Drug counterfeiting: A new Rx for curbing fake meds

The FDA offers a new plan to protect the nation's prescription medications.

Posted March 22, 2004.

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In some countries, concern about the proliferation of fake or phony prescription medications is a sad fact of life. Not so in the United States. Here, a network of state and federal regulation and enforcement over time has afforded patients considerable confidence and peace of mind.

Still, there is no room for complacency.

Recently, the Food and Drug Administration has seen a jump in U.S. cases involving drug counterfeiting. From the late 1990s until 2000, the FDA typically investigated between four and six such cases annually. In 2002, the number rose to 22.

The agency sees this phenomenon as a warning signal. Well-organized criminal operations are attempting to introduce into the marketplace drug products that resemble their legitimate counterparts but contain inactive or incorrect ingredients, are in improper doses or are otherwise contaminated.

Stanching this nefarious trend is a public health and patient care imperative. Doing so will require getting ahead of the problem. After all, patients should rest assured that the prescriptions they fill and the medications they take will improve their health -- not do harm.

That's why the American Medical Association supports the FDA's new blueprint to step up anti-counterfeiting efforts. The plan, outlined in a report released Feb. 18, offers aggressive measures to combat this problem before it becomes widespread. Physicians play a critical part.

Overall, the FDA is advancing a range of safeguards, from taking advantage of new track-and-trace technologies to follow drugs through the distribution chain to enhancing regulatory activity, increasing penalties for wrongdoing and heightening vigilance by health professionals and consumers. To this end, the agency will develop a system that helps ensure reporting of counterfeit drugs, and that strengthens the ability of the FDA, other regulatory agencies and stakeholders to respond rapidly.

The plan also involves new steps to encourage physicians to report suspected counterfeit drugs to FDA's MedWatch system. The AMA long has been a partner in this drug safety reporting program. Now the Association pledges to do even more to team up with the FDA to educate physicians on how to identify and report counterfeit drugs.

Meanwhile, the FDA intends to create a Counterfeit Alert Network to provide timely and effective notification to affected health professionals and the public whenever a counterfeit drug is identified. Additionally, the agency will enhance educational programs aimed at physicians, pharmacists and other health professionals about their role in identifying, minimizing exposure to and reporting counterfeit drugs.

All of this is important. But another piece of the puzzle -- consumers -- receives attention, too. The FDA will reach out to them through public service ads, its Web site and other educational initiatives with very important messages: "Counterfeit medicines are filled with empty promises," and "Don't be a victim."

The agency will encourage consumers to minimize their risks by purchasing only from U.S. state-licensed pharmacies, and it recommends that when using the Internet to purchase medications, consumers should use only Web sites sponsored by state-licensed pharmacies in good standing in their home states.

The FDA's bottom line, of course, is that counterfeit drugs are not only illegal but inherently unsafe. Ultimately, the regulators hope that this message will lead to a heightened degree of awareness. "If you suspect you have purchased a counterfeit drug because you are experiencing unexpected side effects or notice something different or odd about your medicine," notes an FDA ad, "contact your pharmacist or doctor."

Those words -- contact your doctor -- are crucial. It's a reminder that although the FDA is on the front line of this initiative and the AMA has an important supporting role, individual physicians' awareness and communication with patients and the reporting system are essential in the fight against drug counterfeiting.

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External links

The Food and Drug Administration on combating counterfeit drugs (link)

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