This page is part of the FHIR Specification (v4.0.1: R4 - Mixed Normative and STU) in it's permanent home (it will always be available at this URL). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.17 Resource MedicinalProductIngredient - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

An ingredient of a manufactured item or pharmaceutical product.

11.17.1 Scope and Usage

This resource is still undergoing development and review by the appropriate Workgroups. At this time, is considered only as a draft resource not suitable for production implementation

Material used in the preparation of a medicinal/pharmaceutical product

The ingredient is part of a Medicinal Product, either alone or in combination with other ingredients. The ingredient is also a component of a pharmaceutical product. Ingredient is equal to a substance with the indication of the specific role it is playing in the product.

This resource is referenced by MedicinalProductManufactured and MedicinalProductPharmaceutical

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductIngredient	Σ TU		DomainResource	An ingredient of a manufactured item or pharmaceutical product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..1	Identifier	Identifier for the ingredient
role	Σ	1..1	CodeableConcept	Ingredient role e.g. Active ingredient, excipient
allergenicIndicator	Σ	0..1	boolean	If the ingredient is a known or suspected allergen
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this Ingredient
specifiedSubstance	Σ	0..*	BackboneElement	A specified substance that comprises this ingredient
code	Σ	1..1	CodeableConcept	The specified substance
group	Σ	1..1	CodeableConcept	The group of specified substance, e.g. group 1 to 4
confidentiality	Σ	0..1	CodeableConcept	Confidentiality level of the specified substance as the ingredient
strength	Σ	0..*	BackboneElement	Quantity of the substance or specified substance present in the manufactured item or pharmaceutical product
presentation	Σ	1..1	Ratio	The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item
presentationLowLimit	?!Σ	0..1	Ratio	A lower limit for the quantity of substance in the unit of presentation. For use when there is a range of strengths, this is the lower limit, with the presentation attribute becoming the upper limit
concentration	Σ	0..1	Ratio	The strength per unitary volume (or mass)
concentrationLowLimit	?!Σ	0..1	Ratio	A lower limit for the strength per unitary volume (or mass), for when there is a range. The concentration attribute then becomes the upper limit
measurementPoint	Σ	0..1	string	For when strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	The country or countries for which the strength range applies
referenceStrength	Σ	0..*	BackboneElement	Strength expressed in terms of a reference substance
substance	Σ	0..1	CodeableConcept	Relevant reference substance
strength	Σ	1..1	Ratio	Strength expressed in terms of a reference substance
strengthLowLimit	Σ	0..1	Ratio	Strength expressed in terms of a reference substance
measurementPoint	Σ	0..1	string	For when strength is measured at a particular point or distance
country	Σ	0..*	CodeableConcept	The country or countries for which the strength range applies
substance	Σ	0..1	BackboneElement	The ingredient substance
code	Σ	1..1	CodeableConcept	The ingredient substance
strength	Σ	0..*	see strength	Quantity of the substance or specified substance present in the manufactured item or pharmaceutical product
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductIngredient xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..1 Identifier Identifier for the ingredient --></identifier>
 <role><!-- 1..1 CodeableConcept Ingredient role e.g. Active ingredient, excipient --></role>
 <allergenicIndicator value="[boolean]"/><!-- 0..1 If the ingredient is a known or suspected allergen -->
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this Ingredient --></manufacturer>
 <specifiedSubstance>  <!-- 0..* A specified substance that comprises this ingredient -->
  <code><!-- 1..1 CodeableConcept The specified substance --></code>
  <group><!-- 1..1 CodeableConcept The group of specified substance, e.g. group 1 to 4 --></group>
  <confidentiality><!-- 0..1 CodeableConcept Confidentiality level of the specified substance as the ingredient --></confidentiality>
  <strength>  <!-- 0..* Quantity of the substance or specified substance present in the manufactured item or pharmaceutical product -->
   <presentation><!-- 1..1 Ratio The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item --></presentation>
   <presentationLowLimit><!-- 0..1 Ratio A lower limit for the quantity of substance in the unit of presentation. For use when there is a range of strengths, this is the lower limit, with the presentation attribute becoming the upper limit --></presentationLowLimit>
   <concentration><!-- 0..1 Ratio The strength per unitary volume (or mass) --></concentration>
   <concentrationLowLimit><!-- 0..1 Ratio A lower limit for the strength per unitary volume (or mass), for when there is a range. The concentration attribute then becomes the upper limit --></concentrationLowLimit>
   <measurementPoint value="[string]"/><!-- 0..1 For when strength is measured at a particular point or distance -->
   <country><!-- 0..* CodeableConcept The country or countries for which the strength range applies --></country>
   <referenceStrength>  <!-- 0..* Strength expressed in terms of a reference substance -->
    <substance><!-- 0..1 CodeableConcept Relevant reference substance --></substance>
    <strength><!-- 1..1 Ratio Strength expressed in terms of a reference substance --></strength>
    <strengthLowLimit><!-- 0..1 Ratio Strength expressed in terms of a reference substance --></strengthLowLimit>
    <measurementPoint value="[string]"/><!-- 0..1 For when strength is measured at a particular point or distance -->
    <country><!-- 0..* CodeableConcept The country or countries for which the strength range applies --></country>
   </referenceStrength>
  </strength>
 </specifiedSubstance>
 <substance>  <!-- 0..1 The ingredient substance -->
  <code><!-- 1..1 CodeableConcept The ingredient substance --></code>
  <strength><!-- 0..* Content as for MedicinalProductIngredient.specifiedSubstance.strength Quantity of the substance or specified substance present in the manufactured item or pharmaceutical product --></strength>
 </substance>
</MedicinalProductIngredient>

