Generated Narrative: StructureDefinition EHDSMedicationLaboratoryObligations Name Flags Card. Type Description & Constraints EHDSMedication 0..* EHDSMedication Medication model #xD; identifyingCode[x] O 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. Obligations Actor SHALL:able-to-populate Producer #xD; classification O 0..* CodeableConcept Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; productName O 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. Obligations Actor SHOULD:able-to-populate Producer SHOULD:display Consumer #xD; marketingAuthorisationHolder O 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. Obligations Actor SHOULD:able-to-populate Producer #xD; description O 0..1 string Textual description of the product, e.g. including package description. Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; item O 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 Obligations Actor SHOULD:able-to-populate Producer SHALL:display Consumer #xD; ingredient O 1..* Base Ingredients Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; isActive O 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. Obligations Actor SHOULD:able-to-populate Producer #xD; substance O 1..1 CodeableConcept Substance Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; strengthInfo #xD; strength O 1..1 Ratio Concentration or presentation strength, e.g '100 mg/1 ml' or '500 mg per 1 tablet' Obligations Actor SHALL:able-to-populate Producer SHALL:display Consumer #xD; Documentation for this format
Medication laboratory specific obligations
Obligations for the logical model of medication in the scope of laboratory use case
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.