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Director’s Chair
How to Define Drug Safety
Peter Mayberry
Executive Director
Healthcare Compliance
Packaging Council
The biggest bang for
the buck in terms of
improving drug safety
would be to look
at the way U.S.
pharmaceutical
manufacturers are
allowed to package
and distribute
their products.
As the new Democraticmajority
Congress settles
in and begins implementing
its agenda for the next two
years, one issue that has been
getting tremendous attention on
Capitol Hill is drug safety.
Later this year, in fact, the
Prescription Drug User Fee Act
(PDUFA) is slated to expire. If not
reauthorized, FDA will have little
choice but to stop its participation
in the development of new
drug products — a highly unlikely
scenario. And, as commonly
happens when Congress handles
“must-pass” legislation, it is very
likely that PDUFA reauthorization
will become a vehicle for a
number of issues related to pharmaceuticals.
Indeed, there is
already talk on Capitol Hill of
using the bill as a means of better
monitoring drugs once they are
on the market, and allowing drug
reimportation so that seniors can
have access to cheaper medicine.
To date, however, the primary
focus of drug safety discussion
in the 110th Congress
has centered on FDA, with virtually
no apparent interest being
paid to distribution issues. This
is unfortunate, because, arguably,
the biggest bang for the buck in
terms of improving drug safety
would be to look at the way
pharmaceutical manufacturers
are allowed to package and distribute
their products in the
United States.
Simply stated, if manufacturers
shipped more product in
unit-dose formats with uniform
consumer information, some of
the benefits that would accrue
include:
• Fewer dispensing errors in the
pharmacy.
• Highly improved drug efficacy
(i.e., better assurances that
the drugs will actually work
as intended).
• Less opportunity to introduce
counterfeit product and/or
mix expired product with
product that is still good.
• Far greater opportunity for
pharmacists to counsel
consumers.
• Guarantees that accurate and
reliable consumer information
is dispensed with Rx drugs.
• Improved compliance with
pharmaceutical regimens.
The United States is somewhat
unique in that pharmaceutical
manufacturers are allowed
to ship product in bulk containers
with a single leaflet intended for
physicians and pharmacists.
Switching from the U.S. model to
one that is used throughout much
of the rest of the world — whereby
the same drugs are shipped by
the same manufacturers in unitdose
formats with approved consumer
information — is a timely
initiative. It should be a much
greater part of any Congressional
consideration of a PDUFA
reauthorization bill or any other
initiative geared toward increasing
drug safety for that matter.
6 Unit Dose Alert • www.unitdose.org • March 2007