VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
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Objectives Upon conclusion of the program, the participant should be able to: – Describe the prevalence of e-cigarette use across the country – Define vaping and the components of an e-cigarette – Review between the different types of e-cigarette devices – Explain the role of e-cigarettes in smoking cessation – Identify pulmonary risks associated with smoking e- cigarettes
E-cigarettes 2,3 – Electronic cigarettes: battery powered electron devices that aerosolize a solution (e- liquid) which typically contains nicotine, but can also be nicotine free – Electric heating element vaporizes the instilled liquid solution and condenses to form an aerosol – E-liquid: typically contains nicotine, propylene glycol, vegetable glycerin, water, and artificial flavoring – Large variety of product availability (both devices and e-liquids) allow for a high degree of customizability Today, global classification of e-cigarettes is highly variable; however, several countries recognize e-cigarettes as a pharmaceutical product when used for the intent of tobacco cessation
E-Cigarettes Background 2,4 – E-cigarette common names: e-cigs, e-hookah, vape stick, vape pen, Electronic Nicotine Delivery Systems (ENDS), JUUL – E-liquid common names: e-juice, vape juice, vape liquid – Vaping increasing in popularity among younger population as well as adults – Misconceptions: safer, no addiction, no nicotine – Vaping products may contain nicotine or tetrahydrocannabinol (THC)
History on E-cigarettes 2,5 – 1963: Concept of e-cigarettes proposed by Herbert Gilbert as a smokeless, non- tobacco cigarette; patent obtained in 1965 but never entered market – 2003: Han Li, a Chinese Pharmacist, obtains a patent for “a non-flammable electronic atomizing cigarette” – 2004: Ruyan Company of China begins development/distribution of e- cigarettes; obtains an international patent by 2007 – 2006: E-cigarettes in USA August 22nd, 2006 – 2014: E-cigarettes sold in more than 60 countries across the world
Nicotine Content 3 – Older generations utilize free-base nicotine – Newer generations utilize nicotine salts – Salt forms have a lower pH allowing for quicker delivery and higher levels of nicotine with less irritation for the user – No nicotine concentration restrictions in the USA – Sale of 4% nicotine comprised nearly 75% of the e-cigarette market – Europe limits nicotine concentrations to 2% – In a Truth Initiative study, two-thirds of JUUL users aged 15-21 were not aware the product always contains nicotine
Nicotine Content 8
THC Content9 – Measured in milligrams or percent content – i.e. 10 or 25mg; 10% - 90% – November 2018 study in JAMA – “Acute Effects of Smoked and Vaporized Cannabis in Healthy Adults Who Infrequently Use Cannabis” – Vaping devices heat cannabis to higher temperatures – Higher delivery of THC – Increased side effects (anxiety, paranoia, nausea, vomiting, hallucinations) – Especially for first time users
More Discrete Options 10 – Vaping apparel – Hoodies – Backpacks – Phone cases – Pens – Smart watches – USB Drives
1st & 2nd Generation Vapes How do they work?
Pod-Based System
Smoking Methods 11 – Vaping: electronic heating of an e-liquid and subsequent inhalation through an e-cigarette device – Dabbing: heating a sticky oil or wax of THC and inhaling it – Dripping: typically involves taking the e-cigarette device apart, dropping the e-liquid directly on the coils, creating a smoke which is inhaled
Apps for your Mobile Device 12
Apple & Vape Apps 13 – Apple distributes ~1.8 million apps to iPhones, iPads, and other Apple devices – In June 2019, Apple banned the addition of new vaping apps – As of November, “Apple has removed 181 vaping apps from its online store… following the lead of federal, state, and local regulators, which in recent months have cracked down on e-cigarette products” – Apple prohibits many app categories (i.e. nudity, hate speech, physical harm, apps that encourage excessive drinking, tobacco or illegal drugs and more) – Cannabis related apps still allowed “as long as they are restricted to adults, certain states, and don’t offer sales or explicitly encourage recreational use”
Advertising
Marketing Tactics 3 – Public Health Cigarette Smoking Act in 1970 – Congress passed the act to ban cigarette advertisements – 2009: FDA banned flavored combustible cigarettes except menthol – Despite these laws, e-cigarette advertising is prevalent on television, radio, and the internet
