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Is prescribing drugs off-label a form of medical malpractice?

On Behalf of | Mar 6, 2024 | Medication Errors

Healthcare professionals have numerous tools that their disposal. They often work with corporate medical practices or hospitals where they can refer patients to specialists. They may have access to diagnostic equipment and rehabilitative facilities.

Additionally, physicians can prescribe thousands of different medications to help people address the symptoms of a medical issue. Prescription drugs can help with everything from blood pressure to nausea. Typically, any medication available on a prescription basis has undergone testing to ensure that it is reasonably safe and effective for the treatment of certain medical conditions.

Can doctors prescribe a medication for a purpose other than its intended use, or is this effort a medical malpractice lawsuit waiting to happen?

Off-label prescribing is a common practice

The Food and Drug Administration (FDA) reviews data collected by pharmaceutical companies as they develop their drugs. The companies typically fund the research that helps establish whether a new medication is reasonably safe and if it is more effective than a placebo to treat certain symptoms.

If the FDA approves a drug for one purpose, physicians can assume that the drug is overall safe for people to use. They could theoretically prescribe that medication to a patient for a completely different medical challenge. For example, in recent months, there has been a surge of interest in using certain diabetes medications to help people with intentional weight loss.

With that said…

Off-label prescribing is not automatically an act of medical malpractice. However, it can lead to claims of medical malpractice in certain scenarios. For example, medications may have warning labels advising physicians not to use the medication to treat certain types of people or specific medical conditions.

If a doctor’s off-label prescribing violates FDA warnings, then their choice to prescribe that medication could constitute malpractice. Similarly, the decision to use a drug for an off-label purpose when another, potentially safer drug can achieve the same goal might constitute malpractice. The degree of risk for the patient and whether another reasonable physician would have prescribed the same medication are the main considerations in such cases.

A patient’s awareness of the risks can also play a role in whether or not malpractice has occurred in the event of medication-related harm. Physicians should generally warn patients about failure rates, side effects and contraindications when using a medication for an unapproved or experimental purpose. Reviewing medical records and current best practices can help someone determine whether a medication error or other adverse event that they have experienced constitutes malpractice or not.