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See the Directory of published versions

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.

This resource represents (for example) a single physical tablet. It can also represent physical liquids, powders, capsules etc. When prescribing, it is not usually necessary to represent the physical properties of the tablet that the patient will eventually receive and consume. Prescriptions make statements about types of products or substances, in general terms or more specific, which may be fulfilled by tablets (in some cases) but usually without directly talking about the details of those tablets. It is not usual to prescribe a red tablet with an "X" on it, so it is clear that this resource is not needed for the prescribing workflow itself. However it may be useful during a patient consultation (or perhaps in response to an adverse event), to look up which tablet is the red triangle with an "X" imprint. These definitional facts can be captured with this resource. They would likely never be on a prescription, but this resource supports the prescribing process as well as other downstream events. The weights, sizes, chemical properties and so on are naturally important to manufacturers, distributors, and regulators - who need every property detailing.

A defining aspect of this resource is that the item described 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, MedicinalProductDefinition, PackagedProductDefinition 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 (before any necessary transformation)
ManufacturedDoseForm (Example)
... 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. Only needed if these are not specified by incoming references from the Ingredient resource
SNOMEDCTSubstanceCodes (Example)
... property Σ0..*BackboneElementGeneral characteristics of this item
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
SNOMEDCTCharacteristicCodes (Example)
.... 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 (before any necessary transformation)
  fhir:ManufacturedItemDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 The “real world” units in which the quantity of the 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. Only needed if these 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 (before any necessary transformation)
ManufacturedDoseForm (Example)
... 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. Only needed if these are not specified by incoming references from the Ingredient resource
SNOMEDCTSubstanceCodes (Example)
... property Σ0..*BackboneElementGeneral characteristics of this item
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
SNOMEDCTCharacteristicCodes (Example)
.... 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 (before any necessary transformation)
  fhir:ManufacturedItemDefinition.unitOfPresentation [ CodeableConcept ]; # 0..1 The “real world” units in which the quantity of the 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. Only needed if these 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
ManufacturedItemDefinition.manufacturedDoseForm Examplehttp://hl7.org/fhir/ValueSet/manufactured-dose-form
ManufacturedItemDefinition.unitOfPresentation ExampleUnitOfPresentation
ManufacturedItemDefinition.ingredient Examplehttp://hl7.org/fhir/ValueSet/substance-codes
ManufacturedItemDefinition.property.type Examplehttp://hl7.org/fhir/ValueSet/product-characteristic-codes

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