Drug Topics - August 25, 2008 - (Page 4) 4 DRUG TOPICS AUGUST 25, 2008 www.drugtopics.com Of Interest to Pharmacists medicine, this much is clear: In contrast to prescription medications, herbal medicine and other dietary supplements are not subject to the same rigorous premarket testing for quality, safety, and efficacy. Impurities and inconsistencies in manufacturing processes affect the safety and efficacy of these products. The FDA considers herbal medicine/dietary supplements as foods, so the makers of these products do not need to provide evidence of safety and efficacy or satisfy manufacturing standards for identity, purity, packaging, and labeling or perform postmarketing analysis on adverse events — although the mechanisms are in place for more rigorous regulations in the coming years. On the other hand, prescription NAC solution must meet those rigorous standards to go on the market. Studies of herbal medications have been published that compared the ingredients listed on the labels with what is actually in the bottles, and results indicated discrepancies between the two. Therefore, it is possible that the 600-mg NAC capsules that a patient took for renal prophylaxis contained multiple impurities with little or no active ingredient — a situation with potential to lead to harmful consequences. It is important to educate prescribers and patients alike about the potential differences between prescription NAC and dietary supplement NAC. While a pharmaceutical-grade product has met standards of purity and efficacy, a dietary supplement may not have undergone the same stringent testing. A healthcare professional who recommends the nutraceutical (alternative medicine) NAC for certain indications rather than its prescription counter- It is important to educate prescribers and patients alike about the potential differences between prescription NAC versus dietary supplement NAC. While a pharmaceuticalgrade product has met standards of purity and efficacy, a dietary supplement may not have undergone the same stringent testing. part could be held liable if a patient is harmed. If the prescriber insists upon a capsule form of NAC for nephropathy prophylaxis, the pharmacist should make sure that prescriber and patient are educated in the differences between the two forms of NAC. If the choice is to go with the OTC product, the pharmacist should provide the highest quality dietary supplement, choosing one with a standardized manufacturing process. For example, a few herbal supplements will have the “U.S. Pharmacopeia Dietary Supplement Verified” seal on the label, showing that certain manufacturing standards, such as purity and potency, have been met. Bear in mind that the definition of “standardization” varies with each manufacturer and should be treated with caution at all times. With patient health and safety a priority, the best route for the pharmacist to take is to fill prescriptions written for NAC with the pharmaceutical-grade prescription solution. This will ensure that the patient receives a product that has been thoroughly checked for safety, efficacy, and consistency — all of which are questionable, at best, with the herbal NAC products. It would be ideal if a prescription-grade oral capsule or tablet became available for use in nephropathy prophylaxis. However, as of now, it is essential that all healthcare providers are aware of this issue, and that they relay the information to patients to prevent possible adverse events that result from improper use of NAC capsules. Kevin Weissman, PharmD, is the director of drug information services at LAC+USC Healthcare Network, Los Angles. Eric Im is a PharmD candidate, 2009, at the University of Southern California, Los Angeles. http://www.drugtopics.com
Table of Contents Feed for the Digital Edition of Drug Topics - August 25, 2008 Drug Topics - August 25, 2008 Are N-acetylcysteine (NAC) Capsules Available? Largest Generics Firm Teva Gets Even Larger Latest News Roundup Drug Topics - August 25, 2008 Drug Topics - August 25, 2008 - Drug Topics - August 25, 2008 (Page 1) Drug Topics - August 25, 2008 - Drug Topics - August 25, 2008 (Page 2) Drug Topics - August 25, 2008 - Are N-acetylcysteine (NAC) Capsules Available? (Page 3) Drug Topics - August 25, 2008 - Are N-acetylcysteine (NAC) Capsules Available? (Page 4) Drug Topics - August 25, 2008 - Largest Generics Firm Teva Gets Even Larger (Page 5) Drug Topics - August 25, 2008 - Latest News Roundup (Page 6)
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