AdverseEventReporting
Class DrugDosage

Contains information describing the amount, timing, and route of administration of medicinal products (whether suspect or concommittant) given to or taken by the subject near the time of the adverse event occurred. Corresponds to ICH E2B(R3), G.k.4.r.

Attributes
String dosageText dosageText

"Free text information when structured dosage information is not possible, or to provide more detail on structured dosage data elements. There is no need to duplicate information provided in the structured dosage data elements." - ICH E2B(R3), G.k.4.r.8.

«PQ» Quantity dose dose

The amount of medication taken at one time.

"The value (number) of each administered dose." - ICH E2B(R3), G.k.4.r.1a
"The unit for the dose value in G.k.4.r.1a." - ICH E2B(R3), G.k.4.r.1b

Medwatch 3500 form question D.2; Medwatch 3500A form question C.2; Medwatch 3500B form question B.7.

String drugFormText drugFormText

"Free text description of the pharmaceutical dose form when the Pharmaceutical Dose Form TermID is not available." - ICH E2B(R3), G.k.4.r.9.1.

«IVL_TS» Period duration duration

The length of time that the patient used the product, if known. Used when exact dates are unknown.
"This section will usually be computed from the start/end date and time of the administration. However, there might be situations in which the precise duration of the drug administration can be useful, such as minutes or hours. Also, this item should be used in addition to dates if exact dates of drug administration are not available at the time of the report, but there is information concerning the duration of drug administration. In such a case, populate 1 data element for the date (start or end date) and this Section. The information requested is the overall duration of drug administration and covers intermittent administration." - ICH E2B(R3), G.k.4.r.6a and G.k.4.r.6b.
MedWatch 3500 form question D.3 (suspect medication); question F (concomitant medication)
MedWatch 3500A form question C.3 (suspect medication); question C.10 (concomitant medication)
MedWatch 3500B form question B.11 (suspect medication)
(note that the VAERS-1 form does not have this element).

«PQ» TimeQuantity frequency frequency

Indicates how often the medication is taken.

"The value (amount) for the time interval between each administered dose (G.k.4.r.1a and G.k.4.r.1b) If either G.k.4.r.2 or G.k.4.r.3 is unknown, both should be left blank unless the definition of the time interval unit is Cyclical, As necessary, or Total." - ICH E2B(R3), G.k.4.r.2
"The UCUM code that best describes the unit for the dosing time interval (G.k.4.r.2). When a specific time interval for drug administration is not known, but is confirmed that the drug is used cyclically or as necessary, then Cyclical or As Necessary can be used in this data element. When the total amount of a drug is provided without any particular dose and dosing interval (e.g. in the case of an overdose), the quantity and unit (G.k.4.r.1a and G.k.4.r.1b) is provided along with Total in this data element (G.k.4.r.2 is left blank)." - ICH E2B(R3), G.k.4.r.3

Medwatch 3500 form question D.2; Medwatch 3500A form question C.2; Medwatch 3500B form question B.8.

«CS» Code parentRoute parentRoute

"This data element captures the known route of administration of the drug as taken by the parent for the dosage described in G.k.4.r.1 to G.k.4.r.3." - ICH E2B(R3), G.k.4.r.11.2a and G.k.4.r.11.2b.

String parentRouteText parentRouteText

"Free text description of the route of administration when the Parent Route of Administration TermID is not available." - ICH E2B(R3), G.k.4.r.11.1.

«CS» Code route route

Indicates how the medication is administered (e.g., by mouth, by injection, etc.).

"The route of administration. For a parent-child/foetus report, this data element indicates the route of administration for the child/foetus (patient). This is usually an indirect exposure, such as transmammary, but can include more usual routes of administration for other drugs given to the child. The parent’s route of administration should be provided in G.k.4.r.11" - ICH E2B(R3), G.k.4.r.10.2a and G.k.4.r.10.2b

Medwatch 3500 form question D.2; Medwatch 3500A form question C.2; Medwatch 3500B form question B.9.

String routeText routeText

"Free text description of the route of administration when the Route of Administration TermID is not available." - ICH E2B(R3), G.k.4.r.10.1.

