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| ID | Path | Min | Max | Type(s) | Short | Definition | Binding Strength | Binding Description | Läkemedelsverket | E-hälso-myndigheten | Inera | Region |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | PMS-id eller PMS-pack-id borde det väl vara här eftersom det ska gå att förstå över EU? Är på g att införa i NPL. Hur ska man förstå beskrivningen, måste man välja antingen att identifiera på produktnivå eller förpackningsnivå för alla produkter? | Virtuella produkter har väl inte PMS-id? | ||||
| 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 | Finns flera tänkbara klassifikationer, behöver komma överens om vilka som är intressanta att ta med här. ATC finns, | |||
| 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. | Finns produktnamn i NPL, det är lite av en mix av invented name och common name men det stämmer rätt bra med EHDS beskrivning. | |||||
| 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. | En läkemedelsprodukt kan ha både MAH och ombud (manufacturer?). Vad ska anges? Finns även fler roller. | |||||
| 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 | ||||||
| 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 | Finns i NPL, ett fåtal är nationellt unika och saknar mappning till EDQM ST. | |||
| 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. | Antal i förpackning finns numeriskt i VARA. Dock inte möjligt att ange flera. 1 creme & 6 pessaries skulle bli "1 styck" med förpackningstyp "blister och tub". I vissa fall dock uppdelat på flera attribut ex. 5x3 ml 3x28 tabletter Koder delvis enligt EDQM ST. Text finns som beskriver helheten. | |||
| 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 | Tillverkad enhet finns i NPL | |||||
| EHDSMedication.item.doseForm | EHDSMedication.item.doseForm | 0 | 1 | CodeableConcept | Dose form | Dose form | preferred | EDQM Standard Terms | Läkemedelsform för Tillverkad enhet finns i NPL | |||
| EHDSMedication.item.ingredient | EHDSMedication.item.ingredient | 1 | * | Base | Ingredients | Ingredients | Beståndsdelar/referenssubstanser finns i NPL | |||||
| 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. | Finns (motsvarande) i NPL | |||||
| EHDSMedication.item.ingredient.substance | EHDSMedication.item.ingredient.substance | 1 | 1 | CodeableConcept | Substance | Substance | preferred | EMA SPOR SMS | SMS-id är på gång att införas i NSL. | |||
| 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 | ||||||
| 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 | Framgår inte här men man kan gissa att concentration strength ska använda UCUM för måttenheter och presentation strength ska använda EDQM ST för presentationsenheter. Mappning till UCUM kan vi få tag i, presentationsenheter enligt EDQM ST är det lite värre med (se nedan). | |||||
| 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 | Finns (motsvarande) i NPL. Man kan gissa att om basisOfStrengthSubstance saknas så ska man tolka detta som att beståndsdelen i sig själv utgör basis of strength? | |||
| 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 | Sätts sen ca ett år tillbaka på nya produkter som godkänns/registreras, men saknas i regel för äldre produkter. | |||
| 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) | ||||||
| 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. | ||||
| 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. | Förpackningstyp finns i VARA (anges av företag i LiiV). Bara på förpackningsnivå, inte per tillverkad enhet (ex. blister och tub). Koder delvis enligt EDQM ST. | |||
| EHDSMedication.device | EHDSMedication.device | 0 | * | Base | Administration device included in the product | Administration device included in the product | Inte i NPL/VARA | |||||
| EHDSMedication.device.deviceQuantity | EHDSMedication.device.deviceQuantity | 1 | 1 | Quantity | Number of such devices | Number of such devices | ||||||
| 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 | ||||||
| EHDSMedication.characteristic | EHDSMedication.characteristic | 0 | * | Base | Other features of the product | Other features of the product | Svårt att veta vad som förväntas här… | |||||
| EHDSMedication.characteristic.type | EHDSMedication.characteristic.type | 1 | 1 | CodeableConcept | A code expressing the type of characteristic | A code expressing the type of characteristic | ||||||
| EHDSMedication.characteristic.value[x] | EHDSMedication.characteristic.value[x] | 0 | 1 | boolean CodeableConceptstringQuantitydateTimeintegerdecimalRatio | Description of the characteristic | Description of the characteristic | ||||||
| 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. | ||||||
| EHDSMedication.batch.lotNumber | EHDSMedication.batch.lotNumber | 0 | 1 | string | Batch identifier of the medicinal product | Batch identifier of the medicinal product | ||||||
| EHDSMedication.batch.expirationDate | EHDSMedication.batch.expirationDate | 0 | 1 | dateTime | Batch expiration date of the medicinal product. | Batch expiration date of the medicinal product. |
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