4 Ο ΕΚΠΑΙΔΕΥΤΙΚΟ ΣΕΜΙΝΑΡΙΟ ΕΚΘΑ Αθήνα 4 Φεβρουαρίου 2016

1. 4ΟΕΚΠΑΙΔΕΥΤΙΚΟ ΣΕΜΙΝΑΡΙΟ ΕΚΘΑ Αθήνα 4 Φεβρουαρίου 2016 Ηλεκτρονικό τσιγάρο: Η βιομηχανία του καπνού αντεπιτίθεται Βασιλική Ν. Γιαννακοπούλου MD, Phds, FESC, FEAS Διευθ. Μονάδας Εμφραγμάτων Τζάνειο Νοσοκομείο Πειραιά

2. Δεν υπάρχει σύγκρουση συμφερόντων

3. Tobacco Kills More Americans/year Than Alcohol, Cocaine, Crack, Heroin, Homicide, Suicide, Car Accidents, Fires & AIDS combined:

4. History • It was first patented by Herbert A. Gilbert in 1963described as "a smokeless non-tobacco cigarette" (replacing burning tobacco and paper with heated, moist, flavored airheated the nicotine solution and produced steam) • In 1967, was approached by several companies interested in manufacturing it, but it was never commercialized and disappeared from the public record after 1967 • In 2003 Hon Lik, (Chinese pharmacist), is widely credited with the invention of the 1st generation e-cigarette • 2004 introduced to the Chinese domestic market by Golden Dragon Holdings renamed Ruyan (patents in >40 countries, including USA) • In 2005–2006 started exporting its products before receiving its first international patent in 2007(1st in 2004 in Canada)

5. Το ηλεκτρονικό τσιγάρο αποτελείται: • Ένα πλαστικό σωλήνα, που περιέχει μια επαναφορτιζόμενη μπαταρία λιθίου • Ένα ηλεκτρονικό θερμαντήρα/ρυθμιστή • Ένα δοχείο ψεκασμού (atomizer) με μεμβράνη συγκράτησης των συστατικών • Ένα φυσίγγιο (cartridge) μιας χρήσης με διάλυμα νικοτίνης/μη νικοτινούχων ουσιών • Στο μπροστινό τμήμα έχει τοποθετημένη μια δίοδο / λυχνία LED, που παράγει κόκκινο φως, που παρομοιάζει με καύτρα αναμμένου τσιγάρου • Το πίσω τμήμα είναι διαμορφωμένο σε επιστόμιο

6. Τι περιέχει? • Το υγρό αναπλήρωσης του φυσιγγίου μιας χρήσης περιέχει νικοτίνη (σε ποικίλη συγκέντρωση από 0- 24 mg), χημικά πρόσθετα και καρυκεύματα (π.χ. αρωματικό σοκολάτας, μέντας, καφέ, φρούτων κλπ.). Τα χημικά πρόσθετα είναι συνήθως προπυλενογλυκόλη (propylene Glycol- PG) ή φυτική γλυκερίνη (vegetable glycerin). Τα ηλεκτρονικά τσιγάρα είναι σχεδιασμένα να ξαναγεμίζουν είτε με υγρό αναπλήρωσης είτε με νέα φυσίγγια που περιέχουν το κατάλληλο υγρό αναπλήρωσης

7. Επικίνδυνα για τον άνθρωπο • Myosamine • Anabasine • β-nicotyrine Ανάλογο του cialis & του rimonabant • Amino-tadafanil Καρκινογόνες • Nitrosamines Τοξική σε ↑ δόσεις • Glycol

8. Πιθανά μέταλλα και νανοσωματίδια που προκύπτουν από την θερμοκρασία, όπως κασσίτερος, σίδηρος, νικέλιο και χρώμιο • Από κάποια ENDS εκλύονται κεραμικά, πλαστικά, διάφορες ίνες και άλλα αφρώδη υλικά • Φορμαλδεΰδη η οποία είναι καρκινογόνος ουσία,επίσης ερεθίζει τα μάτια, την μύτη και το λαιμό

