Drug products typically fit into
two segments: over-the-counter and prescription. However there are a small
number of drugs that fit in a segment called “behind the counter.” These drugs
require the consumer to get the attention of the pharmacy staff in order to
obtain the medicine. Typically a drug
would not need the high level of doctor supervision but still raises concern
for direct consumer access.
The FDA has been discussing the possibility of
formalizing a behind-the-counter (BTC) product segment since the 1970’s. Even
without specifically establishing a third class of drugs, there is potentially
more pharmacists can do to help patients. Currently there are select products
such as Mucinex, a cough medicine, and Plan B, an emergency contraceptive,
available through BTC status. These products can be purchased without a
prescription and customers have better access to them than prescription
products.
In mid 2002, Adams Laboratories
made a bold move to put its new cough tablet Mucinex in this unique third drug
category. For the first time, consumers can buy a cough medicine tablet that
contains guaifenesin, a powerful phlegm-releasing ingredient. The drug is
available OTC but can be obtained only by getting the attention of someone at
the pharmacy counter. The company
considered placing the product next to the standard OTC cough preparations such
as Vicks and Robitussin, but that would have required the company to spend
millions of dollars in print and TV ads. The company opted for the third drug
category, dispatching its sales force to lobby doctors about Mucinex and its
unusual location in stores.
Drugs containing pseudoephedrine (a
decongestant found in various OTC and prescription products), ephedrine and
phenylpropanolamine have been moved behind the counter due to use in illegal
methamphetamine production. This process was started in 2005 and continued in
2006 with the Patriot Act signed by President Bush in March of 2006. Some
states in the U.S. have required that products containing the drug be limited
to prescriptions only.
Another argument for the addition
of BTC products is the availability of more products at lower prices. The growing consumer trend in using OTC
products would also be seen in the BTC category. The improved access over
prescription medicines could provide consumers with a source for treatments
that only requires a kiosk or pharmacist involvement. Pharmacists could
potentially provide support either through counseling before the purchase or by
limiting the purchase quantities. Pharmacists have the knowledge to advise
patients about drug interactions as well.
Drug companies have also shown an
interest in a BTC option for marketing a product. This may be a good way to
provide access in a way that fits products better, and gives companies more
options. In effect a product may not be safe enough for OTC status but not
unsafe enough for physician monitoring.
The FDA has continued to look at
several ways to increase access to medicines but also remove the burden on
physicians. Physicians offices must take time to see a patient, send in
prescriptions orders, or schedule a second visit even for some routine cases which
takes time away from more critically ill patients. Physicians are considered
the most qualified personnel to make health decisions but there is continued
pressure to change the system in a safe and effective manner.
Insurance companies have reported
mixed feelings about reimbursement for BTC medicines. Some companies say that
if the medication is medically necessary and/or covered under the patient’s
formulary, they would provide reimbursement. However, other health insurers may
be less likely to provide reimbursement if this segment of medicine
materializes. Some of the reimbursement options would likely follow a certain
decision by the FDA concerning the specific type of access granted.
Product classes which could benefit
from a third class of drug include oral contraceptives, influenza antivirals,
sexual dysfunction treatments, bladder treatments, osteoporosis prevention, and
hormone replacement drugs.
An industry evaluation of these
potential costs savings indicates that some of the savings would be shifted to
the pharmacists to pay for added consultation and to the manufacturers. If a
product requires diagnostics the savings may be limited. Expanding OTC access
is likely to be more beneficial on a product-by-product basis. If a consumer is
looking for a simple product that requires only a kiosk, the costs could be
less than if they require a blood test administered at a pharmacy.
Kalorama's Reprot, Rx to OTC Switches, discusses this topic.
