R6 Ballot (2nd Draft)

Publish-box (todo)

15.8 Resource Ingredient - Content

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

An ingredient of a manufactured item or pharmaceutical product.



15.8.1 Scope and Usage

For an overview of this resource and others in the Medication Definition domain, also see the module page

A material used in the preparation of a medicinal/pharmaceutical product, within the context of a particular use or role.

An ingredient is part of a product, either alone or in combination with other ingredients. It is essentially a substance with the addition of the specific role it is playing in the product, or in preparation of the product which may include whether it is an active or inactive substance and what the strength is (the quantity of substance compared to the whole product). The ingredient is represented in the context of a given product, because its role and strength are a function of what it is used in/for. It is expected that the same substance used in a different role, or with a different strength, would be a different Ingredient resource instance. Resource instances may however be shared by very similar products (e.g. different pack sizes of the same "product").

Some other resources, such as Medication and Substance allow specifying a basic ingredient representation. When more detail is needed such as for manufacturing or regulatory use, use the Ingredient resource.

Ingredient is represented as a resource, instead of, for example, a backbone or a datatype within other resources, due to some practical considerations for certain use cases. In some situations, an ingredient could have been represented "in line" within another resource (e.g. embedded within MedicinalProductDefiniton or ManufacturedItemDefinition). However there are cases where it is necessary to refer to an ingredient from another resource - for example when the ingredient associated with a product also has an authorization, or when a multi-part tablet needs to state which ingredient is contained in which component of that tablet (as well as linking the ingredient to the whole tablet and/or the whole product). These cases can only be served by representing the ingredient as an externally referenceable entity, that can be linked from other resources, hence the rationale for Ingredient being a resource in its own right. If such cases are not in scope of a given project, and it is preferred to avoid ingredient being a separate resource, then there is the option for that project to represent an ingredient using a contained Ingredient resource. Even simpler situations, where only a coded or free text ingredient is necessary, can use attributes such as MedicinalProductDefinition.ingredient.

15.8.2 References to this Resource

15.8.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient TU DomainResource An ingredient of a manufactured item or pharmaceutical product
+ Rule: 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

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ 0..1 Identifier An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (Required)
... for Σ 0..* Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) The product which this ingredient is a constituent part of

... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (Example)

... group Σ 0..1 CodeableConcept 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
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this ingredient

.... role Σ 0..1 code allowed | possible | actual
Binding: Ingredient Manufacturer Role (Required)
.... manufacturer Σ 1..1 Reference(Organization) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... code ΣC 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance
Binding: SNOMED CT Substance Codes (Example)
.... strength Σ 0..* BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity

..... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
...... presentationRatio Ratio
...... presentationRatioRange RatioRange
...... presentationCodeableConcept CodeableConcept
...... presentationQuantity Quantity
..... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
..... concentration[x] Σ 0..1 The strength per unitary volume (or mass)
...... concentrationRatio Ratio
...... concentrationRatioRange RatioRange
...... concentrationCodeableConcept CodeableConcept
...... concentrationQuantity Quantity
..... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
..... basis Σ 0..1 CodeableConcept 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)
..... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
..... country Σ 0..* CodeableConcept Where the strength range applies
Binding: Country ValueSet (Example)

..... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance

...... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMED CT Substance Codes (Example)
...... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
....... strengthRatio Ratio
....... strengthRatioRange RatioRange
....... strengthQuantity Quantity
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: Country ValueSet (Example)


doco Documentation for this format icon

See the Extensions for this resource

UML Diagram (Legend)

