...
- Det verkar inte finnas någon styrka styrkebeteckning på läkemedelsprodukten, bara uppgift om styrka på ingående substanser?
- I IDMP-standarden ses styrkebeteckning som en del av produktens namn. Det är möjligt att EHDS tänker sig att det är detta upplägg man ska använda, men det framgår inte riktigt.
| 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. | MAH publiceras i NPL. Tillverkare är inget som publiceras i nuläget, det finns olika typer och alla är inte publik data. Det vi kallar "Ansvarig tillverkare" / "Manufacturer responsible for batch release" skulle vi kunna börja publicera i NPL. | En läkemedelsprodukt kan ha både MAH och ombud (manufacturer?). Vad ska anges? Finns 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 | Finns i NPL. | |||||||
| 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 | NPL har ett nationellt register med organisations-id, men vi har ingen koppling till EMAs så kallade OMS-id. | |||||||
| 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 | 1 creme & 6 pessaries) | preferred | UCUM for units of measure. EDQM Standard Terms for units of presentation. | Detta attribut ligger på översta nivån, lite oklart hur det ska användas. Det är 0..*, ska man lista alla tänkbara förpackningsstorlekar som finns för den ordinerade produkten? Eller ska denna bara användas i de fall när en "EHDSMedication" syftar på en specifik förpackning? Det verkar nämligen också lite inkonsekvent vad en EHDSMedication avser.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 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 presentationStandard Terms for units of presentation. | Detta går att svara på med vår data förutsatt att man vet vilken specifik förpackad läkemedelsprodukt (läkemedelsartikel) som en EHDSMedication avser. Det går inte att beskriva för en läkemedelsprodukt i sig själv, utan förpackningskontexten. | |||||
| 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. | EHDS efterfrågar detta för Tillverkad enhet - vilket torde innebära att det är innerförpackningen som avses. Förpackningstyp enligt EDQM ST finns på i princip alla innerförpackningar i Läkemedelsverkets interna register, och skulle vara möjligt att publicera i NPL. | 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 | Finns ingen strukturerad data för detta i nuläget, det som finns är fritext som del av förpackningsbeskrivningen i NPL. | 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. |
...
| ID | Path | Min | Max | Type(s) | Short | Definition | Binding Strength | Binding Description | E-hälsomyndigheten | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EHDSDosaging | EHDSDosaging | 0 | * | Dosaging model | Logical model for usage instructions for administring the requested product. Based on FHIR Dosage complex data type. When implemented, this model may be reduced significantly according to the specific use case. | |||||||
| EHDSDosaging.sequence | EHDSDosaging.sequence | 0 | 1 | integer | Order of the dosage instruction, in case one treatment consists of several dosaging schemes | Order of the dosage instruction, in case one treatment consists of several dosaging schemes | sekvens I NLL finns även subsekvens. | |||||
| EHDSDosaging.text | EHDSDosaging.text | 0 | 1 | string | Free text usage/dosage instructions | Free text usage/dosage instructions | fritextdosering | |||||
| EHDSDosaging.additionalInstruction | EHDSDosaging.additionalInstruction | 0 | * | CodeableConcept | Coded instructions, e.g warnings to the patient, like 'may cause drowsiness' etc | Coded instructions, e.g warnings to the patient, like 'may cause drowsiness' etc | annan instruktion Fritext i NLL. | |||||
| EHDSDosaging.patientInstruction | EHDSDosaging.patientInstruction | 0 | 1 | string | Patient oriented instructions as free text | Patient oriented instructions as free text | doseringsinstruktion Strukturerade doseringen omvandlad till patientvänlig text. | |||||
| EHDSDosaging.doseAndRate | EHDSDosaging.doseAndRate | 0 | * | Base | Amount of medication administered per one dose (= one timing) | Amount of medication administered per one dose (= one timing) | ||||||
| EHDSDosaging.doseAndRate.type | EHDSDosaging.doseAndRate.type | 0 | 1 | CodeableConcept | The kind of dose or rate specified (e.g calculated, ordered, etc). | The kind of dose or rate specified (e.g calculated, ordered, etc). | inte i NLL | |||||
