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11/21/2003

ASHP, Other Groups, Advise FDA about Solving Counterfeit Drug Problems

Donna Young

The pharmaceutical industry and federal and state regulators must constantly review and consider new technologies to stay ahead of a growing number of drug counterfeiters who are becoming more sophisticated and well-organized in their operations, said FDA Commissioner Mark B. McClellan.

“We are seeing an increasing number of cases that involve not just a few people manufacturing a fake product in their garage, but well-organized international criminal operations that are trying to make use of the latest technologies for making a product that looks like the real thing but isn’t,” he said. “We must keep ahead of the game.”

Many counterfeit operations FDA is investigating are “well-financed” criminals that are “investing in better technologies because they can make a fast buck” at the expense of the American public, McClellan asserted.

The commissioner’s remarks came at an October 15 public meeting in Bethesda, Maryland, convened by FDA’s Anticounterfeit Drug Task Force, which was established in July to address the risks and threats of counterfeit drug products.

In recent years, FDA has seen an increase in the number of criminal investigations involving counterfeit drugs—from an annual average of 5 in the 1990s to more than 20 last year.

A multipronged approach. The task force released an interim report on October 2, which outlined a multipronged strategy for combating drug-counterfeiting operations. The agency plans to release its final report in January.

Pharmacy organizations, drug makers and wholesalers, and officials from other government agencies, including the Secret Service, the Department of Justice, and the Bureau of Engraving and Printing (BEP), expressed opinions at FDA’s meeting about the interim report and provided ideas about how to secure the pharmaceutical supply chain.

“All participants in our drug distribution system, from manufacturers to wholesalers and distributors to pharmacies and patients, have a responsibility to help us prevent and detect the introduction of counterfeit drugs into our drug supply,” McClellan said.

Vendors, such as makers of radio frequency identification (RFID) and bar- coding technologies, displayed products that could be used to make it easier to identify counterfeit pharmaceuticals.

“The United States has a very safe prescription drug supply, and FDA is working hard to keep it that way,” McClellan said. But, he added, “this is not something that we can take for granted. This is a moving game. We constantly need to be finding ways to update our technologies.”

Pharmaceutical manufacturers need to use “multiple layers” of antitampering and track and trace technologies—including RFID, taggants, and bar coding—to keep the nation’s drug supply safe, said McClellan, noting the multilayer security system used by the agency that oversees the production of U.S. bank notes.

Federal experts. Carla Kidwell, associate director of BEP’s technology office, said the bureau uses covert, overt, and forensic detectors in currency notes that help investigators identify legitimate bills.

“With technology growing at a very rapid rate, we need to change our notes every 7 to 10 years” to deter counterfeiters, Kidwell told FDA’s task force.

BEP identifies 1 or 2 counterfeit bills per every 10,000 genuine notes, she said.

Public education campaigns are an essential element when the government is introducing new bills, such as the recently introduced $20 note, Kidwell said.

Education programs can also aid consumers in identifying counterfeit bills, she added.

Similar education programs, Kidwell suggested, could be adopted by FDA and the pharmaceutical industry for counterfeit drug products.

The U.S. Secret Service’s Forensic Services Division conducts laboratory analysis of counterfeit currency and drug packaging, said Sue Fortunato, assistant chief of the division’s forensic automation branch.

The division does not test drug product ingredients, she stressed.

“We are not a full-scale forensic lab like what you see on [the television program] CSI,” she said.

The Secret Service analyzes counterfeit printed products, such as drug packaging and labels, Fortunato said.

The agency has had a memorandum of understanding with FDA for 10 years to conduct forensic testing of counterfeit drug packaging and labels, she added.

“Counterfeiters are attacking the products that they are going to get the most bang for the buck,” Fortunato said.

Many counterfeiters are now using commercial printing techniques, such as offset photography, used by manufacturers, which make it difficult to tell a fake label or package from a genuine one, she said.

The violation for which drug counterfeiters are prosecuted, the Justice Department’s Gene Thierolf told the task force, is “bearing the identifying mark of another drug manufacturer.”

Thierolf said that the sooner a pharmaceutical company communicates a problem about a counterfeit product to FDA, the sooner investigators can get involved and “make a judgment on the public health consequences.”

John M. Taylor III, associate commissioner for regulatory affairs at FDA and cochair of the task force, said the increase and shift in these illicit counterfeit drug activities has occurred for a number of reasons.

