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. and Beyond:. It’s Not Just an Adult Phenomenon. Elizabeth J. Scharman, Pharm.D., DABAT, FAACT, BCPS. Director, West Virginia Poison Center. Professor, WVU School of Pharmacy. Outline . Background. ID: 700643 Download Presentation

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E-cigarettes, Va ping ,




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Slide1

E-cigarettes, Vaping, and Beyond:It’s Not Just an Adult Phenomenon

Elizabeth J. Scharman, Pharm.D., DABAT, FAACT, BCPS

Director, West Virginia Poison Center

Professor, WVU School of Pharmacy

Slide2

Outline BackgroundE-cigarette products

Beyond E-cigarettes

(hookah,

vaping

, etc.)

Substance abuse and

E-cigarettes

Status of new FDA regulations

Slide3

Background In 2015, poison centers received reports of 3,590 exposures to electronic cigarettes and liquid nicotine (out of 2,231,381 total exposure cases).Just over ½ of these reported exposures occurred in children < 6 years of age

Moderate and major effects and death

documented

.

U.S.

high school students:

Prevalence of past 30-day use 1.5% in 2011 to 16.0% in 2015

Slide4

WV High School Use 2015https://www.hhs.gov/ash/oah/facts-and-stats/national-and-state-data-sheets/adolescents-and-substance-abuse/west-virginia/index.html

Slide5

E-cigarettes

ENDS = Electronic Nicotine Delivery System

Slide6

Closed vs. Open SystemsClosed systems typically:Inexpensive, disposable, look most like cigarettesEasiest to use for those new to E-cigarettes

Acts as an entry into the use of open systems

Open systems add options:

Wider range of flavor choices

May be more attractive to children and teens

Can mix flavors

Can customize how the device works

More battery power, alterations in how liquid is vaporized

Add more heat to use non-nicotine liquids

Some would like to ban open systems

Slide7

How E-Cigarettes Work

Individuals can modify: voltage control, heating coil, vaporizing chamber. Kits sold to facilitate this.

Slide8

Disposable (Closed) E-cigarette

Slide9

Closed: E-cigarette Cartridges

Devise is re-used, not disposable

Slide10

Open: E-cigarette Liquid RefillsStrengths can vary significantly

1 cigarette = 1 mg (

avg

) nicotine

Devise holds approx. 20 drops (= 1 mL if water and perfectly calibrated dropper)

Amounts in mg/mL

16 mg/mL = 1.6%

Slide11

Nicotine Liquid

Slide12

Flavored Liquid Nicotine

Slide13

The Dose CatchStudy of 27 e-liquid formulations from USANicotine concentrations were 45 to 131% of labeled conc.18 of 27 had > 10% variation9 had > 20% variation

Propylene

glycol:glycerin

was usually 50:50 as labeled

4/27 had > 10% variation

One had a ratio of 81:19

Propylene glycol and glycerin are humectants to keep the nicotine from drying out

1,3-propanediol, ethylene glycol in some products not studied

Toxic potential of non-nicotine ingredients and heavy metals still being determined

Slide14

Non-Nicotine Liquid FlavorsVape Snack (brand name product line)Non-Nicotine E-Juice or Nicotine Free E-JuiceNon-Nicotine Vape Juice

Slide15

Brand Names Coming

Slide16

Rapidly Growing BusinessMore retail E-cigarette brands comingMore push back from on-line retailers; makes on-line information confusing and inconsistent

More brands showing up with inconsistent labeling (used to get consumers to buy them)

No government standard for terminology used for these products

E-cigarette, Vapor Pen, E-Hookah

Slide17

Marijuana: E-cigarettesMarijuana, can be added to an open system, E-cigarette device that is modifiedModification required in order to obtain the correct heat, vapor stream

Slide18

WV High School Usehttps://www.hhs.gov/ash/oah/facts-and-stats/national-and-state-data-sheets/adolescents-and-substance-abuse/west-virginia/index.html

Slide19

Novel Ingredients: Change DeviceNon-nicotine drugs can be placed in open system E-cigarettesE-cigarette containing marijuana, etc. used after device modification

Vaporizer Pens (aka:

Vape

Pens, Vapor Pens)

Makers changed the name to distinguish them from being a device primary used for nicotine (instead, primarily used for cannabis, etc.)

