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Now Available Without a Prescription

For those who yearn to break their cigarette addiction but don't fancy a trip to the doctor's office, the ability to get the nicotine patch without a physician's prescription may be just what the doctor ordered.

Until less than a year ago, the nicotine patch was available by prescription (Rx) only. In July 1996, the Food and Drug Administration approved the "switch" of the Nicotrol patch to over-the-counter (OTC) status, following on the heels of a February 1996 switch of another stop-smoking aid containing nicotine, Nicorette gum. Then, on Aug. 2, FDA approved the switch of a second nicotine patch, Nicoderm CQ.

The patch and gum join more than 600 other OTC drugs that, according to the Nonprescription Drug Manufacturers Association, would have required a prescription only 20 years ago. The 600-plus products are now available without a prescription because FDA, in cooperation with panels of outside experts, determined they could be used safely and effectively without a doctor's supervision.

In the last year and a half alone, FDA has given OTC approval to drugs with such household names as Children's Advil and Children's Motrin (ibuprofen), Orudis KT (ketoprofen) and Actron (naproxen sodium), for pain relief and fever reduction; Femstat 3 (butoconazole nitrate) for vaginal yeast infection; Pepcid AC (famotidine), Tagamet HB (cimetidine), Zantac 75 (ranitidine hydrochloride), and Axid AR (nizatidine), for heartburn; and Rogaine (minoxidil) for hair growth.

Over-the-counter switches provide increased access to effective drugs. Eighty-five percent of Americans feel it is important to have OTC medications available to relieve minor medical problems, according to a 1992 Heller Research Group study of "Self Medication in the '90s: Practices and Perceptions."

"There is an important trend toward consumer participation in their own health care," says Debra Bowen, M.D., director of FDA's division of over-the-counter drug products. "It's part of our mission to keep up with the consumers' wish to be more involved."

Switches have a huge impact on the health-care economy. The greater availability of medicines over the counter saves approximately $20 billion each year, according to the 1995 Physicians' Desk Reference for Nonprescription Drugs, a book of drug information published annually by Medical Economics in cooperation with drug manufacturers. The $20 billion takes into account prescription costs, doctor visits, lost time from work, insurance costs, and travel.

The Switch Process

The original Federal Food, Drug, and Cosmetic Act of 1938 made no clear-cut distinction between Rx and OTC drugs. The 1951 Durham-Humphrey amendments to the act set up specific standards for classification.

The amendment requires that drugs that cannot be used safely without professional supervision be dispensed only by prescription. Such drugs may be deemed unsafe for nonprescription use because they are habit-forming or toxic, have too great a potential for harmful effects, or are for medical conditions that can't be readily self-diagnosed.

All other drugs can be sold OTC. A drug must be made available without a prescription if, by following the labeling, consumers can use it safely and effectively without professional guidance.

Some drugs are approved initially as OTC drugs. More often, though, medications are first approved Rx and later switched. "While a product is available by prescription, we can learn about the drug's safety profile in a much more controlled environment," Bowen says.

Drugs are commonly switched one of two ways: under the "OTC drug review," or by a manufacturer's submission of additional information to the original drug application.

The OTC drug review is an ongoing assessment by panels of nongovernment experts of the effectiveness of all drugs approved before 1962, before proof of efficacy was a requirement. The panels also review prescription ingredients to determine if some are appropriate for OTC marketing. About 40 former prescription-only drug ingredients have been switched by this process.

The second common path to OTC approval is submission of data to FDA (almost always by a manufacturer) showing the drug is appropriate for self-administration. Often the submission includes studies showing that the product's labeling can be read, understood and followed by the consumer without the guidance of a health-care provider. FDA reviews the new data, along with any information known about the drug from its prescription use.

In almost every case, the agency has sought the recommendation of a joint advisory committee made up of members of the agency's Nonprescription Drugs Advisory Committee and another advisory committee with expertise in the type of drug being considered. For example, because Rogaine is for conditions of the hair and scalp, representatives of the Dermatologic and Ophthalmic Drugs Advisory Committee participated.

