Generated Narrative: StructureDefinition EHDSMedication Name Flags Card. Type Description & Constraints <a href="StructureDefinition-EHDSMedication-definitions.html#EHDSMedication" title="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 0..* Base Medication model #xD; <a href="StructureDefinition-EHDSMedication-definitions.html#EHDSMedication.identifyingCode[x]" title="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.">identifyingCode[x] 0..* 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. #xD; identifyingCodeCodeableConcept CodeableConcept #xD; identifyingCodeIdentifier Identifier #xD; classification 0..* CodeableConcept Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Binding Description: (preferred): WHO ATC #xD; 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. #xD; 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. #xD; organisationName 0..1 string Name of the organisation holding the authorisation for marketing/manufacturing #xD; organisationIdentifier 0..* Identifier Identifier of the organisation and/or its physical location #xD; 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. Binding Description: (preferred): EDQM Standard Terms #xD; description 0..1 string Textual description of the product, e.g. including package description. #xD; 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 #xD; doseForm 0..1 CodeableConcept Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms. Binding Description: (preferred): EDQM Standard Terms #xD; ingredient 1..* Base Ingredients #xD; 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. #xD; substance 1..1 CodeableConcept Substance Binding Description: (preferred): EMA SPOR SMS #xD; strengthInfo 0..1 Base Strength of the product - amount of substance per unit #xD; strength 1..1 Ratio Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet' #xD; basisOfStrengthSubstance 0..1 CodeableConcept Substance that the strength refers to, especially when different from .item.strength.substance Binding Description: (preferred): EMA SPOR SMS #xD; unitOfPresentation 0..1 CodeableConcept Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package. Binding Description: (preferred): EDQM Standard Terms #xD; containedQuantity 0..1 Ratio Manufactured item quantity per one item (3 ml / 1 vial) #xD; 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. Binding Description: (preferred): UCUM for units of measure. EDQM Standard Terms for units of presentation. #xD; packageType 0..1 CodeableConcept Type of package of the medication item Binding Description: (preferred): EDQM Standard Terms for packaging. #xD; device 0..* Base Administration device included in the product. Devices that are not inside the medication package are excluded. #xD; deviceQuantity 1..1 Quantity Number of such devices #xD; device[x] 1..1 Device coded #xD; deviceCodeableConcept CodeableConcept #xD; deviceEHDSDevice EHDSDevice #xD; 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. #xD; type 1..1 CodeableConcept A code expressing the type of characteristic. #xD; value[x] 0..1 Description of the characteristic value. #xD; valueBoolean boolean #xD; valueCodeableConcept CodeableConcept #xD; valueString string #xD; valueQuantity Quantity #xD; valueDateTime dateTime #xD; valueInteger integer #xD; valueDecimal decimal #xD; valueRatio Ratio #xD; batch 0..1 Base Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request. #xD; lotNumber 0..1 string Batch identifier of the medicinal product. #xD; expirationDate 0..1 dateTime Batch expiration date of the medicinal product. #xD; Documentation for this format
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.
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.
Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)
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.
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.
Name of the organisation holding the authorisation for marketing/manufacturing
Identifier of the organisation and/or its physical location
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.
Textual description of the product, e.g. including package description.
A medication item. For combination packs, this can be multiple manufactured items with each item having its own dose form and ingredients+strengths defined
Administrable or manufactured item dose form, depending on the type of medication definition. This should not include combined dose forms.
Marks whether the ingredient is considered an active ingredient. Excipients are typically not needed, and by default only active ingredients are expected.
Strength of the product - amount of substance per unit
Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet'
Substance that the strength refers to, especially when different from .item.strength.substance
Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package.
Manufactured item quantity per one item (3 ml / 1 vial)
Number of such items in this product (5 vials). The combined amount of all items will be considered to be the total package size.
UCUM for units of measure. EDQM Standard Terms for units of presentation.
Administration device included in the product. Devices that are not inside the medication package are excluded.
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.
A code expressing the type of characteristic.
Description of the characteristic value.
Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request.
Batch identifier of the medicinal product.
Batch expiration date of the medicinal product.