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The Journal of the American Medical Association (JAMA) Internal Medicine study, released this month, suggests that doctors should take greater care in prescribing medications to treat conditions for which the medication was neither intended nor approved by the FDA. 12% of drugs prescribed by doctors are prescribed for uses other than those approved by the FDA. "Off label" prescriptions significantly raise the rate of negative side effects, the research showed. Doctors typically choose a drug based upon the experience of other patients with similar conditions or from professional guidelines developed by their practice, association or hospital. Many don't know if the reason they are prescribing the drug is off label or not. Some studies have found that as many as 20% of all prescriptions are off label, or given for reasons other than the intended or approved use.
Sometimes there is strong scientific evidence that supports using a drug off label, such as cancer drugs which are approved for one type of cancer but can be useful in treating another type of cancer. But the JAMA study found that about 80% of off label use was not supported by scientific research. When the FDA approves a drug, the label must detail what conditions the medication should be used for and in what dosage. When drugs are found to help with other conditions not listed on the label and not approved by the FDA, drug manufacturers don't reapply to the FDA because of the enormity and complexity of the approval process. The researchers looked at 151,305 prescriptions for 46,021 patients over five years in Montreal and Quebec City. In the U.S., doctors are not required to note the indication for a drug on the prescription while, in Canada, they must give the reason. About 7.9% of patients had adverse side effects when prescribed medication consistent with the drug label. When prescribed for off label use, the side effects were 44% greater. The adverse side effect rate rose even further where there was no strong scientific data indicating the off label use was effective. There was no difference in the side effect rate between on label and off label drugs where there was strong scientific data to support the off label use.
One drug commonly prescribed for off label is Quinine. Quinine is approved only for treatment of malaria; 99% of the time it is prescribed for restless leg syndrome. In a 2009 study published in Pharmacoepidemiology and Drug Safety, it was revealed that the 1,199 physicians surveyed were able to identify the FDA approved use for the drug only about 55% of the time. Gordon Schiff, associate director for the Center for Patient Safety Research and Practice at Brigham and Women's Hospital in Boston, one of the country's leading hospitals, says "One of the biggest problems we have, particularly when we try to sort out patients' mediations and reconcile which ones may be no longer needed, is that we often don't know why a patient is being started on a drug." Some physicians are resistant to the idea that a prescription contain the indications or diagnosis for which the medication is being prescribed because it may affect reimbursement rates or expose doctors to potential liability if the patient experiences a complication. Either way, it is incumbent upon you, the patient, to understand the approved use of the drug and why you are being prescribed the drug.
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