Generated Narrative: StructureDefinition ISiKMedikament Name Flags Card. Type Description & Constraints Medication C 0..* Medication Definition of a Medication Constraints: isik-med-1 #xD; id S 0..1 id serverseitige, interne ID des Datensatzes #xD; meta #xD; versionId 0..1 id Eindeutiger Name der serverseitigen Version des Datensatzes #xD; lastUpdated 0..1 instant Zeitpunkt der letzten Änderung #xD; implicitRules 0..0 Verweis auf die Regeln, nach denen die Ressource erstellt wurde #xD; code S 0..1 CodeableConcept Medikament in codierter Form oder ggf. als Freitext #xD; Slices for coding S 0..* Coding Code defined by a terminology system Slice: Unordered, Open by pattern:$this #xD; coding:PZN S 0..* ISiKPZNCoding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://fhir.de/CodeSystem/ifa/pzn #xD; coding:ATC-DE S 0..* ISiKATCCoding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://fhir.de/CodeSystem/bfarm/atc #xD; coding:SCT S 0..1 ISiKSnomedCTCoding Code defined by a terminology system Binding: TI Arzneimittel SNOMED CT ValueSet (extensible) Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://snomed.info/sct #xD; text S 0..1 string Plain text representation of the concept #xD; status S 1..1 code Status der Medikamenteninformation #xD; manufacturer S 0..1 Reference(Organization) Hersteller des Medikaments #xD; display S 1..1 string Text alternative for the resource #xD; form S 0..1 CodeableConcept Abgabeform #xD; Slices for coding S 0..* Coding Code defined by a terminology system Slice: Unordered, Open by pattern:$this #xD; coding:EDQM S 0..1 ISiKCoding Code defined by a terminology system Binding: Medicine EDQM Doseform - IPS (required) #xD; amount S 0..1 Ratio Menge des Arzneimittels im verpackten Produkt bzw. Behältnis #xD; numerator S 1..1 MedicationQuantity Numerator value #xD; denominator S 1..1 MedicationQuantity Denominator value #xD; ingredient S 0..* BackboneElement Informationen zu Bestandteilen (Rezeptur) #xD; Slices for extension S 0..* Extension Wirkstofftyp Slice: Unordered, Open by value:url #xD; extension:wirkstofftyp S 0..1 Coding Optional Extensions Element URL: http://fhir.de/StructureDefinition/WirkstofftypEX Binding: ValueSet - Wirkstofftypen (required) #xD; Slices for item[x] 1..1 CodeableConcept, Reference(Substance | Medication) The actual ingredient or content Slice: Unordered, Open by type:$this #xD; item[x]:itemCodeableConcept S 0..1 CodeableConcept Bestandteil in codierter Form oder ggf. als Freitext #xD; Slices for coding S 0..* Coding Code defined by a terminology system Slice: Unordered, Open by pattern:$this #xD; coding:ASK S 0..1 ISiKASKCoding Code defined by a terminology system Required Pattern: At least the following #xD; coding:ATC-DE S 0..1 ISiKATCCoding Code defined by a terminology system Required Pattern: At least the following #xD; coding:PZN S 0..1 ISiKPZNCoding Code defined by a terminology system Required Pattern: At least the following #xD; coding:SCT S 0..1 ISiKSnomedCTCoding Code defined by a terminology system Required Pattern: At least the following #xD; text S 0..1 string Plain text representation of the concept #xD; item[x]:itemReference S 0..1 Reference(Substance | Medication) Bestandteil (Referenz auf ein anderes Medikament) #xD; reference S 1..1 string Literal reference, Relative, internal or absolute URL #xD; isActive S 0..1 boolean handelt es sich um einen aktiven Bestandteil? #xD; strength S 0..1 Ratio Stärke #xD; numerator S 1..1 MedicationQuantity Numerator value #xD; denominator S 1..1 MedicationQuantity Denominator value #xD; batch S 0..1 BackboneElement Angaben zur Charge #xD; lotNumber S 0..1 string Chargennummer #xD; Documentation for this format
Dieses Profil ermöglicht die Abbildung von patientenunabhängigen Informationen zu Medikamenten in ISiK Szenarien. **Motivation** Die strukturierte Bereitstellung von Informationen zu Medikamenten ist eine zentrale Voraussetzung für eine interoperable Arzneimitteltherapie und unterstützt insbesondere Prozesse im Kontext der Arzneimitteltherapiesicherheit (AMTS) sowie der sektorenübergreifenden Versorgung. In FHIR werden Medikamente mit der [Medication](https://hl7.org/fhir/R4/medication.html)-Ressource repräsentiert. **Hinweise zur Verwendung von Medication.amount** `Medication.amount` beschreibt in FHIR R4 die Menge des Arzneimittels im verpackten Produkt bzw. Behältnis. Das Element ist nicht zur Abbildung der Wirkstoffstärke vorgesehen; diese wird über `Medication.ingredient.strength` dokumentiert. Beispiel: Enthält ein Infusionsbeutel 100 ml Paracetamol-Infusionslösung mit einer Wirkstoffkonzentration von 10 mg/ml, beschreibt `Medication.amount` die Füllmenge des Behältnisses, also `100 ml / 1 Beutel`. Die Wirkstoffkonzentration wird separat über `Medication.ingredient.strength` als `10 mg / 1 ml` angegeben. `Medication.amount` ist insbesondere dann relevant, wenn der Arzneimittelcode allein die konkrete Packungsgröße, Füllmenge oder Menge je Verpackungseinheit nicht eindeutig ausdrückt. **Kompatibilität** Für das Profil ISiKMedikament wird eine größtmögliche Kompatibilität mit dem Profil [epa-medication der gematik](https://gemspec.gematik.de/ig/fhir/epa-medication) angestrebt. Ziel ist insbesondere eine vergleichbare semantische Struktur zur Unterstützung interoperabler Nutzungsszenarien. Die spezifischen Extensions des epa-medication-Profils werden in diesem Profil jedoch nicht übernommen. Stattdessen erlaubt das Profil die Nutzung von Extensions, um projektspezifische Anforderungen abzubilden. Es kann nicht sichergestellt werden, dass Instanzen, die gegen ISiKMedikament valide sind, auch valide gegen das epa-medication-Profil sind. Hinweise zu Inkompatibilitäten können über die [Portalseite](https://service.gematik.de/servicedesk/customer/portal/16) gemeldet werden.
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.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
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()
not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
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()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
Medikamenten-Code, -Bezeichnung oder Inhaltsstoffe müssen angegeben werden.
NewRx/MedicationPrescribed -or- RxFill/MedicationDispensed -or- RxHistoryResponse/MedicationDispensed -or- RxHistoryResponse/MedicationPrescribed
serverseitige, interne ID des Datensatzes
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
**bedingtes Pflichtfeld/bedingtes MS:** Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine `id` verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `id`verfügen.
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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Additional content defined by implementations
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.
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.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
Eindeutiger Name der serverseitigen Version des Datensatzes
The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.
Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine `versionID` verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `versionID`verfügen.
When the resource last changed - e.g. when the version changed.
Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein `lastUpdate` verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein `lastUpdate`verfügen.
Identifies where the resource comes from
A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](http://hl7.org/fhir/R4/provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.
In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.
Profiles this resource claims to conform to
A list of profiles (references to [StructureDefinition](http://hl7.org/fhir/R4/structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](http://hl7.org/fhir/R4/structuredefinition-definitions.html#StructureDefinition.url).
It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.
Security Labels applied to this resource
Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.
Security Labels from the Healthcare Privacy and Security Classification System.
Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.
The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.
Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
Verweis auf die Regeln, nach denen die Ressource erstellt wurde
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.
Begründung Constraint: In ISiK existiert kein Use-Case für dieses Element. Da es sich um ein Modifying Element handelt, wird es daher ausgeschlossen. Darüber hinaus werden die Regeln als URI vorgehalten. Dies führt dazu, dass sich hinter der URI eine beliebige Menge an Regeln befinden kann; wodurch nicht sichergestellt werden kann, dass alle Clients die Regeln korrekt interpretieren können.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
The base language in which the resource is written.
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).
Text summary of the resource, for human interpretation
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.
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.
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.
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.
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.
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).
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](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Business identifier for this medication.
The serial number could be included as an identifier.
