Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Active as of 2024-12-04 |
Definitions for the pqcmc-component resource profile.
Guidance on how to interpret the contents of this table can be found here
0. Ingredient | |
2. Ingredient.for | |
Short | Reference to MedicinalProductDefinition |
4. Ingredient.role | |
Binding | The codes SHALL be taken from Drug Product Component Function Category Terminology (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology ) |
6. Ingredient.comment | |
Definition | A placeholder for providing any comments that are relevant to the component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying, etc. |
Short | Drug Product Component Additional Information |
Must Support | true |
8. Ingredient.substance | |
Invariants | cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements.
Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. (defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(
strength
.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension')
.extension.where(
value.coding.where(
code = 'C45420' and
system = %system
).exists()
).exists()
implies (
strength.presentation.ofType(Ratio).exists() and
strength.presentation.numerator.where(
code = '[arb\'U]' and
system = 'http://unitsofmeasure.org'
)
) or (
strength.presentation.ofType(Quantity).exists() and
strength.presentation.where(
code = '[arb\'U]' and
system = 'http://unitsofmeasure.org'
)
)) ) |
10. Ingredient.substance.code | |
Short | Ingredient Substance |
Type | CodeableReference(Literal Coded Reference)(Component Substance)bundled |
Must Support | true |
12. Ingredient.substance.strength | |
Control | 2..2 |
Must Support | true |
Slicing | This element introduces a set of slices on Ingredient.substance.strength . The slices areUnordered and Closed, and can be differentiated using the following discriminators: |
14. Ingredient.substance.strength:amount | |
Slice Name | amount |
Control | 1..1 |
Must Support | true |
16. Ingredient.substance.strength:amount.extension | |
Control | 1..? |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
18. Ingredient.substance.strength:amount.extension:strengthFactors | |
Slice Name | strengthFactors |
Control | 1..1 |
Type | Extension(Strength Extension) (Extension Type: CodeableConcept) |
Must Support | true |
20. Ingredient.substance.strength:amount.concentration[x] | |
Control | 1..? |
Type | Choice of: Ratio, Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.concentration[x] . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
22. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | |
Slice Name | concentrationQuantity |
Control | 0..1 |
Binding | The codes SHALL be taken from Non-Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units ) |
Type | Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Must Support | true |
24. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.value | |
Definition | Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Ingredient Total Amount Numeric = 325 |
Short | Ingredient Total Amount Numeric |
Control | 1..? |
Must Support | true |
26. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | |
Definition | A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics. |
Short | Ingredient Total Amount Operator |
Must Support | true |
28. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.unit | |
Control | 1..? |
30. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio | |
Slice Name | concentrationRatio |
Control | 0..1 |
Type | Ratio |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Must Support | true |
32. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | |
Definition | Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined] |
Control | 1..? |
Binding | The codes SHALL be taken from Non-Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units ) |
Must Support | true |
34. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value | |
Short | Ingredient Total Amount Numeric Numerator |
Control | 1..? |
Must Support | true |
36. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.unit | |
Definition | The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055] Example: mg |
Short | Ingredient Total Amount Numeric Numerator UOM |
38. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.code | |
Control | 1..? |
Must Support | true |
40. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | |
Control | 1..? |
Binding | The codes SHALL be taken from Non-Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units ) |
Must Support | true |
42. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value | |
Definition | Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined] Example: 10mg/syringe, 1mg/ml |
Short | Ingredient Total Amount Numeric Denominator |
Control | 1..? |
Must Support | true |
44. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit | |
Short | Ingredient Total Amount Numeric Denominator UOM |
Control | 1..? |
Must Support | true |
46. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.code | |
Control | 1..? |
Must Support | true |
48. Ingredient.substance.strength:amount.textConcentration | |
Definition | A written description of the strength of the ingredient. [Source: SME Defined] |
Short | Strength Textual |
Control | 1..? |
Must Support | true |
50. Ingredient.substance.strength:percent | |
Slice Name | percent |
Control | 1..1 |
Must Support | true |
52. Ingredient.substance.strength:percent.concentration[x] | |
Control | 1..? |
Binding | The codes SHALL be taken from Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units ) |
Type | Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Must Support | true |
54. Ingredient.substance.strength:percent.concentration[x].value | |
Definition | The percentage of the component in the drug product. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08 |
Short | Ingredient Total Amount Content Percent |
Control | 1..? |
Must Support | true |
56. Ingredient.substance.strength:percent.concentration[x].code | |
Short | Ingredient Total Amount Content Percent UOM |
Control | 1..? |
Must Support | true |
58. Ingredient.substance.strength:percent.textConcentration | |
Control | 0..0 |
Must Support | true |
Guidance on how to interpret the contents of this table can be found here
0. Ingredient | |
Definition | An ingredient of a manufactured item or pharmaceutical product. |
Short | An ingredient of a manufactured item or pharmaceutical product |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | 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().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: 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()) ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource (Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2) |
2. Ingredient.implicitRules | |
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. |
