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The Ethics of Off-Label Prescriptions Questioned

Doctors should be required to inform their patients thoroughly

By Tudor Vieru, Science Editor

11th of November 2008, 14:30 GMT

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Patients should always inquire whether the drugs they are prescribed are FDA sanctioned for their condition or not
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The use of off-label prescriptions is so widespread among American caregivers, that estimates say it accounts for 50 percent of all drug use in the country. That is to say, doctors prescribe medications for the treatment of diseases those drugs were not tested on. The FDA tests all therapies on a specific disease, and the pharmacies sell the approved drugs for that condition only. But doctors can prescribe them regardless, and patients take them.
 

This poses a significant health risk to sufferers, warns the Food and Drug Administration (FDA). The institution declines any responsibility for any side-effects that unsanctioned use of a drug may have on patients. Officials say that this practice is so widespread because it's not illegal. This means that doctors can prescribe medication for any use without appropriate control. This amounts health care costs to astronomical figures, affecting both the federal government and the end-users.
 

Informed decision advocates say that doctors should be required by law to inform their patients as to the possible side-effects of off-label prescriptions, as well as give them the possibility to choose between similar drugs. Given that people are asked for consent before being enlisted in scientific studies, supporters of this idea say that consent should also be obtained after the patient has been correctly and completely informed about the therapeutic action of a certain drug.
 

Furthermore, companies that promote off-label prescriptions should be fined heavily, in order to discourage this practice. The FDA says that, as long as doctors make no mistakes, patients are safe short-termed, but that amounting effects could lead to unpleasant long-term consequences. That's why the Administration urges patients to only ask for medication that has been specifically approved for the condition they are trying to cure. For other symptoms, they should use different drugs, which were also approved by the FDA.

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off-label prescription | Food and Drug Administration | health care
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