«TS» PointInTime startDate startDate

The date the patient began to use the product, if known.
"The date and time when drug administration started." - ICH E2B(R3), G.k.4.r.4
MedWatch 3500 form question D.3 (suspect medication); question F (concomitant medication)
MedWatch 3500A form question C.3 (suspect medication); question C.10 (concomitant medication)
MedWatch 3500B form question B.10 (suspect medication)
VAERS-1 form question 10 (suspect vaccine); question 14 (vaccines given within the past 4 weeks)

«TS» PointInTime stopDate stopDate

The date the patient stopped using the product, if known.
"The date and time when drug administration ended. For ongoing drug administration after the onset of the reaction/event, this item should be blank...." - ICH E2B(R3), G.k.4.r.5
MedWatch 3500 form question D.3 (suspect medication); question F (concomitant medication)
MedWatch 3500A form question C.3 (suspect medication); question C.10 (concomitant medication)
MedWatch 3500B form question B.11 (suspect medication)
(note that the VAERS-1 form does not have this element).


Properties:

Alias
Classifier Behavior
Is Abstractfalse
Is Activefalse
Is Leaffalse
Keywords
NameDrugDosage
Name Expression
NamespaceAdverseEventReporting
Owned Template Signature
OwnerAdverseEventReporting
Owning Template Parameter
PackageAdverseEventReporting
Qualified NameFHIM::AdverseEventReporting::DrugDosage
Representation
Stereotype
Template Parameter
VisibilityPublic

Attribute Details

 dosageText
Public String dosageText

"Free text information when structured dosage information is not possible, or to provide more detail on structured dosage data elements. There is no need to duplicate information provided in the structured dosage data elements." - ICH E2B(R3), G.k.4.r.8.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamedosageText
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::dosageText
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 dose
Public «PQ» Quantity dose

The amount of medication taken at one time.

"The value (number) of each administered dose." - ICH E2B(R3), G.k.4.r.1a
"The unit for the dose value in G.k.4.r.1a." - ICH E2B(R3), G.k.4.r.1b

Medwatch 3500 form question D.2; Medwatch 3500A form question C.2; Medwatch 3500B form question B.7.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Namedose
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::dose
Stereotype
Template Parameter
Type«PQ» Quantity
Upper1
Upper Value(1)
VisibilityPublic


 drugFormText
Public String drugFormText

"Free text description of the pharmaceutical dose form when the Pharmaceutical Dose Form TermID is not available." - ICH E2B(R3), G.k.4.r.9.1.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamedrugFormText
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::drugFormText
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 duration
Public «IVL_TS» Period duration

The length of time that the patient used the product, if known. Used when exact dates are unknown.
"This section will usually be computed from the start/end date and time of the administration. However, there might be situations in which the precise duration of the drug administration can be useful, such as minutes or hours. Also, this item should be used in addition to dates if exact dates of drug administration are not available at the time of the report, but there is information concerning the duration of drug administration. In such a case, populate 1 data element for the date (start or end date) and this Section. The information requested is the overall duration of drug administration and covers intermittent administration." - ICH E2B(R3), G.k.4.r.6a and G.k.4.r.6b.
MedWatch 3500 form question D.3 (suspect medication); question F (concomitant medication)
MedWatch 3500A form question C.3 (suspect medication); question C.10 (concomitant medication)
MedWatch 3500B form question B.11 (suspect medication)
(note that the VAERS-1 form does not have this element).

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Nameduration
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::duration
Stereotype
Template Parameter
Type«IVL_TS» Period
Upper1
Upper Value(1)
VisibilityPublic


 frequency
Public «PQ» TimeQuantity frequency

Indicates how often the medication is taken.