Marketing Tactics 3 – Advertisements are EVERYWHERE: radio, online (YouTube, Twitter, etc.), television – Many advertisements appear to be targeting the younger population – Some e-liquids look like common foods – i.e. Thin Mints, Tootsie Roll, Sweet & Sour Candy – E-liquids come in many different appealing flavors – i.e. Mint, cotton candy, blue raspberry, pink lemonade, and many more
7,000 e-liquid flavors and 460 brands of e-cigarettes 14,15
E-cigarette Ads & Youths 16 More than 18 million (7 in 10) US middle and high school youth were exposed to e-cigarette ads in 2014 More than 1 in 2 middle and high school youth were exposed to e-cigarette ads in retail stores Nearly 2 in 5 middle and high school youth saw e- cigarette ads online
E-cigarette Ads & Youths 16
JUUL 3 – According to Nielsen, as of October 2019, JUUL holds 64.4% of the e-cigarette market share – Altria, makers of Marlboro cigarettes, acquired 35% stake in JUUL in 2018 for $12.8 billion – In September 2019, Altria executive replaced the former head of JUUL as CEO – JUUL has spent more than $1 million in internet marketing (Twitter, Instagram, YouTube) – According to a recent congressional testimony, “JUUL has targeted children as young as third grade by funding summer camps, visiting schools and paying community and church groups to distribute their materials” – Recently announced to “suspend all broadcast, print and digital advertising in the US”
Taxation 3
Prevalence & Statistics
Prevalence of Use 4
QuickStats: Cigarette Smoking Status* Among Current Adult E- cigarette Users,† by Age Group — National Health Interview Survey,§ United States, 2015 17
Adult E-Cigarette Use 19 – National Institutes of Health’s National Cancer Institute, CDC, and FDA – 2017 National Health Interview Survey (NHIS) – Interviewed ~47.4 million US adults – Of these adults 19.3% admitted to currently using “any tobacco product” – Cigarettes (14.0%; 34.3 million) – Cigars, cigarillos, or filtered little cigars (3.8%; 9.3 million) – Electronic cigarettes (2.8%; 6.9 million) – Smokeless tobacco (2.1%; 5.1 million) – Pipes, water pipes, or hookahs (1.0%; 2.6 million) – Among current tobacco product users – 86.7% (41.1 million) smoked combustible tobacco products – 19.0% (9.0 million) used 2 or more tobacco products
Safety
E-Cigarette Safety 6
Diacetyl 20 – Bronchiolitis obliterans (AKA Popcorn Lung) – scarring of tiny air sacs in the lungs which causes thickening and narrowing of the airways – Symptoms similar to COPD – Microwave popcorn factory workers Removal of diacetyl – Many e-cigarette vapor contain diacetyl for flavoring – i.e. vanilla, maple, coconut, etc. – Harvard study on e-cigarettes in 2015 – 39 of 51 e-cigarette brands contain diacetyl – Other harmful chemicals in e-cigs: 2,3 pentaedione and acetoin – 47 of 51(91%) e-cigarettes involved in the study contain one of the there
Exploding Devices 21,22 – According to the U.S. Fire Administration, there have been at least 195 reported cases of e- cigarette explosions between January 2009 and December 31,2016
Health Effects 23 – Nicotine health effects – Highly addictive – Toxic to developing fetus – Harmful to developing brain into early 20’s – Cancer causing chemicals and small particles going deep into lungs – Less so than combustible tobacco products – “Acute nicotine exposure can be toxic. Children and adults have been poisoned by swallowing, breathing, or absorbing e-cigarette liquid through their skin or eyes”
Poison Concern24,25 – American Association of Poison Control Center has managed 5,183 cases of exposure – “Exposure”: contact with the substance in some way (i.e. ingested, inhaled, absorbed via skin/eyes) – Between 2012-2018 there have been 8,269 liquid nicotine exposures reported among children
Vaping & Pregnancy
E-cigarettes & Smoking Cessation
Can e-cigarettes help with smoking cessation? 23 SHORT ANSWER: NO But… Maybe?? Available studies give mixed reviews. – Not FDA approved as a smoking cessation aid – U.S Preventative Services Task Force concluded “evidence is insufficient to recommend e-cigarettes for smoking cessation in adults, including pregnant women”
E-cigarettes & Smoking Cessation 3,23,26 – Cochrane Review September 2016 – “Found evidence from 2 randomized controlled trials that e-cigarettes with nicotine can help smokers stop smoking in the long term compared with placebo (non-nicotine) e-cigarettes”3,7 – CDC Study published April 2017 – Confirmed many adults use e-cigarettes to help quit smoking – However, many report “dual use” – 2019 U.K. National Health Service study – Individuals assigned to either Nicotine Replacement Therapy (NRT) or e-cigarette starter pack – E-cigarettes were more effective for smoking cessation – However, most e-cigarette users were still smoking e-cigarettes at a one year follow up – Difficult to make concrete recommendation – Safety and efficacy lacking, diverse products, quality variation, lack of regulation
