josh mcdonald, pharmd april 18, 2020 · 2020. 4. 17. · josh mcdonald, pharmd. april 18, 2020....

Josh McDonald, PharmDApril 18, 2020

What percentage of high school students vape?

Kids are vaping!

Cullin, et al. (2019)

27.5

72.5

Current e-cigarette users (High School)(%)

Users Non-users

10.5

89.5

Current e-cigarette users (Middle School)(%)

Users Non-users

Vaping on the rise!

Cullin, et al. (2019); FDA (2019)

Escape the Vape: The Who, What, Where, When, Why, And How of E-cigarette and Vaping Induced Lung

Injury (EVALI)

Josh McDonald, PharmD, B.S.PGY1 Pharmacy ResidentUniversity of Utah Health

Disclosure

Relevant Financial Conflicts of Interest◦ CE Presenter, Josh McDonald◦ None

◦ CE mentor, Dave Young◦ Vertex Pharmaceuticals, Honorarium

Off-Label Uses of Medications◦ Corticosteroids for treatment of EVALI

Learning ObjectivesPharmacist objectivesUnderstand current reporting standards by the Centers for Disease Control and Prevention (CDC) and United States Food and Drug Administration (FDA) for EVALI eventsEmploy strategies to address questions about the hazards of e-cigarette use/vaping and patient’s perceived benefitsDistinguish EVALI from other pulmonary disease etiologiesFormulate a treatment plan for patients admitted to the hospital for EVALITechnician objectivesDefine EVALIDistinguish which products are associated with occurrences of EVALIRecognize signs and symptoms of EVALI

What are e-cigarettes? What is vaping?

E-cigarette and vaping products

(United States Food and Drug Administration, 2020)

•Components of ENDS and other vaping products

E-cigarette and vaping products

(United States Food and Drug Administration, 2020)

Can vaping help with smoking cessation?

Vaping entered market as alternative path to smoking cessation

Originally, products not regulated as strictly as traditional tobacco products

2016 FDA extended regulatory action to include electronic nicotine delivery systems (ENDS)


FDA, (2016)


Hajek et al. 2019

Hajek et al. A randomized trial of E-cigarettes versus nicotine-replacement therapy, New England Journal of Medicine, Feb 2019Study Design Randomized, single blinded comparator trialSites 3 sites in the United KingdomIntervention Open label use of nicotine replacement

therapy (NRT) compared to e-cigarette useBoth groups received behavioral therapy support

Primary outcome Cigarette abstinence at 52 weeksSecondary outcomes Continued use of trial medication among

abstinent patients at 52 weeks


Hajek et al. 2019

Hajek et al. A randomized trial of E-cigarettes versus nicotine-replacement therapy, New England Journal of Medicine, Feb 2019Inclusion criteria - > 18 years of age

- Current smoker- No preference for NRT vs ENDS

Exclusion criteria - Pregnant/breastfeeding- Current use of NRT or ENDS

Enrollment 886 patients: 439 in ENDS, 447 NRTDemographics - 52% male

- Median cigarettes per day: 15- Past use of NRT – 75%- Past use of ENDS – 41.5%


Hajek et al. 2019

Hajek et al. A randomized trial of E-cigarettes versus nicotine-replacement therapy, New England Journal of Medicine, Feb 2019Outcome EC

N (%)NRT

N (%)Relative risk

(95% CI)Abstinence at 52 weeks 79

(18.0)44 (9.9)

1.83 (1.30-2.58)

Continued use of trial medication among abstinent patients at 52 weeks

63 (79.7)

4 (9.0)

-


Hajek et al. 2019

Hajek et al. A randomized trial of E-cigarettes versus nicotine-replacement therapy, New England Journal of Medicine, Feb 2019

TakeawaysENDS may have some utility in smoking cessation

Patients appear to be swapping cigarettes for ENDSThis was not comparing to prescription options for smoking cessation like bupropion or vareniclineBehavioral support should be implemented in all strategies


FDA (2019)

ENDS are not approved for smoking cessation

If already using ENDS, do not go back to cigarettes

Children/adolescents and pregnant women should never use ENDS

Adults should not start using ENDS

• FDA guidance on ENDS products

What is EVALI?

What is EVALI?

