HRSA 2024 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG
2.0.0 - STU2 Release 1 - Standard for Trial-Use International flag

This page is part of the HRSA Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+ or uds-plus) FHIR IG (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: UDSPlusMedicationStatement - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 2

Definitions for the uds-plus-medicationstatement resource profile.

Guidance on how to interpret the contents of this table can be found here

0. MedicationStatement
Definition

The UDS+ profile is based on the MedicationStatement resource and establishes the core elements, extensions, vocabularies and value sets for representing medicationstatement for UDS+ program.


A record of a medication that is being consumed by a patient. A MedicationStatement may indicate that the patient may be taking the medication now or has taken the medication in the past or will be taking the medication in the future. The source of this information can be the patient, significant other (such as a family member or spouse), or a clinician. A common scenario where this information is captured is during the history taking process during a patient visit or stay. The medication information may come from sources such as the patient's memory, from a prescription bottle, or from a list of medications the patient, clinician or other party maintains.

The primary difference between a medication statement and a medication administration is that the medication administration has complete administration information and is based on actual administration information from the person who administered the medication. A medication statement is often, if not always, less specific. There is no required date/time when the medication was administered, in fact we only know that a source has reported the patient is taking this medication, where details such as time, quantity, or rate or even medication product may be incomplete or missing or less precise. As stated earlier, the medication statement information may come from the patient's memory, from a prescription bottle or from a list of medications the patient, clinician or other party maintains. Medication administration is more formal and is not missing detailed information.

ShortDe-Identified UDS Plus MedicationStatementRecord of medication being taken by a patient
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.

Control0..*
Is Modifierfalse
Summaryfalse
Invariantsdom-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

De-dentified MedicationStatement resource identifier.


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

ShortThe de-identified MedicationStatement identifier created by the health center to send data to UDS+ Data ReceiverLogical id of this artifact
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.

Control0..1
Typeidstring
Is Modifierfalse
Must Supporttrue
Summarytrue
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.

ShortA 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 it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
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.

ShortCannot include any text in the resource as part of the de-identified data.Text summary of the resource, for human interpretation
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.

Control0..01
TypeNarrative
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. 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.

ShortCannot include any contained resources in the resource as part of the de-identified data.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.

Control0..0*
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
10. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
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
Invariantsele-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())
12. 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.

Shortactive | completed | entered-in-error | intended | stopped | on-hold | unknown | not-taken
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.

Control1..1
BindingThe codes SHALL be taken from Medication Status Codeshttp://hl7.org/fhir/ValueSet/medication-statement-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/medication-statement-status|4.0.1)

A coded concept indicating the current status of a MedicationStatement.

Typecode
Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. 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.

ShortWhat medication was taken
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.

Control1..1
BindingFor example codes, see SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codes
(example to http://hl7.org/fhir/ValueSet/medication-codes)

A coded concept identifying the substance or product being taken.

TypeChoice of: CodeableConcept, Reference(Medication)
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. MedicationStatement.subject
Definition

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

ShortWho is/was taking the medication
Control1..1
TypeReference(De-Identified UDS Plus Patient, Patient, Group)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. MedicationStatement.subject.display
Definition

Plain text narrative that identifies the resource in addition to the resource reference.

ShortText alternative for the resource
Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Control0..01
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. 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).

ShortThe date/time or interval when the medication is/was/will be taken
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.

Control0..1
TypeChoice of: dateTime, Period
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
uds-plus-medstat-1: All dateTime data elements should be truncated to a year only for de-identified resources. ($this is dateTime implies $this.toString().length() = 4)
uds-plus-medstat-1a: All dateTime data elements should have valid year > 1900 ($this is DateTime implies $this.toString() >= '1900')
uds-plus-medstat-1b: All dateTime data elements should have valid year < 2030 ($this is DateTime implies $this.toString() <= '2030')
uds-plus-medstat-2: All Period.start data elements should be truncated to a year only for de-identified resources. ($this is Period and Period.start.exists() implies $this.start.toString().length() = 4)
uds-plus-medstat-2a: All Period.start data elements should have valid year > 1900 ($this is Period and Period.start.exists() implies $this.start.toString() >= '1900')
uds-plus-medstat-2b: All Period.start data elements should have valid year < 2030 ($this is Period and Period.start.exists() implies $this.start.toString() <= '2030')
uds-plus-medstat-3: All Period.end data elements should be truncated to a year only for de-identified resources. ($this is Period and Period.end.exists() implies $this.end.toString().length() = 4)
uds-plus-medstat-3a: All Period.end data elements should have valid year > 1900 ($this is Period and Period.end.exists() implies $this.end.toString() >= '1900')
uds-plus-medstat-3b: All Period.end data elements should have valid year < 2030 ($this is Period and Period.end.exists() implies $this.end.toString() <= '2030')
22. MedicationStatement.dateAsserted
Definition

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

ShortWhen the statement was asserted?
Control0..1
TypedateTime
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
uds-plus-medstat-4: All dateTime data elements should be truncated to a year only for de-identified resources. ($this is dateTime implies $this.toString().length() = 4)
uds-plus-medstat-4a: All dateTime data elements should have valid year > 1900 ($this is DateTime implies $this.toString() >= '1900')
uds-plus-medstat-4b: All dateTime data elements should have valid year < 2030 ($this is DateTime implies $this.toString() <= '2030')
24. MedicationStatement.note
Definition

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

ShortFurther information about the statement
Control0..0*
TypeAnnotation
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. MedicationStatement.dosage
Definition

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

ShortDetails of how medication is/was taken or should be taken
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.

Control0..*
TypeDosage
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. MedicationStatement.dosage.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 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. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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, modifiers
Invariantsele-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())
30. MedicationStatement.dosage.timing
Definition

When medication should be administered.

ShortWhen medication should be administered
Comments

This attribute might not always be populated while the Dosage.text is expected to be populated. If both are populated, then the Dosage.text should reflect the content of the Dosage.timing.

Control0..1
TypeTiming
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

The timing schedule for giving the medication to the patient. This data type allows many different expressions. For example: "Every 8 hours"; "Three times a day"; "1/2 an hour before breakfast for 10 days from 23-Dec 2011:"; "15 Oct 2013, 17 Oct 2013 and 1 Nov 2013". Sometimes, a rate can imply duration when expressed as total volume / duration (e.g. 500mL/2 hours implies a duration of 2 hours). However, when rate doesn't imply duration (e.g. 250mL/hour), then the timing.repeat.duration is needed to convey the infuse over time period.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
uds-plus-medstat-5: All Timing.event data elements should be truncated to a year only for de-identified resources. ($this is Timing and Timing.event.exists() implies $this.event.count() = 1)
uds-plus-medstat-6: All Timing.event data elements should be truncated to a year only for de-identified resources. ($this is Timing and Timing.event.exists() implies $this.event.first().toString().length() = 4)
uds-plus-medstat-7: All Timing data elements should have valid year > 1900 ($this is Timing and Timing.event.exists() implies $this.event.first().toString() >= '1900')
uds-plus-medstat-8: All Timing data elements should have valid year < 2030 ($this is Timing and Timing.event.exists() implies $this.event.first().toString() <= '2030')