QI-Core Implementation Guide: STU Ballot (v3.3.0 for FHIR 4.0.0)

Quality Improvement Core Framework (v3.3.0: STU 4 Ballot 1). The current version is 3.2.0 based on FHIR R4. See the Directory of published versions

D.4.1.4 StructureDefinition: - Detailed Descriptions

Definitions for the StructureDefinition-qicore-medicationdispense Profile.

1. MedicationDispense
Definition

Indicates that a medication product is to be or has been dispensed for a named person/patient. This includes a description of the medication product (supply) provided and the instructions for administering the medication. The medication dispense is the result of a pharmacy system responding to a medication order.

Control0..*
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())
mdd-1: whenHandedOver cannot be before whenPrepared (: whenHandedOver.empty() or whenPrepared.empty() or whenHandedOver >= whenPrepared)
2. MedicationDispense.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. MedicationDispense.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. MedicationDispense.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. MedicationDispense.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. MedicationDispense.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. MedicationDispense.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. MedicationDispense.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. MedicationDispense.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.

10. MedicationDispense.identifier
Definition

Identifiers associated with this Medication Dispense 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.

11. MedicationDispense.partOf
Definition

The procedure that trigger the dispense.

Control0..*
TypeReference(Procedure)
12. MedicationDispense.status
Definition

A code specifying the state of the set of dispense events.

Control1..1
BindingA coded concept specifying the state of the dispense event.
The codes SHALL be taken from MedicationDispense Status Codes
Typecode
Is Modifiertrue
Must Supporttrue
Comments

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

13. MedicationDispense.statusReason[x]
Definition

Indicates the reason why a dispense was not performed.

Control0..1
BindingA code describing why a dispense was not performed.
For example codes, see MedicationDispense Status Reason Codes
TypeChoice of: CodeableConcept, Reference(DetectedIssue)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
14. MedicationDispense.category
Definition

Indicates the type of medication dispense (for example, where the medication is expected to be consumed or administered (i.e. inpatient or outpatient)).

Control0..1
BindingA code describing where the dispensed medication is expected to be consumed or administered.
The codes SHOULD be taken from MedicationDispense Category Codes
TypeCodeableConcept
Comments

The category can be used to include where the medication is expected to be consumed or other types of dispenses. Invariants can be used to bind to different value sets when profiling to bind.

15. MedicationDispense.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
BindingThe set of RxNorm codes to represent medications
The codes SHOULD be taken from US Core Medication Codes (RxNorm)
TypeChoice of: CodeableConcept, Reference(Medication)
[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.

16. MedicationDispense.subject
Definition

A link to a resource representing the person or the group to whom the medication will be given.

Control0..1
TypeReference(QICorePatient)
Must Supporttrue
Comments

SubstanceAdministration->subject->Patient.

17. MedicationDispense.context
Definition

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

Control0..1
TypeReference(Encounter | EpisodeOfCare)
18. MedicationDispense.supportingInformation
Definition

Additional information that supports the medication being dispensed.

Control0..*
TypeReference(Resource)
19. MedicationDispense.performer
Definition

Indicates who or what performed the event.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. MedicationDispense.performer.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
21. MedicationDispense.performer.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..*
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.

22. MedicationDispense.performer.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).

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, modifiers
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.

23. MedicationDispense.performer.function
Definition

Distinguishes the type of performer in the dispense. For example, date enterer, packager, final checker.

Control0..1
BindingA code describing the role an individual played in dispensing a medication.
For example codes, see MedicationDispense Performer Function Codes
TypeCodeableConcept
Requirements

Allows disambiguation of the types of involvement of different performers.

24. MedicationDispense.performer.actor
Definition

The device, practitioner, etc. who performed the action. It should be assumed that the actor is the dispenser of the medication.

Control1..1
TypeReference(Practitioner | PractitionerRole | Organization | Patient | Device | RelatedPerson)
25. MedicationDispense.location
Definition

The principal physical location where the dispense was performed.

Control0..1
TypeReference(Location)
26. MedicationDispense.authorizingPrescription
Definition

Indicates the medication order that is being dispensed against.

Control0..*
TypeReference(QICoreMedicationRequest)
Comments

Maps to basedOn in Event logical model.

27. MedicationDispense.type
Definition

Indicates the type of dispensing event that is performed. For example, Trial Fill, Completion of Trial, Partial Fill, Emergency Fill, Samples, etc.

