REATH OF FRESH AIR - c.ymcdn.com · Common ADE Nausea, Insomnia, Abnormal dreams, Headache...

Breath of Fresh Air Elrod, Lancaster, Corona

11/20/2015

WSPA Annual Meeting 1

A BREATH OF FRESH AIR:

Clinical Update on Smoking Cessation, Asthma and COPD

Steven Elrod, Pharm.D.

T. Levi Lancaster, Pharm.D.

Andrea Corona, Pharm.D., BCACP, CDE

WSPA Annual Meeting

November 20, 2015

Session Flow

COPDAsthmaInhaler Carousel

Electronic Cigarettes

Smoking Cessation

FDA Approved Therapy

Withdrawal Craving

Bupropion (Zyban) Nicotine gum (Nicorette)

Veranicline (Chantix) Nicotine lozenge (Nicorette)

Nicotine patches (Nicoderm) Nicotine inhaler (Nicotrol)

Nicotine nasal spray (Nicotrol)


11/20/2015


Bupropion

Mechanism of ActionAntidepressant, inhibits uptake of dopamine and norepinephrine

Administration Start 1 to 2 weeks before quit date

Initial Dose/Titration 150 mg once daily x3 days

Maintenance Dosing 150 mg twice a day

Available OTC No

Common ADE Insomnia, Agitation, Dry mouth, Headache

Advantages Blunts post‐cessation weight gain, Oral agent (pill)

Disadvantages Contraindicated in patients with seizure disorder

Varenicline

Mechanism of ActionBinds to nicotinic receptors, preventing nicotine binding and acts as an agonist

Administration Start 1 to 4 weeks before quit date

Initial Dose/Titration 0.5 mg daily x3 days, 0.5 mg twice daily x4 days

Maintenance Dosing 1 mg twice daily

Available OTC No

Common ADE Nausea, Insomnia, Abnormal dreams, Headache

Advantages Dual mechanism of action, Oral agent (pill)

Disadvantages Unstable psychiatric status or suicidal ideation

Nicotine Patches

Mechanism of Action Nicotine Replacement Therapy

Administration Apply 1 new patch daily, May start patch before quit date

Initial Dose > 0.5 ppd 21 mg/day, < 0.5 ppd 14 mg/day

Maintenance Dosing Taper every 4‐6 weeks, 14 mg, 7 mg

Available OTC Yes

Common ADE Skin irritation, Insomnia, Vivid dreams

Advantages Provides steady nicotine level

Disadvantages User cannot alter nicotine level in case of craving


11/20/2015


Nicotine Gum


AdministrationNo food or drink for 30 min before and during useMax: 24 pieces per day

DosingFirst cigarette ≥30 min after waking 2 mgFirst cigarette <30 min after waking 4 mg

Onset of Action 5‐30 minutes

Available OTC Yes

Common ADE Mouth irritation, Jaw soreness, Hiccups, Heartburn

Advantages User controls nicotine dose, Oral substitute for cigarettes

DisadvantagesUnpleasant taste, Can damage dental work,Difficult for denture wearers to use

Nicotine Lozenge


AdministrationNo food or drink for 30 min before and during useMax: 5 lozenges per 6 hours, 20 lozenges per day

DosingFirst cigarette ≥30 min after waking 2 mgFirst cigarette <30 min after waking 4 mg

Onset of Action 5‐30 minutes

Available OTC Yes

Common ADEMouth irritation, Jaw soreness, Hiccups, Heartburn, Nausea

AdvantagesCan be used by smokers with poor dentition or dentures,User controls nicotine dose, Oral substitute for cigarettes

Disadvantages Unpleasant taste

Nicotine Inhaler


Administration Max: 16 cartridges per day

Dosing 10mg per cartridge

Onset of Action 3 minutes

Available OTC No

Common ADE Mouth and throat irritation

Advantages User controls nicotine dose, Oral substitute for cigarettes

Disadvantages Device visible when being used


11/20/2015


Nicotine Nasal Spray


Administration Max: 10 sprays per hour, 80 sprays per day

Dosing 0.5 mg per cartridge

Onset of Action Immediate, mimics a cigarette

Available OTC No

Common ADE Nasal burning, Throat irritation,Rhinitis

Advantages User controls nicotine dose

Disadvantages Difficult for many to tolerate

Smoking Cessation Visit

o Identifying patient’s motivation

o Discussing triggers and quantity

o Assessing previous quit attempts

o Reviewing current therapy options

o Setting a quit date vs. tapering goal

“Vaping” not “Smoking”


