A summary or overview of a clinical assessment that identifies the potential for a harmful or undesirable physiological reaction unique to an individual and associated with exposure to a specific substance.

Purpose

To record:

• An assessment of the risk or propensity of a future adverse reaction if exposed, or re-exposed, to an identified substance.
• Evidence supporting the risk assessment, such as a summary of each exposure event or genomics test results.

Misuse

• Not to be used to record a diagnosis of an adverse reaction as the conclusion of a clinical consultation or investigation – use the Problem/Diagnosis data type for this purpose.
• Not to be used for recording predictable physiological reactions on exposure to physical agents or activities, such as heat, cold, sunlight, vibration, exercise, by infectious agents, or food contaminants.
• Not to be used to record adverse events, including failures of clinical processes, interventions, or products. For example, abnormal use, incorrect dosage or maladministration of an agent or substance, mislabelling, overdose, or poisoning.

Supporting Model(s)

• Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: https://ckm.openehr.org/ckm/archetypes/1013.1.7022

• Adverse reaction event, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: https://ckm.openehr.org/ckm/archetypes/1013.1.5795

• AllergyIntolerance, HL7 FHIR Resource [Internet]. Health Level Seven International; [cited: 2024 Feb 05]. Available from: https://hl7.org/fhir/R5/allergyintolerance.html.

• AllergyIntolerance, International Patient Summary Implementation Guide, [Internet]. HL7 International / Patient care; [cited: 2024 Feb 05]. Available from: https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html.

Considerations

• Substances include but are not limited to:
  • A therapeutic substance administered correctly at an appropriate dosage for the individual, including medications or vaccinations,
  • Food,
  • Material derived from plants or animals, or
  • Venom from insect stings.
• Manifestations include any symptom, sign, or diagnosis.
• It is also possible to record the absence of a reaction on re-exposure to a substance where an existing adverse reaction summary exists. This may trigger further investigation to confirm whether the previously assumed causal relationship to the substance is correct or mistaken.
• This data group is intended to provide a single place within the health record to document the propensity for the full range of adverse reactions, from trivial to life-threatening, irrespective of the underlying physical mechanism. This includes but is not limited to:
  • Immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or
  • Non-immune-mediated: such as pseudo-allergic reactions, side effects, intolerances, and drug toxicities in individuals with impaired excretion.
• In Release 1, all adverse reactions are assumed active in the context of a summary for exchange.
• In future updates, it is anticipated this data group will be extended to incorporate additional detail.

@ internal @

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 date when this 'Adverse reaction risk summary' data group was last updated.

Considerations

For example: • 7 February 2015 • 7 February 2015, 1:28 pm • 2015-02-07T13:28:17-05:00

Additional information required to capture local content or to align with other reference models/formalisms.

Considerations

For example: local information requirements or additional metadata to align with FHIR equivalents.

@ internal @

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.

Identification of a specific substance, compounded product, combination therapy product, or class of substances that is considered to have a causal link to the adverse reaction.

Considerations

In this context, appropriate values for ‘Substance name’ include, but are not limited to:

• A therapeutic substance administered correctly at an appropriate dosage for the individual,
• Food,
• Material derived from plants or animals,
• Venom from insect stings, and
• Physical objects commonly recorded as the proxy for a substance, such as Band-Aids or surgical tape.

It is strongly recommended that ‘Substance name’ be coded with a terminology capable of triggering decision support, where possible. Free text entry should only be permitted if no appropriate terminology is available.

Example

AMT provides concepts at various granularities from brand to specific substance:

• TP: 3738011000036101|Amoxil|
• TPUU: 4542011000036104|Amoxil Forte Sugar Free oral liquid|
• MP: 27658006| Product containing amoxicillin|
• MP: 831021000168104 |measles + mumps + rubella live vaccine|

Note: The above examples reflect the future state of AMT, v4.

Specific substances and non-medicinal substances from SCT-AU:

• 372687004| Amoxicillin|
• 764147003 |Cephalosporin|
• 111088007 | Latex |
• 256259004 | Pollen |
• 762952008| Peanut |
• 1222501000168103 | Vegemite |
• 348608005 | Surgical adhesive tape |
• ‘Band-Aid’

Status about whether the adverse reaction risk statement is active or inactive.

