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
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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