Short | A set of rules under which this content was created |
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 its narrative along with other profiles, value sets, etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
4. Ingredient.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
Short | Contained, inline Resources |
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. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
6. Ingredient.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
Summary | true |
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. |
Alternate Names | extensions, user content |
Invariants | 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()) |
8. Ingredient.status | |
Definition | The status of this ingredient. Enables tracking the life-cycle of the content. |
Short | draft | active | retired | unknown |
Comments | Allows filtering of ingredient that are appropriate for use versus not. |
Control | 1..1 |
Binding | The codes SHALL be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 (required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0 )The lifecycle status of an artifact. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
10. Ingredient.for | |
Definition | The product which this ingredient is a constituent part of. |
Short | Reference to MedicinalProductDefinitionThe product which this ingredient is a constituent part of |
Control | 0..* |
Type | Reference(MedicinalProductDefinition, AdministrableProductDefinition, ManufacturedItemDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
12. Ingredient.role | |
Definition | A classification of the ingredient identifying its purpose within the product, e.g. active, inactive. |
Short | Purpose of the ingredient within the product, e.g. active, inactive |
Control | 1..1 |
Binding | The codes SHALL be taken from For example codes, see Drug Product Component Function Category Terminologyhttp://hl7.org/fhir/ValueSet/ingredient-role (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
14. Ingredient.comment | |
Definition | A placeholder for providing any comments that are relevant to the component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying, etc. A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying. |
Short | Drug Product Component Additional InformationA place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
16. Ingredient.substance | |
Definition | The substance that comprises this ingredient. |
Short | The substance that comprises this ingredient |
Control | 1..1 This element is affected by the following invariants: ing-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. ( defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(
strength
.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension')
.extension.where(
value.coding.where(
code = 'C45420' and
system = %system
).exists()
).exists()
implies (
strength.presentation.ofType(Ratio).exists() and
strength.presentation.numerator.where(
code = '[arb\'U]' and
system = 'http://unitsofmeasure.org'
)
) or (
strength.presentation.ofType(Quantity).exists() and
strength.presentation.where(
code = '[arb\'U]' and
system = 'http://unitsofmeasure.org'
)
)) ) |
18. Ingredient.substance.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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()) |
20. Ingredient.substance.code | |
Definition | A reference to a resource (by instance), or instead, a reference to a concept defined in a terminology or ontology (by class). A code or full resource that represents the ingredient's substance. |
Short | Ingredient SubstanceA code or full resource that represents the ingredient substance |
Control | 1..1 This element is affected by the following invariants: ing-1 |
Binding | For example codes, see SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes (example to http://hl7.org/fhir/ValueSet/substance-codes )This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
Type | CodeableReference(Literal Coded Reference)(Component Substance, SubstanceDefinition)bundled |
Is Modifier | false |
Must Support | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
22. Ingredient.substance.strength | |
Definition | The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength. |
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
Control | 20..2* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength . The slices areUnordered and Closed, and can be differentiated using the following discriminators: |
24. Ingredient.substance.strength.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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()) |
26. Ingredient.substance.strength:amount | |
Slice Name | amount |
Definition | The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength. |
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
Control | 10..1* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
28. Ingredient.substance.strength:amount.extension | |
Definition | An Extension 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 managable, 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. |
Short | ExtensionAdditional content defined by implementations |
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. |
Control | 10..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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()) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
30. Ingredient.substance.strength:amount.extension:strengthFactors | |
Slice Name | strengthFactors |
Definition | Strength Type (for API) |
Short | Strength Extension |
Control | 1..1 |
Type | Extension(Strength Extension) (Extension Type: CodeableConcept) |
Is Modifier | false |
Must Support | true |
Invariants | 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()) |
32. Ingredient.substance.strength:amount.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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()) |
34. Ingredient.substance.strength:amount.concentration[x] | |
Definition | The strength per unitary volume (or mass). |
Short | The strength per unitary volume (or mass) |
Control | 10..1 |
Type | Choice of: Ratio, Quantity, RatioRange, CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.concentration[x] . The slices areUnordered and Closed, and can be differentiated using the following discriminators: |
36. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | |
Slice Name | concentrationQuantity |
Definition | The strength per unitary volume (or mass). |
Short | The strength per unitary volume (or mass) |
Control | 0..1 |
Binding | The codes SHALL be taken from For codes, see Non-Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units ) |
Type | Quantity, RatioRange, Ratio, CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
38. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.value | |
