A change may be brewing for U.S. drugstores: The government is
mulling more ``behind-the-counter'' sales, to let patients buy certain
medicines directly from pharmacists without a doctor's prescription.
The Food and Drug Administration announced Wednesday that it was
seeking public reaction to such a switch, including whether it would
ease access for the uninsured.
``This is an issue that has been raised by pharmacists, by
manufacturers, by patients,'' said Ilisa Bernstein, FDA's director of
pharmacy affairs.
Today, most U.S. drugs either require a prescription or are sold in a
traditional over-the-counter method - no prescription required, just
grab a bottle and head for the cashier.
``Behind-the-counter'' sales offer a middle ground. Last year, the
FDA allowed the emergency contraceptive Plan B, also called the
morning-after pill, to be sold without a doctor's note to women 18 and
older - but only by pharmacies that checked women's photo identification
before handing over the pills. Minors still require a prescription.
Now the question is whether requiring additional interaction with a
trained pharmacist - health advice or even, say, a blood pressure or
cholesterol check - might further spur the evolution of nonprescription
drugs from quick symptom relief to more complex therapy.
Routine birth control pills are an often-cited candidate. And in
2005, the FDA rejected a bid to sell cholesterol-lowering Mevacor
without a prescription - although some of the agency's scientific
advisers said such a move might one day be possible if pharmacists could
help guide which customers bought the pills.
Indeed, Britain allows the anti-cholesterol drug Zocor to be sold
behind the counter.
Variations of behind-the-counter sales also are allowed in Australia,
Canada, France, Denmark, Germany, Italy, the Netherlands, New Zealand,
Sweden and Switzerland, the FDA said.
On Nov. 14, FDA will hold a meeting in Washington to solicit input
from patients, pharmacists, doctors - in short, anyone interested - on
whether it's time for such a switch here. FDA also will accept written
comments through Nov. 28.
The agency doesn't have any petitions to switch specific drugs, said
FDA's Bernstein. Nor would she list potential candidates.
``The purpose is just to gather information and find out more about
how behind-the-counter availability of drugs can improve patient access
to certain medications that would be helpful,'' she said.
The National Association of Chain Drug Stores welcomed the FDA
discussion, saying it was open to behind-the-counter sales, depending on
what would be required of pharmacists.
FDA acknowledged that drugstores would face logistical issues, such
as how to stock behind-the-counter drugs. Also, while advising customers
about safe drug use already is part of a pharmacist's job, another
question is whether behind-the-counter sales would increase that
workload enough to raise reimbursement issues.