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Biomedical Research and Regulation icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the Ingredient resource.

Ingredient
Element IdIngredient
Definition

An ingredient of a manufactured item or pharmaceutical product.

Short DisplayAn ingredient of a manufactured item or pharmaceutical product
Cardinality0..*
TypeDomainResource
Summaryfalse
Invariants
Defined on this element
ing-1Rule If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource(Ingredient.allergenicIndicator.where(value='true').count() + Ingredient.substance.code.reference.count()) < 2
Ingredient.identifier
Element IdIngredient.identifier
Definition

The identifier(s) of this Ingredient that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate.

Short DisplayAn identifier or code by which the ingredient can be referenced
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..1
TypeIdentifier
Summarytrue
Ingredient.status
Element IdIngredient.status
Definition

The status of this ingredient. Enables tracking the life-cycle of the content.

Short Displaydraft | active | retired | unknown
Cardinality1..1
Terminology BindingPublicationStatus (Required)
Typecode
Is Modifiertrue (Reason: This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration)
Summarytrue
Comments

Allows filtering of ingredient that are appropriate for use versus not.

Ingredient.for
Element IdIngredient.for
Definition

The product which this ingredient is a constituent part of.

Short DisplayThe product which this ingredient is a constituent part of
Cardinality0..*
TypeReference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)
Summarytrue
Ingredient.role
Element IdIngredient.role
Definition

A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.

Short DisplayPurpose of the ingredient within the product, e.g. active, inactive
Cardinality1..1
Terminology BindingIngredientRole (Example)
TypeCodeableConcept
Summarytrue
Ingredient.function
Element IdIngredient.function
Definition

A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.

Short DisplayPrecise action within the drug product, e.g. antioxidant, alkalizing agent
Cardinality0..*
Terminology BindingIngredientFunction (Example)
TypeCodeableConcept
Summarytrue
Ingredient.group
Element IdIngredient.group
Definition

A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink.

Short DisplayA classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
Cardinality0..1
TypeCodeableConcept
Summarytrue
Ingredient.allergenicIndicator
Element IdIngredient.allergenicIndicator
Definition

If the ingredient is a known or suspected allergen. Note that this is a property of the substance, so if a reference to a SubstanceDefinition is used to decribe that (rather than just a code), the allergen information should go there, not here.

Short DisplayIf the ingredient is a known or suspected allergen
Cardinality0..1
Typeboolean
Meaning if MissingIf this value is not present, there is no statement being made about whether this is an allergen or not. No inference can be made
Summarytrue
Ingredient.description
Element IdIngredient.description
Definition

A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying.

Short DisplayA place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
Cardinality0..1
Typemarkdown
Summaryfalse
Ingredient.manufacturer
Element IdIngredient.manufacturer
Definition

The organization(s) that manufacture this ingredient. Can be used to indicate: 1) Organizations we are aware of that manufacture this ingredient 2) Specific Manufacturer(s) currently being used 3) Set of organisations allowed to manufacture this ingredient for this product Users must be clear on the application of context relevant to their use case.

Short DisplayAn organization that manufactures this ingredient
Cardinality0..*
Summarytrue
Ingredient.manufacturer.role
Element IdIngredient.manufacturer.role
Definition

The way in which this manufacturer is associated with the ingredient. For example whether it is a possible one (others allowed), or an exclusive authorized one for this ingredient. Note that this is not the manufacturing process role.

Short Displayallowed | possible | actual
Cardinality0..1
Terminology BindingIngredientManufacturerRole (Required)
Typecode
Summarytrue
Ingredient.manufacturer.manufacturer
Element IdIngredient.manufacturer.manufacturer
Definition

An organization that manufactures this ingredient.

Short DisplayAn organization that manufactures this ingredient
Cardinality1..1
TypeReference(Organization)
Summarytrue
Ingredient.substance
Element IdIngredient.substance
Definition

The substance that comprises this ingredient.

