In late December 2018, the Food and Drug Administration (FDA) approved a new digital rescue inhaler from Teva Pharmaceuticals that is devised to help ensure individuals correctly take their medication. The inhaler features sensors that connect to a smartphone app, and then records data that can be shared with doctors who can evaluate a patient’s inhaler usage. An estimated 70 to 90 percent of patients make mistakes using their inhalers and don’t get enough medication into their lungs, while other patients may overuse the devices, according to a study published in July 2016 in the journal Respiratory Medicine. While this type of sensor isn’t new, the ProAir Digihaler is the first digital inhaler with built-in sensors that detect when the inhaler is used and measure breathing. “Unlike currently available bolt-on devices, which are add-ons applied to the top of an inhaler device, the technology in ProAir Digihaler is integrated directly into the inhaler itself,” says Tushar Shah, MD, global head of specialty clinical development at Teva Pharmaceuticals. Teva plans to roll out the product to a small number of users and providers this year in order to gather “real world” experience, and then launch the inhaler nationally in 2020. At this time, the device will only be available for quick-release albuterol inhalation powder. The FDA okayed the inhaler for use in people ages 4 and older to treat or prevent bronchospasm with reversible obstructive airway disease (such as asthma and some forms of COPD) and prevent exercise-induced bronchospasm. A bronchospasm triggers a sudden tightening of the airways, often resulting in shortness of breath of wheezing. Albuterol quickly relaxes lung muscles, improving the diameter of airways so people can breathe more comfortably.
Helping Patients Take Medication Properly
“Using this technology first in the rescue inhaler makes a lot of sense because that’s one that patients can overuse without knowing it,” says Todd Mahr, MD, an allergist with Gundersen Health System in La Crosse, Wisconsin, and president of the American College of Allergy, Asthma, and Immunology. “They can inadvertently grab their rescue inhaler by mistake [instead of their daily maintenance inhaler]. It happens all the time,” Dr. Mahr says. “So they’re using the wrong inhaler twice a day, every single day. With this device, we could see something is wrong, reach out to them, and double-check.” Barbara P. Yawn, MD, chief science officer for the COPD Foundation, adds that data from the inhaler may show if a patient is taking too many puffs or not getting enough of the medication. “Getting this information would be a warning sign — a yellow light — telling us that something different is happening and we need to explore what it is,” says Dr. Yawn.
The Potential for Everyday Use
Both Yawn and Mahr see possibilities for the technology applying to long-acting daily maintenance inhalers as well. “One of the biggest issues we have is people not being able to take their medication once or twice a day on a regular basis,” says Yawn, noting that only about 40 to 50 percent of patients with COPD take their medication regularly. “This type of device could give us a more direct measure of their ability to follow this regimen.” Yawn and Mahr say that two of the big questions will be the cost and whether insurance will cover it. At this time, Dr. Shah says that Teva cannot comment on cost until it becomes commercially available. Insurance can currently cover some or all of the cost of inhalers. The consumer information website Health.CostHelper.com estimates that the average price of albuterol and an inhaler is between $30 and $60. Most deliver 200 puffs.
Will Health Professionals Accept the New Technology?
Chris Garvey, a family nurse practitioner at University of California in San Francisco Sleep Disorders and Pulmonary Rehabilitation, says that the technology is interesting, but we don’t completely understand if inhalers that monitor usage can improve the patient-clinician interface and improve patient outcomes. “Clinicians have a remarkable amount of patient information, which can be an asset and at times a burden,” says Garvey. “Although it isn’t clear if this will be an effective clinical tool, I think the concept is a good one.” Len Horovitz, MD, a pulmonary specialist at Lenox Hill in New York City, agrees. “It’s nice data but I don’t see the utility,” he says. “For an asthmatic who is controlled, if they need a rescue inhaler more than twice a week, they should simply phone their doctor.” “They’re going to have to persuade clinicians that it has an advantage,” says Garvey. “The more we interface with our patients and understand their medication needs and usage patterns, the more we understand how to be more helpful to them. The potential for this inhaler being helpful for the clinician is there.”
