R6 Ballot (3rd Draft) FHIR CI-Build

This page is part of the FHIR Specification v6.0.0-ballot3: Release 6 Ballot (3rd Draft) (see Ballot Notes ). The current version is 5.0.0 . For a full list Continuous Integration Build of available versions, see FHIR (will be incorrect/inconsistent at times).
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Responsible Owner: Pharmacy icon Work Group Maturity Level : 4   Trial Use Security Category : Business Compartments : No defined compartments

Detailed Descriptions for the elements in the Medication resource.

Element Id Medication
Definition

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

Short Display Definition of a Medication
Cardinality 0..*
Type DomainResource
Summary false
Element Id Medication.identifier
Definition

Business identifier for this medication.

Short Display Business identifier for this medication
Note This is a business identifier, not a resource identifier (see discussion )
Cardinality 0..*
Type Identifier
Summary true
Comments

The serial number could be included as an identifier.

Element Id Medication.code
Definition

A code (or set of codes) that specify this medication, or a textual description. 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. The name of the medication can be conveyed in the code.text even if it is different from any of the coding displayName values.

Short Display Codes that identify this medication
Cardinality 0..1
Terminology Binding SNOMED CT Medication Codes ( Example )
Type CodeableConcept
Summary true
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).

Element Id Medication.status
Definition

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

Short Display active | inactive | entered-in-error
Cardinality 0..1
Terminology Binding Medication Status Codes ( Required )
Type code
Is Modifier true (Reason: This element changes the interpretation of all descriptive attributes.)
Summary true
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.

Element Id Medication.marketingAuthorizationHolder
Definition

The company or other legal entity that has authorization, from the appropriate drug regulatory authority, to market a medicine in one or more jurisdictions. Typically abbreviated MAH.Note: The MAH may manufacture the product and may also contract the manufacturing of the product to one or more companies (organizations).

Short Display Organization that has authorization to market medication
Cardinality 0..1
Type Reference ( Organization )
Summary true
Element Id Medication.doseForm
Definition

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

Short Display powder | tablets | capsule +
Cardinality 0..1
Terminology Binding SNOMED CT Form Codes ( Example )
Type CodeableConcept
Summary false
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.

Element Id Medication.totalVolume Medication.packageSize
Definition

When the specified product code does not infer a specify the package size, this is backbone element can be used to specify the specific overall amount of drug medication in the 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.). package.

Short Display When the specified product code does not infer a specify the package size, this is backbone element can be used to specify the specific overall amount of drug medication in the product package
Cardinality 0..1
Summary true
Comments

To represent a medication that has 5 vials with 10ml in each vial and the medication code just represents a vial, then the number of Items would be '5 vial' and the amountPerItem would be '10ml/vial'. To represent a medication where there are 300 tablets and the code is for 100mg tablets, the number of items would be '300 tablets'

Constraints
Defined on this element
med-1 Rule Either numberOfItems or amountPerItem must exist numberOfItems.exists() or amountPerItem.exists()
Element Id Medication.packageSize.numberOfItems
Definition

The number of items in the package that are represented by the code, e.g. 5 vials or 100 tablets.

Short Display The number of items in the package that are represented by the code
Cardinality 0..1
Type Quantity SimpleQuantity
Summary true false
Element Id Medication.packageSize.amountPerItem
Definition

The amount per each item, e.g. 10 ml / vial.

Short Display The amount per each item
Cardinality 0..1
Type Ratio
Summary false
Element Id Medication.ingredient
Definition

Identifies a particular constituent of interest in the product.

Short Display Active or inactive Components of a medication. These can be ingredient substances or other medications, in the case of combination packaged medications
Cardinality 0..*
Summary false
Comments

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. If Medication.code represents a fully specified product (the product + the strength + the dosage form) then including ingredients is duplicative. However, there may be implementation considerations which dictate including ingredients when Medication.code is a fully specified product. For compounded products, active and inactive ingredients should be included. However, even with all ingredients specified, a Medication resource should not be considered a "recipe" as the sequence and techniques for preparing the final product cannot be included.

