This page is part of the FHIR Specification (v3.2.0: R4 Ballot 1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.8 Resource MedicinalProductClinicals - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Draft

Compartments: Not linked to any defined compartments

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

11.8.1 Scope and Usage

AdverseEvent is an event resource from a FHIR workflow perspective - see Workflow Event

This resource applies to events that occur during the course of medical care or medical research which may impact an individual as the recipient of care or the participant in a research study. There are also events that occur within a care setting that might or might not impact an individual but had the potential to cause an adverse event. Health care organizations monitor and report both adverse events as well as events that had the potential to cause patient harm. Data are often aggregated for reporting purposes.

An adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects. Examples of adverse events include the administration of an incorrect drug or an incorrect dose of a drug causing an adverse reaction, the use of an implanted device that causes an infection, or a biologic used during a research study that causes unanticipated renal failure. These events are characterized by the need to capture cause and effect (although they might not be known at the time of the event), severity, and outcome.

The context of an adverse event is also important. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause and effect relationship for an adverse event.

A potential adverse event may also be called a near miss or an error. These are also events but because they were detected did not cause harm to a subject. Examples of potential adverse events include a product problem such as a faulty pacemaker that is detected prior implantation, a doctor working simultaneously on two electronic health records realizing the order for a drug was entered on the incorrect patient and then canceling the order, or a patient with a peanut allergy notices that his hospital dinner tray includes peanuts, and he does not eat the peanuts.

11.8.2 Boundaries and Relationships

The AdverseEvent resource is designed to represent events that have a harmful impact on a subject, or had the potential to cause harm to a subject but were avoided. In the course of medical care there are many actions that may impact how a subject responds to a particular treatment impacting patient safety. Therefore the AdverseEvent resource may reference multiple other resources to represent the context or details of an adverse event including but not limited to Observation, Condition, MedicationAdminsitration, Immunization, Procedure, or ResearchStudy.

A DetectedIssue reference is also related to the context of an AdverseEvent to the extent that a known risk for a potential issue such as a drug-drug interaction is documented. If in the context of a known issue, and adverse event occurs, citing this relationship is important for preventing such an occurrence in the future.

The AdverseEvent resource should not be used when a more specific resource exists.

The AllergyIntolerance resource is a case specific means of capturing the condition of an allergy or intolerance and the criticality (or potential for future harm) based on the response of a particular individual.
The Clinical Reasoning module provides resources and operations to enable the representation, distribution, and evaluation of clinical knowledge artifacts such as clinical decision support rules, quality measures, order sets, and protocols. The suite of resources within the clinical reasoning module should be used to capture clinical quality measures and clinical protocols that help drive clinical best practices.
The AdverseEvent resource is not intended to be used to capture potential subject risk in a prospective manner. A more appropriate resource for this purpose would be Risk Assessment which captures predicted outcomes for a patient or population on the basis of source information. Examples include a prognosis statement for a particular condition, risk of health outcome (heart attack, particular type of cancer) on the basis of lifestyle factors and/or family history or list of potential health risks based on a patient's genetic analysis.

This resource is referenced by medicinalproduct

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductClinicals	Σ D		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
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 -->
  <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
    "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.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 DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.