Definition | Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Ingredient Total Amount Numeric = 325 The value of the measured amount. The value includes an implicit precision in the presentation of the value. |
Short | Ingredient Total Amount NumericNumerical value (with implicit precision) |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 10..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
40. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | |
Definition | A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics. How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. |
Short | Ingredient Total Amount Operator< | <= | >= | > | ad - how to understand the value |
Control | 0..1 |
Binding | The codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
42. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.unit | |
Definition | A human-readable form of the unit. |
Short | Unit representation |
Control | 10..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
44. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio | |
Slice Name | concentrationRatio |
Definition | The strength per unitary volume (or mass). |
Short | The strength per unitary volume (or mass) |
Control | 0..1 |
Type | Ratio, RatioRange, Quantity, CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
46. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | |
Definition | Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined] The value of the numerator. |
Short | Numerator value |
Control | 10..1 This element is affected by the following invariants: rat-1 |
Binding | The codes SHALL be taken from For codes, see Non-Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units ) |
Type | Quantity |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
48. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value | |
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value. |
Short | Ingredient Total Amount Numeric NumeratorNumerical value (with implicit precision) |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 10..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
50. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator | |
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. |
Short | < | <= | >= | > | ad - how to understand the value |
Control | 0..1 |
Binding | The codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
52. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.unit | |
Definition | The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055] Example: mg A human-readable form of the unit. |
Short | Ingredient Total Amount Numeric Numerator UOMUnit representation |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
54. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Coded form of the unit |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 10..1 This element is affected by the following invariants: qty-3 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
56. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | |
Definition | The value of the denominator. |
Short | Denominator value |
Control | 10..1 This element is affected by the following invariants: rat-1 |
Binding | The codes SHALL be taken from For codes, see Non-Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units ) |
Type | Quantity(SimpleQuantity) |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
58. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value | |
Definition | Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined] Example: 10mg/syringe, 1mg/ml The value of the measured amount. The value includes an implicit precision in the presentation of the value. |
Short | Ingredient Total Amount Numeric DenominatorNumerical value (with implicit precision) |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 10..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
60. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.comparator | |
Definition | Not allowed to be used in this context How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. |
Short | < | <= | >= | > | ad - how to understand the value |
Control | 0..01 |
Binding | The codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
62. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit | |
Definition | A human-readable form of the unit. |
Short | Ingredient Total Amount Numeric Denominator UOMUnit representation |
Control | 10..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
64. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Coded form of the unit |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 10..1 This element is affected by the following invariants: qty-3 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
66. Ingredient.substance.strength:amount.textConcentration | |
Definition | A written description of the strength of the ingredient. [Source: SME Defined] A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio. |
Short | Strength TextualText of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) |
Control | 10..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
68. Ingredient.substance.strength:percent | |
Slice Name | percent |
Definition | The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength. |
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
Control | 10..1* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
70. Ingredient.substance.strength:percent.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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()) |
72. Ingredient.substance.strength:percent.concentration[x] | |
Definition | The strength per unitary volume (or mass). |
Short | The strength per unitary volume (or mass) |
Control | 10..1 |
Binding | The codes SHALL be taken from For codes, see Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units ) |
Type | Quantity, RatioRange, Ratio, CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
74. Ingredient.substance.strength:percent.concentration[x].value | |
Definition | The percentage of the component in the drug product. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08 The value of the measured amount. The value includes an implicit precision in the presentation of the value. |
Short | Ingredient Total Amount Content PercentNumerical value (with implicit precision) |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 10..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
76. Ingredient.substance.strength:percent.concentration[x].comparator | |
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. |
Short | < | <= | >= | > | ad - how to understand the value |
Control | 0..1 |
Binding | The codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
78. Ingredient.substance.strength:percent.concentration[x].code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Ingredient Total Amount Content Percent UOMCoded form of the unit |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 10..1 This element is affected by the following invariants: qty-3 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
