Generated Narrative: StructureDefinition Ingredient-phpid-pub Name Flags Card. Type Description & Constraints Ingredient Ingredient #xD; id 1..1 id Logical id of this artifact #xD; implicitRules 0..1 uri Not used in this profile #xD; contained 0..* Resource Not used in this profile #xD; modifierExtension 0..* Extension Not used in this profile #xD; for 1..* Reference(AdministrableProductDefinition (publish)) The product which this ingredient is a constituent part of #xD; role 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive Binding: IngredientRole (example) #xD; allergenicIndicator 0..1 boolean Not used in this profile #xD; manufacturer 0..* BackboneElement Not used in this profile #xD; substance #xD; modifierExtension 0..* Extension Not used in this profile #xD; code 1..1 CodeableReference(SubstanceDefinition (publish)) A code or full resource that represents the ingredient substance Binding: http://umcterminologies.org/gsid (required) #xD; concept #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://umcterminologies.org/gsid #xD; code 1..1 code Symbol in syntax defined by the system #xD; text 1..1 string Plain text representation of the concept #xD; strength 0..1 BackboneElement The quantity of substance, per presentation, or per volume or mass, and type of quantity. #xD; modifierExtension 0..* Extension Not used in this profile #xD; Slices for presentation[x] 0..1 Ratio, RatioRange, CodeableConcept, Quantity The quantity of substance in the unit of presentation Slice: Unordered, Open by type:$this #xD; presentation[x]:presentationRatio 0..1 Ratio Not used in this profile #xD; numerator 1..1 Quantity Numerator value #xD; value 1..1 decimal Numerical value (with implicit precision) #xD; unit 1..1 string Unit representation Binding: Strength Unit Value Set (required) #xD; denominator 1..1 SimpleQuantity(5.0.0) Denominator value #xD; value 1..1 decimal Numerical value (with implicit precision) #xD; unit 1..1 string Unit representation Binding: Strength Unit Value Set (required) #xD; presentation[x]:presentationQuantity 0..1 Quantity The quantity of substance in the unit of presentation #xD; value 1..1 decimal Numerical value (with implicit precision) #xD; unit 1..1 string Unit representation Binding: Strength Unit Value Set (required) #xD; presentation[x]:presentationRatioRange 0..1 RatioRange Not used in this profile #xD; presentation[x]:presentationCodeableConcept 0..1 CodeableConcept Not used in this profile #xD; textPresentation 1..1 string Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio) #xD; textConcentration 0..1 string Not used in this profile #xD; referenceStrength 0..1 BackboneElement Strength expressed in terms of a reference substance #xD; modifierExtension 0..* Extension Not used in this profile #xD; substance 1..1 CodeableReference(SubstanceDefinition (publish)) Relevant reference substance. Binding: http://umcterminologies.org/gsid (required) #xD; concept #xD; coding 0..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://umcterminologies.org/gsid #xD; code 1..1 code Symbol in syntax defined by the system #xD; Slices for strength[x] 1..1 Ratio, RatioRange, Quantity Strength of the reference substance. Slice: Unordered, Open by type:$this #xD; strength[x]:strengthRatio 0..1 Ratio Not used in this profile #xD; strength[x]:strengthRatioRange 0..1 RatioRange Not used in this profile #xD; Documentation for this format
This profile defines how the Ingredient is used for PhPID publish (as contained resource in an AdministrableProductDefinition) by UMC terminologies
An ingredient of a manufactured item or pharmaceutical product
An ingredient of a manufactured item or pharmaceutical product.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource
Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
The 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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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 its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The 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).
Text summary of the resource, for human interpretation
A 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 a 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.
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.
Additional content defined by implementations
May 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 managable, 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.
Must have either extensions or value[x], not both
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
An identifier or code by which the ingredient can be referenced
The identifier(s) of this Ingredient that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate.
The status of this ingredient. Enables tracking the life-cycle of the content.
Allows filtering of ingredient that are appropriate for use versus not.
This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
The product which this ingredient is a constituent part of
The product which this ingredient is a constituent part of.
Purpose of the ingredient within the product, e.g. active, inactive
A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.
Precise action within the drug product, e.g. antioxidant, alkalizing agent
A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.
A classification of the ingredient identifying its precise purpose(s) in the drug product (beyond e.g. active/inactive).
A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink
A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink.
If this value is not present, there is no statement being made about whether this is an allergen or not. No inference can be made
A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying
A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
May 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 managable, 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.
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 managable, 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. 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The way in which this manufacturer is associated with the ingredient. For example whether it is a possible one (others allowed), or an exclusive authorized one for this ingredient. Note that this is not the manufacturing process role.
The way in which this manufacturer is associated with the ingredient.
Ingredient.Manufacturer / Establishment (Organisation)
An organization that manufactures this ingredient
An organization that manufactures this ingredient.
The substance that comprises this ingredient
The substance that comprises this ingredient.
A code or full resource that represents the ingredient substance
A code or full resource that represents the ingredient's substance.
Extensions are always sliced by (at least) url
A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.
A reference to a code defined by a terminology system.
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.
Allows for alternative encodings within a code system, and translations to other code systems.
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
The identification of the code system that defines the meaning of the symbol in the code.
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Need to be unambiguous about the source of the definition of the symbol.
fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
The 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.
fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
A 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.
fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
A 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.
C*E.2 - but note this is not well followed
fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
If this coding was chosen directly by the user
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
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.
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.
fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
Plain text representation of the concept
A 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.
Very often the text is the same as a displayName of one of the codings.
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.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
A reference to a resource the provides exact details about the information being referenced.
The quantity of substance, per presentation, or per volume or mass, and type of quantity.
The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength.
The quantity of substance in the unit of presentation
The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').
Numerical value (with implicit precision)
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
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).
Precision is handled implicitly in almost all cases of measurement.
PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
< | <= | >= | > | ad - how to understand the value
How 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.
If there is no comparator, then there is no modification of the value
This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
How the Quantity should be understood and represented.
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
The 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.
CO.codeSystem, PQ.translation.codeSystem
A computer processable form of the unit in some unit representation system.
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.
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.
PQ.code, MO.currency, PQ.translation.code
Text of either the whole presentation strength or a part of it (rest being in Strength.presentation as a ratio)
A textual represention of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio.
The strength per unitary volume (or mass)
The strength per unitary volume (or mass).
A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt)
A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt).
When strength is measured at a particular point or distance
For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization.
The country or countries for which the strength range applies.
Strength expressed in terms of a reference substance
Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed.
Strength expressed in terms of a reference substance.
For when strength is measured at a particular point or distance.