EDITORIAL
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With our third installment of Tracking & Tracing Pharmaceutical Products, we bring you the exciting news that the product on our cover—Avonex—will be serialized in time to meet California’s (current) January 2009 deadline for electronic pedigrees. Many companies have told California’s State Board of Pharmacy Enforcement Committee that such compliance would be impossible. We commend Biogen on its efforts!
Such an achievement couldn’t come at a better time. Reports of questionable drug products are becoming more frequent, demonstrating the distinct need for better supply-chain visibility.
At press time, reports were surfacing about questionable ingredients used for Baxter International Inc.’s heparin sodium injection products. The company has voluntarily recalled all lots and doses of its heparin multiple-dose and single-dose vials and HEP-LOCK heparin flush products, it reports on its Web site. Some reports say that four patients have died and 350 others have suffered adverse reactions.
Attention is shifting to a chemical ingredients manufacturer in China that supplies ingredients to a Wisconsin firm that provides active drug ingredient to Baxter. At press time, neither the Chinese company nor the Wisconsin company had been accused of any wrongdoing. But the New York Times reported that a Baxter spokesperson had “detected unspecified differences between some lots of the ingredient.” The source of the questionable lots was not reported.
In a separate report, the New York Times wrote that “heparin manufactured with Chinese ingredients has been linked to 19 deaths in the United States. Federal drug regulators there said sophisticated tests had found what might be a counterfeit ingredient in the heparin associated with the deaths and serious allergic reactions in more than 700 patients.”
Other products, too, are coming into question because of possible counterfeiting. Americas Watchdog reports that “each of the biggest makers of erectile dysfunction drugs [is] losing at least 2 billion U.S. dollars a year to counterfeiters.” Echoing such concern is the British Medical Association, which warns that “half of impotence drugs purchased on the Internet could be fake.”
Panama has also just released its findings in the mass fatal poisoning of more than 100 people. After exhuming 52 bodies, investigators found that 27 had tested positive for diethylene glycol, the New York Times reported.
FDA had found that same chemical in certain toothpastes imported from China last year.
Finally, a manufacturer of premoistened wipes, including those soon marketed to kill MRSA, has been sued by Philip Morris alleging that the firm imported counterfeit cigarettes from China into Los Angeles. Nice-Pak Products Inc. denies any wrongdoing, saying that it “has nothing whatsoever to do with tobacco products.”
For years, U.S. consumers have been told that its pharmaceutical and healthcare products are safe, given our “golden standards.” Judging from these recent examples, this golden age may have passed.
In today’s increasingly global marketplace, risks to product quality appear to be greater. The only means of protection for U.S. products, U.S. companies, and U.S. consumers is supply-chain visibility. Know what goes into your products, and know where your products go.
It is unclear whether electronic pedigree rules will root out all risks. Developing track-and-trace programs, however, will enable you to identify where each and every one of your products is, at any minute. Once you know that, you may be able to extend your reach back into your own supply chains for an even more-robust track-and-trace system. Some experts have argued for ingredient pedigrees; given Baxter’s concerns, that call may not be far off.
Building a sophisticated track-and-trace system may also help companies defend themselves in the face of any litigation. Baxter may be facing such troubles already. Searching Google, I came across this Web site: www.baxterheparinrecall.com.
Daphne Allen, Editor