NRT & E-cigarettes – Not enough randomized controlled trials – No official guidelines – Assess patient need and vaping habits – All NRT therapy is appropriate – Multiple case studies showing effective smoking cessation
FDA, CDC, & Alaska
What is the FDA doing? 27 – “In January 2020, FDA issued an enforcement policy on unauthorized flavored cartridge-based e-cigarette products, including fruit and mint flavors, that appeal to kids” – Manufactures are required to comply with the FDA’s Tobacco Regulations – Manufactures include anyone who “makes, modifies, manufactures, fabricates, assembles, processes, labels, repacks, relabels or imports any ‘tobacco product’” – Nicotine addictiveness warning statement on packages and advertisements – On December 20, 2019, sale of tobacco products legal age changed from 18 to 21
E-cigarette or Vaping Product Use- Associated Lung Injury (EVALI) 28-30 – EVALI: name given by the Centers for Disease Control and Prevention (CDC) for the newly identified lung disease linked to vaping – First recognized June 2019, number of cases peaked in September but have since declined – Vitamin E acetate, an additive in some THC e-cigarettes, is most closely associated with EVALI – Study published December 20, 2019 – Bronchoalveolar-Lavage Fluid (BAL) collected from 51 patients in 16 states and 99 healthy participants – Performed isotope dilution mass spectrometry measure the following toxicants: vitamin E acetate, plant oils, medium-chain triglyceride oil, coconut oil, petroleum distillates, and diluent terpenes – Vitamin E was identified in 48 of 51 EVALI cases but not in the healthy group – Possible risk factors leading to higher morbidity and mortality – Cardiac disease, chronic pulmonary disease, diabetes, and increased age
CDC Latest Outbreak Info 30 – As of December 27, 2019, there have been 2,561 reported cases of EVALI – In 50 states, the District of Columbia, and two U.S. territories (Puerto Rico and the U.S. Virgin Islands) – Of the 2,561 diagnosed, there have been 55 deaths – Demographics – 67% males – 78% under age 35 – 78% non-Hispanic white – Median age 52 years (range 17 through 75) – Patients that died, were older than the overall population diagnosed – 2 deaths occurred in patients under 25 years of age
Patient Exposure 30 – All EVALI patients reported a history of using e-cigarette, or vaping, products – Vitamin E acetate was identified as a chemical of concern – Most EVALI patients admitted to THC-containing products – THC is present in most samples tested by FDA to date – “Black market” products are linked to most of the EVALI cases – CDC has analyzed THC containing products reported by EVALI patients – 152 different brands were reported – Most commonly reported products: Dank Vapes (56%), TKO (15%), Smart Cart (13%), and Rove (12%)
CDC Statements & Recommendations 30 – “While it appears that vitamin E acetate is associated with EVALI, there are many different substances and product source that are being investigated, and there may be more than one cause” – CDC recommends not to purchase THC-containing products from informal sources – Vitamin E acetate should not be added to any vaping product – Best way to prevent EVALI is by discontinuing use of all e-cigarette, or vaping products
Clinical Evaluation for EVALI 30 – Patient history – Respiratory symptoms (95%): cough, chest pain, SOB – GI issues (77%): abdominal pain, nausea, vomiting, diarrhea – Fever, chills, weight loss (85%) – Important information to gather – Type of substance (i.e. THC, cannabis [oil, dabs], nicotine, modified products, home-made) – Product source, brand, and name – Duration and frequency of use – Deliver system – Method of use (i.e. aerosolization, dabbing, or dripping)
Clinical Evaluation for EVALI 30 – Physical examination – Tachycardia (55%), tachypnea (45%), O2 saturation
32
Why was AK seemingly unaffected from this vaping illness until now? – Illnesses too mild – Misdiagnosis – Did not meet CDC EVALI diagnosis – Happenstance – AK population is low compared to other states – Black market THC products (or chemicals) may not have made it to AK in large quantities – “A review of ingredient lists, the state’s Marijuana Control Board determined that vitamin E acetate did not show up in any approved products in the regulated Alaska Market” – per vice chair of the board Loren Jones
Questions? Nikolina Golob: ngolob@scf.cc Jeremy Hondl: jhondl@scf.cc
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