Implementierungsleitfaden ISiK-Medikation

ISiKMedikament

Dieses Profil ermöglicht die Abbildung von patientenunabhängigen Informationen zu Medikamenten in ISiK Szenarien.

Bestätigungsrelevanz

Name	ISiKCapabilityStatementMedikationInformation	ISiKCapabilityStatementMedikationVerabreichung	ISiKCapabilityStatementMedikationVerordnung
Verbindlichkeit	SHALL	SHALL	SHALL

Metadaten

Canonical	https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament
Status	active
Version	4.0.3
Basis	http://hl7.org/fhir/StructureDefinition/Medication

Inhalt

ISiKMedikament (Medication)	I		Medication	Element id Medication Short description Definition of a Medication Definition This resource is primarily used for the identification and definition of a medication for the purposes of prescribing, dispensing, and administering a medication as well as for making statements about medication use. Data type Medication Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() isik-med-1: Medikamenten-Code, -Bezeichnung oder Inhaltsstoffe müssen angegeben werden. `code.exists() or ingredient.exists()` Mappings rim: Entity. Role, or Act script10.6: NewRx/MedicationPrescribed -or- RxFill/MedicationDispensed -or- RxHistoryResponse/MedicationDispensed -or- RxHistoryResponse/MedicationPrescribed rim: ManufacturedProduct[classCode=ADMM]
id	Σ	0..1	string	There are no (further) constraints on this element Element id Medication.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Medication.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
implicitRules	Σ ?!	0..1	uri	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 uri 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) 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	I	0..*	Extension	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 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 Extension 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	?! I	0..*	Extension	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 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 Extension 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	Σ	0..*	Identifier	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 Identifier 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	CodeableConcept	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 CodeableConcept Binding A coded concept that defines the type of a medication. SNOMEDCTMedicationCodes (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(,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
id		0..1	string	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 string Mappings rim: n/a
extension	I	0..*	Extension	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 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 Extension Sliced: 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..*	Coding	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 Coding Sliced: 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: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
PZN	S Σ	0..1	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 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 ISiKPZNCoding 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: CE.1-8, CE.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.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 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 ISiKATCCoding 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: CE.1-8, CE.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.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 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: CE.1-8, CE.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	string	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 string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.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. Medication Status Codes (required) 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
id		0..1	string	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 string Mappings rim: n/a
extension	I	0..*	Extension	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 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 Extension Sliced: 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 I	0..1	string	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 string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
type	Σ	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 uri 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	Σ	0..1	Identifier	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 Identifier 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	string	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 string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
form	S	0..1	CodeableConcept	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 CodeableConcept 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
id		0..1	string	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 string Mappings rim: n/a
extension	I	0..*	Extension	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 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 Extension Sliced: 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..*	Coding	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 Coding Sliced: 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: CE.1-8, CE.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 MedicineDoseFormUvIps (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.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	Σ	0..1	string	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 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 Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
amount	S Σ	0..1	Ratio	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 Ratio Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .quantity
id		0..1	string	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 string Mappings rim: n/a
extension	I	0..*	Extension	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 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 Extension Sliced: 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 I	1..1	MedicationQuantity	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 MedicationQuantity 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 I	1..1	MedicationQuantity	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 MedicationQuantity 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	S	0..*	BackboneElement	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 BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .scopesRole[typeCode=INGR]
id		0..1	string	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 string Mappings rim: n/a
extension	S I	0..*	Extension	Element id Medication.ingredient.extension Short description Wirkstofftyp 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 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 Extension Sliced: 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 I	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 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 Extension(Coding) Extension URL http://fhir.de/StructureDefinition/WirkstofftypEX 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 ?! I	0..*	Extension	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 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 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 Extension 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). Sliced: 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	S	0..1	CodeableConcept	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 CodeableConcept 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
id		0..1	string	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 string Mappings rim: n/a
extension	I	0..*	Extension	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 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 Extension Sliced: 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..*	Coding	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 Coding Sliced: 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: CE.1-8, CE.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 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: CE.1-8, CE.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 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 ISiKATCCoding 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: CE.1-8, CE.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 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 ISiKPZNCoding 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: CE.1-8, CE.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 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: CE.1-8, CE.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	string	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 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 Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
itemReference	S	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
id		0..1	string	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 string Mappings rim: n/a
extension	I	0..*	Extension	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 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 Extension Sliced: 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 I	1..1	string	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 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 string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
type	Σ	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. 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 uri 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	Σ	0..1	Identifier	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 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 Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .identifier
display	Σ	0..1	string	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 string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
isActive	S	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	S	0..1	Ratio	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 Ratio 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
id		0..1	string	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 string Mappings rim: n/a
extension	I	0..*	Extension	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 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 Extension Sliced: 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 I	1..1	MedicationQuantity	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 MedicationQuantity 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 I	1..1	MedicationQuantity	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 MedicationQuantity 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	S	0..1	BackboneElement	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 BackboneElement 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]
id		0..1	string	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 string Mappings rim: n/a
extension	I	0..*	Extension	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 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 Extension 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 ?! I	0..*	Extension	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 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 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 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 Extension 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	S	0..1	string	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 string 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

