The push to lower drug costs is driving more prescription medicines over the counter and creating a greater need for pharmacist consultations, said pharmacists polled by SN during this month's Food Marketing Institute Pharmacy Conference.
Although the widely anticipated OTC switch of Plan B -- the controversial "morning after" pill -- is on hold, discussions are under way to allow cholesterol-lowering drugs, known as statins, to be sold without a prescription, as was recently approved in Great Britain.
Meanwhile, pharmacists and others interviewed during the conference, which was co-located with the FMI Show in Chicago, said more heartburn and antacid products are likely to follow Prilosec and Pepcid to store shelves, and more non-sedating antihistamines like Claritin can also be expected.
But many of these medications raise concerns about side effects, and if they do switch to OTC, pharmacists will need to be prepared to take a more active counseling role with customers. There is speculation that a new class of drugs will be established to cover medications that can be sold without a prescription, but with a pharmacist's supervision.
"The companies that figure out how to leverage the pharmacist as a good source of information for OTCs are going to be the ones that will be successful down the road," said John Beckner, director of pharmacy and health services, Ukrop's Super Markets, Richmond, Va. "It's an area that presents a really big opportunity for pharmacists if we can free them up to be available to counsel and advise on those products."
"We work with the [health and beauty care] department to educate consumers," said Don Clark, director of pharmacy operations, K-VA-T Food Stores, Abingdon, Va. "We can't lose sight that these are the same powerful medications that were available with prescriptions. We want to involve the pharmacist as much as possible so the people taking these medications don't do anything to cause injury to themselves because they think it's like aspirin."
Pepcid was the first H2 blocker [for reducing stomach acid] to go OTC and its success set a standard for pharmacies, noted Mike LeBlanc, pharmacy business development manager, Winn-Dixie Stores, Jacksonville, Fla. Since then "everybody has gotten smarter and learned how to better manage the pharmacy-to-OTC switch, and how to communicate better with the consumers," he said.
It's an easy transition for patients who have already been taking the switched product with a prescription, LeBlanc said. For those who have not taken it and who are responding perhaps to television advertising, "they are finding that the pharmacist is a very knowledgeable resource when they are thinking about initiating a new therapy," he said.
Pharmacist counseling on OTCs is desirable, but easier said than done, said Curtis Hartin, director of pharmacy, Schnuck Markets, St. Louis. "It's a complicated issue. If a prescription is not required, then a pharmacist has little ability to intervene. It depends on store placement, customer convenience and that sort of thing," he said.
"With an OTC switch, patients are able to get medicine without being counseled about it anymore," said Phil Smith, pharmacy administrator, Save Mart Supermarkets, Modesto, Calif. That brings the possibility of untrained store personnel answering customers' questions, which is a potential liability for a supermarket. "[So] our general merchandise people have been instructed to refer all questions to the pharmacist," he said.
Michele Snider, Save Mart's director of pharmacy, noted there is a line between the different departments in the store. "When something goes OTC, it goes into a different department, although the pharmacy still counsels customers on some of these items. With a prescription, you can insist on counseling," she said.
Retail pharmacy needs to be involved early in the Food and Drug Administration's decision-making process on potential OTC switches so pharmacists can be adequately prepared, noted John Fegan, senior vice president, pharmacy, Ahold USA, Quincy, Mass. This is the case now with the statins, and members have asked the National Association of Chain Drug Stores, Alexandria, Va., to monitor the deliberations, he said.
"We're not out to prevent things from going over the counter, but when there are a lot of issues that require the pharmacist's intervention, we ought to be aware of them so we can arm our pharmacists and plan for the future when those products go OTC," Fegan said. Besides informing customers through consultation with pharmacists or with informational materials, retailers also need to get ready for the impact on business of an OTC switch, he said. "It obviously impacts our pharmacy sales, but we need to then figure out how to convert the pharmacy customer into an OTC customer still in our store. That's why we want to be ahead of this curve," Fegan said.
Hartin of Schnucks sees the FDA as very deliberate in its actions. "I think they understand the pressures from the managed care organizations, as well as from the public, but at the same time, they're pretty judicious in their decisions. I don't see a flood of Rx-to-OTC switches over the next several years; I think it will be pretty well measured like it has been," he said.
