In Australia, nicotine replacement therapy

Transcription

1 Article Reducing Harm Nicotine replacement therapy products over the counter: real-life use in the Australian community Christine L. Paul, Raoul A. Walsh and Afaf Girgis Centre for Health Research & Psycho-oncology (CHeRP), The Cancer Council New South Wales/University of Newcastle, New South Wales In Australia, nicotine replacement therapy (NRT) has grown in popularity, with a doubling of sales volume between Deregulation of NRT products involving over-the-counter (OTC) access and direct-toconsumer advertising has been supported by the public health community on the basis that it would result in an increase in the number of successful quitters. 1-3 Most NRT trials have occurred in primary care settings or in special clinics. 4 In other areas of preventive medicine, the results of efficacy trials are often not achieved under normal or real-world conditions. 5 A recent US survey suggests that since becoming available OTC, NRT may not be effective in increasing long-term cessation rates. 6 The urgent need for research into community use of NRT has been emphasised repeatedly. 7,8 The few studies of OTC use of NRT suggest that inappropriate use of these products is evident 9-11 and may reduce its potential effectiveness. 12 For example, duration of patch use can be as little as 4-5 weeks on average. 9 This is insufficient to cover the likely period of withdrawal symptoms 10 and much shorter than the manufacturers recommendations of weeks. Concomitant smoking (which has been identified as a predictor of failure to quit 7,13 ) is also evident in up to one-third of OTC NRT users in the United Kingdom (UK) and United States (US). 9,14 Further, in contrast to the support provided in the controlled trials of NRT, 4 the amount of information provided to OTC users of NRT may be minimal. A survey of NRT users in Scotland (where health promotion had been a contractual obligation for pharmacies) reported that 26.7% did not recall receiving any counselling, and 90% thought more structured regular individual counselling would be beneficial. 14 Another study also indicated that increased contact with health care providers was related to increased cessation rates. 15 Two additional issues are also of importance to public health policy regarding OTC availability of NRT. The first is whether cost represents a significant barrier to the uptake of NRT. Given the relatively low socio-economic profile of smokers, 16 and the finding that NRT users tend to be more affluent, 6,14,17 it is important to identify whether the high cost of NRT is restricting its uptake among those most in need of smoking cessation support. In Australia, deregulation of NRT products is relatively recent. It is vital to examine NRT use in the Australian community to inform debate regarding issues such as whether the deregulation of NRT should continue in its present form and whether there is a need for additional support for NRT users. Aims This study aims to inform public health debate on the efficacy of community use of NRT, the accessibility of NRT and its deregulation by exploring: Prevalence and patterns of use of NRT. Levels of advice NRT users report receiving from doctors and pharmacists. Reasons for use and non-use of NRT. Characteristics of each of recent NRT users. Abstract Objective: To explore the information received by NRT users; whether patterns of NRT use are in accordance with recommendations; and to identify the characteristics of those using NRT products. Methods: A cross-sectional, omnibus telephone survey of 1,509 community members was conducted in New South Wales, Australia in The survey identified 215 current and former smokers who completed additional questions regarding their most recent quit attempt. Results: Of the 215 current and former smokers, 67 (31.2%) had used NRT on their most recent quit attempt. The majority of NRT use (61%) lasted for less than two weeks. More than 40% of NRT users reported receiving no instructions from a doctor or pharmacist on how to use the product. Approximately one-third of NRT use was associated with concomitant smoking, with 10% of NRT use being associated with little or no reduction in reported daily cigarette consumption. Only 41.8% of NRT users reported a doctor had recommended using the product. Conclusions: Despite the small size of the sample, the data suggest a level of inappropriate use of NRT products in the community. Implications: Wider use and effective provision of support and advice to NRT users in the community must be addressed if this product is to achieve its optimal potential in aiding smoking cessation. (Aust N Z J Public Health 2003; 27: 491-5) Correspondence to: Dr Christine Paul, Centre for Health Research & Psycho-oncology (CHeRP), Locked Bag 10, Wallsend, NSW Fax: (02) ; Chris.Paul@newcastle.edu.au Submitted: November 2002 Revision requested: February 2003 Accepted: July VOL. 27 NO. 5 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 491