Uses same technology as E-cigarettes

Used for wax/oil based solutions, or dried “herbs”

E-Hookah Electronic Pen

A vaporizer pen made by a manufacture of hookah products

The hookah term is attached for cross-branding purposes

Used for water based solutions

Primarily advertised for flavor only liquids; used for other liquids as well

Slide20

Vaporizer Pens

Slide21

Slide22

Marijuana PenSold via the Internet; a vaporizer pen designed specifically for marijuana:Alterations in battery voltage, heating coils, etc.

Slide23

Electronic Hookah (aka Hookah Pen)Traditional HookahTobacco usedTar and smoke producedFrequently, multiple users

Vapor smoke desired

Electronic Hookah

Hookah, Pen

Slide24

E-Hookah Electronic PenTarget buyers are young users, therefore:Colorful and “trendy” in designFruity, candy-like flavors common

Promoted for “

vaping

” flavors only

Slide25

Electronic Hookah AppearanceMay look just like an E-cigaretteMay not look like an E-cigaretteMay be closed (e.g., disposables) or open system design

Slide26

Closed System Disposable Hookahs

Slide27

Contents Electronic HookahUsually flavored E-juice without nicotine Social enjoyment; not cigarette replacementSome contain nicotineSome can be altered to contain other drugs (open systems)

Tobacco used in traditional Hookah

Slide28

“Advanced” Personal Vaporizers“Advanced” Personal Vaporizers vs. E-cigarettesBigger, do not look like traditional cigarette, longer battery live, more flavors and features, promoted as “more consistent nicotine delivery”

Liquid heated with warm air instead of directly heating the E-liquid

Slide29

Personal Vaporizers (cont.d)

Slide30

E-cigars and E-PipesSimilar variations and features (disposable or reusable, closed or open, liquid nicotine/flavor only/other drug) as E-cigarettes

Slide31

Disposables

Slide32

Hookah E-cigar

Slide33

Slide34

Not Always Nicotine or Marijuana

Slide35

If it Burns, it Can be “Vaped”“Bath salt” type drugs (synthetic cathinones/

phenylethylamines

)

Synthetic psychedelics (e.g.,

NBOMe

series)

Salts added to e-liquids then

vaped

Synthetic marijuana (e.g., Spice, K2)

Sold as a liquid for

vaping

, names include:

Cloud 9, Hookah Relax, Crown,

Bizarro

, Shisha, Mad Hatter

As liquids names different, those of high school age may not realize what they are “

vaping

” and underreport use

Slide36

High school students are at risk. Documented in WV (many students had seizures).

Slide37

LegalExoticWeed.com

Slide38

Synthetic Cannabinoids- NFLIS 2014

‘08-’11 Spice & K2

Now

Marijuana = Cannabinoids

Slide39

Why?User preferred:Does not burn throatNo smoky or chemical smell on clothesSmells goodStronger, more potent high

Can conceal use of drugs

May use alone or mixed with hash oil

Slide40

Prevention and Product SafetyPoison center prevention recommendations for E-cigarette users:Use care to protect the skin when handling E-cigarette devices and refill products

Keep devices and refill products out of the sight and out of the reach of children.

Dispose of E-cigarette products properly to prevent exposure to pets and children from the residue or liquid left in the container.

Do not store loose devices in pockets

Do not allow in schools (pre-school through high school)

Slide41

E-cigarette Batteries Can Explode

Slide42

FDA Final Rule: May 5, 2016Statute authorizes the FDA to cover these products under the Tobacco Control Act (Pub Law 111-31, effective 6-22-09 amending the FD&C Act)“The rule now deems tobacco products such as gels, water pipe tobacco, cigars, pipe tobacco, and

e- products including

e-cigarettes, e-hookahs, e-cigars,

vape

pens, e-pipes, and refillable

personal vaporizers

to all be covered by the Tobacco Control Act (as well as “future products” providing

nicotine delivery

e.g., dermal or intranasal

).”

