Expand Over-the-Counter Medications? Very Bad Idea

The Food and Drug Administration is considering removing prescription requirements for medications that treat common conditions, such as high blood pressure, diabetes, asthma, migraines and high cholesterol. This means that you would be able to go to your local pharmacy, fill out a questionnaire, receive a diagnosis and purchase a medication, all without intervention or direction from a physician.

As a doctor, I think this is a very bad idea. Although it is true that diagnoses are often missed — reports estimate that as many as 7 million diabetics in the U.S. remain undiagnosed — and although easier access to drugs could theoretically encourage patients to take their medications, I am concerned that expanding over-the-counter access will lead to wrong diagnoses with improper treatments, which carry side effects.

Remember, medicine is an art, practiced on an individual basis. A medication that works for one person doesn’t always work for another. I am constantly changing cholesterol or high blood pressure medications for my patients because of unanticipated side effects such as muscle aches or dizziness.

Lack of follow up

What would happen if I weren’t involved to monitor treatments and make necessary changes? The upfront cost savings from cutting out doctors and their office fees will be more than made up by longer term costs of improper diagnoses or unmonitored complications.

Advocates of expanding over-the-counter medications point to aspirin or allergy drugs as examples that have proved successful without a doctor’s prescription. But for every patient who is glad not to have to visit my office for an allergy prescription, I can point to another patient who has suffered side effects like fatigue that he or she didn’t realize were due to that same pill, or where the allergic reaction was due instead to food.

The fact that common painkillers have been available over the counter for decades also doesn’t provide a convincing argument for bypassing prescriptions. Consider that more than 100,000 Americans are hospitalized every year due to bleeding from aspirin or other OTC non-steroidal anti-inflammatory pills, and acetaminophen is the No. 1 cause of acute liver failure.

Insurance coverage unlikely

Although the FDA‘s goal is to reduce health care costs by improving access to treatments, remember that both public and private insurers are not likely to cover these treatments if a prescription isn’t involved. Insurance companies typically rely on a doctor’s authorization to document medical necessity. This is another way the FDA plan could backfire, as patients might not be able to afford the out-of-pocket expense and could even go without treatment altogether.

For decades, many pharmacists have felt under-utilized when it comes to advising patients on medical needs. Pharmacists do have a great deal to offer and play a very important role when it comes to knowing about the drugs they dispense and monitoring for drug interactions that physicians might have failed to consider.

But a doctor’s appreciation of a pharmacist’s acumen is not the same thing as saying that he or she should replace a physician. The American Pharmacists Association is wrong to back the FDA proposal, and the American Academy of Family Physicians is right to oppose it.

Easy access to powerful drugs sounds tempting, but it will only add chaos and confusion to an already dysfunctional system.

Marc Siegel, MD, is an associate professor of medicine and medical director of Doctor Radio at NYU Langone Medical Center. He is a member of USA TODAY’s Board of Contributors and the author of The Inner Pulse. This post first appeared at USA TODAY.

3 replies »

  1. Dr Siegal
    As a physician, I cant be accused of bias–so is their evidence can you cite that in the aggregate, physician gate keeping over free access will prevent more harm than good? On its face, your rationale is reasonable. However, “reasonable,” goes down in flames daily via scientific pursuits. You have made an eminence, not evidence based case.

    Moreover, I am not convinced that physicians are the only conduit to dispense Rx, and others might step in handily with some of the meds in question.

    My bigger concern is not ADEs however, but cost, once drugs go OTC and off MCO plans with lesser copays. There we know the additional expense impacts adherence.


  2. In Canada we would never reduce regulation on medications within the classes of drugs being discussed in the US. What we have done in most provinces to reduce the back log in physician offices and to improve continuity of care is to increase prescribing authority for pharmacists. The drugs stay regulated as prescription items and pharmacists prescribe within their competency.

    I would argue that as a prescribing pharmacist, my interventions and prescribing (which includes “re-prescribing” incorrect prescriptions and monitoring and adjusting medication for chronic conditions) saves countless health care dollars and improves patient care.

    Pharmacists prescribe within their competency and I would argue that physicians should do the same. Not all health Professionals are competent to prescribe in all areas of medicine. And certainly the general public does not carry such competency.

  3. I’m agnostic about this proposal but here are a couple of thoughts…

    ==> Many countries in the world don’t have anything like the US system of prescription controls. The downside includes abuse, inappropriate use, overdoses, toxic interactions and a string of predictable horrors. I don’t know if there is an upside, other than the prices would be more competitive and availability wider… until profits dried up altogether.

    ==> There is already a shortage of some generics critical to some conditions. Why? “Not profitable” the companies reply. (Hmm… Very humanitarian. But we sure don’t want no gubmint interference in the marketplace.)

    ==> A determined buyer can purchase nearly anything anyway, in virtually any amount, via black-market and other means.

    ==> In light of the wide use and distribution of ILLEGAL drugs, imagine what might happen to the prices of medicine in the case of an open market. (In other words, illegal drugs are expensive mostly because they are illegal. If they were legal prices would go down, not up. Prescription controls have the same effect on prices. I bet the drug companies are trembling at the idea of selling meds over-the-counter now restricted to prescription.)

    ==> Millions of people, many with insurance, self-medicate anyway rather than face the time, trouble and expense of going to a doctor. They may as well have access to more effective drugs.

    ==> In the case of abuse, misuse and/or overuse that results in tragedy, what would be the liability of drug companies? Just asking.


    This is a meaningless side-show. Big Pharma will never let it happen. And the insurance industry will be their allies. None of those outfits even pretends to be non-profit.

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