Control0..1
BindingIndicates the type of dispensing event that is performed. For example, Trial Fill, Completion of Trial, Partial Fill, Emergency Fill, Samples, etc.
For example codes, see V3 Value SetActPharmacySupplyType
TypeCodeableConcept
28. MedicationDispense.quantity
Definition

The amount of medication that has been dispensed. Includes unit of measure.

Control0..1
TypeQuantity(SimpleQuantity)
Must Supporttrue
29. MedicationDispense.daysSupply
Definition

The amount of medication expressed as a timing amount.

Control0..1
TypeQuantity(SimpleQuantity)
Must Supporttrue
30. MedicationDispense.whenPrepared
Definition

The time when the dispensed product was packaged and reviewed.

Control0..1
TypedateTime
31. MedicationDispense.whenHandedOver
Definition

The time the dispensed product was provided to the patient or their representative.

Control0..1
TypedateTime
Must Supporttrue
32. MedicationDispense.destination
Definition

Identification of the facility/location where the medication was shipped to, as part of the dispense event.

Control0..1
TypeReference(QICoreLocation)
33. MedicationDispense.receiver
Definition

Identifies the person who picked up the medication. This will usually be a patient or their caregiver, but some cases exist where it can be a healthcare professional.

Control0..*
TypeReference(QICorePatient | QICorePractitioner)
34. MedicationDispense.note
Definition

Extra information about the dispense that could not be conveyed in the other attributes.

Control0..*
TypeAnnotation
35. MedicationDispense.dosageInstruction
Definition

Indicates how the medication is to be used by the patient.

Control0..*
TypeDosage
Comments

When the dose or rate is intended to change over the entire administration period (e.g. Tapering dose prescriptions), multiple instances of dosage instructions will need to be supplied to convey the different doses/rates. The pharmacist reviews the medication order prior to dispense and updates the dosageInstruction based on the actual product being dispensed.

36. MedicationDispense.dosageInstruction.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
37. MedicationDispense.dosageInstruction.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..*
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.

SlicingThis element introduces a set of slices on MedicationDispense.dosageInstruction.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
38. MedicationDispense.dosageInstruction.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).

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, modifiers
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.

39. MedicationDispense.dosageInstruction.sequence
Definition

Indicates the order in which the dosage instructions should be applied or interpreted.

Control0..1
Typeinteger
Requirements

If the sequence number of multiple Dosages is the same, then it is implied that the instructions are to be treated as concurrent. If the sequence number is different, then the Dosages are intended to be sequential.

40. MedicationDispense.dosageInstruction.text
Definition

Free text dosage instructions e.g. SIG.

Control0..1
Typestring
Requirements

Free text dosage instructions can be used for cases where the instructions are too complex to code. The content of this attribute does not include the name or description of the medication. When coded instructions are present, the free text instructions may still be present for display to humans taking or administering the medication. It is expected that the text instructions will always be populated. If the dosage.timing attribute is also populated, then the dosage.text should reflect the same information as the timing. Additional information about administration or preparation of the medication should be included as text.

41. MedicationDispense.dosageInstruction.additionalInstruction
Definition

Supplemental instructions to the patient on how to take the medication (e.g. "with meals" or"take half to one hour before food") or warnings for the patient about the medication (e.g. "may cause drowsiness" or "avoid exposure of skin to direct sunlight or sunlamps").

Control0..*
BindingA coded concept identifying additional instructions such as "take with water" or "avoid operating heavy machinery".
For example codes, see SNOMEDCTAdditionalDosageInstructions
TypeCodeableConcept
Requirements

Additional instruction is intended to be coded, but where no code exists, the element could include text. For example, "Swallow with plenty of water" which might or might not be coded.

Comments

Information about administration or preparation of the medication (e.g. "infuse as rapidly as possibly via intraperitoneal port" or "immediately following drug x") should be populated in dosage.text.

42. MedicationDispense.dosageInstruction.patientInstruction
Definition

Instructions in terms that are understood by the patient or consumer.

Control0..1
Typestring
43. MedicationDispense.dosageInstruction.timing
Definition

When medication should be administered.

Control0..1
TypeTiming
Must Supporttrue
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.

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.

44. MedicationDispense.dosageInstruction.asNeeded[x]
Definition

Indicates whether the Medication is only taken when needed within a specific dosing schedule (Boolean option), or it indicates the precondition for taking the Medication (CodeableConcept).

