Look before you pop that pill: anti-counterfeiting technology forces advance on pharmaceutical battlefield

Look before you pop that pill: anti-counterfeiting technology forces advance on pharmaceutical battlefield – RFID/ADC

George Miller

A steady rise in pharmaceutical counterfeiting cases has drawn the attention of regulators and technologists alike. Unfortunately, anti-counterfeiting technologists face the same deliberative regulatory and supply-chain integration challenges as their drug development counterparts. Yet they are applying radio frequency identification (RFID) and coding technologies to the problem and making headway on the integration issues.

The Targets

Targets for counterfeiters tend to be the top 20 best-selling prescription medications, including cholesterol-lowering drugs, high blood pressure drugs, AIDS drugs, drugs used to raise red blood cell counts and drugs that fight depression.

Most recent and perhaps most notorious is the counterfeiting case of the anti-cholesterol drug Lipitor, made by pharmaceutical giant Pfizer. In this case, “a sophisticated, well-organized international criminal enterprise” launched an operation involving as many as 16 companies in 9 countries, according to testimony provided by John Theriault, vice president for global security at New York-based Pfizer, during the FDA’s Anti-Counterfeiting Drug Initiative public meeting last October in Bethesda, Md.

The counterfeits were introduced into the U.S. by repackagers who co-mingled the fakes with authentic pills and distributed them to pharmacies via the secondary wholesale network. Theriault testified that more than 18 million tablets had to be recalled.

Further investigations have led to court filings that indicate the counterfeiting involved tablets made for overseas sales that were illegally diverted to the U.S. (where they fetch a higher price), as well as tablets made under unknown conditions. The fakes contained enough of the medicine’s main ingredient to make them difficult to detect, but not enough to reduce cholesterol levels.

“Visually, the counterfeit tablets are virtually impossible for a consumer to differentiate from the authentic tablets,” Theriault testified.

In other cases, less savvy counterfeiters simply soak off the label of a low-strength version of a drug and replace it with a knock-off label for the higher-strength version, which in some cases can be 200 times more expensive.

Worldwide, drug counterfeiting may be worth as much as 7% of the pharmaceutical market–some $28 billion per year, according to analyst Ray Scraggs in his “Combating Pharmaceutical Fraud & Counterfeiting Report 2004,” published by United Kingdom media company Visiongain.

The Response

The caseload rise has served as a candle flame in the dark sprawling underworld of pharmaceutical counterfeiting, attracting the nearby technology moths first and eventually those from further afield.

“There are fresh new people feeling around in the dark to put together solutions,” says John Thorn, general manager for the supply chain and brand solutions group at Checkpoint Systems Inc. “They don’t fully understand where counterfeiting affects them now. Where’s the hole in the supply chain? A lot of discussion is about understanding the problem.”

At the FDA, recent counterfeiting initiatives are following close on the heels of earlier efforts to protect patients from the simple mistakes that can occur in busy hospitals and pharmacies, and even in the homes of those–many elderly–on extensive drug regimens. The unit-of-dose labeling initiative got its start well before the anti-counterfeiting initiative, and it has involved both bar code and RFID aficionados. For drug makers, drug distributors and the FDA, momentum may push together the unit-of-dose packaging and anti-counterfeiting efforts.

A vocal advocate of aggressive action to prevent counterfeiting is the National Association of Chain Drug Stores (NACDS). NACDS has called for a national classification system to rank pharmaceuticals according to the level of risk to patient safety from counterfeiting. Such a system would focus attention on the drugs most likely to be counterfeited. The association also calls for a track-and-trace system with regulations similar to those in place for imported food. In its advocacy, NACDS has cited RFID technology as suitable for the job.

Among other technologies available and on the horizon that may be applied to anti-counterfeiting efforts are various coding systems, overt and covert printing, chromatography, chemical taggants and even synthetic DNA.

