Drugs for treating the most severe mental illnesses are often prescribed at inappropriately low doses and at considerable expense, for use in conditions where their benefit has not been established, US researchers say.
Prescription drugs that might cost as much as $20 to $25 (Roughly R200-250) a day are being widely used to treat problems for which they were not approved by the US Food and Drug Administration (FDA), they said.
" Some of those problems could have been addressed with generic medications costing $1 (roughly R10) a day, with better results and less risk of serious side effects," the researchers wrote.
Unnecessarily raising medical costs
This is a reflection of widespread use of medications for "off-label" uses that have not been carefully considered or approved by the Food and Drug Administration, they wrote, some of which are unnecessarily raising medical costs and reducing the effectiveness of health care.
The study was published in the Journal of Clinical Psychiatry, and funded by the US National Institutes of Health.
"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, an assistant professor of pharmacy practice at Oregon State University. "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."
Both of those problems were found in the study.
In this case, the health conditions of 830 patients were examined – all of whom had been given one of the newer antipsychotic medications approved only for some of the most severe forms of mental illness, such as schizophrenia or bipolar disorder. However, the researchers found that the vast majority of the people receiving one of these drugs did not have schizophrenia or bipolar disorder, the underlying mental health conditions for which the drugs had been approved.
Most people who received these "atypical antipsychotic" drugs, which are very powerful and have potentially severe side effects, had less serious mental health concerns such as depression, anxiety, post-traumatic stress disorder – or no psychiatric disorder other than insomnia.
Only some patients need the drugs
The newer antipsychotic drugs can cause side effects such as neuromuscular rigidity, increased risk of stroke, heart arrhythmias, moderate-to-severe weight gain, and worsening glucose control that leads to increased risk of diabetes. The drugs may be necessary for patients with major mental health problems such as schizophrenia, Hartung said, but have not been demonstrated to be effective for most of their off-label uses, such as depression or agitation in persons suffering from dementia.
The prescriptions, he said, were also often given at lower doses and for shorter time periods than anything that 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." – (EurekAlert)
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