| EHDSDosaging.doseAndRate.dose[x] | EHDSDosaging.doseAndRate.dose[x] | 0 | 1 | Quantity Range | Amount of medication per one dose. (1 tablet, 2-3 tablets, 20ml) | Amount of medication per one dose. (1 tablet, 2-3 tablets, 20ml) | dos och dosenhet dos min och dos max och dosenhet min och dosenhet max Swedish National Medication List - 21.12 | Dosenhet (nll-ucum-unit) - SIMPLIFIER.NET | |||||
| EHDSDosaging.doseAndRate.rate[x] | EHDSDosaging.doseAndRate.rate[x] | 0 | 1 | Ratio QuantityRange | Time period during which one defined dose is administered (per 1 hour, per 5-10 minutes) | Time period during which one defined dose is administered (per 1 hour, per 5-10 minutes) | doseringshastighet och doseringshastighetsenhet Ingen range i NLL. Hur ska en sådan användas? | |||||
| EHDSDosaging.timing | EHDSDosaging.timing | 0 | 1 | Base | When medication should be administered (period, time of day, frequency, etc) | When medication should be administered (period, time of day, frequency, etc) | ||||||
| EHDSDosaging.timing.event | EHDSDosaging.timing.event | 0 | * | dateTime | Exact date and/or time of the administration | Exact date and/or time of the administration | inte i NLL | |||||
| EHDSDosaging.timing.code | EHDSDosaging.timing.code | 0 | 1 | CodeableConcept | Timing abbreviation (AM - morning, Q4H - once in every 4 hours, BID - twice a day, etc) | Timing abbreviation (AM - morning, Q4H - once in every 4 hours, BID - twice a day, etc) | inte i NLL | |||||
| EHDSDosaging.timing.repeat | EHDSDosaging.timing.repeat | 0 | 1 | Base | Repetition of the administration. | Repetition of the administration. | ||||||
| EHDSDosaging.timing.repeat.bounds | EHDSDosaging.timing.repeat.bounds | 0 | 1 | Base | Time bounds for the treatment (current dosaging scheme). Only one of the following can exist. | Time bounds for the treatment (current dosaging scheme). Only one of the following can exist. | ||||||
| EHDSDosaging.timing.repeat.bounds.duration | EHDSDosaging.timing.repeat.bounds.duration | 0 | 1 | Quantity | Number of time units, e.g 10 days | Number of time units, e.g 10 days | längd doseringssteg och längdenhet doseringssteg (dag) UCUM | |||||
| EHDSDosaging.timing.repeat.bounds.range | EHDSDosaging.timing.repeat.bounds.range | 0 | 1 | Range | A range of numbers of time units, 5-10 days | A range of numbers of time units, 5-10 days | längd doseringssteg min, längd doseringssteg max längdenhet doseringssteg min, längdenhet doseringssteg max (dag) UCUM | |||||
| EHDSDosaging.timing.repeat.bounds.period | EHDSDosaging.timing.repeat.bounds.period | 0 | 1 | Period | Start and end date, 05.08.2023 - 10.08.2023 | Start and end date, 05.08.2023 - 10.08.2023 | inte i NLL | |||||
| EHDSDosaging.timing.repeat.count | EHDSDosaging.timing.repeat.count | 0 | 1 | Base | Number of times to repeat, exact or range | Number of times to repeat, exact or range | ||||||
| EHDSDosaging.timing.repeat.count.count | EHDSDosaging.timing.repeat.count.count | 0 | 1 | integer | Number of times (e.g 'once', '10 times') | Number of times (e.g 'once', '10 times') | antal upprepningar Används endast för engångsdosering, anges då till 1. | |||||
| EHDSDosaging.timing.repeat.count.countMax | EHDSDosaging.timing.repeat.count.countMax | 0 | 1 | integer | Maximum number of times (e.g 'maximum 10 times') | Maximum number of times (e.g 'maximum 10 times') | inte i NLL | |||||
| EHDSDosaging.timing.repeat.duration | EHDSDosaging.timing.repeat.duration | 0 | 1 | Base | Duration of one administration, exact or range | Duration of one administration, exact or range | ||||||
| EHDSDosaging.timing.repeat.duration.duration | EHDSDosaging.timing.repeat.duration.duration | 0 | 1 | Quantity | Duration of administration (e.g '5 minutes', '1 hour') | Duration of administration (e.g '5 minutes', '1 hour') | administreringstillfällets varaktighet enhet för administreringstillfällets varaktighet (minut och timme) UCUM | |||||
| EHDSDosaging.timing.repeat.duration.durationMax | EHDSDosaging.timing.repeat.duration.durationMax | 0 | 1 | Quantity | Maximum duration of administration (e.g 'maximum 1 hour') | Maximum duration of administration (e.g 'maximum 1 hour') | inte i NLL | |||||
| EHDSDosaging.timing.repeat.frequency | EHDSDosaging.timing.repeat.frequency | 0 | 1 | Base | Frequency of intake/administration (e.g 'three times a day') | Frequency of intake/administration (e.g 'three times a day') | ||||||
| EHDSDosaging.timing.repeat.frequency.numberOfTimes | EHDSDosaging.timing.repeat.frequency.numberOfTimes | 0 | 1 | integer | Number of times per period (e.g '3 times') | Number of times per period (e.g '3 times') | antal administreringar | |||||