2 Paul, Walsh and Girgis Article Design and setting The study was conducted as part of a larger omnibus community survey of cancer-related perceptions and behaviours. Telephone numbers of 3,227 households were selected from the New South Wales (NSW) (Australia) Electronic White Pages and an information letter mailed to the corresponding address. This sample size was estimated to yield a sample of smokers sufficient to explore a range of tobacco-related issues. There were no existing data on which to base sample size estimates regarding NRT use. Telephone contact was made in the four weeks following the initial letter. Of the persons in that household aged 16 years or over, the one with the next birthday was asked to participate in a 25- minute survey. Only those aged 18 years or over were eligible to answer the smoking-related questions. Participants Smoking status was identified according to Pierce et al. (1993). 18 Those who had smoked at least 100 cigarettes in their lifetime but were not smoking at all now were defined as former smokers. Those who had smoked at least 100 cigarettes and were still smoking occasionally or daily were defined as current smokers. Former smokers who had quit more than two years ago and current smokers who were not smoking 12 months prior to the survey were excluded from the NRT sample to ensure participants had full exposure to the possibility of NRT use. Current smokers who had made no attempt to quit in the previous 12 months were not asked about NRT use. Measurements Table 1 lists the survey items. Standardised questions were used to assess personal smoking status and NRT use where possible. 18 All other questions were pilot-tested with a sample of community members, using the same recruitment method as for the main study. Analysis Frequencies and 95% confidence intervals were used to describe prevalence of each of the items. Chi-squares were used to compare the proportions for each outcome between groups. Fisher s Exact Test was used for chi-squares where cell sizes were small. Table 1: Survey items. Level of nicotine dependence For daily smokers: How many cigarettes do you smoke per day? For non-daily smokers: During the past 30 days, on the days that you did smoke, about how many cigarettes did you usually smoke? How soon do you smoke cigarettes or cigars/pipes in the morning after awakening? Intention to quit What are your intentions regarding quitting? (in next month, in next 6 months, not in next 6 months, never) NRT use Did you use a (insert product) to help you in your most recent quit attempt? How long did you use the (insert product) for? Smoking while using NRT Did you smoke for at least part of the time you were using (insert product) in your most recent attempt? (more, same, less, much less, only 1-2 cigarettes altogether, only 1-2 puffs altogether, no) Did you smoke while wearing a nicotine skin patch or within a few hours of taking it off? If Yes: How frequently did you smoke? Advice received In relation to using (insert product), did a doctor/pharmacist: recommend using (insert product)? give any instructions on how to use (insert product)? Satisfaction How helpful did you find it in assisting you to quit smoking? (very, somewhat, a little, not at all) Reasons for use /non-use What was the main reason you decided to use (insert product) to help you stop smoking? What was the main reason you did not use (insert product) in your most recent quit attempt? Were there any other reasons you did not use (insert product) in your most recent quit attempt? Demographic characteristics Age, gender, health insurance, GP visit in last 12 months, country of birth, whether of Aboriginal or Torres Strait Islander origin, education level, marital status, employment Findings Sample Of the 3,227 telephone numbers identified in the sampling process, 768 were ineligible (non-residential, disconnected, fax numbers outside NSW, or did not contain anyone with sufficient English to complete the interview), 431 were not contactable, 519 refused to participate or did not complete the interview, and 1,509 gave complete interviews, giving a response rate of 61.37% (1,509/ 2,459) and a consent rate of 74.4% (1,509/2,028). The demographic characteristics of the 1,431 respondents eligible to answer the smoking questions were compared with the demographic characteristics of the NSW population from the 1996 Census 19 and with the main tobacco use monitoring survey in Australia. 20 Some minor differences were found, but overall the sample was broadly comparable with the NSW population and Australian smokers. Of those eligible to answer the smoking questions, 276 (19.23%) were classified as current smokers and 400 (27.95%) were classified as former smokers. Of the current smokers, 123 were not eligible to answer the NRT questions as they had not made a quit attempt in the previous 12 months (n=99), or had not been smoking 12 months previously (n=24). Of the former smokers, 338 were not eligible to answer the NRT questions as they had quit more than two years previously. Of the 215 eligible to answer the NRT questions, 62 (28.8%) were former smokers and 153 (71.2%) were current smokers. 492 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 2003 VOL. 27 NO. 5