Control0..1
BindingA coded concept identifying the precondition that should be met or evaluated prior to consuming or administering a medication dose. For example "pain", "30 minutes prior to sexual intercourse", "on flare-up" etc.
For example codes, see SNOMEDCTMedicationAsNeededReasonCodes
TypeChoice of: boolean, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Comments

Can express "as needed" without a reason by setting the Boolean = True. In this case the CodeableConcept is not populated. Or you can express "as needed" with a reason by including the CodeableConcept. In this case the Boolean is assumed to be True. If you set the Boolean to False, then the dose is given according to the schedule and is not "prn" or "as needed".

45. MedicationDispense.dosageInstruction.site
Definition

Body site to administer to.

Control0..1
BindingA coded concept describing the site location the medicine enters into or onto the body.
For example codes, see SNOMEDCTAnatomicalStructureForAdministrationSiteCodes
TypeCodeableConcept
Requirements

A coded specification of the anatomic site where the medication first enters the body.

Comments

If the use case requires attributes from the BodySite resource (e.g. to identify and track separately) then use the standard extension bodySite. May be a summary code, or a reference to a very precise definition of the location, or both.

46. MedicationDispense.dosageInstruction.route
Definition

How drug should enter body.

Control0..1
BindingA coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject.
For example codes, see SNOMEDCTRouteCodes
TypeCodeableConcept
Must Supporttrue
Requirements

A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.

47. MedicationDispense.dosageInstruction.method
Definition

Technique for administering medication.

Control0..1
BindingA coded concept describing the technique by which the medicine is administered.
For example codes, see SNOMEDCTAdministrationMethodCodes
TypeCodeableConcept
Requirements

A coded value indicating the method by which the medication is introduced into or onto the body. Most commonly used for injections. For examples, Slow Push; Deep IV.

Comments

Terminologies used often pre-coordinate this term with the route and or form of administration.

48. MedicationDispense.dosageInstruction.doseAndRate
Definition

The amount of medication administered.

Control0..*
TypeElement
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
49. MedicationDispense.dosageInstruction.doseAndRate.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
50. MedicationDispense.dosageInstruction.doseAndRate.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..*
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.

SlicingThis element introduces a set of slices on MedicationDispense.dosageInstruction.doseAndRate.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
51. MedicationDispense.dosageInstruction.doseAndRate.type
Definition

The kind of dose or rate specified, for example, ordered or calculated.

Control1..1
BindingMedication dose types (e.g., loading, maintenance, etc.)
The codes SHOULD be taken from SNOMED CT Dosages Codes
TypeCodeableConcept
Must Supporttrue
Requirements

If the type is not populated, assume to be "ordered".

52. MedicationDispense.dosageInstruction.doseAndRate.dose[x]
Definition

Amount of medication per dose.

Control0..1
TypeChoice of: Range, Quantity(SimpleQuantity)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Requirements

The amount of therapeutic or other substance given at one administration event.

Comments

Note that this specifies the quantity of the specified medication, not the quantity for each active ingredient(s). Each ingredient amount can be communicated in the Medication resource. For example, if one wants to communicate that a tablet was 375 mg, where the dose was one tablet, you can use the Medication resource to document that the tablet was comprised of 375 mg of drug XYZ. Alternatively if the dose was 375 mg, then you may only need to use the Medication resource to indicate this was a tablet. If the example were an IV such as dopamine and you wanted to communicate that 400mg of dopamine was mixed in 500 ml of some IV solution, then this would all be communicated in the Medication resource. If the administration is not intended to be instantaneous (rate is present or timing has a duration), this can be specified to convey the total amount to be administered over the period of time as indicated by the schedule e.g. 500 ml in dose, with timing used to convey that this should be done over 4 hours.

53. MedicationDispense.dosageInstruction.doseAndRate.rate[x]
Definition

Amount of medication per unit of time.

Control0..1
TypeChoice of: Ratio, Range, Quantity(SimpleQuantity)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

Identifies the speed with which the medication was or will be introduced into the patient. Typically the rate for an infusion e.g. 100 ml per 1 hour or 100 ml/hr. May also be expressed as a rate per unit of time e.g. 500 ml per 2 hours. Other examples: 200 mcg/min or 200 mcg/1 minute; 1 liter/8 hours. 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.

