AdministrableProductDefinition — Administrable form
The finished form of a pharmaceutical product as it is given to the patient: tablet, capsule, solution for injection, transdermal patch. The ISO IDMP pivot on the FHIR side.
Purpose
AdministrableProductDefinition represents the finished product as it is administered: dosage form, target route, unit of presentation, regulatory maximum doses. It is the FHIR equivalent of the ISO IDMP Pharmaceutical Product concept.
This resource is typically used by regulators (EMA, FDA, ANSM) to describe a product in its marketing authorisation, and by pharma industry to submit structured data (EMA SPOR, FDA SPL).
Key elements
| Field | Type | Cardinality | Role |
|---|---|---|---|
identifier | Identifier[] | 0..* | Regulatory identifiers (EMA PCID, FDA SPL SetID). |
status | code | 0..1 | draft, active, retired, unknown. |
formOf | Reference(MedicinalProductDefinition)[] | 0..* | Medicinal product this is the administrable form of. |
administrableDoseForm | CodeableConcept | 0..1 | Dose form EDQM Standard Terms (tablet, capsule, syrup…). |
unitOfPresentation | CodeableConcept | 0..1 | Unit in which the product is presented. |
producedFrom | Reference(ManufacturedItemDefinition)[] | 0..* | Originating manufactured item. |
ingredient | CodeableConcept[] | 0..* | Active substances (summary; details in Ingredient). |
device | Reference(DeviceDefinition) | 0..1 | Associated administration device (pen, inhaler). |
routeOfAdministration | BackboneElement[] | 1..* | Route + regulatory dosing limits. |
JSON example
Aspirin 300 mg tablet with regulatory dosing:
{
"resourceType": "AdministrableProductDefinition",
"id": "example-tablet",
"identifier": [{
"system": "https://spor.ema.europa.eu/pmswi/",
"value": "PCID-12345"
}],
"status": "active",
"formOf": [{
"reference": "MedicinalProductDefinition/aspirin-300"
}],
"administrableDoseForm": {
"coding": [{
"system": "http://standardterms.edqm.eu",
"code": "10219000",
"display": "Tablet"
}]
},
"unitOfPresentation": {
"coding": [{
"system": "http://standardterms.edqm.eu",
"code": "15054000",
"display": "Tablet"
}]
},
"producedFrom": [{
"reference": "ManufacturedItemDefinition/aspirin-300-mfi"
}],
"ingredient": [{
"coding": [{
"system": "http://snomed.info/sct",
"code": "387458008",
"display": "Aspirin (substance)"
}]
}],
"routeOfAdministration": [{
"code": {
"coding": [{
"system": "http://standardterms.edqm.eu",
"code": "20053000",
"display": "Oral use"
}]
},
"firstDose": {
"value": 300,
"unit": "mg"
},
"maxSingleDose": {
"value": 600,
"unit": "mg"
},
"maxDosePerDay": {
"value": 4000,
"unit": "mg"
}
}]
}Common pitfalls
- Confusion with ManufacturedItemDefinition: the manufactured item is the physical object (blister, strip); AdministrableProductDefinition is the abstract administrable form.
- EDQM Standard Terms required: using non-EDQM codes in
administrableDoseFormbreaks regulatory interoperability. - routeOfAdministration vs Medication.form: the latter is for plain clinical usage; AdministrableProductDefinition is for regulation.
Related resources
- MedicinalProductDefinition — global medicinal product.
- Ingredient — detailed composition.
- PackagedProductDefinition — commercial packaging.
- ClinicalUseDefinition — indications, contra-indications.
- Medication — plain clinical usage (vs regulation).