摘要：Objectives. This study examined whether the change in nicotine replacement therapy sales from prescription to over the counter (OTC) status affected smoking cessation. Methods. We used the 1993–1999 Massachusetts Tobacco Surveys to compare data from adult current smokers and recent quitters before and after the OTC switch. Results. No significant change over time occurred in the proportion of smokers who used nicotine replacement therapy at a quit attempt in the past year (20.1% pre-OTC vs 21.4% post-OTC), made a quit attempt in the past year (48.1% vs 45.2%), or quit smoking in the past year (8.1% vs 11.1%). Fewer non-Whites used nicotine replacement therapy after the switch (20.7% pre-OTC vs 3.2% post-OTC, P = .002), but the proportion of Whites using nicotine replacement therapy did not change significantly (20.6% vs 24.0%). Conclusions. We observed no increase in Massachusetts smokers' rates of using nicotine replacement therapy, making a quit attempt, or stopping smoking after nicotine replacement therapy became available for OTC sale. There appear to be other barriers to the use of nicotine replacement therapy besides visiting a physician, especially among minority smokers. (Am J Public Health. 2002;92:437–442) Although many drugs have changed from prescription to nonprescription status in the past decade, there has been little assessment of the effect of this change on outcomes in the population. Nicotine replacement therapy is a safe, effective, and standard treatment of tobacco use. 1– 4 Nicotine replacement therapy products were sold only by prescription until 1996. By July 1996, nicotine gum and 2 of the 4 brands of nicotine patches were available without a prescription. 5, 6 Most nicotine replacement therapy sales are now over the counter (OTC). The rationale for changing nicotine replacement therapy from prescription to nonprescription status was to increase smokers' access to the products. 5, 6 Visiting a physician to obtain a prescription for nicotine replacement therapy was deemed an unnecessary barrier to acquiring this safe and effective treatment for smoking cessation. Eliminating this barrier was expected to increase the proportion of smokers using nicotine replacement therapy at a quit attempt. 5, 7 The effectiveness of a medication is the product of its efficacy and its reach or access. 5, 6, 8 Therefore, improving smokers' access to nicotine replacement therapy had the potential to increase smoking cessation rates in the US population. Additionally, the OTC availability of nicotine replacement therapy might encourage more smokers to try to quit, which also might produce higher population cessation rates. A decision analysis done before nicotine replacement therapy became available OTC estimated that the switch would result in an additional 450 000 smokers being abstinent at the end of 10 years. 7 These hypotheses assume that the efficacy of nicotine replacement therapy is maintained when it is used in an OTC situation. However, switching nicotine replacement therapy to OTC status could decrease the success of quit attempts if fewer smokers used the medication with adjuvant behavior therapy, which is recommended by the Food and Drug Administration. 1 Although clinical trials have shown that nicotine replacement therapy is effective with minimal concomitant behavior therapy, the absolute cessation rates in clinical trials are much lower when only minimal behavior therapy is provided. 1, 6 The population benefits of increasing smokers' access to the nicotine replacement therapy would be blunted if the product's efficacy declined when it was sold OTC. The effect of switching nicotine replacement therapy to OTC status on the use of nicotine replacement therapy and on cessation rates at a population level is not known. Sales of nicotine replacement therapy have doubled since its switch to OTC status. 5 Analyses based largely on sales data have projected that the OTC availability of nicotine replacement therapy has increased cessation rates. 5, 9 These analyses assume that increased sales of nicotine replacement therapy translate into more smokers using the product for quitting smoking. The validity of this assumption has not yet been confirmed. We analyzed data from a population-based sample of Massachusetts smokers to assess whether switching nicotine replacement therapy sales from prescription to OTC status increased: (1) the proportion of quit attempts at which nicotine replacement therapy was used, (2) the proportion of smokers who made a quit attempt, (3) the rate of smoking cessation among nicotine replacement therapy users, and (4) the rate of smoking cessation among all smokers. We also examined demographic characteristics of nicotine replacement therapy users before and after the OTC switch to determine whether OTC availability was associated with changes in the use of the drug by certain subgroups of smokers.