JSON Template

{
  "resourceType" : "MedicinalProductIngredient",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // Identifier for the ingredient
  "role" : { CodeableConcept }, // R!  Ingredient role e.g. Active ingredient, excipient
  "allergenicIndicator" : <boolean>, // If the ingredient is a known or suspected allergen
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this Ingredient
  "specifiedSubstance" : [{ // A specified substance that comprises this ingredient
    "code" : { CodeableConcept }, // R!  The specified substance
    "group" : { CodeableConcept }, // R!  The group of specified substance, e.g. group 1 to 4
    "confidentiality" : { CodeableConcept }, // Confidentiality level of the specified substance as the ingredient
    "strength" : [{ // Quantity of the substance or specified substance present in the manufactured item or pharmaceutical product
      "presentation" : { Ratio }, // R!  The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item
      "presentationLowLimit" : { Ratio }, // A lower limit for the quantity of substance in the unit of presentation. For use when there is a range of strengths, this is the lower limit, with the presentation attribute becoming the upper limit
      "concentration" : { Ratio }, // The strength per unitary volume (or mass)
      "concentrationLowLimit" : { Ratio }, // A lower limit for the strength per unitary volume (or mass), for when there is a range. The concentration attribute then becomes the upper limit
      "measurementPoint" : "<string>", // For when strength is measured at a particular point or distance
      "country" : [{ CodeableConcept }], // The country or countries for which the strength range applies
      "referenceStrength" : [{ // Strength expressed in terms of a reference substance
        "substance" : { CodeableConcept }, // Relevant reference substance
        "strength" : { Ratio }, // R!  Strength expressed in terms of a reference substance
        "strengthLowLimit" : { Ratio }, // Strength expressed in terms of a reference substance
        "measurementPoint" : "<string>", // For when strength is measured at a particular point or distance
        "country" : [{ CodeableConcept }] // The country or countries for which the strength range applies
      }]
    }]
  }],
  "substance" : { // The ingredient substance
    "code" : { CodeableConcept }, // R!  The ingredient substance
    "strength" : [{ Content as for MedicinalProductIngredient.specifiedSubstance.strength }] // Quantity of the substance or specified substance present in the manufactured item or pharmaceutical product
  }
}

