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Medicinal product model - EHDS Logical Information Models v0.1.0
| ID | Path | Min | Max | Type(s) | Short | Definition | Binding Strength | Binding Description | Base Max |
|---|---|---|---|---|---|---|---|---|---|
| EHDSMedication | EHDSMedication | 0 | * | Medicinal product model | Logical model for prescribed/dispensed medication. The model is shared by statements, requests, dispensations, and treatment lines. Each of those may have different restrictions in FHIR profile. | * | |||
| EHDSMedication.identifyingCode[x] | EHDSMedication.identifyingCode[x] | 0 | * | CodeableConcept Identifier | Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. | Identifier or code for the product (virtual product, branded product or package). If several identifiers are specified, they shall not have conflicting meanings or very different granularities. | * | ||
| EHDSMedication.classification | EHDSMedication.classification | 0 | * | CodeableConcept | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) | Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.) | preferred | WHO ATC | * |
| EHDSMedication.productName | EHDSMedication.productName | 0 | 1 | string | Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided. | Name of the product (full name, invented name, other). When the product has different names, the appropriate one for the context should be used. Translations of names can be provided. | 1 | ||
| EHDSMedication.marketingAuthorisationHolder | EHDSMedication.marketingAuthorisationHolder | 0 | 1 | Base | Marketing authorisation holder or manufacturer of the medicinal product. Relevant for identifying the exact product. | Marketing authorisation holder or manufacturer of the medicinal product. Relevant for identifying the exact product. | 1 | ||
| EHDSMedication.marketingAuthorisationHolder.organizationName | EHDSMedication.marketingAuthorisationHolder.organizationName | 0 | 1 | string | Name of the organisation holding the authorisation for marketing/mahufacturing | Name of the organisation holding the authorisation for marketing/mahufacturing | 1 | ||
| EHDSMedication.marketingAuthorisationHolder.organizationIdentifier | EHDSMedication.marketingAuthorisationHolder.organizationIdentifier | 0 | * | Identifier | Identifier of the organisation and/or its physical location | Identifier of the organisation and/or its physical location | * | ||
| EHDSMedication.doseForm | EHDSMedication.doseForm | 0 | 1 | CodeableConcept | Dose form(s) on a product level. Dose form for a single package item is defined below. | Dose form(s) on a product level. Dose form for a single package item is defined below. | preferred | EDQM Standard Terms | 1 |
| EHDSMedication.packSize | EHDSMedication.packSize | 0 | * | Quantity | Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries) | Overall amount of product in one package (100ml; 20 tablets; 1 creme & 6 pessaries) | preferred | UCUM for units of measure. EDQM Standard Terms for units of presentation. | * |
| EHDSMedication.item | EHDSMedication.item | 0 | * | Base | A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined | A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined | * | ||
| EHDSMedication.item.doseForm | EHDSMedication.item.doseForm | 0 | 1 | CodeableConcept | Dose form | Dose form | preferred | EDQM Standard Terms | 1 |
| EHDSMedication.item.ingredient | EHDSMedication.item.ingredient | 1 | * | Base | Ingredients | Ingredients | * | ||
| EHDSMedication.item.ingredient.isActive | EHDSMedication.item.ingredient.isActive | 0 | 1 | boolean | Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected. | Marks if the ingredient is considered an active ingredient. Typically excipients are not needed, so by default active ingredients are expected. | 1 | ||
| EHDSMedication.item.ingredient.substance | EHDSMedication.item.ingredient.substance | 1 | 1 | CodeableConcept | Substance | Substance | preferred | EMA SPOR SMS | 1 |
| EHDSMedication.item.ingredient.strengthInfo | EHDSMedication.item.ingredient.strengthInfo | 0 | 1 | Base | Strength of the product - amount of substance per unit | Strength of the product - amount of substance per unit | 1 | ||
| EHDSMedication.item.ingredient.strengthInfo.strength | EHDSMedication.item.ingredient.strengthInfo.strength | 1 | 1 | Ratio | Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet | Concentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet | 1 | ||
| EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance | EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance | 0 | 1 | CodeableConcept | Substance that the strength refers to, in case it's different from the main substance | Substance that the strength refers to, in case it's different from the main substance | preferred | EMA SPOR SMS | 1 |
| EHDSMedication.item.unitOfPresentation | EHDSMedication.item.unitOfPresentation | 0 | 1 | CodeableConcept | Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package. | Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package. | preferred | EDQM Standard Terms | 1 |
| EHDSMedication.item.containedQuantity | EHDSMedication.item.containedQuantity | 0 | 1 | Ratio | Manufactured item quantity for liquids (3ml / 1 vial) | Manufactured item quantity for liquids (3ml / 1 vial) | 1 | ||
| EHDSMedication.item.amount | EHDSMedication.item.amount | 0 | 1 | Quantity | Number of such manufactured items in this product (5 vials) | Number of such manufactured items in this product (5 vials) | preferred | UCUM for units of measure. EDQM Standard Terms for units of presentation. | 1 |
| EHDSMedication.item.packageType | EHDSMedication.item.packageType | 0 | 1 | CodeableConcept | Type of package of the medication item | Type of package of the medication item | preferred | EDQM Standard Terms for packaging. | 1 |
| EHDSMedication.device | EHDSMedication.device | 0 | * | Base | Administration device included in the product | Administration device included in the product | * | ||
| EHDSMedication.device.deviceQuantity | EHDSMedication.device.deviceQuantity | 1 | 1 | Quantity | Number of such devices | Number of such devices | 1 | ||
| EHDSMedication.device.device[x] | EHDSMedication.device.device[x] | 1 | 1 | CodeableConcept Reference(https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSDevice) | Device coded | Device coded | 1 | ||
| EHDSMedication.characteristic | EHDSMedication.characteristic | 0 | * | Base | Other features of the product | Other features of the product | * | ||
| EHDSMedication.characteristic.type | EHDSMedication.characteristic.type | 1 | 1 | CodeableConcept | A code expressing the type of characteristic | A code expressing the type of characteristic | 1 | ||
| EHDSMedication.characteristic.value[x] | EHDSMedication.characteristic.value[x] | 0 | 1 | boolean CodeableConceptstringQuantitydateTimeintegerdecimalRatio | Description of the characteristic | Description of the characteristic | 1 | ||
| EHDSMedication.batch | 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. | Batch information of a medicinal product. Typically recorded during dispense or administration, rarely known or relevant for a prescription/request. | 1 | ||
| EHDSMedication.batch.lotNumber | EHDSMedication.batch.lotNumber | 0 | 1 | string | Batch identifier of the medicinal product | Batch identifier of the medicinal product | 1 | ||
| EHDSMedication.batch.expirationDate | EHDSMedication.batch.expirationDate | 0 | 1 | dateTime | Batch expiration date of the medicinal product. | Batch expiration date of the medicinal product. | 1 |