PUBLIC HEALTH GUIDANCE SCOPE

Transcription

1 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE PUBLIC HEALTH GUIDANCE SCOPE 1 Guidance title Tobacco: harm-reduction approaches to smoking 1.1 Short title Tobacco: harm reduction 2 Background a) The National Institute for Health and Clinical Excellence (NICE) has been asked by the Department of Health (DH) to develop public health guidance on the use of harm-reduction approaches to smoking. b) This guidance will support a number of related policy documents including: Cancer reform strategy (DH 2007a). Equity and excellence: liberating the NHS (DH 2010a). Health inequalities: progress and next steps' (DH 2008). Healthy lives, healthy people: our strategy for public health in England (DH 2010b). Healthy lives, healthy people: a tobacco control plan for England (DH 2011a). 'Improving outcomes: a strategy for cancer' (DH 2011b). National stroke strategy (DH 2007b). Tobacco: harm reduction scope Page 1 of 15

2 'No health without mental health: a cross-government mental health strategy for people of all ages' (DH 2011c). Securing good health for the whole population (Wanless 2004). The NHS outcomes framework 2011/12 (DH 2010c). The operating framework for the NHS in England 2011/12 (DH 2011d). c) This guidance will support a range of UK international agreements including: the EU Directive on tobacco products (European Union 2001) and the WHO framework convention on tobacco control (World Health Organization 2003). d) This guidance will provide recommendations for good practice based on the best available evidence of effectiveness, including cost effectiveness. It is aimed at professionals, commissioners and managers with public health as part of their remit. It is especially aimed at those involved in smoking cessation services within the NHS, local authorities and the wider public, private, voluntary and community sectors. It will also be of interest to members of the public, especially people who want to stop or cut down the amount they smoke. e) In this guidance, tobacco harm reduction means reducing the illnesses and deaths caused by smoking tobacco among people who smoke and those around them. People who smoke can do this by: stopping smoking altogether cutting down prior to quitting smoking less abstaining from smoking temporarily. Tobacco: harm reduction scope Page 2 of 15

3 These changes in behaviour might involve completely or partially substituting the nicotine from smoking with nicotine from less hazardous sources that do not contain tobacco. (Examples include pharmaceutical nicotine and electronic cigarettes.) These nicotine sources could be used either temporarily or indefinitely. Although some definitions of harm reduction include the use of reduced exposure cigarettes and oral tobacco products, products containing tobacco will not be covered by this guidance. f) The guidance will complement other NICE guidance on stopping smoking. For further details, see section 6. This guidance will be developed using the NICE public health programme process. 3 The need for guidance a) Tobacco smoking remains the single greatest cause of preventable illness and early death in England, accounting for 81,400 deaths in 2009 (NHS Information Centre 2010). Treating smoking-related illnesses was estimated to cost the NHS 2.7 billion in 2006/07 (Callum et al. 2010). The overall financial burden to society has been estimated at billion a year. This includes both NHS costs and loss of productivity due to illness and early death (Nash and Featherstone 2010). b) Although smoking rates have declined sharply in the last 30 years, more than one in five adults in England (21%) smoked cigarettes in 2008.Those from routine and manual backgrounds were about twice as likely to smoke as those from managerial or professional backgrounds (29% versus 14%) (NHS Information Centre 2010). Smoking is responsible for at least half of the excess risk of premature death faced by middle-aged men in manual occupations, compared to those in professional groups (Jha et al. 2006). The health of babies born into lower-income households is Tobacco: harm reduction scope Page 3 of 15