Ingredient (DomainResource)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 appropriateidentifier : Identifier [0..1]The status of this ingredient. Enables tracking the life-cycle of the content (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)PublicationStatus! »The product which this ingredient is a constituent part offor : Reference [0..*] « MedicinalProductDefinition| AdministrableProductDefinition|ManufacturedItemDefinition »A classification of the ingredient identifying its purpose within the product, e.g. active, inactiverole : CodeableConcept [1..1] « null (Strength=Example)IngredientRole?? »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 agentfunction : CodeableConcept [0..*] « null (Strength=Example)IngredientFunction?? »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 inkgroup : CodeableConcept [0..1]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 hereallergenicIndicator : boolean [0..1] « This element has or is affected by some invariantsC »A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on dryingcomment : markdown [0..1]ManufacturerThe 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 rolerole : code [0..1] « null (Strength=Required)IngredientManufacturerRole! »An organization that manufactures this ingredientmanufacturer : Reference [1..1] « Organization »SubstanceA code or full resource that represents the ingredient's substancecode : CodeableReference [1..1] « SubstanceDefinition; null (Strength=Example) SNOMEDCTSubstanceCodes?? » « This element has or is affected by some invariantsC »StrengthThe 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')presentation[x] : DataType [0..1] « Ratio|RatioRange|CodeableConcept| Quantity »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 ratiotextPresentation : string [0..1]The strength per unitary volume (or mass)concentration[x] : DataType [0..1] « Ratio|RatioRange| CodeableConcept|Quantity »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 ratiotextConcentration : string [0..1]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)basis : CodeableConcept [0..1]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 aerosolizationmeasurementPoint : string [0..1]The country or countries for which the strength range appliescountry : CodeableConcept [0..*] « null (Strength=Example)CountryValueSet?? »ReferenceStrengthRelevant reference substancesubstance : CodeableReference [1..1] « SubstanceDefinition; null (Strength=Example) SNOMEDCTSubstanceCodes?? »Strength expressed in terms of a reference substancestrength[x] : DataType [1..1] « Ratio|RatioRange|Quantity »For when strength is measured at a particular point or distancemeasurementPoint : string [0..1]The country or countries for which the strength range appliescountry : CodeableConcept [0..*] « null (Strength=Example)CountryValueSet?? »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 casemanufacturer[0..*]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 neededreferenceStrength[0..*]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 strengthstrength[0..*]The substance that comprises this ingredientsubstance[1..1]

XML Template

<Ingredient xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..1 Identifier An identifier or code by which the ingredient can be referenced --></identifier>
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <for><!-- 0..* Reference(AdministrableProductDefinition|
   ManufacturedItemDefinition|MedicinalProductDefinition) The product which this ingredient is a constituent part of --></for>
 <role><!-- 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive --></role>
 <function><!-- 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent --></function>
 <group><!-- 0..1 CodeableConcept 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 --></group>
 <allergenicIndicator value="[boolean]"/><!-- I 0..1 If the ingredient is a known or suspected allergen -->
 <comment value="[markdown]"/><!-- 0..1 A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying -->
 <manufacturer>  <!-- 0..* An organization that manufactures this ingredient -->
  <role value="[code]"/><!-- 0..1 allowed | possible | actual -->
  <manufacturer><!-- 1..1 Reference(Organization) An organization that manufactures this ingredient --></manufacturer>
 </manufacturer>
 <substance>  <!-- I 1..1 The substance that comprises this ingredient -->
  <code><!-- I 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance --></code>
  <strength>  <!-- 0..* The quantity of substance, per presentation, or per volume or mass, and type of quantity -->
   <presentation[x]><!-- 0..1 Ratio|RatioRange|CodeableConcept|Quantity The quantity of substance in the unit of presentation --></presentation[x]>
   <textPresentation value="[string]"/><!-- 0..1 Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) -->
   <concentration[x]><!-- 0..1 Ratio|RatioRange|CodeableConcept|Quantity The strength per unitary volume (or mass) --></concentration[x]>
   <textConcentration value="[string]"/><!-- 0..1 Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) -->
   <basis><!-- 0..1 CodeableConcept 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) --></basis>
   <measurementPoint value="[string]"/><!-- 0..1 When strength is measured at a particular point or distance -->
   <country><!-- 0..* CodeableConcept Where the strength range applies --></country>
   <referenceStrength>  <!-- 0..* Strength expressed in terms of a reference substance -->
    <substance><!-- 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance --></substance>
    <strength[x]><!-- 1..1 Ratio|RatioRange|Quantity Strength expressed in terms of a reference substance --></strength[x]>
    <measurementPoint value="[string]"/><!-- 0..1 When strength is measured at a particular point or distance -->
    <country><!-- 0..* CodeableConcept Where the strength range applies --></country>
   </referenceStrength>
  </strength>
 </substance>
</Ingredient>

