Using Digihaler® Technology in the Community Pharmacy in Patients With Asthma

Pharmacy Times, October 2021, Volume 87, Issue 10

This article was sponsored by Teva Respiratory, LLC.

Please see Important Safety Information throughout this article. Please see full Prescribing Information for ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler.

As an integral part of the health care team, pharmacists are well positioned to work with providers and patients along their treatment journey by supporting access to prescribed medications, like the Digihaler® family of inhalers.

ASTHMA ASSESSMENT RECOMMENDATIONS

Guidelines set forth by the 2021 Global Initiative for Asthma (GINA) recommend assessing inhaler technique and inhaler use to help guide treatment decision-making by employing an assessment cycle that includes 3 stages: assess, adjust, and review response.1 However, assessing patient inhaler use can be difficult. Information regarding inhaler use is primarily based on patient-reported information and dose counters.2,3 Self-reporting may not be an accurate measure of use of inhaled therapy (eg, may not capture overuse and underuse of medication).2 There may be errors associated with incorrect timing of inhaler use (eg, missed doses, overuse of inhaler) and poor inhalation techniques.3 Patients may not know their inhaler technique needs improvement and may misperceive their disease severity.4,5

To help guide decision-making, it is important for health care providers to understand key information regarding how patients are using their inhaler, such as inspiratory flow, frequency of inhaler use, and if they are missing doses of their maintenance medication.1

DIGIHALER TECHNOLOGY

Digihaler is the first and only family of breath-actuated digital inhalers with built-in sensors that provide objective data on patient inhaler events.6-8 These built-in sensors can track how often and how well the inhalers are used, as measured by inspiratory flow. Inhaler use is recorded as an event when the cap is opened or a patient inhales. Data on usage and inspiratory flow can be sent directly to the Digihaler app via Bluetooth® wireless technology, giving patients the ability to share their inhaler use information with their providers, if desired (FIGURE 1).6-8

Although connection to the Digihaler app is required for transmission of data, it is not required to deliver medicine from the inhaler. Once connected, the objective data provided, may be used to help inform treatment decisions. There is no evidence the use of Digihaler® technology leads to improved clinical outcomes, including safety and effectiveness.

Support from the pharmacist

When patients or their caregivers come to the pharmacy to pick up their newly prescribed Digihaler inhaler, it is important for pharmacists to dispense as written, as the provider intended, and recognize its ability to capture objective data. Pharmacists can provide an overview of the Digihaler technology and explain its ability to capture objective data. As with any prescription medication, cost may be a concern for some patients1; they may need pharmacists’ help to address financial barriers and provide information to support Digihaler affordability with the Digihaler Savings Program (available to commercial patients regardless of coverage).

During counseling, pharmacists can also give instructions for how to set up their Digihaler device to capture objective data by: 1) downloading the app; 2) setting up a profile; and 3) scanning the inhaler’s QR code (to register the inhaler with the app).6-8

Inhalers in the Digihaler family

There are 3 product inhalers (with 7 total SKUs) in the Digihaler family. ProAir® Digihaler® inhalation powder is a short-acting β2-agonist (SABA) inhaler, and the other 2 products are maintenance inhalers. AirDuo® Digihaler® inhalation powder is a combination inhaled corticosteroid (ICS)/long-acting β2-agonist inhaler, and ArmonAir® Digihaler® inhalation powder is a digital ICS monotherapy inhaler.6-8 The Digihaler family of inhalers do not require washing, shaking, or priming.6-8

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR PROAIR® DIGIHALER®
INDICATIONS

ProAir® Digihaler® Inhalation Powder is indicated inpatients≥4 years of age for the treatment or prevention of bronchospasm with reversible obstructive airway disease and in patients≥4 years of age for the prevention of exercise-induced bronchospasm.

IMPORTANT SAFETY INFORMATION
Contraindications: ProAir Digihaler Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR ARMONAIR® DIGIHALER® AND AIRDUO® DIGIHALER®
INDICATIONS

ArmonAir® Digihaler® (fluticasonepropionate) inhalation powder is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.
Limitation of Use:
ArmonAir Digihaler is not indicated for the relief of acute bronchospasm.

AirDuo® Digihaler® (fluticasone propionate and salmeterol) inhalation powder is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo Digihaler is only for patients uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants an ICS/Long-acting beta2-agonist (LABA).
Limitation of Use:
AirDuo Digihaler is not indicated for the relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION
•Contraindications:
ArmonAir Digihaler and AirDuo Digihaler are contraindicated in:
-Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures
-Patients with known severe hypersensitivity to milk proteins or any ingredients of ArmonAir Digihaler or AirDuo Digihaler

Please see Important Safety Information throughout this article. Please see full Prescribing Information for ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler.