Assertion about the certainty of the propensity, or potential future risk, of the identified 'Substance' to cause a reaction.

Considerations

Decision support would typically raise alerts for 'Unconfirmed' and 'Confirmed', and ignore a 'Refuted' reaction. Clinical systems may choose not to display Adverse reaction entries with a 'Refuted' status in the Adverse Reaction List. However, 'Refuted' may be useful for reconciliation of the adverse reaction list or when communicating between systems. Some implementations may choose to make this field mandatory. 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.

An indication of the potential for critical system organ damage or life threatening consequence.

Considerations

This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value.

Category of the identified 'Substance'.

Considerations

This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation.

The date and/or time of the onset of the last known occurrence of a reaction event.

Considerations

For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.

The onset of the first known occurrence of a reaction event.

Considerations

For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.

Identification of the underlying physiological mechanism for the adverse reaction.

Considerations

Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk.

Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity.

It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute.

Summary details about each adverse reaction event linked to exposure to the identified 'Substance'.

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

Considerations

For example: instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover.

@ internal @

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.

A summary or overview of a clinical assessment that identifies the potential for a harmful or undesirable physiological reaction unique to an individual and associated with exposure to a specific substance.

Purpose

To record:

• An assessment of the risk or propensity of a future adverse reaction if exposed, or re-exposed, to an identified substance.
• Evidence supporting the risk assessment, such as a summary of each exposure event or genomics test results.

Misuse

• Not to be used to record a diagnosis of an adverse reaction as the conclusion of a clinical consultation or investigation – use the Problem/Diagnosis data type for this purpose.
• Not to be used for recording predictable physiological reactions on exposure to physical agents or activities, such as heat, cold, sunlight, vibration, exercise, by infectious agents, or food contaminants.
• Not to be used to record adverse events, including failures of clinical processes, interventions, or products. For example, abnormal use, incorrect dosage or maladministration of an agent or substance, mislabelling, overdose, or poisoning.

Supporting Model(s)

• Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: https://ckm.openehr.org/ckm/archetypes/1013.1.7022

• Adverse reaction event, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: https://ckm.openehr.org/ckm/archetypes/1013.1.5795

• AllergyIntolerance, HL7 FHIR Resource [Internet]. Health Level Seven International; [cited: 2024 Feb 05]. Available from: https://hl7.org/fhir/R5/allergyintolerance.html.

• AllergyIntolerance, International Patient Summary Implementation Guide, [Internet]. HL7 International / Patient care; [cited: 2024 Feb 05]. Available from: https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html.

Considerations

• Substances include but are not limited to:
  • A therapeutic substance administered correctly at an appropriate dosage for the individual, including medications or vaccinations,
  • Food,
  • Material derived from plants or animals, or
  • Venom from insect stings.
• Manifestations include any symptom, sign, or diagnosis.
• It is also possible to record the absence of a reaction on re-exposure to a substance where an existing adverse reaction summary exists. This may trigger further investigation to confirm whether the previously assumed causal relationship to the substance is correct or mistaken.
• This data group is intended to provide a single place within the health record to document the propensity for the full range of adverse reactions, from trivial to life-threatening, irrespective of the underlying physical mechanism. This includes but is not limited to:
  • Immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or
  • Non-immune-mediated: such as pseudo-allergic reactions, side effects, intolerances, and drug toxicities in individuals with impaired excretion.
• In Release 1, all adverse reactions are assumed active in the context of a summary for exchange.
• In future updates, it is anticipated this data group will be extended to incorporate additional detail.

@ internal @

Identification of a specific substance, compounded product, combination therapy product, or class of substances that is considered to have a causal link to the adverse reaction.

Considerations

In this context, appropriate values for ‘Substance name’ include, but are not limited to:

• A therapeutic substance administered correctly at an appropriate dosage for the individual,
• Food,
• Material derived from plants or animals,
• Venom from insect stings, and
• Physical objects commonly recorded as the proxy for a substance, such as Band-Aids or surgical tape.

It is strongly recommended that ‘Substance name’ be coded with a terminology capable of triggering decision support, where possible. Free text entry should only be permitted if no appropriate terminology is available.

