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ValueSet
default
ProductShelfLife Type: The shelf-life and storage information for a medicinal product item or container can be described using this class.
ProductShelfLife
Path
ProductShelfLife
Id
ProductShelfLife
Cardinality
0 - *
Definition
The shelf-life and storage information for a medicinal product item or container can be described using this class.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
type
This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
Path
ProductShelfLife.type
Id
ProductShelfLife.type
Type
Cardinality
0 - 1
Definition
This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
Definition
The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Comment
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
Definition
A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
ProductShelfLife.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
ProductShelfLife.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
Requirements
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
period[x]
The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
Path
ProductShelfLife.period[x]
Id
ProductShelfLife.period[x]
Type
Cardinality
0 - 1
Definition
The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.period[x].Duration.value
Id
Duration.value
Type
Cardinality
0 - 1
Definition
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Comment
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).
Requirements
Precision is handled implicitly in almost all cases of measurement.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.period[x].Duration.comparator
Id
Duration.comparator
Type
Cardinality
0 - 1
Definition
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.
Comment
Requirements
Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Binding
Strength
required
Description
How the Quantity should be understood and represented.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.period[x].Duration.unit
Id
Duration.unit
Type
Cardinality
0 - 1
Definition
A human-readable form of the unit.
Comment
Requirements
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.period[x].Duration.system
Id
Duration.system
Type
Cardinality
0 - 1
Definition
The identification of the system that provides the coded form of the unit.
Comment
Requirements
Need to know the system that defines the coded form of the unit.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
qty-3
Path
ProductShelfLife.period[x].Duration.code
Id
Duration.code
Type
Cardinality
0 - 1
Definition
A computer processable form of the unit in some unit representation system.
Comment
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.
Requirements
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
qty-3
specialPrecautionsForStorage
Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
Path
ProductShelfLife.specialPrecautionsForStorage
Id
ProductShelfLife.specialPrecautionsForStorage
Type
Cardinality
0 - *
Definition
Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
Definition
The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Comment
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
Definition
A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
Requirements
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children