<StructureDefinition xmlns="http://hl7.org/fhir">
    <id value="ISiKMedikament" />
    <url value="https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament" />
    <version value="4.0.3" />
    <name value="ISiKMedikament" />
    <status value="active" />
    <experimental value="false" />
    <date value="2025-03-17" />
    <publisher value="gematik GmbH" />
    <description value="Dieses Profil erm&#246;glicht die Abbildung von patientenunabh&#228;ngigen 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 m&#252;ssen angegeben werden." />
                <expression value="code.exists() or ingredient.exists()" />
                <source value="https://gematik.de/fhir/isik/StructureDefinition/ISiKMedikament" />
            </constraint>
        </element>
        <element id="Medication.code">
            <path value="Medication.code" />
            <short value="Medikament in codierter Form oder ggf. als Freitext" />
            <comment value="Begr&#252;ndung 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="Begr&#252;ndung des Must-Support: Medikamente M&#220;SSEN kodiert werden, hierf&#252;r 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" />
            <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.code.coding:ATC-DE">
            <path value="Medication.code.coding" />
            <sliceName value="ATC-DE" />
            <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.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" />
        </element>
        <element id="Medication.code.text">
            <path value="Medication.code.text" />
            <comment value="Begr&#252;ndung des Must-Support: Falls eine Kodierung nicht m&#246;glich 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="Begr&#252;ndung 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="Begr&#252;ndung des Must-Support: Alignment mit KBV-Profilen\n\n  Hinweis: Hier kann der tats&#228;chliche 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="Begr&#252;ndung 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="Begr&#252;ndung des Must-Support: EDQM definiert eine einheitliche DoseForm auf europ&#228;ischer 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="Begr&#252;ndung 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="Begr&#252;ndung 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="Begr&#252;ndung 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="Begr&#252;ndung des Must-Support: Wirkstoff-Rezepturen m&#252;ssen dokumentierbar sein" />
            <mustSupport value="true" />
        </element>
        <element id="Medication.ingredient.extension">
            <path value="Medication.ingredient.extension" />
            <short value="Wirkstofftyp" />
            <comment value="Begr&#252;ndung des Must-Support: Alignment mit den MII-Profilen\n\n    Hinweis: Hiermit kann gekl&#228;rt 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="$this" />
                </discriminator>
                <ordered value="false" />
                <rules value="open" />
            </slicing>
        </element>
        <element id="Medication.ingredient.item[x]:itemCodeableConcept">
            <path value="Medication.ingredient.item[x]" />
            <sliceName value="itemCodeableConcept" />
            <short value="Bestandteil in codierter Form oder ggf. als Freitext" />
            <comment value="Begr&#252;ndung des Must-Support: Der Bestandteil muss eindeutig benannt sein" />
            <min value="0" />
            <max value="1" />
            <type>
                <code value="CodeableConcept" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Medication.ingredient.item[x]:itemCodeableConcept.coding">
            <path value="Medication.ingredient.item[x].coding" />
            <slicing>
                <discriminator>
                    <type value="pattern" />
                    <path value="$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" />
            <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" />
            <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="Begr&#252;ndung 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="Begr&#252;ndung des Must-Support: Wird eine vollst&#228;ndige 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="St&#228;rke" />
            <comment value="Begr&#252;ndung 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="Begr&#252;ndung 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 gem&#228;&#223; &#167; 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="Begr&#252;ndung des Must-Support: Therapiesicherheit und Nachvollziehbarkeit\n\n    Hinweis: Gem&#228;&#223; Anlage 1 der TA7 kann hier &#252;bergangsweise bis zum 30. Juni 2025 eine Musterchargennummer (&quot;STELLEN&quot;) eingetragen werden. Wenn die &#220;bermittlung der Chargenbezeichnung beim Stellen von Arzneimitteln technisch nicht m&#246;glich ist, z.B. beim Verblistern, wird von der Verpflichtung zur Chargendokumentation abgesehen. Dementsprechend kann anstatt der tats&#228;chlichen Chargenbezeichnungen &quot;STELLEN&quot; 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": "4.0.3",
    "name": "ISiKMedikament",
    "status": "active",
    "experimental": false,
    "date": "2025-03-17",
    "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.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",
                "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.code.coding:ATC-DE",
                "path": "Medication.code.coding",
                "sliceName": "ATC-DE",
                "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.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
            },
            {
                "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",
                "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",
                "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.form.coding:EDQM	required	http://hl7.org/fhir/uv/ips/ValueSet/medicine-doseform