The Inside Scoop on Inhaler Selection and Education · CPE Information. This activity is supported by independent educational grants from GlaxoSmithKline. a ... •Identify strategies

Annual Meeting & ExpositionSeattle, Washington | March 22-25

The Inside Scoop on Inhaler Selection and EducationSuzanne G Bollmeier, Pharm.D., FCCP, BCPS, AE-CProfessor, St. Louis College of Pharmacy

Dennis Williams, Pharm.D., BCPS, AE-CUNC Eshelman School of Pharmacy

• Dr. Bollmeier has nothing to disclose.• Dr. William’s wife is employed by GSK.

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Disclosures

• Target Audience: Pharmacists• ACPE#: 0202-0000-19-055-L01-P• Activity Type: Knowledge-based

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CPE Information

This activity is supported by independent educational grants from GlaxoSmithKline. a

Supporter

At the completion of this knowledge-based activity, participants will be able to:• Describe features of various inhalation devices used in treating

respiratory conditions• Discuss patient-specific factors to consider when selecting among

available inhaler devices• Identify strategies to avoid common errors in inhalation technique • Demonstrate proper use of inhalers used to treat asthma, chronic

obstructive pulmonary disease, and allergic rhinitis

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Learning Objectives

• Which of the following inhalation devices uses a chemical propellant?

a. Metered dose inhaler (MDI)b. Dry Powder Inhaler (DPI)c. Jet Nebulizer d. All inhalation devices require a propellant

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Assessment Questions

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• Which of the following problems may a 5 year old patient have with the correct use of a dry powder inhaler device?

a. Inability to coordinate spraying a dose with inhalation effortb. Ensuring that the inhalation is slow and steadyc. Achieving a forceful inhalation effort to aerosolize the dosed. Holding breath for 20 seconds

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• An exhalation system delivery device is designed to administer medication to the

a. Airwaysb. Nasal mucosac. Lung tissued. Systemic circulation

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Which of the following is an advantage of a dry powdered inhaler (DPI) over a metered-dose inhaler? a. DPIs require a lower inspiratory force during inhalation.b. Correct DPI technique requires less hand to lung coordination.c. Over 80% of patients have good technique with DPIs.d. DPIs are less susceptible to humid conditions.

• Preferred for the treatment of common respiratory conditions (upper and lower airway)

• Offers the advantage of direct deposition on the mucosa and in the airways for (largely) local effects

• Increased local concentration of active agent often associated with greater therapeutic effects

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Inhalational therapy

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Role of Inhaled Medications

• Quick Relief Therapies for asthma and COPD (Rescue, to relieve acute shortness of breath)• SABA• SABA-SAMA

• Long Term Control Therapies for asthma and COPD (To control or prevent bronchospasm and inflammation; to reduce exacerbation risks)• ICS (not used alone for COPD)• LABA (not used alone for asthma)• LAMA (not used alone for asthma)• ICS-LABA• LABA-LAMA (not generally considered for asthma)• ICS-LABA-LAMA

• Common therapies for rhinitis conditions• Nasal decongestants• INS (intranasal steroids)• Antihistamines (inhaled)

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Inhalational Delivery Systems

•For treating airway disease•Metered dose inhaler•Dry powder inhaler•Nebulizers• Inhalation spray • (AKA: Soft mist inhaler)

•For treating nasal conditions•Nasal spray•Nasal aerosol • Exhalation delivery

device

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Inhalational Devices

• Many companies have adopted a specific delivery system that is used as a platform for their product line

• Examples• Aerosphere (MDI)• Diskus (DPI)• Ellipta (DPI)• Neohaler (DPI)• Pressair (DPI)• Respimat (Multidose Liquid, Soft-mist)

• Combinations of ICS/LABA, LABA/LAMA and ICS/LABA/LAMA are available

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Inhalational Delivery Systems

• Inhalation delivery systems have undergone significant technological advances during the last 50 years

• The device used to deliver the dose is as important as the medication itself

• Patient’s ability to use inhalation device is an important and modifiable limitation

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Multiple Factors Impact Delivery to Airways

• Optimal Delivery of

AerosolDrug Molecule Characteristics

Created from Ibrahim M et al. Med Devices: Evidence and Research 2015;8: 131-9

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Inhalational Therapies

• Use of devices is a skill• Requires education, practice and coaching

• Patient should be counseled about the purpose/role of specific medication and expected effects/possible side effects

• Education about proper use and care of inhalational device should be provided

• Periodic assessment of device use with reinforcement is required• Technique can deteriorate without reinforcement

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Proper use is imperative!