3 Reducing Harm NRT over the counter in Australia Table 2: Length of NRT use. Length of time Patch (n=47) Gum (n=26) Inhaler (n=4) Total (n=77) a Current and Current and Current and former smokers former smokers former smokers combined combined combined Current Former All smokers smokers smokers n % n % n % n n n % <1 week < 2 weeks weeks >6-12 weeks >12 weeks to 6 months >6 months Note: (a) Total n>67 as some participants used more than one product on their last quit attempt. Prevalence and patterns of NRT use Of those asked about NRT use (current and former smokers combined), 67 (31.16%) reported using an NRT product in their most recent quit attempt. Reported prevalence of use was 32.7% for current smokers and 27.4% for former smokers. Of the 67 respondents using NRT in their most recent quit attempt, 56.7% (95% CI ) used a patch only, 22.4% (95% CI ) used gum only, while 14.9% (95% CI ) used both the patch and gum. Very few used the nicotine inhaler only (1.5%) or used the inhaler with either the patch (1.5%) or the gum (3.0%). For current and former smokers combined, approximately twofifths of NRT use (39.0%) lasted for less than one week and 22.1% of use lasted between one and two weeks (see Table 2). Only 13.0% of use lasted between six and 12 weeks. A small proportion (1.3%) of product use was for more than six months. Only one of the respondents was still using an NRT product at the time of the survey and this respondent was not included in these analyses. The length of time NRT had been used (less than one week, one week to less than two weeks, 2-6 weeks, more than six weeks to three months, more than three months) was compared with product used and smoking status using Fisher s Exact Test. The nicotine patch appeared to be used for longer periods than either the gum or inhaler (see Table 2), although this difference was not significant (Fisher s Exact Test, p=0.38). Former smokers were more likely than current smokers to have used the product for longer time periods (Fisher s Exact Test, p=0.002). Respondents were asked to report concomitant smoking in relation to each NRT product used. The majority of responses (66.3%) reported not smoking at all while using NRT. Almost one-quarter (23.8%) reported smoking much less, 1-2 cigarettes or 1-2 puffs, and 10.0% of responses reported smoking the same or a little less than usual while using NRT. Of the 49 patch users, 17 (34.7%) reported instances of smoking within a few hours of removing the patch. There were no significant differences in level of concomitant smoking according to latency of smoking (time to first cigarette) or type of NRT product used. Recommendations and advice Of those who had used NRT (current and former smokers combined), 43.8% reported that neither a doctor nor a pharmacist had recommended that they use the product. One-fifth (20.3%) reported that a doctor had recommended using NRT, 17.2% reported a pharmacist had recommended using NRT and 18.8% reported both a doctor and a pharmacist had recommended using NRT. A large proportion of NRT users (40.6%) reported they had not received any instructions about using the product from a doctor or a pharmacist. Just 12.5% reported receiving product instructions from a doctor, 28.1% reported receiving instructions from a pharmacist, and 18.8% received instructions from both a pharmacist and a doctor. There were no significant differences between current and former smokers in whether they had received recommendations to use the product or product instructions. There were no significant differences between those using multiple NRT products and those using only one product regarding whether they had received instructions on the product from a doctor or pharmacist. Satisfaction with NRT and reasons for use or non-use of NRT Of the 47 patch users (current and former smokers combined), 77.6% rated the product as being very or somewhat helpful, as did 40.7% of the 27 gum users. Of those who had used one or more NRT product, patch users were significantly more likely to report that the patch was helpful, than were gum users to report that gum had been somewhat or very helpful (χ 2 =9.736, df=2, p<0.05). For all NRT users, the most frequently reported reasons for using an NRT product in the most recent quit attempt were the recommendation of a friend (20.5%), advertising (17.9%) and thinking it would be effective (17.9%). Recommendation by a doctor (10.3%) or pharmacist (1.3%) was not frequently reported as a main reason for using an NRT product. Reasons for not using each of the NRT products were also explored. Both users and non-users of NRT were asked these ques VOL. 27 NO. 5 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 493

4 Paul, Walsh and Girgis Article tions (e.g. a patch-only user was asked why s/he did not use gum or inhalers, while a non-user was asked to give reasons for nonuse for each of the three products). For both patches (166 respondents) and gum (188 respondents), the most frequently reported main reasons were preferring not to use NRT at all (25.3% and 19.1% respectively), not thinking of it (24.7% and 27.7% respectively), and not needing NRT (13.3% and 11.2% respectively). With regard to non-users of inhalers (n=211), the most frequently cited main reasons for not using the product were being unaware of it (30.8%), and not thinking of it (29.4%). Previous unsuccessful use of the product was cited as a main reason for non-use by 1.8% of those not using the patch and 4.8% of those not using the gum. The cost of the product was given as a main reason for 9.6% of those not using the patch, 3.8% of those not using the inhaler and 2.1% of those not using the gum. Characteristics