There is a good deal of talk in the pharma- ceutical industry about serialization, and for good reason. Serialization combined
with the system of track-and-trace constitutes
the industries vigorous response to the growing problem of drug counterfeiting. Purposely
producing and selling a drug that is intended to
deceive, i.e. drug counterfeiting, is costing the
industry tens of millions of dollars annually. Just
as important, drug counterfeiting is a dangerous act and imperils the lives of those the industry works hardest to protect—the patients
that must rely on safe and effective medications.
EASY TO DEFINE, HARD TO COMBAT
Drug counterfeiting is easy to define. Quite simply, it is a pharmaceutical product that is produced and sold with the deliberate intent of deceptively representing its origin, authenticity or
effectiveness. It may contain incorrect quantities
and qualities of active ingredients, or none at all.
What is difficult to qualify or quantify, however, is the adverse effect drug counterfeiting has on global health and the cost to the
global economy. Estimates of its impact on the industry range
anywhere from $75-$200 billion and can make up nearly half of
all drugs sold in some lower income nations. That means between
eight and fifteen percent of all medicines sold worldwide could be
fakes. In some sub-Saharan African countries, the proportion of
counterfeits in the market is forecasted to be closer to fifty percent!
Looking through the prism of its impact on global health it is
difficult to calculate, but simple to imagine the tens of thousands
of lives that are adversely affected through this fraudulent act.
Authorities worldwide are alarmed about the risk to individual
health and disease control across populations as fake drugs often
have substandard or incorrect formulations that can prolong illness, create resistance, or even result in death. Most counterfeit
versions of drugs are known to be manufactured in the Asian region and distributed globally. However, even countries with strict
surveillance and regulatory policies such as the U.S. and the European Union are not immune to the threat of counterfeits. What
then, is the industry doing to control this problem?
BATTLING DRUG COUNTERFEITERS – AN INDUSTRY
Regulatory agencies have been seeking and implementing new
methods to thwart the counterfeiters and agree—relying primarily on clear means of verification and identification is the right action to take. Known in the industry as serialization and expected
to be an effective solution by many countries, this system involves
the assignment and application of a unique identification code
to a product. With serialization, each saleable unit is assigned a
unique identifier. Additionally, as an added precaution the pallets
upon which the cases are packed are also assigned a unique identifier. The integrity of the packages is also protected with tamper
indicators like pre-perforation, glue points or safety labels.
The term aggregation is used by the industry to define the relationship between multiple items within a product shipment such
as cartons, cases and pallets. Together, serialization and aggregation form the foundation for track-and-trace, which documents a
product’s current and past locations throughout the supply chain.
The ability to track a product’s whereabouts and trace its path
forms the core of a safer and more efficient drug supply chain.
Product and Service Manager, Vetter
The Drug Industry Takes a
Bare-Knuckle Approach to
Serialization and track-and-trace offer a solution to a growing problem