EHDSMedication

ID	Min	Max	Type(s)	Definition
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	*	CodeableConcept	Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
EHDSMedication.productName	0	1	string	Current 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	0	1	Base	Marketing 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	0	1	string	Name of the organisation holding the authorisation for marketing/manufacturing
EHDSMedication.marketingAuthorisationHolder.organisationIdentifier	0	*	Identifier	Identifier of the organisation and/or its physical location
EHDSMedication.doseForm	0	1	CodeableConcept	Dose 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	0	1	string	Textual description of the product, e.g. including package description.
EHDSMedication.item	0	*	Base	A 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	0	1	CodeableConcept	Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.
EHDSMedication.item.ingredient	1	*	Base	Ingredients
EHDSMedication.item.ingredient.isActive	0	1	boolean	Marks 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	1	1	CodeableConcept	Substance
EHDSMedication.item.ingredient.strengthInfo	0	1	Base	Strength of the product - amount of substance per unit
EHDSMedication.item.ingredient.strengthInfo.strength	1	1	Ratio	Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance	0	1	CodeableConcept	Substance that the strength refers to, especially when different from .item.strength.substance
EHDSMedication.item.unitOfPresentation	0	1	CodeableConcept	Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
EHDSMedication.item.containedQuantity	0	1	Ratio	Manufactured item quantity per one item (3 ml / 1 vial)
EHDSMedication.item.amount	0	1	Quantity	Number 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	0	1	CodeableConcept	Type of package of the medication item
EHDSMedication.device	0	*	Base	Administration device included in the product. Devices that are not inside the medication package are excluded.
EHDSMedication.device.deviceQuantity	1	1	Quantity	Number of such devices
EHDSMedication.device.device[x]	1	1	CodeableConcept http://www.xt-ehr.eu/fhir/models/StructureDefinition/EHDSDevice	Device coded
EHDSMedication.characteristic	0	*	Base	Additional 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	1	1	CodeableConcept	A code expressing the type of characteristic.
EHDSMedication.characteristic.value[x]	0	1	boolean CodeableConceptstringQuantitydateTimeintegerdecimalRatio	Description of the characteristic value.
EHDSMedication.batch	0	1	Base	Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
EHDSMedication.batch.lotNumber	0	1	string	Batch identifier of the medicinal product.
EHDSMedication.batch.expirationDate	0	1	dateTime	Batch expiration date of the medicinal product.

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