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Behind-the-Counter Medicines: Improved
access, better health
Newswise — On November
14, the Food and Drug Administration (FDA)
will hold an informational meeting to hear
opinions on the behind-the-counter (BTC)
method of drug distribution. BTC implies the
medications are distributed to patients upon
a pharmacist’s discretion, eliminating the
need for a physician’s prescription and
improving the public health benefit. The
issue is the center of controversy in the
healthcare field.
“The involvement of the
pharmacist in counseling patients will be of
great value in assuring the effective and
safe use of these medications,” said Dr.
Daniel A. Hussar, Remington professor of
pharmacy at USP’s Philadelphia College of
Pharmacy. “Also, this role will enhance the
recognition of pharmacists as sources of
useful information regarding other
medications and healthcare issues.”
Quite a few
prescription drugs potentially qualify for
BTC availability. Dr. Hussar has developed a
preliminary list of medications for which he
believes the public interest would be well
served if they were made available BTC. This
list includes: varenicline (Chantix™);
epinephrine, used to treat serious allergic
reactions; oseltamivir (Tamiflu™), for
influenza infections; and statins, for high
cholesterol.
According to Dr.
Hussar, fears about increased availability
of potentially dangerous medications should
not be a concern. “The products and their
dosages that would be approved for inclusion
in this category are not going to be drugs
that have serious risks, such as seizures,
associated with them.”
As an example, Dr.
Hussar points to the highly-effective
prescription smoking cessation product
Chantix™.
“There are going to be some
patients who want to stop smoking and try
the nonprescription products without
success, but won’t go to see a physician. I
feel availability from pharmacists could
open the door to some people having access
to the drug with the result that they stop
smoking.”
Many pharmacists
support the BTC availability of medications,
but the FDA has long been apprehensive about
making a decision on instating a third
method of drug distribution.
However, the
FDA’s decision to approve nonprescription BTC availability of the drug levonorgestrel
(Plan B®), in late 2006, proved they have
the capacity to make such a call. The choice
to give pharmacists the authority to
distribute this “emergency contraception”
medication to women 18 years of age and
older was made without any new jurisdiction
being granted to the FDA.
“The current leadership
of the FDA has indicated receptiveness to
expanding the concept of BTC availability of
drugs on a nonprescription basis,” said Dr.
Hussar. “They have a series of questions for
which they want input from interested
parties.” On November 14, representatives
from professional pharmacy organizations,
such as the American Pharmacists
Association, as well as individual
pharmacists, will attend the FDA’s public
meeting to present opinions about the
expansion of BTC practices.
Opponents of BTC drug
availability may include pharmaceutical
companies because, as Dr. Hussar explains,
“the goal of nonprescription medication
manufacturers is to make as much profit as
they possibly can. They look at BTC
availability as restricting the
distribution. Therefore, the drugs will not
have the same sales potential as they would
if people could just take them off the
shelf.”
Furthermore,
prescription medications are often patented,
which allows the pharmaceutical companies to
charge top dollar. Dr. Hussar believes,
however, that any loss in revenue would be
offset by increased sales. “I would contend
that even though the price of the BTC
product would be lower, the number of units
sold would be much higher than if it were on
prescription,” he said.
The role of health
insurance companies that cover much of the
cost of many prescription medications also
raises valid concerns. While some insurance
companies do not cover OTC medications in
their prescription plans, others are willing
to reimburse patients for the cost of
certain OTC medicines, such as Prilosec
OTC©, which offer a less-expensive
alternative to similar prescription
medications. Patients could end up paying
for their BTC medicines, but Dr. Hussar
believes there will be pressure on insurance
companies to continue covering BTC
medications that were once obtainable by
prescription only.
“There will be expanded
responsibility for the pharmacist that I
think we should welcome,” said Dr. Hussar.
“I don’t think we should be fearful of
allowing pharmacists to take a higher level
of responsibility.”
University of the
Sciences in Philadelphia is a private,
coeducational institution dedicated to
education, research, and service. Comprising
five colleges, including its new Mayes
College of Healthcare Business and Policy,
USP specializes in educating its 2,800
students for rewarding careers through its
undergraduate, graduate, and doctoral degree
programs in pharmacy, health and related
sciences, and healthcare business and health
policy. Founded in 1821 as the nation’s
first college of pharmacy, it is where the
founders of six of the top pharmaceutical
companies in the world launched their
futures.
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