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OTC LINE EXTENSIONS RUN RISK OF CREATING CONSUMER CONFUSION

This article was originally published in The Tan Sheet

Executive Summary

OTC LINE EXTENSIONS RUN RISK OF CREATING CONSUMER CONFUSION when the new product uses a different formulation or active ingredient from the established brand, Temple University pharmacy professor Michael Cohen, PharmD, asserted in a July 13 presentation at the Drug Information Association's annual meeting in Chicago. A cofounder of the Institute for Safe Medication Practices, Cohen pointed out that the OTC marketplace includes "an awful lot of drugs that have been reformulated" or that have had new ingredients added "yet still carry the same trademark." He suggested that this practice is "awfully confusing" to the consumer. Citing some examples of potentially confusing line extensions, Cohen pointed to Kaopectate II, Upjohn's recently introduced loperamide formulation. He argued that Kaopectate II might be mistaken for its predecessor, Kaopectate, which originally contained kaolin/pectin but has been reformulated with attapulgite. "There's also a tablet form of regular kaopectate and a loperamide tablet form, which easily could be confused," Cohen asserted. In addition, he noted that Upjohn's Dramamine II also does not contain the same active ingredient as its predecessor, Dramamine (dimenhydrinate). Dramamine II, which began shipping in February, contains meclizine HC1 ("The Tan Sheet" March 15, p. 3). In addition, Cohen observed that Schering-Plough has added a non-drowsy Chlor-Trimeton formula that contains pseudoephedrine instead of chlorpheniramine as its antihistamine ingredient. The pharmacy professor also cited Sterling's Bayer Select, Rhone- Poulenc Rorer's Maalox, Bristol-Myers Squibb's Bufferin and Sandoz' Triaminic lines as featuring confusing extension products or reformulations. To minimize the confusion of line extensions, Cohen advised against "keeping the same [brand] name and then adding words like 'the un-aspirin' or the 'non-drowsy formula.'" Companies "tend to highlight the trademark on the package" regardless and "people . . . think its the same old product." Instead, Cohen advocated the addition of suffixes to the brand name that make it completely distinguishable from its predecessor product. However, suffixes can also be problematic, Cohen pointed out. "You should know that there have been major problems for the [prescription drug] industry by them tagging, in a nonstandard way, suffixes to indicate some new formulation [or] some new feature of the drug such as long-acting." Many medication errors have arisen as a result of Rx drug brand name suffixes, he added. Cohen predicted that Rx-to-OTC switches "may actually lead to a worsening of the problem as we get more and more products with new [OTC] ingredients that may be reformulated because of the change in their [prescription] status." When naming a switch product, Cohen suggested that brand "name retention where the active ingredients are the same and in the same proportion" is "fine," but "if you're going to add new ingredients or change the formulation in some way, then the recommendation is that you add suffixes or somehow change that drug name so that the entire drug name changes." OTC manufacturers should also "test [potential] names on consumers and practitioners," Cohen advised. OTC line extensions also have created problems "for emergency rooms in hospitals," Cohen asserted. When nurses and physicians are compiling drug histories, they "have no idea what the ingredients are or how much [the patients are] taking in some cases. They really can't trust the system anymore as they were able to in the past." In addition, "for pharmacists and pharmacies, [line extensions have] meant a lot of trouble in patient counseling and even in storing some of these products. There are so many new products added to the shelves, it's impossible to keep them all," he remarked. Despite arguing against same-brand name line extensions, Cohen acknowledged that "if I were an OTC manufacturer and I had already gained brand name recognition and people were familiar with my product, then I would certainly like to capitalize on that name." However, he maintained that companies should spend more "time educating consumers and practitioners about the reformulation of the product." To that end, Cohen recommended that OTC manufacturers get more pharmacists involved in the process of naming products as well as publish articles about product reformulations or other changes in consumer magazines, such as Redbook or Good Housekeeping. The issue also should be brought to the Nonprescription Drugs Advisory Committee for discussion, he added.
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