<status value="draft" /> <experimental value="true" /> <date value="2018-02-20T22:03:08.307+01:00" /> <publisher value="HL7 International" /> <contact> <name value="Chritof Gessner" /> </contact> <contact> <name value="François Macary" /> </contact> <description value="This profile represents the constraints applied to the Medication resource by the International Patient Summary (IPS) FHIR Implementation Guide, based on FHIR STU3. A medication is described in the patient summary as an instance of a Medication resource constrained by this profile." /> <purpose value="This profile constrains the representation of a medication, in the context of the international patient summary as specified by the IPS project of HL7 International." /> <fhirVersion value="3.0.1" /> <kind value="resource" /> <abstract value="false" /> <type value="Medication" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Medication" /> <derivation value="constraint" /> <differential> <element id="Medication"> <path value="Medication" /> <comment value="IPS Medication" /> </element> <element id="Medication.code"> <path value="Medication.code" /> <short value="Codes that identify this medication, sliced to support IDMP" /> <max value="1" /> <type> <code value="CodeableConcept" /> <profile value="http://hl7.org/fhir/ips/StructureDefinition/CodeableConcept-uv-ips" /> </type> <mustSupport value="true" /> </element> <element id="Medication.code.coding"> <path value="Medication.code.coding" /> <slicing> <discriminator> <type value="value" /> <path value="system" /> </discriminator> <description value="This slicing on the coding element of Medication.code is open, with discriminator based on the value of the Coding.system element. It supports both identifiers and categories or classes for representing the medication. It carries one slice for each of the IDMP identifiers, plus one slice for the ATC classification. Other representations of the medication (such as SNOMED CT, RxNorm, jurisdictional code systems, cross-jursisdiction code systems, or any classification) use extra slices, since the slicing is open. The IDMP slices are provisional, and will be usable when the IDMP identifiers become available." /> <rules value="open" /> </slicing> <definition value="A representation of the medication in a code system. The representation can be granular or may also be a class or category." /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L1"> <path value="Medication.code.coding" /> <sliceName value="pharmaceuticalProduct-L1" /> <short value="Pharmaceutical Product Identifier, Level 1" /> <definition value="IDMP PhPID Level 1 (Implies ingredients) or any equivalent Pharmaceutical Product identifier. Pharmaceutical Product Identifier (PhPID): Uniquely identifies medicinal product based on the generic composition, such as ingredients and route of administration, separate from any other details such as regulatory authorisation, organisation, packaging or naming. The PhPID can be specified at various levels of detail for a given Pharmaceutical Product." /> <max value="1" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L1.system"> <path value="Medication.code.coding.system" /> <min value="1" /> <fixedUri value="http://hl7.org/fhir/sid/phpid-l1" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L1.code"> <path value="Medication.code.coding.code" /> <min value="1" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L2"> <path value="Medication.code.coding" /> <sliceName value="pharmaceuticalProduct-L2" /> <short value="Pharmaceutical Product Identifier, Level 2" /> <definition value="IDMP PhPID Level 2 (Implies ingredients and strength) or any equivalent Pharmaceutical Product identifier. Pharmaceutical Product Identifier (PhPID): Uniquely identifies medicinal product based on the generic composition, such as ingredients and route of administration, separate from any other details such as regulatory authorisation, organisation, packaging or naming. The PhPID can be specified at various levels of detail for a given Pharmaceutical Product." /> <max value="1" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L2.system"> <path value="Medication.code.coding.system" /> <min value="1" /> <fixedUri value="http://hl7.org/fhir/sid/phpid-l2" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L2.code"> <path value="Medication.code.coding.code" /> <min value="1" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L3"> <path value="Medication.code.coding" /> <sliceName value="pharmaceuticalProduct-L3" /> <short value="Pharmaceutical Product Identifier, Level 3" /> <definition