This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.17 Resource MedicinalProductPharmaceutical - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Compartments: Not linked to any defined compartments

A pharmaceutical product described in terms of its composition and dose form.

11.17.1 Scope and Usage

Qualitative and quantitative composition of a Medicinal Product in the dose form approved for administration in line with the regulated product information

Note that in many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item must undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.

This resource is referenced by MedicinalProduct

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductPharmaceutical	Σ TU		DomainResource	A pharmaceutical product described in terms of its composition and dose form Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	An identifier for the pharmaceutical medicinal product
administrableDoseForm	Σ	1..1	CodeableConcept	The administrable dose form, after necessary reconstitution
unitOfPresentation	Σ	0..1	CodeableConcept	Todo
ingredient	Σ	0..*	Reference(MedicinalProductIngredient)	Ingredient
device	Σ	0..*	Reference(MedicinalProductDeviceSpec \| DeviceDefinition)	Accompanying device
characteristics	Σ	0..*	BackboneElement	Characteristics e.g. a products onset of action
code	Σ	1..1	CodeableConcept	A coded characteristic
status	Σ	0..1	CodeableConcept	The status of characteristic e.g. assigned or pending
routeOfAdministration	Σ	1..*	BackboneElement	The path by which the pharmaceutical product is taken into or makes contact with the body
code	Σ	1..1	CodeableConcept	Coded expression for the route
firstDose	Σ	0..1	Quantity	The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement
maxSingleDose	Σ	0..1	Quantity	The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement
maxDosePerDay	Σ	0..1	Quantity	The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation
maxDosePerTreatmentPeriod	Σ	0..1	Ratio	The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation
maxTreatmentPeriod	Σ	0..1	Duration	The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation
targetSpecies	Σ	0..*	BackboneElement	A species for which this route applies
code	Σ	1..1	CodeableConcept	Coded expression for the species
withdrawalPeriod	Σ	0..*	BackboneElement	A species specific time during which consumption of animal product is not appropriate
tissue	Σ	1..1	CodeableConcept	Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
value	Σ	1..1	Quantity	A value for the time
supportingInformation	Σ	0..1	string	Extra information about the withdrawal period
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductPharmaceutical xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier An identifier for the pharmaceutical medicinal product --></identifier>
 <administrableDoseForm><!-- 1..1 CodeableConcept The administrable dose form, after necessary reconstitution --></administrableDoseForm>
 <unitOfPresentation><!-- 0..1 CodeableConcept Todo --></unitOfPresentation>
 <ingredient><!-- 0..* Reference(MedicinalProductIngredient) Ingredient --></ingredient>
 <device><!-- 0..* Reference(MedicinalProductDeviceSpec|DeviceDefinition) Accompanying device --></device>
 <characteristics>  <!-- 0..* Characteristics e.g. a products onset of action -->
  <code><!-- 1..1 CodeableConcept A coded characteristic --></code>
  <status><!-- 0..1 CodeableConcept The status of characteristic e.g. assigned or pending --></status>
 </characteristics>
 <routeOfAdministration>  <!-- 1..* The path by which the pharmaceutical product is taken into or makes contact with the body -->
  <code><!-- 1..1 CodeableConcept Coded expression for the route --></code>
  <firstDose><!-- 0..1 Quantity The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement --></firstDose>
  <maxSingleDose><!-- 0..1 Quantity The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement --></maxSingleDose>
  <maxDosePerDay><!-- 0..1 Quantity The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation --></maxDosePerDay>
  <maxDosePerTreatmentPeriod><!-- 0..1 Ratio The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation --></maxDosePerTreatmentPeriod>
  <maxTreatmentPeriod><!-- 0..1 Duration The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation --></maxTreatmentPeriod>
  <targetSpecies>  <!-- 0..* A species for which this route applies -->
   <code><!-- 1..1 CodeableConcept Coded expression for the species --></code>
   <withdrawalPeriod>  <!-- 0..* A species specific time during which consumption of animal product is not appropriate -->
    <tissue><!-- 1..1 CodeableConcept Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk --></tissue>
    <value><!-- 1..1 Quantity A value for the time --></value>
    <supportingInformation value="[string]"/><!-- 0..1 Extra information about the withdrawal period -->
   </withdrawalPeriod>
  </targetSpecies>
 </routeOfAdministration>
</MedicinalProductPharmaceutical>

