This
page
is
part
of
the
FHIR
Specification
(v3.0.2:
STU
(v5.0.0-ballot:
R5
Ballot
-
see
ballot
notes
3).
).
The
current
version
which
supercedes
this
version
is
5.0.0
.
For
a
full
list
of
available
versions,
see
the
Directory
of
published
versions
.
Page
versions:
R5
R4B
R4
R3
R2
Work
Group
|
Maturity
Level
:
|
Trial
Use
|
Security Category : Patient | Compartments : Patient , Practitioner , RelatedPerson |
Raw
Risk of harmful or undesirable physiological response which is specific to an individual and associated with exposure to a substance.
A record of a clinical assessment of an allergy or intolerance; a propensity, or a potential risk to an individual, to have an adverse reaction on future exposure to the specified substance, or class of substance.
Where a propensity is identified, to record information or evidence about a reaction event that is characterized by any harmful or undesirable physiological response that is specific to the individual and triggered by exposure of an individual to the identified substance or class of 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.
Note for Reviewers
Presently open issues for this resource:
This resource is used to provide a single place within the health record to document a range of clinical statements about adverse reactions to substances/products, including:
Use to record information about the positive presence of the risk of an adverse reaction:
Use to record information about adverse reactions to a broad range of substances, including: biological & blood products; incipients and excipients in medicinal preparations; foods; metal salts; and organic chemical compounds.
Adverse reactions may be:
In clinical practice distinguishing between allergy and intolerance is difficult and might not be practical. Often the term "allergy" is used rather generically and may overlap with "intolerance", and the boundaries between these concepts might not be well-defined or understood. As noted above, the term "intolerance" should generally be applied to a propensity for adverse reactions which is either determined (to the extent that is possible) or perceived to not be allergic or "allergy-like". If it is not possible to determine whether a particular propensity condition is an allergy or an intolerance, then the type element should be omitted from the resource. Identification of the type of reaction is not a proxy for seriousness or risk of harm to the patient, which is better expressed in the documentation of the clinical manifestation and the assessment of criticality.
The sensitivity in the case of either an allergy or intolerance is unique to the individual, and is distinguished from those reactions that are a property of the circumstance, such as toxicity of a food or drug, overdose, drug-drug, drug-food, or drug-disease interaction (which are reactions that would be expected to occur for any individual given the same circumstances).
The risk of an adverse reaction event or manifestation should not be recorded without identifying a proposed causative substance (including pharmaceutical products) or class of substance. If there is uncertainty that a specific substance is the cause, this uncertainty can be recorded using the 'verificationStatus' data element. If there are multiple possible substances that may have caused a reaction/manifestation, each substance should be recorded using a separate instance of this resource with the 'verificationStatus' set to an initial state of 'unconfirmed' so that adverse reaction checking can be supported in clinical systems. If a substance, agent or class is later proven not to be the cause for a given reaction then the 'verificationStatus' can be modified to 'refuted'.
This resource has been designed to allow recording of information about a specific substance (e.g., amoxicillin, oysters, or bee sting venom) or pharmaceutical product or, alternatively, a class of substance (e.g., penicillins). If a class of substance is recorded, then identification of the exact substance can be recorded on a per exposure basis.
The scope of this FHIR resource has deliberately focused on identifying a pragmatic data set that is used in most clinical systems or will be suitable for most common clinical scenarios; extensions can be used to add additional detail if required. Examples of clinical situations where the extension may be required include: a detailed allergist/immunologist assessment, for reporting to regulatory bodies or use in a clinical trial.
The act of recording any adverse reaction in a health record involves the clinical assessment that a potential hazard exists for an individual if they are exposed to the same substance/product/class in the future - that is, a relative contraindication - and, in the absence of additional information indicating a higher level of potential risk, the default 'criticality' value should be set to 'Low Risk'. If a clinician considers that it is not safe for the individual to be deliberately re-exposed to the substance/product again, for example, following a manifestation of a life-threatening anaphylaxis, then the 'criticality' data element should be amended to 'High Risk'.
A formal adverse event report to regulatory bodies is a document that will contain a broad range of information in addition to the specific details about the adverse reaction. The report could utilize parts of this resource plus include additional data as required per jurisdiction.
An adverse reaction or allergy/intolerance list is a record of all identified propensities for an adverse reaction for the individual upon future exposure to the substance/product or class, plus provides potential access to the evidence provided by details about each reaction event, such as manifestation.
Valuable first-level information that could be presented to the clinician when they need to assess propensity for future reactions are:
Second-level information can be drawn from each exposure event and links to additional detailed information such as history, examination and diagnoses stored elsewhere in the record, if it is available.
AllergyIntolerance and RiskAssessment
AllergyIntolerance describes a specific type of risk - propensity to reaction to a substance/product while RiskAssessment describes general risks to a subject, not generally based on a reaction.
AllergyIntolerance and Immunization.reaction
Immunization.reaction may be an indication of an allergy or intolerance. If this is deemed to be the case, a separate AllergyIntolerance record should be created to indicate it, as most systems will not query against past immunization.reactions.
