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Increasing the availability of pharmacological treatments increases their usage and possibly cessation rates.

The availability of treatment for smoking cessation does not reflect the scale of the public health problem associated with tobacco use. For example, compared with cigarettes, access to pharmacological treatments is highly regulated. The potential public health benefit from NRT is determined by how many people use it, which is in turn determined by how many restrictions are placed on its sale and marketing by its licensing status (McNeill et al., 2001).

Although cigarettes are easily and widely available, in some countries (mainly low and middle income countries) NRT and bupropion are not available or are expensive compared with cigarettes (World Bank, 1999). According to the WHO, 38 countries, at minimum, do not have any available NRT (Tobacco Free Initiative-WHO, 2009.) In other countries, NRT is only available through prescription or over the counter in pharmacies; there are currently 25 that have prescription-only NRT. Varenicline is relatively limited in its global market penetration, with most activity occurring to date in industrialized nations. Its US and UK pricing have been about the same as a pack of cigarettes/day for a day's dose of medication.

Research in the US indicated that removal from prescription-only control to general sale increased uptake of products suggesting an increase in cessation attempts (Shiffman et al., 1997; Burton et al., 2000; Shiffman & Sweeney, 2008). However, a study (Thorndike et al., 2002) that examined smokers in Massachusetts before and after the switch to general sale (OTC) found no evidence that this had led to a significant increase in NRT utilization during their most recent quit attempt, the likelihood of smokers making a quit attempt, success of quit attempts made and population cessation rates. There were however changes in the demographics of those using NRT. In addition, consistent with other research (Stead et al., 2008) they found that the efficacy of NRT did not decrease following the switch.

Possible explanations for the lack of impact on quit rates in the Thorndike study include the launch of the patch one year before the pre-switch data were collected as this caused a large increase in patch sales and the introduction of bupropion to the market during the post-switch phase which diminished NRT use. In addition, it is possible that these findings may not be replicable outside Massachusetts, which is unusual because of its intensive and long-standing tobacco control efforts. Further research is therefore needed in this area (Gitchell et al., 2002).

In contrast to Thorndike et al. (2002), Pierce and Gilpin (2002) used California survey data to document substantial increases in NRT utilization following the switch to OTC. However, Pierce and Gilpin (2002) reported no difference in success rates between those who elected to use NRT and those who did not. Given the self-selected nature of the groups (i.e., more dependent smokers would choose to use NRT), these data cannot be used to evaluate the efficacy of NRT. While there may be challenges of assessing NRT efficacy in a real-world population context, West and Zhou (2007) found that NRT use increased cessation success at 6 months among smokers making self-initiated quit attempts without behavioral support. Shiffman's editorial commentary on this paper bolsters the conclusion that NRT can be useful in "real world" settings (Shiffman 2007).

The Royal College of Physicians’ report (Royal College of Physicians, 2007) recommended that NRT should be both widely available and also through reimbursable prescriptions. In the UK most forms of NRT are now available on general sale as well as all being available on prescription. Along these lines, recent findings suggest the providing free samples of NRT produced greater reductions in daily cigarette consumption compared to a group of smokers that did not receive the samples (Jardin et al., 2014). Thus, providing access to free medication might also positively impact quit rates. Lastly, consideration needs also to be given to altering the labeling for NRT to make the products more readable (Stevens et al., 2007), and attractive to smokers (McNeill et al., 2001; Cummings, 2002).
World Health Organization has included NRT as part of the “essential medicines list“ worldwide.

A further consideration is access to not only NRT, but also e-cigarettes and how such access might relate to quit attempts and tobacco abstinence. A recent study by Brown and collegues (2014) included a cross-sectional survey of smokers in England as collected during a national surveillance program (the “Smoking Toolkit Study”). The study was intended to model real-world effectiveness of e-cigarettes as compared to NRT use or willpower alone for self-reported abstinence up to the time of the survey.  Findings indicated that e-cigarette users were more likely to abstain from tobacco (20%) compared to NRT (10.1%) or will power (15.4%). These findings tentatively suggest that increased access to e-cigarettes would be related to increased likelihood of stopping smoking. Please see the Electronic cigarettes section for an in depth overview of this novel nicotine delivery device.

