The good and bad of going over-the-counter
August 29, 2002 Posted: 12:27 PM EDT (1627 GMT)

WASHINGTON (AP) -- It sounds like an easy decision: Lift prescription restrictions on some widely used drugs so people can buy what they need without a note from their doctor.

But making that change turns out to be a complex process, balancing potential health benefits against possible dangers. And it's a decision that involves millions of dollars changing hands among the sometimes conflicting interests of consumers, drug makers and insurance companies.

Studies find many consumers want to treat themselves with nonprescription drugs when possible and an increasing number of drugs once available only with a doctor's approval now are jostling for shelf space in drug stores and supermarkets.

When a drug is switched to over-the-counter sales, the price usually comes down. But whether that's a good thing for users can depend on whether they have insurance.

Insurers generally don't cover nonprescription drugs so selling more of them that way is good for the industry, said Linda Simoni-Wastila, a pharmacy professor at the University of Maryland in Baltimore. "It can be bad policy for consumers, who absorb the entire cost of the drug."

And the use of such drugs without a doctor's oversight can mask medical complications, she added.

"It's a complicated issue that needs to be dealt with on a case-by-case basis," said Dr. Sidney Wolfe of Public Citizen Health Research Group.

Linda Golodner, president of National Consumers League, said consumers are taking a more active role in their health care, even self-diagnosing and medicating.

A survey commissioned by her group found that consumers generally like over-the-counter drugs and use them regularly to treat minor health conditions. But one-third of consumers don't regularly read the labels before purchasing or using them, she added.

According to a paper published by the American Academy of Family Physicians, nonprescription drugs account for about 60 percent of all drugs sold in the United States and are used to treat about 400 ailments.

Former prescription drugs now sold over the counter include painkillers Aleve, Motrin and Advil; heartburn drugs Zantac, Tagamet, Axid and Pepcid; and cold and allergy drugs Tavist-1 and Nasalcrom. Also on the list are the anti-fungal drugs Gyne-Lotrimin, Femstat and Monistat, baldness treatment Rogaine and smoking deterrents Nicotrol, NicoDerm and Nicorette.

Many more drugs could be considered for over-the-counter sale, such as the "morning after" pill that women need in a hurry to prevent pregnancy and vaginal "microbicides" that companies are developing to protect against the AIDS virus.

Lori R. Donnelly, author of the academy's paper and an Ohio pharmacist, said the transfer to over-the-counter from prescription generally lowers health care costs because patients are not going to doctors for simple remedies.

"Thus far I have viewed it as a good change," she said, but added that it might be a problem if drugs requiring more involved dosage and monitoring were taken off prescription.

Simoni-Wastila worries that serious problems won't be caught.

For example, she said many women rely on nonprescription antifungal products to self-treat vaginal yeast infections, but they may be the wrong medicine for the particular organisms.

The switch can have positive results, too. Take, for example, the nicotine patch and gum to help people quit smoking.

In 1996 the products became available over the counter and about 6 million people used them, double the sales of the year before. Within two years it was 9 million.

The primary concerns when the Food and Drug Administration is considering approving the change are that the drug is used for a condition that the consumer can easily diagnose and monitor and it has low toxicity and little potential for abuse.

Wolfe stressed that with many drugs it is important to see a doctor to make sure that the illness is what the patient thinks it is, and that the right drug is being chosen. And, in many cases, the progress of the condition needs to be monitored.

The heartburn drug Prilosec is an example.

The pill is hugely popular and the FDA is considering taking it off prescription at the request of manufacturer AstraZeneca, which hopes to make it a success in the over-the-counter market.

"Heartburn is one of those conditions that when you have it, you know you have it," said Golodner of the Consumers League. "Therefore, we feel that consumers can adequately self-diagnose this condition."

An FDA advisory committee agreed, but had reservations, insisting on strong warnings and explanations pointing out that it isn't just another pill to pop after eating too many spicy meatballs.

Two years ago an FDA advisory committee recommended against allowing nonprescription sales of powerful cholesterol-lowering drugs known as statins out of concern that consumers don't understand cholesterol well enough to self-medicate.