11/20/2015


Disposable, Rechargeable, Refillable, Reusable

FIRST GENERATION NEW GENERATION


11/20/2015


Tanks and Atomizers

New Generation Devices


11/20/2015


E – Juice and E – Liquid

E – Juice and E – Liquid

Mixing your own E – Juice


11/20/2015


Propylene Glycol

o Pharmaceutical solvent

o Food additive

o Additive in moisturizer, toothpaste, hand sanitizer

o Non‐toxic antifreeze (toxic = ethylene glycol)

o Asthma inhalers and nebulizers

Vegetable Glycerin

o Glycerol from vegetables

o Sweetener ~ 60% as sweet

as sucrose

o Food preservative

o Gel capsules

o Personal care products to make them smooth


11/20/2015


Health Effects of E – Cigarettes

Tobacco‐specific nitrosamines (TSNAs)o Human carcinogen

Tobacco specific impurities detected in a majority of the samples tested

May be harmful to humanso Anabasineo Myosamineo B‐nicotyrine

Kim YH, et al. Journal of Chromotography. 2013 48‐55.

Chemical Evaluation of E – Cigarettes

Cheng T. Tob Control 2014;23:ii11‐ii17

Chemical Evaluation of E – Cigarettes


11/20/2015


Daily Exposure to Formaldehyde

Jensen RP, et al. N. Engl. J. Med 2015: 372:392

Carbonyl Compounds in Vapor by Voltage

Kosmider L, et. al., Nicotine and Tobacco Research. 2014

E – Cigarette Use,

Perceptions, and Impact


11/20/2015


Tobacco Use Among Middle and High School Students, 2011 – 2014

CDC MMWR, April 17, 2015 64: (14) 381 ‐ 390

Poison Center Calls involving E – Cigarettes

Users Identified Reasons for E – Cigarette Use

Actkinson SE, et al. Am. J. Prev. Med. 2012 March 44 (3) 207‐15


11/20/2015


Pharmacokinetics

ProductMean Tmax (min)

(95% CI)Mean Cmax (ng/mL)

(95% CI)

Usual cigarette (n = 9)

14.3 (8.8 to 19.9) 13.4 (6.5 to 20.3)

16 mg ENDD (n = 8)

19.6 (4.9 to 34.2) 1.3 (0.0 to 2.6)

Nicotrol Inhaler (n=10)

32.0 (18.7 to 45.3) 2.1 (1.0 to 3.1)

Bullen C, et al. Tobacco Control 2010 19: 98‐103

Plasma vs. Craving

Eisenberg T, Tobacco Control 2010 19: 80‐87

Nicotine Delivery in New Generation E - Cigarettes

Farselinos KE, et al. Science Reports 2014; 4:4133


11/20/2015


Nicotine Delivery in New Generation E - Cigarettes

Farselinos KE, et al. Science Reports 2014; 4:4133

Randomized Trials of E – Cigarettes

Caponnetto, 2013 (PlosOne) Bullen, 2013 (Lancet)

Population Unmotivated to quit Motivated to quit

Inclusion Criteria> 10 cigarettes/day for at least 5 years, aged 18‐70

> 10 cigarettes/day for last year, aged >18

Sample Size 300 657

Intervention7.2 mg E – cigarette7.2 – 5.4 mg E – cigarette0 mg E – cigarette

16 mg E – cigarette21 mg NRT patch0 mg E – cigarette

Intervention Period 12 weeks 13 weeks

Follow up Period 9 months 6 months

Conclusions & Final Thoughts

E – cigarettes are not demonstrably superior to FDA approved medications for smoking cessation

The long term health risk of exposure to e – cigarette constituent chemicals is unknown

No regulatory oversight, such as requirement for good manufacturing practices, is currently in place for e –cigarette devices or e – juice

Because they may not be effective for smoking cessation, dual use may prolong exposure to tobacco


11/20/2015


Inhaler Carousel

First Round: Medications

Inhaled Steroids

Anticholinergic

Beta Agonist

Second Round: Devices

Diskus & Ellipta

Handihaler & Twisthaler

MDI & Respimat

5 minutes per topic, reference supplemental handout

Asthma and COPD

Basic Summary

Primary Issue 1st Line MOA Drug ClassDisease Life Cycle

Asth

ma

Inflammation due to irritant or allergen

Decrease inflammation

InhaledCorticosteroids

(ICS)

Variable because reversible

COPD

Persistent airflow limitation associated

chronic cough and chronic sputum production

Bronchodilation

Long‐Acting Beta‐2 Agonist

(LABA)

