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15.4 Resource ManufacturedItemDefinition - Content

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

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).

15.4.2 References to this Resource

15.4.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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

... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (Required)
... name Σ 0..1 string A descriptive name applied to this item
... unitOfPresentation Σ 0..1 CodeableConcept The “real-world” units in which the quantity of the item is described
Binding: Unit Of Presentation (Example)
... manufacturer Σ 0..* Reference(Organization) Manufacturer of the item, one of several possible

... marketingStatus Σ 0..* MarketingStatus Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated

... ingredient Σ 0..* CodeableConcept The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
Binding: SNOMED CT Substance Codes (Example)

... property Σ 0..* BackboneElement General characteristics of this item

.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: Product Characteristic (Example)
.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueQuantity Quantity
..... valueDate date
..... valueBoolean boolean
..... valueMarkdown markdown
..... valueAttachment Attachment
..... valueReference Reference(Binary)
... component Σ 0..* BackboneElement Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup

.... type Σ 1..1 CodeableConcept Defining type of the component e.g. shell, layer, ink
.... function Σ 0..* CodeableConcept The function of this component within the item e.g. delivers active ingredient, masks taste

.... amount Σ 0..* Quantity The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)

.... constituent Σ 0..* BackboneElement A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)

..... amount Σ 0..* Quantity The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)

..... location Σ 0..* CodeableConcept The physical location of the constituent/ingredient within the component

..... function Σ 0..* CodeableConcept The function of this constituent within the component e.g. binder

..... hasIngredient Σ 0..* CodeableReference(Ingredient) The ingredient that is the constituent of the given component

.... property Σ 0..* see property General characteristics of this component

.... component Σ 0..* see component A component that this component contains or is made from


doco Documentation for this format icon

See the Extensions for this resource

 

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

15.4.3.1 Terminology Bindings

Path ValueSet Type Documentation
ManufacturedItemDefinition.status PublicationStatus Required

The lifecycle status of an artifact.
ManufacturedItemDefinition.manufacturedDoseForm ManufacturedDoseForm Example

Dose form for a medication, as manufactured (and before any mixing etc.), not necessarily ready for administration to the patient.
ManufacturedItemDefinition.unitOfPresentation UnitOfPresentation Example

The presentation type in which an administrable medicinal product is given to a patient.
ManufacturedItemDefinition.ingredient SNOMEDCTSubstanceCodes Example

This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
ManufacturedItemDefinition.property.type ProductCharacteristic Example

This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.



15.4.4 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
dose-form token Dose form as manufactured and before any transformation into the pharmaceutical product ManufacturedItemDefinition.manufacturedDoseForm
identifier token Unique identifier ManufacturedItemDefinition.identifier
ingredient token An ingredient of this item ManufacturedItemDefinition.ingredient
name token A descriptive name applied to this item ManufacturedItemDefinition.name
status token The status of this item. Enables tracking the life-cycle of the content. ManufacturedItemDefinition.status