Aspen, Colo. — For clinicians, battling the growing problem of drug counterfeiting requires wariness and common sense, says a Food and Drug Administration expert who spoke at Cosmetic Boot Camp, held here.
“Medical practitioners are very key players in combating counterfeits and making sure that the supply chain is safe for patients, and for practitioners,” says Karen Rothschild, Esq., regulatory counsel with the FDA Center for Drug Evaluation and Research.
Over the past 18 months, the FDA has established the Office of Drug Security, Integrity and Recalls, which includes the Division of Supply Chain Integrity, where Ms. Rothschild works. As part of this effort, the agency sent informational letters to doctors and other medical practitioners who, according to FDA evidence, had purchased drugs from unlicensed suppliers — whether intentionally or unintentionally.
“We warned against the use of any drugs from unlicensed suppliers because they may be counterfeit,” and urged practices not to use any of these drugs — and to share information that would help the FDA prosecute the unauthorized sellers.
Such efforts are necessary, she says, because the supply chain has changed.
“With globalization and many more parties involved in the manufacture and distribution of drugs, we see more opportunity for malfeasance,” in forms including unapproved, counterfeit or otherwise dangerous products. Additional perils could come from adulterated drugs, stolen drugs, expired drugs and improperly stored or handled drugs.
“Counterfeiters are getting increasingly sophisticated and smart,” Ms. Rothschild says. “You can’t simply look at a pill or package and say, ‘That's counterfeit.’” Accordingly, she offers the following suggestions for avoiding unapproved drugs and their sellers:
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“If it looks too good to be true, it probably is.” Unauthorized distributors frequently send email and fax blasts touting incredible deals, she notes. If something looks questionable, Ms. Rothschild says, “Ask questions, request a pedigree from the distributor, or contact the manufacturer.”
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Only purchase FDA-approved drugs. Drugs approved in other countries but not by the FDA are illegal in the United States, she says. “Even with drugs from Canada, it’s difficult to know what one is getting. And anyone can put a Canadian maple leaf on their website and say ‘we’re Canadian.’ Most of them aren’t.”
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Inspect and double-check. “Look at the expiration dates and lot numbers, the name of the active ingredient and routes of administration. (See: Fraudulent versions of Botox found in the United States: http://www.fda.gov/Drugs/DrugSafety/ucm349503.htm.) And make sure the labeling is in English.”
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Monitor patient feedback. “If you’re getting new adverse events that a product has not previously been associated with,” she says, “consider that it could be a counterfeit product.”
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Know your trading partners. “All wholesale distributors in the United States must be licensed in each state to which they distribute.” State websites list this information, and the FDA has provided links to these websites at: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm281446.htm. Verifying licensing info doesn't guarantee that a distributor is legitimate, Ms. Rothschild says. “But it’s one of the best ways we have right now to do that.”
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Eliminate the middleman, where appropriate. Though Allergan has a distributor network from whom physicians can order Botox (onabotulinumtoxinA), she says, the company drop-ships the product directly to physicians. Many practitioners don’t even realize there shouldn’t be a middleman in this part of the transaction.
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Report suspected counterfeiters.
In this regard, Ms. Rothschild says, “We would love (clinicians)’ help.” One of the easiest ways involves sending a message to drugsupplychainintegrity@fda.hhs.gov. For general questions for the Office of Drug Security, Integrity and Recalls, call 301-796-3130.
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