Prescribing drugs 'off-label': an ethical prescription

More than one in five of the prescriptions U.S. doctors write for 160 common drugs is for a use other than that approved by the Food and Drug Administration. The practice is perfectly legal, though patients are largely in the dark about what "indications" or uses the FDA has approved for different prescription medications. (You can, however, always check the FDA-approved product labels for a prescription drug here.).

These "off-label uses" have not been scrutinized by the FDA for safety and effectiveness. It's not legal for drug companies actively to promote a drug for "off-label" purposes. But the practice means big money for drug makers, and some do it anyway (just last month, Pfizer agreed to plead guilty to promoting off-label uses for some of its medications and was fined $2.3 billion by the Justice Department, according to the Justice Department website).

So, while it's legal, the practice is controversial.

That leaves doctors, who often feel immense pressure to offer something--anything--to relieve a patient's suffering, in uncharted ethical waters. In some cases, the "off-label" use of a drug might be just the treatment the patient needed. But it might just as likely be a waste of time and money--or worse, pose unpredictable dangers to the patient. When "everybody's doing it" (and, yes, even physicians say stuff like that sometimes), what's a physician to do?

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Abuse of ADHD Drugs on the Rise

As more and more prescriptions are being written for medications to treat attention-deficit hyperactivity disorder (ADHD), more and more children are abusing these drugs.

That's the conclusion of new research in the September issue of Pediatrics that found the rate of ADHD medication abuse was up 76 percent from 1998 to 2005, and at the same time, the rates of prescriptions for these medications rose about 80 percent.

"We looked at all the poison control centers across the nation and found a significant increase in the number of calls for ADHD medication abuse that parallels the amount of prescriptions being written," said Dr. Jennifer Setlik, an emergency physician at Cincinnati Children's Hospital Medical Center in Ohio and a study author.

What's more, Setlik said, is that this study is "not an estimate of the total problem" because it looks only at data from poison control centers, but it gives doctors and parents a snapshot of the trend toward rising abuse of these medications with increasing availability.

ADHD affects between 8 percent and 12 percent of children, and as many as 4 percent of adults worldwide, according to background information in the study. The disorder is commonly treated with stimulant medications, which have a seemingly paradoxical effect on people with ADHD, allowing them to concentrate and function more effectively. The drugs most often prescribed are mixed amphetamine salts (Adderall) and methylphenidate (Ritalin, Concerta), according to the study.

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