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Drugs That Can Compound Health Risks

Study: Medications made by pharmacies may be less likely to meet quality standards than commercially made products, research finds.


Pharmacists who will prepare medications to suit a particular patient's needs can be a lifesaver for some people, but a new study shows the drugs may not be as potent or as pure as their commercial counterparts.

U.S. Food and Drug Administration researchers selected more than a dozen commonly used products that had a potential for health risks if made incorrectly, including eyedrops for glaucoma, injectable steroids and Viagra substitutes, from 12 compound pharmacies.

Testing revealed that more than one-third of the 29 products sampled failed to meet quality standards. One product was contaminated with bacteria and nine didn't meet potency standards--of those nine, five had a potency of less than 70% of what was stated on the label for the approved drug.

In comparison, only 1% to 2% of commercially made drugs that are sampled each year by the FDA fail these standard tests.

"These results don't mean that all compound drugs will fail standard tests," says Jane A. Axelrad, associate director for policy in the FDA's Center for Drug Evaluation and Research in Rockville, Md. But the study results should alert consumers to "the importance of carefully compounding products." Results of the tests were presented Sept. 23 at the American College of Clinical Pharmacology meeting in San Francisco.

Compound pharmacies are similar to old-fashioned apothecaries, in which pharmacists use bulk chemicals to make their own versions of prescription drugs. Some consumers need such preparations because they are allergic to a dye or preservative in a traditional drug, use different dosages than are available in commercial preparations, or prefer medications made from natural sources. More than 250 million prescriptions are filled annually by compound pharmacists--about 1% to 8% of total prescriptions.

To get a representative sample of the nation's 20,000 compounding pharmacies, the FDA investigation focused only on high-volume pharmacies.

Improper compounding can have serious health consequences. In one instance, a child died after ingesting a liquid form of the antidepressant imipramine, which was compounded at five times the prescribed dose. Eight recent cases of meningitis, including three deaths, stemmed from a contaminated batch of steroid injections made by a California compounding pharmacy.

To avoid problems, use commercially made drugs, Axelrad says. If consumers need to use a compound pharmacy, "make sure they have a good quality control program," says Loyd V. Allen, editor in chief of the International Journal of Pharmaceutical Compounding in Edmond, Okla.

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