JSON Template

{
  "resourceType" : "MedicinalProductPharmaceutical",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // An identifier for the pharmaceutical medicinal product
  "administrableDoseForm" : { CodeableConcept }, // R!  The administrable dose form, after necessary reconstitution
  "unitOfPresentation" : { CodeableConcept }, // Todo
  "ingredient" : [{ Reference(MedicinalProductIngredient) }], // Ingredient
  "device" : [{ Reference(MedicinalProductDeviceSpec|DeviceDefinition) }], // Accompanying device
  "characteristics" : [{ // Characteristics e.g. a products onset of action
    "code" : { CodeableConcept }, // R!  A coded characteristic
    "status" : { CodeableConcept } // The status of characteristic e.g. assigned or pending
  }],
  "routeOfAdministration" : [{ // R!  The path by which the pharmaceutical product is taken into or makes contact with the body
    "code" : { CodeableConcept }, // R!  Coded expression for the route
    "firstDose" : { Quantity }, // The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement
    "maxSingleDose" : { Quantity }, // The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement
    "maxDosePerDay" : { Quantity }, // The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation
    "maxDosePerTreatmentPeriod" : { Ratio }, // The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation
    "maxTreatmentPeriod" : { Duration }, // The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation
    "targetSpecies" : [{ // A species for which this route applies
      "code" : { CodeableConcept }, // R!  Coded expression for the species
      "withdrawalPeriod" : [{ // A species specific time during which consumption of animal product is not appropriate
        "tissue" : { CodeableConcept }, // R!  Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
        "value" : { Quantity }, // R!  A value for the time
        "supportingInformation" : "<string>" // Extra information about the withdrawal period
      }]
    }]
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:MedicinalProductPharmaceutical;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:MedicinalProductPharmaceutical.identifier [ Identifier ], ... ; # 0..* An identifier for the pharmaceutical medicinal product
  fhir:MedicinalProductPharmaceutical.administrableDoseForm [ CodeableConcept ]; # 1..1 The administrable dose form, after necessary reconstitution
  fhir:MedicinalProductPharmaceutical.unitOfPresentation [ CodeableConcept ]; # 0..1 Todo
  fhir:MedicinalProductPharmaceutical.ingredient [ Reference(MedicinalProductIngredient) ], ... ; # 0..* Ingredient
  fhir:MedicinalProductPharmaceutical.device [ Reference(MedicinalProductDeviceSpec|DeviceDefinition) ], ... ; # 0..* Accompanying device
  fhir:MedicinalProductPharmaceutical.characteristics [ # 0..* Characteristics e.g. a products onset of action
    fhir:MedicinalProductPharmaceutical.characteristics.code [ CodeableConcept ]; # 1..1 A coded characteristic
    fhir:MedicinalProductPharmaceutical.characteristics.status [ CodeableConcept ]; # 0..1 The status of characteristic e.g. assigned or pending
  ], ...;
  fhir:MedicinalProductPharmaceutical.routeOfAdministration [ # 1..* The path by which the pharmaceutical product is taken into or makes contact with the body
    fhir:MedicinalProductPharmaceutical.routeOfAdministration.code [ CodeableConcept ]; # 1..1 Coded expression for the route
    fhir:MedicinalProductPharmaceutical.routeOfAdministration.firstDose [ Quantity ]; # 0..1 The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement
    fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxSingleDose [ Quantity ]; # 0..1 The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement
    fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxDosePerDay [ Quantity ]; # 0..1 The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation
    fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxDosePerTreatmentPeriod [ Ratio ]; # 0..1 The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation
    fhir:MedicinalProductPharmaceutical.routeOfAdministration.maxTreatmentPeriod [ Duration ]; # 0..1 The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation
    fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies [ # 0..* A species for which this route applies
      fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.code [ CodeableConcept ]; # 1..1 Coded expression for the species
      fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod [ # 0..* A species specific time during which consumption of animal product is not appropriate
        fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.tissue [ CodeableConcept ]; # 1..1 Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk
        fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.value [ Quantity ]; # 1..1 A value for the time
        fhir:MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation [ string ]; # 0..1 Extra information about the withdrawal period
      ], ...;
    ], ...;
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = Not Mapped)