Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

Biomedical Research and Regulation 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.

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.

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.

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.

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.

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.

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.

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.

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.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.

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.

Cardinality0..1
Terminology BindingIngredientManufacturerRole (Required)
Typecode
Summarytrue
Ingredient.manufacturer.manufacturer
Element IdIngredient.manufacturer.manufacturer
Definition

An organization that manufactures this ingredient.

Cardinality1..1
TypeReference(Organization)
Summarytrue
Ingredient.substance
Element IdIngredient.substance
Definition

The 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.

Cardinality1..1
Terminology BindingSNOMEDCTSubstanceCodes :
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.

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').

Cardinality0..1
TypeRatio|RatioRange|CodeableConcept|Quantity
[x] NoteSee Choice of Data Types 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.

Cardinality0..1
Typestring
Summarytrue
Ingredient.substance.strength.concentration[x]
Element IdIngredient.substance.strength.concentration[x]
Definition

The strength per unitary volume (or mass).

Cardinality0..1
TypeRatio|RatioRange|CodeableConcept|Quantity
[x] NoteSee Choice of Data Types 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.

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).

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.

Cardinality0..1
Typestring
Summarytrue
Ingredient.substance.strength.country
Element IdIngredient.substance.strength.country
Definition

The country or countries for which the strength range applies.

Cardinality0..*
Terminology BindingCountry (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.

Cardinality0..*
Summarytrue
Ingredient.substance.strength.referenceStrength.substance
Element IdIngredient.substance.strength.referenceStrength.substance
Definition

Relevant reference substance.

Cardinality0..1
Terminology BindingSNOMEDCTSubstanceCodes :
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.

Cardinality1..1
TypeRatio|RatioRange|Quantity
[x] NoteSee Choice of Data Types 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.

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.

Cardinality0..*
Terminology BindingCountry (Example)
TypeCodeableConcept
Summarytrue