Harm-reduction strategies can help people who are unable or unwilling to stop smoking completely and will support existing stop smoking services, says Dr Tonya Gillis

NICE Accreditation Mark

NICE Public Health Guidance 45 on Tobacco: harm-reduction approaches to smoking has been awarded the NICE Accreditation Mark.

This Mark identifies the most robustly produced guidance available. See evidence.nhs.uk/accreditation for further details.

T obacco smoking remains the single greatest cause of preventable illness and early death in England, accounting for 79,100 deaths among adults aged 35 years and over in 2011.1 Smoking contributes more to the pattern of health inequalities than any other single cause. The overall financial burden of smoking has been estimated at £13.74 billion a year, which includes both costs to the NHS and loss of productivity as a result of illness and early death.2

Nicotine is highly addictive, which is why people find it so difficult to stop. Put simply, people smoke because of the nicotine, but die because of the toxins in tobacco smoke. Smoking tobacco harms not only smokers, but also people around them, with children being particularly vulnerable to second-hand smoke. Half of all smokers say that they want to cut down3 but some people may not be ready to give up smoking in one step.


Harm-reduction approaches provide an alternative choice for people who are not currently interested in quitting smoking. Although existing evidence is unclear about the health benefits of a reduction in smoking, for some people this reduction can kick-start a gradual change in behaviour that eventually leads them to quit, especially if they use licensed nicotine-containing products.4

Evidence shows that a reduction in smoking, without the support of a nicotine-replacement product, is unlikely to yield any health benefits because of compensatory smoking (such as inhaling more deeply).5 Ideally, people will seek support from stop smoking services, but harm-reduction options are also available for those not using these services. The key point is to take action to reduce the harm that smoking tobacco causes, and NICE has produced guidance that provides people with new choices on how to achieve this goal.4

NICE guidance on harm-reduction approaches to smoking

NICE has published Public Health (PH) Guidance 45,Tobacco: harm-reduction approaches to smoking
(see www.nice.org.uk/Ph35) to help reduce tobacco-related harm for people who do not feel able to stop smoking in one step.4 The publication of this landmark guidance widens the options for primary care and other professionals supporting people who do not feel able to stop smoking in one step, but who want to reduce tobacco-related harm.4

If a person finds it hard to quit in one step, they are more likely to stop smoking in the longer term if they cut down, and are more likely to stop successfully if they use nicotine replacement therapy (NRT) while they are cutting down.4

Who can this guidance help?

Following a robust evaluation of the evidence, including economic and expert reviews, NICE Ph35 is the first guidance in the world to recommend that licensed nicotine-containing products can be used to help people to reduce the amount they smoke, especially if they are highly dependent on nicotine.4 This includes people who:

  • may not be able (or do not want) to stop smoking in one go
  • want to stop smoking without necessarily giving up nicotine
  • may not be ready to stop but want to reduce the amount they smoke.

The best way for people who smoke to reduce the harm from smoking and to improve their health is to stop smoking completely, and in general the best chance of doing this successfully is still to quit in one step. NICE Ph35, however, recognises that for people who have been unable to stop in one step, the new approaches recommended in this guidance can help.

NICE Ph35 may also encourage more people to consider reducing how much they smoke, with the support of licensed nicotine-containing products (e.g. NRT patches and gum) and advice from stop smoking services, both of which are proven to be effective.6

Stop smoking services provide highly cost-effective interventions to help people stop smoking, and the recommendations in NICE Ph35 are intended to support and extend the reach and impact of these existing services. The guidance is clear that any investment in the new harm-reduction approaches recommended should not detract from the effective services currently provided.4

For a summary of the harm reduction approaches covered by the guidance, see Box 1, below.

Box 1: Harm reduction approaches covered by the guidance4

  • Stopping smoking, but using one or more licensed nicotine-containing products as long as needed to prevent relapse
  • Cutting down prior to stopping smoking (cutting down to quit*):
    • with the help of one or more licensed nicotine-containing products
    • (the products may be used as long as needed to prevent relapse)
    • without using licensed nicotine-containing products
  • Smoking reduction:
    • with the help of one or more licensed nicotine-containing products (the products may be used as long as needed to prevent relapse)
    • without using licensed nicotine-containing products
  • Temporary abstinence from smoking:
    • with the help of one or more licensed nicotine-containing products
    • without using licensed nicotine-containing products.

* Someone gradually reduces the amount of tobacco they smoke with a view to stopping smoking within the next few months.
† Abstaining from smoking. This could be for a particular event or series of events, in a particular location, for specific time periods (for example, while at work, during long-haul flights or during a hospital stay), or even for the foreseeable future. (The latter might include, for example, abstinence while serving a prison sentence or while detained in a secure mental health unit.)

NICE.Tobacco: harm-reduction approaches to smoking. Public health guidance 45. NICE, 2013. Available at:www.nice.org.uk/Ph35. Reproduced with kind permission.

NICE recommendations

NICE Ph35 makes a wide range of recommendations that cover a number of aspects, including:4

  • raising awareness of licensed nicotine-containing products
  • choosing a harm-reduction approach
  • behavioural support
  • advising on, and supplying, licensed nicotine-containing products
  • follow-up appointments
  • commissioning stop smoking services
  • education and training for practitioners.

Some of these recommendations are summarised below.

Raising awareness of licensed nicotine-containing products

The guideline recommends that:4

  • organisations responsible for tackling tobacco use (e.g. stop smoking services and local authorities) should provide information for the public, highlighting licensed nicotine-containing products as an effective way of reducing the harm from tobacco for both the person smoking and those around them
  • training bodies (e.g. local education and training boards) should include the principles and practice of tobacco harm reduction (as outlined in NICE Ph35) in all relevant training for practitioners
  • certain national and local organisations (including professional bodies with a public health responsibility, health and wellbeing boards, and organisations providing practitioner training in reduction of smoking harm) should provide self-help materials to meet the needs of groups where smoking prevalence
  • and tobacco dependency is high
  • tobacco retailers, and retailers of licensed nicotine-containing products, should display licensed nicotine-containing products in shops and supermarkets and on websites selling cigarettes and tobacco products.

