HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot

This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Resource Profile: ICSR MedicationAdministration

Defining URL:http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-medicationadministration
Version:0.1.0
Name:ICSRMedicationAdministration
Title:ICSR MedicationAdministration
Status:Active as of 2021-08-05T14:34:06+00:00
Definition:

The common fields needed for either a FAERS or VAERS drug administration.

Publisher:Biomedical Research & Regulation WG
Source Resource:XML / JSON / Turtle

The official URL for this profile is: 

http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-medicationadministration

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from MedicationAdministration

Summary

Must-Support: 9 elements

Structures

This structure refers to these other structures:

This structure is derived from MedicationAdministration

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicationAdministration 0..*MedicationAdministrationAdministration of medication to a patient
... status S1..1codein-progress | not-done | on-hold | completed | entered-in-error | stopped | unknown
... medication[x] S1..1CodeableConcept, Reference(Medication)What was administered
... subject S1..1Reference(ICSR Patient)Who received medication
... reasonCode S0..*CodeableConceptReason administration performed
... dosage S0..1BackboneElementDetails of how medication was taken
.... text S0..1stringFree text dosage instructions e.g. SIG
.... route S0..1CodeableConceptPath of substance into body
.... dose S0..1SimpleQuantityAmount of medication per dose

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicationAdministration 0..*MedicationAdministrationAdministration of medication to a patient
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierExternal identifier
... instantiates Σ0..*uriInstantiates protocol or definition
... partOf Σ0..*Reference(MedicationAdministration | Procedure)Part of referenced event
... status ?!SΣ1..1codein-progress | not-done | on-hold | completed | entered-in-error | stopped | unknown
Binding: MedicationAdministration Status Codes (required): A set of codes indicating the current status of a MedicationAdministration.

... statusReason 0..*CodeableConceptReason administration not performed
Binding: SNOMEDCTReasonMedicationNotGivenCodes (example): A set of codes indicating the reason why the MedicationAdministration is negated.


... category 0..1CodeableConceptType of medication usage
Binding: MedicationAdministration Category Codes (preferred): A coded concept describing where the medication administered is expected to occur.

... medication[x] SΣ1..1What was administered
Binding: SNOMEDCTMedicationCodes (example): Codes identifying substance or product that can be administered.

.... medicationCodeableConceptCodeableConcept
.... medicationReferenceReference(Medication)
... subject SΣ1..1Reference(ICSR Patient)Who received medication
... context 0..1Reference(Encounter | EpisodeOfCare)Encounter or Episode of Care administered as part of
... supportingInformation 0..*Reference(Resource)Additional information to support administration
... effective[x] SΣ1..1Start and end time of administration
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
... performer Σ0..*BackboneElementWho performed the medication administration and what they did
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... function 0..1CodeableConceptType of performance
Binding: MedicationAdministration Performer Function Codes (example): A code describing the role an individual played in administering the medication.

.... actor Σ1..1Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | Device)Who performed the medication administration
... reasonCode S0..*CodeableConceptReason administration performed
Binding: ReasonMedicationGivenCodes (example): A set of codes indicating the reason why the MedicationAdministration was made.


... reasonReference 0..*Reference(Condition | Observation | DiagnosticReport)Condition or observation that supports why the medication was administered
... request 0..1Reference(MedicationRequest)Request administration performed against
... device 0..*Reference(Device)Device used to administer
... note 0..*AnnotationInformation about the administration
... dosage SI0..1BackboneElementDetails of how medication was taken
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... text S0..1stringFree text dosage instructions e.g. SIG
.... site 0..1CodeableConceptBody site administered to
Binding: SNOMEDCTAnatomicalStructureForAdministrationSiteCodes (example): A coded concept describing the site location the medicine enters into or onto the body.

.... route S0..1CodeableConceptPath of substance into body
Binding: SNOMEDCTRouteCodes (example): A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject.

.... method 0..1CodeableConceptHow drug was administered
Binding: SNOMEDCTAdministrationMethodCodes (example): A coded concept describing the technique by which the medicine is administered.

.... dose S0..1SimpleQuantityAmount of medication per dose
.... rate[x] 0..1Dose quantity per unit of time
..... rateRatioRatio
..... rateQuantityQuantity(SimpleQuantity)
... eventHistory 0..*Reference(Provenance)A list of events of interest in the lifecycle

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicationAdministration 0..*MedicationAdministrationAdministration of medication to a patient
... status ?!Σ1..1codein-progress | not-done | on-hold | completed | entered-in-error | stopped | unknown
Binding: MedicationAdministration Status Codes (required): A set of codes indicating the current status of a MedicationAdministration.

... medication[x] Σ1..1What was administered
Binding: SNOMEDCTMedicationCodes (example): Codes identifying substance or product that can be administered.

.... medicationCodeableConceptCodeableConcept
.... medicationReferenceReference(Medication)
... subject Σ1..1Reference(ICSR Patient)Who received medication
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
... reasonCode 0..*CodeableConceptReason administration performed
Binding: ReasonMedicationGivenCodes (example): A set of codes indicating the reason why the MedicationAdministration was made.