JSON Template

{doco
  "resourceType" : "Ingredient",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // An identifier or code by which the ingredient can be referenced
  "status" : "<code>", // R!  draft | active | retired | unknown
  "for" : [{ Reference(AdministrableProductDefinition|
   ManufacturedItemDefinition|MedicinalProductDefinition) }], // The product which this ingredient is a constituent part of
  "role" : { CodeableConcept }, // R!  Purpose of the ingredient within the product, e.g. active, inactive
  "function" : [{ CodeableConcept }], // Precise action within the drug product, e.g. antioxidant, alkalizing agent
  "group" : { CodeableConcept }, // 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
  "allergenicIndicator" : <boolean>, // I If the ingredient is a known or suspected allergen
  "comment" : "<markdown>", // A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
  "manufacturer" : [{ // An organization that manufactures this ingredient
    "role" : "<code>", // allowed | possible | actual
    "manufacturer" : { Reference(Organization) } // R!  An organization that manufactures this ingredient
  }],
  "substance" : { // I R!  The substance that comprises this ingredient
    "code" : { CodeableReference(SubstanceDefinition) }, // I R!  A code or full resource that represents the ingredient substance
    "strength" : [{ // The quantity of substance, per presentation, or per volume or mass, and type of quantity
      // presentation[x]: The quantity of substance in the unit of presentation. One of these 4:
      "presentationRatio" : { Ratio },
      "presentationRatioRange" : { RatioRange },
      "presentationCodeableConcept" : { CodeableConcept },
      "presentationQuantity" : { Quantity },
      "textPresentation" : "<string>", // Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
      // concentration[x]: The strength per unitary volume (or mass). One of these 4:
      "concentrationRatio" : { Ratio },
      "concentrationRatioRange" : { RatioRange },
      "concentrationCodeableConcept" : { CodeableConcept },
      "concentrationQuantity" : { Quantity },
      "textConcentration" : "<string>", // Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
      "basis" : { CodeableConcept }, // 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)
      "measurementPoint" : "<string>", // When strength is measured at a particular point or distance
      "country" : [{ CodeableConcept }], // Where the strength range applies
      "referenceStrength" : [{ // Strength expressed in terms of a reference substance
        "substance" : { CodeableReference(SubstanceDefinition) }, // R!  Relevant reference substance
        // strength[x]: Strength expressed in terms of a reference substance. One of these 3:
        "strengthRatio" : { Ratio },
        "strengthRatioRange" : { RatioRange },
        "strengthQuantity" : { Quantity },
        "measurementPoint" : "<string>", // When strength is measured at a particular point or distance
        "country" : [{ CodeableConcept }] // Where the strength range applies
      }]
    }]
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:Ingredient;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:identifier [ Identifier ] ; # 0..1 An identifier or code by which the ingredient can be referenced
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:for  ( [ Reference(AdministrableProductDefinition|ManufacturedItemDefinition|
  MedicinalProductDefinition) ] ... ) ; # 0..* The product which this ingredient is a constituent part of
  fhir:role [ CodeableConcept ] ; # 1..1 Purpose of the ingredient within the product, e.g. active, inactive
  fhir:function  ( [ CodeableConcept ] ... ) ; # 0..* Precise action within the drug product, e.g. antioxidant, alkalizing agent
  fhir:group [ CodeableConcept ] ; # 0..1 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
  fhir:allergenicIndicator [ boolean ] ; # 0..1 I If the ingredient is a known or suspected allergen
  fhir:comment [ markdown ] ; # 0..1 A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
  fhir:manufacturer ( [ # 0..* An organization that manufactures this ingredient
    fhir:role [ code ] ; # 0..1 allowed | possible | actual
    fhir:manufacturer [ Reference(Organization) ] ; # 1..1 An organization that manufactures this ingredient
  ] ... ) ;
  fhir:substance [ # 1..1 I The substance that comprises this ingredient
    fhir:code [ CodeableReference(SubstanceDefinition) ] ; # 1..1 I A code or full resource that represents the ingredient substance
    fhir:strength ( [ # 0..* The quantity of substance, per presentation, or per volume or mass, and type of quantity
      # presentation[x] : 0..1 The quantity of substance in the unit of presentation. One of these 4
        fhir:presentation [  a fhir:Ratio ; Ratio ]
        fhir:presentation [  a fhir:RatioRange ; RatioRange ]
        fhir:presentation [  a fhir:CodeableConcept ; CodeableConcept ]
        fhir:presentation [  a fhir:Quantity ; Quantity ]
      fhir:textPresentation [ string ] ; # 0..1 Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
      # concentration[x] : 0..1 The strength per unitary volume (or mass). One of these 4
        fhir:concentration [  a fhir:Ratio ; Ratio ]
        fhir:concentration [  a fhir:RatioRange ; RatioRange ]
        fhir:concentration [  a fhir:CodeableConcept ; CodeableConcept ]
        fhir:concentration [  a fhir:Quantity ; Quantity ]
      fhir:textConcentration [ string ] ; # 0..1 Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
      fhir:basis [ CodeableConcept ] ; # 0..1 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)
      fhir:measurementPoint [ string ] ; # 0..1 When strength is measured at a particular point or distance
      fhir:country  ( [ CodeableConcept ] ... ) ; # 0..* Where the strength range applies
      fhir:referenceStrength ( [ # 0..* Strength expressed in terms of a reference substance
        fhir:substance [ CodeableReference(SubstanceDefinition) ] ; # 1..1 Relevant reference substance
        # strength[x] : 1..1 Strength expressed in terms of a reference substance. One of these 3
          fhir:strength [  a fhir:Ratio ; Ratio ]
          fhir:strength [  a fhir:RatioRange ; RatioRange ]
          fhir:strength [  a fhir:Quantity ; Quantity ]
        fhir:measurementPoint [ string ] ; # 0..1 When strength is measured at a particular point or distance
        fhir:country  ( [ CodeableConcept ] ... ) ; # 0..* Where the strength range applies
      ] ... ) ;
    ] ... ) ;
  ] ;
]

