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Knockoff Drugs Should Worry Patients

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Q: I take Lipitor for high cholesterol and am alarmed over recent news about counterfeit Lipitor. How could this happen?

A: Ineffective or unsafe counterfeit versions of prescription drugs is a growing concern.

The counterfeit Lipitor was discovered after people complained their pills tasted unusually bitter. The FDA has recalled all lots of the product known to be involved.

The problem of knockoff drugs, once relegated to Third World countries, has spread its tentacles. In recent years, at least 10 counterfeit prescription drugs made their way onto pharmacy shelves and were dispensed to patients in the United States.

Besides Lipitor, counterfeited products include Combivir, Epogen, Gamimune, Neupogen, Nutropin AQ, Serostim, Procrit, Viagra and Zyprexa.

The driving force behind this shady market is greed, along with shameless disregard for sick people. The most expensive drugs are chosen for knockoffs because they net the biggest profits.

Counterfeiters typically dilute the amount of active drug in a product, replace it with cheaper ingredients, or mislabel the product.

Here's how one mislabeling scheme worked using Epogen, an injectable drug that builds red blood cells: Counterfeiters purchased vials containing 2,000 IU per mL at a cost of $30 each, then relabeled the vials as the much stronger 40,000 IU per mL version and sold them for $600 each, pocketing a huge profit.

Prescription drugs also are considered to be counterfeit when they are diverted outside traditional channels. That's because you can't trust them to have been stored and handled properly.

Drug diversion usually is associated with closed-door pharmacies or secondary wholesalers, which don't serve walk-in customers. These businesses qualify for deeply discounted prices because they are typically set up to serve nursing home patients. What they actually do is turn around and sell the products at much higher prices to other wholesalers or community pharmacies. Many closed-door pharmacies are legitimate, but some exist only to play this shell game.

Counterfeit drugs also may pose a risk for people buying prescription medications imported from Canada. This tactic has escalated in popularity because prices are much lower. The drugs usually are purchased through the mail from Internet pharmacies.

FDA has been cracking down on illegal "storefronts" and Web pharmacies. Be aware that some of these enterprises aren't even in Canada and some are not licensed. They may advertise "Canadian" drugs but get them from other countries or use counterfeits.

The issue is a big political hot potato. Many people just can't afford the medications they need. AARP is encouraging the tactic and some grandstanding senators are trucking busloads of seniors across the border to get their prescriptions filled.

But that's another column.

As for drug counterfeiting, pharmacists should watch for signs of tampering, check seals and labels, and be alert for anything out of the ordinary in the medications they dispense.


(Richard Harkness is a consultant pharmacist who writes on health care topics. You can write him at 1224 King Henry Drive, Ocean Springs, MS 39564. His e-mail address is Volume of mail prohibits individual replies; selected letters will be answered in his column.)


(c) 2003, The Sun Herald (Biloxi, Miss.). Distributed by Knight Ridder/Tribune News Service.

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