Medicinal Product Manufactured
The medicinal product manufactured profile has been adapted from the MedicinalProductManufactured FHIR resource. It is currently a work in progress. It contains the following elements:
MedicinalProductManufacturedSafest (MedicinalProductManufactured) | I | MedicinalProductManufactured | There are no (further) constraints on this element Element idMedicinalProductManufactured The manufactured item as contained in the packaged medicinal product DefinitionThe manufactured item as contained in the packaged medicinal product.
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id | Σ | 0..1 | string | There are no (further) constraints on this element Element idMedicinalProductManufactured.id Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. |
meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idMedicinalProductManufactured.meta Metadata about the resource DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
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implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idMedicinalProductManufactured.implicitRules A set of rules under which this content was created DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
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language | 0..1 | codeBinding | There are no (further) constraints on this element Element idMedicinalProductManufactured.language Language of the resource content DefinitionThe base language in which the resource is written. Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). A human language.
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text | 0..1 | Narrative | There are no (further) constraints on this element Element idMedicinalProductManufactured.text Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
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contained | 0..* | Resource | There are no (further) constraints on this element Element idMedicinalProductManufactured.contained Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
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extension | I | 0..* | Extension | Element idMedicinalProductManufactured.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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tempSafestManufacturedItemID | I | 1..1 | Extension(Identifier) | Element idMedicinalProductManufactured.extension:tempSafestManufacturedItemID Optional Extensions Element Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. http://legemiddelverket.no/fhir/StructureDefinition/IdentifierExtension Constraints
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modifierExtension | ?! I | 0..* | Extension | There are no (further) constraints on this element Element idMedicinalProductManufactured.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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manufacturedDoseForm | Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm Dose form as manufactured and before any transformation into the pharmaceutical product DefinitionDose form as manufactured and before any transformation into the pharmaceutical product. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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id | 0..1 | string | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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coding | Σ | 0..* | Coding | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
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id | 0..1 | string | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.coding.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.coding.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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system | Σ | 1..1 | uri | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.coding.system Identity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code. Need to be unambiguous about the source of the definition of the symbol. The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.
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version | Σ | 0..0 | string | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.coding.version Version of the system - if relevant DefinitionThe version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
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code | Σ | 1..1 | code | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.coding.code Symbol in syntax defined by the system DefinitionA symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Need to refer to a particular code in the system. Note that FHIR strings SHALL NOT exceed 1MB in size
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display | Σ | 0..1 | string | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.coding.display Representation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system. Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Note that FHIR strings SHALL NOT exceed 1MB in size
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userSelected | Σ | 0..0 | boolean | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.coding.userSelected If this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
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text | Σ | 0..1 | string | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturedDoseForm.text Plain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Very often the text is the same as a displayName of one of the codings.
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unitOfPresentation | Σ | 0..0 | CodeableConcept | There are no (further) constraints on this element Element idMedicinalProductManufactured.unitOfPresentation The “real world” units in which the quantity of the manufactured item is described DefinitionThe “real world” units in which the quantity of the manufactured item is described. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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quantity | Σ I | 1..1 | Quantity | There are no (further) constraints on this element Element idMedicinalProductManufactured.quantity The quantity or "count number" of the manufactured item DefinitionThe quantity or "count number" of the manufactured item. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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id | 0..1 | string | There are no (further) constraints on this element Element idMedicinalProductManufactured.quantity.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idMedicinalProductManufactured.quantity.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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value | Σ | 0..0 | decimal | There are no (further) constraints on this element Element idMedicinalProductManufactured.quantity.value Numerical value (with implicit precision) DefinitionThe value of the measured amount. The value includes an implicit precision in the presentation of the value. Precision is handled implicitly in almost all cases of measurement. The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
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comparator | Σ ?! | 0..0 | codeBinding | There are no (further) constraints on this element Element idMedicinalProductManufactured.quantity.comparator < | <= | >= | > - how to understand the value DefinitionHow the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. Note that FHIR strings SHALL NOT exceed 1MB in size If there is no comparator, then there is no modification of the value How the Quantity should be understood and represented.
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unit | Σ | 0..0 | string | There are no (further) constraints on this element Element idMedicinalProductManufactured.quantity.unit Unit representation DefinitionA human-readable form of the unit. There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. Note that FHIR strings SHALL NOT exceed 1MB in size
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system | Σ I | 0..1 | uri | There are no (further) constraints on this element Element idMedicinalProductManufactured.quantity.system System that defines coded unit form DefinitionThe identification of the system that provides the coded form of the unit. Need to know the system that defines the coded form of the unit. see http://en.wikipedia.org/wiki/Uniform_resource_identifier
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code | Σ | 0..1 | code | There are no (further) constraints on this element Element idMedicinalProductManufactured.quantity.code Coded form of the unit DefinitionA computer processable form of the unit in some unit representation system. Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
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manufacturer | Σ I | 0..0 | Reference(Organization) | There are no (further) constraints on this element Element idMedicinalProductManufactured.manufacturer Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues) DefinitionManufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues). References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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ingredient | Σ I | 0..0 | Reference(MedicinalProductIngredient) | There are no (further) constraints on this element Element idMedicinalProductManufactured.ingredient Ingredient DefinitionIngredient. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(MedicinalProductIngredient) Constraints
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physicalCharacteristics | Σ | 0..0 | ProdCharacteristic | There are no (further) constraints on this element Element idMedicinalProductManufactured.physicalCharacteristics Dimensions, color etc. DefinitionDimensions, color etc.
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otherCharacteristics | Σ | 0..0 | CodeableConcept | There are no (further) constraints on this element Element idMedicinalProductManufactured.otherCharacteristics Other codeable characteristics DefinitionOther codeable characteristics. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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extension
tempSafestManufacturedItemID
(this identifier is not properly defined and will be updated in the future)
The safestManufacturedItemID extension is implemented in order to have a unique identifier for the manufactured item. It is an identifier which is generated by SAFEST for every manufactured item and is mandatory. Identifier URL: http://legemiddelverket.no/fhir/SAFEST/SafestMedicinalProductManufacturedID
The url of the extension is: https://simplifier.net/safest/identifier
manufacturedDoseForm
The manufacturedDoseForm currently only contains coding for SAFEST Simplifier placeholder code system, url: https://simplifier.net/safest/unusedsafest