Changes from both R4 and R4B

This resource did not exist in Release R4

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. Ingredient TU DomainResource An ingredient of a manufactured item or pharmaceutical product
+ Rule: 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

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ 0..1 Identifier An identifier or code by which the ingredient can be referenced
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (Required)
... for Σ 0..* Reference(MedicinalProductDefinition | AdministrableProductDefinition | ManufacturedItemDefinition) The product which this ingredient is a constituent part of

... function Σ 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent
Binding: Ingredient Function (Example)

... group Σ 0..1 CodeableConcept 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
... allergenicIndicator ΣC 0..1 boolean If the ingredient is a known or suspected allergen
... comment 0..1 markdown A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
... manufacturer Σ 0..* BackboneElement An organization that manufactures this ingredient

.... role Σ 0..1 code allowed | possible | actual
Binding: Ingredient Manufacturer Role (Required)
.... manufacturer Σ 1..1 Reference(Organization) An organization that manufactures this ingredient
... substance ΣC 1..1 BackboneElement The substance that comprises this ingredient
.... code ΣC 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance
Binding: SNOMED CT Substance Codes (Example)
.... strength Σ 0..* BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity

..... presentation[x] Σ 0..1 The quantity of substance in the unit of presentation
...... presentationRatio Ratio
...... presentationRatioRange RatioRange
...... presentationCodeableConcept CodeableConcept
...... presentationQuantity Quantity
..... textPresentation Σ 0..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
..... concentration[x] Σ 0..1 The strength per unitary volume (or mass)
...... concentrationRatio Ratio
...... concentrationRatioRange RatioRange
...... concentrationCodeableConcept CodeableConcept
...... concentrationQuantity Quantity
..... textConcentration Σ 0..1 string Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
..... basis Σ 0..1 CodeableConcept 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)
..... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
..... country Σ 0..* CodeableConcept Where the strength range applies
Binding: Country ValueSet (Example)

..... referenceStrength Σ 0..* BackboneElement Strength expressed in terms of a reference substance

...... substance Σ 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance
Binding: SNOMED CT Substance Codes (Example)
...... strength[x] Σ 1..1 Strength expressed in terms of a reference substance
....... strengthRatio Ratio
....... strengthRatioRange RatioRange
....... strengthQuantity Quantity
...... measurementPoint Σ 0..1 string When strength is measured at a particular point or distance
...... country Σ 0..* CodeableConcept Where the strength range applies
Binding: Country ValueSet (Example)


doco Documentation for this format icon

See the Extensions for this resource

UML Diagram (Legend)

Ingredient (DomainResource)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 appropriateidentifier : Identifier [0..1]The status of this ingredient. Enables tracking the life-cycle of the content (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)PublicationStatus! »The product which this ingredient is a constituent part offor : Reference [0..*] « MedicinalProductDefinition| AdministrableProductDefinition|ManufacturedItemDefinition »A classification of the ingredient identifying its purpose within the product, e.g. active, inactiverole : CodeableConcept [1..1] « null (Strength=Example)IngredientRole?? »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 agentfunction : CodeableConcept [0..*] « null (Strength=Example)IngredientFunction?? »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 inkgroup : CodeableConcept [0..1]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 hereallergenicIndicator : boolean [0..1] « This element has or is affected by some invariantsC »A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on dryingcomment : markdown [0..1]ManufacturerThe 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 rolerole : code [0..1] « null (Strength=Required)IngredientManufacturerRole! »An organization that manufactures this ingredientmanufacturer : Reference [1..1] « Organization »SubstanceA code or full resource that represents the ingredient's substancecode : CodeableReference [1..1] « SubstanceDefinition; null (Strength=Example) SNOMEDCTSubstanceCodes?? » « This element has or is affected by some invariantsC »StrengthThe 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')presentation[x] : DataType [0..1] « Ratio|RatioRange|CodeableConcept| Quantity »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 ratiotextPresentation : string [0..1]The strength per unitary volume (or mass)concentration[x] : DataType [0..1] « Ratio|RatioRange| CodeableConcept|Quantity »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 ratiotextConcentration : string [0..1]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)basis : CodeableConcept [0..1]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 aerosolizationmeasurementPoint : string [0..1]The country or countries for which the strength range appliescountry : CodeableConcept [0..*] « null (Strength=Example)CountryValueSet?? »ReferenceStrengthRelevant reference substancesubstance : CodeableReference [1..1] « SubstanceDefinition; null (Strength=Example) SNOMEDCTSubstanceCodes?? »Strength expressed in terms of a reference substancestrength[x] : DataType [1..1] « Ratio|RatioRange|Quantity »For when strength is measured at a particular point or distancemeasurementPoint : string [0..1]The country or countries for which the strength range appliescountry : CodeableConcept [0..*] « null (Strength=Example)CountryValueSet?? »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 casemanufacturer[0..*]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 neededreferenceStrength[0..*]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 strengthstrength[0..*]The substance that comprises this ingredientsubstance[1..1]

