US Pharm. 2013;38(1):2.
While the idea of a “third class of drugs” or “behind-the-counter medications” has been batted around for decades, it has never taken a foothold in retail pharmacy. Despite the fact that some states still have laws on their books that outline procedures and processes for selling Rx medications without a prescription, by many accounts any such practice has been a dismal failure over the years. When I ask pharmacists what they think of such laws, the answers pretty much fit into two categories: “too much liability” or “Who has the time?”
Yet, for some years pharmacists have been endorsing products that were once potent prescription medications and can now be purchased without a prescription under the Rx-to-OTC–switched drugs category. I suppose the FDA’s sanctioning of such products mitigates the liability issue; and since patients choose the drugs themselves, little time is lost by the pharmacist. After all, most pharmacy employers still believe that a pharmacist’s time is better spent behind the counter filling prescriptions. And while the process of granting OTC status to prescription products gets high marks on a number of levels, including cost savings and convenience, are patients ready to accept the full responsibility of taking these drugs properly? How many patients are being harmed by serious, even life-threatening drug interactions and side effects that are never reported?That being said, I was surprised to hear that the American College of Obstetricians and Gynecologists recently published its opinion that oral contraceptives should be sold without a prescription, citing their safety over the long run. The group says its aim is to reduce unintended pregnancies. Morality issues aside, even though birth control pills have been around for decades and have a fairly safe track record, patients have always been closely monitored by the physicians who prescribe them. Without supervision, the safety of these products might very well be different. On the other hand, the problems of unwanted pregnancies and the medical complications that childbearing can often present must be considered as well.
But Rx-to-OTC switching is likely to continue unabated because health care is so expensive in the United States. While Rx products only represent some 10% of the overall health care bill, they are an easy target in helping to reduce those costs. Rx-to-OTC–switched products also extend the life of many pharmaceutical products that have lost their patent protection, which can lead to decreased market share and dollar revenue.
You would also expect patients to like the idea of purchasing prescription-strength products without the encumbrance and expense of visiting a doctor or filling a prescription. Interestingly, a recent Harris poll says otherwise. Data from the poll uncovered that patients tend to treat many of their medical symptoms with traditional OTC products instead of the more potent Rx-to-OTC–switched drugs. While there is much speculation as to why this is so, some analysts believe that many patients are afraid of all the warnings and contraindications on the packaging of the switched drugs and do not always have the safety net of a pharmacist advising them which medication to purchase or consulting with them about their medical condition. I’m all for saving the health care system money by offering more Rx medications without a prescription, but prefer that it be in a more controlled setting where the pharmacist plays an active role in the OTC choices patients make every day in every pharmacy.
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