4 also disproportionately affected by second-hand smoke (see below). In addition, as they are growing up in an environment where smoking is the norm, they are more likely to take up tobacco use in adolescence (British Medical Association 2007; Royal College of Physicians 2010). c) Exposure to secondhand smoke in the home causes an estimated 11,000 deaths a year in the UK from lung cancer, stroke and ischaemic heart disease (Jamrozik 2005). It is estimated that 5 million children under the age of 16 are exposed to secondhand smoke at home (British Medical Association 2007). Children s vulnerability to tobacco smoke has been well documented. A recent UK report estimated that passive smoking caused 22,600 new cases of wheeze and asthma, 121,400 new cases of middle ear infection and 40 sudden infant deaths (Royal College of Physicians 2010). d) About two thirds (67%) of people who smoke say they would like to quit and three quarters of current smokers say they have tried to stop in the past. In 2008, about a quarter (26%) had tried in the past year (Lader 2009). This may indicate how difficult it is to quit. It is estimated that 4% of people who quit without using behavioural or pharmacological therapy are successful for a year or longer (Hughes et al. 2004). About 15% of people who quit using the NHS Stop Smoking Service are still not smoking a year later (Ferguson et al. 2005). e) Those from routine and manual groups take in more nicotine from cigarettes than more affluent people (Jarvis 2010). This increases their exposure to the other toxins in tobacco smoke and, thus, increases their risk of smoking-related disease. Higher nicotine exposure can also make it harder for them to quit and they are more likely to cut down first rather than quit smoking abruptly Tobacco: harm reduction scope Page 4 of 15

5 (Siahpush et al. 2010). As a result, people on a low income may need additional support to quit (The Marmot Review Team 2010). f) The harm associated with cigarette smoking is almost entirely caused by the toxins and carcinogens found in tobacco smoke and not the nicotine (Royal College of Physicians 2007). However, although smokeless tobacco is less harmful, the risks vary between products and are not inconsequential (Royal College of Physicians 2007). g) Nicotine is the addictive chemical that makes it difficult to quit tobacco. The UK s Medicines and Healthcare Products Regulatory Agency (MHRA) has given marketing authorisation for medicinal products containing nicotine that are used for cutting down, temporary abstinence or harm reduction from smoking. These products are known as nicotine replacement therapy. A number of other, non-tobacco-based nicotine products, available in the UK, are not regulated. These products, which include electronic cigarettes, are currently being considered by the MHRA 1. 4 The guidance Public health guidance will be developed according to NICE processes and methods. For details see section 5. This document defines exactly what this guidance will (and will not) examine, and what the guidance developers will consider. The scope is based on a referral from the DH (see appendix A). 1 The Medicines and Healthcare Products Regulatory Agency is currently overseeing a programme of research and information gathering on the regulation of nicotine-containing products. The results of the programme will be announced in Spring 2013 (For further information, visit Tobacco: harm reduction scope Page 5 of 15

6 4.1 Who is the focus? Groups that will be covered The guidance will cover people of all ages who: want to quit smoking but feel unable to do so abruptly (that is, they want to cut down before quitting) are not willing or able to quit, but want to reduce the harm that smoking is doing to their health (or to the health of those around them) want to quit smoking but are not willing or able to stop using nicotine want to stop smoking temporarily, for example, while at work. The guidance will focus, in particular, on groups who are more likely to smoke (this includes those in routine and manual occupations) Groups that will not be covered The guidance will not cover pregnant women. 4.2 Approaches Approaches that will be covered The guidance will cover the following tobacco harm-reduction approaches (see section 2[d] for a definition): a) Pharmacotherapies that are (or will be) licensed for cutting down, temporary abstinence or harm reduction 2. b) Other non-tobacco nicotine-containing products 3, such as electronic nicotine delivery systems (sometimes known as electronic cigarettes or e-cigarettes ) and topical gels. 2 Nicotine replacement therapy (NRT) products are the only pharmacotherapy currently with UK marketing authorisation (that is, they are licensed ) for cutting down, temporary abstinence or harm reduction. For further details, see It is possible that other products may be licensed before consultation begins on the draft NICE guidance, in which case these will be considered. Tobacco: harm reduction scope Page 6 of 15

