{
  "resourceType": "StructureDefinition",
  "id": "ISiKMedikament",
  "url": "https://gematik.de/fhir/isik/v3/Medikation/StructureDefinition/ISiKMedikament",
  "version": "3.1.1",
  "name": "ISiKMedikament",
  "status": "active",
  "experimental": false,
  "date": "2025-12-01",
  "publisher": "gematik GmbH",
  "description": "Dieses Profil ermöglicht die Abbildung von patientenunabhängigen Informationen zu Medikamenten in ISiK Szenarien.",
  "fhirVersion": "4.0.1",
  "kind": "resource",
  "abstract": false,
  "type": "Medication",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Medication",
  "derivation": "constraint",
  "differential": {
    "element": [
      {
        "id": "Medication",
        "path": "Medication",
        "constraint": [
          {
            "key": "isik-med-1",
            "severity": "error",
            "human": "Medikamenten-Code, -Bezeichnung oder Inhaltsstoffe müssen angegeben werden.",
            "expression": "code.exists() or ingredient.exists()",
            "source": "https://gematik.de/fhir/isik/v3/Medikation/StructureDefinition/ISiKMedikament"
          }
        ]
      },
      {
        "id": "Medication.code",
        "path": "Medication.code",
        "short": "Medikament in codierter Form oder ggf. als Freitext",
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding",
        "path": "Medication.code.coding",
        "slicing": {
          "discriminator": [
            {
              "type": "pattern",
              "path": "$this"
            }
          ],
          "rules": "open"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:PZN",
        "path": "Medication.code.coding",
        "sliceName": "PZN",
        "comment": "Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere PZN-Codes existieren können, z. B. existieren für Aspirin 3 verschiedene Packungsgrößen.",
        "min": 0,
        "max": "*",
        "patternCoding": {
          "system": "http://fhir.de/CodeSystem/ifa/pzn"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:PZN.system",
        "path": "Medication.code.coding.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:PZN.code",
        "path": "Medication.code.coding.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:PZN.display",
        "path": "Medication.code.coding.display",
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:ATC-DE",
        "path": "Medication.code.coding",
        "sliceName": "ATC-DE",
        "comment": "Mehrfachcodierung ist zulässig, da für ein abstraktes Medikament auch mehrere ATC-Codes existieren können, z. B. existieren für Aspirin 4 verschiedene Codes, je nachdem wofür das Medikament angewendet wird.",
        "min": 0,
        "max": "*",
        "patternCoding": {
          "system": "http://fhir.de/CodeSystem/bfarm/atc"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:ATC-DE.system",
        "path": "Medication.code.coding.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:ATC-DE.code",
        "path": "Medication.code.coding.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:ATC-DE.display",
        "path": "Medication.code.coding.display",
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:WG14",
        "path": "Medication.code.coding",
        "sliceName": "WG14",
        "min": 0,
        "max": "1",
        "patternCoding": {
          "system": "http://fhir.de/CodeSystem/abdata/wg14"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:WG14.system",
        "path": "Medication.code.coding.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:WG14.code",
        "path": "Medication.code.coding.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.code.coding:WG14.display",
        "path": "Medication.code.coding.display",
        "mustSupport": true
      },
      {
        "id": "Medication.code.text",
        "path": "Medication.code.text",
        "mustSupport": true
      },
      {
        "id": "Medication.status",
        "path": "Medication.status",
        "short": "Status der Medikamenteninformation",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.manufacturer",
        "path": "Medication.manufacturer",
        "short": "Hersteller des Medikaments",
        "comment": "Hier kann der tatsächliche Hersteller des Medikaments benannt werden, vornehmlich im Fall von Wirkstoffmischungen (Rezepturen), beispielsweise die Krankenhausapotheke. Zu beachten ist, dass die zulassende Organisation, wie sie z.B. in den Daten zur PZN benannt ist, nicht als Hersteller gilt.",
        "mustSupport": true
      },
      {
        "id": "Medication.manufacturer.display",
        "path": "Medication.manufacturer.display",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.form",
        "path": "Medication.form",
        "short": "Abgabeform",
        "mustSupport": true
      },
      {
        "id": "Medication.form.coding",
        "path": "Medication.form.coding",
        "slicing": {
          "discriminator": [
            {
              "type": "pattern",
              "path": "$this"
            }
          ],
