HdBe-PharmaceuticalProduct

ProfileStatusURL
HdBe-PharmaceuticalProductdrafthttps://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-PharmaceuticalProduct

medication_code0..1CodeableConcept
pharmaceutical_form0..1CodeableConceptBinding
medication0..1string
description0..1string
substance_code0..1CodeableConcept
ingredient_amount0..1Quantity
product_amount0..1Quantity

pharmaceutical_product0..*
pharmaceutical_product.medication_codeCodeableConcept0..1
pharmaceutical_product.product_specificationsBackboneElement0..1
pharmaceutical_product.product_specifications.pharmaceutical_formCodeableConcept0..1
pharmaceutical_product.product_specifications.medicationstring0..1
pharmaceutical_product.product_specifications.descriptionstring0..1
pharmaceutical_product.product_specifications.ingredientBackboneElement0..*
pharmaceutical_product.product_specifications.ingredient.substance_codeCodeableConcept0..1
pharmaceutical_product.product_specifications.ingredient.concentrationBackboneElement0..1
pharmaceutical_product.product_specifications.ingredient.concentration.ingredient_amountQuantity0..1
pharmaceutical_product.product_specifications.ingredient.concentration.product_amountQuantity0..1



pharmaceutical_product
DefinitionRoot 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. A type of medication can be indicated with **a single code**. That code can be chosen from several possible coding systems (concretely: GPK, PRK, HPK or article numbers). Correct use of these codes in the software systems will sufficiently record the composition of the product used, making a complete product specification unnecessary. In addition to a primary code, **alternative codes **from other coding systems can also be entered (so that the GPK can be sent along in the event that the patient was registered based on PRK, for example). Entering multiple ingredients will enable you to display a compound product. In that case, the **composition of the medication** can be specified implicitly (with the use of a medication code) or explicitly, for example by listing the (active) substance(s) of the medication. **Prescriptions to be prepared by the pharmacy** can be entered as well. This can be done by means of the option listed above to enter coded ingredients and/or by entering the composition and preparation method as free text.
Cardinality0...*
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
DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
TypeSystem.String
Mappings
  • rim:n/a
pharmaceutical_product.extension
DefinitionMay 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.
Cardinality0...*
TypeExtension
Aliasextensions, 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.

SlicingUnordered, 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
DefinitionCoding medication in the Netherlands is done on the basis of the G standard (issued by Z-index), which is filled under the direction of KNMP. The coded medication can be expressed as: * GTIN International Article Number * ZI-nummer (2.16.840.1.113883.2.4.4.8) * Trade product code (HPK) * Prescription code (PRK) * Generic product code (GPK) * Anatomic Therapeutic Classification code (ATC) * Substance Name Code (SNK) * Substance Name Code, in combination with Route of Administration (SSK) * SNOMED CT code The GTIN enables identification of the product including its origin with a barcode. The ZI number represents the tradeproduct and the package size. The HPK is the code for the trade product (with the brand name) as used per dose/per time the medication is taken (1 pill, 1 puff, 1ml) The PRK contains als GPK information supplemented with information needed to prescribe the right product. this level is intended to facilitate generic prescription of drugs. The GPK defines the pharmaceutical characteristics of a product: ingredients, strengths, units, pharmaceutical form and route of administration. The Substance Name Code (SNK) is the (active) compound. Further information about the G-Standaard levels see https://www.z-index.nl So called 90.000.000 numbers are used in local IT systems. These numbers shall not be used for external communication. In the this is necessary only the description (not the code) may be included. This is in accordance with national agreements (Nictiz Standard).
Cardinality0...1
TypeCodeableConcept
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
DefinitionContainer 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.
Cardinality0...1
TypeBackboneElement
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
DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
TypeSystem.String
Mappings
  • rim:n/a
pharmaceutical_product.product_specifications.extension
DefinitionMay 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.
Cardinality0...*
TypeExtension
Aliasextensions, 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.

SlicingUnordered, 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
DefinitionMay 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).
Cardinality0...*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, 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
DefinitionThe pharmaceutical form indicates the form of the medication. Examples include: tablet, suppository, infusion liquid, ointment. If the product has a GPK code in the G standard, the form will be known in the G standard. For products without a code (free text, preparation by the pharmacy), the means of administration can be entered.
Cardinality0...1
TypeCodeableConcept
Binding

PharmaceuticalForm codes

FarmaceutischeVorm (required)
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
DefinitionThere is no code for medication entered in free text. In these cases, enter the complete description.
Cardinality0...1
Typestring
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
DefinitionA textual description of the type of medication (including relevant properties of the composition and preparation method if possible), which is only used if no coded indication from the G Standard is available (magistral preparation).
Cardinality0...1
Typestring
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
DefinitionContainer 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).
Cardinality0...*
TypeBackboneElement
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
DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
TypeSystem.String
Mappings
  • rim:n/a
pharmaceutical_product.product_specifications.ingredient.extension
DefinitionMay 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.
Cardinality0...*
TypeExtension
Aliasextensions, 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.

SlicingUnordered, 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
DefinitionMay 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).
Cardinality0...*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, 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
DefinitionActive substance or excipient. Here, the same codes can be used as for the ProductCode (for dilutions and compounds in particular), but now, the ATC, SSK and SNK codes can also be used to indicate a substance (to list ingredients of local products prepared by the pharmacy). * GTIN International Article Number * KNMP article number * Trade product code (HPK) * Prescription code (PRK) * Generic product code (GPK) * ATC (anatomic therapeutic classification) * SSK (substance name code with route of administration) * SNK (substance name code) For further explanation about ATC see https://www.whocc.no/atc/structure_and_principles/
Cardinality0...1
TypeCodeableConcept
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
DefinitionThe 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.
Cardinality0...1
TypeBackboneElement
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
DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
TypeSystem.String
Mappings
  • rim:n/a
pharmaceutical_product.product_specifications.ingredient.concentration.extension
DefinitionMay 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.
Cardinality0...*
TypeExtension
Aliasextensions, 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.

SlicingUnordered, 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
DefinitionMay 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).
Cardinality0...*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, 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
DefinitionThe amount and unit of this ingredient. This is the numerator for the calculation of the concentration. The unit should be selected from the G-Standard (Table 902).
Cardinality0...1
TypeQuantity
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
DefinitionAmount of the product. This is the denominator for the calculation of the concentration. Optionally a translation to NHG table Gebruiksvoorschriften(Table 25) is also allowed.
Cardinality0...1
TypeQuantity
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

[CBB name]
[Concept name ] [example value]

// example of NameInformation

## Example instances

| name_information      |                   |
|----------------------|-------------------|
| first_names | Johanna Petronella Maria   
| initials | J.P.M. 
| given_name | Jo 
| name_usage | Geslachtsnaam partner gevolgd door eigen geslachtsnaam
| last_name.prefix | van
| last_name.last_name | Putten
| last_name_partner.partner_prefix | van der
| last_name_partner.partner_last_name | Giessen
| titles |

zib [zib name + version](https://zibs.nl/wiki/[zib name + version(release)]) difference

Concept Category Description
[element.path] [category of change] [Description of change]([Reference to ticket/issue/zulip chat using MarkDown link])



Terminology Bindings

PathNameStrengthURL
product_specifications.pharmaceutical_formFarmaceutischeVormrequiredhttps://fhir.healthdata.be/ValueSet/FarmaceutischeVorm