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The hype surrounding any prescription drug's switch to over-the-counter status consistently brings customers and sales into the store, and not just for the new product, retailers and industry experts told SN. Switch drugs have the ability to grow entire categories. However, retailers marketing these new powerful medications might take a lesson from the superhero Spider-Man's words: With great power

The hype surrounding any prescription drug's switch to over-the-counter status consistently brings customers and sales into the store, and not just for the new product, retailers and industry experts told SN. Switch drugs have the ability to grow entire categories.

However, retailers marketing these new powerful medications might take a lesson from the superhero Spider-Man's words: “With great power comes great responsibility.” For retailers, that means helping customers choose properly.

One such hyped-up switcher is orlistat. Marketed by manufacturer GlaxoSmithKline, Philadelphia, as Alli, the drug is the only FDA-approved weight-loss medication available over the counter.

Due in stores by July, Alli is sure to call consumers' attention to the weight-loss category. “As we get into the summer months, people will say, ‘I want to look good and I want to take this drug,’” said John Fegan, senior vice president of pharmacy, Ahold USA, Quincy, Mass.

“But we will be getting involved because we want them to be prepared for any side effects,” he added.

Curtis Hartin, senior director of pharmacy at Bi-Lo in Maudlin, S.C., told SN that Bi-Lo stores will stock Alli in the pharmacy, even as an OTC item. This will ensure pharmacists have the ability to counsel patients in product use, discuss expected outcomes and offer support, he said.

Alli, when taken with meals, prevents stomach enzymes from digesting about one-fourth of the fat in those foods. Undigested fat can't be absorbed and passes through the body naturally, according to a GlaxoSmithKline website for the drug.

“Making the pharmacist available to customers in a case like this is very important,” said Peter Lurie, deputy director of the Public Citizen's Health Research Group, Washington.

As the fat passes out of the body, unsettling changes in bowel habits follow, known as treatment effects, the website said. Such dramatic side effects are not common with OTC products, many industry experts said.

However, “the incidence of gastrointestinal side effects is very high” for orlistat, said Lurie. A February press release from the group called the FDA's approval of orlistat “reckless.”

The group found links not just to bothersome side effects but also to the inhibition of absorption of fat-soluble vitamins such as A, D, E and K, and lab tests done on rats that link the drug to colon cancer. However, no human studies back this up, the research group has reported.


Ahold plans to promote the drug, as well as the availability of pharmacists to answer questions. Signs and documentation will be provided. “We will work with the manufacturer to support the switch and remind customers that we are there to help them,” Fegan said.

“We will draw attention to the product in order to alert consumers that our pharmacists would be happy to discuss the potential side effects and any interactions it might have,” noted Dan Milovich, director of pharmacy operations, Bashas', Chandler, Ariz.

The introduction of a new OTC drug option for consumers presents the opportunity for retailers to partner with manufacturers in reaching out to the public, said David Spangler, senior vice president, policy and international for the Consumer Healthcare Products Association, Washington.

“Manufacturers often put together comprehensive programs around these products,” Spangler said. For example, when smoking cessation aids were first introduced OTC, manufacturers trained pharmacists to lead committed “quitters clubs,” he said.


Aside from television, newspaper and magazine articles, when a drug goes OTC, “not only is the company introducing the product advertising, but all the competitors in the product class tend to increase their marketing efforts in an attempt to maintain hold and build their own market shares,” said Jim Wisner, president, Wisner Marketing Group, Libertyville, Ill.

This in turn brings people to market in a product class where they weren't buying before, or where they were infrequent buyers, he said. “This is significant for a retailer because how often do you find a category that gets increased sales from new growth? That growth is not just accounted for by the new product either; all of the other products grow collectively, as well,” he said.

One niche in the stomach remedies category that might see new growth over the next year is laxatives. MiraLAX from Schering/Plough, Kenilworth, N.J., was approved as an OTC laxative late last month, said Milovich.

The drug is the first laxative to switch from prescription to OTC in 30 years, according to Schering/Plough. It claims to work “without causing the side effects of cramps and gas,” the company said in a release.

A positive outcome in drug launches like this one is that consumers are more likely to speak with a pharmacist or technician, both of whom they perceive as trusted resources, retailers and industry observers told SN.

In addition to advising consumers on newly switched medicines, pharmacists are in the position to educate consumers on the efficacy of related items, including store-brand items, said Tony Harrington, director, program management, Topco Associates, Skokie, Ill.

“This helps strengthen the loyalty and relationship between the pharmacy and its consumer, and creates additional margin potential for the store,“ he said.

While new products are usually very beneficial to the consumer, “there is still a segment of the population that needs to ask the pharmacist questions and involve them in making the recommendation,” Fegan said.

This presents an opportunity to increase the pharmacist's exposure to customers, he said.


Lurie of Public Citizen's Health Research Group recommends that retailers review the safety of each drug before choosing to carry it, make educational materials available and even consider generating their own patient leaflets. They should “make sure there is a proper balance between risk and benefit,” he said.

“If it makes sense, you really do want to make the drug available,” Wisner said. “From a public health standpoint there are a lot of individuals who don't have access to professional medical care either because of cost, location or language, this is an opportunity for those people to address their health needs.”

With each switch, the U.S. Food and Drug Administration, Rockville, Md., evaluates whether the product has a safety profile that is appropriate to the OTC setting. It considers whether the condition to be treated is one that a consumer can self-diagnose or recognize as a recurrence. It also determines the potential to develop labeling that the consumer can meaningfully review and act on in the marketplace, said Spangler.

“Of course manufacturers want some of their products to go OTC because it increases exposure,” Fegan said. “But they also recognize the possibility of side effects and other occurrences that they hadn't seen prior to such wide usage.”

Most FDA reviews also require an “actual use” trial, Spangler said. These trials sample a wide range of patients taking the drug and going about everyday life. “Having a choice to take a medicine for a self-diagnosed condition is a win for customers' time and money and for the health care system,” he said.

Shelf Help

Supermarkets are poised to take advantage of heavily promoted medicines going from prescription status to over-the-counter, but they have to let customers know where to look, industry experts told SN.

Because new Rx-to-OTC drugs are usually preceded by manufacturers' advertising campaigns and heavy media coverage, “you want to put yourself in a position where customers know they can find the product at your store,” said Jim Wisner, president, Wisner Marketing Group, Libertyville, Ill.

Before the product is released, retailers should create space for it on the shelf and post a sign saying, “Coming Soon,” Wisner said.

Retailers can work with the manufacturer to provide informational brochures ahead of the product's introduction. Then “you want to have the product displayed so people know that its there,” he said.

Once advertising from the manufacturer drives customers into the store, retailers should also make the products easy to find, said Rick DeSantis, partner, Henry Rak Consulting Partners, Libertyville, Ill.

“Although they should be highlighted in some way, the products should be located in sections where customers usually find products that treat the same afflictions,” he said.

Education should have a place on store shelves, as well. “In-store education with shelf pockets or informational brochures is a job that needs to be done and that can drive sales.”

Consumer education is in line with supermarket retailers having a greater role in health care, Wisner said. “The aisle of the supermarket is where people make their decisions on diet, lifestyle and managing their health.”
— W.T.