Name Flags Card. Type Description & Constraints SubstanceDefinition 0..* SubstanceDefinition The detailed description of a substance, typically at a level beyond what is used for prescribing grade S 0..* CodeableConcept The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP) informationSource S 0..* Reference(Citation) Supporting literature manufacturer S 0..* Reference(Organization - Drug PQ) The entity that creates, makes, produces or fabricates the substance Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url site-utilization S 0..* Coding site-utilization URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-site-utilization-pq Binding: Product Site Utilization (example) property S 0..* BackboneElement General specifications for this substance Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url substance-property-range S 0..* Range substance-property-range URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq substance-property-parameter S 0..* (Complex) substance-property-parameter URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-parameter-pq type S 1..1 CodeableConcept A code expressing the type of property Binding: Substance Property (example) value[x] S 0..1 CodeableConcept, Quantity, date, boolean, Attachment A value for the property Binding: Substance Property Value (example) name S 0..* BackboneElement Names applicable to this substance relationship S 0..* BackboneElement A link between this substance and another Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url impurity-origin S 0..* CodeableConcept impurity-origin URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-impurity-origin-pq Binding: Impurity Origins (example) type S 1..1 CodeableConcept For example "salt to parent", "active moiety" Binding: Impurity Types (example) sourceMaterial S 0..1 BackboneElement Material or taxonomic/anatomical source Documentation for this format
SubstanceDefinition - Component Substance Drug PQ
HL7 International / Biomedical Research and Regulation
HL7 International - Biomedical Research and Regulation
This SubstanceDefinition profile represents the chemical or biological details about a substance associated with an active ingredient (molecular weight, molecular formula, stereochemistry, protein or nucleic acid subunits).
The detailed description of a substance, typically at a level beyond what is used for prescribing
The detailed description of a substance, typically at a level beyond what is used for prescribing.
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
Substance (and derived classes: Chemical, Polymer, Protein, Nucleic_Acid, Structurally_Diverse)
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.
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
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).
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
Identifier by which this substance is known
Identifier by which this substance is known.
A business level version identifier of the substance
A business level version identifier of the substance.
Status of substance within the catalogue e.g. active, retired
Status of substance within the catalogue e.g. active, retired.
A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity
A high level categorization, e.g. polymer or nucleic acid, or food, chemical, biological, or a lower level such as the general types of polymer (linear or branch chain) or type of impurity (process related or contaminant).
Substance_Classification.Substance_Classification and Substance_classification.Substance_Classification_Subtype
If the substance applies to human or veterinary use
If the substance applies to human or veterinary use.
Applicable domain for this product (e.g. human, veterinary).
Substance_Classification.Substance_Classification (and Code and Type) and Substance_Classification.Substance_Classification_Subtype
The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
The quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard).
The quality standard, established benchmark, to which a substance complies
Textual comment about the substance's catalogue or registry record
Textual comment about the substance's catalogue or registry record.
The entity that creates, makes, produces or fabricates the substance
The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive.
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
Literal reference, Relative, internal or absolute URL
A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.
Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.
Type the reference refers to (e.g. "Patient") - must be a resource in resources
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Aa resource (or, for logical models, the URI of the logical model).
Logical reference, when literal reference is not known
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.
When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any). This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Plain text narrative that identifies the resource in addition to the resource reference.
This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.
An entity that is the source for the substance. It may be different from the manufacturer
An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor.
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 are expected to modify the meaning or interpretation of the element that contains them
Identifier by which this moiety substance is known
Identifier by which this moiety substance is known.
The optical rotation type of a substance.
Molecular formula for this moiety (e.g. with the Hill system)
Molecular formula for this moiety of this substance, typically using the Hill system.
The measurement type of the quantitative value
The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio.
The relationship between two substance types.
General specifications for this substance
General specifications for this substance.
The method used to find the characterization e.g. HPLC
The method used to elucidate the characterization of the drug substance. Example: HPLC.
