R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.13 Resource MedicinalProductUndesirableEffect - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Compartments: Not linked to any defined compartments

Describe the undesirable effects of the medicinal product.

11.13.1 Scope and Usage

A potential negative outcome from the use of a medicinal product. This is part of the definional information about a product and is not realted to any particular actual use of a medication. See also AdverseEvent, which is for actual events (or near misses), and AllergyIntolerance.

This resource is referenced by MedicinalProduct and MedicinalProductIndication

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductUndesirableEffect	Σ TU		DomainResource	MedicinalProductUndesirableEffect Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
subject	Σ	0..*	Reference(MedicinalProduct \| Medication)	The medication for which this is an indication
symptomConditionEffect	Σ	0..1	CodeableConcept	The symptom, condition or undesirable effect
classification	Σ	0..1	CodeableConcept	Classification of the effect
frequencyOfOccurrence	Σ	0..1	CodeableConcept	The frequency of occurrence of the effect
population	Σ	0..*	BackboneElement	The population group to which this applies
age[x]	Σ	0..1		The age of the specific population
ageRange			Range
ageCodeableConcept			CodeableConcept
gender	Σ	0..1	CodeableConcept	The gender of the specific population
race	Σ	0..1	CodeableConcept	Race of the specific population
physiologicalCondition	Σ	0..1	CodeableConcept	The existing physiological conditions of the specific population to which this applies
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductUndesirableEffect xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <subject><!-- 0..* Reference(MedicinalProduct|Medication) The medication for which this is an indication --></subject>
 <symptomConditionEffect><!-- 0..1 CodeableConcept The symptom, condition or undesirable effect --></symptomConditionEffect>
 <classification><!-- 0..1 CodeableConcept Classification of the effect --></classification>
 <frequencyOfOccurrence><!-- 0..1 CodeableConcept The frequency of occurrence of the effect --></frequencyOfOccurrence>
 <population>  <!-- 0..* The population group to which this applies -->
  <age[x]><!-- 0..1 Range|CodeableConcept The age of the specific population --></age[x]>
  <gender><!-- 0..1 CodeableConcept The gender of the specific population --></gender>
  <race><!-- 0..1 CodeableConcept Race of the specific population --></race>
  <physiologicalCondition><!-- 0..1 CodeableConcept The existing physiological conditions of the specific population to which this applies --></physiologicalCondition>
 </population>
</MedicinalProductUndesirableEffect>

JSON Template

{
  "resourceType" : "MedicinalProductUndesirableEffect",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "subject" : [{ Reference(MedicinalProduct|Medication) }], // The medication for which this is an indication
  "symptomConditionEffect" : { CodeableConcept }, // The symptom, condition or undesirable effect
  "classification" : { CodeableConcept }, // Classification of the effect
  "frequencyOfOccurrence" : { CodeableConcept }, // The frequency of occurrence of the effect
  "population" : [{ // The population group to which this applies
    // age[x]: The age of the specific population. One of these 2:
    "ageRange" : { Range },
    "ageCodeableConcept" : { CodeableConcept },
    "gender" : { CodeableConcept }, // The gender of the specific population
    "race" : { CodeableConcept }, // Race of the specific population
    "physiologicalCondition" : { CodeableConcept } // The existing physiological conditions of the specific population to which this applies
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:MedicinalProductUndesirableEffect;
  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:MedicinalProductUndesirableEffect.subject [ Reference(MedicinalProduct|Medication) ], ... ; # 0..* The medication for which this is an indication
  fhir:MedicinalProductUndesirableEffect.symptomConditionEffect [ CodeableConcept ]; # 0..1 The symptom, condition or undesirable effect
  fhir:MedicinalProductUndesirableEffect.classification [ CodeableConcept ]; # 0..1 Classification of the effect
  fhir:MedicinalProductUndesirableEffect.frequencyOfOccurrence [ CodeableConcept ]; # 0..1 The frequency of occurrence of the effect
  fhir:MedicinalProductUndesirableEffect.population [ # 0..* The population group to which this applies
    # MedicinalProductUndesirableEffect.population.age[x] : 0..1 The age of the specific population. One of these 2
      fhir:MedicinalProductUndesirableEffect.population.ageRange [ Range ]
      fhir:MedicinalProductUndesirableEffect.population.ageCodeableConcept [ CodeableConcept ]
    fhir:MedicinalProductUndesirableEffect.population.gender [ CodeableConcept ]; # 0..1 The gender of the specific population
    fhir:MedicinalProductUndesirableEffect.population.race [ CodeableConcept ]; # 0..1 Race of the specific population
    fhir:MedicinalProductUndesirableEffect.population.physiologicalCondition [ CodeableConcept ]; # 0..1 The existing physiological conditions of the specific population to which this applies
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductUndesirableEffect	Σ TU		DomainResource	MedicinalProductUndesirableEffect Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
subject	Σ	0..*	Reference(MedicinalProduct \| Medication)	The medication for which this is an indication
symptomConditionEffect	Σ	0..1	CodeableConcept	The symptom, condition or undesirable effect
classification	Σ	0..1	CodeableConcept	Classification of the effect
frequencyOfOccurrence	Σ	0..1	CodeableConcept	The frequency of occurrence of the effect
population	Σ	0..*	BackboneElement	The population group to which this applies
age[x]	Σ	0..1		The age of the specific population
ageRange			Range
ageCodeableConcept			CodeableConcept
gender	Σ	0..1	CodeableConcept	The gender of the specific population
race	Σ	0..1	CodeableConcept	Race of the specific population
physiologicalCondition	Σ	0..1	CodeableConcept	The existing physiological conditions of the specific population to which this applies
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductUndesirableEffect xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <subject><!-- 0..* Reference(MedicinalProduct|Medication) The medication for which this is an indication --></subject>
 <symptomConditionEffect><!-- 0..1 CodeableConcept The symptom, condition or undesirable effect --></symptomConditionEffect>
 <classification><!-- 0..1 CodeableConcept Classification of the effect --></classification>
 <frequencyOfOccurrence><!-- 0..1 CodeableConcept The frequency of occurrence of the effect --></frequencyOfOccurrence>
 <population>  <!-- 0..* The population group to which this applies -->
  <age[x]><!-- 0..1 Range|CodeableConcept The age of the specific population --></age[x]>
  <gender><!-- 0..1 CodeableConcept The gender of the specific population --></gender>
  <race><!-- 0..1 CodeableConcept Race of the specific population --></race>
  <physiologicalCondition><!-- 0..1 CodeableConcept The existing physiological conditions of the specific population to which this applies --></physiologicalCondition>
 </population>
</MedicinalProductUndesirableEffect>