XML Template

<Ingredient xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..1 Identifier An identifier or code by which the ingredient can be referenced --></identifier>
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <for><!-- 0..* Reference(AdministrableProductDefinition|
   ManufacturedItemDefinition|MedicinalProductDefinition) The product which this ingredient is a constituent part of --></for>
 <role><!-- 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive --></role>
 <function><!-- 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent --></function>
 <group><!-- 0..1 CodeableConcept 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 --></group>
 <allergenicIndicator value="[boolean]"/><!-- I 0..1 If the ingredient is a known or suspected allergen -->
 <comment value="[markdown]"/><!-- 0..1 A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying -->
 <manufacturer>  <!-- 0..* An organization that manufactures this ingredient -->
  <role value="[code]"/><!-- 0..1 allowed | possible | actual -->
  <manufacturer><!-- 1..1 Reference(Organization) An organization that manufactures this ingredient --></manufacturer>
 </manufacturer>
 <substance>  <!-- I 1..1 The substance that comprises this ingredient -->
  <code><!-- I 1..1 CodeableReference(SubstanceDefinition) A code or full resource that represents the ingredient substance --></code>
  <strength>  <!-- 0..* The quantity of substance, per presentation, or per volume or mass, and type of quantity -->
   <presentation[x]><!-- 0..1 Ratio|RatioRange|CodeableConcept|Quantity The quantity of substance in the unit of presentation --></presentation[x]>
   <textPresentation value="[string]"/><!-- 0..1 Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) -->
   <concentration[x]><!-- 0..1 Ratio|RatioRange|CodeableConcept|Quantity The strength per unitary volume (or mass) --></concentration[x]>
   <textConcentration value="[string]"/><!-- 0..1 Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio) -->
   <basis><!-- 0..1 CodeableConcept 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) --></basis>
   <measurementPoint value="[string]"/><!-- 0..1 When strength is measured at a particular point or distance -->
   <country><!-- 0..* CodeableConcept Where the strength range applies --></country>
   <referenceStrength>  <!-- 0..* Strength expressed in terms of a reference substance -->
    <substance><!-- 1..1 CodeableReference(SubstanceDefinition) Relevant reference substance --></substance>
    <strength[x]><!-- 1..1 Ratio|RatioRange|Quantity Strength expressed in terms of a reference substance --></strength[x]>
    <measurementPoint value="[string]"/><!-- 0..1 When strength is measured at a particular point or distance -->
    <country><!-- 0..* CodeableConcept Where the strength range applies --></country>
   </referenceStrength>
  </strength>
 </substance>
</Ingredient>