Misuse
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
![]() |
|---|---|---|---|---|
![]() | TU | DomainResource |
Allergy
or
Intolerance
(generally:
Risk
of
adverse
reaction
to
a
substance)
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension | |
![]() ![]() | Σ | 0..* | Identifier |
External
ids
for
this
item
|
![]() ![]() | ?! Σ | 0..1 | CodeableConcept |
active
|
inactive
|
resolved
AllergyIntolerance Clinical Status Codes ( |
![]() ![]() | ?! Σ | 0..1 | CodeableConcept |
unconfirmed
|
presumed
|
confirmed
|
refuted
|
entered-in-error
AllergyIntolerance Verification Status ( Required ) |
![]() ![]() | Σ TU | 0..1 | code |
allergy
|
intolerance
-
Underlying
mechanism
(if
known)
AllergyIntoleranceType ( Required ) |
![]() ![]() | Σ | 0..* | code |
food
|
medication
|
environment
|
biologic
AllergyIntoleranceCategory ( Required ) |
![]() ![]() | Σ | 0..1 | code |
low
|
high
|
unable-to-assess
AllergyIntoleranceCriticality ( Required ) |
![]() ![]() | Σ | 0..1 | CodeableConcept |
Code
that
identifies
the
allergy
or
intolerance
AllergyIntolerance Substance/Product, Condition and Negation Codes ( Example ) |
![]() ![]() | Σ | 1..1 | Reference ( Patient ) |
Who
the
sensitivity
is
for
|
![]() ![]() | 0..1 | Reference ( Encounter ) |
Encounter
when
the
allergy
or
intolerance
was
asserted
| |
![]() ![]() | 0..1 |
When
allergy
or
intolerance
was
identified
| ||
![]() ![]() ![]() | dateTime | |||
![]() ![]() ![]() | Age | |||
![]() ![]() ![]() | Period | |||
![]() ![]() ![]() | Range | |||
![]() ![]() ![]() | string | |||
![]() ![]() | 0..1 | dateTime |
Date
allergy
or
intolerance
was
first
recorded
| |
![]() ![]() | Σ | 0..* | BackboneElement |
Who
or
what
participated
in
the
activities
related
to
the
allergy
or
intolerance
and
how
they
were
involved
|
![]() ![]() ![]() | Σ | 0..1 | CodeableConcept |
Type
of
involvement
ParticipationRoleType ( Extensible ) |
![]() ![]() ![]() | Σ | 1..1 | Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson | Device | Organization | CareTeam ) |
Who
or
what
participated
in
the
activities
related
to
the
allergy
or
intolerance
|
![]() ![]() | 0..1 | dateTime |
Date(/time)
of
last
known
occurrence
of
a
reaction
| |
![]() ![]() | 0..* | Annotation |
Additional
text
not
captured
in
other
fields
| |
![]() ![]() | TU | 0..* | BackboneElement |
Adverse
Reaction
Events
linked
to
exposure
to
substance
|
![]() ![]() ![]() | 0..1 | CodeableConcept |
Specific
substance
or
pharmaceutical
product
considered
to
be
responsible
for
event
Substance Code ( Example ) | |
![]() ![]() ![]() | 1..* | CodeableReference ( Observation ) |
Clinical
symptoms/signs
associated
with
the
Event
SNOMED CT Clinical Findings ( Example ) | |
![]() ![]() ![]() | 0..1 | string |
Description
of
the
event
as
a
whole
| |
![]() ![]() ![]() | 0..1 | dateTime |
Date(/time)
when
manifestations
showed
| |
![]() ![]() ![]() | 0..1 | code |
mild
|
moderate
|
severe
(of
event
as
a
whole)
AllergyIntoleranceSeverity ( Required ) | |
![]() ![]() ![]() | 0..1 | CodeableConcept |
How
the
subject
was
exposed
to
the
substance
SNOMED CT Route Codes ( Example ) | |
![]() ![]() ![]() | 0..* | Annotation |
Text
about
event
not
captured
in
other
fields
| |
Documentation
for
this
format
| ||||
See the Extensions for this resource
Definition
UML
Diagram
(
Legend
)
XML Template
<AllergyIntolerance xmlns="http://hl7.org/fhir"><!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier External ids for this item --></identifier> <clinicalStatus><!-- 0..1 CodeableConcept active | inactive | resolved --></clinicalStatus> <verificationStatus><!-- 0..1 CodeableConcept unconfirmed | presumed | confirmed | refuted | entered-in-error --></verificationStatus> <type value="[code]"/><!-- 0..1 allergy | intolerance - Underlying mechanism (if known) --> <category value="[code]"/><!-- 0..* food | medication | environment | biologic --> <criticality value="[code]"/><!-- 0..1 low | high | unable-to-assess --> <code><!-- 0..1 CodeableConcept Code that identifies the allergy or intolerance --></code> <patient><!-- 1..1 Reference(Patient) Who the sensitivity is for --></patient> <encounter><!-- 0..1 Reference(Encounter) Encounter when the allergy or intolerance was asserted --></encounter> <onset[x]><!-- 0..1 dateTime|Age|Period|Range|string When allergy or intolerance was identified --></onset[x]> <recordedDate value="[dateTime]"/><!-- 0..1 Date allergy or intolerance was first recorded --> <participant> <!-- 0..* Who or what participated in the activities related to the allergy or intolerance and how they were involved --> <function><!-- 0..1 CodeableConcept Type of involvement --></function> <actor><!