When accompanied by behavioural support, nicotine replacement therapy (NRT) has proven to be effective for smoking cessation, including for adolescents, although to a lesser degree. Since 2008, the National Institute for Health and Care Excellence recommends prescribing slow acting NRTs, such as patches and gum, for young smokers aged 12 to 17 years old, combined with behavioural support. Further information on the use of NRTs, which includes nicotine gum, in local NHS Stop Smoking Services is available at the following link:

https://digital.nhs.uk/data-and-information/publications/statistical/statistics-on-nhs-stop-smoking-services-in-england/april-2021-to-march-2022/part-3---stop-smoking-services.

In 2022/23, 360,619 NRTs were dispensed, a decrease from 2021/22, in which 374,169 NRTs were dispensed. The number of NRTs prescribed has been decreasing for a number of years, and is now less than a quarter of the total dispensed items in 2010/11, which was 1.5 million. However, the Department does not hold data on the level of nicotine gum usage specifically, for either adults or children.

Our assessment is that nicotine replacement therapy, such as gum and patches, as well as vapes, alongside behavioural support from stop smoking services, are the most effective ways to reduce smoking. This assessment is based on the ‘Nicotine vaping in England’ report published in September 2022, and the National Institute for Health and Care Excellence guideline PH209, ‘Tobacco: preventing uptake, promoting quitting and treating dependence’ published in 2021.

The 2022 ‘Nicotine vaping in England’ report also includes a chapter on heated tobacco products. Although there is currently a limited evidence base on the health harms presented by heated tobacco products, it is clear that they do pose harm to users. The Government does not recommend use of these products and encourages users to quit.

There is limited research and evidence into the harms of nicotine pouches and their ability to support smoking quit attempts. However, in April this year the Committee on Toxicity published their ‘Statement on the bioavailability of nicotine from the use of oral nicotine pouches and assessment of the potential toxicological risk to users’, which is available at the following link:

https://cot.food.gov.uk/Statement%20on%20the%20bioavailability%20of%20nicotine%20from%20the%20use%20of%20oral%20nicotine%20pouches%20and%20assessment%20of%20the%20potential%20toxicological%20risk%20to%20users

It has not proved possible to respond to the hon. Member in the time available before Prorogation.

The following table shows the number of nicotine dependence prescription items dispensed in the community, via an FP10 form, in England 2010-17. There are various other routes in which such medication can be supplied to a patient from the National Health Service including from community pharmacies via voucher schemes and a direct supply to patients from a Patient Group Direction, this data is not collected centrally.

Source: Prescription Cost Analysis (PCA) NHS Digital

Notes:

Prescriptions are written on a prescription form known as an FP10. Each single item written on the form is counted as a prescription item.

PCA Data

Prescription information is taken from the PCA system, supplied by NHS Prescription Services, a division of NHS Business Services Authority, and is based on a full analysis of all prescriptions dispensed in the community i.e. by community pharmacists and appliance contractors, dispensing doctors, and prescriptions submitted by prescribing doctors for items personally administered in England. Also included are prescriptions written in Wales, Scotland, Northern Ireland and the Isle of Man but dispensed in England. The data do not cover drugs dispensed in hospitals, including mental health trusts, or private prescriptions.

Prescribers are general practitioners, hospital doctors, dentists and non-medical prescribers such as nurses and pharmacists.

British National Formulary (BNF) Classifications

The PCA system uses the therapeutic classifications defined in the BNF using the classification system prior to edition 70. Information on why a drug is prescribed is not available in this dataset. Since drugs can be prescribed to treat more than one condition, it may not be possible to separate the different conditions for which a drug may have been prescribed.

The primary purpose of the BNF is to provide information for clinicians. The format of the BNF was changed with Edition 70 (September 2015 - March 2016) to make it more user friendly. However, the NHS Business Service Authority, who process dispensed prescription forms and collects dispensed prescribing data and produce the PCA data, continue to use the old BNF classification system to code medicines, which has become widely used in the United Kingdom as a classification to allow comparisons between drug groups. For example, it is used to report cost and trend in medicines use and supports several NHS Digital official publications. The data are used in many NHS IT systems.

There is no central National Health Service collection of information on nicotine replacement therapy dispensed in hospitals in England.

This information is not available in the format requested.

The Department has and will continue to keep abreast of all evidence and consider it in developing policy. The report published by the Royal College of Physicians is consistent with the Government’s current policy that the best thing a smoker can do for their health is to quit smoking and quit for good, but we recognise that e-cigarettes have a role to play in helping some people to quit.

The Department has and will continue to keep abreast of all evidence and consider it in developing policy. The report published by the Royal College of Physicians is consistent with the Government’s current policy that the best thing a smoker can do for their health is to quit smoking and quit for good but that e-cigarettes have a role to play in helping some people quit.

Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects ADR reports from across the United Kingdom and includes all medicines, including those from prescriptions, those bought over-the-counter in pharmacies or general retail sales outlets. Reports are also received for herbal medicines and other unlicensed medicines.

The table below shows the total number of UK spontaneous ‘suspected’ ADR reports in association with school children (ages 5-16), received by the MHRA up to 30 September 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline.

There is unknown and variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence. We are unable to calculate this incidence because neither the total number of reactions occurring in the population, nor the number of patients using the drug is known.

The MHRA does not hold data on the number of fatalities associated with nicotine replacement therapies varenicline or e-cigarettes in other countries.

The requirements for medicines labelling and patient information are set out in European and national legislation. Provisions already exist for a series of warning statements to appear on the packs of nicotine replacement therapy medicines. All medicines are also accompanied by a patient information leaflet which includes detailed information on the safe and effective use of the product and warnings about known adverse effects.

Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects ADR reports from across the United Kingdom and includes all medicines, including those from prescriptions, those bought over-the-counter in pharmacies or general retail sales outlets. Reports are also received for herbal medicines and other unlicensed medicines.

The table below shows the total number of UK spontaneous ‘suspected’ ADR reports in association with school children (ages 5-16), received by the MHRA up to 30 September 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline.

There is unknown and variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence. We are unable to calculate this incidence because neither the total number of reactions occurring in the population, nor the number of patients using the drug is known.

The MHRA does not hold data on the number of fatalities associated with nicotine replacement therapies varenicline or e-cigarettes in other countries.

The requirements for medicines labelling and patient information are set out in European and national legislation. Provisions already exist for a series of warning statements to appear on the packs of nicotine replacement therapy medicines. All medicines are also accompanied by a patient information leaflet which includes detailed information on the safe and effective use of the product and warnings about known adverse effects.

Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects ADR reports from across the United Kingdom and includes all medicines, including those from prescriptions, those bought over-the-counter in pharmacies or general retail sales outlets. Reports are also received for herbal medicines and other unlicensed medicines.

The table below shows the total number of UK spontaneous ‘suspected’ ADR reports in association with school children (ages 5-16), received by the MHRA up to 30 September 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline.

There is unknown and variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence. We are unable to calculate this incidence because neither the total number of reactions occurring in the population, nor the number of patients using the drug is known.

The MHRA does not hold data on the number of fatalities associated with nicotine replacement therapies varenicline or e-cigarettes in other countries.

The requirements for medicines labelling and patient information are set out in European and national legislation. Provisions already exist for a series of warning statements to appear on the packs of nicotine replacement therapy medicines. All medicines are also accompanied by a patient information leaflet which includes detailed information on the safe and effective use of the product and warnings about known adverse effects.

Reports of ‘suspected’ adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme; the Yellow Card Scheme. The scheme collects ADR reports from across the whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. Reports are also received for herbal medicines and other unlicensed medicines.

There is unknown and a variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence, as such we cannot provide the number of serious health events per thousand. We are unable to calculate this incidence because neither the total number of reactions occurring in the population, nor the number of patients using the drug is known.

The following table shows the total number of serious UK spontaneous ‘suspected’ ADR reports received by the MHRA between 23 July 2013 and 22 July 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline:

The Government wants to enable nicotine containing products, including electronic cigarettes, that meet appropriate standards of safety, quality and efficacy to be widely available to help reduce the harms from smoking, to smokers and those around them. It has recognised the potential of e-cigarettes to assist some smokers to quit.

Consistent delivery of nicotine will help to ensure that products can meet the need of smokers and that they have information to help manage their use of these products.

Any electronic cigarette product licensed by the Medicines and Healthcare products Regulatory Agency for cutting down, quitting or reducing the harms of smoking could be promoted within the medicines regulatory framework. This allows products to be advertised within their licensed indication and their rational use must be promoted. Medicines regulation prohibits advertising to children.

The National Institute for Health and Care Excellence (NICE) guidance on tobacco harm reduction (www.nice.org.uk/PH45) recommends that health professionals should offer only licensed nicotine-containing products to people who smoke, as part of a harm-reduction strategy. Licensed products are required to demonstrate that they meet appropriate standards of safety, quality and that they are effective in reducing the harms of smoking.

There is extensive evidence around the efficacy of nicotine replacement therapy for smoking cessation, cutting down and for harm reduction. A Cochrane review looked at 132 trials of nicotine replacement therapy (NRT), in over 40,000 people. It found evidence that all forms of NRT made it more likely that a person's attempt to quit smoking would succeed. The chances of stopping smoking were increased by 50 to 70%.

Wider availability of licensed NRT has been a priority for successive Governments with the aim of ensuring that NRT is available wherever cigarettes can bought, as well as being available on prescription.