Release 4B Ballot #1

This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

15.4 Resource ManufacturedItemDefinition - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 1

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product.

15.4.1 Scope and Usage

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

ManufacturedItemDefinition is to be used when you need to describe an actual physical medication item such as a tablet or capsule. This is typically for regulatory or manufacturing use cases, rather than day to day prescribing or dispensing.

The manufactured item describes the physical characteristics of the item, as opposed to its pharmaceutical aspects (which may only apply after mixing with other items - to become an AdministrableProductDefinition), or its packaging, or legal aspects (which apply only to the whole group of packing and manufactured items). There are typically multiple instances of the item in the packaging (a PackagedProductDefinition resource) and this is indicated by the quantity within the package (e.g. 12 tablets), referencing a single copy of the manufactured item.

This is the only resource that treats the "tablet" (or whatever it may be) as a physical object. It is still definitional however - it describes all instances of this tablet. The resource aims to capture the definition of a single medication item type, such as a tablet of aspirin with a certain form, shape, manufacturer. It is not intended to describe and be instantiated for each medication item, i.e. it is not an actual real instance of a tablet, but rather represents (e.g.) all tablets of the same medication item type, that are described by the ManufacturedItemDefinition.

To define several package variations, e.g. pack of 10 tablets and of 50 tablets, you would need only one ManufacturedItemDefinition, referenced from both (and associated with a numeric quantity of 10 or 50 in the respective PackagedProductDefintions). To prescribe or dispense 100 tablets, you would not generally need this resource at all, because usually the code of the medication as a whole is sufficient, plus a quantity, e.g. 100 of "ABC123" (meaning e.g. aspirin 75 mg).

This resource excludes devices and other items found in medication packaging such as scissors, bottle stoppers, applicators and so on (which would use DeviceDefinition).

15.4.2 References

This resource is referenced by AdministrableProductDefinition and PlanDefinition.

This resource does not implement any patterns.

Structure

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	TU		DomainResource	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Unique identifier
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured and before any transformation into the pharmaceutical product
unitOfPresentation	Σ	0..1	CodeableConcept	The “real world” units in which the quantity of the manufactured item is described
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
ingredient	Σ	0..*	CodeableReference(Ingredient)	The ingredients that make up this manufactured item
property	Σ	0..*	BackboneElement	General characteristics of this item
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

UML Diagram (Legend)

XML Template

<ManufacturedItemDefinition xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <manufacturedDoseForm><!-- 1..1 CodeableConcept Dose form as manufactured and before any transformation into the pharmaceutical product --></manufacturedDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept The “real world” units in which the quantity of the manufactured item is described --></unitOfPresentation>
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues) --></manufacturer>
 <ingredient><!-- 0..* CodeableReference(Ingredient) The ingredients that make up this manufactured item --></ingredient>
 <property>  <!-- 0..* General characteristics of this item -->
  <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type>
  <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|Attachment A value for the characteristic --></value[x]>
 </property>
</ManufacturedItemDefinition>

JSON Template

{
  "resourceType" : "ManufacturedItemDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "manufacturedDoseForm" : { CodeableConcept }, // R!  Dose form as manufactured and before any transformation into the pharmaceutical product
  "unitOfPresentation" : { CodeableConcept }, // The “real world” units in which the quantity of the manufactured item is described
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
  "ingredient" : [{ CodeableReference(Ingredient) }], // The ingredients that make up this manufactured item
  "property" : [{ // General characteristics of this item
    "type" : { CodeableConcept }, // R!  A code expressing the type of characteristic
    // value[x]: A value for the characteristic. One of these 5:
    "valueCodeableConcept" : { CodeableConcept }
    "valueQuantity" : { Quantity }
    "valueDate" : "<date>"
    "valueBoolean" : <boolean>
    "valueAttachment" : { Attachment }
  }]
}

