Featured, In the News / Politics:

Bridging medicine and technology: FDA approves first digital inhaler

By: Michael Lim, PharmD Candidate c/o 2020

           As modern technology continues to grow ever more complex and powerful, it is no surprise that the healthcare industry is constantly searching for medical applications of the latest technological advancements. Whether it be new health system software or medical devices for at home testing, the integration of medicine and technology has been essential for enhancing and streamlining patient care. December 2018 marked another milestone for the consolidation of medicine and technology with the Food and Drug Administration’s (FDA) approval of the first digital inhaler. While separate attachable sensor technology for inhalers is available worldwide, this approval marks the introduction of the sole digital inhaler containing built-in technology to the global market.

Teva’s ProAir® Digihaler™ (albuterol sulfate 117 mcg) Inhalation Powder is the first and only digital inhaler approved for use in the United States (U.S.). Equipped with built-in sensors that capture inhaler use data, the digital inhaler connects to a companion mobile application to provide asthma and Chronic Obstructive Pulmonary Disease (COPD) patients with the recorded information. The sensors can detect when the inhaler is used and measure inspiratory flow.1According to Sven Dethlefs, Teva’s Executive Vice President in Global Marketing and Portfolio, the device, “provides patients with data on their inhaler use, which may help them have a more informed dialogue with their healthcare provider regarding their asthma or COPD management.”1 Furthermore, from a healthcare professional’s perspective, being able to study a patient’s inhaler use data may be helpful in identifying issues such as incorrect inhaler use or a pattern of frequent use indicating the need for better asthma control.

Structurally, the ProAir® Digihaler™ closely resembles other metered dose inhalers with its familiar mouthpiece, cap, dose counter, and vent. However, it distinguishes itself from other inhalers due to its electronic feature. Built into the top of the inhaler is an electronic module that records and stores information about inhaler events. The module then sends the information wirelessly to the patient’s mobile application.2

Similar to the ProAir RespiClick®, the digital inhaler does not require priming.2 In fact, the digital inhaler is used essentially according to the same directions as the RespiClick®. First, the inhaler’s cap is opened fully until a “click” is felt and heard. This loads the dose.  The patient then exhales as much air from their lungs as possible prior to placing his or her lips over the mouthpiece. With their mouth covering the mouthpiece, a quick and deep inhalation delivers the dose as the patient holds their breath for about ten seconds before exhaling. Finally, the cap is closed to cover the mouthpiece.2 The inhaler does not require routine maintenance.3 However, the mouthpiece may be wiped with a dry cloth.3

Currently, the ProAir® Digihaler™ is indicated for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients aged four and older.4 Furthermore, while compatibility with a mobile app is the product’s defining feature, connection to the app is not required to use the inhaler itself as the electronic components do not control or interfere with medication delivery.4 Each inhaler contains 200 inhalation doses and may be used for up to thirteen months before expiring.3

Common side effects of the digital inhaler include back pain, oropharyngeal pain, and sinus headache. As with other albuterol inhalers, use should be discontinued with the occurrence of life-threatening paradoxical bronchospasm and resumed with an alternative agent such as levalbuterol tartrate (Xopenex HFA®).3 In regard to patient counseling, the digital inhaler appears to present an interesting situation in which pharmacists would counsel on not only proper inhaler technique but also on using the companion mobile application.

Like Abilify MyCite® (aripiprazole), a tablet that uses sensor technology which was approved in November 2017, Proair® Digihaler™ represents one of the few digital or “smart” medications available on the U.S. market. Moving forward, it will be interesting to see whether these medical innovations make a meaningful impact on the nature of pharmacologic therapy or conversely prove to be nothing more than trivial and expensive electronic accessories. After all, there is no current evidence of improved clinical outcomes associated with use of the inhaler’s mobile application.3 Regardless of the outcome, this integration of medicine and technology holds exciting possibilities for the future of pharmacy and patient care. The digital inhaler will be available in 2019 through a number of “Early Experience” Programs with a national launch planned for 2020.5


  1. The New York Times. ADDING MULTIMEDIA Teva Announces FDA Approval of First and Only Digital Inhaler with Built-In Sensors – ProAir® Digihaler™ (albuterol sulfate 117 mcg) Inhalation Powder. The New York Times. https://markets.on.nytimes.com/research/stocks/news/press_release.asp?docTag=201812211519BIZWIRE_USPRX____BW5554&feedID=600&press_symbol=267307. Published 12/21/18. Accessed 02/19/19.
  2. Teva. Instructions for Use ProAir Dighialer (albuterol sulfate) Inhalation powder. ProAir® digihler™. https://www.proairdigihaler.com/globalassets/proair_digihaler/Proair_Digihaler_IFU.pdf. Published 12/18. Accessed 02/27/19.
  3. ProAir Digihaler (albuterol sulfate) [package insert]. Frazer, PA; Teva Respiratory, LLC; Revised 12/2018.
  4. Teva. Patient Information ProAir Digihaler (albuterol sulfate) Inhalation Powder. ProAir® digihaler™. https://www.proairdigihaler.com/globalassets/proair_digihaler/Proair_Digihaler_PIL.pdf. Published 12/18. Accessed 02/27/19.
  5. AAFA Community Services. Teva Announces FDA Approval of ProAir® Digihaler™. Asthma and Allergy Foundation of America. https://community.aafa.org/blog/teva-announces-fda-approval-of-proair-digihaler. Published 12/27/18. Accessed 02/27/19.
Published by Rho Chi Post
Both comments and trackbacks are currently closed.