JSON Template

{
  "resourceType" : "MedicinalProductUndesirableEffect",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "subject" : [{ Reference(MedicinalProduct|Medication) }], // The medication for which this is an indication
  "symptomConditionEffect" : { CodeableConcept }, // The symptom, condition or undesirable effect
  "classification" : { CodeableConcept }, // Classification of the effect
  "frequencyOfOccurrence" : { CodeableConcept }, // The frequency of occurrence of the effect
  "population" : [{ // The population group to which this applies
    // age[x]: The age of the specific population. One of these 2:
    "ageRange" : { Range },
    "ageCodeableConcept" : { CodeableConcept },
    "gender" : { CodeableConcept }, // The gender of the specific population
    "race" : { CodeableConcept }, // Race of the specific population
    "physiologicalCondition" : { CodeableConcept } // The existing physiological conditions of the specific population to which this applies
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:MedicinalProductUndesirableEffect;
  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:MedicinalProductUndesirableEffect.subject [ Reference(MedicinalProduct|Medication) ], ... ; # 0..* The medication for which this is an indication
  fhir:MedicinalProductUndesirableEffect.symptomConditionEffect [ CodeableConcept ]; # 0..1 The symptom, condition or undesirable effect
  fhir:MedicinalProductUndesirableEffect.classification [ CodeableConcept ]; # 0..1 Classification of the effect
  fhir:MedicinalProductUndesirableEffect.frequencyOfOccurrence [ CodeableConcept ]; # 0..1 The frequency of occurrence of the effect
  fhir:MedicinalProductUndesirableEffect.population [ # 0..* The population group to which this applies
    # MedicinalProductUndesirableEffect.population.age[x] : 0..1 The age of the specific population. One of these 2
      fhir:MedicinalProductUndesirableEffect.population.ageRange [ Range ]
      fhir:MedicinalProductUndesirableEffect.population.ageCodeableConcept [ CodeableConcept ]
    fhir:MedicinalProductUndesirableEffect.population.gender [ CodeableConcept ]; # 0..1 The gender of the specific population
    fhir:MedicinalProductUndesirableEffect.population.race [ CodeableConcept ]; # 0..1 Race of the specific population
    fhir:MedicinalProductUndesirableEffect.population.physiologicalCondition [ CodeableConcept ]; # 0..1 The existing physiological conditions of the specific population to which this applies
  ], ...;
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis

11.13.3 Search Parameters

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
subject	reference	The medication for which this is an undesirable effect	MedicinalProductUndesirableEffect.subject (Medication, MedicinalProduct)