Regulation of e-cigarettes: ensuring patient safety and product quality
PHE ePoster Library. Bird H.
Sep 12, 2017; 186659
Helena Bird
Helena Bird
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Abstract
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Abstract In May 2016, the Tobacco Products Directive[1] came into force introducing regulation of nicotine-containing electronic cigarettes in the UK. With an estimated 2.8 million users[2] in the UK, any safety concern regarding e-cigarettes is likely to have a significant Public Health impact.Although acknowledged by Public Health England to be 95% safer than tobacco cigarette smoking,[3] it cannot be assumed that e-cigarettes are entirely without their own risks.The overall aim of regulating e-cigarettes is to ensure that products available on the market are consistently of a high quality standard with known safe ingredients to minimise public health risk.The MHRA Yellow Card Scheme was established over 50 years ago to collect data of Adverse Drug Reactions in the UK, this how now been expanded to include the collection of suspected adverse reactions and safety concerns regarding nicotine-containing e-cigarettes/refills. To date, we have received 18 reports of adverse reactions, 2 reports of safety concerns associated with e-cigarettes and 3 product quality complaints. It is recognised that communication and public awareness campaigns are needed to promote reporting of adverse effects associated with e-cigarettes to the Yellow Card Scheme.The data collected is analysed using traditional pharmacovigilance methods for signal prioritisation and detection to identify emerging signals or safety concerns. Comparisons in safety profile can be made to nicotine replacement therapy medicinal products. This will expand our knowledge of the safety of these products and regulatory action, such as labelled warnings and patient communication, may be used as appropriate.[1]http://ec.europa.eu/health/tobacco/products/revision/index_en.htm[2]http://www.ash.org.uk/files/documents/ASH_891.pdf.[3]https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/457102/Ecigarettes_an_evidence_update_A_report_commissioned_by_Public_Health_England_FINAL.pdf
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