Recent controversies over prescription medicines may result in a slower pace in switching drugs to over-the-counter status, supermarket pharmacy executives told SN.
Because of the increased scrutiny given drugs in the COX-2 class of nonsteroidal anti-inflammatory drugs, such as Vioxx, Celebrex and Bextra, the U.S. Food and Drug Administration is likely to be more careful in approving OTC switches. For example, the anti-cholesterol drugs known as statins, although long mentioned as candidates for OTC status, are now unlikely to be switched because of the need for monitoring by a physician, many of the pharmacy executives said when interviewed during a recent Food Marketing Institute conference.
Last fall, Merck & Co., Whitehouse Station, N.J., withdrew Vioxx from the market, citing cardiovascular risks. The FDA later found Vioxx safe, but asked Pfizer, New York, to withdraw Bextra. The FDA has allowed Pfizer's Celebrex to remain on the market with stronger labeling.
Following the controversy over the COX-2 (short for cyclooxygenase) drugs, the FDA has recommended more restrictive warnings on related OTC products, noted Michele Snider, director of pharmacy, Save Mart Supermarkets, Modesto, Calif. "So, I think the government is going to look very, very closely before they release anything over the counter. I think there definitely will be a slowdown," she said.
"It is going to be a very slow process, and rightly so," said John Fegan, senior vice president, pharmacy, Ahold USA, Braintree, Mass. "Because of what's happened, there will not be a rush to get things out quicker than in the past. There will be lots of studies."
When it comes to Rx-to-OTC switches, the FDA is likely to review "down to the minute detail why, what benefit, how do you manage it, who's involved with it -- meaning the pharmacists, doctors -- and how do you monitor the ultimate results of having a product go to OTC," Fegan said.
"You are seeing the FDA getting a little more conservative in what they are doing," said Don Clark, director of pharmacy operations, K-VA-T Food Stores, Abingdon, Va. "They will just be a little more cautious in what they allow to go over the counter, and that's not necessarily a bad thing."
That is likely to slow down the movement to change statins to OTC status, he said. "That might be by design. They may have drawn the line in the sand with the COX-2s because they knew the statins were on the horizon." There may be greater concern over statins than the pain medications because OTC switches take into consideration whether the condition is treatable without a doctor, "and I'm not sure they are ready to say that something like cholesterol is able to be treated without a physician," Clarke said.
Statins have gone OTC in England, Snider noted, but "I don't think we're going to see it happen anytime soon [in the United States]. There are a lot of warnings on those drugs, a lot of side effects and interactions, and that also will slow down the process," she said.
There were many questions about the statins to begin with, noted John Beckner, director of pharmacy and health services, Ukrop's Super Markets, Richmond, Va. "Even if you are taking them correctly, you could have liver problems." The COX-2 controversy has had "a definite impact on the move of statins to over the counter," he said.
Besides slowing the pace of OTC switches, the controversy over COX-2 drugs will result in patients relying more on their pharmacist, Beckner said.
"The FDA is now requesting that the labeling be changed on OTC products. More and more, you are going to see consumers asking for professional advice and opinions from the pharmacist on over-the-counter products. That's going to raise the importance of the pharmacist's role in recommending over-the-counter products," Beckner said.
Concern over the COX-2 products, including worries about COX-1 drugs already switched to OTC status like naproxen, may boost the sales of natural products like glucosamine, he said.
"There's no question that everybody is more sensitive about the side effects of medications because it is in the public eye today. Everybody is talking about it," said Edward Saba, vice president, pharmacy, Bashas', Chandler, Ariz.
However, he does not see the pace of Rx-to-OTC switches slowing. "The manufacturers want to get them to the OTC area because they get better sales from that. I don't see that is going to slow up very much," he said.
Once drugs are going off-patent, drug manufacturers have a strong incentive to get them switched to OTC status, something that also benefits retailers and consumers, said Roy White, vice president, education, General Merchandise Distributors Council Educational Foundation, New York.
However, "all the low-hanging fruit, so to speak -- the uncomplicated medicines that disappear from your system after a day or so -- are gone. They have already been switched," he said.
The controversy over the COX-2 drugs is actually an indication that the FDA's system is working, said Verne Mounts, director of pharmacy, Buehler Food Markets, Wooster, Ohio. "I wouldn't want to make any drastic changes to it."
