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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Resource Profile: Medication - Batch Information

This Medication profile represents information about the batches that underwent testing or analysis.

Usage:

• Use this Resource Profile: Bundle – Batch Analysis PQ, Bundle – Batch Formula PQ, Bundle – drug Product Batch Information PQ, Bundle - Drug Product Compatibility PQ... Show 4 more, Bundle – Drug Product Microbiological Attributes PQ, Bundle – Drug Stability PQ, Bundle - Product Impurities PQ and Bundle - Product Process Validation PQ
• Examples for this Resource Profile: Medication/medication-batch-information-drug-pq-ex1

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 Medication

Name	Flags	Card.	Type	Description & Constraints
Medication		0..*	Medication	Definition of a Medication
id		0..1	id	Logical id of this artifact
code	S	0..1	CodeableConcept	Codes that identify this medication
batch	S	0..1	BackboneElement	Details about packaged medications
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Medication		0..*	Medication	Definition of a Medication
id	Σ	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
code	SΣ	0..1	CodeableConcept	Codes that identify this medication Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
status	?!Σ	0..1	code	active | inactive | entered-in-error Binding: MedicationStatusCodes (required): A coded concept defining if the medication is in active use.
batch	S	0..1	BackboneElement	Details about packaged medications
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Medication.code	example	SNOMEDCTMedicationCodes
Medication.status	required	MedicationStatusCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Medication	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Medication	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	Medication	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	Medication	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Medication	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
Medication		0..*	Medication	Definition of a Medication
id	Σ	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
identifier	Σ	0..*	Identifier	Business identifier for this medication
code	SΣ	0..1	CodeableConcept	Codes that identify this medication Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
status	?!Σ	0..1	code	active | inactive | entered-in-error Binding: MedicationStatusCodes (required): A coded concept defining if the medication is in active use.
marketingAuthorizationHolder	Σ	0..1	Reference(Organization)	Organization that has authorization to market medication
doseForm		0..1	CodeableConcept	powder | tablets | capsule + Binding: SNOMEDCTFormCodes (example): A coded concept defining the form of a medication.
totalVolume	Σ	0..1	Quantity	When the specified product code does not infer a package size, this is the specific amount of drug in the product
ingredient		0..*	BackboneElement	Active or inactive ingredient
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
item		1..1	CodeableReference(Substance | Medication)	The ingredient (substance or medication) that the ingredient.strength relates to Binding: SNOMEDCTMedicationCodes (example)
isActive		0..1	boolean	Active ingredient indicator
strength[x]		0..1		Quantity of ingredient present Binding: MedicationIngredientStrengthCodes (preferred): A coded concpet defining the strength of an ingredient.
strengthRatio			Ratio
strengthCodeableConcept			CodeableConcept
strengthQuantity			Quantity
batch	S	0..1	BackboneElement	Details about packaged medications
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
lotNumber		0..1	string	Identifier assigned to batch
expirationDate		0..1	dateTime	When batch will expire
definition		0..1	Reference(MedicationKnowledge)	Knowledge about this medication
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Medication.language	required	AllLanguages
Medication.code	example	SNOMEDCTMedicationCodes
Medication.status	required	MedicationStatusCodes
Medication.doseForm	example	SNOMEDCTFormCodes
Medication.ingredient.item	example	SNOMEDCTMedicationCodes
Medication.ingredient.strength[x]	preferred	MedicationIngredientStrengthCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Medication	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Medication	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	Medication	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	Medication	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Medication	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 Medication

Summary

Must-Support: 2 elements

Differential View

This structure is derived from Medication

Name	Flags	Card.	Type	Description & Constraints
Medication		0..*	Medication	Definition of a Medication
id		0..1	id	Logical id of this artifact
code	S	0..1	CodeableConcept	Codes that identify this medication
batch	S	0..1	BackboneElement	Details about packaged medications
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Medication		0..*	Medication	Definition of a Medication
id	Σ	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
code	SΣ	0..1	CodeableConcept	Codes that identify this medication Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
status	?!Σ	0..1	code	active | inactive | entered-in-error Binding: MedicationStatusCodes (required): A coded concept defining if the medication is in active use.
batch	S	0..1	BackboneElement	Details about packaged medications
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Medication.code	example	SNOMEDCTMedicationCodes
Medication.status	required	MedicationStatusCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Medication	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Medication	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	Medication	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	Medication	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Medication	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
Medication		0..*	Medication	Definition of a Medication
id	Σ	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
identifier	Σ	0..*	Identifier	Business identifier for this medication
code	SΣ	0..1	CodeableConcept	Codes that identify this medication Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
status	?!Σ	0..1	code	active | inactive | entered-in-error Binding: MedicationStatusCodes (required): A coded concept defining if the medication is in active use.
marketingAuthorizationHolder	Σ	0..1	Reference(Organization)	Organization that has authorization to market medication
doseForm		0..1	CodeableConcept	powder | tablets | capsule + Binding: SNOMEDCTFormCodes (example): A coded concept defining the form of a medication.
totalVolume	Σ	0..1	Quantity	When the specified product code does not infer a package size, this is the specific amount of drug in the product
ingredient		0..*	BackboneElement	Active or inactive ingredient
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
item		1..1	CodeableReference(Substance | Medication)	The ingredient (substance or medication) that the ingredient.strength relates to Binding: SNOMEDCTMedicationCodes (example)
isActive		0..1	boolean	Active ingredient indicator
strength[x]		0..1		Quantity of ingredient present Binding: MedicationIngredientStrengthCodes (preferred): A coded concpet defining the strength of an ingredient.
strengthRatio			Ratio
strengthCodeableConcept			CodeableConcept
strengthQuantity			Quantity
batch	S	0..1	BackboneElement	Details about packaged medications
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
lotNumber		0..1	string	Identifier assigned to batch
expirationDate		0..1	dateTime	When batch will expire
definition		0..1	Reference(MedicationKnowledge)	Knowledge about this medication
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Medication.language	required	AllLanguages
Medication.code	example	SNOMEDCTMedicationCodes
Medication.status	required	MedicationStatusCodes
Medication.doseForm	example	SNOMEDCTFormCodes
Medication.ingredient.item	example	SNOMEDCTMedicationCodes
Medication.ingredient.strength[x]	preferred	MedicationIngredientStrengthCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Medication	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Medication	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	Medication	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	Medication	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Medication	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 Medication

Summary

Must-Support: 2 elements

Other representations of profile: CSV, Excel, Schematron