HdBe-PharmaceuticalProduct

Profile	Status	URL
HdBe-PharmaceuticalProduct	draft	https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-PharmaceuticalProduct

pharmaceutical_product		pharmaceutical_product	There are no (further) constraints on this element Element Id pharmaceutical_product Short description PharmaceuticalProduct Definition Root concept of the PharmaceuticalProduct partial information model.This root concept contains all data elements of the PharmaceuticalProduct partial information model. The prescribed product is usually a medicine. However, medical aids and bandages can also be prescribed and supplied via the pharmacy. Strictly speaking, food and blood products do not belong in the medication category, but can be prescribed and supplied by a pharmacy as well. Data Type pharmaceutical_product
medication_code	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element Id pharmaceutical_product.medication_code Short description MedicationCode Definition Code of the Medication. Data Type CodeableConcept Binding ProductCode (extensible)
product_specifications	0..1	BackboneElement	There are no (further) constraints on this element Element Id pharmaceutical_product.product_specifications Short description ProductSpecifications Definition Container of the ProductSpecifications concept. This container contains all data elements of the ProductSpecifications concept. Product specifications are required if the product code is not sufficient to ascertain the active substances and strength. Data Type BackboneElement
pharmaceutical_form	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element Id pharmaceutical_product.product_specifications.pharmaceutical_form Short description PharmaceuticalForm Definition The pharmaceutical form indicates the form of the medication. Examples include: tablet, suppository, infusion liquid, ointment. Data Type CodeableConcept Binding PharmaceuticalForm codes PharmaceuticalForm (extensible)
medication	0..1	string	There are no (further) constraints on this element Element Id pharmaceutical_product.product_specifications.medication Short description Medication Definition There is no code for medication entered in free text. In these cases, enter the complete description. Data Type string
description	0..1	string	There are no (further) constraints on this element Element Id pharmaceutical_product.product_specifications.description Short description Description Definition A textual description of the type of medication (including relevant properties of the composition and preparation method if possible). Data Type string
ingredient	0..*	BackboneElement	There are no (further) constraints on this element Element Id pharmaceutical_product.product_specifications.ingredient Short description Ingredient Definition Container of the Ingredient concept. This container contains all data elements of the Ingredient concept. A product contains one or more active substances and excipients. These are usually determined by the product code. For medication prepared or compounded by the local pharmacy, each ingredient must be entered separately. The active substances play an important role, as they: a) determine the pharmacotherapeutic effect of the medication and b) serve as the basis for the indication of the strength of the medication (e.g. 200mg). Data Type BackboneElement
substance_code	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element Id pharmaceutical_product.product_specifications.ingredient.substance_code Short description SubstanceCode Definition Active substance or excipient. Data Type CodeableConcept Binding SubstanceCode (extensible)
concentration	0..1	BackboneElement	There are no (further) constraints on this element Element Id pharmaceutical_product.product_specifications.ingredient.concentration Short description Concentration Definition The relative amount of this ingredient in this product. Calculation of Concentration = Ingredient Amount ÷ Product Amount. This could be a concentration if the medication is dissolved in liquid, for example. Data Type BackboneElement
ingredient_amount	0..1	Quantity	There are no (further) constraints on this element Element Id pharmaceutical_product.product_specifications.ingredient.concentration.ingredient_amount Short description IngredientAmount Definition The amount and unit of this ingredient. This is the numerator for the calculation of the concentration. Data Type Quantity
product_amount	0..1	Quantity	There are no (further) constraints on this element Element Id pharmaceutical_product.product_specifications.ingredient.concentration.product_amount Short description ProductAmount Definition Amount of the product. This is the denominator for the calculation of the concentration. Data Type Quantity