9. Higher e-liquidnicotine content was associated with higher particle numbersin the resulting aerosol, with little effect on the particle sizedistribution. Fuoco et al Environ Pollut. 2014. Concentrationsof fine particles in the air increased from a medianof 400 particles/1 cm3 with people simply sitting in theroom for 2 h Medians of 49 000 to 88 000 particles/1 cm3 (depending on the e-cigarette fluid used) after 2 h ofe-cig use in the same room Schober et alInt J Hyg Environ Health 2014

11. In Austria nicotine-containing cartridges are classified as medicinal products & e-cigarettes for nicotine inhalation as medical devices • In Bulgaria, Czech Republic, Hungary, Germany, Ireland, Latvia, Lithuania, Poland, Romania, are legal • In Danemark, Netherlands, Finland, Italy, Switzerland, and in theUnited Kingdom there are controversies • The FDA classified electronic cigarettes as drug delivery devices and subject to regulation under the Food, Drug, and Cosmetic Act (FDCA) before importation and sale in the USA. The classification was challenged in court, and overruled in January 2010 by Federal District Court Judge Richard J. Leon, citing that "the devices should be regulated as tobacco products rather than drug or medical products

12. In Australia, the Federal Department of Health & Ageing classifies every form of nicotine, except for replacement therapies, as a form of poison in April 2014 Western Australia made it illegal • In Brazil, Mexico, Panama, Singapore, Turkey & United Arab Emirates is forbidden • In Hong Kong the sale and possession of nicotine-based e- cigarettes, classified as a Type I Poison • In South Korea, Nepal, Pakistan, Malaysia, Lebanon, Israel, India, Japan, Egypt have no clarified guidelines • In China is legal

13. On 19 December 2012 the European Commission adopted its proposal to revise the European Union Tobacco Products Directive 2001/37/EC which included proposals to introduce restrictions on the use and sales of e-cigarettes • On 8 October 2013 the European Parliament in Strasbourg voted down the Commission's proposal to introduce medical regulation for e-cigarettes, but proposed that cross-border marketing of e-cigarettes be regulated similarly to tobacco products, meaning that sales of e-cigarettes to under 18s would be prohibited in the European Union, along with most cross-border advertising • Warning labels also would be required

14. Regulation • In February 2014 the EU Tobacco Products Directive was passed by the EuropeanParliament. E-cigarettes containing up to 20 mg/ml come under the TPD. Above thatlevel, or where medicinal claims are made they come under medicines regulation • Once the TPD comes into force, which is expected to be in the mid 2016 Member States willhave two years to transpose the new rules into national law • Until then e-cigarettesnot licenced as medicines will continue to be subject to general consumer protection Iaw andit is the responsibility of trading standards officers to rule on their safety

15. 59 single-brand e-cig retail Web sites in 2012 • Healthier 95% • Cheaper 93% • Cleaner 95% • Can be smoked anywhere 88% • Can be used to circumvent smoke-free policies 71% • Do not produce secondhand smoke 76% • Are modern 73% • Cessation-related claims were found in 64% • Health claims made through text, pictorial, video representations, where doctorswere present in 22% of sites Grana RA & Ling PMAm J Prev Med. 2014

16. Reasons for trying e-cigarettes among Montana adults (>5000 participants) Montana Adult Tobacco Survey, Nov 2013

17. Findings 1: Many surveyed e-cig companies are promoting their products through sponsorship of youth-oriented events, and some companies are offering free samples of e-cig 2: Surveyed e-cig companies market them in flavors that appear to be designed to appeal to youth 3: E-cig are available for purchase in stores and online by children and teenagers 4: Many surveyed e-cig companies air television & radio advertisements, often with celebrity spokespeople, including during events & programs 5: Surveyed e-cigcompanies extensively utilize social media & product websites to promote their products 6: E-cig product warning labels lack uniformity and may confuse or mislead consumers

21. CDC (Center for Disease Control & Prevention) • The nr of high school students who use e-cig was doubled in 2012 (2011: 4,7% to 10%) • The nr of middle school students >20% • About 1.78 million U.S. students had tried e-cig in 2012 • 2 billion $ from the sales of e-cig which are sold under 200 brand names in 2013 • “Wells Fargo has predicted that sales of e-cig could grow to 10 billion $ by 2017”!!!

