IS YOUR MEDICAL LICENSEAT RISK IF YOU ADMINISTER DRUGS OFF-LABEL?
Updated: Nov 3
As a physician, you take an oath to help people and to do no harm. Sometimes, individuals present for medical care with symptoms or situations that require creative solutions. Not everyone responds to the same treatment. You may even truly find yourself looking for a creative solution when you can’t access certain resources or when a patient proves unresponsive to more traditional treatment.
Some physicians will recommend or administer a drug for off-label use. Off-label use involves using a medication approved by the Food and Drug Administration (FDA) for a purpose other than its stated and approved purpose. Will you potentially lose your medical license or face other career consequences for recommending off-label drug treatment for a patient?
FDA-APPROVED DRUGS ARE GENERALLY SAFE
When the FDA evaluates the safety and efficacy of a drug, they typically investigate a specific medical claim and then approve the medication for that specific purpose. However, there is an assumption that the medication is generally safe unless there are certain populations that should not take the medication.
For example, the FDA may approve a drug but then note that it interacts with certain other medications or that it poses an elevated risk for certain groups of people, like pregnant women. So long as theoff-label use of a medication is not contrary to the labeling and safety information for the drug, recommending or administering it off-label will not likely lead to disciplinary action or endanger your license.
However, if you use a drug for a purpose that it bears a label specifically advising against or on a person specifically prohibited from taking that drug, then your decision might leave you open to consequences later.
KEEPING INFORMED IS CRUCIAL TO PROTECTING YOURSELF
There is constantly new information coming out about the safety and effectiveness of different drugs for different uses.
Cancer drugs approved for one form of cancer later undergo new trials because they showed promise against other forms of cancer, for example. Doctors reporting latent consequences of a medication long after a patient takes it could lead to the publication of data about long-term risks for certain groups that weren’t known after the initial approval.
Knowing your rights and keeping up to date on drug and treatment data helps medical professionals protect their licensing and careers.