American Lung Association (2020)

EVALI is a respiratory disease

similar to many other respiratory

diseases

It is a diagnosis of exclusion

One major component: recent

use of e-cigarette or vaping products

What is EVALI?

American Lung Association (2020)

Shortness of breath

Fever and chills

Cough

Diarrhea Headache or

dizziness

Rapid heart rate

Chest pain

EVALI?

Symptoms

Who is developing EVALI?

0%

10%

20%

30%

40%

Age

16%

38%

24%

13%8% 2%

Age distribution of patients hospitalized for EVALI, Aug-Dec 2019(N = 2291)

13-17 18-24 25-34 35-44 45-64 > 65


Lozier et al. (2020)



0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Male, 67%

Female, 33%

Sex distribution of patients hospitalized for EVALI, Aug-Dec

2019 (N = 2291)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

White, 75%

Hispanic, 16%

Black or African

American, 4%

Asian, Native

Hawaiian, other Pacific

Islander, 2%

Native American or Alaska

Native, 1%

Race/ethnicity distribution of patients hospitalized for EVALI, Aug-Dec 2019

(N = 2291)

Where does Utah fit in?Prevalence of hospitalized cases of EVALI, Aug–Dec 2019 (reported as cases per million)(N = 2,291)


A patient makes their way through your OTC section and walks up to the pharmacy counter. They have a pack of cough drops, loperamide, and ibuprofen that they want you to ring up. After a few coughs they ask, “So what’s up with all this news about vaping being bad all of a sudden? I keep seeing EVALI; is that a brand of vape?” How should you respond?A. EVALI was a vaping product linked to battery explosionsB. EVALI is a new pulmonary disease in people who vape that has caused hospitalizations and deathsC. EVALI is an infection caused by vaping products that aren’t sterilized by the manufacturerD. EVALI is a new pulmonary disease seen in people that vape but only affects the elderly

In the aisles of your local pharmacy…

What is causing EVALI?

0%20%40%60%80%

100%

Any THCcontaining

product use

Daily THCcontaining

product use

Any nicotinecontaining

product use

Daily nicotinecontaining

product use

Any CBDcontaining

product use

Both THC andnicotine

containingproduct use

80% 75% 54%85%

12%40%

E-cigarette or vaping product use in 90 days prior to EVALI hospitalization, Aug-Dec 2019(N = 2291)

What products are causing EVALI?


THC = tetrahydrocannabinol; CBD = cannabidiol

•Vitamin E acetate (VEA) a possible culprit• Used as a thickening agent in some THC containing

products• Commercially available as a topical or oral agent where

it is non-toxic

•Study of New York State data from September 2019 by FDA • VEA found in 49% of THC-containing product samples

from patients with EVALI tested by FDA

What is causing EVALI?

New York State Department of Health (2019)

Vitamin E Acetate in Bronchoalveolar-Lavage

Fluid Associated with EVALIBlount BC et al. (2019)

BAL Samples collected from 51 patients in 16

states

Compared to 52 control samples

Assessing for presence of THC, nicotine, or CBD in BAL samples

Do we know what is causing EVALI?

Blount, B. C., et al. (2019)

Do we know what is causing EVALI?

Blount, B. C., et al. (2019)

Vitamin E Acetate in Bronchoalveolar-Lavage

Fluid Associated with EVALI

Blount BC et al. (2019):Results

VEA was found in 94% of EVALI BAL fluid samples,

0% of controls

THC detectable in 84% of EVALI BAL fluid samples

Nicotine detectable in 64% of EVALI BAL fluid

samples

The patient thanks you for the info. They turn to leave and take a couple of cough drops. They don’t help and the patient coughs one onto the floor. They turn back to you, “Well, I just started vaping a week ago. I only use the brands I see on T.V. with nicotine. Vaping marijuana is what causes that kind of thing right?” The most appropriate response would be:A. No, people who vaped nicotine products have also developed EVALIB. Yes, there’s only confirmed reports of EVALI in people who’ve been vaping THCC. There’s no link between commercial products and EVALI. If it’s an established product with commercials on TV, it’s alright to use since the FDA regulates thoseD. Yes, but the there was only 1 THC containing brand that was associated with EVALI