Example

AMT provides concepts at various granularities from brand to specific substance:

• TP: 3738011000036101|Amoxil|
• TPUU: 4542011000036104|Amoxil Forte Sugar Free oral liquid|
• MP: 27658006| Product containing amoxicillin|
• MP: 831021000168104 |measles + mumps + rubella live vaccine|

Note: The above examples reflect the future state of AMT, v4.

Specific substances and non-medicinal substances from SCT-AU:

• 372687004| Amoxicillin|
• 764147003 |Cephalosporin|
• 111088007 | Latex |
• 256259004 | Pollen |
• 762952008| Peanut |
• 1222501000168103 | Vegemite |
• 348608005 | Surgical adhesive tape |
• ‘Band-Aid’

Status about whether the adverse reaction risk statement is active or inactive.

Assertion about the certainty of the propensity, or potential future risk, of the identified 'Substance' to cause a reaction.

Considerations

Decision support would typically raise alerts for 'Unconfirmed' and 'Confirmed', and ignore a 'Refuted' reaction. Clinical systems may choose not to display Adverse reaction entries with a 'Refuted' status in the Adverse Reaction List. However, 'Refuted' may be useful for reconciliation of the adverse reaction list or when communicating between systems. Some implementations may choose to make this field mandatory. 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.

Category of the identified 'Substance'.

Considerations

This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation.

An indication of the potential for critical system organ damage or life threatening consequence.

Considerations

This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value.

The date and/or time of the onset of the last known occurrence of a reaction event.

Considerations

For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.

The onset of the first known occurrence of a reaction event.

Considerations

For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.

Identification of the underlying physiological mechanism for the adverse reaction.

Considerations

Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk.

Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity.

It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute.

Summary details about each adverse reaction event linked to exposure to the identified 'Substance'.

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

Considerations

For example: instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover.

@ internal @

The date when this 'Adverse reaction risk summary' data group was last updated.

Considerations

For example: • 7 February 2015 • 7 February 2015, 1:28 pm • 2015-02-07T13:28:17-05:00

Additional information required to capture local content or to align with other reference models/formalisms.

Considerations

For example: local information requirements or additional metadata to align with FHIR equivalents.

A summary or overview of a clinical assessment that identifies the potential for a harmful or undesirable physiological reaction unique to an individual and associated with exposure to a specific substance.

Purpose

To record:

• An assessment of the risk or propensity of a future adverse reaction if exposed, or re-exposed, to an identified substance.
• Evidence supporting the risk assessment, such as a summary of each exposure event or genomics test results.

Misuse

• Not to be used to record a diagnosis of an adverse reaction as the conclusion of a clinical consultation or investigation – use the Problem/Diagnosis data type for this purpose.
• Not to be used for recording predictable physiological reactions on exposure to physical agents or activities, such as heat, cold, sunlight, vibration, exercise, by infectious agents, or food contaminants.
• Not to be used to record adverse events, including failures of clinical processes, interventions, or products. For example, abnormal use, incorrect dosage or maladministration of an agent or substance, mislabelling, overdose, or poisoning.

Supporting Model(s)

• Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: https://ckm.openehr.org/ckm/archetypes/1013.1.7022

• Adverse reaction event, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2024 Feb 05]. Available from: https://ckm.openehr.org/ckm/archetypes/1013.1.5795

• AllergyIntolerance, HL7 FHIR Resource [Internet]. Health Level Seven International; [cited: 2024 Feb 05]. Available from: https://hl7.org/fhir/R5/allergyintolerance.html.

• AllergyIntolerance, International Patient Summary Implementation Guide, [Internet]. HL7 International / Patient care; [cited: 2024 Feb 05]. Available from: https://build.fhir.org/ig/HL7/fhir-ips/StructureDefinition-AllergyIntolerance-uv-ips.html.

