In the US, doctors prescribe drugs to treat any condition they see fit, even if it is not approved by the Food and Drug Administration (FDA) for that condition. These uses are considered “off-label” and make up over 20% of all prescriptions in the US.
The Los Angeles Times, Forbes Magazine, the Veterans Administration, physicians writing to the New England Journal of Medicine, and many other medical organizations have each made calls for better measurement and understanding of off-label drug use in the last year. Each of these calls comes as a direct result of reported increases in morbidity and mortality from non-approved uses of drugs in the US. Our work provides the first library we are aware of with estimates of off-label drug use in the US for a large number of (ie. greater than 10) medications.
Our analysis of fourteen years of data from the Medical Expenditure Panel Survey shows that off-label drug use happens in large numbers for many medications. This infographic shows case studies for three drugs (metoprolol, cymbalta, and methadone) which highlight how research, word-of-mouth and foreign drug use approvals can drive off-label use, in some cases impacting use more than FDA approvals that typically come much later. The data analysis we have done provides easy access to analagous analyses by condition codes for over 2,000 medications.