Patients who need medical care typically trust their doctors. They expect their physicians to make decisions that align with current best practices and lead to the best possible outcome. Patients typically trust their doctors to diagnose them and propose an appropriate course of treatment given the situation.
Occasionally, patients may eventually question the decisions made by health care professionals. They may wonder whether a doctor failed in their professional duty or made mistakes that resulted in a worse outcome. In some circumstances, medical errors and negligence can lead to credible claims of medical malpractice.
Medication errors are one of the top types of medical malpractice claims. Does off-label prescribing typically constitute medical malpractice?
Off-label prescribing is common
Off-label prescribing involves recommending a medication for a purpose other than its approved use. Drug manufacturers typically have to fund clinical trials that help validate that a drug is both safe and effective. Typically, drug manufacturers test medications for a specific intended use.
If the testing shows that the drug is reasonably safe and that it is more effective than a placebo at treating an illness or managing symptoms, then the Food and Drug Administration (FDA) may approve the medication for use in specific situations.
A drug that works effectively to treat a particular health challenge could also help people manage other medical challenges. Generally speaking, physicians can reasonably assume that medications are safe for patients to use if they have FDA approval for any purpose. Doctors do not necessarily commit malpractice just because they recommend using a drug for a purpose other than the approved purpose.
When does off-label prescribing become malpractice?
Although off-label prescribing is not automatically a form of malpractice, it can easily become malpractice. If physicians do not follow standard procedures when deciding what drug to prescribe to a patient and what dosage to authorize, they might eventually face allegations of malpractice because of their prescribing habits.
Typically, doctors need to advise their patients that they are recommending a drug for off-label use. They should ensure that the patient is aware of potential side effects and adverse outcomes associated with the medication. Doctors also usually need to educate their patients about alternative treatment options.
They should check the patient’s chart carefully to ensure that there are no contraindications for a specific medication. They also need to ensure that the dosage that they recommend is appropriate given the patient’s age, weight and unique medical challenges.
If doctors recommend a medication that is obviously not safe for a patient given their pre-existing conditions or other prescriptions, then their actions may lead to claims of medical malpractice. Failing to secure informed consent from a patient, prescribing an inappropriate medication and providing insufficient medical oversight could also all lead to allegations of drug-related medical malpractice.
Reviewing medical records and the consequences of a poor reaction to a medication can help a patient determine if they experienced medical malpractice. When other doctors may have made vastly different treatment choices, the decisions of a health care professional could constitute a medical mistake or negligence.