• Misuse of respiratory devices is common • Education and reinforcing proper technique of respiratory devices is a

must!• Correct device technique is linked to improved patient outcomes

• Poor technique leads to poor adherence which influences disease control• Impact on patient QOL • Impacts healthcare costs

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Metered Dose Inhalers (MDIs)…..Issues We’ve Encountered…………

• Problems with inhalation • rate • depth• duration

• “hand-lung” coordination• Multiple sprays with single inhalation• Clogged inhalation port

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Dry Powder Inhalers (DPIs)…..Issues We’ve Encountered…………


• Failure to load dose• Dumping dose• Improper cleaning

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Holding Chambers…..Issues We’ve Encountered…………


• Loading multiple doses• Static electricity• Inadequate cleaning

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Nebulizers…..Issues We’ve Encountered…………

• Incorrect preparation of dose• Long administration times• Failure to adequately clean equipment• Intolerance to mask (e.g., infants and children)

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Googleimages.com

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Nasal Inhalers…..Issues We’ve Encountered…………

• Not clearing nasal passages• Inhalation technique• Head position• Hand position• Overuse of decongestants

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General Inhalation Device Selection Considerations

• Hand-lung coordination• Manual dexterity considerations

• Assembly of device• Loading doses• Actuating device

• Inspiratory force required• Poor vision• Ability to clean device

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Aerosol Product RecipeDrug

Molecular Characteris

tics and Properties

Delivery Device

Characteristics and

Properties

Equal Parts??

The perfect inhalation device does not exist

The optimal inhalation device is the one that is best for an individual patient in a specific situation and setting

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Disclaimer

• All inhalational devices have advantages and limitations• The perfect inhalational delivery device does not exist• Examples presented in this presentation are designed to illustrate

potential problems and are based on the presenters’ personal experiences with input from other clinicians

• Appropriate education, counseling, and monitoring can improve the potential issues presented here

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Common Mistakes with Inhalation Devices

• Not shaking• Not priming• Not correctly loading dose• Not exhaling prior to dose• Not holding breath• Multiple actuations with single

inhalation

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Common mistakes with inhalation devices

• Holding incorrectly• Poor coordination of spray and inhalation• Wrong inhalation rate• Using empty inhaler• Inadequate cleaning

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Prevalence of errors

Step Mean %(95% CI)

Preparation 30 (24-36)Exhalation 48 (43-53)Coordination 45 (41-49)Inhalation 44 (40-47)Breath hold 46 (42-49)

Step Mean %(95% CI)

Preparation 29 (26-33)Exhalation 46 (42-50)Placement 18 (11-25)Inhalation 22 (19-25)Breath hold 37 (33-40)

MDI (n = 23,720) DPI (n = 21,497)

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Problems with Inhalation Delivery Systems

• Hand-lung coordination with pMDI• Electrostatic forces with VHC• Poor inspiratory force with DPI• Inefficient dose delivery with nebulizer

• Suboptimal technique with all devices• Lack of knowledge and instruction among clinicians with all devices

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Considerations When Counseling Patients Regarding Inhalation Devices

• Inhalation techniques vary• pMDI-slow, deep inhalation• DPI – rapid, forceful inhalation

• MDI is often 2 puffs, DPI is usually 1 puff• Mouth-rinsing recommended for ICS• Periodic cleaning of devices is required, but differs according to product• For patients using multiple inhalers, consider using the same device

technology if possible

Symbicort (Turbohaler) Twist errors (Device not held upright, base not twisted until it clicks or turn back to original position) (48.8)Did not have head tilted such that chin is slightly upward (34.3)Insufficient inspiratory effort (32.1)Did not breathe out to empty lungs before inhalation (26.2)No breath-hold following inhalation (or holds breath for < 3 seconds) (22.1)Incorrect second dose preparation, timing, or inhalation (20.8)Dose compromised after preparation because of shaking or tipping (3.4)Patient had an empty inhaler (2.75)After inhalation did not replace cover (2.65)Did not put device in mouth and seal lips around mouthpiece (2.1)Exhaled into the inhaler before inhalation (1.74)Patient has expired inhaler (1.16)Did not inhale through mouth (0.5)Did not remove cap (0.43)

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Price DB, et al. J Allergy Clin Immunol Prac 2017;5:1071-81 (CRITIKAL Study)

Inhaler error (%) n=2074

Diskus Insufficient inhalation effort (38.4)Did not have head tilted such that chin is slightly upward (34.6)Did not breathe out to empty lungs before inhalation (32.4)No breath-hold following inhalation (or holds breath < 3 seconds) (24.7)Compromised dose after preparation because of holding downward (11.9)Incorrect second dose preparation, timing, or inhalation (6.3)Did not put inhaler in mouth and seal lips around mouthpiece (4.7)Exhaled into device before inhalation (4.6)Did not slide cover fully open (4)Dose compromised after preparation because of shaking or tipping (3.5)After inhalation did not replace cover (2.1)Patient had an empty inhaler (1.9)Did not inhale through mouth (0.85)Patient has expired inhaler (0.5)