80. Ingredient.substance.strength:percent.textConcentration | |
Definition | A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio. |
Short | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) |
Control | 0..01 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here
0. Ingredient | |
Definition | An ingredient of a manufactured item or pharmaceutical product. |
Short | An ingredient of a manufactured item or pharmaceutical product |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | 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().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: 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() )ing-1: If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource ( Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 ) |
2. Ingredient.id | |
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
Short | Logical id of this artifact |
Comments | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. |
Control | 0..1 |
Type | id |
Is Modifier | false |
Must Support | false |
Summary | true |
4. Ingredient.meta | |
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. |
Short | Metadata about the resource |
Control | 0..1 |
Type | Meta |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
6. Ingredient.implicitRules | |
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. |
Short | A set of rules under which this content was created |
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 its narrative along with other profiles, value sets, etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
8. Ingredient.language | |
Definition | The base language in which the resource is written. |
Short | Language of the resource content |
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). |
Control | 0..1 |
Binding | The codes SHALL be taken from AllLanguages (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0 )IETF language tag for a human language |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
10. Ingredient.text | |
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. |
Short | Text summary of the resource, for human interpretation |
Comments | Contained resources do not have a 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. |
Control | 0..1 This element is affected by the following invariants: dom-6 |
Type | Narrative |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | narrative, html, xhtml, display |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
12. Ingredient.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
Short | Contained, inline Resources |
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. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
14. Ingredient.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
16. Ingredient.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
Summary | true |
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. |
Alternate Names | extensions, user content |
Invariants | 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() ) |
18. Ingredient.identifier | |
Definition | The identifier(s) of this Ingredient that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate. |
Short | An identifier or code by which the ingredient can be referenced |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
20. Ingredient.status | |
Definition | The status of this ingredient. Enables tracking the life-cycle of the content. |
Short | draft | active | retired | unknown |
Comments | Allows filtering of ingredient that are appropriate for use versus not. |
Control | 1..1 |
Binding | The codes SHALL be taken from PublicationStatus (required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0 )The lifecycle status of an artifact. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
22. Ingredient.for | |
Definition | The product which this ingredient is a constituent part of. |
Short | Reference to MedicinalProductDefinition |
Control | 0..* |
Type | Reference(MedicinalProductDefinition, AdministrableProductDefinition, ManufacturedItemDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
24. Ingredient.role | |
Definition | A classification of the ingredient identifying its purpose within the product, e.g. active, inactive. |
Short | Purpose of the ingredient within the product, e.g. active, inactive |
Control | 1..1 |
Binding | The codes SHALL be taken from Drug Product Component Function Category Terminology (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
26. Ingredient.function | |
Definition | A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent. |
Short | Precise action within the drug product, e.g. antioxidant, alkalizing agent |
Control | 0..* |
Binding | For example codes, see IngredientFunction (example to http://hl7.org/fhir/ValueSet/ingredient-function )A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive). |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
28. Ingredient.group | |
Definition | A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink. |
Short | A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink |
Control | 0..1 |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
30. Ingredient.allergenicIndicator | |
Definition | If the ingredient is a known or suspected allergen. Note that this is a property of the substance, so if a reference to a SubstanceDefinition is used to decribe that (rather than just a code), the allergen information should go there, not here. |
Short | If the ingredient is a known or suspected allergen |
Control | 0..1 This element is affected by the following invariants: ing-1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Meaning if Missing | If this value is not present, there is no statement being made about whether this is an allergen or not. No inference can be made |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
32. Ingredient.comment | |
Definition | A placeholder for providing any comments that are relevant to the component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying, etc. |
Short | Drug Product Component Additional Information |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
34. Ingredient.manufacturer | |
Definition | The organization(s) that manufacture this ingredient. Can be used to indicate: 1) Organizations we are aware of that manufacture this ingredient 2) Specific Manufacturer(s) currently being used 3) Set of organisations allowed to manufacture this ingredient for this product Users must be clear on the application of context relevant to their use case. |
Short | An organization that manufactures this ingredient |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
36. Ingredient.manufacturer.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