DIGIHALER FEATURES

TABLE 1 provides key Digihaler features.6-9 For providers, access to Digihaler objective data may allow for more personalized conversations during patient visits and help inform data-driven treatment decisions (FIGURE 2).

Inspiratory flow rates

Each Digihaler contains a built-in electronic module that detects, records, and stores data on inhaler events, including peak inspiratory flow rate (L/min), for transmission to the mobile app, where inhaler events are categorized. Inspiratory flow rates are categorized in the app as good (> 45 L/min), fair (30-45 L/min), low or no inhalation (< 30 L/min), and exhalation or possible air vent block.6-8 Tracking these inspiratory flow rates over time may help providers establish a baseline, access patients’ trends, and help identify if inhaler technique might need improvement.1,6-8

Inhaler events

The Digihaler family of inhalers record objective inhaler use data (inhaler use is recorded as an event when the cap is opened or a patient inhales). Inhaler events can be viewed as daily and monthly reports on the Digihaler app for the connected Digihaler.

If a patient chooses to share this information with their provider, seeing when and how often patients use their SABA inhalers may help providers assess if patients’ events are increasing (eg, increased frequency of SABA inhaler use). Additionally, data on maintenance inhaler events may help assess whether patients are taking their medication as prescribed.1,6-8

IMPORTANT SAFETY INFORMATION FOR PROAIR® DIGIHALER® CONTINUED

Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs
Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids
Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids
Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma

IMPORTANT SAFETY INFORMATION FOR ARMONAIR® DIGIHALER® AND AIRDUO® DIGIHALER® CONTINUED

Serious Asthma-Related Events – Hospitalizations, Intubations, Death: Use of a LABA as monotherapy (without an ICS) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS (such as AirDuo Digihaler), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone

Deterioration of Disease and Acute Episodes: AirDuo Digihaler should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. ArmonAir Digihaler and AirDuo Digihaler are not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not ArmonAir Digihaler or AirDuo Digihaler, should be used to relieve acute symptoms such as shortness of breath

Please see Important Safety Information throughout this article. Please see full Prescribing Information for ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler.

DIGIHALER SAVINGS PROGRAM

Pharmacists can provide eligible commercially insured patients with information regarding the Digihaler Savings Program, including full terms and conditions for eligibility restrictions at digihaler.com/savings. The program is available to all eligible commercially insured patients, regardless of formulary status, and can be used for the entire Digihaler® family of inhalers. Eligible commercially insured patients may pay as little as $20 for their prescription with the Digihaler Savings Program. Instructions are available with each card to assist pharmacists when processing the card.

IMPORTANT SAFETY INFORMATION FOR PROAIR® DIGIHALER® CONTINUED

Immediate Hypersensitivity Reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler.
Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines.
Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation
Adverse Reactions: In controlled studies in patients 12 years of age and older, adverse events that occurred in≥1% and >placebo included back pain (2% vs 1%), pain (2% vs <1%), gastroenteritis viral (1% vs <1%), sinus headache (1% vs <1%), and urinary tract infection (1% vs <1%). In controlled studies in patients 4 to 11 years of age, adverse events that occurred in≥ 2% and > placebo included nasopharyngitis (2% vs 1%), oropharyngeal pain (2% vs 1%), and vomiting (3% vs 1%)

IMPORTANT SAFETY INFORMATION FOR ARMONAIR® DIGIHALER® AND AIRDUO® DIGIHALER® CONTINUED

Avoid Excessive Use and Avoid Use with Other Long acting Beta2-Agonists: AirDuo Digihaler should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
Patients using AirDuo Digihaler should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason
Oropharyngeal Candidiasis has occurred in patients treated with ArmonAir Digihaler or AirDuo Digihaler. Advise patients to rinse the mouth with water without swallowing following inhalation
Immunosuppression and Risks of Infections: Patients who use corticosteroids, such as found in AirDuo Digihaler and ArmonAir Digihaler are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution in patients with the above because of the potential for worsening of these infections
Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. Taper patients slowly from systemic corticosteroids if transferring to ArmonAir Digihaler or AirDuo Digihaler

Please see Important Safety Information throughout this article. Please see full Prescribing Information for ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler.

GETTING STARTED WITH DIGIHALER

Pharmacists have an important opportunity to help patients understand features of the Digihaler app and how to get started.6-8 Pharmacists can ensure that patients understand that the data capture works only if the patient downloads the app and syncs the device.

For patients who may need assistance with connecting their device to the app on their smartphone, pharmacists can walk them through these 3 steps:

SUMMARY

Refer to TABLE 2 for a summary of information that can be used to help pharmacists prepare for counseling sessions with patients and their caregivers regarding their prescription for a Digihaler product.

