- The Washington Times - Sunday, January 20, 2002

Now available without a prescription.

Time was, Americans needed a doctor's prescription to wear a nicotine patch, settle heartburn or reverse hair loss. In the past two decades, though, some 700 drugs that once needed a prescription have been cleared to be sold over the counter.

That makes those drugs easier to get, not to mention cheaper to buy.

Buying off the shelf saves consumers an average of $20 billion annually in health care costs, says Bill Soller, senior vice president and director of science and technology for the Consumer Healthcare Products Association (CHPA), the trade organization for over-the-counter drug products.

Self-medicating means that those who do not have access to health care can treat themselves for common ailments. It also means that the Food and Drug Administration, the federal agency that reviews whether drugs can make the switch, sees today's consumers as smart enough to know what ails them and literate enough to read a package label.

"Over the past 10 or 15 years, consumers have become much more educated and informed," says Dr. Linda Katz, deputy director of the FDA's Over-the-Counter (OTC) Drug Division. "Consumers are more interested in being engaged in their health care process."

The estimated $19.1 billion that Americans spent on OTC drugs in 2000 doesn't mean fewer people are taking prescriptions. Americans also spent $132 billion on prescriptions the same year, about double what they spent a decade ago and a 20 percent increase from 1999.

Part of that dollar increase has to do with the rise in costs of prescription medication, but also with the increase in the number of products on the market. The recent jump also can be traced to aggressive direct-to-consumer marketing. A recent study by the National Institute for Health Care Management Foundation, a nonprofit research group, found that heavily advertised drugs such as Lipitor (for cholesterol), Celebrex (arthritis), Prevacid (ulcers), Vioxx (arthritis) and Glucophage (diabetes) accounted for one-fifth of the rise in sales.

Still, the CHPA reports that 77 percent of Americans take at least one over-the-counter drug. In a CHPA survey of 1,505 consumers, half said they would take other OTCs if it meant they could treat their own diabetes, cholesterol and high blood pressure.

"Clearly, there is an enormous potential upside to consumers having drugs available over the counter," says Dr. Eric Brass, a professor of medicine at the University of California at Los Angeles and the former chairman of the FDA's nonprescription drug committee. "If safe and effective drugs are available, it means you do not have to go to the doctor, and it means the segment of people with no health care coverage have more drugs available to them."

But just because OTC drugs are self-service, it does not mean they are harmless. The downside of millions of Americans taking charge of their health care is the risk of overmedicating, mixing medications that can cause side effects or misdiagnosing the problem.

Consumers still need to read labels and follow up with a physician if symptoms persist, says Dr. Lynn McPherson, associate professor of pharmacy at the University of Maryland's School of Pharmacy in Baltimore.

"There are a lot of drugs that can interact with one another," Dr. McPherson says. "It is still a good idea to check with a pharmacist, particularly for older adults who may be taking several medications at the same time."

The FDA has strict criteria as to what can be sold over the counter and what can not. The 1951 Durham-Humphrey Amendment still sets the standard for the organization today. The Durham-Humphrey states that drugs that cannot be used safely without professional supervision, that are habit-forming, have potential harmful side effects or are for conditions that cannot be readily self-diagnosed must be sold by prescription. All others are eligible to be sold over the counter.

But while many drugs start out with the above criteria, many change to OTC status once they have been on the market a few years and have shown they are being safely used. Drug companies can petition the FDA for a review or submit additional information on the original drug application. Often, drugs made available over the counter are a lower dosage than the same product sold by prescription.

The FDA then determines whether patients alone can administer the drug without endangering their safety, Dr. Katz says. Since no drug is absolutely safe, the group does a benefit-to-risk comparison. It also looks at the drug's toxicity, both from recommended use and in case of potential misuse.

Those drugs that have made the switch have benefited both consumers and manufacturers. For instance, when the heartburn medicine Pepcid AC was approved for OTC sales in April 1995, its first-year sales topped $200 million. In the 1980s, when topical hydrocortisone (0.5 percent formula) was switched to OTC, sales of the dermatological medication went from $12 million to $88 million annually.

"There is great interest by the pharmaceutical companies in making certain drugs over the counter," Dr. Brass says. "There is an enormous upside for the consumer, as well, in having safe and effective drugs available and not having to take time off work to go to the doctor."

Self-medicating, however, can have drawbacks as well, says Dr. Brass, who recently wrote an article for the New England Journal of Medicine on the changing status of drugs.

"Self-administration relies on the patient's judgment, supplemented by the information on the label, for correct diagnosis of the disorder or symptoms," he says. "If the patient misdiagnoses himself, then the drug might not be effective."

Another risk is that a patient might put off seeing a doctor. That could be particularly dangerous when symptoms that seemed routine might be indicative of something more serious, Dr. Brass says.

Eventually, the increase in OTC drugs could lead to a change in the role of a physician, he says. Patients who self-medicate and misdiagnose may indeed be quite sick by the time they see their doctor. Other patients who do seek medical help may be disappointed if their doctor recommends an OTC drug when the patient was expecting a prescription.

There is also, of course, the risk of overmedicating. In 1999, however, the FDA changed its label standards, partly because of the large number of medications making the switch to OTC. The new OTC labels are easier to read and simpler to understand, with clear instructions on follow-up care and drug interactions.

"I believe the new labels are much more readable for consumers," Dr. Katz says. "Obviously, you want to know how much to take and the possible interactions, but the set format helps keep consumers better informed. Just because a drug is OTC doesn't mean there are not potential risks. Hopefully, consumers will understand that and take as directed."

A revolution at the drugstore

In the past several years, anti-inflammatory drugs such as ibuprofen and naproxen have made the jump. Smoking cessation aids such as nicotine patches and gums have gone to the other side of the counter. Hair-growth stimulants such as Minoxidil (sold as Rogaine) became more popular when sold alongside shampoos.

One of the greatest switches occurred when yeast-infection ointments were made available to women without a prescription, says Dr. Arthur Hull Hayes, chairman of the Council on Family Health, a consumer group that promotes safe use of medicine.

Mr. Soller of the CHPA says nicotine replacement has also had monumental impact.

"Making nicotine replacement available OTC has demonstrated what access can do to complement consumer empowerment," he says.

So what is next? As people are living longer with chronic conditions such as osteoporosis, heart disease, high cholesterol, hypertension and the need for hormone replacement therapy, Mr. Soller predicts those classes of drugs will be the next to make the switch to OTC.

"That could potentially save seniors a lot of money," he says.

The group of drugs known as statins, the cholesterol-lowering medications (sold under brand names such as Zocor, Pravachol and Lipitor, for instance), have been available by prescription for five years and could eventually make the move, along with an OTC cholesterol test-kit.

Birth-control pills, whose safety has increased during their four decades on the market, have also recently been discussed as an OTC option.

That is where the benefit analysis continues. There are social issues involved in dispensing birth control pills over the counter. There is also the concern that women on birth control pills would not see their physicians for checkups and pap smears as often, and that could lead to increased gynecological cancer rates, Dr. McPherson says.

The concern over inadequate care is a risk for those taking statins, as well.

"The question has been raised that if a patient takes OTC statins, will he stop getting input form his doctor?" Dr. Brass says. "A person with high cholesterol probably needs assessment and behavior modification, not just medication."

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