Choosing a harm-reduction approach

Stop smoking advisers and healthcare professionals should:4

  • advise people to stop smoking in one step, but suggest a harm-reduction approach for people who are not ready (or are not able) to stop in one step
  • ensure people know that licensed nicotine-containing products (e.g. nicotine patches, gum, or spray) make it easier to:
    • cut down smoking prior to stopping
    • reduce the amount they smoke.

Use of licensed nicotine-containing products also:

  • helps to avoid compensatory smoking
  • increases the chances of a person stopping smoking in the longer term.4

Behavioural support

Advisers should discuss reduction strategies, which may include:4

  • increasing the time interval between cigarettes
  • delaying the first cigarette of the day
  • choosing periods during the day (or specific occasions) when the person will not smoke.

Advising on, and supplying, licensed nicotine-containing products

Advisers and healthcare professionals should:4

  • offer all types of licensed nicotine-containing products to people who smoke, as part of a harm-reduction strategy
  • offer products either singly or in combination, according to the individual’s preference and level of dependence (e.g. patches could be offered with gum or lozenges)
  • advise people that using a combination of products is likely to be more successful than using just one, particularly if they are highly dependent smokers.

NICE implementation tools

NICE has developed the following tools to support implementation of Public Health guidance 45 (Ph35) on Tobacco: harm-reduction approaches to smoking. The tools are now available to download from the NICE website: www.nice.org.uk/Ph35

NICE support for commissioners

Costing reportCommissioning.eps

Costing reports are estimates of the national cost impact arising from implementation based on assumptions about current practice, and predictions of how it might change following implementation of the guideline.

Costing templateCommissioning.eps

A costing template helps services in estimating the local cost of implementing guidelines and public health guidance. This template allows individual NHS organisations and local health economies to quickly assess the impact guidance will have on local budgets.

NICE support for service improvement systems and audit

Baseline assessment toolAudit.eps

The baseline assessment tool is an Excel spreadsheet that can be used by organisations to identify if they are in line with practice recommended in NICE guidance and to help them plan activity that will help them meet the recommendations.

Follow-up appointments

The person should be invited to follow-up appointments to review progress, when:4

  • exhaled carbon monoxide level should be measured at appropriate intervals to gauge progress and help motivate the person
  • the person should be asked whether daily activities (e.g. climbing the stairs, walking uphill) have become easier.

Feedback should be used at these appointments to prompt discussion about the benefits of reducing smoking and (where appropriate) to encourage a further reduction in smoking, or stopping completely. People who have not achieved their goals should be:4

  • encouraged to try again
  • asked whether they would like to:
  • continue using the same licensed nicotine-containing product
  • try a different one (or a different combination of products).


In NICE Ph35 (and this article), the phrase ‘licensed nicotine-containing products’ refers only to the use of licensed nicotine-containing products that have been given marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) for use as a smoking cessation aid and for tobacco harm reduction. Authorisation by the MHRA ensures these products:

  • are effective
  • deliver nicotine safely
  • are manufactured to a consistent quality.

Currently, NRT products are the only type of licensed nicotine-containing product. They include:4

  • transdermal patches
  • gum
  • inhalation cartridges
  • sublingual tablets
  • nasal spray.

The MHRA announced in June 2013 that it intends to start regulating electronic cigarettes.7 So, if in future any electronic cigarettes or other new nicotine-containing products receive a licence from the MHRA to show that they are safe, effective, and quality assured, then they also will be covered by the recommendations in NICE Ph35.


The cost to the NHS in England of treating smoking-related illnesses is an estimated £2.7 billion a year.8 As 1 in 5 adults in England smokes, and around two-thirds of people who smoke say they would like to quit, Ph35 provides an important opportunity to reduce the harm associated with smoking tobacco.4

  1. Health and Social Care Information Centre. Statistics on smoking: England, 2012. Available at: catalogue.ic.nhs.uk/publications/public-health/smoking/smok-eng-2012/smok-eng-2012-rep.pdf
  2. Action on smoking and health (ASH).The economics of tobacco. Available at: www.ash.org.uk/files/documents/ASH_121.pdf
  3. Lindson N, Aveyard P, Hughes J. Reduction versus abrupt cessation in smokers who want to quit. Cochrane Database of Systematic Reviews 2010, Issue 3. Art No: CD008033. Available at: eprints.bham.ac.uk/1034/1/Lindson_2009_Cochrane_Database_of_Systematic_Reviews.pdf
  4. NICE.Tobacco: harm-reduction approaches to smoking. Public health guidance 45. NICE, 2013. Available at: www.nice.org.uk/PH45 (accessed 11 November 2013). nhs_accreditation
  5. Shiffman S, Ferguson S, Strahs K. Quitting by gradual smoking reduction using nicotine gum: a randomized controlled trial. Am J Prev Med 2009; 36 (2): 96–104.e1.
  6. Smoking in England website. STS documents. Smoking and smoking cessation in England. Findings from the Smoking Toolkit Study 2011. STS120501, 2013. Available at: www.smokinginengland.info/sts-documents/
  7. MHRA website.Nicotine containing products. www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice–M–T/NicotineContainingProducts/index.htm (accessed 22 October 2013).
  8. Callum C, Boyle S, Sandford A. Estimating the cost of smoking to the NHS in England and the impact of declining prevalence.Health Econ Policy Law 2011; 6 (4): 489–508. G