Additional resources to support pharmacists during counseling are available from Digihalerhcp.com

IMPORTANT SAFETY INFORMATION FOR PROAIR® DIGIHALER® CONTINUED

Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler
-Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers
-Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels
-Digoxin: Carefully evaluate the serum digoxin levels in patients whoare currently receiving digoxin and ProAir Digihaler
-Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy

IMPORTANT SAFETY INFORMATION FOR ARMONAIR® DIGIHALER® AND AIRDUO® DIGIHALER® CONTINUED

Hypercorticism and Adrenal Suppression may occur with high doses of ICS, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such changes occur, discontinue ArmonAir Digihaler or AirDuo Digihaler slowly
Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with ArmonAir Digihaler or AirDuo Digihaler is not recommended because increased systemic corticosteroid adverse effects may occur; increased cardiovascular adverse effects may also occur with AirDuo Digihaler
Paradoxical Bronchospasm and Upper Airway Symptoms: Paradoxical bronchospasm may occur. if bronchospasm occurs treat immediately with an inhaled, short-acting bronchodilator discontinue AirDuo Digihaler or ArmonAir Digihaler and institute alternative therapy
Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ArmonAir Digihaler or AirDuo Digihaler. Discontinue ArmonAir Digihaler or AirDuo Digihaler if such reactions occur
Cardiovascular and Central Nervous System Effects: The salmeterol component of AirDuo Digihaler, can be associated with excessive beta-adrenergic stimulation which could present as the following symptoms: seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Use with caution in patients with cardiac arrhythmias, hypertension, coronary insufficiency. Drug may need to be discontinued in certain patients.
Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of products containing ICS. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care when using ArmonAir Digihaler or AirDuo Digihaler
Effect on Growth: ICS may cause a reduction in growth velocity, Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients receiving ArmonAir Digihaler and AirDuo Digihaler.
Glaucoma and Cataracts: Long-term use of ICS, including fluticasone propionate, a component of ArmonAir Digihaler and AirDuo Digihaler, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered
Eosinophilic Conditions and Churg-Strauss Syndrome: Systemic eosinophilic conditions, such as Churg-Strauss syndrome, may occur when using ArmonAir Digihaler or AirDuo Digihaler. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy
Coexisting Conditions: Use AirDuo Digihaler with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines
Hypokalemia and Hyperglycemia: Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. Decrease in serum potassium are usually transient, not requiring supplementation. Be alert to hypokalemia and hyperglycemia in patients using AirDuo Digihaler
Adverse Reactions with ArmonAir Digihaler: Most common adverse reactions (greater than or equal to 3%) are: upper respiratory tract infection, nasopharyngitis, oral candidiasis, headache, and cough
Adverse Reactions with AirDuo Digihaler: Most common adverse reactions (greater than or equal to 3%) include nasopharyngitis, oral candidiasis, headache, cough and back pain

Please see Important Safety Information throughout this article. Please see full Prescribing Information for ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler.

REFERENCES

  1. Global Initiative for Asthma. GINA Global Strategy for Asthma Management and Prevention, 2021. https://www.ginasthma.org. Updated April 26, 2021. Accessed on May 17, 2021. https://ginasthma.org/wp-content/uploads/2021/04/21_04_26-GINA-COVID-19-and-asthma.pdf
  2. Patel M, Perrin K, Pritchard A, et al. Accuracy of patient self-report as a measure of inhaled asthma medication use. Respirology. 2013;18(3):546-552.
  3. Sulaiman I, Seheult J, MacHale E, et al. Irregular and ineffective: a quantitative observational study of the time and technique of inhaler use. J Allergy Clin Immunol Pract. 2016;4(5):900-909.
  4. Sastre J, Fabbri LM, Price D, et al. Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016;9:13. Published 2016 May 4. doi:10.1186/s40413-016-0105-4
  5. Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic review of errors in inhaler use: has patient technique improved over time? Chest. 2016;150(2):394-406.
  6. AirDuo Digihaler. Prescribing information. Teva Respiratory, LLC; July 2019. Accessed June 2, 2021. https://www.digihaler.com/globalassets/airduo_digihaler/airduo_digihaler_pi.pdf
  7. ArmonAir Digihaler. Prescribing information. Teva Respiratory, LLC; February 2020. Accessed June 2, 2021. https://www.digihaler.com/globalassets/armonair_digihaler/armonair_digihaler_pi.pdf
  8. ProAir Digihaler. Prescribing information. Teva Respiratory, LLC; September 2020. Accessed June 2, 2021. https://www.digihaler.com/globalassets/proair_digihaler/proair_digihaler_pi.pdf
  9. Khassawneh BY, Al-Ali MK, Alzoubi KH, et al. Handling of inhaler devices in actual pulmonary practice: metered-dose inhaler versus dry powder inhalers. Respir Care. 2008;53(3):324-328.

ADH-40497 08/2021