pharmaceutical_product		0..*
pharmaceutical_product.medication_code	CodeableConcept	0..1
pharmaceutical_product.product_specifications	BackboneElement	0..1
pharmaceutical_product.product_specifications.pharmaceutical_form	CodeableConcept	0..1
pharmaceutical_product.product_specifications.medication	string	0..1
pharmaceutical_product.product_specifications.description	string	0..1
pharmaceutical_product.product_specifications.ingredient	BackboneElement	0..*
pharmaceutical_product.product_specifications.ingredient.substance_code	CodeableConcept	0..1
pharmaceutical_product.product_specifications.ingredient.concentration	BackboneElement	0..1
pharmaceutical_product.product_specifications.ingredient.concentration.ingredient_amount	Quantity	0..1
pharmaceutical_product.product_specifications.ingredient.concentration.product_amount	Quantity	0..1

pharmaceutical_product
Definition	Root concept of the PharmaceuticalProduct partial information model.This root concept contains all data elements of the PharmaceuticalProduct partial information model. The prescribed product is usually a medicine. However, medical aids and bandages can also be prescribed and supplied via the pharmacy. Strictly speaking, food and blood products do not belong in the medication category, but can be prescribed and supplied by a pharmacy as well.
Cardinality	0...*
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim:n/a
pharmaceutical_product.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality	0...1
Type	System.String
Mappings	rim:n/a
pharmaceutical_product.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Slicing	Unordered, Open, by url(Value)
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim:n/a rim:N/A
pharmaceutical_product.medication_code
Definition	Code of the Medication.
Cardinality	0...1
Type	CodeableConcept
Binding	ProductCode (extensible)
Comments	Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
pharmaceutical_product.product_specifications
Definition	Container of the ProductSpecifications concept. This container contains all data elements of the ProductSpecifications concept. Product specifications are required if the product code is not sufficient to ascertain the active substances and strength.
Cardinality	0...1
Type	BackboneElement
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim:n/a
pharmaceutical_product.product_specifications.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality	0...1
Type	System.String
Mappings	rim:n/a
pharmaceutical_product.product_specifications.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Slicing	Unordered, Open, by url(Value)
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim:n/a rim:N/A
pharmaceutical_product.product_specifications.modifierExtension
Definition	May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality	0...*
Type	Extension
Modifier	True
Summary	True
Alias	extensions, user content, modifiers
Requirements	Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim:n/a rim:N/A
pharmaceutical_product.product_specifications.pharmaceutical_form
Definition	The pharmaceutical form indicates the form of the medication. Examples include: tablet, suppository, infusion liquid, ointment.
Cardinality	0...1
Type	CodeableConcept
Binding	PharmaceuticalForm codes PharmaceuticalForm (extensible)
Comments	Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
pharmaceutical_product.product_specifications.medication
Definition	There is no code for medication entered in free text. In these cases, enter the complete description.
Cardinality	0...1
Type	string
Comments	Note that FHIR strings SHALL NOT exceed 1MB in size
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim:n/a
pharmaceutical_product.product_specifications.description
Definition	A textual description of the type of medication (including relevant properties of the composition and preparation method if possible).
Cardinality	0...1
Type	string
Comments	Note that FHIR strings SHALL NOT exceed 1MB in size
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim:n/a
pharmaceutical_product.product_specifications.ingredient
Definition	Container of the Ingredient concept. This container contains all data elements of the Ingredient concept. A product contains one or more active substances and excipients. These are usually determined by the product code. For medication prepared or compounded by the local pharmacy, each ingredient must be entered separately. The active substances play an important role, as they: a) determine the pharmacotherapeutic effect of the medication and b) serve as the basis for the indication of the strength of the medication (e.g. 200mg).
Cardinality	0...*
Type	BackboneElement
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim:n/a
pharmaceutical_product.product_specifications.ingredient.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality	0...1
Type	System.String
Mappings	rim:n/a
pharmaceutical_product.product_specifications.ingredient.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Slicing	Unordered, Open, by url(Value)
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim:n/a rim:N/A
pharmaceutical_product.product_specifications.ingredient.modifierExtension
Definition	May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality	0...*
Type	Extension
Modifier	True
Summary	True
Alias	extensions, user content, modifiers
Requirements	Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim:n/a rim:N/A
pharmaceutical_product.product_specifications.ingredient.substance_code
Definition	Active substance or excipient.
Cardinality	0...1
Type	CodeableConcept
Binding	SubstanceCode (extensible)
Comments	Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim:n/a v2:CE/CNE/CWE rim:CD orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
pharmaceutical_product.product_specifications.ingredient.concentration
Definition	The relative amount of this ingredient in this product. Calculation of Concentration = Ingredient Amount ÷ Product Amount. This could be a concentration if the medication is dissolved in liquid, for example.
Cardinality	0...1
Type	BackboneElement
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim:n/a
pharmaceutical_product.product_specifications.ingredient.concentration.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality	0...1
Type	System.String
Mappings	rim:n/a
pharmaceutical_product.product_specifications.ingredient.concentration.extension
Definition	May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Slicing	Unordered, Open, by url(Value)
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim:n/a rim:N/A
pharmaceutical_product.product_specifications.ingredient.concentration.modifierExtension
Definition	May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality	0...*
Type	Extension
Modifier	True
Summary	True
Alias	extensions, user content, modifiers
Requirements	Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1:Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim:n/a rim:N/A
pharmaceutical_product.product_specifications.ingredient.concentration.ingredient_amount
Definition	The amount and unit of this ingredient. This is the numerator for the calculation of the concentration.
Cardinality	0...1
Type	Quantity
Comments	The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3:If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()`
Mappings	rim:n/a v2:SN (see also Range) or CQ rim:PQ, IVL<PQ>, MO, CO, depending on the values
pharmaceutical_product.product_specifications.ingredient.concentration.product_amount
Definition	Amount of the product. This is the denominator for the calculation of the concentration.
Cardinality	0...1
Type	Quantity
Comments	The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
Invariants	ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3:If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()`
Mappings	rim:n/a v2:SN (see also Range) or CQ rim:PQ, IVL<PQ>, MO, CO, depending on the values

