Guide d'implémentation du GT Standards et Interopérabilité pour les EDS
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Resource Profile: FrMedicationCompound - Detailed Descriptions

Draft as of 2025-01-23

Definitions for the FrMedicationCompound resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Medication
Definition

Medication compound of a Medication representing the composition of a MedicationRequest, a MedicationDispense or a MedicationUsage (pka MedicationStatement). For instance, Glucose 5% 1L part of an infusion made of 3 compounds, Glucose 5% 1L + Sodium chloride 3g + Potassium chloride 2g.


This resource is primarily used for the identification and definition of a medication for the purposes of prescribing, dispensing, and administering a medication as well as for making statements about medication use.

ShortDefinition of a Medication compound of a MedicinalRequest, Dispense or Usage
Control0..*
Is Modifierfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Medication.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Medication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it 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 is allowed to 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).

ShortExtensions that cannot be ignored
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
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.

Alternate Namesextensions, user content
Invariantsele-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())
6. Medication.code
Definition

Defines the text of the compound detailed in this compound Medication.


A code (or set of codes) that specify this medication, or a textual description if no code is available. Usage note: This could be a standard medication code such as a code from RxNorm, SNOMED CT, IDMP etc. It could also be a national or local formulary code, optionally with translations to other code systems.

ShortNo code that identify this medicationCodes that identify this medication
Comments

Depending on the context of use, the code that was actually selected by the user (prescriber, dispenser, etc.) will have the coding.userSelected set to true. As described in the coding datatype: "A coding may be marked as a "userSelected" if a user selected the particular coded value in a user interface (e.g. the user selects an item in a pick-list). If a user selected coding exists, it is the preferred choice for performing translations etc. Other codes can only be literal translations to alternative code systems, or codes at a lower level of granularity (e.g. a generic code for a vendor-specific primary one).

Control10..1
BindingFor example codes, see SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codes
(example to http://hl7.org/fhir/ValueSet/medication-codes)

A coded concept that defines the type of a medication.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Text of compound SHALL be provided.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Medication.code.coding
Definition

A code identifing the compound medicinal product. Generaly none : no code defined for G5 1L + NaCl 3g + KCl 2g.


A reference to a code defined by a terminology system.

ShortGeneraly no code for compound medicinal productCode defined by a terminology system
Comments

Codes may be defined very casually in enumerations.


Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Control0..*
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Medication.code.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Although a code is genraly unavailable for a compoud medicinal product, there is alway a denomination for it.


The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Medication.status
Definition

A code to indicate if the medication is in active use.

Shortactive | inactive | entered-in-error
Comments

This status is intended to identify if the medication in a local system is in active use within a drug database or inventory. For example, a pharmacy system may create a new drug file record for a compounded product "ABC Hospital Special Cream" with an active status. At some point in the future, it may be determined that the drug record was created with an error and the status is changed to "entered in error". This status is not intended to specify if a medication is part of a particular formulary. It is possible that the drug record may be referenced by multiple formularies or catalogues and each of those entries would have a separate status.

Control0..1
BindingThe codes SHALL be taken from Medication Status Codeshttp://hl7.org/fhir/ValueSet/medication-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/medication-status|4.0.1)

A coded concept defining if the medication is in active use.

Typecode
Is Modifiertrue because This element changes the interpretation of all descriptive attributes.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Medication.form
Definition

Describes the form of the item. Powder; tablets; capsule.

Shortpowder | tablets | capsule +
Comments

When Medication is referenced from MedicationRequest, this is the ordered form. When Medication is referenced within MedicationDispense, this is the dispensed form. When Medication is referenced within MedicationAdministration, this is administered form.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from For example codes, see French Medicinal product Dose formhttp://hl7.org/fhir/ValueSet/medication-form-codes
(extensible to https://interop.esante.gouv.fr/ig/fhir/eds/ValueSet/FrMpDoseForm)
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Medication.amount
Definition

Specific amount in Medication defined by the element collection. For instance 1 L for the amount of the compound Glucose 5% of an infusion Glucose 5% 1L + Sodium chloride 3g + Potassium chloride 2g. Or 3 g for the amount of compound Sodium chloride of the same infusion. SHALL be 1 (without unit, ie. code = 1 in UCUM system) when there is multiple ingredient element with at least the strenght element of two of them expressed in asbolute quantity (ie. simple quantity).


Specific amount of the drug in the packaged product. For example, when specifying a product that has the same strength (For example, Insulin glargine 100 unit per mL solution for injection), this attribute provides additional clarification of the package amount (For example, 3 mL, 10mL, etc.).

ShortAmount of drug in package
Comments

The Ratio datatype is limited to numerator value, leading back to the SimpleQuantity datatype.

Control0..1
TypeRatio(Ratio with UCUM quantity units)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Medication.ingredient
Definition

Identifies a medicinal component of the compound medicinal product


Identifies a particular constituent of interest in the product.

ShortMedication component of compound medicationActive or inactive ingredient
Comments

The Medication SHALL contain ALL the items of the item element list AND ONLY the items of the item element list.


The ingredients need not be a complete list. If an ingredient is not specified, this does not indicate whether an ingredient is present or absent. If an ingredient is specified it does not mean that all ingredients are specified. It is possible to specify both inactive and active ingredients.

Control10..*
TypeBackboneElement
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Medication.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).

ShortExtensions that cannot be ignored even if unrecognized
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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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.

Alternate Namesextensions, user content, modifiers
Invariantsele-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())
22. Medication.ingredient.item[x]
Definition

The actual compound, either nonproprietary named medication or branded named medication identified by a UCD code.


The actual ingredient - either a substance (simple ingredient) or another medication of a medication.

ShortThe actual compoundThe actual ingredient or content
Control1..1
TypeReference(French non proprietary name Medication, French branded name Medication, Substance, Medication), CodeableConcept
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Summaryfalse
Requirements

The ingredient may reference a substance (for example, amoxicillin) or another medication (for example in the case of a compounded product, Glaxal Base).

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Medication.ingredient.strength
Definition

Specifies how many (or how much) of the items there are in this Medication. For example, 250 mg per tablet. This is expressed as a ratio where the numerator is 250mg and the denominator is 1 tablet.

ShortQuantity of ingredient present
Control0..01
TypeRatio
Is Modifierfalse
Summaryfalse
Requirements

The amount and strength of the medication component are described in the item element referencing a Medication ressource profiled fr-medication-1.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Medication.batch
Definition

Information that only applies to packages (not products).

ShortDetails about packaged medications
Control0..01
TypeBackboneElement
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))