CHAINS AND BUSINESS

R.Ph.s play major role in the battle against counterfeiting

In the past three years, an average of 20 drug-product counterfeiting cases have occurred each year in the United States—an increase from five cases in 1999. Tom McGinnis, the Food & Drug Administration's director of pharmacy affairs, presented the statistics to attendees of a media briefing, held recently in Washington, D.C., to underscore the growing threat of counterfeit drugs and the dangers of importation. The conference was hosted by the Institute for Policy Innovation.

McGinnis said that, in addition to being concerned about counterfeit drugs getting into the United States, the FDA is worried that consumers might unknowingly be taking recalled drugs that have been purchased from outside the country. He went on to cite a case that occurred a few months ago involving Glaxo's Serevent (salmeterol xinafoate).

"The product that is sold in the United States comes out of Great Britain. Since that product didn't have a problem, there was no notice to U.S. consumers. Three days later we learned of the Canadian recall, so we came out with a press release. We found that U.S. patients were ordering this product from Canada, and they were not being notified by the Canadian pharmacies or other pharmacies around the world that there was a class 1 recall of that type of medicine. There is no systematic regulatory structure for these medications that people are ordering from outside of the system," warned McGinnis.

The FDA official believes that as the demand for drugs from Canada increases, counterfeiters will show up with products that are indistinguishable from the real products. "Canada has the perfect storm brewing. It takes counterfeiters six months to have a copy of a product. "

Internet sites that pop up and disappear within 48 hours after orders for drugs are placed are also a worry. "[Counterfeiters] are looking for quick orders and are moving quickly behind the Internet. It's difficult to find them," acknowledged McGinnis.

Another speaker at the conference was Maureen Casey, VP, Giuliani Partners LLC, which has been studying safety issues associated with the importation of medications. Casey echoed McGinnis' sentiments concerning the danger inherent in ordering prescriptions from the Internet. "You are playing Russian roulette when you go on the Internet," she said. "We've been working with a Canadian firm that randomly selected six Internet pharmacies out of Toronto, and none of them was licensed by the province of Ontario. Four out of the six were residential locations acting as call-taking centers for operations outside of the country. People need to be aware that just because there is a Canadian flag on a Web site doesn't mean the product is coming from Canada or that it is Health Canada- or FDA-approved."

Casey said the problem is compounded by a network of secondary wholesalers that might be registered in states to conduct business but that receive very little oversight and might be unscrupulous.

Casey emphasized that before embarking on legislation that would expand the system, we need to look at the resources needed by FDA, customs, and the Drug Enforcement Administration to make counterfeiting laws and penalties stricter.

Giuliani Partners looked at packages coming into JFK airport and found expired and mispackaged medications as well as those that had labels and instructions in a foreign language. They also found what appeared to be products that had been tampered with.

Kristina Lunner, director of federal government affairs, American Pharmacists Association, was also on hand at the conference. She urged pharmacists to do the following to protect patients from counterfeit products:

• Evaluate your sources. Be wary of faxes that offer great deals on drugs.

• Keep track of old stock, and how you discard empty stock bottles.

• Help identify counterfeit products. For example, if patients come in and their pills have always been blue but now are green, the pharmacist should determine if this is a legitimate change in the prescription.

• Notify consumers if you suspect that your supply has potentially been counterfeited.

• Encourage patients to tell you if something doesn't seem right with their medication.

• Educate patients about the medicines they are taking, including what they look like and what the common side effects are.

• Help filter consumer reporting to the FDA and other agencies.

• Have information on what a product looks like as well as any potential changes in the look of the product or the packaging.

• Be aware of regulatory actions.

Lunner concluded, "If there is any legalization of importation, the pharmacist has to be confident that whatever system we put in place keeps the integrity of the drug the same as it is today."

Sandra Levy

Sandra Levy. R.Ph.s play major role in the battle against counterfeiting.

Drug Topics

Aug. 23, 2004;148:58.