R6 Ballot (2nd Draft)

Publish-box (todo)

Biomedical Research and Regulation icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Anonymous Compartments: No defined compartments

Detailed Descriptions for the elements in the Ingredient resource.

Ingredient
Element Id Ingredient
Definition

An ingredient of a manufactured item or pharmaceutical product.

Short Display An ingredient of a manufactured item or pharmaceutical product
Cardinality 0..*
Type DomainResource
Summary false
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 resourceIngredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2
Ingredient.identifier
Element Id Ingredient.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 Display An identifier or code by which the ingredient can be referenced
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..1
Type Identifier
Summary true
Ingredient.status
Element Id Ingredient.status
Definition

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

Short Display draft | active | retired | unknown
Cardinality 1..1
Terminology Binding PublicationStatus (Required)
Type code
Is Modifier true (Reason: This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration)
Summary true
Comments

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

Ingredient.for
Element Id Ingredient.for
Definition

The product which this ingredient is a constituent part of.

Short Display The product which this ingredient is a constituent part of
Cardinality 0..*
Type Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition)
Summary true
Ingredient.role
Element Id Ingredient.role
Definition

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

Short Display Purpose of the ingredient within the product, e.g. active, inactive
Cardinality 1..1
Terminology Binding Ingredient Role (Example)
Type CodeableConcept
Summary true
Ingredient.function
Element Id Ingredient.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 Display Precise action within the drug product, e.g. antioxidant, alkalizing agent
Cardinality 0..*
Terminology Binding Ingredient Function (Example)
Type CodeableConcept
Summary true
Ingredient.group
Element Id Ingredient.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 Display 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
Cardinality 0..1
Type CodeableConcept
Summary true
Ingredient.allergenicIndicator
Element Id Ingredient.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 Display If the ingredient is a known or suspected allergen
Cardinality 0..1
Type boolean
Meaning if Missing If this value is not present, there is no statement being made about whether this is an allergen or not. No inference can be made
Summary true
Invariants
Affect 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 resourceIngredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2
Ingredient.comment
Element Id Ingredient.comment
Definition

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

Short Display A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
Cardinality 0..1
Type markdown
Summary false
Ingredient.manufacturer
Element Id Ingredient.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 Display An organization that manufactures this ingredient
Cardinality 0..*
Summary true
Ingredient.manufacturer.role
Element Id Ingredient.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 Display allowed | possible | actual
Cardinality 0..1
Terminology Binding Ingredient Manufacturer Role (Required)
Type code
Summary true
Ingredient.manufacturer.manufacturer
Element Id Ingredient.manufacturer.manufacturer
Definition

An organization that manufactures this ingredient.

Short Display An organization that manufactures this ingredient
Cardinality 1..1
Type Reference(Organization)
Summary true
Ingredient.substance
Element Id Ingredient.substance
Definition

The substance that comprises this ingredient.

Short Display The substance that comprises this ingredient
Cardinality 1..1
Summary true
Invariants
Affect 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 resourceIngredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2
Ingredient.substance.code
Element Id Ingredient.substance.code
Definition

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

Short Display A code or full resource that represents the ingredient substance
Cardinality 1..1
Terminology Binding SNOMED CT Substance Codes (Example)
Type CodeableReference(SubstanceDefinition)
Summary true
Invariants
Affect 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 resourceIngredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2
Ingredient.substance.strength
Element Id Ingredient.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 Display The quantity of substance, per presentation, or per volume or mass, and type of quantity
Cardinality 0..*
Summary true
Ingredient.substance.strength.presentation[x]
Element Id Ingredient.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 Display The quantity of substance in the unit of presentation
Cardinality 0..1
Type Ratio|RatioRange|CodeableConcept|Quantity
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
Ingredient.substance.strength.textPresentation
Element Id Ingredient.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 Display Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
Cardinality 0..1
Type string
Summary true
Ingredient.substance.strength.concentration[x]
Element Id Ingredient.substance.strength.concentration[x]
Definition

The strength per unitary volume (or mass).

Short Display The strength per unitary volume (or mass)
Cardinality 0..1
Type Ratio|RatioRange|CodeableConcept|Quantity
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
Ingredient.substance.strength.textConcentration
Element Id Ingredient.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 Display Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
Cardinality 0..1
Type string
Summary true
Ingredient.substance.strength.basis
Element Id Ingredient.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 Display 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)
Cardinality 0..1
Type CodeableConcept
Summary true
Ingredient.substance.strength.measurementPoint
Element Id Ingredient.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 Display When strength is measured at a particular point or distance
Cardinality 0..1
Type string
Summary true
Ingredient.substance.strength.country
Element Id Ingredient.substance.strength.country
Definition

The country or countries for which the strength range applies.

Short Display Where the strength range applies
Cardinality 0..*
Terminology Binding Country ValueSet (Example)
Type CodeableConcept
Summary true
Ingredient.substance.strength.referenceStrength
Element Id Ingredient.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 Display Strength expressed in terms of a reference substance
Cardinality 0..*
Summary true
Ingredient.substance.strength.referenceStrength.substance
Element Id Ingredient.substance.strength.referenceStrength.substance
Definition

Relevant reference substance.

Short Display Relevant reference substance
Cardinality 1..1
Terminology Binding SNOMED CT Substance Codes (Example)
Type CodeableReference(SubstanceDefinition)
Summary true
Ingredient.substance.strength.referenceStrength.strength[x]
Element Id Ingredient.substance.strength.referenceStrength.strength[x]
Definition

Strength expressed in terms of a reference substance.

Short Display Strength expressed in terms of a reference substance
Cardinality 1..1
Type Ratio|RatioRange|Quantity
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
Ingredient.substance.strength.referenceStrength.measurementPoint
Element Id Ingredient.substance.strength.referenceStrength.measurementPoint
Definition

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

Short Display When strength is measured at a particular point or distance
Cardinality 0..1
Type string
Summary true
Ingredient.substance.strength.referenceStrength.country
Element Id Ingredient.substance.strength.referenceStrength.country
Definition

The country or countries for which the strength range applies.

Short Display Where the strength range applies
Cardinality 0..*
Terminology Binding Country ValueSet (Example)
Type CodeableConcept
Summary true