of NRT users NRT users and non-users were compared on demographic characteristics, plans to quit (current smokers only), use of counselling or self-help on most recent quit attempt, cigarette consumption (prior to quitting for former smokers) and latency to smoke. It was found that for both current and former smokers, NRT users were more likely to report smoking more than 20 cigarettes per day than those who had not used NRT products (p=0.03, p=0.04 respectively using Fisher s Exact Test) and using counselling or self-help during their most recent quit attempt (χ 2 =51.9, df=1, p<0.001, χ 2 =27.7, df=1, p<0.001 respectively). For former smokers only, NRT users were more likely to report having their first cigarette within 20 minutes of waking when they used to smoke (p<0.001). Conclusions The data provide a useful indicator of how NRT products are used in the OTC environment. Approximately one-third (31.2%) of the study sample reported having used an NRT product on their most recent quit attempt. This is comparable with the finding of a marketing survey 1 that in early 1999, 29% of committed quitters had ever used a nicotine patch. However, this is a relatively small proportion of smokers given that all had tried to quit within the time NRT products were available over the counter, and the recommendation that smokers be offered NRT by their primary care doctor. 21 Although the role of counselling in increasing quit rates among NRT users is debated, the provision of brief advice is recommended 4 as the minimum that should be offered to ensure NRT is effective. This contrasts with only 59.4% of NRT users reporting receipt of any product instructions from either a doctor or pharmacist. Clearly for an OTC product, a pharmacist is better placed to provide information. While pharmacists may choose to provide considerable support to their customers, the costs of doing so in a commercial environment are likely to be a disincentive for all but the most committed pharmacists. Most NRT users are not using the product for a sufficient length of time, on the basis of research on withdrawal 10 and manufacturers recommendations. More than 80% of NRT use was for less than six weeks, while 61% of use was for less than two weeks. Nicotine patches were used for longer periods than the gum or inhalers. This result is not surprising given that previous studies have indicated higher compliance for patches compared with gum and inhalers. 22 Almost 20% of NRT users reported using more than one product at a time. As product instructions do not provide guidance on this, advice from a health care provider is required to ensure that products are used in a safe and appropriate manner. Also of concern are the findings that approximately 10% of NRT users reported smoking the same or only a little less than usual while using NRT products. Despite previous research suggesting that NRT users are the more affluent, 6,17 only 10% of non-users cited cost as their main reason for not using the product. It was not possible given the size of the sample to explore this issue further. The main reasons given for not using NRT were not considering the product or preferring not to use the product. This data and the low proportion reporting a doctor recommended NRT use suggests that there may be a large number of smokers who are unaware of the potential benefits of using NRT. More than three-quarters of patch users and only 40% of gum users report that the product was very or somewhat helpful in their attempt to quit. It appears that gum users in particular might benefit from more advice or support. The sample size of just 67 NRT users is relatively small, resulting in a low level of statistical power. The different time periods asked about for former versus current smokers must also be considered when interpreting the differences found between these two groups. Former smokers were asked about a quit attempt up to two years ago, while current smokers had to have made their quit attempt within the previous 12 months. Therefore, the present study provides only the first indication of the nature of NRT use in the Australian community. However, study data reinforce the concerns raised by overseas studies of OTC use of NRT products low levels of advice and support and potentially high levels of inappropriate use. Despite the widespread publicity about the availability of NRT OTC, the majority of current and former smokers do not use this potentially effective cessation aid. Furthermore, when NRT is used, the vast majority of users do not maintain therapy for recommended periods, resulting in a likely erosion of its effectiveness. This could be related to the low level of advice they report receiving from health care providers. In the OTC environment there is a need to address the inappropriate use of NRT and the substantial proportion of NRT users who report receiving no instruction on product use. Acknowledgements The work of Ms Flora Tzelepis on this project, particularly during the data collection phase, is gratefully acknowledged. This paper was prepared by The Centre for Health Research & Psycho-oncology (CHeRP), formerly The Cancer Council NSW 494 AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH 2003 VOL. 27 NO. 5

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