VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION

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VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
Vaping & E-cigarettes

Nikolina Golob, PharmD, MBA, PGY1 Pharmacy Resident

               Jeremy Hondl, PharmD
VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
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
VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
Background
VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
Nicotine
Dependence1
VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
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
VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
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)
VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
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
VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
Types of E-Cigarettes 6
VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
7
VAPING & E-CIGARETTES - NIKOLINA GOLOB, PHARMD, MBA, PGY1 PHARMACY RESIDENT JEREMY HONDL, PHARMD - ALASKA PHARMACISTS ASSOCIATION
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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