James C. McAllister III, MS, FASHP
Mr. McAllister is a health-systems
consultant based in Chapel Hill,
North Carolina.
An FDA advisory panel has recommended
for the third time in
less than 10 years that lovastatin
20 mg not be made available as a
nonprescription drug. That news follows
testimony by the American Society of
Health-System Pharmacists and the
American Pharmacists Association, in a
separate but related issue, strongly
encouraging the FDA to create an intermediate
class of drugs, sometimes
referred to as "behind-the-counter"
drugs. Both organizations submitted
compelling arguments for the creation of
a class of drugs that could be dispensed
with appropriate patient education and
monitoring but without a physician's prescription.
Benefits of creating such a class of
drugs include improving access to care
that would benefit public health, reducing
health care costs, improving patient
safety, avoiding overuse, improved
patient adherence, and more fully engaging
patients in managing their own
health. From a selfish point of view the
comments to the FDA leadership, the
health care community, and the public
again reflect that the pharmacy profession
is fully capable of assuming these
responsibilities.
Many hospital pharmacists have
broader responsibilities than are routinely
offered outside hospital care, including
therapeutic substitution, dosage adjustment,
therapeutic drug monitoring, and
much more. This role expansion is the
result of early pharmacy pioneers, collaborative
practice, establishment of trust,
shifting responsibilities from physicians
who are already overworked,
and, most importantly, because
pharmacists have
proven themselves capable
of performing these important
patient care functions
and have asked for the opportunity.
Regrettably, I am skeptical
that it will be adopted at the
present time. I suspect that
the office-based medical community
will remain opposed
to an intermediate class of
drugs for a time. Doctors see
this evolution through myopic
eyes as a threat, rather
than an opportunity to create
relationships with pharmacists
who, in many cases,
would increase referrals to physicians
rather than let patients go untreated for
conditions that require physician care.
We should remain optimistic since virtually
all physicians train in hospitals and
will be exposed to these expanded roles
and appreciate their availability when
they enter private practice.
I am confident that most pharmacists
practicing in the retail setting generally
would welcome the opportunity to
expand their practice by managing
patients receiving drugs from an intermediate
class of drugs. I wonder whether
corporate executives from the major
chains are fully supportive. I understand
the concerns of ensuring availability of
appropriately trained pharmacists, the
financial impact of taking on more work
(especially initially), the risks associated
with dealing with a litigious clientele, and
more. We must reassure them that it is
our destiny to play a more important role
in our patients' health and we are committed
and determined to do so.
Our associations are championing our
collective cause, but our help is needed.
We need to discuss this issue with our
patients, our neighbors, and physiciansin-
training. When the time is right, we
need to educate legislators. For now, we
need to be supportive of the concept and
do what we can to support professional
evolution.