value="IDMP PhPID Level 3 (Implies ingredients and dose form) or any equivalent Pharmaceutical Product identifier. Pharmaceutical Product Identifier (PhPID): Uniquely identifies medicinal product based on the generic composition, such as ingredients and route of administration, separate from any other details such as regulatory authorisation, organisation, packaging or naming. The PhPID can be specified at various levels of detail for a given Pharmaceutical Product." /> <max value="1" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L3.system"> <path value="Medication.code.coding.system" /> <min value="1" /> <fixedUri value="http://hl7.org/fhir/sid/phpid-l3" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L3.code"> <path value="Medication.code.coding.code" /> <min value="1" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L4"> <path value="Medication.code.coding" /> <sliceName value="pharmaceuticalProduct-L4" /> <short value="Pharmaceutical Product Identifier, Level 4" /> <definition value="IDMP PhPID Level 4 (Implies ingredients, strength, and dose form) or any equivalent Pharmaceutical Product identifier. Pharmaceutical Product Identifier (PhPID): Uniquely identifies medicinal product based on the generic composition, such as ingredients and route of administration, separate from any other details such as regulatory authorisation, organisation, packaging or naming. The PhPID can be specified at various levels of detail for a given Pharmaceutical Product." /> <max value="1" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L4.system"> <path value="Medication.code.coding.system" /> <min value="1" /> <fixedUri value="http://hl7.org/fhir/sid/phpid-l4" /> </element> <element id="Medication.code.coding:pharmaceuticalProduct-L4.code"> <path value="Medication.code.coding.code" /> <min value="1" /> </element> <element id="Medication.code.coding:medicinalProduct"> <path value="Medication.code.coding" /> <sliceName value="medicinalProduct" /> <short value="Medicinal Product Identifier" /> <definition value="IDMP Medicinal Product Identifier (MPID) or any equivalent Medicinal Product Identifier. IDMP MPID uniquely identifies a Medicinal Product, reflecting (but not replacing) any other authorisation numbers allocated by a regulator. MPID implies one (set of) PhPID. The MPID shall use a common segment pattern related to a Medicinal Product, which when each segment is valued shall define a specific MPID concept. The pattern is: • a) Country code segment (ISO 3166-1 alpha-2 code elements); • b) Marketing Authorization Holder (Organization Identifier) code segment; • c) Medicinal Product code segment (Unique Medicinal Product Identifier). • Any change of the values related to these three code segments shall result in the assignment of a new MPID." /> <max value="1" /> </element> <element id="Medication.code.coding:medicinalProduct.system"> <path value="Medication.code.coding.system" /> <min value="1" /> <fixedUri value="http://hl7.org/fhir/sid/mpid" /> </element> <element id="Medication.code.coding:medicinalProduct.code"> <path value="Medication.code.coding.code" /> <min value="1" /> </element> <element id="Medication.code.coding:packagedProduct"> <path value="Medication.code.coding" /> <sliceName value="packagedProduct" /> <short value="Packaged Medicinal Product Identifier" /> <definition value="IDMP Packaged Medicinal Product Identifier or any equivalent Packaged Medicinal Product Identifier. Uniquely identifies a Medicinal Product based on its packaging. This implies one MPID can be associated with more than one PCID, if the same Medicinal Product has more than one type of package; The PCID shall use a common segment pattern related to a package of a Medicinal Product, which when each segment is valued, shall define a specific PCID concept. The pattern is: • a) MPID for the Medicinal Product • b) package description code segment, which refers to a unique identifier for each package." /> <max value="1" /> </element> <element id="Medication.code.coding:packagedProduct.system"> <path value="Medication.code.coding.system" /> <min value="1" /> <fixedUri value="http://hl7.org/fhir/sid/pcid" /> </element> <element id="Medication.code.coding:packagedProduct.code"> <path value="Medication.code.coding.code" /> <min value="1" /> </element> <element id="Medication.code.coding:atcClass"> <path value="Medication.code.coding" /> <sliceName value="atcClass" /> <short value="Product classification or cluster" /> <definition value="ATC classification for medication product" /> <max value="1" /> <binding> <strength value="extensible" /> <description