-- 1..1 Reference(CareTeam|Device|Organization|Patient|Practitioner| PractitionerRole|RelatedPerson) Who or what participated in the activities related to the allergy or intolerance --></actor> </participant> <lastOccurrence value="[dateTime]"/><!-- 0..1 Date(/time) of last known occurrence of a reaction --> <note><!-- 0..* Annotation Additional text not captured in other fields --></note> <reaction> <!-- 0..* Adverse Reaction Events linked to exposure to substance --> <substance><!-- 0..1 CodeableConcept Specific substance or pharmaceutical product considered to be responsible for event --></substance> <manifestation><!-- 1..* CodeableReference(Observation) Clinical symptoms/signs associated with the Event --></manifestation> <description value="[string]"/><!-- 0..1 Description of the event as a whole --> <onset value="[dateTime]"/><!-- 0..1 Date(/time) when manifestations showed --> <severity value="[code]"/><!-- 0..1 mild | moderate | severe (of event as a whole) --> <exposureRoute><!-- 0..1 CodeableConcept How the subject was exposed to the substance --></exposureRoute> <note><!-- 0..* Annotation Text about event not captured in other fields --></note> </reaction> </AllergyIntolerance>
JSON Template
{
"resourceType" : "AllergyIntolerance",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // External ids for this item
"clinicalStatus" : { CodeableConcept }, // active | inactive | resolved
"verificationStatus" : { CodeableConcept }, // unconfirmed | presumed | confirmed | refuted | entered-in-error
"type" : "<code>", // allergy | intolerance - Underlying mechanism (if known)
"category" : ["<code>"], // food | medication | environment | biologic
"criticality" : "<code>", // low | high | unable-to-assess
"code" : { CodeableConcept }, // Code that identifies the allergy or intolerance
"patient" : { Reference(Patient) }, // R! Who the sensitivity is for
"encounter" : { Reference(Encounter) }, // Encounter when the allergy or intolerance was asserted
// onset[x]: When allergy or intolerance was identified. One of these 5:
"onsetDateTime" : "<dateTime>",
"onsetAge" : { Age },
"onsetPeriod" : { Period },
"onsetRange" : { Range },
"onsetString" : "<string>",
"recordedDate" : "<dateTime>", // Date allergy or intolerance was first recorded
"participant" : [{ // Who or what participated in the activities related to the allergy or intolerance and how they were involved
"function" : { CodeableConcept }, // Type of involvement
"actor" : { Reference(CareTeam|Device|Organization|Patient|Practitioner|
PractitionerRole|RelatedPerson) } // R! Who or what participated in the activities related to the allergy or intolerance
}],
"lastOccurrence" : "<dateTime>", // Date(/time) of last known occurrence of a reaction
"note" : [{ Annotation }], // Additional text not captured in other fields
"reaction" : [{ // Adverse Reaction Events linked to exposure to substance
"substance" : { CodeableConcept }, // Specific substance or pharmaceutical product considered to be responsible for event
"manifestation" : [{ CodeableReference(Observation) }], // R! Clinical symptoms/signs associated with the Event
"description" : "<string>", // Description of the event as a whole
"onset" : "<dateTime>", // Date(/time) when manifestations showed
"severity" : "<code>", // mild | moderate | severe (of event as a whole)
"exposureRoute" : { CodeableConcept }, // How the subject was exposed to the substance
"note" : [{ Annotation }] // Text about event not captured in other fields
}]
}
Usage
note:
every
effort
Turtle
Template
@prefix fhir: <http://hl7.org/fhir/> .[ a fhir:AllergyIntolerance; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtension fhir:AllergyIntolerance.identifier [ Identifier ], ... ; # 0..* External ids for this item fhir:AllergyIntolerance.clinicalStatus [ CodeableConcept ]; # 0..1 active | inactive | resolved fhir:AllergyIntolerance.verificationStatus [ CodeableConcept ]; # 0..1 unconfirmed | presumed | confirmed | refuted | entered-in-error fhir:AllergyIntolerance.type [ code ]; # 0..1 allergy | intolerance - Underlying mechanism (if known) fhir:AllergyIntolerance.category [ code ], ... ; # 0..* food | medication | environment | biologic fhir:AllergyIntolerance.criticality [ code ]; # 0..1 low | high | unable-to-assess fhir:AllergyIntolerance.code [ CodeableConcept ]; # 0..1 Code that identifies the allergy or intolerance fhir:AllergyIntolerance.patient [ Reference(Patient) ]; # 1..1 Who the sensitivity is for fhir:AllergyIntolerance.encounter [ Reference(Encounter) ]; # 0..1 Encounter when the allergy or intolerance was asserted # AllergyIntolerance.onset[x] : 0..1 When allergy or intolerance was identified. One of these 5 fhir:AllergyIntolerance.onsetDateTime [ dateTime ] fhir:AllergyIntolerance.onsetAge [ Age ] fhir:AllergyIntolerance.onsetPeriod [ Period ] fhir:AllergyIntolerance.onsetRange [ Range ] fhir:AllergyIntolerance.onsetString [ string ] fhir:AllergyIntolerance.recordedDate [ dateTime ]; # 0..1 Date allergy or intolerance was first recorded fhir:AllergyIntolerance.participant [ # 0..