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

11.9 Resource MedicinalProductClinicals - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Compartments: Not linked to any defined compartments

The clinical particulars - indications, contraindications etc. of a medicinal product, including for regulatory purposes.

11.9.1 Scope and Usage

A set of clinically relevent aspects relating to the potential uses and problems associated with a medicinal product

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductClinicals	Σ TU		DomainResource	MedicinalProductClinicals Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
undesirableEffects	Σ	0..*	BackboneElement	Describe the undesirable effects of the medicinal product
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
therapeuticIndication	Σ	1..*	BackboneElement	Indication for the Medicinal Product
diseaseSymptomProcedure	Σ	0..1	CodeableConcept	The disease, symptom or procedure that is the indication for treatment
diseaseStatus	Σ	0..1	CodeableConcept	The status of the disease or symptom for which the indication applies
comorbidity	Σ	0..*	CodeableConcept	Comorbidity (concurrent condition) or co-infection as part of the indication
intendedEffect	Σ	0..1	CodeableConcept	The intended effect, aim or strategy to be achieved by the indication
duration	Σ	0..1	Quantity	Timing or duration information as part of the indication
undesirableEffects	Σ	0..*	see undesirableEffects	Information about the use of the medicinal product in relation to other therapies as part of the indication
otherTherapy	Σ	0..*	BackboneElement	Information about the use of the medicinal product in relation to other therapies described as part of the indication
therapyRelationshipType	Σ	1..1	CodeableConcept	The type of relationship between the medicinal product indication or contraindication and another therapy
medication[x]	Σ	1..1		Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication
medicationCodeableConcept			CodeableConcept
medicationReference			Reference(MedicinalProduct \| Medication \| Substance \| SubstanceSpecification)
population	Σ	0..*	see population	The population group to which this applies
contraindication	Σ	0..*	BackboneElement	Contraindication for the medicinal product
disease	Σ	0..1	CodeableConcept	The disease, symptom or procedure for the contraindication
diseaseStatus	Σ	0..1	CodeableConcept	The status of the disease or symptom for the contraindication
comorbidity	Σ	0..*	CodeableConcept	A comorbidity (concurrent condition) or coinfection
therapeuticIndication	Σ	0..*	see therapeuticIndication	Information about the use of the medicinal product in relation to other therapies as part of the indication
otherTherapy	Σ	0..*	see otherTherapy	Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
population	Σ	0..*	see population	The population group to which this applies
interactions	Σ	0..*	BackboneElement	The interactions of the medicinal product with other medicinal products, or other forms of interactions
interaction	Σ	0..1	string	The interaction described
interactant	Σ	0..*	CodeableConcept	The specific medication, food or laboratory test that interacts
type	Σ	0..1	CodeableConcept	The type of the interaction
effect	Σ	0..1	CodeableConcept	The effect of the interaction
incidence	Σ	0..1	CodeableConcept	The incidence of the interaction
management	Σ	0..1	CodeableConcept	Actions for managing the interaction
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductClinicals xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <undesirableEffects>  <!-- 0..* Describe the undesirable effects of the medicinal product -->
  <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>
 </undesirableEffects>
 <therapeuticIndication>  <!-- 1..* Indication for the Medicinal Product -->
  <diseaseSymptomProcedure><!-- 0..1 CodeableConcept The disease, symptom or procedure that is the indication for treatment --></diseaseSymptomProcedure>
  <diseaseStatus><!-- 0..1 CodeableConcept The status of the disease or symptom for which the indication applies --></diseaseStatus>
  <comorbidity><!-- 0..* CodeableConcept Comorbidity (concurrent condition) or co-infection as part of the indication --></comorbidity>
  <intendedEffect><!-- 0..1 CodeableConcept The intended effect, aim or strategy to be achieved by the indication --></intendedEffect>
  <duration><!-- 0..1 Quantity Timing or duration information as part of the indication --></duration>
  <undesirableEffects><!-- 0..* Content as for MedicinalProductClinicals.undesirableEffects Information about the use of the medicinal product in relation to other therapies as part of the indication --></undesirableEffects>
  <otherTherapy>  <!-- 0..* Information about the use of the medicinal product in relation to other therapies described as part of the indication -->
   <therapyRelationshipType><!-- 1..1 CodeableConcept The type of relationship between the medicinal product indication or contraindication and another therapy --></therapyRelationshipType>
   <medication[x]><!-- 1..1 CodeableConcept|Reference(MedicinalProduct|Medication|
     Substance|SubstanceSpecification) Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication --></medication[x]>
  </otherTherapy>
  <population><!-- 0..* Content as for MedicinalProductClinicals.undesirableEffects.population The population group to which this applies --></population>
 </therapeuticIndication>
 <contraindication>  <!-- 0..* Contraindication for the medicinal product -->
  <disease><!-- 0..1 CodeableConcept The disease, symptom or procedure for the contraindication --></disease>
  <diseaseStatus><!-- 0..1 CodeableConcept The status of the disease or symptom for the contraindication --></diseaseStatus>
  <comorbidity><!-- 0..* CodeableConcept A comorbidity (concurrent condition) or coinfection --></comorbidity>
  <therapeuticIndication><!-- 0..* Content as for MedicinalProductClinicals.therapeuticIndication Information about the use of the medicinal product in relation to other therapies as part of the indication --></therapeuticIndication>
  <otherTherapy><!-- 0..* Content as for MedicinalProductClinicals.therapeuticIndication.otherTherapy Information about the use of the medicinal product in relation to other therapies described as part of the contraindication --></otherTherapy>
  <population><!-- 0..* Content as for MedicinalProductClinicals.undesirableEffects.population The population group to which this applies --></population>
 </contraindication>
 <interactions>  <!-- 0..* The interactions of the medicinal product with other medicinal products, or other forms of interactions -->
  <interaction value="[string]"/><!-- 0..1 The interaction described -->
  <interactant><!-- 0..* CodeableConcept The specific medication, food or laboratory test that interacts --></interactant>
  <type><!-- 0..1 CodeableConcept The type of the interaction --></type>
  <effect><!-- 0..1 CodeableConcept The effect of the interaction --></effect>
  <incidence><!-- 0..1 CodeableConcept The incidence of the interaction --></incidence>
  <management><!-- 0..1 CodeableConcept Actions for managing the interaction --></management>
 </interactions>
</MedicinalProductClinicals>

