Vaping & E-cigarettes

Nikolina Golob, PharmD, MBA, PGY1 Pharmacy Resident

Jeremy Hondl, PharmD

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

Background

Nicotine

Dependence1

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

Types of E-Cigarettes 6

7

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 <6 years old

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 <95% (57%)

– Pulmonary findings on auscultation exam – unremarkable

– This is consistently true even for those with severe lung injury

– Laboratory Testing

– Guided by clinical findings

– Imaging

– CXR: pulmonary infiltrates

– CT Scan: opacities on chest

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

References

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