Medikament in codierter Form oder ggf. als Freitext
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.
Begründung des Must-Support: grundlegende Information
A coded concept that defines the type of a medication.
coding.code = //element(*,MedicationType)/DrugCoded/ProductCode coding.system = //element(*,MedicationType)/DrugCoded/ProductCodeQualifier coding.display = //element(*,MedicationType)/DrugDescription
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
A reference to a code defined by a terminology system.
Begründung des Must-Support: Medikamente MÜSSEN kodiert werden, hierfür kann eine PZN, ATC-Code oder SnomedCT Code verwendet werden
Allows for alternative encodings within a code system, and translations to other code systems.
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
Merfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, bspw. existieren für Aspirin 3 verschiedene Packungsgrößen.
Merfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, bspw. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird.
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.
Plain text representation of the concept
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.
Begründung des Must-Support: Falls eine Kodierung nicht möglich ist kann das Medikament alternativ per Freitext erfasst werden
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.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
A code to indicate if the medication is in active use.
Begründung des Must-Support: Erforderliche Angabe im FHIR-Standard
This element changes the interpretation of all descriptive attributes.
A coded concept defining if the medication is in active use.
Describes the details of the manufacturer of the medication product. This is not intended to represent the distributor of a medication product.
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.
RXD-20-Substance Manufacturer Name / RXG-21-Substance Manufacturer Name / RXA-17-Substance Manufacturer Name
Literal reference, Relative, internal or absolute URL
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.
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.
Type the reference refers to (e.g. "Patient")
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).
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.
Aa resource (or, for logical models, the URI of the logical model).
Logical reference, when literal reference is not known
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.
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).
Plain text narrative that identifies the resource in addition to the resource reference.
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.
Describes the form of the item. Powder; tablets; capsule.
Begründung des Must-Support: Basis-Information eines Medikaments
A coded concept defining the form of a medication.
coding.code = //element(*,DrugCodedType)/FormCode coding.system = //element(*,DrugCodedType)/FormSourceCode
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
Begründung des Must-Support: EDQM definiert eine einheitliche DoseForm auf europäischer Ebene
Very often the text is the same as a displayName of one of the codings.
Menge des Arzneimittels im verpackten Produkt bzw. Behältnis
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.).
Begründung des Must-Support: Die Packungsgröße bzw. Füllmenge kann erforderlich sein, um ein Arzneimittelprodukt eindeutig von anderen Produkten gleicher Wirkstoffstärke und Darreichungsform zu unterscheiden.
Begründung des Must-Support: Gibt die enthaltene Menge bzw. Füllmenge an, z.B. `100 ml`.
Begründung des Must-Support: Gibt die zugehörige Verpackungs- oder Bezugseinheit an, z.B. `1 Beutel`.
Informationen zu Bestandteilen (Rezeptur)
Identifies a particular constituent of interest in the product.
Begründung des Must-Support: Wirkstoff-Rezepturen müssen dokumentierbar sein
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.
Optional Extension Element - found in all resources.
exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
Extensions that cannot be ignored even if unrecognized
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).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The actual ingredient - either a substance (simple ingredient) or another medication of a medication.
The ingredient may reference a substance (for example, amoxicillin) or another medication (for example in the case of a compounded product, Glaxal Base).
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
Bestandteil in codierter Form oder ggf. als Freitext
Begründung des Must-Support: Der Bestandteil muss eindeutig benannt sein
Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, z.B. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird.
Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, z.B. existieren für Aspirin 3 verschiedene Packungsgrößen.
Bestandteil (Referenz auf ein anderes Medikament)
handelt es sich um einen aktiven Bestandteil?
Indication of whether this ingredient affects the therapeutic action of the drug.
Begründung des Must-Support: Wird eine vollständige Rezeptur dokumentiert, muss erkennbar sein, welches die Wirkstoffe sind
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).
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.
Begründung des Must-Support: Basisinformation in Rezepturen
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
Information that only applies to packages (not products).
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.
The assigned lot number of a batch of the specified product.
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.
RXA-15 Substance Lot Number / RXG-19 Substance Lot Number
When this specific batch of product will expire.
RXA-16 Substance Expiration Date / RXG-20 Substance Expiration Date