Smoking cessation success equally good with over-the-counter or prescription nicotine replacement

April 26, 2002

Pittsburgh, PA, April 26, 2002 -- Nicotine replacement therapies (NRT), such as a skin patch or gum, when used by smokers on their own as over-the-counter (OTC) medicines, safely yield smoking cessation success rates as good as when administered under a physician's prescription, according to study results in the current issue of Addiction. The study analyzed data collected from smokers prior to the U.S. Food and Drug Administration's (FDA) switch of nicotine gum and the nicotine patch from prescription to OTC status.

"The fact that smoking cessation rates with NRT compare favorably whether the products are self-administered in an OTC fashion or by physicians under a prescription-only regimen is significant, because OTC status dramatically increased the number of smokers who use the products to quit smoking," says study author Saul Shiffman, Ph.D., research professor of psychology at the University of Pittsburgh. "Moreover, we found that NRT can be used safely without physician intervention."

OTC NRT had success comparable to that of prescription NRT both at six weeks of therapy, while smokers could still use the products under the recommended guidelines, and at a six-month follow-up, long after the end of their treatment. The success pattern held for both the gum, which requires active involvement and compliance from smokers, and the patch, which requires considerably less involvement.

In the study, OTC NRT gum users generally had higher abstinence rates than prescription users. At six weeks, OTC users had a verified success rate of 16.1 percent, compared to prescription users, 7.7 percent. At six months, the OTC users still had higher rates than the prescription users, 8.4 percent versus 7.7 percent.

Similarly, OTC patch users had higher verified abstinence rates, 19.0 percent, at six weeks, compared to prescription patch users, 16.0 percent. At six months, the OTC users achieved a 9.2 percent cessation rate and prescription users, a 3.0 percent rate.

"The comparability of the OTC and prescription success rates seems surprising, as physician intervention might have been expected to boost efficacy through counseling and enhanced compliance. However, we found that physicians had not done all they could and should do to help smokers use the medications to quit. This has been seen in other studies, too," says Shiffman.

In fact, patients reported that physicians often failed to provide essential elements of counseling, instruction or advice in smoking cessation. The physicians sometimes issued prescriptions without seeing the patient and had follow-up conversations about quitting with less than 25 percent of the patients. Moreover, some physicians who prescribed NRT under-dosed patients, which can undermine cessation, Shiffman notes. However, he adds, these dosing variations did not account for the difference between the OTC and prescription success rates.

"Training physicians and pharmacists on proper prescribing and counseling may promote cessation and proper use of effective treatments," says Shiffman. "However, given increasing pressures on doctors' time, achieving widespread cessation through them seems unlikely. Requiring a prescription to access smoking cessation treatment presents significant barriers for patients, and far more use NRT when it is freely accessible via OTC."

To instruct patients, products like Nicoretteâ nicotine gum and NicoDermâ CQâ nicotine patch come with a user's guide and audiotape with explicit directions. Both products also offer optional written cessation materials and patient support programs that have been proven to increase success rates. However, these optional materials were not available at the time of Shiffman's study, and so were not part of that evaluation.

Study participants used these products safely without physician intervention, the researchers note, with adverse reactions under OTC comparable in type and severity to those among patients who used prescription NRT and those in previous clinical trials of the products. Among common side effects associated with the patch and gum, respectively, were headaches (3.2 and 13.3 percent), nausea (2.0 and 10.7 percent) and insomnia (2.5 and 2.4 percent).

Of the 48 million current adult U.S. smokers, approximately 70 percent--some 34 million--report they would like to stop smoking, and 1.2 million successfully quit permanently, according to the U.S. Centers for Disease Control and Prevention (CDC). The introduction of OTC status for NRT in the U.S. increased quitting by an estimated 20 percent, according to previous studies.

The FDA initially approved NRTs for prescription-only sales, in the form of a chewing gum, Nicorette, in 1984 and a skin patch, NicoDerm CQ, in 1991. The FDA reclassified the NRT gum and the patch products as OTC in 1996. In addition to the United States, several countries including France, Australia and Brazil, are removing regulatory barriers to NRT access, with early results suggesting favorable public health impact, Shiffman notes.

Both the nicotine patch and gum help to relieve smoking withdrawal symptoms by providing temporary, alternate nicotine resources to smoking, allowing a person to gradually reduce his or her dependence on nicotine, a quitting method recommended by physicians.

Study design

The paper included independent assessments of the patch and gum when received in two environments: in simulated OTC settings in which 5,348 enrolled smokers bought and used the patch or gum based on instructions on the package, without provider instruction or intervention; and via physician-provided NRT prescriptions filled by 933 smokers at pharmacies of a national U.S. merchandiser.

The enrolled OTC participants purchased products from a simulated NRT retail product display at participating trial sites, mainly malls and market research sites, after reviewing product labels and deciding the dose and quantity. The investigators later refunded the costs but participants did not know this at the time of purchase. The gum was either 2 or 4 milligrams (mg) of Nicorette and the patch, either three steps (21, 14 and 7 mg) or two steps (14 and 7 mg) of NicoDerm CQ. The NicoDerm CQ users could elect to use the patch either for 24 hours a day or for a 16-hour waking day. Prescription patients received the same products but at doses selected by their physicians.

The authors note as a limitation the fact that smokers were not randomly assigned to be treated under prescription or OTC conditions, and that the two groups were recruited by different methods.

In both groups, to check if participants reporting abstinence were telling the truth, investigators tested the carbon monoxide (CO) levels in their breath. Participants who did not show up for the test or whose CO level was high were counted as treatment failures. Success rates estimated in this way are considered conservative.
The predecessor of GlaxoSmithKline Consumer Healthcare supported the study, in collaboration with the predecessor of Aventis and ALZA Corporation.

Kristin Zajaczkowski

Porter Novelli

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