Asked by: David T C Davies (Conservative - Monmouth)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what the implications are for his policy of the statement by the Chief Medical Officer that e-cigarettes represent one of the three major health threats to the UK.
Answered by Jane Ellison
The Government’s policy on e-cigarettes is to enable the availability of products which meet appropriate standards of safety, quality and efficacy to support smoking cessation and to reduce the harm of smoking to smokers and those around them.
Beyond licenced medicinal products, the Government is working to transpose the provision of the Tobacco Products Directive (Directive 2014/40/EU) which will provide a framework for e-cigarettes which are not licensed as medicines. In addition to the safeguards the Tobacco Products Directive will introduce, the Government is committed to banning the sale of e-cigarettes to under 18s to protect children from the potential for nicotine addiction and the unknown risks of using e-cigarettes to developing lungs.
The Government’s policy will remain evidence based and we will continue to closely monitor all emerging research.
Asked by: David T C Davies (Conservative - Monmouth)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many adverse drug reaction reports have been received relating to the use of (a) nicotine replacement therapies, (b) varenicline and (c) e-cigarettes by school children.
Answered by Jane Ellison
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.
| Total Number of Reports |
Varenicline | 3 |
Nicotine Replacement therapy | 8 |
E-Cigarettes | 0 |
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.