Wholesalers. One weak link in the pharmaceutical supply chain involves the wholesaling industry, that acquire most of their inventory from second sources and do not maintain “due diligence efforts on these sources,” he said.

The American Society of Health-System Pharmacists (ASHP) remains extremely concerned about vulnerabilities in the pharmaceutical supply chain, particularly with respect to secondary distributors, said Douglas Scheckelhoff, director of ASHP’s pharmacy practice sections.Doug Scheckelhoff

“While these entities may perform a role in providing needed medications in some select situations, ASHP believes that stronger state and federal oversight may be needed,” he advised the task force.

Any changes to federal law and regulation, Scheckelhoff counseled, should be patterned after recent legislation enacted in Florida, which requires wholesalers doing business in the state, including primary wholesalers, to provide a pedigree for 30 drug products that have been identified as having a high risk for diversion and counterfeiting.

Under Florida’s law, implemented in September, wholesalers are required to submit to background checks, pay a $100,000 bond, and provide a contact person responsible for all transactions.

“Florida’s new law begins to address the lack of authenticating and documenting the chain of custody of a product from the originating manufacturer, Scheckelhoff said. “This is particularly important with respect to the high-risk drugs identified by the state as being prone to counterfeiting.”

Recent discussions by ASHP’s policy recommending councils noted the need for uniformity in state regulation of a national standard in order to maintain the integrity of the drug supply, he informed the task force.

However, Scheckelhoff cautioned, “we should be sensitive to the unintended consequence of the creation of new barriers in distributing prescription drugs, particularly with respect to legitimate returns of unused product from pharmacies.”

Jon Borschow, chairman of the board of the Healthcare Distribution Management Association (HDMA), a trade association for wholesalers, noted that his organization has recently developed a set of voluntary best practices for wholesalers.

“Pharmaceutical wholesalers have been following similar business practices for a number of years, but recognizing our unique position in handling pharmaceutical products, we decided it was time to come together, pool our combined knowledge and experience, and raise the bar even further regarding our own due diligence,” he said.

Track and trace. HDMA has also established a product safety task force that is examining the business requirements needed for implementation of track and trace technologies, Borschow said.

“Track and trace technology supports the unique identification of each individual product unit, allowing distributors to easily identify and locate specific items in the supply chain,” he said.

HDMA supports implementation of RFID, a “tiny radio frequency chip containing essential data in the form of an electronic product code (EPC) [that] will allow supply chain stakeholders to track every unit of medication in the country on an individual basis,” Borschow said. “By tying each product unit to a unique ID, any item can be tracked through the entire supply chain with an unalterable electronic pedigree.”

The EPC chip, which Borschow described as “a product’s DNA,” is equipped with “high technology security protection that will make it impossible to duplicate or steal the identity of an authentic unit.”

“Even if criminals developed the technology required to create an exact replica of the EPC, the technology’s ability to track product movement from manufacturer to patient would detect duplicate drugs in an incorrect location within the system,” he said.

Products with RFID and EPC technology, Borschow said, can help health care professionals “track product expiration dates, simplify the process of product recalls, and reduce the number of medication errors by uniquely matching a specific product to a specific patient.”

Model act. Carmen A. Catizone, executive director of the National Association of Boards of Pharmacy (NABP), said his organization has established a task force on behalf of all states to update model practice acts for wholesalers and distributors.

NABP’s task force met for two days in October and included representatives from pharmacy organizations, officials from FDA and the Drug Enforcement Administration, and other stakeholders, he said.

The task force examined rules governing wholesalers in California, Nevada, and Florida, Catizone noted.

Pharmacists’ role. Pharmacists should be the focal point for patient contact, education, and follow-up when a product is suspected of being counterfeit, said ASHP’s Scheckelhoff. 

ASHP has developed a list of strategies that pharmacists can use to protect against drug counterfeiting.

Training materials should also be developed to educate pharmacy and product-receiving staff about how to screen product packaging and what steps to take when a suspicious product is found, he added. 

Electronic means and systems for alerting pharmacists to counterfeit products already exist through professional organizations, Scheckelhoff advised FDA’s task force, noting that ASHP maintains an e-mail list of over 23,000 members who receive news items from the Society on a weekly basis.

“ASHP stands ready to provide rapid alerts to members and hospital pharmacy departments about counterfeit drug incidents,” he said.