* Who or what participated in the activities related to the allergy or intolerance and how they were involved fhir:AllergyIntolerance.participant.function [ CodeableConcept ]; # 0..1 Type of involvement fhir:AllergyIntolerance.participant.actor [ Reference(CareTeam|Device|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 1..1 Who or what participated in the activities related to the allergy or intolerance ], ...; fhir:AllergyIntolerance.lastOccurrence [ dateTime ]; # 0..1 Date(/time) of last known occurrence of a reaction fhir:AllergyIntolerance.note [ Annotation ], ... ; # 0..* Additional text not captured in other fields fhir:AllergyIntolerance.reaction [ # 0..* Adverse Reaction Events linked to exposure to substance fhir:AllergyIntolerance.reaction.substance [ CodeableConcept ]; # 0..1 Specific substance or pharmaceutical product considered to be responsible for event fhir:AllergyIntolerance.reaction.manifestation [ CodeableReference(Observation) ], ... ; # 1..* Clinical symptoms/signs associated with the Event fhir:AllergyIntolerance.reaction.description [ string ]; # 0..1 Description of the event as a whole fhir:AllergyIntolerance.reaction.onset [ dateTime ]; # 0..1 Date(/time) when manifestations showed fhir:AllergyIntolerance.reaction.severity [ code ]; # 0..1 mild | moderate | severe (of event as a whole) fhir:AllergyIntolerance.reaction.exposureRoute [ CodeableConcept ]; # 0..1 How the subject was exposed to the substance fhir:AllergyIntolerance.reaction.note [ Annotation ], ... ; # 0..* Text about event not captured in other fields ], ...; ]
Changes since R4
| AllergyIntolerance | |
| AllergyIntolerance.participant |
|
| AllergyIntolerance.participant.function |
|
| AllergyIntolerance.participant.actor |
|
| AllergyIntolerance.reaction.manifestation |
|
| AllergyIntolerance.recorder |
|
| AllergyIntolerance.asserter |
|
See the Full Difference for further information
This analysis is available as XML or JSON .
See R3 <--> R4 Conversion Maps (status = 3 tests that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
![]() |
|---|---|---|---|---|
![]() | TU | DomainResource |
Allergy
or
Intolerance
(generally:
Risk
of
adverse
reaction
to
a
substance)
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension | |
![]() ![]() | Σ | 0..* | Identifier |
External
ids
for
this
item
|
![]() ![]() | ?! Σ | 0..1 | CodeableConcept |
active
|
inactive
|
resolved
AllergyIntolerance Clinical Status Codes ( Required ) |
![]() ![]() | ?! Σ | 0..1 | CodeableConcept |
unconfirmed
|
presumed
|
confirmed
|
refuted
|
entered-in-error
AllergyIntolerance Verification Status ( Required ) |
![]() ![]() | Σ TU | 0..1 | code |
allergy
|
intolerance
-
Underlying
mechanism
(if
known)
AllergyIntoleranceType ( Required ) |
![]() ![]() | Σ | 0..* | code |
food
|
medication
|
environment
|
biologic
AllergyIntoleranceCategory ( Required ) |
![]() ![]() | Σ | 0..1 | code |
low
|
high
|
unable-to-assess
AllergyIntoleranceCriticality ( Required ) |
![]() ![]() | Σ | 0..1 | CodeableConcept |
Code
that
identifies
the
allergy
or
intolerance
AllergyIntolerance Substance/Product, Condition and Negation Codes ( Example ) |
![]() ![]() | Σ | 1..1 | Reference ( Patient ) |
Who
the
sensitivity
is
for
|
![]() ![]() | 0..1 | Reference ( Encounter ) |
Encounter
when
the
allergy
or
intolerance
was
asserted
| |
![]() ![]() | 0..1 |
When
allergy
or
intolerance
was
identified
| ||
![]() ![]() ![]() | dateTime | |||
![]() ![]() ![]() | Age | |||
![]() ![]() ![]() | Period | |||
![]() ![]() ![]() | Range | |||
![]() ![]() ![]() | string | |||
![]() ![]() | 0..1 | dateTime |
Date
allergy
or
intolerance
was
first
recorded
| |
![]() ![]() | Σ | 0..* | BackboneElement |
Who
or
what
participated
in
the
activities
related
to
the
allergy
or
intolerance
and
how
they
were
involved
|
![]() ![]() ![]() | Σ | 0..1 | CodeableConcept |
Type
of
involvement
ParticipationRoleType ( Extensible ) |
![]() ![]() ![]() | Σ | 1..1 | Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson | Device | Organization | CareTeam ) |
Who
or
what
participated
in
the
activities
related
to
the
allergy
or
intolerance
|
![]() ![]() | 0..1 | dateTime |
Date(/time)
of
last
known
occurrence
of
a
reaction
| |
![]() ![]() | 0..* | Annotation |
Additional
text
not
captured
in
other
fields
| |
