Medicinal Product Indication

$10 / year

A medical situation in which a medicinal product is appropriate for use for the treatment of a specific disease.

Complexity

An indication for a drug refers to the use of that medicinal product for treating a particular disease. For example, diabetes is an indication for insulin. Another way of stating this relationship is that insulin is indicated for the treatment of diabetes. Medicinal products often have more than one indication, which means that there is more than one disease for which it is used. The Food and Drug Administration (FDA) classifies indications for drugs in the United States. Indications for drugs can be classified in two categories:

– FDA-approved, also called labeled indications, and
– Non FDA-approved, also called off-label indications.

Early in the process of developing a drug, the drug’s manufacturer decides what disease(s) the drug might treat effectively based on the drug’s known effects on the body. The manufacturer then conducts studies using people with the disease(s) to determine if the drug is, in fact, effective. These studies are designed and conducted under strict FDA guidelines and under the watchful eye of the FDA. If the studies show efficacy (benefit to patients with the disease) and no serious side effects for the drug, the manufacturer applies to the FDA for approval of the drug for that indication (disease).

Date Created

2018-09-20

Last Modified

2018-12-27

Version

4.0.0

Update Frequency

Annual

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; Health Level Seven International;

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

FHIR, HL7, Medical Terminology, Processes Data, Processes Information, Processes Documentation, Health Information Exchange, Electronic Health Records, FHIR Smart, Smart on FHIR

Other Titles

FHIR Medicinal Product Indication Resource, Electronic Health Records Exchange Through FHIR

NameDescriptionTypeConstraints
Concept_NameName of the concept in the FHIR structure.stringrequired : 1
Computer_Ready_NameA Computer-ready name (e.g. a token) that identifies the structure - suitable for code generation. Note that this name (and other names relevant for code generation, including element & slice names, codes etc) may collide with reserved words in the relevant target language, and code generators will need to handle this.string-
TypeThe type the structure describes.string-
Dollar_RefThe "$ref" string value contains a Uniform Resource Identifier (URI) which identifies the location of the JSON value being referenced.string-
DescriptionA free text natural language description of the structure and its use.string-
ItemsThe value of the keyword should be an object or an array of objects. If the keyword value is an object, then for the data array to be valid each item of the array should be valid according to the schema in this value.string-
RequiredThe value of the keyword should be an array of unique strings. The data object to be valid should contain all properties with names equal to the elements in the keyword value.string-
ConstThe value of this keyword can be anything. The data is valid if it is deeply equal to the value of the keyword.string-
Concept_NameComputer_Ready_NameTypeDollar_RefDescriptionItemsRequiredConst
MedicinalProductIndication['resourceType']
MedicinalProductIndication_OtherTherapy['therapyRelationshipType']
MedicinalProductIndication_language#/definitions/ElementExtensions for language
MedicinalProductIndication_implicitRules#/definitions/ElementExtensions for implicitRules
MedicinalProductIndicationlanguage#/definitions/codeThe base language in which the resource is written.
MedicinalProductIndicationresourceTypeThis is a MedicinalProductIndication resourceMedicinalProductIndication
MedicinalProductIndicationduration#/definitions/QuantityTiming or duration information as part of the indication.
MedicinalProductIndicationsubjectarrayThe medication for which this is an indication.{'$ref': '#/definitions/Reference'}
MedicinalProductIndicationpopulationarrayThe population group to which this applies.{'$ref': '#/definitions/Population'}
MedicinalProductIndicationdiseaseStatus#/definitions/CodeableConceptThe status of the disease or symptom for which the indication applies.
Related Data Packages