This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

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• Detailed Descriptions
• Mappings
• Examples

Resource Profile: Composition - Drug

TBD

Usage:

• Use this Resource Profile: Bundle - Drug Product PQ
• Examples for this Resource Profile: Composition/composition-drug-pq-formulation and Composition/composition-drug-pq-risk

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
id	S	0..1	id	Logical id of this artifact
status	S	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
type	S	1..1	CodeableConcept	Kind of composition (LOINC if possible)
subject	S	0..*	Reference(Resource)	Who and/or what the composition is about
date	S	1..1	dateTime	Composition editing time
author	S	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
title	S	1..1	string	Human Readable name/title
section	S	0..*	BackboneElement	Composition is broken into sections
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
id	SΣ	0..1	id	Logical id of this artifact
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition.
type	SΣ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
subject	SΣ	0..*	Reference(Resource)	Who and/or what the composition is about
date	SΣ	1..1	dateTime	Composition editing time
author	SΣ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
title	SΣ	1..1	string	Human Readable name/title
section	SC	0..*	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Composition.status	required	CompositionStatus
Composition.type	preferred	FHIRDocumentTypeCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Composition	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	error	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
id	SΣ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	Σ	0..1	uri	Canonical identifier for this Composition, represented as a URI (globally unique)
identifier	Σ	0..*	Identifier	Version-independent identifier for the Composition
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the Composition
status	?!SΣ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition.
type	SΣ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
category	Σ	0..*	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject	SΣ	0..*	Reference(Resource)	Who and/or what the composition is about
encounter	Σ	0..1	Reference(Encounter)	Context of the Composition
date	SΣ	1..1	dateTime	Composition editing time
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	SΣ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
name	Σ	0..1	string	Name for this Composition (computer friendly)
title	SΣ	1..1	string	Human Readable name/title
note		0..*	Annotation	For any additional notes
attester		0..*	BackboneElement	Attests to accuracy of composition
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
mode		1..1	CodeableConcept	personal | professional | legal | official Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
time		0..1	dateTime	When the composition was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the composition
custodian	Σ	0..1	Reference(Organization)	Organization which maintains the composition
relatesTo		0..*	RelatedArtifact	Relationships to other compositions/documents
event	Σ	0..*	BackboneElement	The clinical service(s) being documented
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
period	Σ	0..1	Period	The period covered by the documentation
detail	Σ	0..*	CodeableReference(Resource)	The event(s) being documented, as code(s), reference(s), or both Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
section	SC	0..*	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Composition.language	required	AllLanguages
Composition.status	required	CompositionStatus
Composition.type	preferred	FHIRDocumentTypeCodes
Composition.category	example	ReferencedItemCategoryValueSet
Composition.attester.mode	preferred	CompositionAttestationMode
Composition.event.detail	example	ActCode
Composition.section.code	example	DocumentSectionCodes
Composition.section.orderedBy	preferred	ListOrderCodes
Composition.section.emptyReason	preferred	ListEmptyReasons

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Composition	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	error	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Composition

Summary

Must-Support: 8 elements

Differential View

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
id	S	0..1	id	Logical id of this artifact
status	S	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
type	S	1..1	CodeableConcept	Kind of composition (LOINC if possible)
subject	S	0..*	Reference(Resource)	Who and/or what the composition is about
date	S	1..1	dateTime	Composition editing time
author	S	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
title	S	1..1	string	Human Readable name/title
section	S	0..*	BackboneElement	Composition is broken into sections
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
id	SΣ	0..1	id	Logical id of this artifact
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition.
type	SΣ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
subject	SΣ	0..*	Reference(Resource)	Who and/or what the composition is about
date	SΣ	1..1	dateTime	Composition editing time
author	SΣ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
title	SΣ	1..1	string	Human Readable name/title
section	SC	0..*	BackboneElement	Composition is broken into sections
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Composition.status	required	CompositionStatus
Composition.type	preferred	FHIRDocumentTypeCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Composition	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	error	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
id	SΣ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url	Σ	0..1	uri	Canonical identifier for this Composition, represented as a URI (globally unique)
identifier	Σ	0..*	Identifier	Version-independent identifier for the Composition
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the Composition
status	?!SΣ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition.
type	SΣ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
category	Σ	0..*	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject	SΣ	0..*	Reference(Resource)	Who and/or what the composition is about
encounter	Σ	0..1	Reference(Encounter)	Context of the Composition
date	SΣ	1..1	dateTime	Composition editing time
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	SΣ	1..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the composition
name	Σ	0..1	string	Name for this Composition (computer friendly)
title	SΣ	1..1	string	Human Readable name/title
note		0..*	Annotation	For any additional notes
attester		0..*	BackboneElement	Attests to accuracy of composition
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
mode		1..1	CodeableConcept	personal | professional | legal | official Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
time		0..1	dateTime	When the composition was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the composition
custodian	Σ	0..1	Reference(Organization)	Organization which maintains the composition
relatesTo		0..*	RelatedArtifact	Relationships to other compositions/documents
event	Σ	0..*	BackboneElement	The clinical service(s) being documented
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
period	Σ	0..1	Period	The period covered by the documentation
detail	Σ	0..*	CodeableReference(Resource)	The event(s) being documented, as code(s), reference(s), or both Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
section	SC	0..*	BackboneElement	Composition is broken into sections
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Composition.language	required	AllLanguages
Composition.status	required	CompositionStatus
Composition.type	preferred	FHIRDocumentTypeCodes
Composition.category	example	ReferencedItemCategoryValueSet
Composition.attester.mode	preferred	CompositionAttestationMode
Composition.event.detail	example	ActCode
Composition.section.code	example	DocumentSectionCodes
Composition.section.orderedBy	preferred	ListOrderCodes
Composition.section.emptyReason	preferred	ListEmptyReasons

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Composition	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	error	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Composition

Summary

Must-Support: 8 elements

Other representations of profile: CSV, Excel, Schematron