![]() ![]() | TU | 0..* | BackboneElement |
Adverse
Reaction
Events
linked
to
exposure
to
substance
|
![]() ![]() ![]() | 0..1 | CodeableConcept |
Specific
substance
or
pharmaceutical
product
considered
to
be
responsible
for
event
Substance Code ( Example ) | |
![]() ![]() ![]() | 1..* | CodeableReference ( Observation ) |
Clinical
symptoms/signs
associated
with
the
Event
SNOMED CT Clinical Findings ( Example ) | |
![]() ![]() ![]() | 0..1 | string |
Description
of
the
event
as
a
whole
| |
![]() ![]() ![]() | 0..1 | dateTime |
Date(/time)
when
manifestations
showed
| |
![]() ![]() ![]() | 0..1 | code |
mild
|
moderate
|
severe
(of
event
as
a
whole)
AllergyIntoleranceSeverity ( Required ) | |
![]() ![]() ![]() | 0..1 | CodeableConcept |
How
the
subject
was
exposed
to
the
substance
SNOMED CT Route Codes ( Example ) | |
![]() ![]() ![]() | 0..* | Annotation |
Text
about
event
not
captured
in
other
fields
| |
Documentation
for
this
format
| ||||
See the Extensions for this resource
UML Diagram ( Legend )
XML Template
<AllergyIntolerance xmlns="http://hl7.org/fhir"><!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier External ids for this item --></identifier> <clinicalStatus><!-- 0..1 CodeableConcept active | inactive | resolved --></clinicalStatus> <verificationStatus><!-- 0..1 CodeableConcept unconfirmed | presumed | confirmed | refuted | entered-in-error --></verificationStatus> <type value="[code]"/><!-- 0..1 allergy | intolerance - Underlying mechanism (if known) --> <category value="[code]"/><!-- 0..* food | medication | environment | biologic --> <criticality value="[code]"/><!-- 0..1 low | high | unable-to-assess --> <code><!-- 0..1 CodeableConcept Code that identifies the allergy or intolerance --></code> <patient><!-- 1..1 Reference(Patient) Who the sensitivity is for --></patient> <encounter><!-- 0..1 Reference(Encounter) Encounter when the allergy or intolerance was asserted --></encounter> <onset[x]><!-- 0..1 dateTime|Age|Period|Range|string When allergy or intolerance was identified --></onset[x]> <recordedDate value="[dateTime]"/><!-- 0..1 Date allergy or intolerance was first recorded --> <participant> <!-- 0..* Who or what participated in the activities related to the allergy or intolerance and how they were involved --> <function><!-- 0..1 CodeableConcept Type of involvement --></function> <actor><!-- 1..1 Reference(CareTeam|Device|Organization|Patient|Practitioner| PractitionerRole|RelatedPerson) Who or what participated in the activities related to the allergy or intolerance --></actor> </participant> <lastOccurrence value="[dateTime]"/><!-- 0..1 Date(/time) of last known occurrence of a reaction --> <note><!-- 0..* Annotation Additional text not captured in other fields --></note> <reaction> <!-- 0..* Adverse Reaction Events linked to exposure to substance --> <substance><!-- 0..1 CodeableConcept Specific substance or pharmaceutical product considered to be responsible for event --></substance> <manifestation><!-- 1..* CodeableReference(Observation) Clinical symptoms/signs associated with the Event --></manifestation> <description value="[string]"/><!-- 0..1 Description of the event as a whole --> <onset value="[dateTime]"/><!-- 0..1 Date(/time) when manifestations showed --> <severity value="[code]"/><!-- 0..1 mild | moderate | severe (of event as a whole) --> <exposureRoute><!-- 0..1 CodeableConcept How the subject was exposed to the substance --></exposureRoute> <note><!-- 0..* Annotation Text about event not captured in other fields --></note> </reaction> </AllergyIntolerance>
JSON Template
{
"resourceType" : "AllergyIntolerance",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // External ids for this item
"clinicalStatus" : { CodeableConcept }, // active | inactive | resolved
"verificationStatus" : { CodeableConcept }, // unconfirmed | presumed | confirmed | refuted | entered-in-error
"type" : "<code>", // allergy | intolerance - Underlying mechanism (if known)
"category" : ["<code>"], // food | medication | environment | biologic
"criticality" : "<code>", // low | high | unable-to-assess
"code" : { CodeableConcept }, // Code that identifies the allergy or intolerance
"patient" : { Reference(Patient) }, // R! Who the sensitivity is for
"encounter" : { Reference(Encounter) }, // Encounter when the allergy or intolerance was asserted
// onset[x]: When allergy or intolerance was identified. One of these 5:
"onsetDateTime" : "<dateTime>",
"onsetAge" : { Age },
"onsetPeriod" : { Period },
"onsetRange" : { Range },
"onsetString" : "<string>",
"recordedDate" : "<dateTime>", // Date allergy or intolerance was first recorded
