Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. Example: Tylenol

Product Non-proprietary Name: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]

The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids). For example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the "product overall release profile" is "ER". [Source: SME Defined]

TThe dosage form design used to achieve an ER release profile. Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]

A property that identifies whether the drug product contains any coatings. [Source: SME Defined]

The total number of layers in the tablet. [Source: SME Defined] Note: Non-layered tablets will be considered as one layer tablets.

TThe total number of type of beads present in a tablet [Source: SME Defined] Example: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2.

Categorization of the capsule shell based on factors such as the shell’s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]

The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined] Example: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2.

The pictorial representation of the drug product. [Source: SME Defined]

A physical (content) or activity measurement of the weight of the drug product unit. [Source: SME Defined] Example: Mass, Activity

Specifies the total quantity of all ingredients in a single unit of the drug product. [Source: SME Defined] Note: a single unit of a solid oral dose form could be a tablet or a capsule

Specifies the quantity of the ingredient (s) consistent with a single unit dose or as expressed on the label. [Source: SME Defined] Note: For solid oral dose forms, by definition this is 1

A written description of the weight of the drug product. [Source: SME Defined] Note: This is typically applicable to biologics Example: International Units for Enzymes

A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics.

The established benchmark to which the component complies. [Source: SME Defined] Examples: USP/NF, EP, Company Standard

Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined] Example: Layer, Bead, Minitablet, Capsule Shell, Coating

The main purpose for the part in the dosage form. [Source: SME Defined] Example: In a two layer tablet with two APIs: Product Part Function Description for Layer 1 = Deliver API 1 and Product Part Function Description for Layer 2 = Deliver API 2

Specifies the total quantity of all ingredients in a single part of the drug product. [Source: SME Defined] Note: a single unit of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule

The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI E C117055] Example: mg

Specifies the quantity of an ingredient in a single part of the drug product. [Source: SME Defined] Note: a single part of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule Note: Amount can also be referred to as potency in biologics and other products.

The labeled unit of measure for the content of an ingredient, expressed quantitatively per product part. [Source: Adapted for NCI EVS C117055]

Identifies where the ingredient physically resides within the product part. [Source: SME Defined] Examples: Intragranular, Extra granular, Blend

A classification that identifies the higher level purpose of that material. [Source: SME Defined] Example: Active Ingredient, Inactive Ingredient, Adjuvant.

A sub-classification of part ingredients identifying its purpose/role in the drug product part (e.g., in the layer, bead, minitablet). [Source: SME Defined] Examples: Filler, Surfactant

If the Product does not have parts the Product Part Role is 'Primary'. If the Product does have parts and the Product Part does not have a Product Part Identifier Reference then the component is a 'Parent'.
If the Product does have parts and there is a Product Part Identifier Reference the component is a 'Child'.

A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined] Examples: 1, A1, Red bead, Blue minitablet

Identifies the parent or outer-level product part. [Source: SME Defined] Example: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead.

The behavior in which drug substance migrates from the drug product part to the surrounding environment (e.g., biological fluids, dissolution media, etc.) [Source: SME Defined]

The method employed to realize the specified part release profile. [Source: SME Defined] Example: matrix or reservoir

The reason the coating or covering was added. [Source: SME Defined] Examples: rate-controlling, color, release type, protective, taste masking.

The hue or the tint of the drug product part. [Source: SME Defined] Examples: yellow, pink, blue, pale yellow.

The percentage of the drug product as a whole, that is represented by this part. [Source: SME Defined] Example: total tablet weight = 400 mg, total weight of layer = 250 mg, then Content Percent for the layer = 62.5

A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.

The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product.

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

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.

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 its narrative along with other profiles, value sets, etc.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

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 managable, 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).

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.

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.

Unique identifier.

The status of this item. Enables tracking the life-cycle of the content.

Allows filtering of manufactured items that are appropriate for use versus not.

The lifecycle status of an artifact.

Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. Example: Tylenol

Product Non-proprietary Name: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]

Dose form as manufactured and before any transformation into the pharmaceutical product.

Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.

A reference to a code defined by a terminology system.

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.

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

General characteristics of this item.

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 managable, 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).

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.

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.

A code expressing the type of characteristic.

This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

General characteristics of this item.

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 managable, 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).

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.

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.

A code expressing the type of characteristic.

A value for the characteristic.

The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids). For example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the "product overall release profile" is "ER". [Source: SME Defined]

A reference to a code defined by a terminology system.

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.

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

General characteristics of this item.

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 managable, 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).

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.

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.

A code expressing the type of characteristic.

A value for the characteristic.

TThe dosage form design used to achieve an ER release profile. Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]

A reference to a code defined by a terminology system.

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.

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

General characteristics of this item.

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 managable, 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).

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.

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.

A code expressing the type of characteristic.

A value for the characteristic.

A property that identifies whether the drug product contains any coatings. [Source: SME Defined]

General characteristics of this item.

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 managable, 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).

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.

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.

A code expressing the type of characteristic.

A value for the characteristic.

The total number of layers in the tablet. [Source: SME Defined] Note: Non-layered tablets will be considered as one layer tablets.

The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

Precision is handled implicitly in almost all cases of measurement.

How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

How the Quantity should be understood and represented.

Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

A computer processable form of the unit in some unit representation system.

The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

General characteristics of this item.

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 managable, 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).

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.

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.

A code expressing the type of characteristic.

A value for the characteristic.

TThe total number of type of beads present in a tablet [Source: SME Defined] Example: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2.

The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

Precision is handled implicitly in almost all cases of measurement.

How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

How the Quantity should be understood and represented.

Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

A computer processable form of the unit in some unit representation system.

The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

General characteristics of this item.

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 managable, 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).

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.

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.

A code expressing the type of characteristic.

A value for the characteristic.

Categorization of the capsule shell based on factors such as the shell’s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]

A reference to a code defined by a terminology system.

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.

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

General characteristics of this item.

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 managable, 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).

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.

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.

A code expressing the type of characteristic.

A value for the characteristic.

The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined] Example: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2.

The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

Precision is handled implicitly in almost all cases of measurement.

How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

How the Quantity should be understood and represented.

Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

A computer processable form of the unit in some unit representation system.

The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

General characteristics of this item.

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 managable, 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).

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.

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.

A code expressing the type of characteristic.

A value for the characteristic.

The pictorial representation of the drug product. [Source: SME Defined]

General characteristics of this item.

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 managable, 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).

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.

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.

A code expressing the type of characteristic.

A value for the characteristic.

A physical (content) or activity measurement of the weight of the drug product unit. [Source: SME Defined] Example: Mass, Activity

A reference to a code defined by a terminology system.

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.

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

General characteristics of this item.