication",

"id": "ExampleISiKMedikament9",

"meta": {

"profile": [

"https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament"

]

"ingredient": [

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 142,
"unit": "mg",
"code": "mg"

"denominator": {

"system": "http://unitsofmeasure.org",
"value": 500,
"unit": "Milliliter",
"code": "mL"

}

"coding": [

{

"system": "http://fhir.de/CodeSystem/bfarm/atc",
"code": "L01CD01",
"display": "Paclitaxel",
"version": "2024"

}

]

"isActive": true

{

"strength": {

"numerator": {

"system": "http://unitsofmeasure.org",
"value": 50,
"unit": "mg",
"code": "mg"

"denominator": {

"system": "http://unitsofmeasure.org",
"value": 1,
"unit": "Milliliter",
"code": "mL"

}