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Washington,
DC, November 14, 2007 -– At a public hearing of the Food and
Drug Administration today, where the agency heard testimony
on the possibility of creating a third class of drugs,
behind-the-counter (BTC), the National Consumers League offered
general support for the new class but raised concerns of safety,
privacy, and quality of counseling. NCL has favored a third
class of drugs, with certain products placed behind the pharmacy
counter and available to consumers only upon consultation with a
pharmacist. NCL’s Vice President for Public Policy, Rebecca
Burkholder, testified on behalf of the nation’s oldest consumer
organization. Highlights of her testimony include:
“NCL believes that behind-the-counter (BTC) Drugs could improve
access for patients, but we have concerns about how such a
system will work safely and effectively. Consumers today are
taking a more active role in their health care, self-diagnosing
and self-medicating. For the 47 million consumers without health
insurance, a BTC class would increase options for self-treatment
without the added expense of a doctor’s visit. That carries with
it some concerns moreover, the underserved and rural communities
do not always have easy access to a pharmacy, and thus could
have limited access to BTC drugs.”
“To ensure that costs are not shifted to the consumer, and that
consumers continue to take needed medications, we would suggest
that when a drug moves from prescription to BTC, the insurance
coverage stays the same.”
Burkholder also raised issues related to
practical application of the new class using examples from other
countries:
“Concerns about privacy regarding medications may also
impact access because most pharmacies do not have private places
to talk to the pharmacist. Establishment of a truly private
pharmacy counseling area should be required for a BTC class to
ensure that access would increase, and not decrease.
“A 2004 study of Australian pharmacy counseling found
that the majority of time the advice given was “poor” and
questions were not asked to ensure that the medication discussed
was appropriate. In a 2002 study of New Zealand pharmacies,
consumers often found it difficult to distinguish between the
pharmacist and other assistant staff. Consumers were able to
confirm that a pharmacist was definitely involved in counseling
in only 46% of visits. And no counseling was given at all for
10% of the consumers obtaining an anti-fungal medication (which
required pharmacy intervention).
On how drugs would move into a BTC class:
“Regarding how the FDA determines which drugs are
moved into a BTC class, we suggest that rather than respond to
random petitions to move a drug to a BTC status, that FDA
convene an advisory committee once a year to consider several
drugs the FDA staff believes are good candidates for BTC.” |
