Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq | Version: 1.0.0 | |||
Active as of 2024-05-08 | Computable Name: SubstanceDrugPq | |||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.39 |
This Substance profile represents identifying information about an actual batch of substance (an instance).
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Substance
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Substance | 0..* | Substance | A homogeneous material with a definite composition | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
medication-manufacturingBatch | S | 0..1 | (Complex) | medication-manufacturingBatch URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch |
batch-release-date | S | 0..* | dateTime | batch-release-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq |
batch-retest-date | S | 0..* | dateTime | batch-retest-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq |
manufacturing-process | S | 0..* | Reference(PlanDefinition - Drug PQ) | manufacturing-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq |
actual-yield | S | 0..* | Quantity | actual-yield URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq |
batch-derived-from | S | 0..* | Reference() | batch-derived-from URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq |
identifier | S | 0..* | Identifier | Unique identifier |
status | S | 0..1 | code | active | inactive | entered-in-error |
Documentation for this format |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Substance | 0..* | Substance | A homogeneous material with a definite composition | |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
medication-manufacturingBatch | S | 0..1 | (Complex) | medication-manufacturingBatch URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch |
batch-release-date | S | 0..* | dateTime | batch-release-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq |
batch-retest-date | S | 0..* | dateTime | batch-retest-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq |
manufacturing-process | S | 0..* | Reference(PlanDefinition - Drug PQ) | manufacturing-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq |
actual-yield | S | 0..* | Quantity | actual-yield URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq |
batch-derived-from | S | 0..* | Reference() | batch-derived-from URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | SΣ | 0..* | Identifier | Unique identifier |
instance | ?!Σ | 1..1 | boolean | Is this an instance of a substance or a kind of one |
status | ?!SΣ | 0..1 | code | active | inactive | entered-in-error Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used. |
code | Σ | 1..1 | CodeableReference(SubstanceDefinition) | What substance this is Binding: SubstanceCode (example): Substance codes. |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Substance.status | required | FHIRSubstanceStatushttp://hl7.org/fhir/ValueSet/substance-status|5.0.0 from the FHIR Standard | |
Substance.code | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-code from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Substance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Substance | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Substance | 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 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Substance | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
Substance | 0..* | Substance | A homogeneous material with a definite composition | |||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
medication-manufacturingBatch | S | 0..1 | (Complex) | medication-manufacturingBatch URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch | ||||
batch-release-date | S | 0..* | dateTime | batch-release-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq | ||||
batch-retest-date | S | 0..* | dateTime | batch-retest-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq | ||||
manufacturing-process | S | 0..* | Reference(PlanDefinition - Drug PQ) | manufacturing-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq | ||||
actual-yield | S | 0..* | Quantity | actual-yield URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq | ||||
batch-derived-from | S | 0..* | Reference() | batch-derived-from URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq | ||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | SΣ | 0..* | Identifier | Unique identifier | ||||
instance | ?!Σ | 1..1 | boolean | Is this an instance of a substance or a kind of one | ||||
status | ?!SΣ | 0..1 | code | active | inactive | entered-in-error Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used. | ||||
category | Σ | 0..* | CodeableConcept | What class/type of substance this is Binding: SubstanceCategoryCodes (extensible): Category or classification of substance. | ||||
code | Σ | 1..1 | CodeableReference(SubstanceDefinition) | What substance this is Binding: SubstanceCode (example): Substance codes. | ||||
description | Σ | 0..1 | markdown | Textual description of the substance, comments | ||||
expiry | Σ | 0..1 | dateTime | When no longer valid to use | ||||
quantity | Σ | 0..1 | SimpleQuantity | Amount of substance in the package | ||||
ingredient | Σ | 0..* | BackboneElement | Composition information about the substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
quantity | Σ | 0..1 | Ratio | Optional amount (concentration) | ||||
substance[x] | Σ | 1..1 | A component of the substance Binding: SubstanceCode (example): Substance Ingredient codes. | |||||
substanceCodeableConcept | CodeableConcept | |||||||
substanceReference | Reference(Substance) | |||||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
Substance.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
Substance.status | required | FHIRSubstanceStatushttp://hl7.org/fhir/ValueSet/substance-status|5.0.0 from the FHIR Standard | |
Substance.category | extensible | SubstanceCategoryCodeshttp://hl7.org/fhir/ValueSet/substance-category from the FHIR Standard | |
Substance.code | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-code from the FHIR Standard | |
Substance.ingredient.substance[x] | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-code from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Substance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Substance | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Substance | 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 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Substance | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Substance
Summary