value="ATC class for the medication" /> <valueSetUri value="http://hl7.org/fhir/ips/ValueSet/whoatc-uv-ips" /> </binding> </element> <element id="Medication.code.coding:atcClass.system"> <path value="Medication.code.coding.system" /> <min value="1" /> <fixedUri value="http://www.whocc.no/atc" /> </element> <element id="Medication.code.coding:atcClass.code"> <path value="Medication.code.coding.code" /> <min value="1" /> </element> <element id="Medication.code.text"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true" /> </extension> <path value="Medication.code.text" /> <definition value="This element is supposed to be valorized with the complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction. The name may be applicable in one or more country/language combinations." /> <mustSupport value="true" /> </element> <element id="Medication.status"> <path value="Medication.status" /> <max value="0" /> </element> <element id="Medication.isBrand"> <path value="Medication.isBrand" /> <max value="0" /> </element> <element id="Medication.isOverTheCounter"> <path value="Medication.isOverTheCounter" /> <max value="0" /> </element> <element id="Medication.manufacturer"> <path value="Medication.manufacturer" /> <max value="0" /> </element> <element id="Medication.form"> <path value="Medication.form" /> <definition value="Describes the form of the item. Powder; tablets; capsule. Administrable Pharmaceutical Dose Form. This code represents the form of the medication (e.g. tablet, capsule, liquid) Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration. It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT." /> <type> <code value="CodeableConcept" /> <profile value="http://hl7.org/fhir/ips/StructureDefinition/CodeableConcept-uv-ips" /> </type> <mustSupport value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="MedicationForm" /> </extension> <strength value="example" /> <valueSetReference> <reference value="http://hl7.org/fhir/ips/ValueSet/medicine-doseform" /> </valueSetReference> </binding> </element> <element id="Medication.form.coding.system"> <path value="Medication.form.coding.system" /> <binding> <strength value="required" /> <description value="EDQM Standard Terms" /> <valueSetUri value="http://hl7.org/fhir/ips/ValueSet/medicine-doseform" /> </binding> </element> <element id="Medication.ingredient"> <path value="Medication.ingredient" /> <mustSupport value="true" /> </element> <element id="Medication.ingredient.itemCodeableConcept:itemCodeableConcept"> <path value="Medication.ingredient.itemCodeableConcept" /> <sliceName value="itemCodeableConcept" /> <comment value="The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances. The Global Ingredient Archival System (GInAS) will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard. Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances. This choice will be revised based on the availability and the maturity of GInAS." /> <type> <code value="CodeableConcept" /> <profile value="http://hl7.org/fhir/ips/StructureDefinition/CodeableConcept-uv-ips" /> </type> <binding> <strength value="preferred" /> <description value="SNOMED CT drug substances" /> <valueSetUri value="http://hl7.org/fhir/ips/ValueSet/medicine-active-substances-uv-ips" /> </binding> </element> <element id="Medication.ingredient.itemCodeableConcept:itemCodeableConcept.coding"> <path value="Medication.ingredient.itemCodeableConcept.coding" /> <mustSupport value="true" /> </element> <element id="Medication.ingredient.itemCodeableConcept:itemCodeableConcept.coding.system"> <path value="Medication.ingredient.itemCodeableConcept.coding.system" /> <binding> <strength value="preferred" /> <valueSetUri value="http://hl7.org/fhir/ips/ValueSet/medicine-active-substances-uv-ips" /> </binding> </element> <element id="Medication.ingredient.itemCodeableConcept:itemCodeableConcept.text"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true" /> </extension> <path value="Medication.ingredient.itemCodeableConcept.text" /> <mustSupport value="true" /> </element> <element id="Medication.ingredient.isActive"> <path value="Medication.ingredient.isActive" /> <max value="0" /> </element> <element id="Medication.ingredient.amount"> <path value="Medication.ingredient.amount" /> <type> <code value="Ratio" /> <profile value="http://hl7.org/fhir/ips/StructureDefinition/Ratio-uv-ips" /> </type> <mustSupport value="true" /> </element> <element id="Medication.package"> <path value="Medication.package" /> <definition value="Removed as pre-adoption of R4." /> <max value="0" /> </element> </differential> </StructureDefinition>