Both pharmacists and consumers are paying increasing attention to the use of some OTCs as a solution to the Medicare Part D "coverage gap," according to Timothy L. Tucker, president-elect of the American Pharmacists Association.

The option of nonprescription drugs in certain classes has become more important to more people since the Medicare Part D prescription drug coverage program launched in 2006 (¹ Also see "Expensive Rx Drugs Put Spotlight On OTC Opportunity – Economist" - Pink Sheet, 2 April, 2007., p. 3).

In an interview with "The Tan Sheet" concerning the appropriate use of nonprescription products in lieu of Rx drugs, Tucker, a Huntingdon, Tenn., pharmacist, said pharmacists are generally getting more comfortable with this approach.

"I remember that first year when I was helping so many of my patients evaluate the medicines they were taking. Some of them asked me about over-the-counter alternatives and at the time I didn't think they were that necessary because most of us felt as though this program was going to cover the drugs our patients were taking."

"Through the first year we were all just trying to hold our breath to stay above water to learn how the system was working," Tucker said. "This year we've learned even more from that process and part of that is how do we help the patients not hit the coverage gap or stay out of the coverage gap. There are over-the-counter alternatives."

Part D clients have incentives to consider using OTCs when appropriate rather than buying prescription drugs, adding to their total annual costs in the program and getting closer to the "coverage gap," when their prescription costs are not covered.

"Over-the-counter alternatives seem to have taken even a more important focus as we have patients that may be taking the more expensive brand drugs, which are great drugs and there's nothing wrong with them. But when these senior patients are concerned about the amount of money that they're spending or about reaching the coverage gap too soon, we're encouraging patients to visit with their physicians and their pharmacists to see if there are" OTC options, Tucker said.

"It may be a little money out of pocket when they buy those medicines over the counter, but at the same time it doesn't apply toward their Medicare Part D spend. Therefore, they don't reach that coverage gap as soon or may potentially stay completely out of the coverage gap."

The importance of an OTC option for his patients is clear to Tucker. "I have so many patients now that can take their medicines and not have to decide whether they were going to eat this month or buy their medication," he said.

However, there are no appropriate OTC alternatives for some conditions, and some Part D clients do not have the option of buying nonprescription drugs to avoid driving up their program costs.

"It's a real challenge because each patient is very individual and that's something not a lot of people understand," Tucker said.

Like OTC drugs, dietary supplements now have a higher priority with some of Tucker's patients who are Part D clients.

"They've taken a proactive stand. I have seen that increase. That's part of this process. We've got to get the patient to believe in their total health care. For so long they've expected the doctor and the pharmacist to just take care of them. We do need to take care of them, but each one also needs to understand it is their responsibility to take their medicine every day and to keep their doctor's appointment and to take their vitamins every day. It doesn't work if you don't take it," Tucker said.

New Products, New Roles For Pharmacists

FDA's interest in fostering behind-the-counter switches and innovative solutions for switches of drugs that may require more complex risk management approaches than the traditional OTC sales model could open up opportunities for more products that could help bridge the coverage gap.

The agency has scheduled a public meeting Nov. 14 for comments generally on why there should or should not be behind-the-counter availability of certain drugs. FDA specifically asks about the possible duties for pharmacists in dispensing behind-the-counter drugs, including whether they should be reimbursed for performing additional duties (see story, p. 3).

Tucker, also a member of the APhA board, said giving pharmacists more authority to advise consumers on medications would facilitate making more drugs available as nonprescription products.

"There are several areas that I think the FDA is probably very comfortable with putting over the counter, but in our environment today some people are very much against that third class of drug or that pharmacy-only class of drugs," he said.

"But I hope as a pharmacist that that's where you see it going because there are a lot of patients that I can treat with very simple medications to treat simple issues that they have and make them feel a lot better. If it doesn't get better, then it's my job to send them to a physician."

"There is a lot of discussion about how we would be paid to take care of those patients. I think part of that is increasing the demand by the patient and also increasing the expectation from the pharmacist."

"There would be high expectations for the pharmacist community, but we also need to increase the expectations for the public of what they demand from pharmacists," he said. "However, the FDA would have to have requirements that the pharmacist would need to be knowledgeable and ready to lend their assistance to the patient if they come and make those requests."

Statins At The Center

Cholesterol-lowering drugs are at the center of the debate over the behind-the-counter sales model for switches, and Tucker is among those who question whether statins are appropriate candidates for over-the-counter sales, although he supports moving more drugs from prescription to nonprescription status.

Bayer, which holds the OTC rights for Bristol-Myers Squibb's Pravachol (pravastatin), is pursuing an active program to switch the drug to OTC, and the Johnson & Johnson/Merck joint venture is still seeking a switch for Merck's Mevacor (lovastatin).

The FDA advisory panels in 2005 recommended against approving switches for those products, but several members said the drugs were good candidates for behind-the-counter status, although the agency at that time had yet to assign the status to any products (² Also see "Mevacor OTC Panel Rejection Elicits Third Drug Class Talk" - Pink Sheet, 17 January, 2005., p. 3).

Since then, FDA approved switching Barr's Plan B emergency contraceptive to nonprescription status but available only through behind-the-counter sales by pharmacists to consumers 18 years of age and up (³ Also see "Plan B Pioneers OTC “Pharmacy Counter” Approval, Dual-Status Marketing" - Pink Sheet, 28 August, 2006., p. 3).

FDA is likely to revisit statins in the near future.

A joint meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee and its Nonprescription Drugs Advisory Committee is tentatively scheduled for Dec. 13 and 14.

While FDA will not discuss the planned topic until publishing a Federal Register notice announcing a confirmed meeting, the panel may be planning to consider the suitability of statins for OTC sales, as the panels previously did in 2005 and 2000 (⁴ 'The Tan Sheet' Sept. 17, 2007, In Brief).

Tucker said moving statins to OTC status could lead to unsafe usage by consumers, but behind-the-counter status would work.

"The statins are an issue where if we had somebody to monitor is the statin working and what is the level and are we really treating the cholesterol, then I think the statins would be a great idea," said Tucker, who will become association president in March 2008.

"But if a patient just wants to take a 10 mg and because they don't feel better then they're going to go to a 20, 40 or an 80, I'm not sure as a health care professional I think that's the best idea," he added.

Ads Help Create Consumer Habits

It appears most consumers are not in the habit of first considering OTCs for their health problems, he said. "I think most of us, whether we're 18 or whether we're 85, when we get sick we think we need a prescription from the doctor."

That thinking is generated in part from drug firms' advertising, but the industry's ad spending could be put to better use, Tucker added.

"When the drug manufacturers make a drug look so glamorous or so wonderful, every patient thinks they need that. That's not necessarily the case," he said.

"I think we spend a whole lot of money on direct-to-consumer advertising that might could have been better used in other areas, or even more importantly would have been better not spent and decreased the cost of the medication to the end user, the consumer."

- Malcolm Spicer (m.spicer@elsevier.com)

Pharmacists’ Regard Grows For OTCs As Rx Alternatives, APhA Officer Says

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