International Patient Summary Implementation Guide (Release 0.3.0 STU1 Ballot)

This page is part of the International Patient Summary Implementation Guide (v0.3.0: STU 1 (FHIR R4) Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.1.0. For a full list of available versions, see the Directory of published versions

Definitions for the StructureDefinition-Medication-uv-ips Profile.

1. Medication
Definition

This resource is primarily used for the identification and definition of a medication for the purposes of prescribing, dispensing, and administering a medication as well as for making statements about medication use.

Control0..*
Must Supporttrue
Comments

IPS Medication

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. Medication.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
Must Supporttrue
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. Medication.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
Must Supporttrue
4. Medication.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. Medication.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. Medication.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. Medication.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. Medication.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. Medication.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. Medication.identifier
Definition

Business identifier for this medication.

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

The serial number could be included as an identifier.

11. Medication.code
Definition

Medication that was administered or was to be administered.

Several kinds of medication coding could be provided as:

  1. The IDMP Pharmaceutical Product Identifier (PhPID), Level 1, [Substance(s)]. Example: Amoxicillin and Clavulanate Potassium; or any other equivalent coded concept;
  2. The IDMP Pharmaceutical Product Identifier (PhPID), Level 2 [Substance(s) + Strength + reference strength]. Example: Amoxicillin 875 mg and Clavulanate Potassium 125 mg; or any other equivalent coded concept;
  3. The IDMP Pharmaceutical Product Identifier (PhPID), Level 3 [Substance(s) + administrable dose form]. Example: Amoxicillin and Clavulanate Potassium, Oral Tablet; or any other equivalent coded concept;
  4. The IDMP Pharmaceutical Product Identifier (PhPID), Level 4 [Substance(s) + strength + reference strength + administrable dose form]. Example: Amoxicillin 875 mg and clavulanate potassium 125 mg, oral tablet; or any other equivalent coded concept 5. The IDMP Medicinal Product Identifier (MPID) or any equivalent Medicinal Product Identifier. IDMP MPID uniquely identifies a Medicinal Product, reflecting (but not replacing) any other authorization numbers allocated by a regulator. MPID implies one (set of) PhPID. The MPID shall use a common segment pattern related to a Medicinal Product, which, when each segment is valued shall define a specific MPID concept.
  5. The IDMP Packaged Medicinal Product Identifier (PCID) or any equivalent Packaged Medicinal Product Identifier. Uniquely identifies a Medicinal Product based on its packaging. This implies one MPID can be associated with more than one PCID, if the same Medicinal Product has more than one type of package.
  6. Any other kind of code that that identifies, classifies or cluster the administered product (e.g. the medicinal product or the product class)

The value sets used for the PhPID, MPID and PCID identifiers are provisional and include only few equivalent concepts used for exemplification purposes, they will be updated with real IDMP identifiers when they will become available.

Control1..1 This element is affected by the following invariants: ele-1
BindingThe type of medication
For example codes, see Medications (example)
TypeCodeableConcept(CodeableConceptIPS)
Must Supporttrue
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
12. Medication.code.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
13. Medication.code.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 Medication.code.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
14. Medication.code.coding
Definition

A reference to a code defined by a terminology system.

Control1..* This element is affected by the following invariants: ele-1
TypeCoding(CodingIPS)
Must Supporttrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Medication.code.coding. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
15. Medication.code.coding:atcClass
SliceNameatcClass
Definition

WHO ATC classification

Control0..1 This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from WHO ATC
TypeCoding(CodingIPS)
Must Supporttrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. Medication.code.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

17. Medication.status
Definition

A code to indicate if the medication is in active use.

Control0..1
BindingA coded concept defining if the medication is in active use.
The codes SHALL be taken from Medication Status Codes
Typecode
Is Modifiertrue
Comments

This status is intended to identify if the medication in a local system is in active use within a drug database or inventory. For example, a pharmacy system may create a new drug file record for a compounded product "ABC Hospital Special Cream" with an active status. At some point in the future, it may be determined that the drug record was created with an error and the status is changed to "entered in error". This status is not intended to specify if a medication is part of a particular formulary. It is possible that the drug record may be referenced by multiple formularies or catalogues and each of those entries would have a separate status.