JSON Template

{doco
  "resourceType" : "Ingredient",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // An identifier or code by which the ingredient can be referenced
  "status" : "<code>", // R!  draft | active | retired | unknown
  "for" : [{ Reference(AdministrableProductDefinition|
   ManufacturedItemDefinition|MedicinalProductDefinition) }], // The product which this ingredient is a constituent part of
  "role" : { CodeableConcept }, // R!  Purpose of the ingredient within the product, e.g. active, inactive
  "function" : [{ CodeableConcept }], // Precise action within the drug product, e.g. antioxidant, alkalizing agent
  "group" : { CodeableConcept }, // 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
  "allergenicIndicator" : <boolean>, // I If the ingredient is a known or suspected allergen
  "comment" : "<markdown>", // A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
  "manufacturer" : [{ // An organization that manufactures this ingredient
    "role" : "<code>", // allowed | possible | actual
    "manufacturer" : { Reference(Organization) } // R!  An organization that manufactures this ingredient
  }],
  "substance" : { // I R!  The substance that comprises this ingredient
    "code" : { CodeableReference(SubstanceDefinition) }, // I R!  A code or full resource that represents the ingredient substance
    "strength" : [{ // The quantity of substance, per presentation, or per volume or mass, and type of quantity
      // presentation[x]: The quantity of substance in the unit of presentation. One of these 4:
      "presentationRatio" : { Ratio },
      "presentationRatioRange" : { RatioRange },
      "presentationCodeableConcept" : { CodeableConcept },
      "presentationQuantity" : { Quantity },
      "textPresentation" : "<string>", // Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
      // concentration[x]: The strength per unitary volume (or mass). One of these 4:
      "concentrationRatio" : { Ratio },
      "concentrationRatioRange" : { RatioRange },
      "concentrationCodeableConcept" : { CodeableConcept },
      "concentrationQuantity" : { Quantity },
      "textConcentration" : "<string>", // Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
      "basis" : { CodeableConcept }, // 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)
      "measurementPoint" : "<string>", // When strength is measured at a particular point or distance
      "country" : [{ CodeableConcept }], // Where the strength range applies
      "referenceStrength" : [{ // Strength expressed in terms of a reference substance
        "substance" : { CodeableReference(SubstanceDefinition) }, // R!  Relevant reference substance
        // strength[x]: Strength expressed in terms of a reference substance. One of these 3:
        "strengthRatio" : { Ratio },
        "strengthRatioRange" : { RatioRange },
        "strengthQuantity" : { Quantity },
        "measurementPoint" : "<string>", // When strength is measured at a particular point or distance
        "country" : [{ CodeableConcept }] // Where the strength range applies
      }]
    }]
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:Ingredient;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:identifier [ Identifier ] ; # 0..1 An identifier or code by which the ingredient can be referenced
