HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU Ballot 1

HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU Ballot 1 - Local Development build (v0.9.1). See the Directory of published versions

MedicationStatement

Definitions for obf-MedicationStatement.

1. MedicationStatement
Definition

A record of the use of a medication (individual administration or entire course). The use may be reported by the patient or clinician and adminstration does not have to be directly observed.

Implementation note: Although FHIR supports the asserter (information source) and date asserted, it does not have a place for the author (who created and is responsible for the statement) and recorder (who entered the statement). Extensions are provided.

Conformance note: The treatment of 'not taken' has changed from DSTU2 and STU3 to R4. In R4, status and statusReason are used to indicate medications not taken. For upward compatibility, the 'not taken' attributes are profiled out. ReasonCode is a choice of CodeableConcept or ref(Condition) in DSTU2, and limited to one reason (pick a type). In STU3 and R4, there can be multiple reason codes, and multiple reason references, simultaneously.

Implementation note: Preference is given to using the National Library of Medicine (NLM) RxNorm terminology for medications. RxNorm is a coding standard established by the Office of the National Coordinator (ONC). However, RxNorm is restricted to FDA-approved drugs and does not include clinical trial drugs. MedicationStatement allows for the inclusion of other coding systems like the NCI Thesaurus (NCIT) to represent clinical trial oncology drugs.

Control0..*
Comments

When interpreting a medicationStatement, the value of the status and NotTaken needed to be considered: MedicationStatement.status + MedicationStatement.wasNotTaken Status=Active + NotTaken=T = Not currently taking Status=Completed + NotTaken=T = Not taken in the past Status=Intended + NotTaken=T = No intention of taking Status=Active + NotTaken=F = Taking, but not as prescribed Status=Active + NotTaken=F = Taking Status=Intended +NotTaken= F = Will be taking (not started) Status=Completed + NotTaken=F = Taken in past Status=In Error + NotTaken=N/A = In Error.

InvariantsDefined on this element
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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
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())
2. MedicationStatement.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Control0..1
Typeid
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

3. MedicationStatement.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.

Control0..1
TypeMeta
4. MedicationStatement.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.

Control0..1
Typeuri
Is Modifiertrue
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 it's narrative along with other profiles, value sets, etc.

5. MedicationStatement.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language.
The codes SHOULD be taken from CommonLanguages
Max Binding: AllLanguages
Typecode
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).

6. MedicationStatement.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.

Control0..1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

7. MedicationStatement.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained 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.

8. MedicationStatement.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

9. MedicationStatement.extension:treatmentintent
Definition

The purpose of a treatment.

Control0..1
TypeExtension(TreatmentIntent) (Extension Type: CodeableConcept)
Must Supporttrue
10. MedicationStatement.extension:terminationreason
Definition

A code explaining unplanned or premature termination of a plan of treatment, course of medication, or research study.

Control0..*
TypeExtension(TerminationReason) (Extension Type: CodeableConcept)
Must Supporttrue
11. MedicationStatement.extension:terminationreason.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
12. MedicationStatement.extension:terminationreason.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..0
TypeExtension
Alternate Namesextensions, user content
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.

13. MedicationStatement.extension:terminationreason.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuehttp://hl7.org/fhir/us/mcode/StructureDefinition/obf-TerminationReason-extension
14. MedicationStatement.extension:terminationreason.valueCodeableConcept
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
BindingThe codes SHALL be taken from TreatmentTerminationReasonVS
TypeCodeableConcept
15. MedicationStatement.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content
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.

16. MedicationStatement.identifier
Definition

Identifiers associated with this Medication Statement that are defined by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate. They are business identifiers assigned to this resource by the performer or other systems and remain constant as the resource is updated and propagates from server to server.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Comments

This is a business identifier, not a resource identifier.

17. MedicationStatement.basedOn
Definition

A plan, proposal or order that is fulfilled in whole or in part by this event.

Control0..*
TypeReference(ServiceRequest | USCoreMedicationRequestProfile)
Requirements

Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

18. MedicationStatement.partOf
Definition

A larger event of which this particular event is a component or step.

Control0..*
TypeReference(MedicationAdministration | MedicationStatement | Procedure | Observation)
Requirements

This should not be used when indicating which resource a MedicationStatement has been derived from. If that is the use case, then MedicationStatement.derivedFrom should be used.

19. MedicationStatement.status
Definition

A code representing the patient or other source's judgment about the state of the medication used that this statement is about. Generally, this will be active or completed.

Control1..1
BindingA set of codes indicating the current status of a MedicationStatement.
The codes SHALL be taken from Medication Status Codes
Typecode
Is Modifiertrue
Must Supporttrue
Comments

MedicationStatement is a statement at a point in time. The status is only representative at the point when it was asserted. The value set for MedicationStatement.status contains codes that assert the status of the use of the medication by the patient (for example, stopped or on hold) as well as codes that assert the status of the medication statement itself (for example, entered in error).