38. Ingredient.manufacturer.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
40. Ingredient.manufacturer.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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() ) |
42. Ingredient.manufacturer.role | |
Definition | The way in which this manufacturer is associated with the ingredient. For example whether it is a possible one (others allowed), or an exclusive authorized one for this ingredient. Note that this is not the manufacturing process role. |
Short | allowed | possible | actual |
Control | 0..1 |
Binding | The codes SHALL be taken from IngredientManufacturerRole (required to http://hl7.org/fhir/ValueSet/ingredient-manufacturer-role|5.0.0 )The way in which this manufacturer is associated with the ingredient. |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
44. Ingredient.manufacturer.manufacturer | |
Definition | An organization that manufactures this ingredient. |
Short | An organization that manufactures this ingredient |
Control | 1..1 |
Type | Reference(Organization) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
46. Ingredient.substance | |
Definition | The substance that comprises this ingredient. |
Short | The substance that comprises this ingredient |
Control | 1..1 This element is affected by the following invariants: ing-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )cmc-strength-type-cases2: IF Strength Type = Activity THEN Strength Textual, Strength UOM ([arb'U]) and Strength Operator are applicable data elements. Strength Textual and Strength UOM will be Mandatory and Operator will be Optional. Codes 75765 [arb'U]; C45420 Activity. ( defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(
strength
.extension('http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension')
.extension.where(
value.coding.where(
code = 'C45420' and
system = %system
).exists()
).exists()
implies (
strength.presentation.ofType(Ratio).exists() and
strength.presentation.numerator.where(
code = '[arb\'U]' and
system = 'http://unitsofmeasure.org'
)
) or (
strength.presentation.ofType(Quantity).exists() and
strength.presentation.where(
code = '[arb\'U]' and
system = 'http://unitsofmeasure.org'
)
)) ) |
48. Ingredient.substance.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
50. Ingredient.substance.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
52. Ingredient.substance.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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() ) |
54. Ingredient.substance.code | |
Definition | A reference to a resource (by instance), or instead, a reference to a concept defined in a terminology or ontology (by class). |
Short | Ingredient Substance |
Control | 1..1 |
Binding | For example codes, see SNOMEDCTSubstanceCodes (example to http://hl7.org/fhir/ValueSet/substance-codes )This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
Type | CodeableReference(Literal Coded Reference)(Component Substance)bundled |
Is Modifier | false |
Must Support | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
56. Ingredient.substance.strength | |
Definition | The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength. |
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
Control | 2..2 |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength . The slices areUnordered and Closed, and can be differentiated using the following discriminators: |
58. Ingredient.substance.strength.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
60. Ingredient.substance.strength.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
62. Ingredient.substance.strength.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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() ) |
64. Ingredient.substance.strength.presentation[x] | |
Definition | The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg'). |
Short | The quantity of substance in the unit of presentation |
Control | 0..1 |
Type | Choice of: Ratio, RatioRange, CodeableConcept, Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
66. Ingredient.substance.strength.textPresentation | |
Definition | A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio. |
Short | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
68. Ingredient.substance.strength.concentration[x] | |
Definition | The strength per unitary volume (or mass). |
Short | The strength per unitary volume (or mass) |
Control | 0..1 |
Type | Choice of: Ratio, RatioRange, CodeableConcept, Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
70. Ingredient.substance.strength.textConcentration | |
Definition | A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio. |
Short | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
72. Ingredient.substance.strength.basis | |
Definition | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt). |
Short | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) |
Control | 0..1 |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
74. Ingredient.substance.strength.measurementPoint | |
Definition | For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization. |
Short | When strength is measured at a particular point or distance |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
76. Ingredient.substance.strength.country | |
Definition | The country or countries for which the strength range applies. |
Short | Where the strength range applies |
Control | 0..* |
Binding | For example codes, see CountryValueSet (example to http://hl7.org/fhir/ValueSet/country )Jurisdiction codes |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
78. Ingredient.substance.strength.referenceStrength | |
Definition | Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed. |
Short | Strength expressed in terms of a reference substance |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
80. Ingredient.substance.strength.referenceStrength.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
82. Ingredient.substance.strength.referenceStrength.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
84. Ingredient.substance.strength.referenceStrength.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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() ) |
86. Ingredient.substance.strength.referenceStrength.substance | |
Definition | Relevant reference substance. |
Short | Relevant reference substance |
Control | 1..1 |
Binding | For example codes, see SNOMEDCTSubstanceCodes (example to http://hl7.org/fhir/ValueSet/substance-codes )This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
Type | CodeableReference(SubstanceDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
88. Ingredient.substance.strength.referenceStrength.strength[x] | |
Definition | Strength expressed in terms of a reference substance. |
Short | Strength expressed in terms of a reference substance |
Control | 1..1 |
Type | Choice of: Ratio, RatioRange, Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
