People with strep throat usually receive a prescription for antibiotics in one of three main families known to be effective against that type of bacteria. People dealing with whiplash might receive a variety of different medications intended to help their muscles relax, promote faster healing, reduce their pain or help them sleep.
Occasionally, doctors may take liberties with medications that lead to questions about whether they committed medical malpractice. Despite the proliferation of drugs for a variety of different purposes, doctors may prescribe a medication for a purpose other than the approved purpose of that medication.
People refer to that practice as off-label prescribing. Is off-label prescribing typically medical malpractice?
Off-label prescribing is common
The process of obtaining approval from the Food and Drug Administration FDA for a new medication is quite lengthy. Drug companies generally need to establish that the medication is reasonably safe by conducting a series of clinical trials. They also need to show that the medication is more effective than a placebo at addressing certain symptoms.
Frequently, medications may be effective for multiple different symptoms or conditions, but the manufacturer may only seek FDA approval for one particular use. Off-label prescribing is not automatically an act of malpractice. Physicians can reasonably assume that medications approved by the FDA for one treatment are acceptably safe to administer to patients.
When does off-label prescribing become malpractice?
The decision to administer a drug for an unapproved purpose may become malpractice in cases where the prescription causes a predictable and therefore preventable negative reaction in the patient. In some cases, doctors may do something that other medical professionals readily acknowledge is unsafe or unnecessarily risky.
For example, some medical professionals use the drug Cytotec or misoprostol to speed up cervical effacement and dilation during labor and delivery. However, Cytotec is a drug approved for the treatment of ulcers, not for labor and delivery applications. In fact, the medication bears a warning label that it is not for use in pregnant women because of the risk of catastrophic side effects.
In cases where a doctor misses clear indications that a specific drug is not the best choice, their prescribing habits could constitute medical malpractice. Additionally, doctors engaging in off-label prescribing typically need to discuss the decision with their patients. They need to inform them of alternative treatments, success rates and known risks so that the patient can provide informed consent.
When doctors do not adhere to best practices, they may ultimately be liable when their decisions have negative repercussions for others. Off-label prescribing is not automatically a form of medical malpractice, but it can constitute malpractice in some scenarios. Having legal guidance when reviewing medical decisions can help people recognize when they’ve experienced medical malpractice.