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

20. MedicationStatement.statusReason
Definition

Captures the reason for the current state of the MedicationStatement.

Control0..*
BindingA coded concept indicating the reason for the status of the statement.
For example codes, see SNOMEDCTDrugTherapyStatusCodes
TypeCodeableConcept
Comments

This is generally only used for "exception" statuses such as "not-taken", "on-hold", "cancelled" or "entered-in-error". The reason for performing the event at all is captured in reasonCode, not here.

21. MedicationStatement.category
Definition

Indicates where the medication is expected to be consumed or administered.

Control0..1
BindingA coded concept identifying where the medication included in the MedicationStatement is expected to be consumed or administered.
The codes SHOULD be taken from Medication Status Codes
TypeCodeableConcept
22. MedicationStatement.medication[x]
Definition

Identifies the medication being administered. This is either a link to a resource representing the details of the medication or a simple attribute carrying a code that identifies the medication from a known list of medications.

Control1..1
BindingPrescribable medications
The codes SHALL be taken from US Core Medication Codes (RxNorm); other codes may be used where these codes are not suitable
TypeChoice of: CodeableConcept, Reference(USCoreMedicationProfile)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Comments

If only a code is specified, then it needs to be a code for a specific product. If more information is required, then the use of the medication resource is recommended. For example, if you require form or lot number, then you must reference the Medication resource.

23. MedicationStatement.subject
Definition

The person, animal or group who is/was taking the medication.

Control1..1
TypeReference(Patient)
Must Supporttrue
24. MedicationStatement.context
Definition

The encounter or episode of care that establishes the context for this MedicationStatement.

Control0..1
TypeReference(USCoreEncounterProfile | EpisodeOfCare)
25. MedicationStatement.effective[x]
Definition

The interval of time during which it is being asserted that the patient is/was/will be taking the medication (or was not taking, when the MedicationStatement.taken element is No).

Control1..1
TypeChoice of: dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Comments

This attribute reflects the period over which the patient consumed the medication and is expected to be populated on the majority of Medication Statements. If the medication is still being taken at the time the statement is recorded, the "end" date will be omitted. The date/time attribute supports a variety of dates - year, year/month and exact date. If something more than this is required, this should be conveyed as text.

26. MedicationStatement.dateAsserted
Definition

The date when the medication statement was asserted by the information source.

Control1..1
TypedateTime
Must Supporttrue
27. MedicationStatement.informationSource
Definition

The person or organization that provided the information about the taking of this medication. Note: Use derivedFrom when a MedicationStatement is derived from other resources, e.g. Claim or MedicationRequest.

Control0..1
TypeReference(Patient | USCorePractitionerProfile | RelatedPerson | USCoreOrganizationProfile)
28. MedicationStatement.derivedFrom
Definition

Allows linking the MedicationStatement to the underlying MedicationRequest, or to other information that supports or is used to derive the MedicationStatement.

Control0..*
TypeReference(Resource)
Must Supporttrue
Comments

Likely references would be to US Core MedicationRequest Profile, MedicationDispense, Claim, Observation or QuestionnaireAnswers. The most common use cases for deriving a MedicationStatement comes from creating a MedicationStatement from a MedicationRequest or from a lab observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the MedicationStatement from.

29. MedicationStatement.reasonCode
Definition

A reason for why the medication is being/was taken.

Control0..1
BindingA coded concept identifying why the medication is being taken.
For example codes, see Condition/Problem/DiagnosisCodes
TypeCodeableConcept
Comments

This could be a diagnosis code. If a full condition record exists or additional detail is needed, use reasonForUseReference.

30. MedicationStatement.reasonReference
Definition

Condition or observation that supports why the medication is being/was taken

Control0..1
TypeReference(Condition | Observation | DiagnosticReport)
Comments

This is a reference to a condition that is the reason why the medication is being/was taken. If only a code exists, use reasonForUseCode.

31. MedicationStatement.note
Definition

Provides extra information about the medication statement that is not conveyed by the other attributes.

Control0..*
TypeAnnotation
32. MedicationStatement.dosage
Definition

Indicates how the medication is/was or should be taken by the patient.

Control0..1
TypeDosage
Comments

The dates included in the dosage on a Medication Statement reflect the dates for a given dose. For example, "from November 1, 2016 to November 3, 2016, take one tablet daily and from November 4, 2016 to November 7, 2016, take two tablets daily." It is expected that this specificity may only be populated where the patient brings in their labeled container or where the Medication Statement is derived from a MedicationRequest.