Affiliations: [a] Strategic Planning, Global Security, Pfizer Inc., New York, NY, USA | [b] Pharmaceutical Security Institute, Vienna, VA, USA
Abstract: Counterfeit medicines are, first and foremost, a matter of patient health
and safety. Counterfeit medicines pose a threat to patients because of the
conditions under which they are manufactured, in unlicensed, unregulated,
uninspected and often unsanitary sites. The ``medicines'' themselves pose a threat to patient health and safety
because their contents are not regulated and they may not contain the
correct active pharmaceutical ingredient (API) to deliver the therapeutic
benefit for which they were prescribed, or even ingredients that are
themselves harmful such as heavy metals or pesticides. To mitigate that threat, and ensure that their patients receive safe and
effective medicines, pharmaceutical companies have incorporated
anti-counterfeiting technologies into their packaging and implemented
campaigns to detect and disrupt those counterfeiters who place greed above
patient safety. Although counterfeiting presents a global threat from which no company,
therapeutic area, region or country is immune; gauging the true scope of the
problem has remained a challenge. There are hopeful signs, however, as we
have seen improved reporting and greater transparency by enforcement and
regulatory agencies.