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:for  ( [ Reference(AdministrableProductDefinition|ManufacturedItemDefinition|
  MedicinalProductDefinition) ] ... ) ; # 0..* The product which this ingredient is a constituent part of
  fhir:role [ CodeableConcept ] ; # 1..1 Purpose of the ingredient within the product, e.g. active, inactive
  fhir:function  ( [ CodeableConcept ] ... ) ; # 0..* Precise action within the drug product, e.g. antioxidant, alkalizing agent
  fhir:group [ CodeableConcept ] ; # 0..1 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
  fhir:allergenicIndicator [ boolean ] ; # 0..1 I If the ingredient is a known or suspected allergen
  fhir:comment [ markdown ] ; # 0..1 A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
  fhir:manufacturer ( [ # 0..* An organization that manufactures this ingredient
    fhir:role [ code ] ; # 0..1 allowed | possible | actual
    fhir:manufacturer [ Reference(Organization) ] ; # 1..1 An organization that manufactures this ingredient
  ] ... ) ;
  fhir:substance [ # 1..1 I The substance that comprises this ingredient
    fhir:code [ CodeableReference(SubstanceDefinition) ] ; # 1..1 I A code or full resource that represents the ingredient substance
    fhir:strength ( [ # 0..* The quantity of substance, per presentation, or per volume or mass, and type of quantity
      # presentation[x] : 0..1 The quantity of substance in the unit of presentation. One of these 4
        fhir:presentation [  a fhir:Ratio ; Ratio ]
        fhir:presentation [  a fhir:RatioRange ; RatioRange ]
        fhir:presentation [  a fhir:CodeableConcept ; CodeableConcept ]
        fhir:presentation [  a fhir:Quantity ; Quantity ]
      fhir:textPresentation [ string ] ; # 0..1 Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
      # concentration[x] : 0..1 The strength per unitary volume (or mass). One of these 4
        fhir:concentration [  a fhir:Ratio ; Ratio ]
        fhir:concentration [  a fhir:RatioRange ; RatioRange ]
        fhir:concentration [  a fhir:CodeableConcept ; CodeableConcept ]
        fhir:concentration [  a fhir:Quantity ; Quantity ]
      fhir:textConcentration [ string ] ; # 0..1 Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
      fhir:basis [ CodeableConcept ] ; # 0..1 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)
      fhir:measurementPoint [ string ] ; # 0..1 When strength is measured at a particular point or distance
      fhir:country  ( [ CodeableConcept ] ... ) ; # 0..* Where the strength range applies
      fhir:referenceStrength ( [ # 0..* Strength expressed in terms of a reference substance
        fhir:substance [ CodeableReference(SubstanceDefinition) ] ; # 1..1 Relevant reference substance
        # strength[x] : 1..1 Strength expressed in terms of a reference substance. One of these 3
          fhir:strength [  a fhir:Ratio ; Ratio ]
          fhir:strength [  a fhir:RatioRange ; RatioRange ]
          fhir:strength [  a fhir:Quantity ; Quantity ]
        fhir:measurementPoint [ string ] ; # 0..1 When strength is measured at a particular point or distance
        fhir:country  ( [ CodeableConcept ] ... ) ; # 0..* Where the strength range applies
      ] ... ) ;
    ] ... ) ;
  ] ;
]

