A recent study suggests that medications indicated for severe mental illnesses like schizophrenia or bipolar disorder are often prescribed "off-label" at inappropriately low doses for patients with less severe illnesses.
A recent study conducted by researchers at the College of Pharmacy at Oregon State University (OSU), the Department of Psychiatry at Columbia University, and Oregon Health and Science University suggests that medications indicated for severe mental illnesses like schizophrenia or bipolar disorder are often prescribed “off-label” at inappropriately low doses for patients with less severe illnesses, like depression, anxiety, post-traumatic stress disorder, or even no psychiatric disorder other than insomnia.
"It's legal for a physician to prescribe a medication for something other than its FDA-approved uses, and based on good studies or clinical judgment it may be justified," said Daniel Hartung, assistant professor of pharmacy practice, OSU. "However, the approved uses are usually a pretty good proxy for real, proven effectiveness. And if in fact drugs are being used inappropriately, it not only can be very expensive but also pose an unnecessary health risk."
Speaking to the high expense of off-label drug use, the study found that prescription medications that could cost as high as $20-$25 per day were used to treat conditions that could have been treated with generic drugs that run $1.00 per day—and with better results and a lower risk of the serious side effects that often accompany the newer antipsychotics (eg, neuromuscular rigidity, increased risk of stroke, heart arrhythmias, moderate-to-severe weight gain, and worsening glucose control that leads to increased risk of diabetes). Additionally, more than 7% of Medicaid program expenditures in 2002 were for antipsychotics, and they accounted for almost 30% of outpatient fee-for-service drug expenditures in Oregon in 2006, the same year “the Oregon Medicaid program spent about $2.5 million for chronic, subtherapeutic use of a single antipsychotic drug in adult patients.”
According to Hartung, the drugs used in the study have no proven effectiveness for most of their off-label uses, and they were often prescribed at doses and durations lower than has been shown to be therapeutic.
"Some drug companies have been accused of encouraging and expanding the off-label use of drugs, and that may be where part of this misinformation is coming from," Hartung said. "That is an illegal practice, and some companies have been successfully sued on that basis. Regardless of what's causing this, it's a serious concern, both for ensuring resources are used judiciously and protecting health care quality."
As the results of the Oregon study are likely a reflection of nation-wide trends, according to Hartung, the researchers wrote in their report that "states wishing to reduce costs and improve the quality of use for atypical antipsychotic medications should examine prescribing patterns to ensure that these drugs are prescribed within acceptable practice limits, and are not used for off-label uses when other approaches may be more appropriate and less expensive."