SPL Mapping FHIR R5 Implementation Guide
0.2.5 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.5 - Build CI
SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.5 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel | Version: 0.2.5 | |||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: SubmittedMedicationLogicalModel | ||
Details about the Medication that is submitted to the FDA.
The following UML diagram shows the data elements of a Submitted Medication. More details about the data elements can be found in the definition tables below.
A Submitted Medication has a set of medication-related elements and then is broken into an optional set of Parts of products as well as optional sets of Packaging.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  SubmittedMedicationLogicalModel |
0..* | Element | Elements defined in Ancestors:@id, extension Submitted Medication Logical Model Instances of this logical model can be the target of a Reference ele-1: All FHIR elements must have a @value or children | |
  @id |
0..1 | string | Unique id for inter-element referencing | |
 extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
 ndcCode |
0..1 | CodeableConcept | NDC Code | |
| proprietaryName |
1..1 | string | Proprietary Name | |
| proprietaryNameSuffix |
0..1 | string | Proprietary Name Suffix | |
| nonProprietaryName |
0..1 | string | Non-Proprietary Name | |
| form |
0..1 | CodeableConcept | Medication Form | |
| sourceMedicationCode |
0..1 | CodeableConcept | Source Medication | |
| MedicationIdentifier |
0..* | Identifier | Additional Identifiers | |
| deaSchedule |
0..1 | CodeableConcept | DEA Schedule Code | |
| route |
0..* | CodeableConcept | Route of Administration | |
 ingredient |
0..* | BackboneElement | Medication Ingredients ele-1: All FHIR elements must have a @value or children | |
 @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| type |
1..1 | code | Ingredient Type | |
| unii |
1..1 | CodeableConcept | Ingredient Code | |
| name |
1..1 | string | Ingredient Name | |
| strength |
0..1 | Ratio | Ingredient Strength | |
| activeMoiety |
1..2 | BackboneElement | Ingredient Active Moiety ele-1: All FHIR elements must have a @value or children | |
| @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| unii |
1..1 | CodeableConcept | Active Moiety Code | |
 name |
1..1 | string | Active Moiety Name | |
 strengthReference |
0..1 | BackboneElement | Reference Ingredient for Strength ele-1: All FHIR elements must have a @value or children | |
 @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| unii |
1..1 | CodeableConcept | Reference Ingredient Code | |
| name |
1..1 | string | Reference Ingredient Name | |
| packaging |
0..1 | BackboneElement | Medication Packaging ele-1: All FHIR elements must have a @value or children | |
| @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| quantity |
1..1 | Quantity | Amount of medication in the package. | |
| type |
1..1 | CodeableConcept | Packaging Type | |
| code |
0..1 | CodeableConcept | Packaging Identifier | |
| sample |
1..1 | boolean | Drug Sample Flag | |
| combinationMedicationType |
0..1 | CodeableConcept | Combination Medication Type | |
| marketingStatusPeriod |
0..1 | Period | Marketing Status Period | |
| characteristic |
0..* | See characteristic | Packaging Characteristics | |
| packaging |
0..1 | See packaging | Outer Packaging | |
| part |
0..* | BackboneElement | Medication Part ele-1: All FHIR elements must have a @value or children | |
| @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| quantity |
1..1 | Quantity | Part Quantity | |
 Medication |
1..1 | Reference(Submitted Medication Logical Model) | Part Medication | |
| marketing |
0..1 | See marketing | Part Marketing | |
| marketing |
0..1 | BackboneElement | Marketing Application Information ele-1: All FHIR elements must have a @value or children | |
| @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| number |
0..1 | Identifier | Markting Application Number | |
| category |
0..1 | CodeableConcept | Marketing Category | |
| approvalDate |
0..1 | dateTime | Marketing Approval Date | |
| marketingStatusPeriod |
1..1 | Period | Marketing Status Period | |
| characteristic |
0..* | BackboneElement | Medication Characteristics ele-1: All FHIR elements must have a @value or children | |
| @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| type |
1..1 | CodeableConcept | Characteristic Type | |
 value[x] |
1..1 | Characteristic Value | ||
| valueQuantity |
Quantity | |||
| valueInteger |
integer | |||
| valueRange |
Range | |||
| valueCodeableConcept |
CodeableConcept | |||
| valueString |
string | |||
| valueBase64Binary |
base64Binary | |||
| valueBoolean |
boolean | |||
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.5 based on FHIR 5.0.0. Generated 2025-02-27
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