Impact of large-scale distribution and subsequent use of free nicotine patches on primary care physician interaction

Physicians are thought to play a critical role in the provision of smoking cessation assistance to patients [1]. As more than 70% of smokers visit a physician annually [2], medical practitioners are seen to have optimal opportunity to promote smoking cessation to their patients. Primary care practitioners in particular are visited on average more than 4 times per year by patients that smoke, and have thus been directed by clinical practice guidelines to identify and offer support to smokers at every visit. The Clinical Practice Guidelines for Treating Tobacco Use and Dependence, originally developed in 1996 by the United States Department of Human Health Services, stress that primary care physicians should treat tobacco dependence as a chronic disease and follow the 5A’s model of: asking about smoking, assessing readiness to quit, advising smokers to stop, assisting patients with treatment, and arranging follow-up. These forms of intervention have been shown to be quite effective in motivating and driving smokers to quit, where even brief advice increases the odds of cessation [3, 4]. Combined behavioral counseling and pharmacotherapy however, has been shown to be the most effective at treating tobacco dependence, producing the highest odds of quitting and progressively higher quitting estimates with increased number of counseling sessions [5].

Despite evidence showing that smoking cessation intervention in primary care is effective at helping smokers quit and offers a cost-effective option of reaching most smokers [6], studies have shown that physicians have not been active in providing such assistance. Population-based surveys of smokers have revealed that between 44 and 71% were ever advised to quit, and even fewer received any form of intervention [7‐9]. One telephone-based population survey had further documented that discussion about smoking was largely dependent on whether smokers were women, in the preparation stage of change, in fair or poor health, and smoked for a greater number of years [9]. With follow-up care also arranged in less than 10% of all visits [8, 9], these practice gaps confirm findings from physician surveys that report physician behavior is below recommended guidelines [10‐12].

To address such gaps, researchers have called for specific strategies aimed at enhancing the integration of clinical smoking cessation interventions into primary care settings. Some of these strategies include advanced training initiatives for physicians, enhanced use of established interventions, establishing performance feedback for practitioners, as well as the provision and combined use of low-cost or cost-free pharmacotherapy for patients [10, 13]. While several trials have evaluated the effectiveness of multi-component interventions in primary settings, to date, only one investigated the provision of cost-free medication. The trial revealed that the provision of cost-free nicotine replacement therapy (NRT) or bupropion in combination with general practitioner training strongly increases the odds of cessation (odds ratio of 4.77) and is markedly cost-effective in reducing smoking-related morbidity [14, 15]. As these findings suggest that smoking cessation support and provision of free pharmacotherapy in primary practice is an effective strategy of reducing smoking prevalence in the general population, cost-free medication provision appears to be an important component of achieving higher abstinence rates.

Over the past decade, many giveaway programs outside of clinical settings have provided NRT to large samples of smokers as part of a telephone quitline or large-scale distribution program. Studies evaluating these programs have generally revealed that compared to non-treatment cohorts, smokers receiving NRT were able to achieve higher quit rates, and that offering free NRT is an effective intervention in encouraging program participation, improves treatment satisfaction, and is cost-effective [16‐20]. Direct causal evidence on the efficacy of large-scale distribution of free NRT has also been recently established, documenting that despite concerns over the ‘real-world’ effectiveness of NRT [21, 22], the mailed distribution of free nicotine patches in absence of behavioral support more than doubled the odds of cessation at a 6-month follow-up [23]. Nonetheless, no previous studies had evaluated whether the provision of free NRT had promoted further help-seeking and what impact that interaction may have had. As mass distribution of NRT is being considered in many jurisdictions across the United States and Canada, it is important to identify whether this form of intervention drives smokers to seek out additional front-line support.

In the context of a randomized controlled trial evaluating the efficacy of mass distribution of free NRT to smokers, the aim of this study was to examine whether and to what extent the provision of free NRT impacts smokers’ interaction with primary care physicians. In particular, the research attempted to answer the question: does the provision and subsequent use of free nicotine patches to smokers interested in quitting promote interaction with their primary care physicians, and whether that interaction has a role in quitting smoking?

To our knowledge, this is the only intervention study to date to evaluate the impact of free (to the end user) NRT provision on further help seeking and its associated smoking cessation implications. The study identified that while smokers are generally comfortable in turning to their primary care physicians for smoking-related support, most participants, regardless of whether they received and used nicotine patches, did not discuss cessation with their physician by either the 8 week or 6 month follow-ups. Among nicotine patch users at the 8 week follow-up, predominant reasons for not seeking support were beliefs that they did not need to visit a physician, it is time consuming to do so, and the perception that smoking is not a serious medical problem. Such reluctance to proactive support seeking suggests that most smokers generally hold passive views towards primary care physicians’ role in smoking cessation when considering or initiating quitting. Other research has also documented that while some reluctance to consult a practitioner stems from individuals not seeing smoking as an illness [30, 31], others do not seek physician support due to the perception that they have little to offer or the belief that smoking is not a condition that requires medical help [32].

