Name Flags Card. Type Description & Constraints Ingredient 0..* Ingredient An ingredient of a manufactured item or pharmaceutical product Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url novel-excipient S 0..1 boolean novel-excipient URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-novel-excipient-pq suitability-for-use S 0..1 string suitability-for-use URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-suitability-for-use-pq identifier S 0..1 Identifier An identifier or code by which the ingredient can be referenced role 1..1 CodeableConcept Purpose of the ingredient within the product, e.g. active, inactive Binding: IngredientRole (preferred): A classification of the ingredient identifying its purpose within the product, e.g. active, inactive. data-absent-reason S 0..1 code data-absent-reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required) function 0..* CodeableConcept Precise action within the drug product, e.g. antioxidant, alkalizing agent Binding: Ingredient Function (example): 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. substance code S 1..1 CodeableReference(SubstanceDefinition - Component Substance Drug PQ) Ingredient Substance strength referenceStrength S 0..* BackboneElement Strength expressed in terms of a reference substance Documentation for this format
HL7 International / Biomedical Research and Regulation
HL7 International - Biomedical Research and Regulation
This Ingredient profile represents the active ingredient(s) of a drug substance or product. It references one SubstanceDefinition resource and can include the strength or concentration of that substance.
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())
A set of rules under which this content was created
A 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 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.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
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.
Must have either extensions or value[x], not both
May 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 managable, 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).
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.
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 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.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Additional content defined by implementations
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.
Provides a reason why the expected value or elements in the element that is extended are missing.
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
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
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 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 the ingredient is a known or suspected allergen
If the ingredient is a known or suspected allergen. Note that this is a property of the substance, so if a reference to a SubstanceDefinition is used to decribe that (rather than just a code), the allergen information should go there, not here.
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.
An organization that manufactures this ingredient
The organization(s) that manufacture this ingredient. Can be used to indicate: 1) Organizations we are aware of that manufacture this ingredient 2) Specific Manufacturer(s) currently being used 3) Set of organisations allowed to manufacture this ingredient for this product Users must be clear on the application of context relevant to their use case.
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 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.
The substance that comprises this ingredient
The substance that comprises this ingredient.
A code or full resource that represents the ingredient's substance.
This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
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').
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).
Text of either the whole concentration strength or a part of it (rest being in Strength.concentration as a ratio)
A textual represention of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio.
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.