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MDI Inspiratory effort not slow and deep (47.2)Did not have head tilted such that chin is slightly upward (34.1)Lack of device knowledge, or incorrect second dose preparation, timing, or inhalation (34.7)No breath-hold following inhalation (or holds breath for < 3 seconds) (33.4)Did not breathe out to empty lungs before inhalation (25.4)Actuation did not correspond with inhalation, actuation BEFORE inhalation (24.9)Did not remove cap or shake device before actuation (19)Exhaled into the inhaler or did not hold inhaler upright (14.3)Actuation did not correspond with inhalation, actuation AFTER inhalation (12.1) Did not seal lips around mouthpiece (10.3)Did not actuate or did not inhale through mouth (3.9) Patient had an empty inhaler (3)Patient has expired inhaler (1.5)After inhalation did not replace cap (1.2)

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Patients using multiple inhaler technologies have poorer outcomes

Bosnic-Anticevich S, et al. International Journal of COPD 2017;12:59-71

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Errors of Use of Inhalation Devices by Health Professionals

• Systematic review of 55 studies over 39 year period• Correct inhaler technique was demonstrated by 15.5% of subjects

overall, with a trend toward lower rates over time • MDI errors

• Not breathing out completely prior, lack of coordination, and post-inhalation breath hold (all >63%)

• DPI errors• Deficient preparation, not breathing out completely prior, and no breath hold (all

>76%)

Plaza V, et al. J Allergy Clin Immunol: In Practice 2018: in press

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Solving Device Issues: Example #1

• Bob is a 72 year old male with COPD. His physician plans to start him on a long-acting bronchodilator today. His COPD is Group B.

• The only inhaler he has ever used is a metered dose inhaler. He has a hard time holding his breath and has poor eyesight.

• Bob also reports that he has arthritis in his hands that make him sort of clumsy at times.

• What are some considerations in recommending a product?

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Poll Everywhere: Question

• Which of the following is a recommended pharmacotherapy option for Bob?

1. SABA/SAMA combination2. LABA alone3. LAMA alone4. LABA or LAMA

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Drug Class Device Tiotropium (Spiriva) LAMA RespimatAclidinium (Tudorza) LAMA PressairUmeclidinium (Incruse) LAMA ElliptaGlycopyrrolate (Seebri) LAMA NeohalerGlycopyrrolate (Lonhala) LAMA Magnair hand held nebulizer Salmeterol (Serevent) LABA Diskus Formoterol (Perforomist) LABA nebulizer Arformoterol (Brovana) LABA NebulizerIndacaterol (Arcapta) LABA NeohalerOlodaterol (Striverdi) LABA Respimat

Long acting agents for COPD

Not a DPI

Neb

Neb

Neb

Not a DPI

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Practical Considerations in Selecting a Device for Bob

• Ability to understand and follow instructions for use• Manual dexterity required to assemble device or load doses• Vision, including reading dose counter• Inspiratory force required• Patient preference

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Solving Device Issues: Example 2

• June is a 12 year old female recently diagnosed with moderate persistent asthma.

• She has a significant history of lactose intolerance and cannot tolerate any dairy

• Provider is seeking a recommendation for appropriate asthma therapy

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Lactose ---why?

• Lactose is a common inactive ingredient in DPIs• An excipient that acts to stabilize the drug

• Product manufacturers list severe milk protein allergy as a contraindication• Purification processes have resulted in lactose contamination with milk proteins

• Typically, lactose intolerant patients can utilize DPIs• If patient has a severe milk protein allergy, avoid use

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Which DPIs contain lactose?

Drug Brand name and Device Fluticasone furoate ArmonAir RespiClick

Airduo RespiClickArnuity ElliptaFlovent Diskus

Budesonide Pulmicort FlexhalerMometasone Asmanex Twisthaler Salmeterol Serevent DiskusFluticasone furoate/ vilanterol Breo ElliptaUmeclidinium / vilanterol Anoroa ElliptaFluticasone furoate / umeclidinium / vilanterol

Trelegy Ellitpa

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What to pick for June…

• It is likely that the patient can tolerate any DPI• If patient or parent is concerned about lactose, consider MDI option

• Symbicort• Dulera• Asmanex HFA• Flovent HFA• QVAR Redihaler• Advair HFA• Bevespi Aerosphere

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Poll everywhere: Question

• If June receives a holding chamber with her MDI device, what instruction should she receive about weekly cleaning of the chamber?