In sum, providing a range of treatment options, could better help smokers overcome the barriers associated with stopping smoking and could increase the number of quit attempts made by a smoker (Zhu et al., 2012).  Most smokers have a history of unsuccessful quit attempts (Partos et al., 2013), thus emphasizing the need to provide a variety of evidence-based interventions so as to allow for more tailored smoking cessation assistance and ideally a greater likelihood of success.  However, should the number of treatment options be reduced, for example by payers restricting covered treatments, there is a risk that quitting behavior could be disrupted and likelihood of relapse increased.  As reviewed in the 2008 Clinical Practice Guideline, “Treating Tobacco Use and Dependence”, providing coverage for tobacco dependence treatments increases quit rates (Fiore, 2008).

With regards to pharmacotherapy specifically, while the Framework Convention on Tobacco Control does address availability of medication support for cessation in Article 14, and has also developed Guidelines for countries implementation of Article 14, there are challenges to creating uniform approaches among different national pharmaceutical regulatory approaches.  This area is certainly ripe for further research and “best practice” development.

Brown J, Beard E, Kotz D, Michie S, West R. Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study. Addiction. 2014; 109: 1531-1540.

Burton SL, Gitchell JG, Shiffman S. Use of FDA-approved pharmacologic treatments for tobacco dependence - United States, 1984-1998 . Mob Mortal Wkly Rep. 2000; 49: 665-668.

Cummings KM. Can capitalism advance the goals of tobacco control? Addiction. 2002; 97(8): 957-958.

Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. May 2008.

Gitchell JG, Di Marion ME, Rohay JM, Shiffman S. Population trends in smoking cessation and correlations to pharmacotherapy utilization: results from the current population survey. Poster presented at SRNT Conference, Savannah. 2002.

Jardin BF, Cropsey KL, Wahlquist AE, Gray KM, Silvestri GA, Cummings KM, Carpenter MJ. Evaluating the Effect of Access to Free Medication to Quit Smoking: A Clinical Trial Testing the Role of Motivation. Nicotine Tob Res. 2014; 16: 992-999.

McNeill A, Foulds J, Bates C. Regulation of nicotine replacement therapies (NRT). A critique of current practice. Addiction. 2001; 96: 1757-1768.

Partos TR, Borland R, Yong HH, Hyland A, Cummings KM. The quitting rollercoaster: how recent quitting history affects future cessation outcomes (data from the International Tobacco Control 4-country cohort study). Nicotine Tob Res. 2013; 15:1578-1587.

Pierce J, Gilpin EA. Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA. 2002; 288: 1260-1264.

Royal College of Physicians. Harm reduction in nicotine addiction: Helping people who can't quit. London: RCP, 2007; 1-242.

Shiffman S. Nicotine replacement therapy for smoking cessation in the "real world". Thorax. 2007; 62(11): 930-931.

Shiffman S, Gitchell J, Pinney JM et al. Public health benefit of over-the-counter nicotine medications. Tob Control. 1997; 6: 306-310.

Shiffman S, Sweeney CT. Ten years after the Rx-to-OTC switch of nicotine replacement therapy: What have we learned about the benefits and risks of non-prescription availability.  Health Policy. 2008; 86: 17-26.

Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database of Systematic Reviews, 2008 Issue 1.

Stevens AB, McDaniel KS, Glover ED, Wallace LS. Are instructions for over-the-counter nicotine replacement therapy products readable? Am J Health Behav. 2007; 31(Suppl1): S79-S84.

Thorndike AN, Biener L, Rigotti NA. Effect on smoking cessation of switching nicotine replacement therapy to over-the-counter status. Am J Public Health. 2002; 92: 437-442.

West R, Zhou X. Is nicotine replacement therapy for smoking cessation effective in the "real world"? Findings from a prospective multinational cohort study. Thorax. 2007; 62(11): 998-1002.

World Bank. Curbing the epidemic: governments and the economics of tobacco control. World Bank Development in Practice Series. Washington, DC: World Bank. 1999.

World Health Organisation. Two forms of nicotine replacement therapy chosen as WHO "Essential Medicines". 17th Expert Committee on the Selection and Use of Essential Medicines. 2009.

Zhu SH, Lee M, Zhuang YL, Gamst A, Wolfson T. Interventions to increase smoking cessation at the population level: how much progress has been made in the last two decades? Tob Control. 2012; 21: 110-118. logo
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