On the track-and-trace front, packaging and label maker CCL Label recently joined forces with ORBID Corp. to combine the latter’s 2DMI coding system into security packaging that can be applied at the individual dose level. The goal of the collaboration is to provide validation throughout the supply chain.

The 2DMI system uses unobtrusive security marks incorporated into CCL Label’s packaging and label designs. Each mark is unique and can be printed in color, at any size, and on any surface while remaining scannable by commercial cameras and standard imagers, according to ORBID. Pills and capsules printed or etched with 2DMI marks are unique, the company claims, and can be cross-checked for authenticity against a database kept by the manufacturer.

As anti-counterfeiting efforts gathered momentum in the second half of last year, two formerly unrelated companies joined to form Authentix, hailed as a leader in fuel authentication and now making inroads to the pharmaceutical and other industries. Authentix combines molecular marking technology used to authenticate products and their packaging, which was developed by the former Isotag Technology Inc., with marker pair technology for ingestible products developed by the former Biocode Inc. Authentix uses overt color-shifting inks, covert machine-readable inks and forensic markers for detection in the laboratory to battle counterfeiting.

Such high-tech approaches may sound futuristic, but they are in development and being applied now. Yet an anti-counterfeiting measure does not have to be newfangled to be effective, although it must surpass the capabilities of the in-place methods currently being faked.

For example, says Liz Churchill, director for life sciences solutions at Matrics Inc., some states have implemented track-and-trace initiatives to provide a trail of all hands through which a drug passes.

“But the bar codes used are easy to duplicate, rendering the track-and-trace initiatives ineffective,” she says. “A bar code is only as good as a bar code is. It can be duplicated.”

Electronic Product Code (EPC)-based RFID, she contends, is much more difficult to duplicate. “For the network in place, each item number is unique. It is logged in at all places in the same way. At the pharmacy, I can key in an EPC to determine the manufacturer and also to track via the Internet where the item has been,” she says.

Someone attempting to introduce a fake or new EPC code, or to reuse an existing one, “will be raising a big red flag,” says Churchill.

The Lipitor counterfeiting case, she explains, involved an easily duplicated bar code and easily mimicked packaging. With EPC, however, each bottle would have its own ID, and fakes would be spotted.

“EPC will solve most of the counterfeiting problem,” says Churchill.

But in the case of counterfeiting, technology solutions may represent only the tip of the iceberg.

“The challenge is integration issues,” says Terri Adelstein, supply chain practice manager, Intrasphere Technologies Inc. “Supply chain [professionals] are spending a lot of time on business process changes. At the same time, the FDA is starting to emphasize integration and automation. Suppliers must be able to track inventory. There is no be-all, endall solution.”

The FDA agrees. Its counterfeit drug task force stated last fall that “there is no single ‘magic bullet’ against the growing number of sophisticated counterfeiters; rather, a multi-pronged strategy to secure the drug supply could be much more difficult for counterfeiters to overcome than any single method. It could also be less costly, because a ‘one-size-fits-all’ approach is unlikely to work for all parts of the complex prescription drug supply system.”

Theriault of Pfizer concurs: “Technology alone is not the answer. It should be viewed as one important part of a multilayered solution.” He advocated that those involved in distributing pharmaceuticals be made “active participants in ensuring the integrity of the supply. They must improve business practices to authenticate and track products, and stricter penalties must be imposed on those willing to jeopardize public health and safety by engaging in reckless business practices that facilitate counterfeiting.”

Wholesalers and repackagers, he urges, should be regularly inspected to determine their compliance with existing laws and regulations. The industry must also be alert for signs of counterfeiting through enhanced product surveillance and close monitoring of distribution channels.

In late December, Pfizer placed new requirements on wholesalers and distributors that handle its products. Pfizer stated in a letter to wholesale customers that its products could be purchased only from Pfizer or from wholesalers authorized by the company. Products are to be sold only to Pfizer-authorized wholesalers or to pharmacies, hospitals, physicians or other distributors in the U.S. who are licensed by the states in which they operate. The company said it would refuse to do business with those who don’t comply.

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