7 c) Behavioural support, counselling or advice for individuals or groups. d) Self-help Approaches that will not be covered The guidance will not include: Any products containing tobacco. This includes products which are claimed to deliver reduced levels of toxicity (such as 'low tar' cigarettes) or which reduce exposure to tobacco smoke, for example, by warming instead of burning it. Products that are smoked that do not contain tobacco, such as herbal cigarettes. Smokeless tobacco products 4 such as gutka, or paan. (These products are associated with a number of health problems and are the focus of NICE guidance in development see section 6.) Snus or similar oral snuff products as defined in the European Union s Tobacco Product Directive (European Parliament and the Council of the European Union 2001). Alternative or complementary therapies, such as hypnotherapy or acupuncture. (Note: non-nhs services, including complementary therapies, were reviewed for NICE public health guidance 10 on Smoking cessation services.) 3 The Medicines and Healthcare Products Regulatory Agency is currently overseeing a programme of research and information gathering on the regulation of nicotine-containing products. The results of the programme will be announced in Spring 2013 (For further information, visit 4 Smokeless tobacco is any product containing tobacco that is placed in the mouth or nose and not burned. Tobacco: harm reduction scope Page 7 of 15

8 4.3 Key questions and outcomes Below are the overarching questions that will be addressed, along with some of the outcomes that would be considered as evidence of effectiveness: Question 1: How effective and cost effective are pharmacotherapies in helping people to: cut down smoking before quitting cut down or abstain from smoking, temporarily or indefinitely? How effective and cost effective are different combinations of NRT products? Question 2: How effective and cost effective are nicotine-containing products in helping people to: cut down smoking before quitting cut down or abstain from smoking, temporarily or indefinitely? Question 3: Which kinds of behavioural support, counselling, advice or selfhelp (with or without pharmacotherapy) are effective and cost effective in helping people to: cut down smoking before quitting cut down or abstain from smoking, temporarily or indefinitely. Question 4: Do some tobacco harm-reduction approaches have a differential impact on different groups (for example, people of different ages, gender, socioeconomic status or ethnicity)? Question 5: Are there any unintended consequences from adopting a tobacco harm-reduction approach, for example, does it deter people from trying to stop smoking? Question 6: How can practitioners deliver messages about tobacco harm reduction without weakening the impact of advice about the benefits of stopping smoking? Tobacco: harm reduction scope Page 8 of 15

9 Question 7: What factors might act as barriers or facilitators to tobacco harmreduction approaches? Question 8: Does long-term use of pharmacotherapies or nicotine-containing products have any ill-effects on health? Expected outcomes: Continuous abstinence for 6 or 12 months or longer (biochemically validated or self-reported). Abstinence at 6 or 12 months or later (biochemically validated or selfreported). A sustained reduction for 6 or 12 months or longer (biochemically validated or self-reported) Status of this document This is the final scope, incorporating comments from a 4-week consultation. 5 Further information The public health guidance development process and methods are described in The NICE public health guidance development process: An overview for stakeholders including public health practitioners, policy makers and the public (second edition, 2009) available at and Methods for development of NICE public health guidance (second edition, 2009) available at 6 Related NICE guidance Published Quitting smoking in pregnancy and following childbirth. NICE public health guidance 26 (2010). Available from 5 Please note: these tests only provide limited information, particularly when used to assess abstinence over differing lengths of time. Tobacco: harm reduction scope Page 9 of 15

10 School-based interventions to prevent smoking. NICE public health guidance 23 (2010). Available from Preventing the uptake of smoking by children and young people. NICE public health guidance 14 (2008). Available from Smoking cessation services. NICE public health guidance 10 (2008). Available from Varenicline for smoking cessation. NICE technology appraisal 123 (2007). Available from Workplace interventions to promote smoking cessation. NICE public health guidance 5 (2007). Available from Brief interventions and referral for smoking cessation. NICE public health guidance 1 (2006). Available from Under development Smokeless tobacco: South Asians. NICE public health guidance (publication expected September 2012). Smoking cessation in secondary care. NICE public health guidance (publication expected Summer 2013). Tobacco: harm reduction scope Page 10 of 15

11 Appendix A Referral from the Department of Health In February 2010 the Department of Health asked NICE: 'To produce public health guidance for PCTs and NHS smoking cessation services on the use of harm-reduction approaches to smoking cessation.' Tobacco: harm reduction scope Page 11 of 15