Turtle Template

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


[ a fhir:ManufacturedItemDefinition;
  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:ManufacturedItemDefinition.identifier [ Identifier ], ... ; # 0..* Unique identifier
  fhir:ManufacturedItemDefinition.manufacturedDoseForm [ CodeableConcept ]; # 1..1 Dose form as manufactured and before any transformation into the pharmaceutical product
  fhir:ManufacturedItemDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 The “real world” units in which the quantity of the manufactured item is described
  fhir:ManufacturedItemDefinition.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
  fhir:ManufacturedItemDefinition.ingredient [ CodeableReference(Ingredient) ], ... ; # 0..* The ingredients that make up this manufactured item
  fhir:ManufacturedItemDefinition.property [ # 0..* General characteristics of this item
    fhir:ManufacturedItemDefinition.property.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
    # ManufacturedItemDefinition.property.value[x] : 0..1 A value for the characteristic. One of these 5
      fhir:ManufacturedItemDefinition.property.valueCodeableConcept [ CodeableConcept ]
      fhir:ManufacturedItemDefinition.property.valueQuantity [ Quantity ]
      fhir:ManufacturedItemDefinition.property.valueDate [ date ]
      fhir:ManufacturedItemDefinition.property.valueBoolean [ boolean ]
      fhir:ManufacturedItemDefinition.property.valueAttachment [ Attachment ]
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	TU		DomainResource	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Unique identifier
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured and before any transformation into the pharmaceutical product
unitOfPresentation	Σ	0..1	CodeableConcept	The “real world” units in which the quantity of the manufactured item is described
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
ingredient	Σ	0..*	CodeableReference(Ingredient)	The ingredients that make up this manufactured item
property	Σ	0..*	BackboneElement	General characteristics of this item
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

UML Diagram (Legend)

XML Template

<ManufacturedItemDefinition xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <manufacturedDoseForm><!-- 1..1 CodeableConcept Dose form as manufactured and before any transformation into the pharmaceutical product --></manufacturedDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept The “real world” units in which the quantity of the manufactured item is described --></unitOfPresentation>
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues) --></manufacturer>
 <ingredient><!-- 0..* CodeableReference(Ingredient) The ingredients that make up this manufactured item --></ingredient>
 <property>  <!-- 0..* General characteristics of this item -->
  <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type>
  <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|Attachment A value for the characteristic --></value[x]>
 </property>
</ManufacturedItemDefinition>

JSON Template

{
  "resourceType" : "ManufacturedItemDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "manufacturedDoseForm" : { CodeableConcept }, // R!  Dose form as manufactured and before any transformation into the pharmaceutical product
  "unitOfPresentation" : { CodeableConcept }, // The “real world” units in which the quantity of the manufactured item is described
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
  "ingredient" : [{ CodeableReference(Ingredient) }], // The ingredients that make up this manufactured item
  "property" : [{ // General characteristics of this item
    "type" : { CodeableConcept }, // R!  A code expressing the type of characteristic
    // value[x]: A value for the characteristic. One of these 5:
    "valueCodeableConcept" : { CodeableConcept }
    "valueQuantity" : { Quantity }
    "valueDate" : "<date>"
    "valueBoolean" : <boolean>
    "valueAttachment" : { Attachment }
  }]
}

Turtle Template

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


[ a fhir:ManufacturedItemDefinition;
  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:ManufacturedItemDefinition.identifier [ Identifier ], ... ; # 0..* Unique identifier
  fhir:ManufacturedItemDefinition.manufacturedDoseForm [ CodeableConcept ]; # 1..1 Dose form as manufactured and before any transformation into the pharmaceutical product
  fhir:ManufacturedItemDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 The “real world” units in which the quantity of the manufactured item is described
  fhir:ManufacturedItemDefinition.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
  fhir:ManufacturedItemDefinition.ingredient [ CodeableReference(Ingredient) ], ... ; # 0..* The ingredients that make up this manufactured item
  fhir:ManufacturedItemDefinition.property [ # 0..* General characteristics of this item
    fhir:ManufacturedItemDefinition.property.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
    # ManufacturedItemDefinition.property.value[x] : 0..1 A value for the characteristic. One of these 5
      fhir:ManufacturedItemDefinition.property.valueCodeableConcept [ CodeableConcept ]
      fhir:ManufacturedItemDefinition.property.valueQuantity [ Quantity ]
      fhir:ManufacturedItemDefinition.property.valueDate [ date ]
      fhir:ManufacturedItemDefinition.property.valueBoolean [ boolean ]
      fhir:ManufacturedItemDefinition.property.valueAttachment [ Attachment ]
  ], ...;
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis

15.4.4 Search Parameters

Search parameters for 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
dose-form	token	Dose form as manufactured and before any transformation into the pharmaceutical product	ManufacturedItemDefinition.manufacturedDoseForm
identifier	token	Unique identifier	ManufacturedItemDefinition.identifier
ingredient D	reference	Reference to a resource (by instance)	ManufacturedItemDefinition.ingredient.reference
ingredient-code D	token	Reference to a concept (by class)	ManufacturedItemDefinition.ingredient.concept