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    The switch to OTC: Are urologic drugs next?


    Let’s focus on urology. An OTC drug has to be safe, effective, and treat a condition that the patient can recognize and manage without the supervision of a licensed health care provider. What urologic conditions lend themselves to these parameters?

    The one that we have the most recent experience with is overactive bladder, which is a symptom syndrome that involves urgency frequency and urge incontinence, which are patient-perceived symptoms. We put a lot of regulatory constraints on how we measure that condition when we do trials that result in regulatory approval for prescription branding. But for OTC, those controls are different and then the decision to take a drug defers to the patient to make a decision based upon their symptoms.

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    You allude to something that’s a key part of the OTC process, which is the ability to appropriately self-select. Self-selection is one of three cardinal aspects of the OTC switch process and one that essentially gets at the patient’s level of comprehension of symptoms but also their level of medical literacy. Medical health literacy is something that I’ve been very interested in the last several years, mainly as a way to improve informed consent around risks/benefits and potential options.

    What we deal with in pelvic medicine are very complicated conditions. Self-selection is a critical aspect of the success and safety of the OTC switch, and there are controls and algorithms in place to not only assess patient literacy but also to assess the individual’s ability to appropriately self-select based upon the labeling of the drug.

    The other aspects of the switch process include the ability to understand the label (label comprehension), and lastly, stop or do not use criteria (centering on co-morbidities and other issues that could result in delayed diagnosis that may put the individual at risk).


    Let’s discuss the large overactive bladder market. Are there any OTC drugs for overactive bladder currently available in the U.S.?

    No. Transdermal oxybutynin, marketed as Oxytrol for Women when it was switched to an OTC drug, is no longer available. OTC Oxytrol for Women was removed from the market because it was not a commercial success. Rightfully so, there were constraints regarding hematuria and how that should be assessed and recurrent urinary tract infections and how that should be assessed, and it became a relatively complicated process.

    Despite the efforts of a very experienced group of people who had done multiple OTC switches very successfully in the past and knew the process, the commercial failure was probably due to the complexity of self-selection and also due to the fact that the drug had a just-above-placebo effect and patients probably didn’t perceive enough benefit to stay with it.

    I was very much involved in the clinical trials for the regulatory approval of the prescription version of Oxytrol. Statistically, the transdermal delivery system worked. Patients had less dry mouth than those taking the oral formulation, and they separated from placebo. But one of the interesting phenomena that we deal with in functional medicine is that statistical superiority does not necessarily imply clinically meaningful benefit for individuals. This is the conundrum of clinical trials.


    Should we be concerned about Brody and Light’s inverse benefit law stating that, as a drug is promoted for milder cases of a disorder or used for unapproved conditions, which can happen in the OTC market, the benefit/harm ratio worsens because effectiveness is diluted but the risks of harm are the same?

    That brings up a very interesting part of the OTC process as far as I’m concerned, which is the labeling. Labeling is supposed to inform the individual when to use, when not to use, when to contact a physician, and what aspects of their particular presenting scenario should or shouldn’t be considered for the drug. But, again, you’re giving the individual consumer a box that has labeling at a sixth-grade reading level that they should intellectualize and understand.

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    Ultimately, you’re giving them the decision about whether or not they should use it in an unapproved circumstance. It comes down to that decision.

    Next: Actual-use studies

    Philip M. Hanno, MD, MPH
    Philip M. Hanno, a Urology Times editorial consultant, is professor of urology at the University of Pennsylvania, Philadelphia.


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