90. Ingredient.substance.strength.referenceStrength.measurementPoint | |
Definition | For when strength is measured at a particular point or distance. |
Short | When strength is measured at a particular point or distance |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
92. Ingredient.substance.strength.referenceStrength.country | |
Definition | The country or countries for which the strength range applies. |
Short | Where the strength range applies |
Control | 0..* |
Binding | For example codes, see CountryValueSet (example to http://hl7.org/fhir/ValueSet/country )Jurisdiction codes |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
94. Ingredient.substance.strength:amount | |
Slice Name | amount |
Definition | The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength. |
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
Control | 1..1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
96. Ingredient.substance.strength:amount.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
98. Ingredient.substance.strength:amount.extension | |
Definition | An Extension |
Short | Extension |
Control | 1..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Invariants | 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() ) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
100. Ingredient.substance.strength:amount.extension:strengthFactors | |
Slice Name | strengthFactors |
Definition | Strength Type (for API) |
Short | Strength Extension |
Control | 1..1 |
Type | Extension(Strength Extension) (Extension Type: CodeableConcept) |
Is Modifier | false |
Must Support | true |
Invariants | 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() ) |
102. Ingredient.substance.strength:amount.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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() ) |
104. Ingredient.substance.strength:amount.presentation[x] | |
Definition | The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg'). |
Short | The quantity of substance in the unit of presentation |
Control | 0..1 |
Type | Choice of: Ratio, RatioRange, CodeableConcept, Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
106. Ingredient.substance.strength:amount.textPresentation | |
Definition | A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio. |
Short | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
108. Ingredient.substance.strength:amount.concentration[x] | |
Definition | The strength per unitary volume (or mass). |
Short | The strength per unitary volume (or mass) |
Control | 1..1 |
Type | Choice of: Ratio, Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.concentration[x] . The slices areUnordered and Closed, and can be differentiated using the following discriminators: |
110. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity | |
Slice Name | concentrationQuantity |
Definition | The strength per unitary volume (or mass). |
Short | The strength per unitary volume (or mass) |
Control | 0..1 |
Binding | The codes SHALL be taken from Non-Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units ) |
Type | Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
112. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
114. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.concentration[x].extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
116. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.value | |
Definition | Specifies the quantity of an ingredient in a single dose unit (e.g., one tablet, capsule) of the drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Ingredient Total Amount Numeric = 325 |
Short | Ingredient Total Amount Numeric |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 1..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
118. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.comparator | |
Definition | A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics. |
Short | Ingredient Total Amount Operator |
Control | 0..1 |
Binding | The codes SHALL be taken from QuantityComparator (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
120. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.unit | |
Definition | A human-readable form of the unit. |
Short | Unit representation |
Control | 1..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
122. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.system | |
Definition | The identification of the system that provides the coded form of the unit. |
Short | System that defines coded unit form |
Control | 0..1 This element is affected by the following invariants: qty-3 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to know the system that defines the coded form of the unit. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
124. Ingredient.substance.strength:amount.concentration[x]:concentrationQuantity.code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Coded form of the unit |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 0..1 This element is affected by the following invariants: qty-3 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
126. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio | |
Slice Name | concentrationRatio |
Definition | The strength per unitary volume (or mass). |
Short | The strength per unitary volume (or mass) |
Control | 0..1 |
Type | Ratio |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
128. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
130. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.concentration[x].extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
132. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator | |
Definition | Specifies the quantity of an ingredient in a single dose unit of the drug product. [Source: SME Defined] |
Short | Numerator value |
Control | 1..1 This element is affected by the following invariants: rat-1 |
Binding | The codes SHALL be taken from Non-Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units ) |
Type | Quantity |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
134. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
136. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.concentration[x].numerator.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
138. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.value | |
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value. |
Short | Ingredient Total Amount Numeric Numerator |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 1..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
140. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.comparator | |
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. |
Short | < | <= | >= | > | ad - how to understand the value |
Control | 0..1 |
Binding | The codes SHALL be taken from QuantityComparator (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
142. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.unit | |
Definition | The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055] Example: mg |
Short | Ingredient Total Amount Numeric Numerator UOM |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
144. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.system | |
Definition | The identification of the system that provides the coded form of the unit. |
Short | System that defines coded unit form |
Control | 0..1 This element is affected by the following invariants: qty-3 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to know the system that defines the coded form of the unit. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
146. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.numerator.code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Coded form of the unit |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 1..1 This element is affected by the following invariants: qty-3 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
148. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator | |
Definition | The value of the denominator. |
Short | Denominator value |
Control | 1..1 This element is affected by the following invariants: rat-1 |
Binding | The codes SHALL be taken from Non-Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units ) |
Type | Quantity(SimpleQuantity) |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
150. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
152. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.concentration[x].denominator.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
154. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.value | |
Definition | Specifies the quantity of the ingredients within a single dose unit (e.g., vial, syringe) of drug product. [Source: SME Defined] Example: 10mg/syringe, 1mg/ml |
Short | Ingredient Total Amount Numeric Denominator |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 1..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
156. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.comparator | |
Definition | Not allowed to be used in this context |
Short | < | <= | >= | > | ad - how to understand the value |
Control | 0..0 |
Binding | The codes SHALL be taken from QuantityComparator (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
158. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.unit | |
Definition | A human-readable form of the unit. |
Short | Ingredient Total Amount Numeric Denominator UOM |
Control | 1..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
160. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.system | |
Definition | The identification of the system that provides the coded form of the unit. |
Short | System that defines coded unit form |
Control | 0..1 This element is affected by the following invariants: qty-3 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to know the system that defines the coded form of the unit. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
162. Ingredient.substance.strength:amount.concentration[x]:concentrationRatio.denominator.code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Coded form of the unit |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 1..1 This element is affected by the following invariants: qty-3 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
164. Ingredient.substance.strength:amount.textConcentration | |
Definition | A written description of the strength of the ingredient. [Source: SME Defined] |
Short | Strength Textual |
Control | 1..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
166. Ingredient.substance.strength:amount.basis | |
Definition | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt). |
Short | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) |
Control | 0..1 |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
168. Ingredient.substance.strength:amount.measurementPoint | |
Definition | For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization. |
Short | When strength is measured at a particular point or distance |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
170. Ingredient.substance.strength:amount.country | |
Definition | The country or countries for which the strength range applies. |
Short | Where the strength range applies |
Control | 0..* |
Binding | For example codes, see CountryValueSet (example to http://hl7.org/fhir/ValueSet/country )Jurisdiction codes |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
172. Ingredient.substance.strength:amount.referenceStrength | |
Definition | Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed. |
Short | Strength expressed in terms of a reference substance |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
174. Ingredient.substance.strength:amount.referenceStrength.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
176. Ingredient.substance.strength:amount.referenceStrength.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
178. Ingredient.substance.strength:amount.referenceStrength.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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() ) |
180. Ingredient.substance.strength:amount.referenceStrength.substance | |
Definition | Relevant reference substance. |
Short | Relevant reference substance |
Control | 1..1 |
Binding | For example codes, see SNOMEDCTSubstanceCodes (example to http://hl7.org/fhir/ValueSet/substance-codes )This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
Type | CodeableReference(SubstanceDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
182. Ingredient.substance.strength:amount.referenceStrength.strength[x] | |
Definition | Strength expressed in terms of a reference substance. |
Short | Strength expressed in terms of a reference substance |
Control | 1..1 |
Type | Choice of: Ratio, RatioRange, Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
184. Ingredient.substance.strength:amount.referenceStrength.measurementPoint | |
Definition | For when strength is measured at a particular point or distance. |
Short | When strength is measured at a particular point or distance |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
186. Ingredient.substance.strength:amount.referenceStrength.country | |
Definition | The country or countries for which the strength range applies. |
Short | Where the strength range applies |
Control | 0..* |
Binding | For example codes, see CountryValueSet (example to http://hl7.org/fhir/ValueSet/country )Jurisdiction codes |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
188. Ingredient.substance.strength:percent | |
Slice Name | percent |
Definition | The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength. |
Short | The quantity of substance, per presentation, or per volume or mass, and type of quantity |