22. Ash.briefingaction on smoking & health March 2014 2.6 million in 2015 (17%)

23. Characteristics, Perceived Side Effects & Benefits ofE-cig Use: A Worldwide Survey of More than19,000 Consumers Results:19,414 participants were included (0.5% reported not being smokers at the time of E-cig useinitiation) Complete substitution of smoking was reported by 81.0% of participants (formersmokers) Current smokers had reduced smoking consumption from 20 to 4 cig./day (using ECs for a median of 10 months), initiated EC use with amedian of 18 mg/mL nicotine-concentration liquids; 21.5% >20 mg/mL. Only 3.5% were using 0-nicotine liquids Themost important reasons for initiating EC use for both subgroups was to reduce the harmassociated with smoking and to reduce exposure of family members to second-handsmoking. Most considered ECs as less harmful than tobacco cigarettes, while 11.0%considered them absolutely harmless Side effects were reported by more than half of theparticipants (59.8%), with the most common being sore/dry mouth and throat; side effectswere mild and in most cases were subsequently resolved (partially or completely). Participants experienced significant benefits in physical status and improvements in pre-existing disease conditions (including respiratory disease such as asthma and chronicobstructive lung disease). Being former smoker was independently associated with positiveeffects in health and improvements in disease conditions Int. J. Environ. Res. Public Health22 April 2014

24. Conclusions: • The results of thisworldwide survey of dedicated users indicate that ECs are mostly used to avoid the harmassociated with smoking • They can be effective even in highly-dependent smokers and areused as long-term substitutes for smoking • High levels of nicotine are used at initiation;subsequently, users try to reduce nicotine consumption, with only a small minority usingnon-nicotine liquids • Side effects are minor and health benefits are substantial, especiallyfor those who completely substitute smoking with EC use • Further population andinterventional studies are warranted Int. J. Environ. Res. Public Health22 April 2014 Onassis Cardiac Surgery Center Greece, Biol & Chem. Tox.Research Inst. Italy

25. Pasquale Caponnetto et al PLoS ONE June 2013

26. Pasquale Caponnetto et al PLoS ONE June 2013

27. 10% 8% Pasquale Caponnetto et al PLoS ONE June 2013

28. Electronic cigarettes for smoking cessation: a randomisedcontrolled trialChristopher Bullen, et al Auckland, New Zealand Lancet 6 September 2013 • 657 participants ≥ 18years • 289 used e-cig (A)--295 patches (B)--73 placebo e-cig (C) • Follow up for 6 months (September 2011-July 2013) • Verified abstinence:7,3% in (A)--5,8% in (B)--4,1% in (C) • Adverse events: 137 in (A)---119 in (B)---36 in (C)

29. Christopher Bullen et alLancet Sept. 2013

30. The statement of AACR and ASCO(American Association for Cancer Research--American Society of Clinical Oncology) • "We are concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop nicotine addiction. While e-cigarettes may reduce smoking rates and attendant adverse health risks, we will not know for sure until these products are researched and regulated" • "The FDA has signaled its willingness to regulate e-cigarettes and other electronic nicotine delivery systems, and we urge the agency to follow through on this intention" Clinical Cancer Research Journal of Clinical Oncology. January 08, 2015