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Solving Device Issues: Example 3

• TC is a 68 year old man with COPD who was recently started on tiotropium (handihaler) daily and ipratropium/albuterol (respimat) at discharge from the hospital for a COPD exacerbation

• During a pharmacy refill visit:• TC mentions that he doesn’t like all the work required to use his daily dose of

tiotropium• He also reports that he feels that he wastes a lot of his albuterol/ipratropium

when he is trying to use it

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What is the patient doing with this device?

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Can you detect the problem here with his respimat device?

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• Why might this patient feel that he is wasting doses?

a. He is excessively priming the deviceb. He is shaking the device to see if it is emptyc. He is loading doses with the cap opend. He is not able to inhale when the dose is quickly released

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• One year later, TC’s COPD has continued to progress because he is still smoking

• You recommend that TC be started on a LABA-LAMA combination• He is switched from tiotropium to Vilanterol/umeclidinium (Anoro

Ellipta)• At his return visit in the clinic, he states that he is having a hard time

inhaling the powder from the device and wonders if he is doing something wrong

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• Based on the photo, what might be the cause of the problem that TC is experiencing with inhaling his dose?

a. Not holding the device horizontally when inhalingb. Covering the air vents when inhalingc. Not correctly loading a dose

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• Three months later, TC has received coupons for albuterol in the respiclick device (Proair). He returns to the pharmacy three days later complaining that it doesn’t seem to work as well as the MDI that he had previously.

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• What problem might TC be experiencing in using his new Respiclickdevice?

a. Failing to coordinate pressing and breathingb. Failing to correctly load a dose in the devicec. The port for medication delivery may be clogged with propellantd. Inhaling too fast

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• One year later, TC’s medication regimen includes and ICS/LABA combo (fluticasone/vilanterol—Breo Ellipta), a LAMA (aclidinium—TudorzaPressair), and PRN albuterol

• He now complains that he doesn’t think the LAMA is working for him

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• What problem may TC be having with his new device?

a. Not pressing and inhaling in a coordinated mannerb. Failure to correctly load the capsule in the devicec. Failure to correctly load a dose to prepare for inhalation

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Resources for Counseling and Educating about Inhalation Device Use

• Inhaler chart• Manufacturer website and support• In Check Dial device for assessing inspiratory force• Placebo demonstration devices

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InCheck Dial

Quickmedical.com

incheckdial.com

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Poll Everywhere: Opinion Poll

I agree with having Primatene Mist available as an OTC option for use by patients with asthma.

a. Yes b. No

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Primatene Mist Approved by FDA as OTC Medication

• Amid much controversy• Supporters and Detractors• But not a “new” controversy

Googleimages.com

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New Primatene Mist

• FDA approved as OTC in November 2018• Propellant is now HFA

65Googleimages.com

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Primatene Mist has now been reintroduced. Why did it go away to begin with?

• Original L-epinephrine product contained CFCs as propellants• OTC therapy from 1963 through December 31, 2011• CFC-containing Primatene Mist was discontinued in 2011 as part of the

Montreal Protocol (addressing ozone-depleting substances)• Removal was controversial because of concerns about access and impact

on underserved populations• Several attempts have been made (since 2014) to reintroduce a CFC-free

version

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Primatene Mist Inhaler Reintroduced to OTC Market

• Approved for use by people with mild intermittent asthma• FDA provides rationale for the approval • Numerous professional and public asthma and allergy organizations

voice opposition

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Does inhaled epinephrine work and is it safe?Pharmacology Principles

• Epinephrine is a sympathomimetic agent that has actions on beta2 (adrenergic) receptors in the lungs (resulting in bronchodilation)

• Epinephrine is a nonselective sympathomimetic and also has actions on beta1 receptors (heart) and alpha receptors (blood vessels)• Action at all receptors is why it is life-saving for anaphylaxis

• Beta2 selective therapies (e.g., albuterol) were developed to be more selective for the lungs when treating asthma or COPD

• Epinephrine’s duration of action is very short (~ 2 hours)

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So….