Element Id Medication.ingredient.item
Definition

The ingredient (substance or medication) that the ingredient.strength relates to. This is represented as a concept from a code system or described in another resource (Substance or Medication).

Short Display The ingredient (substance specific substance or medication) medication that is the ingredient.strength relates to ingredient
Cardinality 1..1
Terminology Binding SNOMED CT Medication Codes ( Example )
Type CodeableReference ( Substance | SubstanceDefinition | Medication )
Summary false
Comments

The ingredient may reference a medication substance (for example, amoxicillin) or another medication (for example in the case of a compounded product, Glaxal Base). A referenced medication may be fully specified (amoxicillin 250 mg capsule), partially specified (amoxicillin 250mg), or may refer to an abstract ingredient (e.g., amoxicillin).

Element Id Medication.ingredient.isActive
Definition

Indication of whether this ingredient affects the therapeutic action of the drug.

Short Display Active ingredient indicator
Cardinality 0..1
Type boolean
Requirements

True indicates that the ingredient affects the therapeutic action of the drug (i.e. active). False indicates that the ingredient does not affect the therapeutic action of the drug (i.e. inactive).

Summary false
Element Id Medication.ingredient.role
Definition

Indication of whether this ingredient affects the therapeutic action of the drug.

Short Display A code that defines the type of ingredient, active, base, etc.
Cardinality 0..1
Terminology Binding RoleClassIngredientEntity icon ( Example )
Type CodeableConcept
Requirements

This can be used in combination with the isActive element to provide further information about the type of ingredient.

Summary false
Element Id Medication.ingredient.strength[x]
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 but can also be expressed a quantity when the denominator is assumed to be 1 tablet.

Short Display Quantity of ingredient present
Cardinality 0..1
Terminology Binding Medication Ingredient Strength Codes ( Preferred )
Type Ratio | CodeableConcept | Quantity
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary false
Comments

Medication.ingredient.strength.denominator can cause some confusion. For example, the concentration of a pediatric acetaminophen suspension can be '32 mg / 1 ml' or '160 mg / 5 ml'. Both strengths are the same (32 mg * 5 = 160 mg). In clinical systems (drug databases) strengths are usually to unit volumes (32 mg / 1 ml). While on a consumer product it's preferred to say how much per 'typical' dose (160 mg / 5 ml, with 5 ml (1 tsp) being the typical dose). Both representations are valid. Best practice is to select the denominator most relevant to the situation and use that same denominator for all ingredients. Ingredient.strength is problematic for multi-ingredient ingredients. For example, antacid products often contain multiple ingredients, such as 'aluminum & magnesium hydroxide with simethicone 400-400-40 mg/5ml'. Expressing a 'final concentration' in these cases is intractable and the best option is to not include ingredient.strength.

Element Id Medication.batch Medication.instance
Definition

Information that only applies to packages (not products).

Short Display Details about packaged medications
Cardinality 0..1
Summary false
Element Id Medication.batch.lotNumber Medication.instance.identifier
Definition

Identifier for the physical instance, typically a serial number.

Short Display Identifier for the physical instance, typically a serial number
Note This is a business identifier, not a resource identifier (see discussion )
Cardinality 0..*
Type Identifier
Summary false
Element Id Medication.instance.lotNumber
Definition

The assigned lot number of a batch of the specified product.

Short Display Identifier assigned to batch
Cardinality 0..1
Type string
Summary false
Element Id Medication.batch.expirationDate Medication.instance.expirationDate
Definition

When this specific batch instance of product will expire.

Short Display When batch instance will expire
Cardinality 0..1
Type dateTime
Summary false
Element Id Medication.definition
Definition

A reference to a knowledge definitional resource that provides more information about this medication. This element can be used to help with Cross Border use cases and separately it may also be useful if someone needs to drill into more medication specific information.

Short Display Knowledge about this Formal definition of the medication
Cardinality 0..1
Type Reference ( MedicationKnowledge MedicinalProductDefinition | AdministrableProductDefinition | PackagedProductDefinition | ManufacturedItemDefinition )
Summary false