Risk of harmful or undesirable, physiological response which is unique to an individual and associated with exposure to a substance.

Substances 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; or venom from insect stings.

Optional Extensions Element - found in all resources.

This records identifiers associated with this allergy/intolerance concern that are defined by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate (e.g. in CDA documents, or in written / printed documentation).

The portion of the identifier typically displayed 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.

Record of the date and/or time of the onset of the Allergy or Intolerance.

Date when the sensitivity was recorded.

Individual who recorded the record and takes responsibility for its conten.

The patient who has the allergy or intolerance.

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.

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.

Identification of a substance, or a class of substances, that is considered to be responsible for the adverse reaction risk.

It is strongly recommended that the substance be coded with a terminology, where possible. For example, some terminologies used include RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, IDC-10, UNI, ATC and CPT. Plain text should only be used if there is no appropriate terminology available. Additional details about a substance can be specified in the text.

A reference to a code defined by a terminology system.

Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labelled as UserSelected = true.

The identification of the code system that defines the meaning of the symbol in the code.

Need to be unambiguous about the source of the definition of the symbol.

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Need to refer to a particular code in the system.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Very often the text is the same as a displayName of one of the codings.

Assertion about certainty associated with the propensity, or potential risk, of a reaction to the identified Substance.

Decision support would typically raise alerts for 'Unconfirmed', 'Confirmed', and 'Resolved' and ignore a 'Refuted' reaction. In particular, 'Refuted' may be useful for reconciliation of the Adverse Reaction List. Some implementations may choose to make this field mandatory.

Estimate of the potential clinical harm, or seriousness, of the reaction to the identified Substance.

The default criticality value for any propensity to an adverse reaction should be 'Low Risk', indicating at the very least a relative contraindication to deliberate or voluntary exposure to the Substance. 'High Risk' is flagged if the clinician has identified a propensity for a more serious or potentially life-threatening reaction, such as anaphylaxis, and implies an absolute contraindication to deliberate or voluntary exposure to the substance. If this element is missing, the criticality is unknown (though it may be known elsewhere).

Identification of the underlying physiological mechanism for the reaction risk.

Allergic (typically immune-mediated) reactions have been traditionally regarded as an indicator for potential escalation to significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune-mediated are, in fact, non-immune, but in some cases can still pose a life threatening risk. It is acknowledged that many clinicians may not be in a position to distinguish the mechanism of a particular reaction. Often the term "allergy" is used rather generically and may overlap with the use of "intolerance" - in practice the boundaries between these two concepts may not be well-defined or understood. This data element is included nevertheless, because many legacy systems have captured this attribute. Immunologic testing may provide supporting evidence for the basis of the reaction and the causative substance, but no tests are 100% sensitive or specific for sensitivity to a particular substance. If, as is commonly the case, it is unclear whether the reaction is due to an allergy or an intolerance, then the type element should be omitted from the resource.

Category of the identified Substance.

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.

Additional narrative about the propensity for the Adverse Reaction, not captured in other fields.

For example: including reason for flagging a seriousness of 'High Risk'; and instructions related to future exposure or administration of the Substance, such as administration within an Intensive Care Unit or under corticosteroid cover. The notes should be related to an allergy or intolerance as a condition in general and not related to any particular episode of it. For episode notes and descriptions, use AllergyIntolerance.event.description and AllergyIntolerance.event.notes.

The text of the annotation.

Details about each adverse reaction event linked to exposure to the identified Substance.

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 that contains it. Usually modifier elements provide negation or qualification. In order 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 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.

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.

Identification of the specific substance considered to be responsible for the Adverse Reaction event. Note: the substance for a specific reaction may be different to the substance identified as the cause of the risk, but must be consistent with it. For instance, it may be a more specific substance (e.g. a brand medication) or a composite substance that includes the identified substance. It must be clinically safe to only process the AllergyIntolerance.substance and ignore the AllergyIntolerance.event.substance.

Coding of the specific substance with a terminology capable of triggering decision support should be used wherever possible. The substance field allows for the use of a specific substance or a group or class of substances, for example "Penicillins". The specific substance field could be used for Amoxycillin. Duplication is acceptable when a specific substance has been recorded in the 'substance' field.

A reference to a code defined by a terminology system.

Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labelled as UserSelected = true.

The identification of the code system that defines the meaning of the symbol in the code.

Need to be unambiguous about the source of the definition of the symbol.

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Need to refer to a particular code in the system.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Very often the text is the same as a displayName of one of the codings.

Statement about the degree of clinical certainty that the specific substance was the cause of the manifestation in this reaction event.

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

Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash or no reaction. 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, as recommended in the UK NHS CUI guidelines. Terminologies commonly used include, but are not limited to, SNOMED CT or ICD10.

A reference to a code defined by a terminology system.

Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labelled as UserSelected = true.

The identification of the code system that defines the meaning of the symbol in the code.

Need to be unambiguous about the source of the definition of the symbol.

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Need to refer to a particular code in the system.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Very often the text is the same as a displayName of one of the codings.

Record of 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.

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 as extensions.

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

Use this field to record information indirectly related to a particular event and not captured in the description. For example: Clinical records are no longer available, recorded based on information provided to the patient by her mother and her mother is deceased.

The text of the annotation.