IDFörslag svensk termMinMaxNationella krav på kardinalitetType(s)DefinitionFörslag svensk beskrivningRequirementsNationellt kodsystemRIM-mappningKommentarer
EHDSMedication
0*

Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and administrations. Each of those may have different restrictions in a FHIR profile. The model is suitable for generic/virtual medications as well as branded/real products. The model aims to have basic alignment with ISO IDMP but it does not cover the full complexity needed for medication registries.




EHDSMedication.identifyingCode[x]
0*
CodeableConcept
Identifier
An identifier (e.g. from EMA SPOR PMS or national registry) or a code (e.g. from SNOMED CT or national code system) for the product (virtual product, branded product, or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. An identifier might not exist e.g. for substance-based prescriptions.




EHDSMedication.classification
0*
CodeableConceptClassification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)




EHDSMedication.productName
01
stringCurrent trade name (authorised name) of the product. When medication is specified by a CodeableConcept, the name may be omitted when available as the display name of the concept.




EHDSMedication.marketingAuthorisationHolder
01
BaseMarketing authorisation holder of the medicinal product. Relevant for identifying the exact product. If the product does not have a marketing authorisation, the manufacturer information may be used.




EHDSMedication.marketingAuthorisationHolder.organisationName
01
stringName of the organisation holding the authorisation for marketing/manufacturing




EHDSMedication.marketingAuthorisationHolder.organisationIdentifier
0*
IdentifierIdentifier of the organisation and/or its physical location




EHDSMedication.doseForm
01
CodeableConceptDose form at the package level (e.g. authorised dose form), corresponding to IDMP Combined Pharmaceutical Dose Form (this includes terms from EDQM Combination Pack or Combined Dose Form lists). Dose form for a single package item is defined in item.doseForm.




EHDSMedication.description
01
stringTextual description of the product, e.g. including package description.




EHDSMedication.item
0*
BaseA medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined




EHDSMedication.item.doseForm
01
CodeableConceptAdministrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.




EHDSMedication.item.ingredient
1*
BaseIngredients




EHDSMedication.item.ingredient.isActive
01
booleanMarks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.




EHDSMedication.item.ingredient.substance
11
CodeableConceptSubstance




EHDSMedication.item.ingredient.strengthInfo
01
BaseStrength of the product - amount of substance per unit




EHDSMedication.item.ingredient.strengthInfo.strength
11
RatioConcentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'




EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance
01
CodeableConceptSubstance that the strength refers to, especially when different from .item.strength.substance




EHDSMedication.item.unitOfPresentation
01
CodeableConceptUnit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.




EHDSMedication.item.containedQuantity
01
RatioManufactured item quantity per one item (3 ml / 1 vial)




EHDSMedication.item.amount
01
QuantityNumber of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size.




EHDSMedication.item.packageType
01
CodeableConceptType of package of the medication item




EHDSMedication.device
0*
BaseAdministration device included in the product. Devices that are not inside the medication package are excluded.




EHDSMedication.device.deviceQuantity
11
QuantityNumber of such devices




EHDSMedication.device.device[x]
11
CodeableConcept
http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSDevice
Device coded




EHDSMedication.characteristic
0*
BaseAdditional features of the product (e.g. reimbursable, sugar-free, easy-open cap, score-lined). It is expected that implementers will define a valueset supporting their use cases.




EHDSMedication.characteristic.type
11
CodeableConceptA code expressing the type of characteristic.




EHDSMedication.characteristic.value[x]
01
boolean
CodeableConceptstringQuantitydateTimeintegerdecimalRatio
Description of the characteristic value.




EHDSMedication.batch
01
BaseBatch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.




EHDSMedication.batch.lotNumber
01
stringBatch identifier of the medicinal product.




EHDSMedication.batch.expirationDate
01
dateTimeBatch expiration date of the medicinal product.