Information about a specific adverse reaction event caused by exposure to a specific substance.

Purpose

To record information about a specific adverse reaction event caused by exposure to a specific substance.

Misuse

Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose.

Considerations

Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested.

This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate.

The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.

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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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.

The substance considered to be responsible for the specific adverse reaction event.

Considerations

For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.

The degree of clinical certainty that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Specific substance'.

Considerations

The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology.

Clinical symptoms and/or signs that are observed or associated with the adverse reaction.

Considerations

Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction' may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions.

Narrative description about the adverse reaction as a whole, including details of the manifestation if required.

The date and/or time of the onset of the reaction.

Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.

Considerations

It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.

Additional details about the adverse reaction.

Considerations

May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.

The date and/or time of the first exposure to the Substance for this Reaction Event.

Considerations

Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.

The route by which the subject was exposed to the identified 'Specific substance'.

Considerations

Coding of the Route of Exposure with a terminology should be used wherever possible.

Narrative description about the exposure to the identified 'Specific substance'.

Additional details about exposure to the 'Specific substance'.

Narrative description about the clinical management provided.

Additional structured details about clinical management for this reaction event.

Additional structured details required for reporting to regulatory bodies.

Details about the provenance of the information.

Considerations

This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.

Additional narrative about the adverse reaction event not captured in other fields.

Information about a specific adverse reaction event caused by exposure to a specific substance.

Purpose

To record information about a specific adverse reaction event caused by exposure to a specific substance.

Misuse

Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose.

Considerations

Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested.

This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate.

The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.

The substance considered to be responsible for the specific adverse reaction event.

Considerations

For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.

The degree of clinical certainty that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Specific substance'.

Considerations

The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology.

Clinical symptoms and/or signs that are observed or associated with the adverse reaction.

Considerations

Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction' may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions.

Narrative description about the adverse reaction as a whole, including details of the manifestation if required.

The date and/or time of the onset of the reaction.

Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.

Considerations

It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.

Additional details about the adverse reaction.

Considerations

May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.

The date and/or time of the first exposure to the Substance for this Reaction Event.

Considerations

Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.

The route by which the subject was exposed to the identified 'Specific substance'.

Considerations

Coding of the Route of Exposure with a terminology should be used wherever possible.

Narrative description about the exposure to the identified 'Specific substance'.

Additional details about exposure to the 'Specific substance'.

Narrative description about the clinical management provided.

Additional structured details about clinical management for this reaction event.

Additional structured details required for reporting to regulatory bodies.

Details about the provenance of the information.

Considerations

This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.

Additional narrative about the adverse reaction event not captured in other fields.

Information about a specific adverse reaction event caused by exposure to a specific substance.

Purpose

To record information about a specific adverse reaction event caused by exposure to a specific substance.

Misuse

Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose.

Considerations

Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested.

This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate.

The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.

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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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.

The substance considered to be responsible for the specific adverse reaction event.

Considerations

For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.

The degree of clinical certainty that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Specific substance'.

Considerations

The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology.

Clinical symptoms and/or signs that are observed or associated with the adverse reaction.

Considerations

Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction' may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions.

Narrative description about the adverse reaction as a whole, including details of the manifestation if required.

The date and/or time of the onset of the reaction.

Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.

Considerations

It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.

Additional details about the adverse reaction.

Considerations

May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.

The date and/or time of the first exposure to the Substance for this Reaction Event.

Considerations

Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.

The route by which the subject was exposed to the identified 'Specific substance'.

Considerations

Coding of the Route of Exposure with a terminology should be used wherever possible.

Narrative description about the exposure to the identified 'Specific substance'.

Additional details about exposure to the 'Specific substance'.

Narrative description about the clinical management provided.

Additional structured details about clinical management for this reaction event.

Additional structured details required for reporting to regulatory bodies.

Details about the provenance of the information.

Considerations

This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.

Additional narrative about the adverse reaction event not captured in other fields.