Example instances

pharmaceutical_product
medication_code	322236009 - Acetaminophen 500 mg oral tablet (code by SNOMED CT)
product_specifications	---
product_specifications.pharmaceutical_form	385055001 - Tablet (code by SNOMED CT)
product_specifications.medication
product_specifications.description
product_specifications.ingredient	---
product_specifications.ingredient.substance_code
product_specifications.ingredient.concentration
product_specifications.ingredient.concentration.ingredient_amount
product_specifications.ingredient.concentration.product_amount

zib PharmaceuticalProduct-v2.1.2 difference

Concept	Category	Description
Concept	textual	Removed context on Dutch coding system specific codes from the Concept section in the `StructureDefinition.description`.
`pharmaceutical_product` (root)	textual	Removed Dutch specific context.
`medication_code`	terminology	Removed all defined valueSets and replaced them with one ProductCode valueSet with the SNOMED descendent-of 763158003 (Medicinal product). Also set binding strength to extensible.
`medication_code`	textual	Removed G-standard specific context.
`product_specification.pharmaceutical_form`	terminology	Replaced values in PharmaceuticalForm valueSet them with the ProductCode valueSet with the SNOMED descendent-of 736478001 (Basic dose form) and loosened the binding from required to extensible.
`product_specification.pharmaceutical_form`	textual	Removed G-standard specific context.
`product_specification.description`	textual	Removed G-standard specific context.
`product_specification.ingredient.substance_code`	textual	Removed context about removed ValueSets in medication_code.
`product_specification.ingredient.substance_code`	terminology	Replaced all defined valueSets and replaced them with the SubstanceCode valueSet with the SNOMED descendent-of 105590001 (Substance). Also set binding strength to extensible.
`product_specification.ingredient.concentration.ingredient_amount`	textual	Removed G-standard specific context.
`product_specification.ingredient.concentration.product_amount`	textual	Removed Dutch specific context.

Terminology Bindings

Path	Name	Strength	URL
medication_code	ProductCode	extensible	https://fhir.healthdata.be/ValueSet/ProductCode
product_specifications.pharmaceutical_form	PharmaceuticalForm	extensible	https://fhir.healthdata.be/ValueSet/PharmaceuticalForm
product_specifications.ingredient.substance_code	SubstanceCode	extensible	https://fhir.healthdata.be/ValueSet/SubstanceCode