Of those that did visit their physician however, an overwhelming majority reported that their doctors were active in encouraging them to quit. Again, regardless of whether smokers had received and used free nicotine patches, between 83% and 93% of those that discussed smoking cessation with their doctor throughout the 6 month duration of the study were advised to quit, and over 70% were offered additional or alternative support. While the provision and use of nicotine patches, and possibly just surveying about smoking habits, may aid in stimulating patient-initiated discussion of smoking cessation with primary care physicians, these findings point to an encouraging trend of greater physician compliance with the advise and assist components of the 5A model, as seen in recent representative U.S. population surveys [33, 34]. They may also be indicative of a shift in practice guideline adherence among specifically Canadian physicians, which were reported in 2012 to offer advice to quit to merely 56% of smokers who had visited them in the past year, and fewer than 30% of surveyed smokers received information about assistance [35]. As recipients and users of nicotine patches in the current study were more likely to discuss smoking with their physicians compared to the no intervention control group, the findings suggest that the provision of free NRT particularly to those who are likely to use it may facilitate opportunities for benefits beyond the direct pharmacological effects of the medication, such as the receipt of physician-assisted brief or supplementary intervention. Indeed, nicotine patch users who had discussed cessation with a physician between the 8 week and 6 month follow-ups were more likely to make a serious quit attempt compared to controls. From a public health perspective, the mailed out provision of free nicotine patches may therefore be effective in not only promoting cessation but also in stimulating conversations and support from health professionals that help towards achieving that goal.

It is important to note that approximately 70% of participants who had used the freely provided nicotine patches by 8 weeks and informed their physicians of doing so, were provided with supplementary support, the most common being prescribed varenicline or bupropion. The majority (73.7%) of nicotine patch users had used only some of the provided NRT, therefore it is most likely that the medications were prescribed subsequent to their discontinuation of nicotine patches. The remaining 26.3% however, reported to have used all their nicotine patches by 8 weeks, in which case it is plausible to suspect that these participants were prescribed the medications while they were still using the nicotine patches, contrary to the recommendations of the National Institute for Health and Care Excellence (NICE) [36] and US Public Health Clinical Practice Guidelines for Treating Tobacco Use and Dependence (for varenicline only) [37]. Nearly one half (45.5%) of those who used all their nicotine patches and informed their physician of doing so were prescribed varenicline or bupropion. The combination of bupropion and NRT has been reported to provide similar benefit as either therapy alone [38], and only until a recent systematic review and meta-analysis [39], combination therapy of varenicline and NRT produced favorable, albeit non-significant effects on cessation [40, 41]. However, in the event that the prescribed cessation medications were utilized, it is unclear what role, if any, that would have had on the observed effects in this study. Further research is necessary to evaluate the effectiveness of combination therapy on cessation outcomes in primary care settings, as well as directly contrast the effectiveness of nicotine patches and combination nicotine patch and varenicline in an open label design.

Several limitations of the current study should be noted. First, as nicotine patch users in the experimental group were asked specifically whether they had informed their physician of patch use at 8 weeks, as opposed to whether they had discussed smoking cessation with their physician, direct comparisons between this group of smokers and control participants could not be made. Second, as we were intent on examining how the receipt and specifically use of free nicotine patches is associated with physician interaction, thus necessitating case control matching, the employed random assignment to condition was compromised and placed limits on our ability to infer causality of intervention. Third, the temporal order of nicotine patch use and physician interaction was not captured, therefore nicotine patch use could have either preceded and caused participants to visit their physician (whether due to side effects or additional support), or some participants may have sought physician advice prior to initiating patch use. It is therefore important to emphasize again that the present findings pertain specifically to an association between use of freely provided nicotine patches and physician support, and are not causal in any regard. Third, recipients of the 5 week course of nicotine patches were advised to talk to their physician or pharmacist if they had additional questions to the included instructions on how to use the patches, in compliance with common pharmacotherapy distribution practices and our research ethics board recommendations. Some individuals however, may have perceived this as direct instructions to seek out physician support. Fourth, asking whether participants had visited a physician and discussed smoking cessation could have been subject to recall bias. Finally, biochemical verification of smoking status could not be effectively executed [23], therefore cessation outcomes are based on self-report data.

Use of freely distributed nicotine patches promoted further smoking cessation centered discussion with family physicians, compared to non-recipients of NRT. Although this was associated with increased likelihood of making a quit attempt, nicotine patch users as a whole generally did not turn to their physicians for cessation assistance, expressing reluctance in seeking their support. In line with grater adherence to clinical practice guidelines of following the 5A model, promotion of physician capacity in addressing tobacco dependence with patients could be enhanced through non-judgmental, stage-based brief motivational interviewing methods. Future research is warranted to examine whether the free NRT distribution as part of smokers’ helplines also mobilizes additional health-care provider support, in particular among pharmacists, who are generally more easily accessible than physicians.