Release 5 Draft Ballot

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15.4 Resource ManufacturedItemDefinition - Content

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity 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.

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.

A defining aspect is that the item is in the state as it comes from being manufactured, and has had no other preparatory steps - such as crushing or mixing. It is in the state ready for packaging and distribution to consumers, and not necessarily in the state ready for administration (for which see AdministrableProductDefinition). This is the state where medication items are commonly encountered, within packaging, before actually being used. It is a medication item "as manufactured", recognizing that other non-medication items are also manufactured, and that even the administrable form of a drug, and the packaging that an item is placed into, have been manufactured at some stage.

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 containing 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 product 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, applicators and so on (which would use DeviceDefinition), and components of packaging that are not considered devices, such bottle stoppers (use PackagedProductDefintion.package.package).

This resource is referenced by AdministrableProductDefinition, Ingredient and PlanDefinition.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition TUDomainResourceThe 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 Σ0..*IdentifierUnique identifier
... status ?!Σ1..1codedraft | active | retired | unknown
PublicationStatus (Required)
... manufacturedDoseForm Σ1..1CodeableConceptDose form as manufactured and before any transformation into the pharmaceutical product
... manufacturer Σ0..*Reference(Organization)Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
... ingredient Σ0..*CodeableConceptThe ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource
... property Σ0..*BackboneElementGeneral characteristics of this item
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment

doco Documentation for this format

Turtle Template

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


[ 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.status [ code ]; # 1..1 draft | active | retired | unknown
  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 [ CodeableConcept ], ... ; # 0..* The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource
  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

NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition TUDomainResourceThe 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 Σ0..*IdentifierUnique identifier
... status ?!Σ1..1codedraft | active | retired | unknown
PublicationStatus (Required)
... manufacturedDoseForm Σ1..1CodeableConceptDose form as manufactured and before any transformation into the pharmaceutical product
... manufacturer Σ0..*Reference(Organization)Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
... ingredient Σ0..*CodeableConceptThe ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource
... property Σ0..*BackboneElementGeneral characteristics of this item
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueQuantityQuantity
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment

doco Documentation for this format

Turtle Template

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


[ 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.status [ code ]; # 1..1 draft | active | retired | unknown
  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 [ CodeableConcept ], ... ; # 0..* The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource
  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 spreadsheet version & the dependency analysis a

PathDefinitionTypeReference
ManufacturedItemDefinition.status RequiredPublicationStatus

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
dose-formtokenDose form as manufactured and before any transformation into the pharmaceutical productManufacturedItemDefinition.manufacturedDoseForm
identifiertokenUnique identifierManufacturedItemDefinition.identifier
ingredient DtokenAn ingredient of this itemManufacturedItemDefinition.ingredient