The COX-2 situation was "unfortunate," he added, because "it was an excellent class of medications."
Prescription drugs that have been on the market longer with a good safety track record probably will not be held back from going OTC because of the COX-2 issue, said Mike LeBlanc, director of pharmacy business development, Winn-Dixie Stores, Jacksonville, Fla. "Good science will allow those drugs to go out."
While there will be some delays now in switching medications to OTC, "generally, there are a number of drugs that are probably very safe and effective that can be sold without a prescription," said Curtis Hartin, director of pharmacy, Schnuck Markets, St. Louis. Considering the COX-2 problem, "it would be prudent for FDA to slow down just a little bit" on the pace of OTC switches, he said.
Plan B's OTC Outlook
The outlook for the emergency contraceptive product, also known as the "morning after pill," making the switch from prescription to over the counter is very uncertain, said Susan Bishop, associate director, regulatory affairs, American Pharmacists Association, Washington. "It's anyone's guess what is going to happen."
About a year ago, the U.S. Food and Drug Administration rejected the recommendation of its advisers and decided to keep Plan B, or Levonorgestrel, a high-dosage contraceptive from Barr Laboratories, Woodcliff Lake, N.J., a prescription item. More research was needed on whether the product was safe for girls under age 16, the FDA said.
The FDA is currently reviewing Barr's application to move Plan B over the counter, Bishop said. "There have been a lot of reports of pressure being applied to the FDA to come out with that decision. Obviously, they are getting pressure from groups asking them to make the decision to move it over the counter. They are also getting some pressure from other groups that are asking the FDA not to allow it to move over the counter, to keep it a prescription item. They are getting pressure from all sides, including from Congress currently," she said.
"It has been recommended by FDA's panel of experts that it be allowed to go over the counter," said Michele Snider, director of pharmacy, Save Mart Supermarkets, Modesto, Calif. "I'm really not sure what is going to happen."
People feel very strongly on both sides of the Plan B debate, noted Don Clark, director of pharmacy operations, K-VA-T Food Stores, Abingdon, Va., "but I can also see from the type of medication it is that it is very important that it be prescribed and monitored by some kind of a caregiver."
It has been proposed that Plan B be sold by pharmacists from behind the pharmacy counter without a prescription as a third category of drug between prescription and OTC, according to media reports.
-- Dan Alaimo
Aging Population Drives OTCs
Rx-to-OTC growth is fueled by a number of factors, not the least of which is consumer interest, said presenters at the recent Food Marketing Institute show in Chicago. However, an aging population, combined with a trend toward self-treatment, has helped drive the recent strong growth in the OTC market, they said.
By 2030, there will be 71 million people over the age of 65, according to U.S. Census data. Today, about 12% of the population is over 65, and that segment will grow to 20% by 2030, said Jim Hertel, senior vice president, Willard Bishop Consulting, Barrington, Ill., at the show.
Prevention Magazine's "13th Annual Shopping for Health Survey" showed that 70% of shoppers agree that they have become more likely in the past year to treat themselves before seeking the input of a doctor.
There is good news for supermarkets in that 32% of consumers rate grocery stores as doing the best job of providing products that help them maintain good health, the survey revealed. However, the bad news is that figure has dropped 10 points since 2000, Hertel said.
What's important is that the key to good health has always been a combination of pharmaceuticals, the pharmacist's advice, and the ability to sell both food and OTC medications to consumers -- the complete picture, Hertel said.
"Treating the whole consumer is critically important," he said.
As supermarkets start to see challenges to their dominance in this area, pricing, merchandising, communication and how retailers navigate the Rx-to-OTC launch process become increasingly important, added Jon Hauptman, vice president, Willard Bishop Consulting.
"The more items that go over the counter, the more opportunity I have to be part of that patient's care," said Michael Halliwell, director of pharmacy and whole health, Ball's Food Stores, Kansas City, Kan. "So, I am in favor of OTC switches when they are justified and when they are safe, and when the benefits outweigh the risks."
"We have done very well on some of the initial rollouts in OTC. We've been very successful," said Steve McCann, director of pharmacy operations, Supervalu, Eden Prairie, Minn. "There is decreased prescription volume, but we will still capture that over the counter and even expand it more."