ClinicalUseDefinition
An indication, contra-indication, interaction, adverse effect or warning for a pharmaceutical product. The structured SmPC on the FHIR side.
Purpose
ClinicalUseDefinition wraps a regulatory clinical fact associated with a medicinal product: indication, absolute or relative contra-indication, drug-drug interaction, pharmacovigilance-observed adverse effect, or warning. It is dimensioned to carry the FHIR equivalent of the SmPC (Summary of Product Characteristics) and is used by the EMA in the SPOR project (Substance, Product, Organisation, Referential).
Key elements
| Field | Type | Cardinality | Role |
|---|---|---|---|
identifier | Identifier[] | 0..* | External identifiers (SPOR PCID). |
type | code | 1..1 | `indication`, `contraindication`, `interaction`, `undesirable-effect`, `warning`. |
category | CodeableConcept[] | 0..* | Sub-category (e.g. moderate or severe interaction). |
subject | Reference(MedicinalProductDefinition | Medication | ...)[] | 0..* | Concerned product, substance or device. |
status | CodeableConcept | 0..1 | Status (current, retired, draft). |
contraindication | BackboneElement | 0..1 | Detail when type=contraindication: disease, comorbidity, comedication. |
indication | BackboneElement | 0..1 | Detail when type=indication: target disease, duration, comorbidity. |
interaction | BackboneElement | 0..1 | Detail when type=interaction: interacting substance, mechanism, effect. |
undesirableEffect | BackboneElement | 0..1 | Adverse effect detail: frequency, affected organ. |
warning | BackboneElement | 0..1 | General warning (at-risk population, pregnancy). |
JSON example
{
"resourceType": "ClinicalUseDefinition",
"id": "example-contraindication-aspirin",
"type": "contraindication",
"subject": [{
"reference": "MedicinalProductDefinition/aspirin-300"
}],
"contraindication": {
"diseaseSymptomProcedure": {
"concept": {
"coding": [{
"system": "http://snomed.info/sct",
"code": "37796009",
"display": "Migraine syndrome"
}]
}
},
"comorbidity": [{
"concept": {
"coding": [{
"system": "http://snomed.info/sct",
"code": "13200003",
"display": "Peptic ulcer"
}]
}
}]
}
}Common pitfalls
- Confusing `indication` and `subject.indication` (CarePlan): ClinicalUseDefinition is for regulation, CarePlan for patient follow-up.
- Type=interaction without specifying the interacting substance: useless info.
- Maturity 1 — the API may evolve before R6.
Related resources
- medicinalproductdefinition — global medicinal product.
- administrableproductdefinition — administrable form.
- ingredient — composition.
- adverseevent — patient-level adverse event.