In the aisles of your local pharmacy…

In the aisles of your local pharmacy…The customer looks disgruntled, “I just started vaping to help me quit smoking. I know it’s gotta be better for me than smoking cigarettes. I have some friends who completely stopped cigarettes by vaping! They let me use their vape and I liked it so I thought I’d try it out. They can be used to quit smoking right?” The best response to this is:A. No, ENDS have not been shown to be effective to help people quit smokingB. Yes, studies have shown consistent results that ENDS are a safe and effective way to quit smoking. The FDA approved them as a smoking cessation aidC. Yes, but there isn’t consistent data to recommend ENDS for smoking cessation. However, the FDA says not to go back to cigarettes if you’re already vapingD. No, the FDA actually recommends going back to cigarettes due to the risk of EVALI with vaping

How do I know it’s EVALI?


CDC (2019)

E-cigarette or any other vaping or

dabbing in 90 days prior to

symptom onset

Pulmonary infiltrates on

chest x-ray or on chest

computed-tomography

(CT)

Absence of pulmonary infection on

initial work-up

No alternative plausible causes

CDC definition of confirmed case


CDC (2019)

E-cigarette or any other vaping or

dabbing in 90 days prior to

symptom onset

Pulmonary infiltrates on

chest x-ray or on chest

computed-tomography

(CT)

Infection identified or not

yet ruled out BUT healthcare

team believe lung injury is

not solely caused by infection

No other alternative plausible causes

CDC definition of probable case

Presentation

• 95% had respiratory symptoms

• 77% had gastrointestinal symptoms

• 85% had systemic symptoms

On Physical exam

• 55% had tachycardia• 45% had tachypnea• 57% had O2 saturation <

95% on room air at rest• Most patients have

lungs clear to auscultation


Siegal et al. (2019)

• Elevated:• White blood cells• Inflammatory markers• Liver function markers

• All are very non-specific for EVALI• Urinary toxicology can help

determine definitive THC use

Laboratory Findings



• Pulmonary infiltrates on X-ray• Opacities on chest CT

• In absence of positive chest x-ray, chest CT has provided findings such as ground glass opacities in some cases

Imaging



•Further workup•BAL

• Not necessary to perform on all suspected EVALI cases• Decision to perform BAL should be guided by pulmonologist• Non-specific findings of lipid-laden macrophages have been reported

in cases of EVALI


Siegal et al. (2019); Maddock et al. (2019)

Do I need to report EVALI cases?

•CDC recommends assessing e-cigarette or vaping use in all patients presenting with new onset respiratory symptoms•Not a mandatory reportable event but highly encouraged to report cases to state departments of health• Utah Department of health: https://health.utah.gov/lung-disease-investigation/advice-for-clinicians

Event reporting

Jatlaoui et al., (2019); UDOH, EPI, (2019)

https://health.utah.gov/lung-disease-investigation/advice-for-clinicians

History to be

gathered in EVALI

patients

Timing of use

Amount of use

Active ingredients

used

Brands of products

used

Devices used

Any other inhalation product

use

Where they

purchased products

from

Event reporting

Jatlaoui et al., (2019); UDOH, EPI, (2019)

What can be done for EVALI?

Who to admit:

O2 saturation < 95% on room air

In respiratory distress

Comorbidities that can affect

pulmonary function

Heart failure, COPD, asthma, etc.



Who to treat as an outpatient

Clinically stableClose follow-up can be assured

in 1-2 days

Normal O2saturation

Strong social support systems





96% of patients end up

hospitalized

Patients with mild symptoms can

have rapid worsening

Discontinue use of ENDS or other vaping products!

Early, guideline-directed treatment for possible infectious etiologies, supportive therapy

Glucocorticoids• Methylprednisolone

120mg-500mg x 10-15 days (more common in ICU)

• Prednisone 40-60mg x 5-7 days (more common in floor patients, outpatients)


Siegal et al. (2019); Davidson et al. (2019); Blagev et al. (2019)

Treatment

In the aisles of your local pharmacy…As the customer is about to leave, they have a coughing fit and start to sweat. You notice an ENDS falls out of their pocket. They ask, “Do you think I could have EVALI? I’ve been coughing like this for a few days and have had diarrhea, chills, and a fever. Maybe it’s the flu but I haven’t been around any sick people. Should I see a doctor?” Your response should be:A. No, EVALI doesn’t cause symptoms like diarrhea or fever, just coughB. Yes, those symptoms are all signs of EVALI if you’ve vaped recently. Most people get better after a couple days though, no need to see a doctorC. No, people with EVALI have been using e-cigarette or vaping products for yearsD. Yes, those symptoms are all signs of EVALI if you’ve vaped recently. It can be mild at first but get worse quickly. You should see a doctor today