Must-Support: 8 elements
Extensions
This structure refers to these extensions:
Differential View
This structure is derived from Substance
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Substance | 0..* | Substance | A homogeneous material with a definite composition | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
medication-manufacturingBatch | S | 0..1 | (Complex) | medication-manufacturingBatch URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch |
batch-release-date | S | 0..* | dateTime | batch-release-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq |
batch-retest-date | S | 0..* | dateTime | batch-retest-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq |
manufacturing-process | S | 0..* | Reference(PlanDefinition - Drug PQ) | manufacturing-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq |
actual-yield | S | 0..* | Quantity | actual-yield URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq |
batch-derived-from | S | 0..* | Reference() | batch-derived-from URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq |
identifier | S | 0..* | Identifier | Unique identifier |
status | S | 0..1 | code | active | inactive | entered-in-error |
Documentation for this format |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Substance | 0..* | Substance | A homogeneous material with a definite composition | |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
medication-manufacturingBatch | S | 0..1 | (Complex) | medication-manufacturingBatch URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch |
batch-release-date | S | 0..* | dateTime | batch-release-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq |
batch-retest-date | S | 0..* | dateTime | batch-retest-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq |
manufacturing-process | S | 0..* | Reference(PlanDefinition - Drug PQ) | manufacturing-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq |
actual-yield | S | 0..* | Quantity | actual-yield URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq |
batch-derived-from | S | 0..* | Reference() | batch-derived-from URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | SΣ | 0..* | Identifier | Unique identifier |
instance | ?!Σ | 1..1 | boolean | Is this an instance of a substance or a kind of one |
status | ?!SΣ | 0..1 | code | active | inactive | entered-in-error Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used. |
code | Σ | 1..1 | CodeableReference(SubstanceDefinition) | What substance this is Binding: SubstanceCode (example): Substance codes. |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Substance.status | required | FHIRSubstanceStatushttp://hl7.org/fhir/ValueSet/substance-status|5.0.0 from the FHIR Standard | |
Substance.code | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-code from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Substance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Substance | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Substance | 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 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Substance | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
Substance | 0..* | Substance | A homogeneous material with a definite composition | |||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
medication-manufacturingBatch | S | 0..1 | (Complex) | medication-manufacturingBatch URL: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch | ||||
batch-release-date | S | 0..* | dateTime | batch-release-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq | ||||
batch-retest-date | S | 0..* | dateTime | batch-retest-date URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq | ||||
manufacturing-process | S | 0..* | Reference(PlanDefinition - Drug PQ) | manufacturing-process URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq | ||||
actual-yield | S | 0..* | Quantity | actual-yield URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq | ||||
batch-derived-from | S | 0..* | Reference() | batch-derived-from URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq | ||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | SΣ | 0..* | Identifier | Unique identifier | ||||
instance | ?!Σ | 1..1 | boolean | Is this an instance of a substance or a kind of one | ||||
status | ?!SΣ | 0..1 | code | active | inactive | entered-in-error Binding: FHIRSubstanceStatus (required): A code to indicate if the substance is actively used. | ||||
category | Σ | 0..* | CodeableConcept | What class/type of substance this is Binding: SubstanceCategoryCodes (extensible): Category or classification of substance. | ||||
code | Σ | 1..1 | CodeableReference(SubstanceDefinition) | What substance this is Binding: SubstanceCode (example): Substance codes. | ||||
description | Σ | 0..1 | markdown | Textual description of the substance, comments | ||||
expiry | Σ | 0..1 | dateTime | When no longer valid to use | ||||
quantity | Σ | 0..1 | SimpleQuantity | Amount of substance in the package | ||||
ingredient | Σ | 0..* | BackboneElement | Composition information about the substance | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
quantity | Σ | 0..1 | Ratio | Optional amount (concentration) | ||||
substance[x] | Σ | 1..1 | A component of the substance Binding: SubstanceCode (example): Substance Ingredient codes. | |||||
substanceCodeableConcept | CodeableConcept | |||||||
substanceReference | Reference(Substance) | |||||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
Substance.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
Substance.status | required | FHIRSubstanceStatushttp://hl7.org/fhir/ValueSet/substance-status|5.0.0 from the FHIR Standard | |
Substance.category | extensible | SubstanceCategoryCodeshttp://hl7.org/fhir/ValueSet/substance-category from the FHIR Standard | |
Substance.code | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-code from the FHIR Standard | |
Substance.ingredient.substance[x] | example | SubstanceCodehttp://hl7.org/fhir/ValueSet/substance-code from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | Substance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | Substance | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | Substance | 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 | error | Substance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | Substance | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Substance
Summary
Must-Support: 8 elements
Extensions
This structure refers to these extensions:
Other representations of profile: CSV, Excel, Schematron