E-cigarette use or vaping: reminder to remain vigilant for suspected adverse reactions and safety concerns and report them to the Yellow Card scheme

Healthcare professionals should be vigilant for suspected adverse reactions and safety concerns associated with e-cigarettes and e-liquids, commonly known as vapes. Please report adverse reactions to the Yellow Card scheme and promote vigilance among patients.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 23 November 2023

• Therapeutic area: Respiratory disease and allergy

The MHRA is responsible for assessing whether the manufacturer or submitter has met the requirements in their notification for nicotine-containing e-cigarettes and e-liquids before the product comes to market. Trading Standards are responsible for enforcing the safety and quality of nicotine-containing e-cigarettes and e-liquids once they have been supplied to the UK market. The MHRA is also responsible for collecting and monitoring information about safety concerns related to these products through the Yellow Card Scheme.

Advice for healthcare professionals:

• document use of e-cigarette products, commonly referred to as ’vapes’ and ‘vaping’ in the medical records for all patients when taking a medical history (see Document e-cigarette use in medical records)
• advise patients to be vigilant about suspected adverse reactions that occur after the use of e-cigarettes and e-liquids
• advise patients to purchase and use legally compliant e-cigarette and e-liquid products
• report any suspected adverse reactions or safety concerns to the Yellow Card Scheme and include as many details as possible to ensure the MHRA can continue to perform safety vigilance

Advice for healthcare professionals to give to patients:

• continuous reviews by the Office for Health Improvement and Disparities (OHID) have found that whilst not risk-free, vaping (e-cigarette use) is significantly less harmful than smoking and is one of the most effective tools to help adults quit smoking
• only purchase and use ‘notified’ products from reputable retailers; check if a product has been notified to the MHRA and meets the minimum requirements for supply in the UK by verifying if the product is present in the MHRA ECIG Publications List (see Advice for consumers)
• talk to your doctor, a stop-smoking advisor or another healthcare professional if you experience any side effects or have any concerns about the product you are using
• report any side effects or safety concerns that you have to the Yellow Card scheme and provide as much information as possible to help the MHRA assess your report

E-cigarette use in the UK

The UK Government’s Smokefree 2030 plan for England, which aims to reduce the prevalence of tobacco smoking and its associated harms, encourages adult smokers to seek safer alternatives to smoking. As part of this, a new ‘Swap to Stop’ scheme has been announced which promotes replacing tobacco cigarettes with e-cigarettes to support smokers to quit. ^{[footnote 1]}

It is estimated that over 4.3 million adults in the UK use vapes. They contribute to an extra 50,000 to 70,000 smoking quits a year in England. The Government is currently piloting a world first programme to provide 1 million smokers with free vape kits to help them quit.

Evidence reviews by the Office for Health Improvement and Disparities (OHID), and previously Public Health England^{[footnote 2]} show that e-cigarettes have been proven to be an effective smoking cessation tool and evidence shows that, in the short and medium term, vaping poses a much smaller overall risk than smoking. However, vaping is not risk free.^{[footnote 3] [footnote 4]} Vaping is not recommended for non-smokers and children and the long-term risks are currently unknown.

In the UK, nicotine-containing e-cigarettes and e-liquids are regulated under the Tobacco and Related Products Regulations 2016 (as amended) which set the minimum requirements for the safety and quality of e-cigarette products. Before a nicotine-containing e-cigarette product can be placed on the market, it must be ‘notified’ to the MHRA through the e-cigarette notification scheme to assess whether it meets the notification requirements to be placed on the market in the UK. The MHRA works with Trading Standards who are responsible for enforcing the safety and quality requirements for nicotine-containing e-cigarette products on the UK market to monitor the safety of e-cigarettes by collecting information about suspected safety concerns through the Yellow Card Scheme.

Document e-cigarette use in medical records

Clinicians should ask about and document the use of e-cigarette products and vaping in the medical records for all patients as they would for smoking. Routine documentation will facilitate any future study on long-term effects of e-cigarettes or vaping using medical records. Clinicians should routinely document:

• Name and brand of the product or products used

• Type of products (for example, a pre-filled disposable device or an e-liquid used with a refillable device)

• Duration and frequency of use

• Substances vaped (for example, nicotine, cannabidiol [CBD] or psychoactive substances)

• Strength of substances

Advice for consumers

Under the regulations, only e-cigarette products with a nicotine concentration of up to 20mg/ml (2%) and a volume of nicotine-containing liquid not exceeding 2ml for pre-filled disposable e-cigarettes, cartridges and pods, or 10ml for e-liquid refills, can be supplied to consumers; any e-cigarettes or e-liquids with a nicotine strength and/or volume exceeding these limits are not legally compliant and are not approved for supply in the UK.

E-cigarettes and e-liquids that have been successfully notified and therefore meet the requirements for supply in the UK are published on the MHRA ECIG Publications List. Consumers can view this list and verify whether a product is notified by searching for the brand and product name or ECID number. Consumers should only purchase nicotine-containing e-cigarette products that are included on the MHRA Publications List.

How to report any suspected adverse reactions and safety concerns

Healthcare professionals and members of the public can report any suspected adverse reactions (ADRs) or safety concerns associated with nicotine-containing e-cigarettes and e-liquids to the MHRA via the Yellow Card website. Reporting contributes to the continuous monitoring and safety evaluation of e-cigarettes.

When submitting a Yellow Card report, please provide as much information as possible. The following information is particularly valuable for our assessment of reports:

• name and brand, strength, flavour, and batch number of the product used
• ECID number of the product (this is a 12-digit number that may be printed on the outer packaging or product itself)
• duration and frequency of use
• time to onset of the adverse reaction
• medical history including tobacco use and smoking status, details of any pre-existing respiratory disease, seizure disorders and cardiovascular history

Please include any other relevant information including concomitant medications or substances used.

As of October 2023, the MHRA has received 357 suspected ADR reports associated with nicotine containing e-cigarettes and e-liquids through the Yellow Card scheme and from industry. We routinely publish a summary of this data in our e-cigarette Analysis Print.

Article citation: Drug Safety Update volume 17, issue 4: November 2023: 3.

References

1. Smokers urged to swap cigarettes for vapes in world first scheme. ↩

2. Nicotine vaping in England: an evidence update including health risks and perceptions, September 2022 ↩

3. Nicotine vaping in England: 2022 evidence update main findings. ↩

4. Electronic cigarettes for smoking cessation - Hartmann-Boyce, J. 2022 Cochrane Library ↩

Published 23 November 2023