While not bound by the advisory committee's counsel, FDA almost always follows its recommendation.

According to data from the Nonprescription Drug Manufacturers Association (illustrated in a 52K PDF file), the cumulative number of drugs switched from prescription-only to OTC availability by FDA on a yearly basis is:
1976: 6; 1977: 6; 1978: 7; 1979: 9; 1980: 16; 1981: 19; 1982: 27; 1983: 28; 1984: 29; 1985: 33; 1986: 35; 1987: 40; 1988: 41: 1989: 43; 1990: 45; 1991: 48; 1992: 51; 1993: 51; 1994: 54; 1995: 60; 1996: 65 (this is the total as of Sept. 15, 1996).

Benefit-Risk Comparison

When considering an Rx-to-OTC switch, the key question for FDA is whether patients alone can achieve the desired medical result without endangering their safety.

No drug is absolutely safe. There are risks associated with every medication, so FDA does a benefit-to-risk comparison to determine whether it is appropriate for consumers to self-medicate with a drug for a certain use.

On the safety side, the agency looks at the drug's toxicity--its potential for poisonous effects--when the drug is used according to its labeled directions, and also from foreseeable misuse of the drug.

While misuse by some consumers is inevitable--some people may overmedicate on the mistaken assumption that more is better--the Heller study showed that consumers appreciate the risks of taking any drug. Ninety percent of those surveyed said medications should be used only when absolutely necessary. Seventy percent said they prefer to fight symptoms without any medication.

FDA weighs a drug's safety against its benefit to patients. The agency considers whether consumers will be able to understand and follow label directions, whether patients can diagnose the condition themselves--or at least recognize the symptoms they want to treat--and whether routine medical examinations or laboratory tests are required for continued safe use of a drug.

No easy risk-benefit formula exists. FDA does a case-by-case review of each drug. Recently, the agency considered OTC switch applications for two very different drugs--Rogaine for hair growth and the nicotine patch for smoking cessation. Each raised unique issues, yet the risk-benefit comparison led FDA to the same conclusions in the two assessments--over-the-counter status is appropriate. (See accompanying articles.)

Concerns about side effects can sometimes be managed by approving OTC drugs at lower doses than their prescription counterparts. The drugs must still be effective for the short-term symptoms for which they're intended.

The issue of whether a condition can be self-diagnosed was a central one for the Rogaine advisory committee. Most OTC drugs are intended for treatment of symptoms that can be easily recognized, like headache or upset stomach. Others, though, are intended to treat diseases like asthma or vaginal fungal infections, which cannot be consumer-diagnosed.

Consumer-Friendly Labeling

Labeling is an influential element in the OTC risk-benefit comparison. The decision about a drug's safety for OTC use can't be made in a vacuum, by looking only at the drug ingredients. Every drug, used improperly, can cause adverse reactions. Even appropriate use can lead to side effects (antihistamine use may cause drowsiness, for example). And some drugs can be dangerously unsafe or ineffective if taken while using certain other drugs.

Labeling can alert consumers to such potential problems. Labeling of all drugs must be clear and truthful. For OTC drugs, the intended uses, directions and warnings have to be written so consumers, including individuals with low reading comprehension, can understand them.

FDA is working with the pharmaceutical industry to increase the readability of OTC labels by making the language more consumer-friendly and standardizing the format, including where important information is placed.

In some cases, Bowen says, consumers can get more information in the OTC labeling than they would get from their doctors. "For the nicotine patch, we developed a package--a package containing not only a drug that relieves withdrawal symptoms, but also behavioral modification information. The package provides an element of support that studies showed some people weren't getting from their doctors, by telling them when they'll most likely feel the urge to smoke, what they can do in place of smoking, and where they can go for support."

A Popular Alternative

Under the law, OTC drugs may be advertised directly to consumers without the many restrictions placed on Rx products. OTC status provides a greater opportunity for direct communication with the consumer, not only by advertising in magazines and on television, but also with packaging, brochures, and retail displays.