The method used to elucidate the characterization of the drug substance.
Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form.
The description or justification in support of the interpretation of the data file
The description or justification in support of the interpretation of the data file.
The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis
The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis.
Physical Characteristics, attribute's value
General information detailing this substance
General information detailing this substance.
The average mass of a molecule of a compound
The average mass of a molecule of a compound compared to 1/12 the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms.
The method by which the weight was determined
The method by which the molecular weight was determined.
The method by which the substance weight was measured.
Type of molecular weight e.g. exact, average, weight average
Type of molecular weight such as exact, average (also known as. number average), weight average.
The type of substance weight measurement.
Used to capture quantitative values for a variety of elements
Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field.
An expression which states the number and type of atoms present in a molecule of a substance
An expression which states the number and type of atoms present in a molecule of a substance.
Specified per moiety according to the Hill system
Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot.
The molecular weight or weight range (for proteins, polymers or nucleic acids).
The method used to find the structure e.g. X-ray, NMR
The method used to elucidate the structure of the drug substance. Examples: X-ray, NMR, Peptide mapping, Ligand binding assay.
The method used to elucidate the structure of the drug substance.
The source of information about the structure.
A depiction of the structure of the substance
A depiction of the structure of the substance.
The kind of structural representation (e.g. full, partial)
The kind of structural representation (e.g. full, partial).
The structural representation as a text string in a standard format
The structural representation as a text string in a standard format.
The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.
An attachment with the structural representation e.g. a structure graphic or AnIML file
An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.
Substance_Code.Code, Substance_Code.Code_System, Substance_Code.Code_System_Id
Status of the code assignment, for example 'provisional', 'approved'
Status of the code assignment, for example 'provisional', 'approved'.
The date at which the code status was changed
The date at which the code status was changed as part of the terminology maintenance.
Any comment can be provided in this field
Any comment can be provided in this field, if necessary.
Name type e.g. 'systematic', 'scientific, 'brand'
Name type, for example 'systematic', 'scientific, 'brand'.
The type of a name given to a substance.
The status of the name e.g. 'current', 'proposed'
The status of the name, for example 'current', 'proposed'.
If this is the preferred name for this substance
If this is the preferred name for this substance.
If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
Human language that the name is written in
Human language that the name is written in.
The use context of this name e.g. as an active ingredient or as a food colour additive
The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.
The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.
The jurisdiction where this name applies
The jurisdiction where this name applies.
A synonym of this particular name, by which the substance is also known
A synonym of this particular name, by which the substance is also known.
A translation for this name into another human language
A translation for this name into another human language.
Details of the official nature of this name
Details of the official nature of this name.
Which authority uses this official name.
An authority that officates substance names.
The status of the official name, for example 'draft', 'active'
The status of the official name, for example 'draft', 'active', 'retired'.
A link between this substance and another
A link between this substance and another, with details of the relationship.
A pointer to another substance, as a resource or a representational code
A pointer to another substance, as a resource or just a representational code.
For example "salt to parent", "active moiety"
For example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of".
For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.
If this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made
A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.
For use when the numeric has an uncertain range
For use when the numeric has an uncertain range.
An operator for the amount, for example "average", "approximately", "less than"
An operator for the amount, for example "average", "approximately", "less than".
(used to add specifics of Nucleic Acids to Substances)
(used to add specifics of Polymers to Substances)
(used to add specifics of Proteins to Substances)
Material or taxonomic/anatomical source for the substance.
Classification of the origin of the raw material. e.g. cat hair is an Animal source type
A classification that provides the origin of the raw material. Example: cat hair would be an Animal source type.
A classification that provides the origin of the substance raw material.
The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.
The species of an organism e.g. the Latin epithet of the species of the plant/animal
The species of an organism, typically referring to the Latin epithet of the species of the plant/animal.
A species of origin a substance raw material.
An anatomical origin of the source material within an organism
An anatomical origin of the source material within an organism.
The country or countries where the material is harvested
The country or countries where the material is harvested.