Newsletters are one way of educating customers about OTC switch products, said Glenn Hausfater, managing director, Partners in Loyalty Marketing, Chicago. By using loyalty card data to target customers who buy related products already on the shelves, such a newsletter can help retailers retain pharmacy customers after an OTC switch, he said.
Such a newsletter should start a year before the switch and be condition specific, rather than focused on products, he said. "That gives you a platform both for introducing new products and for holding onto your heavy buyers of the brand in the face of an Rx-to-OTC switch that might be heavily promoted and advertised," he said.
"As more and more drugs come off patent, and there's a new market for them to sell over the counter with safety and efficacy, the trend will only accelerate," said Clark of K-VA-T.
Some pharmacists believe statins, or cholesterol-lowering drugs such as Lipitor and Crestor, will be the next big over-the-counter switch. Great Britain recently moved some low-dosage statins to OTC, and it could happen in this country as early as this year. However, pharmacists interviewed by SN during the Food Marketing Institute Pharmacy Conference held this month in Chicago were concerned that this changeover might be moving too fast.
"I question whether the statins ever will go OTC," said a pharmacy director with a Northeastern retailer who asked not to be identified. "There are too many side effects associated with them. But as we can see with the Medicare bill and other things, the push is to reduce drug costs in the U.S. So there's a lot of heavy pushing on the Food and Drug Administration to allow statins to go OTC, especially from employer groups that pay hundreds of dollars for them."
Statins have been linked to liver problems and muscle weakness, noted John Beckner, director of pharmacy and health services, Ukrop's Super Markets, Richmond, Va. "I've got stronger concerns about the statins than I do about the Prilosecs and the Claritins," he said. However, Beckner predicted they will probably go over the counter, although "I think it's going to be delayed because of those concerns."
David Meador, director of pharmacy, Dierbergs Markets, Chesterfield, Mo., said of statins going OTC: "I don't know if that's a good idea. There are a lot of side effects for some of those products, and if they are not monitored, people might use them incorrectly. Of course, that gives pharmacists a chance to do a little more one-on-one with the patients."
"There has been a push to take the statin drugs OTC, but I think there's going to be some concern there," said Mike LeBlanc, pharmacy business development manager, Winn-Dixie Stores, Jacksonville, Fla. Drugs that don't require as much intervention and management by physicians, such as the non-sedating antihistamines, are more likely to go OTC before statins. Muscle relaxants might also be switched, he said.
Yet the combination of publicity over high cholesterol levels and the push by manufacturers, pharmacy benefit managers and insurers to cut costs make the OTC switch of statins a "slam dunk," said Glenn Hausfater, managing director, Partners in Loyalty Marketing, Chicago. "In the next year to 18 months, you are going to see a lot of emphasis on driving down cholesterol levels," he said.
While pharmacy executives see Rx to over-the-counter switches cutting into prescription business, they have as much of an impact on existing OTC products, said Carol Hill, retail services, Homescan specialist, ACNielsen, Schaumburg, Ill.
For example, among the households that switched to Prilosec, about 54% of the volume came from prescription gastrointestinal medicines, while the rest came from OTC products, she told a seminar at the Food Marketing Institute Pharmacy Conference, which was co-located with the FMI show held this month in Chicago.
"Although this represents more than 50% of the pie, the Rx business did not get hit disproportionately while the OTC side did, and its share probably declined a little bit more than anticipated," Hill said.
As long as drug manufacturers keep developing new products, "there will be another blockbuster drug to replace the statins or any other therapy that goes OTC for us," said a pharmacy director with a Northeastern retailer who asked to not be identified. "So, I don't see that really affecting our pharmacy business."
On balance, Rx-to-OTC switches are good for retailers because they grow the category, said Glenn Hausfater, managing director, Partners in Loyalty Marketing, Chicago. The switches also move customers from prescriptions, which are tend to be lower profit because of managed care, to a higher margin item, he noted.
"What this means to retailers is you have to be prepared, and not just on the pharmacy side of your business," Hill said. "You have to be prepared in everything from shelf allocation decisions to what is being presented to category managers by manufacturers, and be prepared with promotions and advertising."