counterfeit prescription drugs

[Guest guest]

Using track and trace technologies to combat counterfeit drugs and gain

efficiencies in the supply chain

Until recently, drug counterfeiting has been fairly uncommon in the

United States, but the FDA reports its investigations of pharmaceutical

counterfeiting have quadrupled since 2000. And, according to the World

Health Organization, an estimated eight to 10% of all pharmaceuticals

worldwide are believed to be counterfeit. (8/10/2004)

Some countries report that nearly 50% of drugs used within their borders

are counterfeit, a situation that creates a losing proposition for

pharmaceutical makers and patients alike.

The FDA cautions that the importation of prescription drugs from foreign

countries creates a portal of entry for counterfeit drugs into the U.S.

distribution system. With more than 20 counterfeit investigations in the

US each year since 2000, including cases involving Lipitor and Procrit

in 2003, strategies and technologies to stop counterfeiters in their

tracks have solidly hit the radar screens of both pharmaceutical makers

and the FDA.

The FDA has stepped up its efforts to halt drug counterfeiting and

diversion, forming an anti-counterfeiting task force to examine

counterfeit pharmaceutical threats and potential protections in July

2003.

The task force received extensive comment from security experts, federal

and state law enforcement officials, technology developers,

manufacturers, wholesalers, retailers, consumer groups and the general

public on a broad range of ideas for deterring counterfeiters.

Based on the input collected, the FDA suggested a comprehensive

framework for a pharmaceutical supply chain that will be secure against

modern counterfeit threats. The group issued its final report,

highlighting it findings and recommendations, in February 2004.

The FDA’s recommendations suggest the use of a multi-pronged approach to

address weaknesses in the drug distribution system, including stricter

licensing requirements for pharmacies, tougher penalties for

counterfeiters, more secure business practices, increased education of

consumers and health professionals, enhanced international collaboration

and improved reporting systems.

But the main emphasis of its recommendations centers on new technologies

for tracking and tracing pharmaceutical products from the moment of

creation to the time they are dispensed to a patient.

Because the capabilities of counterfeiters evolve rapidly, the FDA says

there is no “magic bullet” technology, however, that provides long-term

assurance of drug security. Therefore, the agency recommends a

combination of rapidly improving " track and trace " technologies and

product authentication technologies be adopted by the industry to

protect the pharmaceutical supply chain from counterfeiting.

“Authentication technologies for pharmaceuticals have been sufficiently

perfected that they can now serve as a critical component of any

strategy to protect products against counterfeiting,” the task force

concluded in its report. “Radiofrequency Identification tagging of

products appears to be the most promising approach to reliable product

tracking and tracing.”

The agency said it believes radio frequency identification (RFID)

tagging of products in the pharmaceutical supply chain will be feasible

by 2007, but stopped short of proposing a rule dictating their use. In

fact, the agency said it would not specify a single technology for

authentication, so that potential counterfeiters could not concentrate

on defeating a single approach. Instead, the task force recommended that

drug packaging contain at least two different authentication

technologies.

According to Debbie , life sciences market expert for Zebra

Technologies a provider of on-demand specialty printing solutions for

business improvement, the FDA’s anti-counterfeit recommendations

compliment other mandates in the industry to adopt advanced track and

trace technologies.

says the FDA’s unit-of-use bar coding requirements for

prescription drugs and many OTC medications, which will become mandatory

in April 2006, and RFID requirements by the U.S. Department of Defense

and many large retailers, including Wal-Mart, Target and Albertson’s,

for RFID case and pallet tagging by an array of suppliers, some of which

take effect as early as 2005, are converging to help drive

pharmaceutical manufacturers to quickly adopt new labeling systems.

“Although the unit-of-use bar code rule was primarily developed to

reduce medical errors, folks quickly realized it would also provide a

track and trace methodology to monitor where products were moving

throughout the distribution chain,” said. “Then, a natural

extension of that was that bar code, RFID and secure media solutions

could be brought together, layered and used to combat the growing

counterfeit threat.”

Many brand protection and security experts agree that layering several

forms of product protection into packaging is the safest approach to

ensure product integrity. According to , technologies that can be

layered include secure label stock and laminates, taggants that hold

encoded information, tamper-evident patterned adhesives, RFID tags and

unit-of-use bar codes.

And although many pharmaceutical makers will need to implement separate

labeling systems for unit-of-use bar coding, anti-counterfeiting and

RFID marking over the next two to three years, says for many, a

single labeling system can satisfy all three requirements.

“Bar code, RFID and security media technologies are complementary and

can be combined to successfully fulfill responsibilities at all points

in the pharmaceutical supply chain and provide business benefits to the

labeler,” said.

According to , the added benefits to track and trace technologies

are many.

Adding lot numbers and expiration dates to unit-of-use bar codes could

streamline recall and returns management and significantly reduce the

effort and cost of order, distribution, transportation and inventory

management, she said. And RFID tagging allows labels to be read through

multiple layers of packaging without operator intervention, which can

reduce the labor and time for product handling in the supply chain.

The Kearney report, which focuses on OTC drug makers, estimates RFID

systems could reduce manufacturers’ labor requirements by nine percent

and inventory holding costs by six percent, in addition to an 18%

reduction in diversion. The group suggests that OTC manufacturers can

recoup their capital outlays for RFID systems and generate a positive

ROI in just more than a year by using the technology for internal

inventory control and distribution operations.

In addition, an Accenture study concluded that improved visibility from

RFID could allow manufacturers to reduce their safety stock by up to

30%.

According to , track and trace technologies could also help the

industry meet pending pedigree requirements and improve and streamline

prescription sample management.

“There really is a lot of movement within the industry – a lot of

sharing and teamwork that’s starting to evolve into addressing the

problems in the supply chain,” said. “I think if we look back a

year from now, we will see that companies have implemented some good

systems from the current pilots that will have brought us a long way

toward a truly secure supply chain.”

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