Call it do-it-yourself medicine. A range of diagnostic and treatment decisions now rooted in the doctor’s office will shift to patients if the United States government follows through on a proposal to sell many prescription drugs over the counter. This has set off alarm bells in some corners of health care, though others love the idea.
Supporters of the proposal argue that self-medication can be safe with certain restricted drugs if patients are given the right information and pharmacists are trained to step up in place of doctors in carefully managed circumstances. Below-the-radar maladies often go untreated, they say, because people avoid the bother, cost or stress of a doctor’s appointment for conditions that could be readily relieved if more meds were available without a doctor’s directive.
“I strongly believe that medicine needs to take medical care to where the patients are,” says Janet Woodcock, director of the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA).
The FDA is the lead agency proposing the idea of lifting prescription restrictions on certain drugs used for diabetes, asthma, migraines, hypertension, illicit-drug overdoses and more. The agency says it would craft a list of specific pharmaceuticals but has not yet done so, although its federal registry notice indicated it could include epinephrine, anti-hypertensives and all diabetes medications (www.gpo.gov/fdsys/pkg/FR-2012-02-28/pdf/2012-4597.pdf).
To skeptics, that’s like letting passengers fly the plane with flight attendants looking over their shoulder and the pilot nowhere in sight.
“Chilling and a little scary,” Dr. Bobby Quentin Lanier, executive director of the American College of Allergy, Asthma and Immunology, told the FDA’s hearing on the matter. “Now let me say we’re not Luddites. We know change is inevitable. But we want the change to be better. And what we envision, with hearing some of the issues today, is chaos.”
Over the decades, various drugs have migrated to nonprescription status and become more widely used, from fluoride to antifungals. Self-treatment advocates say many lives have been saved by making smoking-cessation aids available over the counter. They also believe treatment would reach many of the estimated seven million Americans with undiagnosed diabetes if easier pathways to drugs were established.
As envisioned by the FDA, information kiosks at pharmacies and user-friendly computer algorithms online would walk people through questionnaires helping them determine if they need a drug or should visit a doctor. Pharmacists are key players — the only health care professionals patients would need to consult in most cases. In some instances, an initial doctor’s visit would be required, but not follow-ups to remain on a medication.
Robb McGory, pharmacy director at the Indian River Medical Center in Vero Beach, Florida, welcomes the initiative even if there are many unresolved questions about how it might unfold. “Years ago, patients started going to nurse-practitioners who had diagnostic capabilities,” he says. “The pharmacist is stepping into that role. We are going through a time of change, legally and professionally. We are expected to do more than fill a prescription.”
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Self-diagnosis is a risky foundation on which to base the use of pharmaceuticals, critics say of the United States Food and Drug Administration’s proposal to create a new category of drugs for diabetes, asthma, migraines, hypertension and other diseases.
Image courtesy of © 2012 Thinkstock
Among the questions is who pays for the drugs. Both the private health insurance industry and government coverage for the elderly and the poor typically pay for prescription drugs, with other meds coming out of pocket. The new category of drugs is likely to fall into the latter group, which makes it appealing to politicians and health administrators. Cutting doctors out of some diagnoses may save the health system considerable money, shifting more costs to patients.
Dr. Richard Milsten, a urologist and member of the Indian River Medical Center Foundation board, says patients will likely diagnose themselves based solely on symptoms, without regard to other nuances that physicians utilize, such as physical appearance and examination findings.
“Patients will be right many times in their diagnosis, but I think there will be a significant error rate as well,” Milsten says. “When you hear hoof beats, it is usually a horse; but every now and then it will be a raging bull. I think some patients are going to get trampled by their own misdiagnosis resulting in a delay in accurate diagnosis. This will result in prolonged suffering or worse.”
With more than 30 million people expected to gain health insurance as a result of President Barack Obama’s health reforms, moving some into self-diagnosis and self-medication mode would not only reduce costs and strain on primary care facilities but, in theory, free doctors from some of the burdens of routine care and give them more time for complex cases.
But the American Medical Association isn’t keen on any plan that sidelines doctors, suggesting that personalized medical information from a computer is not the same as personal care from a physician. The risks of dispensing drugs without a prescription can include a failure to detect a disease’s progression or the need for changes in dosage.
Others have countered that there are dangers in the status quo which point to the need to make drugs more accessible, including the tendency for people with certain conditions, such as chronic diseases, to leave therapy at alarmingly high rates.