          "rules": "open"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.form.coding:EDQM",
        "path": "Medication.form.coding",
        "sliceName": "EDQM",
        "min": 0,
        "max": "1",
        "mustSupport": true,
        "binding": {
          "strength": "required",
          "valueSet": "http://hl7.org/fhir/uv/ips/ValueSet/medicine-doseform"
        }
      },
      {
        "id": "Medication.form.coding:EDQM.system",
        "path": "Medication.form.coding.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.form.coding:EDQM.code",
        "path": "Medication.form.coding.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.form.coding:EDQM.display",
        "path": "Medication.form.coding.display",
        "mustSupport": true
      },
      {
        "id": "Medication.amount",
        "path": "Medication.amount",
        "short": "Menge",
        "mustSupport": true
      },
      {
        "id": "Medication.amount.numerator",
        "path": "Medication.amount.numerator",
        "min": 1,
        "patternQuantity": {
          "system": "http://unitsofmeasure.org"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.amount.numerator.value",
        "path": "Medication.amount.numerator.value",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.amount.numerator.unit",
        "path": "Medication.amount.numerator.unit",
        "mustSupport": true
      },
      {
        "id": "Medication.amount.numerator.system",
        "path": "Medication.amount.numerator.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.amount.numerator.code",
        "path": "Medication.amount.numerator.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.amount.denominator",
        "path": "Medication.amount.denominator",
        "patternQuantity": {
          "system": "http://unitsofmeasure.org"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.amount.denominator.value",
        "path": "Medication.amount.denominator.value",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.amount.denominator.unit",
        "path": "Medication.amount.denominator.unit",
        "mustSupport": true
      },
      {
        "id": "Medication.amount.denominator.system",
        "path": "Medication.amount.denominator.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.amount.denominator.code",
        "path": "Medication.amount.denominator.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient",
        "path": "Medication.ingredient",
        "short": "Informationen zu Bestandteilen (Rezeptur)",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.extension",
        "path": "Medication.ingredient.extension",
        "short": "Wirkstofftyp",
        "comment": "Handelt es sich um eine Angabe zum Wirkstoff oder zum exakter Inhaltsstoff (z.B. Salze)?",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.extension:wirkstofftyp",
        "path": "Medication.ingredient.extension",
        "sliceName": "wirkstofftyp",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "https://www.medizininformatik-initiative.de/fhir/core/modul-medikation/StructureDefinition/wirkstofftyp"
            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]",
        "path": "Medication.ingredient.item[x]",
        "slicing": {
          "discriminator": [
            {
              "type": "type",
              "path": "$this"
            }
          ],
          "ordered": false,
          "rules": "open"
        }
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept",
        "path": "Medication.ingredient.item[x]",
        "sliceName": "itemCodeableConcept",
        "short": "Bestandteil in codierter Form oder ggf. als Freitext",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding",
        "path": "Medication.ingredient.item[x].coding",
        "slicing": {
          "discriminator": [
            {
              "type": "pattern",
              "path": "$this"
            }
          ],
          "rules": "open"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ASK",
        "path": "Medication.ingredient.item[x].coding",
        "sliceName": "ASK",
        "min": 0,
        "max": "1",
        "patternCoding": {
          "system": "http://fhir.de/CodeSystem/ask"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ASK.system",
        "path": "Medication.ingredient.item[x].coding.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ASK.code",
        "path": "Medication.ingredient.item[x].coding.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ASK.display",
        "path": "Medication.ingredient.item[x].coding.display",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ATC-DE",
        "path": "Medication.ingredient.item[x].coding",
        "sliceName": "ATC-DE",
        "min": 0,
        "max": "1",
        "patternCoding": {
          "system": "http://fhir.de/CodeSystem/bfarm/atc"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ATC-DE.system",
        "path": "Medication.ingredient.item[x].coding.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ATC-DE.code",
        "path": "Medication.ingredient.item[x].coding.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:ATC-DE.display",