| EHDSDosaging.timing.repeat.frequency.maxNumberOfTimes | EHDSDosaging.timing.repeat.frequency.maxNumberOfTimes | 0 | 1 | integer | Maximum number of times per period (e.g. 'maximum 3 times') | Maximum number of times per period (e.g. 'maximum 3 times') | antal administreringar max | |||||
| EHDSDosaging.timing.repeat.frequency.period | EHDSDosaging.timing.repeat.frequency.period | 0 | 1 | Quantity | Duration to which the frequency applies (e.g '... / 1 day') | Duration to which the frequency applies (e.g '... / 1 day') | period periodenhet (dag, timme) Swedish National Medication List - 21.12 | Periodenhet (dose-period-units) - SIMPLIFIER.NET UCUM | |||||
| EHDSDosaging.timing.repeat.frequency.periodMax | EHDSDosaging.timing.repeat.frequency.periodMax | 0 | 1 | Quantity | Upper limit of the period (e.g ... / 4-6 hours) | Upper limit of the period (e.g ... / 4-6 hours) | period max | |||||
| EHDSDosaging.timing.repeat.dayOfWeek | EHDSDosaging.timing.repeat.dayOfWeek | 0 | * | CodeableConcept | The day of the week of administration, e.g Mon, Tue, etc | The day of the week of administration, e.g Mon, Tue, etc | veckodag | |||||
| EHDSDosaging.timing.repeat.timeOfDay | EHDSDosaging.timing.repeat.timeOfDay | 0 | * | time | Time of day of administration (e.g '10:00') | Time of day of administration (e.g '10:00') | klockslag | |||||
| EHDSDosaging.timing.repeat.eventTime | EHDSDosaging.timing.repeat.eventTime | 0 | * | Base | An event the administration is bound to, e.g 'before meal', '30 min before meal' | An event the administration is bound to, e.g 'before meal', '30 min before meal' | ||||||
| EHDSDosaging.timing.repeat.eventTime.when | EHDSDosaging.timing.repeat.eventTime.when | 0 | * | CodeableConcept | Time period or event ('before meal', 'immediately', 'morning') | Time period or event ('before meal', 'immediately', 'morning') | period på dygnet (morgon, lunchtid, kväll, natt) Swedish National Medication List - 21.12 | Period på dygnet (nll-event-timing) - SIMPLIFIER.NET | |||||
| EHDSDosaging.timing.repeat.eventTime.offset | EHDSDosaging.timing.repeat.eventTime.offset | 0 | 1 | integer | minutes from event, before or after (?not sure how to show before/after with only positive integers) | minutes from event, before or after (?not sure how to show before/after with only positive integers) | inte i NLL | |||||
| EHDSDosaging.asNeeded | EHDSDosaging.asNeeded | 0 | 1 | boolean | Take as needed | Take as needed | vid behov | |||||
| EHDSDosaging.asNeededFor | EHDSDosaging.asNeededFor | 0 | * | CodeableConcept | Take as needed for the coded reason | Take as needed for the coded reason | inte i NLL | |||||
| EHDSDosaging.bodySite | EHDSDosaging.bodySite | 0 | 1 | CodeableConcept | Body site of administration | Body site of administration | administreringsställe Swedish National Medication List - 21.12 | nll-snomed-site - SIMPLIFIER.NET Snomed CT | |||||
| EHDSDosaging.routeOfAdministration | EHDSDosaging.routeOfAdministration | 0 | 1 | CodeableConcept | Route of administration | Route of administration | administreringsväg Swedish National Medication List - 21.12 | nll-snomed-route - SIMPLIFIER.NET Snomed CT | |||||
| EHDSDosaging.methodOfAdministration | EHDSDosaging.methodOfAdministration | 0 | 1 | CodeableConcept | Method of administration | Method of administration | administreringsmetod Swedish National Medication List - 21.12 | nll-snomed-method - SIMPLIFIER.NET Snomed CT | |||||
| EHDSDosaging.maxDose | EHDSDosaging.maxDose | 0 | * | Base | Maximum dose for the patient | Maximum dose for the patient | ||||||
| EHDSDosaging.maxDose.maxDosePerPeriod | EHDSDosaging.maxDose.maxDosePerPeriod | 0 | * | Ratio | Upper limit on medication per unit of time | Upper limit on medication per unit of time | maxdos maxdosenhet Swedish National Medication List - 21.12 | Dosenhet (nll-ucum-unit) - SIMPLIFIER.NET maxdosperiod maxdosperiodenhet (endast dygn) | |||||
| EHDSDosaging.maxDose.maxDosePerAdministration | EHDSDosaging.maxDose.maxDosePerAdministration | 0 | 1 | Quantity | Upper limit on medication per one administration | Upper limit on medication per one administration | inte i NLL | |||||
| EHDSDosaging.maxDose.maxDosePerLifetime | EHDSDosaging.maxDose.maxDosePerLifetime | 0 | 1 | Quantity | Upper limit on medication per lifetime of the patient | Upper limit on medication per lifetime of the patient | inte i NLL |