“The

rule subjects all manufacturers, importers and/or retailers of these newly-regulated tobacco

products to

all provisions currently applicable to traditional tobacco cigarettes, e.g., minimum purchase age (18

), health

warnings on product packaging and ads, and prohibition of vending machine sales (unless in

a facility

where retailer ensures individuals under 18 are prohibited from entering at any time

).”

Slide43

FDA Rule (cont.’d)“ Requirements also include registering manufacturing establishments and providing product listings

to the

FDA; reporting ingredients and harmful and potentially harmful constituents; requiring

premarket review

and

authorization

; and not allowing free samples

.”

“…

vape

shops that mix or prepare e-liquids or create or modify

aerosolizing apparatuses

for direct sale to consumers are now deemed to be tobacco product manufacturers

for regulatory

purposes

.”

Slide44

2016 Monitoring the Future SurveyBetween 1996 and 2016, initiation of cigarettes by 8

th

grade students dropped

:

Peak of 49% in 1996 to 10% by 2016

Use of E-cigarettes

declined by 4% between 2015 (peak) and 2016 for 8

th

, 10

th

, 12

th

grade students

E.g., from 16% to 12% for 12

th

grade students

However, cigarette use 10.5% in 12

th

grade students

For 8

th

and 10

th

grade students, use twice that of cigarettes

In this MTF Survey, hookah smoking not included in the E-cigarette data

No information on how “

vaping

” data separated out.

Slide45

May 2, 2017 (1 year later)The Trump administration delays enforcement of the finalized rule.Vaping and tobacco industries working together to stop regulations using proposed legislative changes (in critical funding bills) and litigationDelays effect pieces of the FDA rule set to begin May 10, 2017 or later. Three set to begin August 8

,

2017:

Cigar manufacturers do not have to submit their plans for placement of addictive warnings on products

Information on e-cigarette and cigar ingredients will not have to be submitted by

Use of labels: “light”, “mild” will not be banned

Slide46

July 21, 2017A federal district court sided with the FDANicopure Labs, LLC v. FDA allege the ruleExceeded the FDA;s authority under the Tobacco Act

Judge agreed with FDA that the act allows it to cover “parts” and “components” of regulated components and that e-liquid can be covered since nicotine liquid could be combined with e-liquid

Violated the First Amendment

Judge ruled that First Amendment only covers what the manufacturers say, not what they do – therefore, restricting free samples is allowed

Was arbitrary and capricious

Washington Post, July 25, 2017; Story by Jonathan H. Adler,

FDA ‘deeming rule’ survives first court challenge

Slide47

Other Legal ChallengesCompetitive Enterprise Institute v. U.S. Dept. of TransportationD.C. Circuit court ruled that the Transportation Department could extend the smoking ban on airplanes to include use of e-cigarettes

Washington Post, July 25, 2017; Story by Jonathan H. Adler,

FDA ‘deeming rule’ survives first court challenge

Slide48

JAMA Pediatr June 26, 2017Soneji S, Barrington-Rrimis

, JL, Wills TA, et. al.

Literature analysis

6,959 studies; 9 met inclusion

cirteria

17,389 teens to adults (? 16,621)

Range 14 to 30 years old

56% female

Findings

Probability of past 30-day cigarette smoking

30.4% for ever e-cigarette users

7.9% for never e-cigarette users

Slide49

Current ResearchDo e-cigarettes work to help people quit use of cigarettes?2014 Cochrane Review repeated 2016; still no answer15 randomized controlled studies currently ongoingCancer risk specifics

Extent of long term harm

Exposure to formaldehyde, other chemicals, high nicotine concentrations, heated vapor

Slide50

Questions?


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