Consumers’ Rx: Fewer Prescription Drugs : Health: The trend to make more medicines available over-the-counter is expected to accelerate with the pressure to reduce care costs.

As the trend toward self-medication accelerates and pharmaceutical companies seek to breathe life into aging products, consumers can expect to see more drugs previously available only by prescription for sale over-the-counter.

Several important drugs are awaiting Food and Drug Administration approval for over-the-counter sales. Among them are versions of Tagamet, SmithKline Beecham’s ulcer drug, Burroughs Wellcome’s herpes drug Zovirax, and Syntex’s Anaprox, a pain reliever.

For drug companies, so-called “switching” is a way to boost revenues, since over-the-counter sales often exceed the revenue the drug generated as a prescription medicine. It is thought that switching could help drug companies in an increasingly competitive market.

Last year, retail sales of drugs based on ingredients whose status had switched from prescription to over-the-counter totaled $3.3 billion, says FIND-SVP Inc., a New York research concern. By 1998, however, it predicts that figure will burgeon to $7.3 billion.

To successfully switch a drug, pharmaceutical companies must prove any misuse will not endanger consumers’ health. If the companies are also able to convince regulators that people can make the related diagnoses and follow clear-cut package directions, the public probably will be able to buy everything from hair-loss treatments to anti-smoking gum without having to visit a doctor.

For the drug companies, switch drugs are virtually guaranteed successes. Fourteen of the 15 best-selling over-the-counter drugs introduced since 1975 were switches or switch-related, said Arthur Rosen, an executive vice president with the health care advertising firm Sudler & Hennessey.

Consumers perceive them to be better because they have an “ethical heritage,” he said. “They are associated with office visits, memories of doctors prescribing them. Without exception there is an assumption that they are more effective.”

“It’s a very positive trend for the consumer,” said Frank Rathbun, spokesman for the Nonprescription Drug Manufacturers Assn. “And in the context of the health-care reform debate, what’s being discussed is cost and access. Non-prescription medicines offer solutions to both issues.”

Besides consumers’ appreciating the convenience of over-the-counter drugs, insurers and other third-party payers such as health maintenance organizations like them “because they no longer have to cover the medicine” as a prescription drug, said Albert Wertheimer, a vice president with First Health Services Corp., a health care concern in Glen Allen, Va.

In other countries, more than 30 drugs are available over-the-counter that still require prescriptions in the United States. However, in this country today, more than 400 over-the-counter products use ingredients or dosages that had been available only by prescription 15 years ago. The most successful switch to date has been Advil, a pain reliever whose active ingredient is ibuprofen. Advil wholesale sales for last year totaled $320 million.

“A lot boils down to being first,” said Sharon Wagoner, an analyst with Argus Research Corp.

Schering-Plough, for example, was able to dominate a new $400-million over-the-counter market for vaginal yeast infection treatments. As a prescription medication, Gyne-Lotrimin had many competitors and therefore commanded only about 8% of its market. In 1991, it became the first such treatment available without a prescription--narrowly beating Johnson & Johnson’s Monistat 7 to market. Gyne-Lotrimin’s annual sales surged above $100 million, more than four times what its prescription sales had been.

SmithKline envisions a huge new market for Tagamet. The drug in its prescription strength is for ulcers, but an over-the-counter version would be marketed as a treatment for heartburn, which afflicts about 25 million Americans daily. “This is a whole additional market,” spokesman Jeremy Heimfeld said, “and it’s a big market.”

Several over-the-counter drugs are intended for recurrent problems initially diagnosed by a doctor.

“Consumers have grown very knowledgeable about the drugs they take, and that has changed dramatically over the past few years,” said Neil Sweig, an analyst with Ladenburg, Thalmann & Co. “It’s been accelerated by the fact that the FDA is allowing TV advertising of prescription drugs.”

Drug makers can seek approval to switch a drug at any time, but the decision is usually related to a drug’s patent. “Switching extends the life of a product when patent protection is about to expire,” Wagoner said. Tagamet’s patent, for example, is due to expire in May, making it available for companies to copy.

For years pharmaceutical companies were able to maintain drug prices--or even raise them--when a patent expired, since doctors did not alter their prescribing habits and had no incentive to choose lower-priced alternatives.

But with the emphasis on cost-containment spurred by managed care, many doctors are often required to substitute generics for name-brands whenever possible. Consequently, some industry experts say drug makers will have to slash prices on name-brand prescription medications if they want to maintain market share. Naturally, generics pose a threat to the profitability of prescription drugs--they cut as much as 40% of a brand-name drug’s market.

When it comes to over-the-counter medications, consumers are far less aware of generic alternatives. “Consumers believe it is a lot safer to use an established brand” rather than a generic, Wertheimer said.

The cost of introducing a drug to consumers is extremely high, Ladenburg’s Sweig said, requiring “marketing partners with very deep pockets who already know the consumer marketing side.”

That’s why drug makers sometimes collaborate with major consumer products companies. Syntex, for example, will work with Procter & Gamble in introducing an over-the-counter version of Anaprox.

Another factor is that marketing to doctors is difficult and expensive, often requiring one-on-one pitches from salespeople.

“You have to convince a very tough audience--300,000 or 400,000 doctors,” Wertheimer said. “It’s much more fun and successful to go directly to the public, who oftentimes have less education, are less discerning and more moved by snazzy advertising.”

Some drugs, however, will not be candidates for a switch.

Take oral contraceptives. Earlier this year, the FDA canceled a meeting to open a discussion about possible over-the-counter status for birth control pills.

“Here’s a product that’s been on the market since the ‘60s, it’s used by millions of women, and it works,” Wertheimer said. “But there’s the argument that it’s good to have a pelvic exam once a year.”