Tobacco - harm reduction: call for evidence - safety and risks
The National Institute for Health and Clinical Excellence (NICE) has been asked by the Department of Health to develop public health guidance on the use of tobacco harm reduction approaches to smoking cessation. See the final scope for this guidance for more information.
To inform the development of the guidance NICE has commissioned a number of reviews and an economic analysis. One of the reviews focuses on tobacco harm reduction technologies and aims to:
- summarise the evidence on the safety, or risks, of tobacco harm reduction technologies when used by people who may or may not continue to smoke. This includes people who may use nicotine replacement therapy (NRT) or other nicotine containing products (NCPs) indefinitely.
- summarise the pharmacokinetic factors which influence the safety, or risks, of tobacco harm reduction technologies when used as above, principally NRT and other nicotine containing products.
We would like to receive details of evidence that relate to the above aims and more specifically address the questions set out below:
Question 1: What specific risks have been associated with the technologies within the scope of the review? What adverse events or serious adverse events have been identified and how frequently do they occur? Is there any evidence that use of the technologies may cause significant drug interactions? Of particular concern is whether there are any interactions between nicotine and psychiatric medication since smoking prevalence is much higher among individuals with mental illness.
Question 2: What data are available to support the safety of long term use of the technologies?
Question 3: What are the risks associated with use of NCPs which are currently unlicensed? (Questions especially relevant to the e-cigarette: What is the nature of the absorbent material? Are there other components present in the nicotine solution used in this device? Do these represent risks to the user? Are any harmful chemicals released when the nicotine solution is heated?)
Question 4: Do the data suggest the technologies could generate an appropriate blood concentration of nicotine, a concentration high enough to prevent craving and withdrawal symptoms, yet not high enough to result in nicotine toxicity?
Question 5: Do the data suggest the combination of nicotine replacement therapies could generate an appropriate blood concentration of nicotine, a concentration high enough to prevent craving and withdrawal symptoms, yet not high enough to result in nicotine toxicity?
Question 6: Are kinetic data available which allow comparison of the relative bioavailability of different technologies i.e. maximum (peak) concentration (Cmax), time to peak concentration (Tmax) and half life (t ½)?
Question 7: Do the data support the safety of an approach where smokers receive doses of medicinal nicotine (potentially by different routes) while continuing to smoke. Is there a greater risk of adverse effects?
Question 8: There are marked differences in smoking rates among socioeconomic groups, Black and minority ethnic (BME) groups, age (lifestage) and people with mental illness. Do the data suggest there may be inequalities among these groups with respect to the risk, safety and pharmacokinetics of smoking harm reduction technologies?
Appendix B of the guidance scope lists some further issues that we anticipate the Programme Development Group (PDG) will consider in relation to the approaches considered for the guidance.
We are interested in a broad range of different types of evidence. This includes quantitative or qualitative research, published or unpublished.
Please note we not need to receive evidence on the following as they will not be covered by the guidance:
- Pregnant women
- 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 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’.)
- Behavioural, social or educational interventions e.g. support groups, counselling.
In terms of published material, we are interested in identifying studies that have been published since 1980 that relate to the questions outlined above. The studies may be published in journals, texts or monographs.
In terms of unpublished material, we are interested in identifying unpublished manuscripts relating to research conducted since 1980, or any ongoing research that is being conducted, and which relates to the review questions outlined above.
Please note that the following material is not eligible for consideration:
- Promotional material
- Undocumented assertions of effectiveness.
- Opinion pieces
- Forms with electronic attachments of published material, or hard copies of published material. For copyright reasons, we cannot accept these copies. However, if you give us the full citation, we will obtain our own copy
Instructions for published material
Please send either full reference details (which are to include author/s, title, date, journal or publication details including volume and issue number and page numbers), - not a PDF/Word attachment or hard copy - using this form by 5pm on 30 August 2011 to email@example.com
Instructions for unpublished material
If you are aware of trials/ongoing research relevant to our questions which are in progress please could you help us to identify that information by providing relevant information such as a link to a registered trial with the Cochrane Central Register of Controlled Trials (Clinical Trials), or with the US National Institutes of Health trials registry.
If you wish to submit academic in confidence material (i.e. written but not yet published), or commercial in confidence (i.e. internal documentation), please could you highlight which sections are confidential by using the highlighter function in Word. Such content will not be made public. Please refer to section 4.4 of the Process Manual for further information on submissions of confidential material.
We look forward to receiving information on this and thank you in advance for your help.
Products that will be covered
Licensed nicotine containing medicines (both prescription only medications and those available over the counter), including
- nicotine chewing gum
- nicotine transdermal patches
- nicotine inhalers
- nicotine microtabs
- nicotine nasal spray
- nicotine lozenges
- Non licensed nicotine containing products (e.g. electronic cigarettes)
Products that will not be covered
- Tobacco (oral moist tobacco [snus], oral compressed tobacco, oral loose tobacco, bidis, pipe tobacco, snuff)
Tobacco containing products, including those that are potential reduced exposure products (PREPS):
- combustible products that are smoked e.g. low nitrosamine or low tar cigarettes
- cigarette-like products that heat, rather than burn tobacco
- Medicines that do not contain nicotine but that are licensed for use in the UK for smoking cessation: bupropion and varenicline
Groups that will be covered
Smokers of all ages who:
- want to quit smoking but feel unable to do so abruptly or
- smoke and do not feel willing or able to quit but want to reduce the amount they smoke.
Particular attention will be paid to following:
- Socio-economic status
- Black and minority ethnic groups
- Age (lifestage: children, adults, older people)
- People taking psychiatric medication
This page was last updated: 11 August 2011