Comments

It is possible to supply both a rate and a doseQuantity to provide full details about how the medication is to be administered and supplied. If the rate is intended to change over time, depending on local rules/regulations, each change should be captured as a new version of the MedicationRequest with an updated rate, or captured with a new MedicationRequest with the new rate.

It is possible to specify a rate over time (for example, 100 ml/hour) using either the rateRatio and rateQuantity. The rateQuantity approach requires systems to have the capability to parse UCUM grammer where ml/hour is included rather than a specific ratio where the time is specified as the denominator. Where a rate such as 500ml over 2 hours is specified, the use of rateRatio may be more semantically correct than specifying using a rateQuantity of 250 mg/hour.

54. MedicationDispense.dosageInstruction.maxDosePerPeriod
Definition

Upper limit on medication per unit of time.

Control0..1
TypeRatio
Requirements

The maximum total quantity of a therapeutic substance that may be administered to a subject over the period of time. For example, 1000mg in 24 hours.

Comments

This is intended for use as an adjunct to the dosage when there is an upper cap. For example "2 tablets every 4 hours to a maximum of 8/day".

55. MedicationDispense.dosageInstruction.maxDosePerAdministration
Definition

Upper limit on medication per administration.

Control0..1
TypeQuantity(SimpleQuantity)
Requirements

The maximum total quantity of a therapeutic substance that may be administered to a subject per administration.

Comments

This is intended for use as an adjunct to the dosage when there is an upper cap. For example, a body surface area related dose with a maximum amount, such as 1.5 mg/m2 (maximum 2 mg) IV over 5 – 10 minutes would have doseQuantity of 1.5 mg/m2 and maxDosePerAdministration of 2 mg.

56. MedicationDispense.dosageInstruction.maxDosePerLifetime
Definition

Upper limit on medication per lifetime of the patient.

Control0..1
TypeQuantity(SimpleQuantity)
Requirements

The maximum total quantity of a therapeutic substance that may be administered per lifetime of the subject.

57. MedicationDispense.substitution
Definition

Indicates whether or not substitution was made as part of the dispense. In some cases, substitution will be expected but does not happen, in other cases substitution is not expected but does happen. This block explains what substitution did or did not happen and why. If nothing is specified, substitution was not done.

Control0..1
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
58. MedicationDispense.substitution.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
59. MedicationDispense.substitution.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..*
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.

60. MedicationDispense.substitution.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).

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, modifiers
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.

61. MedicationDispense.substitution.wasSubstituted
Definition

True if the dispenser dispensed a different drug or product from what was prescribed.

Control1..1
Typeboolean
62. MedicationDispense.substitution.type
Definition

A code signifying whether a different drug was dispensed from what was prescribed.

Control0..1
BindingA coded concept describing whether a different medicinal product may be dispensed other than the product as specified exactly in the prescription.
For example codes, see V3 Value SetActSubstanceAdminSubstitutionCode
TypeCodeableConcept
63. MedicationDispense.substitution.reason
Definition

Indicates the reason for the substitution (or lack of substitution) from what was prescribed.

Control0..*
BindingA coded concept describing the reason that a different medication should (or should not) be substituted from what was prescribed.
For example codes, see V3 Value SetSubstanceAdminSubstitutionReason
TypeCodeableConcept
64. MedicationDispense.substitution.responsibleParty
Definition

The person or organization that has primary responsibility for the substitution.

Control0..*
TypeReference(QICorePractitioner)
65. MedicationDispense.detectedIssue
Definition

Indicates an actual or potential clinical issue with or between one or more active or proposed clinical actions for a patient; e.g. drug-drug interaction, duplicate therapy, dosage alert etc.

Control0..*
TypeReference(DetectedIssue)
Alternate NamesContraindication, Drug Utilization Review (DUR), Alert
Comments

This element can include a detected issue that has been identified either by a decision support system or by a clinician and may include information on the steps that were taken to address the issue.

66. MedicationDispense.eventHistory
Definition

A summary of the events of interest that have occurred, such as when the dispense was verified.

Control0..*
TypeReference(Provenance)
Comments

This might not include provenances for all versions of the request – only those deemed “relevant” or important. This SHALL NOT include the Provenance associated with this current version of the resource. (If that provenance is deemed to be a “relevant” change, it will need to be added as part of a later update. Until then, it can be queried directly as the Provenance that points to this version using _revinclude All Provenances should have some historical version of this Request as their subject.).