Turtle Template

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


[ a fhir:MedicinalProductIngredient;
  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:MedicinalProductIngredient.identifier [ Identifier ]; # 0..1 Identifier for the ingredient
  fhir:MedicinalProductIngredient.role [ CodeableConcept ]; # 1..1 Ingredient role e.g. Active ingredient, excipient
  fhir:MedicinalProductIngredient.allergenicIndicator [ boolean ]; # 0..1 If the ingredient is a known or suspected allergen
  fhir:MedicinalProductIngredient.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Ingredient
  fhir:MedicinalProductIngredient.specifiedSubstance [ # 0..* A specified substance that comprises this ingredient
    fhir:MedicinalProductIngredient.specifiedSubstance.code [ CodeableConcept ]; # 1..1 The specified substance
    fhir:MedicinalProductIngredient.specifiedSubstance.group [ CodeableConcept ]; # 1..1 The group of specified substance, e.g. group 1 to 4
    fhir:MedicinalProductIngredient.specifiedSubstance.confidentiality [ CodeableConcept ]; # 0..1 Confidentiality level of the specified substance as the ingredient
    fhir:MedicinalProductIngredient.specifiedSubstance.strength [ # 0..* Quantity of the substance or specified substance present in the manufactured item or pharmaceutical product
      fhir:MedicinalProductIngredient.specifiedSubstance.strength.presentation [ Ratio ]; # 1..1 The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item
      fhir:MedicinalProductIngredient.specifiedSubstance.strength.presentationLowLimit [ Ratio ]; # 0..1 A lower limit for the quantity of substance in the unit of presentation. For use when there is a range of strengths, this is the lower limit, with the presentation attribute becoming the upper limit
      fhir:MedicinalProductIngredient.specifiedSubstance.strength.concentration [ Ratio ]; # 0..1 The strength per unitary volume (or mass)
      fhir:MedicinalProductIngredient.specifiedSubstance.strength.concentrationLowLimit [ Ratio ]; # 0..1 A lower limit for the strength per unitary volume (or mass), for when there is a range. The concentration attribute then becomes the upper limit
      fhir:MedicinalProductIngredient.specifiedSubstance.strength.measurementPoint [ string ]; # 0..1 For when strength is measured at a particular point or distance
      fhir:MedicinalProductIngredient.specifiedSubstance.strength.country [ CodeableConcept ], ... ; # 0..* The country or countries for which the strength range applies
      fhir:MedicinalProductIngredient.specifiedSubstance.strength.referenceStrength [ # 0..* Strength expressed in terms of a reference substance
        fhir:MedicinalProductIngredient.specifiedSubstance.strength.referenceStrength.substance [ CodeableConcept ]; # 0..1 Relevant reference substance
        fhir:MedicinalProductIngredient.specifiedSubstance.strength.referenceStrength.strength [ Ratio ]; # 1..1 Strength expressed in terms of a reference substance
        fhir:MedicinalProductIngredient.specifiedSubstance.strength.referenceStrength.strengthLowLimit [ Ratio ]; # 0..1 Strength expressed in terms of a reference substance
        fhir:MedicinalProductIngredient.specifiedSubstance.strength.referenceStrength.measurementPoint [ string ]; # 0..1 For when strength is measured at a particular point or distance
        fhir:MedicinalProductIngredient.specifiedSubstance.strength.referenceStrength.country [ CodeableConcept ], ... ; # 0..* The country or countries for which the strength range applies
      ], ...;
    ], ...;
  ], ...;
  fhir:MedicinalProductIngredient.substance [ # 0..1 The ingredient substance
    fhir:MedicinalProductIngredient.substance.code [ CodeableConcept ]; # 1..1 The ingredient substance
    fhir:MedicinalProductIngredient.substance.strength [ See MedicinalProductIngredient.specifiedSubstance.strength ], ... ; # 0..* Quantity of the substance or specified substance present in the manufactured item or pharmaceutical product
  ];
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.