After Heparin: - The Pew Charitable Trusts

PHARMACEUTICAL DISTRIBUTION
3.4 Pew conference and policy
recommendations
Despite actions by industry and regulators, counterfeit and diverted products continue to enter the U.S.
distribution market, a complex system involving many companies. To better secure distribution, as well
as to greatly increase the effectiveness of drug recalls, drug tracking must be improved and regulation of
distribution strengthened.
Participants at the Pew Health Group roundtable recognized that counterfeit and stolen drugs have been
able to enter the legitimate U.S. distribution system, and that this ongoing risk must be addressed. A
number of participants referred to the current benefits of a closed distribution system, from manufacturer
to distributor to pharmacy. However, one state regulator gave a 2010 example of a counterfeit product
discovered at a chain retail location that purchased its products from a national wholesaler, suggesting
that even an apparently closed supply chain would benefit from measures to secure distribution.
There was broad agreement among participants that the United States needs uniform national standards
for licensure of pharmaceutical wholesalers to overcome a patchwork of sometimes lax state requirements.
One pharmacy representative said that additional certification or some additional accountability
for distributors is necessary so that, if a pharmacy needs to turn to an alternate supplier for product, it
will have some assurance that the distributor is legitimate.
In addition to wholesaler licensure improvements, many participants also supported a national drug
traceability system. However, retail pharmacy representatives expressed concerns about implementation
costs and had questions about how a track-and-trace system would be operationalized at the pharmacy
level. If track-and-trace were to be required, however, most participants, including pharmacy trade association
representatives, expressed a preference for uniform national standards rather than state-by-state
regulations.
Regulators, manufacturer representatives, large and small distributors, and consumer groups supported
nationally applied serialization and electronic tagging systems to track drugs. The FDA would like to
see a system that includes tracking and traceability for all components throughout the supply chain.
Just like other products contain a bar code that can be scanned for information, drugs should be able to
carry the same type of identifier. Wholesalers agreed to a need for a tracking system, noting that small
distributors are able to pass pedigree now, without a great cost burden. Participants noted that such a
system has been under discussion for many years, but that agreement on uniform standards has not
been reached. The majority of participants who voiced an opinion believe that implementing such a
system will require a new federal statute.
After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 75