Nonprescription Options for Smoking Cessation

Introduction

The adverse events that occur as a result of cigarette smoking have been thoroughly documented. If one wanted to lengthen the average life span of U.S. citizens, cessation of cigarette smoking would be the most useful thing to focus on, since it is a modifiable cause of early death.[1]

The World Health Organization (WHO) estimates the total number of tobacco smokers at 1.1 billion.[2] Approximately 47% of men and 12% of women in the world smoke at this time.[2] The 1999 National Health Interview Survey (NHIS) estimated that, in the U.S., 46.5 million adults smoke (25.7% of men and 21.5% of women).[3]

Smoking is strongly correlated to age. An estimated 27.9% of those aged 18 to 24 years smoke, followed by 27.3% of those aged 25-44, 23.3% of those aged 45-64, and only 10.5% of people who are 65 or older.[3] The relatively low number of older smokers is probably due to the fact that many smokers die prematurely as a result of their habit.[2]

According to the NHIS, those who had only 9-11 years of education marked the highest smoking group (37.7%), followed by those with a high school education (26.3%), 13-15 years of education (25.3%), and those with more than 16 years of education (8.5%).

For many years, the only over-the-counter products available to assist smoking cessation were of unknown safety and/or efficacy. This changed when the FDA approved an Rx-to-OTC switch to give the self-care market its first effective smoking cessation product, nicotine polacrilex (Nicorette Gum, in 2 mg and 4 mg strengths).[4] Just as pharmacists were beginning to learn about its use, the Nonprescription Drugs Advisory Committee to the FDA moved again by recommending that Nicotrol and NicoDerm be switched to OTC status.[5] Nicotrol (a single-strength patch) was subsequently granted OTC status (about July of 1996), followed closely by NicoDerm CQ (as a three-step patch) in August of 1996.[6,7] Manufacturers attempted to increase product penetration by introducing mint and orange versions of Nicorette Gum and clear versions of the NicoDerm CQ Patch.

The situation changed dramatically in late 2002. With little advance notice to pharmacists, the two manufacturers made major changes in their smoking cessation lineups. Pharmacia Consumer Products changed Nicotrol into a three-step patch, accompanied by a "Craving Man" campaign beginning on October 21, 2002.[8] On October 31, 2002, the FDA approved a nicotine polacrilex lozenge known as Commit (GlaxoSmithKline).[9,10]

Television ads have been aired by one manufacturer that express frank criticism of one brand. Consumers can justifiably be confused about the place of these new products in the anti-smoking armamentarium. Since the U.S. lacks a third class of drugs, there is no professional to advise patients about smoking cessation options in the various non-pharmacy outlets that sell them (e.g., grocery stores, gas stations, convenience stores, hotel lobbies, airport shops). Consumers who desire counseling may prefer to purchase these products in a pharmacy. Pharmacists must be willing and ready to provide information in a supportive, friendly atmosphere to people who are attempting to quit smoking.

Those wishing to purchase these products fall into several categories. Some may be attempting to stop smoking for the first time, and some may have already undergone one or more attempts. Others may be purchasing the products on someone else's behalf. If the patient is attempting to quit for the first time, the pharmacist should offer encouragement and support for the decision. If the patient has previously attempted to quit, the pharmacist should ask which product(s) the patient has tried before, whether use directions were followed, and the circumstances which caused the product to be ineffective or the patient to relapse.

Patients who have a stomach ulcer or diabetes should not use gum or lozenges, but may use patches. However, patients who have an allergy to adhesive tape or preexisting skin problems should not choose NicoDerm CQ or Nicotrol. All Nicotrol products are meant for those who smoke more than 10 cigarettes a day. NicoDerm CQ Step 1 is also for those who smoke more than 10 cigarettes a day, but those who smoke fewer than 10 daily should begin with NicoDerm CQ Step 2 instead. Nicorette 2 mg is for those who smoke fewer than 25 cigarettes daily, but Nicorette 4 mg is for those who smoke 25 or more daily. Commit Lozenges use a different index for the initial choice. Those who smoke their first cigarette more than 30 minutes after waking should begin with the 2-mg lozenge, and those who smoke their first cigarette within 30 minutes of waking up should begin by using the 4-mg lozenge.

Originally, the ability to use a patch for only 16 hours was an advantage in preventing bizarre dreams resulting from wearing the product while asleep. On the other hand, 24-hour use was helpful in preventing overwhelming craving upon waking. Nicotrol advises using the patch for only 16 hours. This has led to counter-advertising (e.g., television ads, special stickers placed on boxes) by the manufacturer of NicoDerm CQ stating, "Use it 16 hours or 24 hours--You decide!"

NicoDerm CQ patches have always delivered 21, 14, or 7 mg of nicotine, tapering over the course of 10 weeks.

The original Nicotrol delivered 15 mg. The new Nicotrol Steps 1, 2, and 3 deliver 15, 10, and 5 mg of nicotine, respectively. The original Nicotrol was to be stopped after 6 weeks of use, as it was a non-tapering, one-strength patch. The new patches are used once-daily in a tapering manner. Nicotrol Step 1 is used on weeks 1-6, Step 2 on weeks 7 and 8, and Step 3 on weeks 9 and 10.

Unlike the tapering process used with patch strengths, Nicorette Gum was never tapered on the basis of the strength of the product, but rather on the number of pieces chewed daily. In a sim-ilar manner, Commit lozenges are never tapered in regard to the strength used (e.g., 2 mg versus 4 mg). Rather, the patient tapers the number of pieces used daily, in a schedule identical to that used for Nicorette Gum (1 piece of gum or lozenge every 1-2 hours for weeks 1-6; 1 every 2-4 hours for weeks 7-9; 1 every 4-8 hours for weeks 10-12). The patient must allow the lozenge to dissolve slowly over a 20-30 minute period, swallowing as little as possible. The lozenge should not be chewed or swallowed. The patient should occasionally move the lozenge from one side of the mouth to the other. A warm feeling or tingling sensation may result.

Some have questioned the possibility of oral cancer from close contact of the lozenges with oral mucosa. While oral cancer results from use of chewing tobacco and snuff, Commit lozenges (like Nicorette Gum) are free of the carcinogens that are formed from nicotine during curing, aging, and fermentation of tobacco.[11]

Each of the companies marketing smoking cessation products supplies a support program. The Pharmacia program is called "Pathways to Change," while the GlaxoSmithKline program is known as "Committed Quitters." Pharmacists should urge patients to enroll in these programs, fill out surveys when requested, and call the toll-free numbers on the packages (in addition to the pharmacy) if they have questions. Patients should also read the product's enclosed booklet and listen to the audio tape or compact disk, if one is included.

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