"participant" : [{ // Who or what participated in the activities related to the allergy or intolerance and how they were involved
"function" : { CodeableConcept }, // Type of involvement
"actor" : { Reference(CareTeam|Device|Organization|Patient|Practitioner|
PractitionerRole|RelatedPerson) } // R! Who or what participated in the activities related to the allergy or intolerance
}],
"lastOccurrence" : "<dateTime>", // Date(/time) of last known occurrence of a reaction
"note" : [{ Annotation }], // Additional text not captured in other fields
"reaction" : [{ // Adverse Reaction Events linked to exposure to substance
"substance" : { CodeableConcept }, // Specific substance or pharmaceutical product considered to be responsible for event
"manifestation" : [{ CodeableReference(Observation) }], // R! Clinical symptoms/signs associated with the Event
"description" : "<string>", // Description of the event as a whole
"onset" : "<dateTime>", // Date(/time) when manifestations showed
"severity" : "<code>", // mild | moderate | severe (of event as a whole)
"exposureRoute" : { CodeableConcept }, // How the subject was exposed to the substance
"note" : [{ Annotation }] // Text about event not captured in other fields
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .[ a fhir:AllergyIntolerance; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtension fhir:AllergyIntolerance.identifier [ Identifier ], ... ; # 0..* External ids for this item fhir:AllergyIntolerance.clinicalStatus [ CodeableConcept ]; # 0..1 active | inactive | resolved fhir:AllergyIntolerance.verificationStatus [ CodeableConcept ]; # 0..1 unconfirmed | presumed | confirmed | refuted | entered-in-error fhir:AllergyIntolerance.type [ code ]; # 0..1 allergy | intolerance - Underlying mechanism (if known) fhir:AllergyIntolerance.category [ code ], ... ; # 0..* food | medication | environment | biologic fhir:AllergyIntolerance.criticality [ code ]; # 0..1 low | high | unable-to-assess fhir:AllergyIntolerance.code [ CodeableConcept ]; # 0..1 Code that identifies the allergy or intolerance fhir:AllergyIntolerance.patient [ Reference(Patient) ]; # 1..1 Who the sensitivity is for fhir:AllergyIntolerance.encounter [ Reference(Encounter) ]; # 0..1 Encounter when the allergy or intolerance was asserted # AllergyIntolerance.onset[x] : 0..1 When allergy or intolerance was identified. One of these 5 fhir:AllergyIntolerance.onsetDateTime [ dateTime ] fhir:AllergyIntolerance.onsetAge [ Age ] fhir:AllergyIntolerance.onsetPeriod [ Period ] fhir:AllergyIntolerance.onsetRange [ Range ] fhir:AllergyIntolerance.onsetString [ string ] fhir:AllergyIntolerance.recordedDate [ dateTime ]; # 0..1 Date allergy or intolerance was first recorded fhir:AllergyIntolerance.participant [ # 0..* Who or what participated in the activities related to the allergy or intolerance and how they were involved fhir:AllergyIntolerance.participant.function [ CodeableConcept ]; # 0..1 Type of involvement fhir:AllergyIntolerance.participant.actor [ Reference(CareTeam|Device|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 1..1 Who or what participated in the activities related to the allergy or intolerance ], ...; fhir:AllergyIntolerance.lastOccurrence [ dateTime ]; # 0..1 Date(/time) of last known occurrence of a reaction fhir:AllergyIntolerance.note [ Annotation ], ... ; # 0..* Additional text not captured in other fields fhir:AllergyIntolerance.reaction [ # 0..* Adverse Reaction Events linked to exposure to substance fhir:AllergyIntolerance.reaction.substance [ CodeableConcept ]; # 0..1 Specific substance or pharmaceutical product considered to be responsible for event fhir:AllergyIntolerance.reaction.manifestation [ CodeableReference(Observation) ], ... ; # 1..* Clinical symptoms/signs associated with the Event fhir:AllergyIntolerance.reaction.description [ string ]; # 0..1 Description of the event as a whole fhir:AllergyIntolerance.reaction.onset [ dateTime ]; # 0..1 Date(/time) when manifestations showed fhir:AllergyIntolerance.reaction.severity [ code ]; # 0..1 mild | moderate | severe (of event as a whole) fhir:AllergyIntolerance.reaction.exposureRoute [ CodeableConcept ]; # 0..1 How the subject was exposed to the substance fhir:AllergyIntolerance.reaction.note [ Annotation ], ... ; # 0..* Text about event not captured in other fields ], ...; ]
Changes since Release 4
| AllergyIntolerance | |
| AllergyIntolerance.participant |
|
| AllergyIntolerance.participant.function |
|
| AllergyIntolerance.participant.actor |
|
| AllergyIntolerance.reaction.manifestation |
|
| AllergyIntolerance.recorder |
|
| AllergyIntolerance.asserter |
|
See the Full Difference for further information
This analysis is available as XML or JSON .
