Generated Narrative: StructureDefinition clinical-use-definition-contraindication-uv-epi Language: en Name Flags Card. Type Description & Constraints ClinicalUseDefinition 0..* ClinicalUseDefinition A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure #xD; id 1..1 id Logical id of this artifact #xD; meta 1..1 Meta Metadata about the resource #xD; profile 1..* canonical(StructureDefinition) Profiles this resource claims to conform to #xD; identifier 1..* Identifier Business identifier for this issue #xD; system 1..1 uri The namespace for the identifier value #xD; value 1..1 string The value that is unique #xD; type 1..1 code indication | contraindication | interaction | undesirable-effect | warning Fixed Value: contraindication #xD; category 1..* CodeableConcept A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" #xD; subject 1..* Reference(MedicinalProductDefinition (ePI)) The medication, product, substance, device, procedure etc. for which this is an indication #xD; status 1..1 CodeableConcept Whether this is a current issue or one that has been retired etc #xD; contraindication 1..1 BackboneElement Specifics for when this is a contraindication #xD; diseaseSymptomProcedure 0..1 CodeableReference(ObservationDefinition) The situation that is being documented as contraindicating against this item #xD; diseaseStatus 0..1 CodeableReference(ObservationDefinition) The status of the disease or symptom for the contraindication #xD; comorbidity 0..* CodeableReference(ObservationDefinition) A comorbidity (concurrent condition) or coinfection #xD; indication 0..* Reference(ClinicalUseDefinition) The indication which this is a contraidication for #xD; applicability 0..1 Expression An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements #xD; otherTherapy 0..* BackboneElement Information about use of the product in relation to other therapies described as part of the contraindication #xD; relationshipType 1..1 CodeableConcept The type of relationship between the product indication/contraindication and another therapy #xD; treatment 1..1 CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition) Reference to a specific medication, substance etc. as part of an indication or contraindication #xD; population 1..* Reference(Group) The population group to which this applies #xD; Documentation for this format
ClinicalUseDefinition Contraindication (ePI)
HL7 International - Biomedical Research & Regulation Work Group
ClinicalUseDefinition Contraindication (ePI) - Profile for Contraindication
A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.
Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance
(ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2
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
Contraindication, Therapeutic Indication, Interactions, Undesirable Effects
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())
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.
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
The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.
The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.
When the resource last changed - e.g. when the version changed.
This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a [read](http://hl7.org/fhir/R5/http.html#read) interaction.
Identifies where the resource comes from
A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](http://hl7.org/fhir/R5/provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.
The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.
Profiles this resource claims to conform to
A list of profiles (references to [StructureDefinition](http://hl7.org/fhir/R5/structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](http://hl7.org/fhir/R5/structuredefinition-definitions.html#StructureDefinition.url).
It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.
Security Labels applied to this resource
Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.
Security Labels from the Healthcare Privacy and Security Classification System.
Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.
The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.
Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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.
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.
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
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Allows users to make use of identifiers when the identifier system is not known.
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Identifier.system is always case sensitive.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
Role.effectiveTime or implied by context
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
indication | contraindication | interaction | undesirable-effect | warning
indication | contraindication | interaction | undesirable-effect | warning.
Overall defining type of this clinical use definition.
(the type of IDMP class, out of Contraindication, Therapeutic Indication, Interactions, Undesirable Effects)
A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines".
A categorisation for a clinical use information item.
The medication, product, substance, device, procedure etc. for which this is an indication
The medication, product, substance, device, procedure etc. for which this is an indication.
(the link between the IDMP class and Medicinal Product)
Whether this is a current issue or one that has been retired etc
Whether this is a current issue or one that has been retired etc.
Specifics for when this is a contraindication
Specifics for when this is a contraindication.
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 situation that is being documented as contraindicating against this item
The situation that is being documented as contraindicating against this item.
Contraindication.Contraindications as "Disease / Symptom / Procedure" and Contraindication.Contraindications Text
The status of the disease or symptom for the contraindication
The status of the disease or symptom for the contraindication, for example "chronic" or "metastatic".
A comorbidity (concurrent condition) or coinfection
A comorbidity (concurrent condition) or coinfection.
The indication which this is a contraidication for
The indication which this is a contraidication for.
(the link from Contraindication to Therapeutic Indication)
An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements.
The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.
Information about use of the product in relation to other therapies described as part of the contraindication
Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.
Contraindication.Other Therapy Specifics
The type of relationship between the product indication/contraindication and another therapy
The type of relationship between the medicinal product indication or contraindication and another therapy.
Classification of relationship between a therapy and a contraindication or an indication.
Other Therapy Specifics.Therapy Relationship Type
Reference to a specific medication, substance etc. as part of an indication or contraindication
Reference to a specific medication (active substance, medicinal product or class of products, biological, food etc.) as part of an indication or contraindication.
Specifics for when this is an indication
Specifics for when this is an indication.
The situation that is being documented as an indicaton for this item
The situation that is being documented as an indicaton for this item.
Therapeutic Indication.Indication as "Disease / Symptom / Procedure", and Therapeutic Indication.Indication Text
The status of the disease or symptom for the indication
The status of the disease or symptom for the indication, for example "chronic" or "metastatic".
A comorbidity or coinfection as part of the indication
A comorbidity (concurrent condition) or coinfection as part of the indication.
The intended effect, aim or strategy to be achieved
The intended effect, aim or strategy to be achieved.
Timing or duration information, that may be associated with use with the indicated condition e.g. Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months).
Therapeutic Indication.Timing / Duration
An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
An unwanted side effect or negative outcome that may happen if you use the drug (or other subject of this resource) for this indication.
Therapeutic Indication.Undesirable Effects
The use of the medicinal product in relation to other therapies described as part of the indication
Information about the use of the medicinal product in relation to other therapies described as part of the indication.
Therapeutic Indication.Other Therapy Specifics
Specifics for when this is an interaction
Specifics for when this is an interaction.
The specific medication, product, food etc. or laboratory test that interacts
The specific medication, product, food, substance etc. or laboratory test that interacts.
Interactions.Interactant and Interactions.Interactions Text
An interactant - a substance that may have a clinically significant effect on another.
The type of the interaction e.g. drug-drug interaction, drug-lab test interaction
The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction.
A categorisation for an interaction between two substances.
The effect of the interaction, for example "reduced gastric absorption of primary medication"
The effect of the interaction, for example "reduced gastric absorption of primary medication".
A interaction effect of clinical use of a medication or other substance.
The incidence of the interaction, e.g. theoretical, observed
The incidence of the interaction, e.g. theoretical, observed.
A categorisation for incidence of occurence of an interaction.
A type of management for an interaction of a medication or other substance.
The population group to which this applies
The population group to which this applies.
Logic used by the clinical use definition
Logic used by the clinical use definition.
A possible negative outcome from the use of this treatment
Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment.
The situation in which the undesirable effect may manifest
The situation in which the undesirable effect may manifest.
Undesirable Effects.Undesirable Effect as "Symptom / Condition / Effect"
High level classification of the effect.
A categorisation for an undesirable effect.
Undesirable Effects.Symptom / Condition / Effect Classification
A categorisation for a frequency of occurence of an undesirable effect.
Undesirable Effects.Frequency of Occurrence
Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness', or 'Get medical advice/attention if you feel unwell'.
A textual definition of this warning, with formatting
A textual definition of this warning, with formatting.
A coded or unformatted textual definition of this warning
A coded or unformatted textual definition of this warning.