Considerations

• Substances include but are not limited to:
  • A therapeutic substance administered correctly at an appropriate dosage for the individual, including medications or vaccinations,
  • Food,
  • Material derived from plants or animals, or
  • Venom from insect stings.
• Manifestations include any symptom, sign, or diagnosis.
• It is also possible to record the absence of a reaction on re-exposure to a substance where an existing adverse reaction summary exists. This may trigger further investigation to confirm whether the previously assumed causal relationship to the substance is correct or mistaken.
• This data group is intended to provide a single place within the health record to document the propensity for the full range of adverse reactions, from trivial to life-threatening, irrespective of the underlying physical mechanism. This includes but is not limited to:
  • Immune-mediated: Types I-IV (including allergic reactions and hypersensitivities); or
  • Non-immune-mediated: such as pseudo-allergic reactions, side effects, intolerances, and drug toxicities in individuals with impaired excretion.
• In Release 1, all adverse reactions are assumed active in the context of a summary for exchange.
• In future updates, it is anticipated this data group will be extended to incorporate additional detail.

@ internal @

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 date when this 'Adverse reaction risk summary' data group was last updated.

Considerations

For example: • 7 February 2015 • 7 February 2015, 1:28 pm • 2015-02-07T13:28:17-05:00

Additional information required to capture local content or to align with other reference models/formalisms.

Considerations

For example: local information requirements or additional metadata to align with FHIR equivalents.

@ internal @

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.

Identification of a specific substance, compounded product, combination therapy product, or class of substances that is considered to have a causal link to the adverse reaction.

Considerations

In this context, appropriate values for ‘Substance name’ include, but are not limited to:

• A therapeutic substance administered correctly at an appropriate dosage for the individual,
• Food,
• Material derived from plants or animals,
• Venom from insect stings, and
• Physical objects commonly recorded as the proxy for a substance, such as Band-Aids or surgical tape.

It is strongly recommended that ‘Substance name’ be coded with a terminology capable of triggering decision support, where possible. Free text entry should only be permitted if no appropriate terminology is available.

Example

AMT provides concepts at various granularities from brand to specific substance:

• TP: 3738011000036101|Amoxil|
• TPUU: 4542011000036104|Amoxil Forte Sugar Free oral liquid|
• MP: 27658006| Product containing amoxicillin|
• MP: 831021000168104 |measles + mumps + rubella live vaccine|

Note: The above examples reflect the future state of AMT, v4.

Specific substances and non-medicinal substances from SCT-AU:

• 372687004| Amoxicillin|
• 764147003 |Cephalosporin|
• 111088007 | Latex |
• 256259004 | Pollen |
• 762952008| Peanut |
• 1222501000168103 | Vegemite |
• 348608005 | Surgical adhesive tape |
• ‘Band-Aid’

Status about whether the adverse reaction risk statement is active or inactive.

Assertion about the certainty of the propensity, or potential future risk, of the identified 'Substance' to cause a reaction.

Considerations

Decision support would typically raise alerts for 'Unconfirmed' and 'Confirmed', and ignore a 'Refuted' reaction. Clinical systems may choose not to display Adverse reaction entries with a 'Refuted' status in the Adverse Reaction List. However, 'Refuted' may be useful for reconciliation of the adverse reaction list or when communicating between systems. Some implementations may choose to make this field mandatory. 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.

An indication of the potential for critical system organ damage or life threatening consequence.

Considerations

This can be regarded as a predictive judgement of a 'worst case scenario'. In most contexts 'Low' would be regarded as the default value.

Category of the identified 'Substance'.

Considerations

This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the Substance where coding systems are used, and is effectively redundant in that situation.

The date and/or time of the onset of the last known occurrence of a reaction event.

Considerations

For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.

The onset of the first known occurrence of a reaction event.

Considerations

For example: the actual date and/or time of onset; the interval of time during which the onset occurred; the age of the individual at the time of the onset; or the duration of time since the onset occurred. A partial date is valid, using the DV_DATE_TIME data type, to record only a year.

Identification of the underlying physiological mechanism for the adverse reaction.

Considerations

Immune-mediated responses have been traditionally regarded as an indicator for escalation of significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune are actually non-immune and still carry life threatening risk.

Immunological testing may provide supporting evidence for the mechanism and causative substance , but no tests are 100% sensitive or specific for a sensitivity.

It is acknowledged that most clinicians will NOT be able to distinguish the mechanism of any specific reaction. However this data element is included because many legacy systems have captured this attribute.

Summary details about each adverse reaction event linked to exposure to the identified 'Substance'.

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

Considerations

For example: instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover.

@ internal @

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.