JSON Template

{
  "resourceType" : "MedicinalProductClinicals",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "undesirableEffects" : [{ // Describe the undesirable effects of the medicinal product
    "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
    }]
  }],
  "therapeuticIndication" : [{ // R!  Indication for the Medicinal Product
    "diseaseSymptomProcedure" : { CodeableConcept }, // The disease, symptom or procedure that is the indication for treatment
    "diseaseStatus" : { CodeableConcept }, // The status of the disease or symptom for which the indication applies
    "comorbidity" : [{ CodeableConcept }], // Comorbidity (concurrent condition) or co-infection as part of the indication
    "intendedEffect" : { CodeableConcept }, // The intended effect, aim or strategy to be achieved by the indication
    "duration" : { Quantity }, // Timing or duration information as part of the indication
    "undesirableEffects" : [{ Content as for MedicinalProductClinicals.undesirableEffects }], // Information about the use of the medicinal product in relation to other therapies as part of the indication
    "otherTherapy" : [{ // Information about the use of the medicinal product in relation to other therapies described as part of the indication
      "therapyRelationshipType" : { CodeableConcept }, // R!  The type of relationship between the medicinal product indication or contraindication and another therapy
      // medication[x]: 
       Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication. One of these 2:
      "medicationCodeableConcept" : { CodeableConcept }
      "medicationReference" : { Reference(MedicinalProduct|Medication|Substance|
     SubstanceSpecification) }
    }],
    "population" : [{ Content as for MedicinalProductClinicals.undesirableEffects.population }] // The population group to which this applies
  }],
  "contraindication" : [{ // Contraindication for the medicinal product
    "disease" : { CodeableConcept }, // The disease, symptom or procedure for the contraindication
    "diseaseStatus" : { CodeableConcept }, // The status of the disease or symptom for the contraindication
    "comorbidity" : [{ CodeableConcept }], // A comorbidity (concurrent condition) or coinfection
    "therapeuticIndication" : [{ Content as for MedicinalProductClinicals.therapeuticIndication }], // Information about the use of the medicinal product in relation to other therapies as part of the indication
    "otherTherapy" : [{ Content as for MedicinalProductClinicals.therapeuticIndication.otherTherapy }], // Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
    "population" : [{ Content as for MedicinalProductClinicals.undesirableEffects.population }] // The population group to which this applies
  }],
  "interactions" : [{ // The interactions of the medicinal product with other medicinal products, or other forms of interactions
    "interaction" : "<string>", // The interaction described
    "interactant" : [{ CodeableConcept }], // The specific medication, food or laboratory test that interacts
    "type" : { CodeableConcept }, // The type of the interaction
    "effect" : { CodeableConcept }, // The effect of the interaction
    "incidence" : { CodeableConcept }, // The incidence of the interaction
    "management" : { CodeableConcept } // Actions for managing the interaction
  }]
}

