NAV

Indication Structure & Examples

Structure Overview

The general structure of an indication includes a "condition" (or other concept, see below) that is being treated or modified with a drug, followed by descriptive qualifiers that further define how and when the drug can be used. Below is an example of an indication for the drug Pyrazinamide, which is used in the treatment of Tuberculosis:

{
    "kind": "treatment_of",
    "off_label": false,
    "otc_use": false,
    "drug": {
        "name": "Pyrazinamide",
        "drugbank_id": "DB00339"
    },
    "condition": {
        "title": "Active Tuberculosis",
        "meddra_id": "llt/10071157",
        "icd10_id": "c/A15-A19",
        "modification_of": {
            "status": "active",
            "base": {
                "title": "Tuberculosis",
                "meddra_id": "llt/10044755",
                "icd10_id": "c/A15-A19"
            }
        }
    },
    "age_groups": ["adult"]
}
Translation: Pyrazinamide is used to treat adult patients with active tuberculosis. The condition is linked to medical term sets MedDRA and ICD-10 by the meddra_id and icd10_id.

Indication Concept Types

Indications most commonly include a "condition" that is being treated or modified with a drug. However, this is not the only possible concept type an indication may reference. Indications may refer to any of the following concepts, which may occur alone or in combination:

  • condition: A medical condition targeted by the drug, ex: diabetes.
  • induction_of: A state induced by the drug, ex: sedation.
  • therapy: A therapy that the drug is a part of, ex. supplementary nutrition.
  • process: A process that the drug is used during, ex. surgery.
  • mechanism: A specific action the drug is performing, ex. reduce dextromethorphan metabolism.

Kinds of Indications

Goals of use of the drug are reflected in the kind label used to describe it. The following kinds are covered:

  • Treatment: The drug will cure or eradicate the specified condition. Also used if the goal of therapy is to cure, regardless of whether it succeeds or not (ex. cancer treatments).
  • Management: The drug will modify the disease course of the specified condition (ie. controls, halts, or alters the progression) but doesn’t cure or reverse it.
  • Symptomatic treatment: The drug will treat the symptoms but will not modify or treat the underlying cause of those symptoms. Can also be used to describe palliative treatments.
  • Prevention: The drug will be used to prevent the occurrence of a condition that may or may not occur, usually over a longer time span and for an indefinite period. Usually (but not always) related to infectious diseases.
  • Prophylaxis: The drug is being used to prevent a specified condition that will likely occur in the short term.
  • Therapy: The drug is not being used to treat or manage a medical condition; it is being used to induce a state for therapeutic purposes (ex: birth control, assisted reproductive technology, anesthesia, etc.).
  • Induction: The drug is used to induce a state or process.
  • Reversal: The drug is used to reverse a state. Mainly for overdoses and poisonings.
  • Diagnostic agent: The drug is used to diagnose a condition.
  • Diagnostic process: The drug is used as part of a process to diagnose a condition.

Descriptive qualifiers are included after the condition to further define the drug’s use, and can be:

  • Patient-specific: Age, sex, concurrent co-morbidities or characteristics.
  • Condition-specific: Severity, location, stage of disease, associated gene expressions or other conditions, etc.
  • Formulation- or Product-specific: Dose form (oral, IV, subcutaneous, topical, etc), specified for Over-The-Counter (OTC) use, off-label use, country of approval.