In the halls of your local hospital…A patient on your floor was admitted due to suspected EVALI with recent history of vaping a THC-containing, cartridge type product. The team is discussing how they can tell if this is EVALI or not. What is true about distinguishing EVALI from other pulmonary diseases and etiologies?A. EVALI can be diagnosed based on elevated WBC, ESR, CRP, LFTs if a patient has used a vaping product recentlyB. Obtaining a BAL is necessary and can give a definitive diagnosis of EVALIC. Ground glass opacities on chest CT are highly sensitive for EVALI in the presence of recent vaping product useD. EVALI is a diagnosis of exclusion in the presence of history of vaping product use

In the halls of your local hospital…The team has decided to make a formal diagnosis of EVALI after ruling out all other pulmonary etiologies and obtaining a thorough history of vaping product use. They are wondering if they need to report it somewhere. You suggest that you should fill out a form provided by the Utah Department of Health. What information do you need to collect about the vaping product in question?A. Where they got the productB. The last time they used the product and how often they use itC. What brand the product was (if not homemade)D. What other kinds of vaping products they have used (if any)E. All of the above

In the halls of your local hospital…EDA few weeks pass and another patient is admitted to the ED for suspected EVALI. You are discussing with the ED provider the best course of action. They heard that the last EVALI patient got a course of corticosteroids and was able to discharge 5 days later. They want to start something right away and request you to place an order for prednisone 50mg daily. What is the best response to that request?A. Actually, methylprednisolone is currently the preferred corticosteroid in hospitalized patients with EVALIB. Prednisone sounds good. For duration, current data supports 5-7 days of therapy. What duration would you prefer?C. Instead of treating with corticosteroids immediately, we should treat or rule out CAP and influenza D. How about dexamethasone?

Escape the Vape: The Who, What, Where, When, Why, And How of E-cigarette and Vaping Induced Lung

Injury (EVALI)

What question do you have?


EVALI is a pulmonary disease associated

with e-cigarettes and vaping

THC, CBC, and nicotine containing products

have all been implicated in EVALI

ENDS are not FDA approved for smoking cessation and can lead to prolonged nicotine

use

Signs and symptoms of EVALI are non-specific

and resemble other pulmonary diseases

and infections

EVALI is a diagnosis of exclusion but always

includes recent use of ENDS or other vaping

products

An adequate history is important in reporting

cases of EVALI

Treatment should always include ruling out other possible explanations. Corticosteroids have been used effectively in EVALI patients

1. Cullin KA, et al. e-Cigarette Use Among Youth in the United States, 2019. JAMA, 322(21), 2095–2103.

2. E-cigarette or Vaping Use-Associated Lung Injury (EVALI). (2020, January 9). Retrieved February 20, 2020, from https://www.lung.org/lung-health-and-diseases/lung-disease-lookup/evali/

3. United States Food and Drug Administration.(2020, February 14). Vaporizers, E-Cigarettes, and other ENDS. Retrieved February 20, 2020, from https://www.fda.gov/tobacco-products/products-ingredients-components/vaporizers-e-cigarettes-and-other-electronic-nicotine-delivery-systems-ends

4. Blount BC, et al. (2019). Vitamin E Acetate in Bronchoalveolar-Lavage Fluid Associated with EVALI. New England Journal of Medicine, 382(8), 697–705.

5. Lozier MJ, et al. Update: Demographic, Product, and Substance-Use Characteristics of Hospitalized Patients in a Nationwide Outbreak of E-cigarette, or Vaping, Product Use–Associated Lung Injuries — United States, December 2019. MMWR Morb Mortal Wkly Rep 2019;68:1142–1148.

6. Jatlaoui TC, et al. Update: Interim Guidance for Health Care Providers for Managing Patients with Suspected E-cigarette, or Vaping, Product Use–Associated Lung Injury — United States, November 2019. MMWR Morb Mortal Wkly Rep 2019;68:1081-1086.

