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Is off-label prescribing a form of medical malpractice?

On Behalf of | Jan 22, 2024 | Prescription Errors

Prescription errors are among the most devastating forms of malpractice, as medications can cause fatal reactions or cause life-altering side effects. Patients who have poor outcomes in treatment often wonder if their case meets the standards for a medical malpractice lawsuit.

If a patient realizes that a doctor prescribed them a medication not approved for a specific type of treatment, they may wonder if that decision constitutes medical malpractice. Professionals refer to using a drug for an unapproved purpose as off-label prescribing. Is an off-label prescription potentially a form of medical malpractice?

Off-labeled prescriptions can be safe

Drug companies have to pay for studies that show both the safety and overall efficacy of a new medication. It needs to perform better than a placebo in a clinical trial to gain approval as a useful form of treatment. Generally, the company also needs to make disclosures about any side effects noted during clinical trials.

Given how much it costs to conduct clinical trials, pharmaceutical companies often only seek approval for one specific medical purpose when testing a drug. Doctors may then prescribe that drug for a host of different medical conditions, as there is an assumption that the medication is generally safe.

There are limits to off-label prescriptions

Medications may have contraindications for people with certain underlying medical conditions or known allergies. They also sometimes have known interactions with other drugs. A physician prescribing a medication off-label to a patient should first validate that it is safe and appropriate for them to do so. The failure to ensure that prescribing a certain medication is reasonably safe for a patient could be medical malpractice even though off-label prescribing is not inherently medical malpractice.

Showing that another medical professional would have handled the situation differently could help someone develop a medical malpractice claim after a potential prescription medication error.