12 Appendix B Potential considerations It is anticipated that the Programme Development Group (PDG) will consider the following issues in relation to the approaches considered: Whether the approach is based on an underlying theory or conceptual model. The relative effectiveness and cost effectiveness of different approaches. Critical elements. For example, whether effectiveness and cost effectiveness varies according to: the diversity of the population (for example, in terms of the person s age, gender or ethnicity) the status of the person delivering it and the way it is delivered its frequency, length and duration, where it takes place and whether it is transferable to other settings its intensity. Any trade-offs between equity and efficiency. Any techniques that may be more (or less) effective, for example, drawing up a schedule to help someone reduce the amount they smoke. Any factors that prevent or support effective implementation. Any adverse or unintended effects, such as encouraging people only to cut down smoking instead of stopping completely. Current practice. Availability and accessibility for different groups. Tobacco: harm reduction scope Page 12 of 15

13 Appendix C References British Medical Association (2007) Breaking the cycle of children s exposure to cigarette smoke. London: British Medical Association Callum C, Boyle S, Sandford A (2010) Estimating the cost of smoking to the NHS in England and the impact of declining prevalence in Health Economics, Policy and Law [online}. Available from Department of Health (2007a) Cancer reform strategy. London: Department of Health Department of Health (2007b) National stroke strategy. London: Department of Health Department of Health (2008) Health inequalities: progress and next steps. London: Department of Health Department of Health (2010a) Equity and excellence: liberating the NHS. London: Department of Health Department of Health (2010b) Healthy lives, healthy people: our strategy for public health in England. London: Department of Health Department of Health (2010c) The NHS outcomes framework 2011/12. London: Department of Health Department of Health (2011a) Healthy lives, healthy people: a tobacco control plan for England. London: Department of Health Department of Health (2011b) Improving outcomes: a strategy for cancer. London: Department of Health Department of Health (2011c) No health without mental health: a crossgovernment mental health strategy for people of all ages. London: Department of Health Tobacco: harm reduction scope Page 13 of 15

14 Department of Health (2011d) The operating framework for the NHS in England 2011/12. London: Department of Health European Parliament and the Council of the European Union (2001) Directive 2001/37/EC [online]. Available online at Ferguson J, Bauld L, Chesterman J et al. (2005) The English smoking treatment services one-year outcomes. Addiction 100 (supplement 2): Hughes J, Keely J, Maud S (2004) Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 99 (1) Jamrozik K (2005) Estimate of deaths attributable to passive smoking among UK adults: database analysis. BMJ 330 (7495): 812 Jarvis M (2010) Smoking and health inequalities. In: Inquiry into the effectiveness and cost effectiveness of tobacco control. London: All Party Group on Smoking and Health Jha P, Peto R, Zatonski W et al. (2006) Social inequalities in male mortality, and in male mortality from smoking: indirect estimation from national death rates in England and Wales, Poland and North America. Lancet 368 (9533): Lader D (2009) Smoking-related behaviour and attitudes, 2008/09. Opinions survey report 40 [online]. Available from Nash R, Featherstone H (2010) Cough up: balancing tobacco income and costs in society. London: Policy Exchange NHS Information Centre (2010) Statistics on Smoking: England Leeds: NHS Information Centre Tobacco: harm reduction scope Page 14 of 15

15 Royal College of Physicians (2007) Harm reduction in nicotine addiction. London: Royal College of Physicians Royal College of Physicians (2010) Passive smoking and children. London: Royal College of Physicians Siahpush M, Yong H-H, Borland R et al. (2010) Socioeconomic position and abrupt versus gradual method of quitting smoking: findings from the International Tobacco Control Four-Country Survey. Nicotine and Tobacco Research 12 (supplement 1): S58 63 The Marmot Review Team (2010) Fair society, healthy lives. Strategic review of health inequalities in England, post London: The Marmot Review Wanless D (2004) Securing good health for the whole population: final report. London: HM Treasury World Health Organization (2003) WHO framework convention on tobacco control [online]. Available from [accessed 15 March 2011] Tobacco: harm reduction scope Page 15 of 15