Turtle Template

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


[ a fhir:MedicinalProductClinicals;
  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:MedicinalProductClinicals.undesirableEffects [ # 0..* Describe the undesirable effects of the medicinal product
    fhir:MedicinalProductClinicals.undesirableEffects.symptomConditionEffect [ CodeableConcept ]; # 0..1 The symptom, condition or undesirable effect
    fhir:MedicinalProductClinicals.undesirableEffects.classification [ CodeableConcept ]; # 0..1 Classification of the effect
    fhir:MedicinalProductClinicals.undesirableEffects.frequencyOfOccurrence [ CodeableConcept ]; # 0..1 The frequency of occurrence of the effect
    fhir:MedicinalProductClinicals.undesirableEffects.population [ # 0..* The population group to which this applies
      # MedicinalProductClinicals.undesirableEffects.population.age[x] : 0..1 The age of the specific population. One of these 2
        fhir:MedicinalProductClinicals.undesirableEffects.population.ageRange [ Range ]
        fhir:MedicinalProductClinicals.undesirableEffects.population.ageCodeableConcept [ CodeableConcept ]
      fhir:MedicinalProductClinicals.undesirableEffects.population.gender [ CodeableConcept ]; # 0..1 The gender of the specific population
      fhir:MedicinalProductClinicals.undesirableEffects.population.race [ CodeableConcept ]; # 0..1 Race of the specific population
      fhir:MedicinalProductClinicals.undesirableEffects.population.physiologicalCondition [ CodeableConcept ]; # 0..1 The existing physiological conditions of the specific population to which this applies
    ], ...;
  ], ...;
  fhir:MedicinalProductClinicals.therapeuticIndication [ # 1..* Indication for the Medicinal Product
    fhir:MedicinalProductClinicals.therapeuticIndication.diseaseSymptomProcedure [ CodeableConcept ]; # 0..1 The disease, symptom or procedure that is the indication for treatment
    fhir:MedicinalProductClinicals.therapeuticIndication.diseaseStatus [ CodeableConcept ]; # 0..1 The status of the disease or symptom for which the indication applies
    fhir:MedicinalProductClinicals.therapeuticIndication.comorbidity [ CodeableConcept ], ... ; # 0..* Comorbidity (concurrent condition) or co-infection as part of the indication
    fhir:MedicinalProductClinicals.therapeuticIndication.intendedEffect [ CodeableConcept ]; # 0..1 The intended effect, aim or strategy to be achieved by the indication
    fhir:MedicinalProductClinicals.therapeuticIndication.duration [ Quantity ]; # 0..1 Timing or duration information as part of the indication
    fhir:MedicinalProductClinicals.therapeuticIndication.undesirableEffects [ See MedicinalProductClinicals.undesirableEffects ], ... ; # 0..* Information about the use of the medicinal product in relation to other therapies as part of the indication
    fhir:MedicinalProductClinicals.therapeuticIndication.otherTherapy [ # 0..* Information about the use of the medicinal product in relation to other therapies described as part of the indication
      fhir:MedicinalProductClinicals.therapeuticIndication.otherTherapy.therapyRelationshipType [ CodeableConcept ]; # 1..1 The type of relationship between the medicinal product indication or contraindication and another therapy
      # MedicinalProductClinicals.therapeuticIndication.otherTherapy.medication[x] : 1..1 Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication. One of these 2
        fhir:MedicinalProductClinicals.therapeuticIndication.otherTherapy.medicationCodeableConcept [ CodeableConcept ]
        fhir:MedicinalProductClinicals.therapeuticIndication.otherTherapy.medicationReference [ Reference(MedicinalProduct|Medication|Substance|SubstanceSpecification) ]
    ], ...;
    fhir:MedicinalProductClinicals.therapeuticIndication.population [ See MedicinalProductClinicals.undesirableEffects.population ], ... ; # 0..* The population group to which this applies
  ], ...;
  fhir:MedicinalProductClinicals.contraindication [ # 0..* Contraindication for the medicinal product
    fhir:MedicinalProductClinicals.contraindication.disease [ CodeableConcept ]; # 0..1 The disease, symptom or procedure for the contraindication
    fhir:MedicinalProductClinicals.contraindication.diseaseStatus [ CodeableConcept ]; # 0..1 The status of the disease or symptom for the contraindication
    fhir:MedicinalProductClinicals.contraindication.comorbidity [ CodeableConcept ], ... ; # 0..* A comorbidity (concurrent condition) or coinfection
    fhir:MedicinalProductClinicals.contraindication.therapeuticIndication [ See MedicinalProductClinicals.therapeuticIndication ], ... ; # 0..* Information about the use of the medicinal product in relation to other therapies as part of the indication
    fhir:MedicinalProductClinicals.contraindication.otherTherapy [ See MedicinalProductClinicals.therapeuticIndication.otherTherapy ], ... ; # 0..* Information about the use of the medicinal product in relation to other therapies described as part of the contraindication
    fhir:MedicinalProductClinicals.contraindication.population [ See MedicinalProductClinicals.undesirableEffects.population ], ... ; # 0..* The population group to which this applies
  ], ...;
  fhir:MedicinalProductClinicals.interactions [ # 0..* The interactions of the medicinal product with other medicinal products, or other forms of interactions
    fhir:MedicinalProductClinicals.interactions.interaction [ string ]; # 0..1 The interaction described
    fhir:MedicinalProductClinicals.interactions.interactant [ CodeableConcept ], ... ; # 0..* The specific medication, food or laboratory test that interacts
    fhir:MedicinalProductClinicals.interactions.type [ CodeableConcept ]; # 0..1 The type of the interaction
    fhir:MedicinalProductClinicals.interactions.effect [ CodeableConcept ]; # 0..1 The effect of the interaction
    fhir:MedicinalProductClinicals.interactions.incidence [ CodeableConcept ]; # 0..1 The incidence of the interaction
    fhir:MedicinalProductClinicals.interactions.management [ CodeableConcept ]; # 0..1 Actions for managing the interaction
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = Not Mapped)