Short DisplayThe substance that comprises this ingredient
Cardinality1..1
Summarytrue
Ingredient.substance.code
Element IdIngredient.substance.code
Definition

A code or full resource that represents the ingredient's substance.

Short DisplayA code or full resource that represents the ingredient substance
Cardinality1..1
Terminology BindingSNOMED CT Substance Codes (Example)
TypeCodeableReference(SubstanceDefinition)
Summarytrue
Ingredient.substance.strength
Element IdIngredient.substance.strength
Definition

The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength.

Short DisplayThe quantity of substance, per presentation, or per volume or mass, and type of quantity
Cardinality0..*
Summarytrue
Ingredient.substance.strength.presentation[x]
Element IdIngredient.substance.strength.presentation[x]
Definition

The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').

Short DisplayThe quantity of substance in the unit of presentation
Cardinality0..1
TypeRatio|RatioRange|CodeableConcept|Quantity
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
Ingredient.substance.strength.textPresentation
Element IdIngredient.substance.strength.textPresentation
Definition

A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio.

Short DisplayText of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
Cardinality0..1
Typestring
Summarytrue
Ingredient.substance.strength.concentration[x]
Element IdIngredient.substance.strength.concentration[x]
Definition

The strength per unitary volume (or mass).

Short DisplayThe strength per unitary volume (or mass)
Cardinality0..1
TypeRatio|RatioRange|CodeableConcept|Quantity
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
Ingredient.substance.strength.textConcentration
Element IdIngredient.substance.strength.textConcentration
Definition

A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio.

Short DisplayText of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
Cardinality0..1
Typestring
Summarytrue
Ingredient.substance.strength.basis
Element IdIngredient.substance.strength.basis
Definition

A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt).

Short DisplayA code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
Cardinality0..1
TypeCodeableConcept
Summarytrue
Ingredient.substance.strength.measurementPoint
Element IdIngredient.substance.strength.measurementPoint
Definition

For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization.

Short DisplayWhen strength is measured at a particular point or distance
Cardinality0..1
Typestring
Summarytrue
Ingredient.substance.strength.country
Element IdIngredient.substance.strength.country
Definition

The country or countries for which the strength range applies.

Short DisplayWhere the strength range applies
Cardinality0..*
Terminology BindingCountry ValueSet (Example)
TypeCodeableConcept
Summarytrue
Ingredient.substance.strength.referenceStrength
Element IdIngredient.substance.strength.referenceStrength
Definition

Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed.

Short DisplayStrength expressed in terms of a reference substance
Cardinality0..*
Summarytrue
Ingredient.substance.strength.referenceStrength.substance
Element IdIngredient.substance.strength.referenceStrength.substance
Definition

Relevant reference substance.

Short DisplayRelevant reference substance
Cardinality1..1
Terminology BindingSNOMED CT Substance Codes (Example)
TypeCodeableReference(SubstanceDefinition)
Summarytrue
Ingredient.substance.strength.referenceStrength.strength[x]
Element IdIngredient.substance.strength.referenceStrength.strength[x]
Definition

Strength expressed in terms of a reference substance.

Short DisplayStrength expressed in terms of a reference substance
Cardinality1..1
TypeRatio|RatioRange|Quantity
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
Ingredient.substance.strength.referenceStrength.measurementPoint
Element IdIngredient.substance.strength.referenceStrength.measurementPoint
Definition

For when strength is measured at a particular point or distance.

Short DisplayWhen strength is measured at a particular point or distance
Cardinality0..1
Typestring
Summarytrue
Ingredient.substance.strength.referenceStrength.country
Element IdIngredient.substance.strength.referenceStrength.country
Definition

The country or countries for which the strength range applies.

Short DisplayWhere the strength range applies
Cardinality0..*
Terminology BindingCountry ValueSet (Example)
TypeCodeableConcept
Summarytrue