References

https://www.lung.org/lung-health-and-diseases/lung-disease-lookup/evali/https://www.fda.gov/tobacco-products/products-ingredients-components/vaporizers-e-cigarettes-and-other-electronic-nicotine-delivery-systems-ends

7. Utah Department of Health, Bureau of Epidemiology. (November 2019). E-cigarette or Vaping Product Use Associated Lung Injury (EVALI) Preliminary Case Report Form. Retrieved from https://health.utah.gov/wp-content/uploads/EVALI-Case-Report-Form.pdf

8. Respiratory Illnesses Associated with Use of Vaping Products. U.S. Food and Drug Administration. https://www.fda.gov/news-events/public-health-focus/lung-injuries-associated-use-vaping-products. Published February 14, 2020. Accessed February 27, 2020.

9. New York State Department of Health. New York State Department of Health announces update on investigation into vaping-associated pulmonary illnesses: department warns against use of black market vaping products: lab test results show high levels of vitamin E acetate, now focus of investigation. September 5, 2019 (https://www .health .ny .gov/ pres)

10. 2019 Lung Injury Primary Case Definitions. CDC.gov. https://www.cdc.gov/tobacco/basic_information/e-cigarettes/assets/2019-Lung-Injury-Surveillance-Case-Definition-508.pdf. Published September 18, 2019. Accessed February 27, 2020.

References

https://health.utah.gov/wp-content/uploads/EVALI-Case-Report-Form.pdf

11. Siegel DA, et al. Update: Interim Guidance for Health Care Providers Evaluating and Caring for Patients with Suspected E-cigarette, or Vaping, Product Use Associated Lung Injury — United States, October 2019. MMWR Morb Mortal Wkly Rep 2019;68:919–927.

12. Maddock SD, et al. Pulmonary lipid-laden macrophages and vaping. N Engl J Med, 381 (2019), pp. 1488-1489.

13. Davidson K, et al. Outbreak of Electronic-Cigarette–Associated Acute Lipoid Pneumonia — North Carolina, July–August 2019. MMWR Morb Mortal Wkly Rep 2019;68:784–786.

14. Blagev DP, Harris D, Dunn AC, Guidry DW, Grissom CK, Lanspa MJ. Clinical presentation, treatment, and short-term outcomes of lung injury associated with e-cigarettes or vaping: a prospective observational cohort study. Lancet 2019;19:32679–0.

15. Youth Tobacco Use: Results from the National Youth Tobacco Survey. U.S. Food and Drug Administration. https://www.fda.gov/tobacco-products/youth-and-tobacco/youth-tobacco-use-results-national-youth-tobacco-survey. Published June 11, 2019. Accessed March 12, 2020.

References

Slide Number 1What percentage of high school students vape?Kids are vaping!Vaping on the rise!Slide Number 5DisclosureLearning ObjectivesWhat are e-cigarettes? What is vaping?E-cigarette and vaping products E-cigarette and vaping products Can vaping help with smoking cessation?Can vaping help with smoking cessation?Can vaping help with smoking cessation?Can vaping help with smoking cessation?Can vaping help with smoking cessation?Can vaping help with smoking cessation?Can vaping help with smoking cessation?What is EVALI?What is EVALI?What is EVALI?Who is developing EVALI?Who is developing EVALI?Who is developing EVALI?Where does Utah fit in?In the aisles of your local pharmacy…What is causing EVALI?What products are causing EVALI?What is causing EVALI?Do we know what is causing EVALI?Do we know what is causing EVALI?In the aisles of your local pharmacy…In the aisles of your local pharmacy…How do I know it’s EVALI?How do I know it’s EVALI?How do I know it’s EVALI?How do I know it’s EVALI?How do I know it’s EVALI?How do I know it’s EVALI?How do I know it’s EVALI?Do I need to report EVALI cases?Event reportingEvent reportingWhat can be done for EVALI?What can be done for EVALI?What can be done for EVALI?What can be done for EVALI?What can be done for EVALI?In the aisles of your local pharmacy…In the halls of your local hospital…In the halls of your local hospital…In the halls of your local hospital…EDSlide Number 52Slide Number 53ReferencesReferencesReferences

josh mcdonald, pharmd april 18, 2020 · 2020. 4. 17. · josh mcdonald, pharmd. april 18, 2020....

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