Examples

NULOJIX® (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. NULOJIX is to be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
{
    "kind": "used_in_combination_for_prophylaxis_of",
    "off_label": false,
    "otc_use": false,
    "combination_type": "regimen",
    "age_groups": [
        "adult"
    ],
    "drug": {
        "name": "Belatacept",
        "drugbank_id": "DB06681"
    },
    "condition": {
        "name": "Kidney Transplant Rejection",
        "drugbank_id": "DBCOND0066662",
        "meddra_id": "llt/10023439",
        "icd10_id": "c/T86.11"
    },
    "patient_characteristics": [
        {
            "name": "Epstein-Barr Virus seropositive",
            "drugbank_id": "DBCOND0023315",
            "meddra_id": "pt/10064545"
        }
    ],
    "combination_drugs": [
        {
            "name": "Mycophenolate mofetil",
            "drugbank_id": "DB00688"
        },
        {
            "name": "Basiliximab",
            "drugbank_id": "DB00074"
        }
    ],
    "combination_drug_categories": [
        {
            "name": "Adrenal Cortex Hormones",
            "drugbank_id": "DBCAT000556",
            "mesh_id": "D000305"
        }
    ]
}
Follitropin alfa injection is indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
{
    "kind": "for_therapy",
    "off_label": false,
    "otc_use": false,
    "drug": {
        "name": "Follitropin",
        "drugbank_id": "DB09024"
    },
    "therapy": {
        "name": "Assisted Reproductive Technology",
        "drugbank_id": "DBCOND0020336",
        "meddra_id": "llt/10003438",
        "related_concepts": [
            {
                "name": "Fertility and fertilisation interventions female",
                "drugbank_id": "DBCOND0024683",
                "meddra_id": "hlt/10016471"
            }
        ]
    }
}
Gadoxetate is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in patients with known or suspected focal liver disease.
{
    "kind": "diagnostic_agent",
    "off_label": false,
    "otc_use": false,
    "drug": {
        "name": "Gadoxetic acid",
        "drugbank_id": "DB08884"
    },
    "condition": {
        "name": "Focal liver disease",
        "drugbank_id": "DBCOND0023495",
        "meddra_id": "llt/10008953",
        "icd10_id": "c/K70-K77"
    },
    "process": {
        "name": "MRI",
        "drugbank_id": "DBCOND0020716",
        "meddra_id": "llt/10028049"
    }
}
Vedolizumab is indicated for use in adult patients with moderately or severely active ulcerative colitis in patients who have had an inadequate response with tumor necrosis factor-alpha (TNF-alpha) blockers or immunomodulators.
 {
    "kind": "management_of",
    "off_label": false,
    "otc_use": false,
    "age_groups": [
        "adult"
    ],
    "drug": {
        "name": "Vedolizumab",
        "drugbank_id": "DB09033"
    },
    "condition": {
        "name": "Severe Ulcerative Colitis",
        "drugbank_id": "DBCOND0033634",
        "modification_of": {
            "base": {
                "name": "Ulcerative Colitis",
                "drugbank_id": "DBCOND0029012",
                "meddra_id": "llt/10045365",
                "icd10_id": "c/K51.9"
            },
            "severity": {
                "includes": [
                    "severe"
                ],
                "excludes": []
            }
        }
    }
},
{
    "kind": "management_of",
    "off_label": false,
    "otc_use": false,
    "age_groups": [
        "adult"
    ],
    "drug": {
        "name": "Vedolizumab",
        "drugbank_id": "DB09033"
    },
    "condition": {
        "name": "Moderate Ulcerative colitis",
        "drugbank_id": "DBCOND0020388",
        "modification_of": {
            "base": {
                "name": "Ulcerative Colitis",
                "drugbank_id": "DBCOND0029012",
                "meddra_id": "llt/10045365",
                "icd10_id": "c/K51.9"
            },
            "severity": {
                "includes": [
                    "moderate"
                ],
                "excludes": []
            }
        }
    }
}
Dexchlorpheniramine maleate is an over-the-counter drug used temporarily to relieve symptoms due to hay fever or other upper respiratory allergies.
{
    "kind": "management_of",
    "off_label": false,
    "otc_use": true,
    "drug": {
        "name": "Dexchlorpheniramine maleate",
        "drugbank_id": "DB09555"
    },
    "condition": {
        "name": "Allergic Rhinitis",
        "drugbank_id": "DBCOND0029366",
        "meddra_id": "llt/10001723",
        "icd10_id": "c/J30.9"
    }
}

Linked Terms

The conditions described in the indications are linked to the following term sets:

  • meddra_id: Links to MedDRA (Medical Dictionary for Regulatory Activities) the ID includes two parts llt for low-level terms or hlt for high level terms as well as the numerical identifier for example: llt/10045365
  • icd10_id: Links to ICD-10 (International Statistical Classification of Diseases and Related Health Problems 10th Revision) the id includes two parts: c for context, and the alpha-numeric identifier for the ICD-10 concept. The identifier may be a single id such as c/A11, or a range, such as c/A00-B99, which indicates a concept with other concepts below it in the ICD-10 hierarchy.
  • snomed_id: Links to SNOMED CT (Systematized Nomenclature of Medicine - Clinical Terms) the id includes two parts: c for concept, or d for description, as well as the numeric identifier. Example: c/6071000119100

For full details on indication attributes, see the Data Details page.