Changes from both R4 and R4B

This resource did not exist in Release R4

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

15.8.3.1 Terminology Bindings

Path ValueSet Type Documentation
Ingredient.status PublicationStatus Required

The lifecycle status of an artifact.
Ingredient.role IngredientRole Example

A classification of the ingredient identifying its purpose within the product.
Ingredient.function IngredientFunction Example

A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
Ingredient.manufacturer.role IngredientManufacturerRole Required

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.
Ingredient.substance.code SNOMEDCTSubstanceCodes Example

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Ingredient.substance.strength.country CountryValueSet (a valid code from ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code icon) Example

This value set defines a base set of codes for countries.

Note: The codes for countries are taken from ISO 3166 icon.
Ingredient.substance.strength.referenceStrength.substance SNOMEDCTSubstanceCodes Example

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Ingredient.substance.strength.referenceStrength.country CountryValueSet (a valid code from ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code icon) Example

This value set defines a base set of codes for countries.

Note: The codes for countries are taken from ISO 3166 icon.

15.8.3.2 Constraints

UniqueKeyLevelLocationDescriptionExpression
img ing-1Rule (base)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



15.8.4 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
for reference The product which this ingredient is a constituent part of Ingredient.for
(AdministrableProductDefinition, ManufacturedItemDefinition, MedicinalProductDefinition)
function token 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 Ingredient.function
identifier token An identifier or code by which the ingredient can be referenced Ingredient.identifier
manufacturer reference The organization that manufactures this ingredient Ingredient.manufacturer.manufacturer
role token A classification of the ingredient identifying its purpose within the product, e.g. active, inactive Ingredient.role
status token The status of this ingredient. Enables tracking the life-cycle of the content Ingredient.status
strength-concentration-denominator quantity Ingredient concentration strength denominator (mainly for use in strength-concentration-ratio) Ingredient.substance.strength.concentration.ofType(Ratio).denominator
strength-concentration-numerator quantity Ingredient concentration strength numerator (mainly for use in strength-concentration-ratio) Ingredient.substance.strength.concentration.ofType(Ratio).numerator
strength-concentration-quantity quantity Ingredient concentration strength as quantity Ingredient.substance.strength.concentration.ofType(Quantity)
strength-concentration-ratio composite Ingredient concentration strength as ratio, numerator and denominator parameter pair On Ingredient.substance.strength.concentration.ofType(Ratio):
  numerator: strength-concentration-numerator
  denominator: strength-concentration-denominator
strength-presentation-denominator quantity Ingredient presentation strength denominator (mainly for use in strength-presentation-ratio) Ingredient.substance.strength.presentation.ofType(Ratio).denominator
strength-presentation-numerator quantity Ingredient presentation strength numerator (mainly for use in strength-presentation-ratio) Ingredient.substance.strength.presentation.ofType(Ratio).numerator
strength-presentation-quantity quantity Ingredient presentation strength as quantity Ingredient.substance.strength.presentation.ofType(Quantity)
strength-presentation-ratio composite Ingredient presentation strength as ratio, numerator and denominator parameter pair On Ingredient.substance.strength.presentation.ofType(Ratio):
  numerator: strength-presentation-numerator
  denominator: strength-presentation-denominator
substance reference Reference to a resource (by instance) Ingredient.substance.code.reference
substance-code token Reference to a concept (by class) Ingredient.substance.code.concept
substance-definition reference Reference to a resource (by instance) Ingredient.substance.code.reference