        "path": "Medication.ingredient.item[x].coding.display",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:PZN",
        "path": "Medication.ingredient.item[x].coding",
        "sliceName": "PZN",
        "min": 0,
        "max": "1",
        "patternCoding": {
          "system": "http://fhir.de/CodeSystem/ifa/pzn"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:PZN.system",
        "path": "Medication.ingredient.item[x].coding.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:PZN.code",
        "path": "Medication.ingredient.item[x].coding.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:PZN.display",
        "path": "Medication.ingredient.item[x].coding.display",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:WG14",
        "path": "Medication.ingredient.item[x].coding",
        "sliceName": "WG14",
        "min": 0,
        "max": "1",
        "patternCoding": {
          "system": "http://fhir.de/CodeSystem/abdata/wg14"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:WG14.system",
        "path": "Medication.ingredient.item[x].coding.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:WG14.code",
        "path": "Medication.ingredient.item[x].coding.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.coding:WG14.display",
        "path": "Medication.ingredient.item[x].coding.display",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemCodeableConcept.text",
        "path": "Medication.ingredient.item[x].text",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemReference",
        "path": "Medication.ingredient.item[x]",
        "sliceName": "itemReference",
        "short": "Bestandteil (Referenz auf ein anderes Medikament)",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Substance",
              "http://hl7.org/fhir/StructureDefinition/Medication"
            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.item[x]:itemReference.reference",
        "path": "Medication.ingredient.item[x].reference",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.isActive",
        "path": "Medication.ingredient.isActive",
        "short": "handelt es sich um einen aktiven Bestandteil?",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength",
        "path": "Medication.ingredient.strength",
        "short": "Stärke",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength.numerator",
        "path": "Medication.ingredient.strength.numerator",
        "min": 1,
        "patternQuantity": {
          "system": "http://unitsofmeasure.org"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength.numerator.value",
        "path": "Medication.ingredient.strength.numerator.value",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength.numerator.unit",
        "path": "Medication.ingredient.strength.numerator.unit",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength.numerator.system",
        "path": "Medication.ingredient.strength.numerator.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength.numerator.code",
        "path": "Medication.ingredient.strength.numerator.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength.denominator",
        "path": "Medication.ingredient.strength.denominator",
        "patternQuantity": {
          "system": "http://unitsofmeasure.org"
        },
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength.denominator.value",
        "path": "Medication.ingredient.strength.denominator.value",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength.denominator.unit",
        "path": "Medication.ingredient.strength.denominator.unit",
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength.denominator.system",
        "path": "Medication.ingredient.strength.denominator.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.ingredient.strength.denominator.code",
        "path": "Medication.ingredient.strength.denominator.code",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Medication.batch",
        "path": "Medication.batch",
        "short": "Angaben zur Charge",
        "comment": "Bitte beachten Sie gegebenenfalls die Regelungen der zwischen GKV-SV und DAV: https://www.gkv-datenaustausch.de/leistungserbringer/apotheken/apotheken.jsp . Insbesondere den Technischen Anhang 7 (TA7) zur Arzneimittelabrechnungsvereinbarung gemäß § 300 Absatz 3 SGB V in der aktuellsten Fassung.",
        "mustSupport": true
      },
      {
        "id": "Medication.batch.lotNumber",
        "path": "Medication.batch.lotNumber",
        "short": "Chargennummer",
        "comment": "Gemäß Anlage 1 der TA7 kann hier übergangsweise bis zum 30. Juni 2025 eine Musterchargennummer (\"STELLEN\") eingetragen werden. Wenn die Übermittlung der Chargenbezeichnung beim Stellen von Arzneimitteln technisch nicht möglich ist, z.B. beim Verblistern, wird von der Verpflichtung zur Chargendokumentation abgesehen. Dementsprechend kann anstatt der tatsächlichen Chargenbezeichnungen \"STELLEN\" in das hierbeschirebene Datenfeld eingetragen werden.",
        "mustSupport": true
      }
    ]
  }
}