"The value (amount) for the time interval between each administered dose (G.k.4.r.1a and G.k.4.r.1b) If either G.k.4.r.2 or G.k.4.r.3 is unknown, both should be left blank unless the definition of the time interval unit is Cyclical, As necessary, or Total." - ICH E2B(R3), G.k.4.r.2
"The UCUM code that best describes the unit for the dosing time interval (G.k.4.r.2). When a specific time interval for drug administration is not known, but is confirmed that the drug is used cyclically or as necessary, then Cyclical or As Necessary can be used in this data element. When the total amount of a drug is provided without any particular dose and dosing interval (e.g. in the case of an overdose), the quantity and unit (G.k.4.r.1a and G.k.4.r.1b) is provided along with Total in this data element (G.k.4.r.2 is left blank)." - ICH E2B(R3), G.k.4.r.3

Medwatch 3500 form question D.2; Medwatch 3500A form question C.2; Medwatch 3500B form question B.8.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Namefrequency
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::frequency
Stereotype
Template Parameter
Type«PQ» TimeQuantity
Upper1
Upper Value(1)
VisibilityPublic


 parentRoute
Public «CS» Code parentRoute

"This data element captures the known route of administration of the drug as taken by the parent for the dosage described in G.k.4.r.1 to G.k.4.r.3." - ICH E2B(R3), G.k.4.r.11.2a and G.k.4.r.11.2b.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Terminologies[
HL7_ICSR FDA SPL Drug Route of Administration Terminology 2.16.840.1.113883.3.88.12.3221.8.7
]
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NameparentRoute
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::parentRoute
StereotypeValueSetConstraints
Template Parameter
Type«CS» Code
Upper1
Upper Value(1)
VisibilityPublic


 parentRouteText
Public String parentRouteText

"Free text description of the route of administration when the Parent Route of Administration TermID is not available." - ICH E2B(R3), G.k.4.r.11.1.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NameparentRouteText
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::parentRouteText
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 route
Public «CS» Code route

Indicates how the medication is administered (e.g., by mouth, by injection, etc.).

"The route of administration. For a parent-child/foetus report, this data element indicates the route of administration for the child/foetus (patient). This is usually an indirect exposure, such as transmammary, but can include more usual routes of administration for other drugs given to the child. The parent’s route of administration should be provided in G.k.4.r.11" - ICH E2B(R3), G.k.4.r.10.2a and G.k.4.r.10.2b

Medwatch 3500 form question D.2; Medwatch 3500A form question C.2; Medwatch 3500B form question B.9.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Terminologies[
HL7_ICSR FDA SPL Drug Route of Administration Terminology 2.16.840.1.113883.3.88.12.3221.8.7
]
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Nameroute
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::route
StereotypeValueSetConstraints
Template Parameter
Type«CS» Code
Upper1
Upper Value(1)
VisibilityPublic


 routeText
Public String routeText

"Free text description of the route of administration when the Route of Administration TermID is not available." - ICH E2B(R3), G.k.4.r.10.1.

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamerouteText
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::routeText
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 startDate
Public «TS» PointInTime startDate

The date the patient began to use the product, if known.
"The date and time when drug administration started." - ICH E2B(R3), G.k.4.r.4
MedWatch 3500 form question D.3 (suspect medication); question F (concomitant medication)
MedWatch 3500A form question C.3 (suspect medication); question C.10 (concomitant medication)
MedWatch 3500B form question B.10 (suspect medication)
VAERS-1 form question 10 (suspect vaccine); question 14 (vaccines given within the past 4 weeks)

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamestartDate
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::startDate
Stereotype
Template Parameter
Type«TS» PointInTime
Upper1
Upper Value(1)
VisibilityPublic


 stopDate
Public «TS» PointInTime stopDate

The date the patient stopped using the product, if known.
"The date and time when drug administration ended. For ongoing drug administration after the onset of the reaction/event, this item should be blank...." - ICH E2B(R3), G.k.4.r.5
MedWatch 3500 form question D.3 (suspect medication); question F (concomitant medication)
MedWatch 3500A form question C.3 (suspect medication); question C.10 (concomitant medication)
MedWatch 3500B form question B.11 (suspect medication)
(note that the VAERS-1 form does not have this element).

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassDrugDosage
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamestopDate
Name Expression
NamespaceDrugDosage
Opposite
OwnerDrugDosage
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::DrugDosage::stopDate
Stereotype
Template Parameter
Type«TS» PointInTime
Upper1
Upper Value(1)
VisibilityPublic