See R3 <--> R4 Conversion Maps (status = 3 tests that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)
Additional definitions: Master Definition XML + JSON , XML Schema / Schematron + JSON Schema , ShEx (for Turtle ) + see the extensions , the spreadsheet version & the dependency analysis
| Path | Definition | Type | Reference |
|---|---|---|---|
| AllergyIntolerance.clinicalStatus | Preferred value set for AllergyIntolerance Clinical Status. | Required | AllergyIntoleranceClinicalStatusCodes |
| AllergyIntolerance.verificationStatus | The verification status to support or decline the clinical status of the allergy or intolerance. | Required | AllergyIntoleranceVerificationStatus |
| AllergyIntolerance.type | Identification of the underlying physiological mechanism for a Reaction Risk. | Required | AllergyIntoleranceType |
| AllergyIntolerance.category | Category of an identified substance associated with allergies or intolerances. | Required | AllergyIntoleranceCategory |
| AllergyIntolerance.criticality | Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance. | Required | AllergyIntoleranceCriticality |
| AllergyIntolerance.code | This value set includes concept codes for specific substances/pharmaceutical products, allergy or intolerance conditions, and negation/exclusion codes to specify the absence of specific types of allergies or intolerances. | Example | AllergyIntoleranceSubstance/Product,ConditionAndNegationCodes |
| AllergyIntolerance.participant.function | This FHIR value set is comprised of Actor participation Type codes, which can be used to value FHIR agents, actors, and other role elements. The codes are intended to express how the agent participated in some activity. Sometimes refered to the agent functional-role relative to the activity. | Extensible | ParticipationRoleType |
| AllergyIntolerance.reaction.substance |
This
value
set
contains
concept
codes
for
specific
substances.
It
includes
codes
from
SNOMED
| Example | SubstanceCode |
| AllergyIntolerance.reaction.manifestation |
This
value
set
includes
all
the
"Clinical
finding"
SNOMED
CT
| Example | SNOMEDCTClinicalFindings |
| AllergyIntolerance.reaction.severity | Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations. | Required | AllergyIntoleranceSeverity |
| AllergyIntolerance.reaction.exposureRoute | This value set includes all Route codes from SNOMED CT - provided as an exemplar. | Example | SNOMEDCTRouteCodes |
It is important to differentiate between affirmatively stating that a patient has no known allergies versus either not including allergies in the record (for example an episodic document where the allergies are not considered relevant to the document); or asserting that allergies were not reviewed and are unknown.
Allergies with the verificationStatus "entered-in-error" indicates that the allergy or intolerance statement is entered by mistake and hence invalid.
Allergies
with
the
verificationStatus
"refuted"
must
be
displayed
to
indicate
that
a
reaction
to
a
substance
has
been
made
ruled
out
with
the
high
level
of
clinical
certainty
(e.g.
additional
testing,
re-challenging).
When
the
allergy
or
intolerance
is
refuted,
other
elements
may
be
retained
for
legal
reasons,
but
those
other
elements
are
no
longer
clinically
relevant.
Prior to adding a new allergy/intolerance, a list of existing negated and refuted reactions should be reviewed and reconciled.
Allergies Not Reviewed, Not Asked
When a sending system does not have any information about allergies being reviewed or the statement is about allergies not being asked yet, then the List resource should be used to indicate the List.emptyReason.code="notasked".
Allergies Reviewed, None Identified
Systems may use the List.emptyReason when a statement is about the full scope of the list (i.e. the patient has no known allergies or intolerances of any type). However, it is generally preferred to use an AllergyIntolerance.code such as "No known allergies" (e.g., SNOMED CT: 716186003 |No known allergy (situation)|), so that all allergy data will be available and queryable from AllergyIntolerance resource instances. Negated AllergyIntolerance instances are also typically used when the record is more fine-grained (e.g. no drug allergies, no food allergies, no nut allergies, etc.).
However,
it
is
possible
to
include
negation
statements
that
apply
at
the
level
of
the
whole
list
and
it
is
also
possible
to
have
separate
lists
for
things
like
medication
allergies
vs.
food
allergies,
where
that
is
appropriate
to
the
architecture.
Also
note
that
care
should
be
used
when
adding
new
AllergyIntolerances
to
a
list
to
ensure
that
any
negation
statements
that
are
voided
by
the
examples
addition
of
a
new
record
are
correct
removed
from
the
list.
E.g.
If
the
list
contains
a
"no
known
food
allergies"
record
and
useful,
you
add
an
"intolerance
to
grape
flavor"
record,
then
be
sure
you
remove
the
"no
known
food
allergies"
record.
The
substanceExposureRisk
extension
is
also
available
for
use
as
a
more
completely
structured
and
flexible
alternative
to
the
'code'
element
for
representing
positive
and
negative
allergy
and
intolerance
statements
(either
the
'code'
element
or
the
substanceExposureRisk
extension
may
be
used,
but
they
are
not
both).