Nicorette gum magazine ads announce, "Nicorette Gum Is Now Available Full Strength Without A Prescription. Hallelujah!" "Hallelujah" may be the victory cry for those who, with the aid of OTC nicotine gum, were able to beat the cravings. But consumers aren't the only ones with something to gain from Rx-to-OTC switches.

Some manufacturers are exclaiming "Hallelujah" as well, over profits gained from direct access to millions of consumers. Pepcid AC for heartburn, for example, had sales topping $200 million in the first year after the product's April 1995 switch approval, making it the most profitable switch to date.

Today's emphasis on self-care fuels the popularity of nonprescription drugs. But OTC products are intended to supplement the medical options of the consumer, not substitute for a prescriber's medical knowledge. If a health problem persists or worsens while using an OTC drug, consult a health-care provider.

"People must be in a partnership with their health-care providers for optimal health," Bowen says. "Many situations aren't appropriate for self-treatment, and others may require professional guidance for self-treatment."

If you do choose OTC treatment, heed Bowen's warning: "Drugs aren't candy; they aren't risk-free. You have to follow the label and take appropriate responsibility for your own self-care."

Tamar Nordenberg is a staff writer for FDA Consumer.

9-0 Vote for OTC Nicotrol

It received an advisory committee's unanimous recommendation for a prescription-to-OTC switch on April 19, 1996. Worn for 16 hours a day, the patch reduces nicotine cravings by providing a constant, controlled flow of nicotine into the bloodstream.

The committee concluded that the benefits of the stop-smoking aid outweigh its risks, but only after considering manufacturer McNeil Consumer Products' proposed labeling and marketing plans, and the company's studies comparing quit rates for OTC and prescription patches.

The company presented data showing that prescription and OTC patch users achieved similar quit rates (19 percent of OTC users abstained in weeks 2 through 6, versus 16.6 percent of Rx users) and experienced no serious adverse reactions.

McNeil demonstrated that smokers understood the proposed labeling, including the warning not to smoke while using the patch and directions on how to apply and remove the patch. According to the company, more than 80 percent of consumers used the behavioral modification materials, including handbooks, an audiotape, and toll-free help-line.

The committee was told that abuse was not expected to be a problem, especially for adults. The patches are not to be sold to minors and will not be distributed through vending machines. Advertising will be targeted to adults.

FDA agreed that the benefits of the patch--an increased chance for people to quit smoking--outweighed any slight risks, and approved the product for OTC sale last July 3. The OTC patches became available in retail stores July 18.

--T.N.

12-4 Vote for OTC Rogaine

This wasn't the first time an FDA advisory committee had considered the switch. A July 1994 meeting ended in a 10-to-4 vote against OTC availability. Ten of fourteen advisory committee members weren't convinced that the benefit of Rogaine outweighed the drug's risks. Mainly, the committee was concerned that consumers would misdiagnose their hair-loss problem, and in some cases dangerously delay needed treatment.

To address this issue, Rogaine's manufacturer, Pharmacia & Upjohn, conducted six studies to see whether consumers could understand the labeling and determine if they had the common hereditary hair loss for which the product is intended. The studies showed, to the second committee's satisfaction, that consumers could self-diagnose their condition and comprehend the directions and other labeling information.

Upjohn also previewed the marketing campaign for the committee. The television ads, the company said, would be designed to educate consumers about whether the product is right for them. A toll-free number for consumers and an educational brochure at the place of purchase would be available, too.

The brochure graphically depicts the hair loss at the top of the head for which the drug is most effective. It states, in bold lettering, "If you have no family history of gradual thinning hair or hair loss, or if you are unsure of the cause of your hair loss, talk to your doctor."

The second time, members voted 12-to-4 in favor of the switch. Following the committee's recommendation, FDA approved OTC Rogaine on Feb. 9, 1996.

The product, which has been marketed since 1988 and used by over 3 million people, is now available over the counter.

--T.N.