31. The FDA should regulate all ENDS that meet the statutory definition of tobacco products • Manufacturers should be required to register with the FDA and report all product and ingredient listings, as well as the nicotine concentration in the ENDS solution • Packaging and advertising should be required to carry safety labels that include a warning about nicotine addiction • All ENDS advertising and marketing targeted at youth should be prohibited • Internet and other mail-order sellers of ENDS should be required to check the age and identification of customers at the point of purchase and delivery. • Childproof caps should be required for all e-liquid containers

32. ENDS and ENDS liquid–containing candy, along with other products aimed at youth, should be banned, unless evidence is produced that they do not encourage use by this population • Use should be prohibited in places where federal, state, or local law prohibit combustible tobacco products until the safety of secondhand aerosol exposure is established • Funding generated through tobacco product taxes, including any potential taxes levied on ENDS, should be used to help support research on ENDS and other tobacco products • All data related to ENDS composition, use, and health effects should be disclosed for dissemination and should inform policy decisions for ENDS product regulation • State and local governments should implement ENDS regulations appropriate for public health safety

33. ΠΡΟΤΑΣΕΙΣ ΕΚΕ<Προς τον ΕΟΦ (19- 3- 2012 ) υπ’ αριθμ. 16791/5-3-2012> • Απαιτούνται περαιτέρω ανεξάρτητες πολυκεντρικές τυχαιοποιημένες μελέτες • Δεδομένης της αβεβαιότητας στις κανονιστικές διατάξεις αν τα e-cig πρέπει να θεωρούνται προϊόντα καπνού εάν περιέχουν νικοτίνη ή ως συμπλήρωμα υγείας χρήσιμα για το μετριασμό ή τη διακοπή του καπνίσματος εφ’ όσον δεν περιέχουν προϊόντα καπνού και της ασφάλειας της χρήσης των, συνιστάται η διακοπή εισαγωγής, διανομής και πώλησης των προϊόντων αυτών • Έως ότου υπάρξει σαφής απόδειξη της ασφάλειας και της δραστικότητας των ηλεκτρονικών τσιγάρων, συνιστάται να σταματήσει κάθε δραστηριότητα διαφήμισης

34. Συνιστάται να σταματήσει η χρήση ηλεκτρονικών τσιγάρων σε περιοχές μη καπνιζόντων • Θα πρέπει να ξεκινήσουν καμπάνιες από το Υπουργείο Υγείας και Κοινωνικής Αλληλεγγύης, την ιατρική κοινότητα, μη κυβερνητικούς οργανισμούς προκειμένου να ενημερωθεί σωστά ο πληθυσμός σχετικά για τα e-cig • Ιατροί, νοσηλευτές, προσωπικό ιατρείων ή κλινικών διακοπής του καπνίσματος, δάσκαλοι και άλλα άτομα, τα οποία έχουν την ευκαιρία επαφής με καπνιστές, που επιθυμούν να διακόψουν το κάπνισμα, να αποθαρρύνουν τη χρήση e-cig ως μεθόδου μετριασμού, διακοπής /πρόληψης της υποτροπής του καπνίσματος, έως ότου υπάρξουν σαφείς ερευνητικές και κλινικές αποδείξεις του ισχυρισμού αυτού • Ιδιαίτερα θα πρέπει να αποθαρρύνεται η χρήση των ηλεκτρονικών τσιγάρων από τα νέα άτομα

35. Συμπερασματικά • Τα e-cig πιθανόν να είναι λιγότερο τοξικά από τα κοινά • Είναι προϊόντα που ακόμα δεν υπόκεινται σε κανονισμούς • Περιέχουν τοξικά χημικά • Δεν έχει αποδειχθεί η ένδειξή τους για την διακοπή του καπνίσματος • Τα e-cig ενώ έχουν αρκετά χαμηλότερα επίπεδα από τις περισσότερες τοξικές ουσίες των τσιγάρων, έχει αποδειχθεί ότι απελευθερώνουν μεγαλύτερα ποσοστά μικροσωματιδίων

36. ΕΥΧΑΡΙΣΤΩ