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Från eHealth Network guidelines

Patient Summary Guideline

Data Element Description Preferred Code Systems Pågående arbeten


A.2.4 Medication summary

•Nationella läkemedelslistan (NLL)
•Pågående arbete inom EMA och ISO-standarder för läkemedel,särskilt IDMP (Identification of Medicinal Products), Snomed



A.2.4.1 Current and relevant past medicines (Relevant prescribed medicines whose period of time indicated for the treatment has not yet expired whether it has been dispensed or not, or medicines that influence current health status or are relevant to a clinical decision)




A.2.4.1.1 Medication reason The reason why the medication is or was prescribed, or used This is the reason why the medication is being prescribed or used. It provides a link to the Past or current health conditions or problems that the patient has had or has. ICD-10* SNOMED CT GPS Orphacode if rare disease is diagnosed 



A.2.4.1.2 Intended useIndication intended use as: prevention or treatment Example: prophylaxis, treatment, diagnostic, anaesthesia, care of equipment,  




A.2.4.1.3 Brand name Brand name if biological medicinal product or when justified by the health professional (ref. Commission Directive 2012/52/EU) 




A.2.4.1.4 Active ingredient lists Substance that alone or in combination with one or more other ingredients produces the intended activity of a medicinal product. Example: "paracetamol" ATC* (IDMP identifier, when available) 



A.2.4.1.5 Strength The content of the active ingredient expressed quantifiably per dosage unit, per unit of volume or per unit of weight, according to the pharmaceutical dose form. Example: 500 mg per tablet UCUM, EDQM Standard Terms 



A.2.4.1.6 Pharmaceutical dose form The form in which a pharmaceutical product is presented in the medicinal product package (e.g. tablet, syrup) EDQM Standard Terms 



A.2.4.1.7 Dosage Regimen Number of units per intake and frequency of intake over a specified duration of time. Example: 1 tablet every 24h, for 10 days




 A.2.4.1.8 Route of administration Path by which the pharmaceutical product is taken into or makes contact with the body. EDQM Standard Terms 



A.2.4.1.9 Date of onset of treatment Date when patient needs to start taking the medicine prescribed ISO 8601





Exporterat från logisk modell för Medicinal product

Medicinal product model - EHDS Logical Information Models v0.1.0

IDPathMinMaxType(s)ShortDefinitionBinding StrengthBinding DescriptionBase Max
EHDSMedicationEHDSMedication0*
Medicinal product modelLogical 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.classificationEHDSMedication.classification0*CodeableConceptClassification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)Classification (e.g. ATC; narcotic/psychotropic; orphan drug; etc.)preferredWHO ATC*
EHDSMedication.productNameEHDSMedication.productName01stringName 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.marketingAuthorisationHolderEHDSMedication.marketingAuthorisationHolder01BaseMarketing 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.organizationNameEHDSMedication.marketingAuthorisationHolder.organizationName01stringName of the organisation holding the authorisation for marketing/mahufacturingName of the organisation holding the authorisation for marketing/mahufacturing

1
EHDSMedication.marketingAuthorisationHolder.organizationIdentifierEHDSMedication.marketingAuthorisationHolder.organizationIdentifier0*IdentifierIdentifier of the organisation and/or its physical locationIdentifier of the organisation and/or its physical location

*
EHDSMedication.doseFormEHDSMedication.doseForm01CodeableConceptDose 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.preferredEDQM Standard Terms1
EHDSMedication.packSizeEHDSMedication.packSize0*QuantityOverall 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)preferredUCUM for units of measure. EDQM Standard Terms for units of presentation.*
EHDSMedication.itemEHDSMedication.item0*BaseA medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths definedA medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined

*
EHDSMedication.item.doseFormEHDSMedication.item.doseForm01CodeableConceptDose formDose formpreferredEDQM Standard Terms1
EHDSMedication.item.ingredientEHDSMedication.item.ingredient1*BaseIngredientsIngredients

*
EHDSMedication.item.ingredient.isActiveEHDSMedication.item.ingredient.isActive01booleanMarks 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.substanceEHDSMedication.item.ingredient.substance11CodeableConceptSubstanceSubstancepreferredEMA SPOR SMS1
EHDSMedication.item.ingredient.strengthInfoEHDSMedication.item.ingredient.strengthInfo01BaseStrength of the product - amount of substance per unitStrength of the product - amount of substance per unit

1
EHDSMedication.item.ingredient.strengthInfo.strengthEHDSMedication.item.ingredient.strengthInfo.strength11RatioConcentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tabletConcentration or presentation strength, e.g 100mg/1ml or 500mg per 1 tablet

1
EHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstanceEHDSMedication.item.ingredient.strengthInfo.basisOfStrengthSubstance01CodeableConceptSubstance that the strength refers to, in case it's different from the main substanceSubstance that the strength refers to, in case it's different from the main substancepreferredEMA SPOR SMS1
EHDSMedication.item.unitOfPresentationEHDSMedication.item.unitOfPresentation01CodeableConceptUnit 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.preferredEDQM Standard Terms1
EHDSMedication.item.containedQuantityEHDSMedication.item.containedQuantity01RatioManufactured item quantity for liquids (3ml / 1 vial)Manufactured item quantity for liquids (3ml / 1 vial)

1
EHDSMedication.item.amountEHDSMedication.item.amount01QuantityNumber of such manufactured items in this product (5 vials)Number of such manufactured items in this product (5 vials)preferredUCUM for units of measure. EDQM Standard Terms for units of presentation.1
EHDSMedication.item.packageTypeEHDSMedication.item.packageType01CodeableConceptType of package of the medication itemType of package of the medication itempreferredEDQM Standard Terms for packaging.1
EHDSMedication.deviceEHDSMedication.device0*BaseAdministration device included in the productAdministration device included in the product

*
EHDSMedication.device.deviceQuantityEHDSMedication.device.deviceQuantity11QuantityNumber of such devicesNumber of such devices

1
EHDSMedication.device.device[x]EHDSMedication.device.device[x]11CodeableConcept
Reference(https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSDevice)
Device codedDevice coded

1
EHDSMedication.characteristicEHDSMedication.characteristic0*BaseOther features of the productOther features of the product

*
EHDSMedication.characteristic.typeEHDSMedication.characteristic.type11CodeableConceptA code expressing the type of characteristicA code expressing the type of characteristic

1
EHDSMedication.characteristic.value[x]EHDSMedication.characteristic.value[x]01boolean
CodeableConceptstringQuantitydateTimeintegerdecimalRatio
Description of the characteristicDescription of the characteristic

1
EHDSMedication.batchEHDSMedication.batch01BaseBatch 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.lotNumberEHDSMedication.batch.lotNumber01stringBatch identifier of the medicinal productBatch identifier of the medicinal product

1
EHDSMedication.batch.expirationDateEHDSMedication.batch.expirationDate01dateTimeBatch expiration date of the medicinal product.Batch expiration date of the medicinal product.

1




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