Long‐Acting Anticholinergic

Progressive because

irreversible


11/20/2015


Initiation

Asthma care quick reference: diagnosing and managing asthma. (NAEPP EPR3) NHLBI

Initiation

Optimization


11/20/2015


Stepwise Approach

Asthma care quick reference: diagnosing and managing asthma. (NAEPP EPR3) NHLBI

Asthma Control Test (ACT)

o Forced expiratory flow rate

o Technique coaching

o Peak flow log

o Personal Best vs Predicted

o Daily use in certain patients

o moderate‐severe disease

o severe exacerbations

o inability to perceive airflow obstruction

Peak Flow Meter


11/20/2015


Asthma action plan. NHLBI, National Institutes of Health

Tiotropium in Uncontrolled AsthmaDesign: o Randomized, double‐blinded, triple‐dummy, crossover trial

Population: o 210 patients with poorly controlled asthma on ICS monotherapy

Treatment: o Double ICS dose vs add‐on tiotropium vs add‐on salmeterol

Results: o Tiotropium improved morning peak expiratory flow (PEF) as

compared to doubling the ICS dose. Tiotropium was non‐inferior to salmeterol at improving PEF.

TALC Trial. NEJM. 2010. 363(18):1715‐26.

Chronic Obstructive

Pulmonary Disorder (COPD)


11/20/2015


COPD Classification

CharacteristicSpirometricClassification

Exacerbations per year

mMRC CAT

ALow RiskLess Symptoms

Gold‐ 1‐2 ≤ 1 0‐1 < 10

BLow RiskMore Symptoms

Gold 1‐2 ≤ 1 ≥ 2 ≥ 10

CHigh RiskLess Symptoms

Gold 3‐4 ≥ 2 0‐1 < 10

DHigh RiskMore Symptoms

Gold 3‐4 ≥ 2 ≥ 2 ≥ 10

Spirometric Classification

Diagnostic: FEV1/FVC <0.70

SpirometricClassification

DescriptionFEV1 % Predicted

Gold 1 Mild ≥ 80%

Gold 2 Moderate 50% ‐ 79%

Gold 3 Severe 30% ‐49%

Gold 4 Very Severe < 30%

Symptom Assessment

COPD Assessment Test (CAT): 8 questions

– Less Symptoms: < 10

– More Symptoms: ≥ 10


11/20/2015


Symptom Assessment

Modified British Medical Research Council (mMRC)

– Less Symptoms: 0‐1

– More Symptoms: ≥ 2


11/20/2015


COPD Classification

CharacteristicSpirometricClassification

Exacerbations per year

mMRC CAT

ALow RiskLess Symptoms

Gold‐ 1‐2 ≤ 1 0‐1 < 10

BLow RiskMore Symptoms

Gold 1‐2 ≤ 1 ≥ 2 ≥ 10

CHigh RiskLess Symptoms

Gold 3‐4 ≥ 2 0‐1 < 10

DHigh RiskMore Symptoms

Gold 3‐4 ≥ 2 ≥ 2 ≥ 10

Pharmacologic Therapy for Stable COPD

Patient Group

First Choice

AShort‐acting anticholinergic PRN ORShort‐acting B2‐agonist PRN

BADD Long‐acting anticholinergic ORLong‐acting B2‐agonist

C ADD Inhaled Corticosteroid

D Consider triple therapy

Basic Summary

Primary Issue 1st Line MOA Drug ClassDisease Life Cycle

Asth

ma

Inflammation due to irritant or allergen

Decrease inflammation

InhaledCorticosteroids

(ICS)

Variable because reversible

COPD

Persistent airflow limitation associated

chronic cough and chronic sputum production

Bronchodilation

Long‐Acting Beta‐2 Agonist

(LABA)

Long‐Acting Anticholinergic

Progressive because

irreversible


11/20/2015


A BREATH OF FRESH AIR:

Clinical Update on Smoking Cessation, Asthma and COPD

Steven Elrod, Pharm.D.

T. Levi Lancaster, Pharm.D.

Andrea Corona, Pharm.D., BCACP, CDE

WSPA Annual Meeting

November 20, 2015

REATH OF FRESH AIR - c.ymcdn.com · Common ADE Nausea, Insomnia, Abnormal dreams, Headache...

Documents

Transcript of REATH OF FRESH AIR - c.ymcdn.com · Common ADE Nausea, Insomnia, Abnormal dreams, Headache...