Drug indication
What is a drug indication?
A drug indication is a particular disease that a drug can be used to treat, prevent, or diagnose. For example, a drug indication of insulin is diabetes.
One drug will often have more than one indication, meaning it can be used to treat more than one disease. All of a drug’s approved indications are listed on the drug label and must be submitted when applying for FDA approval.
When an indication has been FDA-approved, it is called a labeled indication, and if a drug indication is not FDA-approved, it is considered off-label. Whether an indication is covered or not can affect whether a prescription is covered by insurance, with most insurers not covering off-label use of a drug. So, a drug may be able to treat a patient, but if that particular indication is not FDA-approved, the patient may have to pay the full cost themselves.
Why are drug indications important?
Drug indications show which diseases a medication is effective for. As such, drug indications allow healthcare practitioners to identify appropriate therapies for the patient and are a critical component of clinical decision-making.
Furthermore, it is the responsibility of the pharmaceutical manufacturer to determine all of the medication’s drug indications—the more indications, the more people who can use the drug, and the greater profits they will see.