No Known Allergies
<?xml version="1.0" encoding="UTF-8"?> <AllergyIntolerance xmlns="http://hl7.org/fhir"> <id value="nka"/> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> <p> No Known Allergy</p> <p> recordedDate:2015-08-06</p> </div> </text> <code> <coding> <system value="http://snomed.info/sct"/> <code value="716186003"/> <display value="No Known Allergy (situation)"/> </coding> <text value="NKA"/> </code> <patient> <reference value="Patient/mom"/> </patient> <!-- the date that this entry was recorded --> <recordedDate value="2015-08-06T15:37:31-06:00"/> <!-- who made the record / last updated it --> <recorder> <reference value="Practitioner/example"/> </recorder> </AllergyIntolerance>
No Known Allergies, using List .emptyReason (discouraged)
<List xmlns="http://hl7.org/fhir" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://hl7.org/fhir ..\..\schema\list.xsd">
<id value="example-empty-allergy"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<p> The patient is not aware of any allergies.</p>
</div>
</text>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="52472-8"/>
<display value="Allergies and Adverse Drug Reactions"/>
</coding>
<text value="Current Allergy List"/>
</code>
<source>
<reference value="Patient/example"/>
</source>
<status value="current"/>
<date value="2012-11-26T07:30:23+11:00"/>
<mode value="snapshot"/>
<emptyReason>
<coding>
<system value="http://hl7.org/fhir/special-values"/>
<code value="nil-known"/>
<display value="Nil Known"/>
</coding>
<text value="The patient is not aware of any allergies."/>
</emptyReason>
</List>
No Known Food Allergies and Medication Allergy List
<?xml version="1.0" encoding="UTF-8"?>
<List xmlns="http://hl7.org/fhir" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://hl7.org/fhir ..\..\schema\list.xsd">
<id value="current-allergies"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<p>Patient Peter Chalmers, DOB = Dec 25, 1974, MRN = 12345 (Acme Healthcare) has the following allergies</p>
<ul>
<li>No known food allergies</li>
<li>Allergenic extract, penicillin (high)</li>
</ul>
</div>
</text>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="52472-8"/>
<display value="Allergies and Adverse Drug Reactions"/>
</coding>
<text value="Current Allergy List"/>
</code>
<source>
<reference value="Patient/example"/>
</source>
<status value="current"/>
<date value="2015-07-14T23:10:23+11:00"/>
<mode value="snapshot"/>
<entry>
<item>
<reference value="AllergyIntolerance/nofoodallergies"/>
</item>
</entry>
<entry>
<item>
<reference value="AllergyIntolerance/penicillin"/>
</item>
</entry>
</List>
If
a
normative
part
new
allergy
is
discovered,
the
negated
allergy
record
must
be
updated
with
the
"refuted"
verificationStatus
-
to
ensure
that
systems
referring
to
this
record
are
aware
that
this
is
no
longer
true.
Systems
that
only
support
one
notion
will
have
to
determine
whether
what
they're
capturing
is
criticality
or
severity
and
map
to
the
appropriate
place.
Criticality
refers
to
the
likelihood
the
allergy/intolerance
could
result
in
significant
harm.
Severity
refers
to
the
degree
of
manifestation
of
the
specification.
reaction
symptom.
Moderate
breathing
difficulty
would
have
high
criticality
while
a
severe
rash
would
have
low
criticality.
Severity
is
specific
to
a
particular
reaction
occurrence.
For systems that only track generic reaction characteristics rather than a specific reaction will provide guidance to use the "reaction" structure and simply provide no date.
(accessed
Jan
16,
2012).
(accessed
06
July
2014).
(accessed
Jan
16,
2012).
.
.
.
.



Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
| Name | Type | Description | Expression | In Common |
| category N | token | food | medication | environment | biologic | AllergyIntolerance.category | |
| clinical-status | token | active | inactive | resolved | AllergyIntolerance.clinicalStatus | |
| code | token | Code that identifies the allergy or intolerance | AllergyIntolerance.code | AllergyIntolerance.reaction.substance | |
| criticality N | token | low | high | unable-to-assess | AllergyIntolerance.criticality | |
| date N | date | Date first version of the resource instance was recorded | AllergyIntolerance.recordedDate | |
| identifier | token | External ids for this item | AllergyIntolerance.identifier | |
| last-date N | date | Date(/time) of last known occurrence of a reaction | AllergyIntolerance.lastOccurrence | |
| manifestation-code | token | Clinical symptoms/signs associated with the Event | AllergyIntolerance.reaction.manifestation.concept | |
| manifestation-reference | reference | Clinical symptoms/signs associated with the Event | AllergyIntolerance.reaction.manifestation.reference | |
| participant | reference | Who or what participated in the activities related to the allergy or intolerance |
AllergyIntolerance.participant.actor
( Practitioner , Organization , CareTeam , Device , Patient , PractitionerRole , RelatedPerson ) | |
| patient | reference | Who the sensitivity is for |
AllergyIntolerance.patient
( Patient ) | |
| route | token | How the subject was exposed to the substance | AllergyIntolerance.reaction.exposureRoute | |
| severity N | token | mild | moderate | severe (of event as a whole) | AllergyIntolerance.reaction.severity | |
| type N | token | allergy | intolerance - Underlying mechanism (if known) | AllergyIntolerance.type | |
| verification-status | token | unconfirmed | presumed | confirmed | refuted | entered-in-error | AllergyIntolerance.verificationStatus |