18. Medication.manufacturer
Definition

Describes the details of the manufacturer of the medication product. This is not intended to represent the distributor of a medication product.

Control0..1
TypeReference(Organization)
19. Medication.form
Definition

Describes the form of the item. Powder; tablets; capsule.

Administrable Pharmaceutical Dose Form. This code represents the form of the medication (e.g. tablet, capsule, liquid)

Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration.

It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT.

Control0..1 This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from Medicine Doseform
TypeCodeableConcept(CodeableConceptIPS)
Must Supporttrue
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. Medication.amount
Definition

A relationship of two Quantity values - expressed as a numerator and a denominator.

Control0..1 This element is affected by the following invariants: ele-1
TypeRatio(RatioUvIps)
Must Supporttrue
Comments

The Ratio datatype should only be used to express a relationship of two numbers if the relationship cannot be suitably expressed using a Quantity and a common unit. Where the denominator value is known to be fixed to "1", Quantity should be used instead of Ratio.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present (: (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists()))
21. Medication.ingredient
Definition

Identifies a particular constituent of interest in the product.

Control0..*
TypeBackboneElement
Must Supporttrue
Comments

The ingredients need not be a complete list. If an ingredient is not specified, this does not indicate whether an ingredient is present or absent. If an ingredient is specified it does not mean that all ingredients are specified. It is possible to specify both inactive and active ingredients.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. Medication.ingredient.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
23. Medication.ingredient.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.

24. Medication.ingredient.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.

25. Medication.ingredient.item[x]
Definition

The actual ingredient - either a substance (simple ingredient) or another medication of a medication.

Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

The ingredient may reference a substance (for example, amoxicillin) or another medication (for example in the case of a compounded product, Glaxal Base).

SlicingThis element introduces a set of slices on Medication.ingredient.item[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
26. Medication.ingredient.item[x]:itemCodeableConcept
SliceNameitemCodeableConcept
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

Control1..1 This element is affected by the following invariants: ele-1
BindingSNOMED CT drug substances
The codes SHOULD be taken from Medicine Active Substances
TypeCodeableConcept(CodeableConceptIPS)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Requirements

The ingredient may reference a substance (for example, amoxicillin) or another medication (for example in the case of a compounded product, Glaxal Base).

Comments

The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances. The Global Ingredient Archival System (GInAS) will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard. Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances. This choice will be revised based on the availability and the maturity of GInAS.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
27. Medication.ingredient.item[x]:itemCodeableConcept.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
28. Medication.ingredient.item[x]:itemCodeableConcept.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 Medication.ingredient.item[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
29. Medication.ingredient.item[x]:itemCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

Control0..* This element is affected by the following invariants: ele-1
TypeCoding(CodingIPS)
Must Supporttrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
30. Medication.ingredient.item[x]:itemCodeableConcept.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Must Supporttrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

31. Medication.ingredient.isActive
Definition

Indication of whether this ingredient affects the therapeutic action of the drug.

Control0..1
Typeboolean
Requirements

True indicates that the ingredient affects the therapeutic action of the drug (i.e. active). False indicates that the ingredient does not affect the therapeutic action of the drug (i.e. inactive).

32. Medication.ingredient.strength
Definition

Specifies how many (or how much) of the items there are in this Medication. For example, 250 mg per tablet. This is expressed as a ratio where the numerator is 250mg and the denominator is 1 tablet.

Control0..1
TypeRatio
33. Medication.batch
Definition

Information that only applies to packages (not products).

Control0..1
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
34. Medication.batch.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
35. Medication.batch.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.

36. Medication.batch.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.

37. Medication.batch.lotNumber
Definition

The assigned lot number of a batch of the specified product.

Control0..1
Typestring
38. Medication.batch.expirationDate
Definition

When this specific batch of product will expire.

Control0..1
TypedateTime