• Inhaled epinephrine (as Primatene Mist) does do what it is supposed to do (provide temporary relief of shortness of breath)

• Inhaled epinephrine can have effects on heart rate and blood pressure, but likely not a problem at usual doses• Problems could occur if overused, and/or if person has cardiac disease or

hypertension• Inhaled epinephrine is very short-acting which could result in overuse• Inhaled epinephrine does not treat inflammation (neither does

albuterol, or LABAs such as salmeterol or formoterol)

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The Metaproterenol Story

• October 1982: FDA acted on its own initiative to move metaproterenol (a beta2 selective agonist) to OTC status• Unusual for FDA to act without NDA from company

• May 17, 1983: FDA removed metaproterenol from OTC status after receiving 97 (out of 102) responses opposing the switch

• FDA suggested that it had erred in making the switch while the comment period was still open

• In 1985, BI filed application to take metaproterenol OTC, but abandoned the effort in May 1986

• In recent years, there have been public discussions about making albuterol (and other asthma therapies) available as OTC agents

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New Primatene Mist: Practical Considerations

• Contains L-epinephrine 125 mcg per spray; 160 sprays per canister• Individual should have clinical diagnosis of asthma and be receiving

ongoing care• Person with worsening symptoms should not delay seeking treatment

• Indicated for ages 12 and older • Previous product was 4 and older

• Instructions state that inhaler should be cleaned each day (of use), and shaken and sprayed into the air prior to each use

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Delivery by the Nasal Route

• Common medications include decongestants, steroids, and antihistamines

• Devices are sprays or pumps

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Generic instructions for Nasal Administration

• Gently blow nose into a tissue• Shake the medication bottle• Close other nostril with finger• Place tip of device inside nostril• Direct away from nasal septum• Actuate dose while gently sniffing

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Poll Everywhere: question

• What is the recommended position for the head when administering products to the nasal cavity?

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Head Position for Nasal Administration

• For nasal sprays, recommendation is to hold head straight• For nasal pumps, recommendation is to tilt head slightly forward• For some other products (e.g., naloxone), recommendation is to tilt head

back

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Nasal Administration

At this point, you should be sitting up, with your head upright. Insert the tip of the bottle or the canister opening inside one nostril.

Googleimages.com

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Method of Administering topical nasal sprays Use of the Contralateral Hand

Right nostril: Use left hand, point nozzle toward outer portion of right eye or top of the right ear.

Left nostril: Use right hand, point nozzle toward outer portion of left eye or top of the left ear.

Adapted from Benninger MS, et al. Otolaryngol Head Neck Surg. 2004;130:5-24.

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Googleimages.com

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Principles of the Exhalation Delivery Device (for nasal administration)

• The exhalation maneuver (exhaling into device) seals the soft palate• This separates the nasal cavity from the mouth and the lung• Distribution of medication in the nasal mucosal through the nasal port is

improved

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Exhalation delivery device

Googleimages.com

Xhance.com

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Inhalational Therapies

• Primary strategy for managing upper and lower respiratory conditions• Use of devices is a skill

• Requires education, practice and coaching• Patient should be counseled about the purpose/role of specific

medication and expected effects/possible side effects• Education about proper use and care of inhalational device should be

provided• Periodic assessment of device use with reinforcement is required

• Technique can deteriorate without reinforcement

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The perfect inhalation device does not exist

The optimal inhalation device is the one that is best for an individual patient in a specific situation and setting

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Recommendations for Improving Inhalation Technique

• Review device instructions and practice with placebo prior to teaching• Demonstrate assembly and correct use with a checklist• Provide patient written instruction on how to use device and written plan for

medication frequency• Have patient practice use while being observed by clinician• Review use of device at each return visit• Review patient’s understanding of the inhaled medication at each return visit

(when to use, purpose of drug, prescribed frequency)• Have high index of suspicion for incorrect use or non-adherence if poor

management of airway disease occurs

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Closing remarks/conclusion

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• Which of the following inhalation devices uses a chemical propellant?

a. Metered Dose Inhaler (MDI)b. Dry Powder Inhaler (DPI)c. Jet Nebulizer d. All inhalation devices require a propellant

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• Which of the following problems may a 5 year old patient have with the correct use of a dry powder inhaler device?

a. Inability to coordinate spraying a dose with inhalation effortb. Ensuring that the inhalation is slow and steadyc. Achieving a forceful inhalation effort to aerosolize the dosed. Holding breath for 20 seconds

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• An exhalation system delivery device is designed to administer medication to the

a. Airwaysb. Nasal mucosac. Lung tissued. Systemic circulation

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Which of the following is an advantage of a dry powdered inhaler (DPI) over a metered-dose inhaler? a. DPIs require a lower inspiratory force during inhalation.b. Correct DPI technique requires less hand to lung coordination.c. Over 80% of patients have good technique with DPIs.d. DPIs are less susceptible to humid conditions.

Documents

The Inside Scoop on Inhaler Selection and Education · CPE Information. This activity is supported by independent educational grants from GlaxoSmithKline. a ... •Identify strategies