Recent drug counterfeiting cases sound alarm for U.S. pharmacists
The problem is not likely to go away soon
Drug counterfeiting isn’t just a problem in other parts of the world. Recent cases in the United States show that pharmacists need to be on alert here, too.
In May and June alone, drug manufacturers GlaxoSmithKline, Eli Lilly, Serono, and Amgen reported counterfeiting of one of their products. The Food and Drug Administration (FDA) is investigating, but cannot yet comment on the recent cases, says a spokesperson for the FDA’s Center for Drug Evaluation and Research. Most of the cases are considered isolated and limited in scope, with no resulting injuries reported.
"Historically, there have been few true domestic cases of counterfeit pharmaceutical products. It is certainly too soon to conclude that these recent reports of counterfeiting represent anything like a new trend," the FDA spokesperson says.
Pharmacists should definitely be concerned about the recent counterfeiting cases, says Susan C. Winckler, RPh, Esq., vice president of policy and communications and staff counsel for the American Pharmaceutical Association in Washington, DC. "The number of cases is unique."
Some of the recent cases have been labeled as "tampering" because they involved substitution of a lower-priced drug for a higher-priced one under the higher-priced drug label. Winckler, however, prefers to consider them counterfeits because the reason behind the switching seems to be money, she says. "These are expensive products. It costs some money to make a good counterfeit product, but certainly much less than to make the actual product."
The counterfeiting issue is not likely to go away soon, she says. "Counterfeiting is a significant issue worldwide, not only with pharmaceuticals. We will continue to see people try to corrupt our drug supply system. It will take everyone from the manufacturer down to the patient to figure out how to stop it."
The majority of counterfeits are caught by pharmacists themselves. Here are some tips from the FDA and Winckler on what pharmacists can do to protect their patients from counterfeits:
• Carefully inspect products that come into the pharmacy.
"Look for variations in the label, box, or packaging; cracks in the product; irregular or odd borders; chips; and differences in widths, colors, or dyes," says Thomas McGinnis, PharmD, FDA’s director of pharmacy affairs.
Pharmacists need to realize that counterfeiters can be sophisticated in their deception, Winckler says. For instance, a different font size on the labeling may be the only way to tell a product is counterfeit.
• Put aside (and don’t dispense from) any suspicious product or package.
"We ask pharmacists to contact either FDA or the manufacturer. The manufacturer will send a pharmaceutical representative to the pharmacy to look at the product and compare it to the firm’s product," McGinnis says. "If a problem exists, such as a counterfeit, the manufacturer will contact FDA."
• Remember to be vigilant about your source of supply.
"It’s time for pharmacists to refocus their efforts on ensuring they are using a quality wholesaler," Winckler says.
• Continue talking to your patients.
Patients need to know that they should report anything unusual about a product. "The counterfeiting of one of the injectable products was discovered because the product burned upon injection," Winckler says.
If consumers have an adverse event from a counterfeit, usually they will contact their physician, who will contact the dispensing pharmacist, McGinnis says. Depending on what was in or not in the product, the physician will have to act accordingly to accommodate the needs of the patient. "Patients should contact their physician if taking a product and not receiving a benefit, especially when they usually benefited from the product. This could be a sign of a counterfeit with no active ingredient."
The patient may not have a noticeable adverse reaction, but no reaction to a product is of great concern as well, and could be another sign that the drug is a counterfeit, he continues. "FDA’s advice to patients and consumers is simply to report anything funny’ or unusual. Many times, the unusual situation is simply due to a defective product or defective batch, but other times, it is a counterfeit."
"These things need to be reported to the manufacturer and to the FDA so we can start to identify some of these issues," Winckler says. "Pharmacists can play a key role in that."
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