... dosage I0..1BackboneElementDetails of how medication was taken
.... text 0..1stringFree text dosage instructions e.g. SIG
.... route 0..1CodeableConceptPath of substance into body
Binding: SNOMEDCTRouteCodes (example): A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject.

.... dose 0..1SimpleQuantityAmount of medication per dose

doco Documentation for this format

This structure is derived from MedicationAdministration

Summary

Must-Support: 9 elements

Structures

This structure refers to these other structures:

Differential View

This structure is derived from MedicationAdministration

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicationAdministration 0..*MedicationAdministrationAdministration of medication to a patient
... status S1..1codein-progress | not-done | on-hold | completed | entered-in-error | stopped | unknown
... medication[x] S1..1CodeableConcept, Reference(Medication)What was administered
... subject S1..1Reference(ICSR Patient)Who received medication
... reasonCode S0..*CodeableConceptReason administration performed
... dosage S0..1BackboneElementDetails of how medication was taken
.... text S0..1stringFree text dosage instructions e.g. SIG
.... route S0..1CodeableConceptPath of substance into body
.... dose S0..1SimpleQuantityAmount of medication per dose

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicationAdministration 0..*MedicationAdministrationAdministration of medication to a patient
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierExternal identifier
... instantiates Σ0..*uriInstantiates protocol or definition
... partOf Σ0..*Reference(MedicationAdministration | Procedure)Part of referenced event
... status ?!SΣ1..1codein-progress | not-done | on-hold | completed | entered-in-error | stopped | unknown
Binding: MedicationAdministration Status Codes (required): A set of codes indicating the current status of a MedicationAdministration.

... statusReason 0..*CodeableConceptReason administration not performed
Binding: SNOMEDCTReasonMedicationNotGivenCodes (example): A set of codes indicating the reason why the MedicationAdministration is negated.


... category 0..1CodeableConceptType of medication usage
Binding: MedicationAdministration Category Codes (preferred): A coded concept describing where the medication administered is expected to occur.

... medication[x] SΣ1..1What was administered
Binding: SNOMEDCTMedicationCodes (example): Codes identifying substance or product that can be administered.

.... medicationCodeableConceptCodeableConcept
.... medicationReferenceReference(Medication)
... subject SΣ1..1Reference(ICSR Patient)Who received medication
... context 0..1Reference(Encounter | EpisodeOfCare)Encounter or Episode of Care administered as part of
... supportingInformation 0..*Reference(Resource)Additional information to support administration
... effective[x] SΣ1..1Start and end time of administration
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
... performer Σ0..*BackboneElementWho performed the medication administration and what they did
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... function 0..1CodeableConceptType of performance
Binding: MedicationAdministration Performer Function Codes (example): A code describing the role an individual played in administering the medication.

.... actor Σ1..1Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | Device)Who performed the medication administration
... reasonCode S0..*CodeableConceptReason administration performed
Binding: ReasonMedicationGivenCodes (example): A set of codes indicating the reason why the MedicationAdministration was made.


... reasonReference 0..*Reference(Condition | Observation | DiagnosticReport)Condition or observation that supports why the medication was administered
... request 0..1Reference(MedicationRequest)Request administration performed against
... device 0..*Reference(Device)Device used to administer
... note 0..*AnnotationInformation about the administration
... dosage SI0..1BackboneElementDetails of how medication was taken
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... text S0..1stringFree text dosage instructions e.g. SIG
.... site 0..1CodeableConceptBody site administered to
Binding: SNOMEDCTAnatomicalStructureForAdministrationSiteCodes (example): A coded concept describing the site location the medicine enters into or onto the body.

.... route S0..1CodeableConceptPath of substance into body
Binding: SNOMEDCTRouteCodes (example): A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject.

.... method 0..1CodeableConceptHow drug was administered
Binding: SNOMEDCTAdministrationMethodCodes (example): A coded concept describing the technique by which the medicine is administered.

.... dose S0..1SimpleQuantityAmount of medication per dose
.... rate[x] 0..1Dose quantity per unit of time
..... rateRatioRatio
..... rateQuantityQuantity(SimpleQuantity)
... eventHistory 0..*Reference(Provenance)A list of events of interest in the lifecycle

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
MedicationAdministration.languagepreferredCommonLanguages
Max Binding: AllLanguages
MedicationAdministration.statusrequiredMedicationAdministration Status Codes
MedicationAdministration.statusReasonexampleSNOMEDCTReasonMedicationNotGivenCodes
MedicationAdministration.categorypreferredMedicationAdministration Category Codes
MedicationAdministration.medication[x]exampleSNOMEDCTMedicationCodes
MedicationAdministration.performer.functionexampleMedicationAdministration Performer Function Codes
MedicationAdministration.reasonCodeexampleReasonMedicationGivenCodes
MedicationAdministration.dosage.siteexampleSNOMEDCTAnatomicalStructureForAdministrationSiteCodes
MedicationAdministration.dosage.routeexampleSNOMEDCTRouteCodes
MedicationAdministration.dosage.methodexampleSNOMEDCTAdministrationMethodCodes