Control | 1..1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
190. Ingredient.substance.strength:percent.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
192. Ingredient.substance.strength:percent.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
194. Ingredient.substance.strength:percent.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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() ) |
196. Ingredient.substance.strength:percent.presentation[x] | |
Definition | The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg'). |
Short | The quantity of substance in the unit of presentation |
Control | 0..1 |
Type | Choice of: Ratio, RatioRange, CodeableConcept, Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
198. Ingredient.substance.strength:percent.textPresentation | |
Definition | A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio. |
Short | Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
200. Ingredient.substance.strength:percent.concentration[x] | |
Definition | The strength per unitary volume (or mass). |
Short | The strength per unitary volume (or mass) |
Control | 1..1 |
Binding | The codes SHALL be taken from Percentage Units (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units ) |
Type | Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
202. Ingredient.substance.strength:percent.concentration[x].id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
204. Ingredient.substance.strength:percent.concentration[x].extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
Slicing | This element introduces a set of slices on Ingredient.substance.strength.concentration[x].extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
206. Ingredient.substance.strength:percent.concentration[x].value | |
Definition | The percentage of the component in the drug product. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08 |
Short | Ingredient Total Amount Content Percent |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 1..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
208. Ingredient.substance.strength:percent.concentration[x].comparator | |
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. |
Short | < | <= | >= | > | ad - how to understand the value |
Control | 0..1 |
Binding | The codes SHALL be taken from QuantityComparator (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
210. Ingredient.substance.strength:percent.concentration[x].unit | |
Definition | A human-readable form of the unit. |
Short | Unit representation |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
212. Ingredient.substance.strength:percent.concentration[x].system | |
Definition | The identification of the system that provides the coded form of the unit. |
Short | System that defines coded unit form |
Control | 0..1 This element is affected by the following invariants: qty-3 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to know the system that defines the coded form of the unit. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
214. Ingredient.substance.strength:percent.concentration[x].code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Ingredient Total Amount Content Percent UOM |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 1..1 This element is affected by the following invariants: qty-3 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
216. Ingredient.substance.strength:percent.textConcentration | |
Definition | A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio. |
Short | Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) |
Control | 0..0 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
218. Ingredient.substance.strength:percent.basis | |
Definition | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt). |
Short | A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt) |
Control | 0..1 |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
220. Ingredient.substance.strength:percent.measurementPoint | |
Definition | For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization. |
Short | When strength is measured at a particular point or distance |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
222. Ingredient.substance.strength:percent.country | |
Definition | The country or countries for which the strength range applies. |
Short | Where the strength range applies |
Control | 0..* |
Binding | For example codes, see CountryValueSet (example to http://hl7.org/fhir/ValueSet/country )Jurisdiction codes |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
224. Ingredient.substance.strength:percent.referenceStrength | |
Definition | Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed. |
Short | Strength expressed in terms of a reference substance |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
226. Ingredient.substance.strength:percent.referenceStrength.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
228. Ingredient.substance.strength:percent.referenceStrength.extension | |
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 managable, 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. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
230. Ingredient.substance.strength:percent.referenceStrength.modifierExtension | |
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 managable, 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). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | 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() ) |
232. Ingredient.substance.strength:percent.referenceStrength.substance | |
Definition | Relevant reference substance. |
Short | Relevant reference substance |
Control | 1..1 |
Binding | For example codes, see SNOMEDCTSubstanceCodes (example to http://hl7.org/fhir/ValueSet/substance-codes )This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. |
Type | CodeableReference(SubstanceDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
234. Ingredient.substance.strength:percent.referenceStrength.strength[x] | |
Definition | Strength expressed in terms of a reference substance. |
Short | Strength expressed in terms of a reference substance |
Control | 1..1 |
Type | Choice of: Ratio, RatioRange, Quantity |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
236. Ingredient.substance.strength:percent.referenceStrength.measurementPoint | |
Definition | For when strength is measured at a particular point or distance. |
Short | When strength is measured at a particular point or distance |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
238. Ingredient.substance.strength:percent.referenceStrength.country | |
Definition | The country or countries for which the strength range applies. |
Short | Where the strength range applies |
Control | 0..* |
Binding | For example codes, see CountryValueSet (example to http://hl7.org/fhir/ValueSet/country )Jurisdiction codes |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |