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Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, email@example.com.
Sensors and communication capability support proper usage, improve compliance, and may enable telemedicine.
When confronted with a treatment regimen involving an inhaler, many people feel intimidated. Proper use generally takes some training and practice. Until the patient feels comfortable with the device, compliance may be low, and treatment won’t be as effective as it could be.
“Smart” inhalers, which are equipped with sensors and other technology, can improve compliance. At the most basic level, smart units track the number of times the medicine is dispensed so the clinician can record the data at the patient’s next visit. Newer technology enables remote transmission of usage data to healthcare providers and may include software that provides feedback to patients and analytics to providers.
One product on the market, the cloud-based CareTRx solution from Gecko Health Innovations, now part of Teva Pharmaceutical Industries, combines remote monitoring and real-time adherence tools in a Bluetooth-equipped, battery-operated device that fits on metered-dose inhalers (MDIs). Pressure sensors boost actuation accuracy. Another facet of the solution, the CareTRx Population Monitoring Dashboard, monitors behavior, reviews trends, aggregates data, and connects patients and caregivers (1).
Another option, the Smartinhaler platform from Adherium, a New Zealand company with a US office in San Mateo, CA, recently won the "Most Innovative Hi-Tech Hardware Product" in New Zealand’s Hi-Tech Awards competition. The judges noted in a press release (2), “Adherium has developed a deceptively simple asthma drug-delivery system, which elegantly embeds multiple sensor technologies into a small device, and combines it with smart applications and cloud data services to help people with asthma and other chronic obstructive pulmonary diseases (COPDs). It gives healthcare providers and pharmaceutical companies access to a rich database of medication use that can be used for continuous improvement and application to achieve better health outcomes. The Adherium platform has enormous potential, not only with asthma and COPD medication, but also many other medication regimes.” Compatible with MDIs, dry powder inhalers, and nebulizers, the platform relies on sensors, touchscreens, audiovisual medication reminders, cloud data storage, and wireless technology (2). Clinical evidence shows the technology substantially improves outcomes (3).
Emerging smart inhaler technology being developed by HealthFactors and Koronis Biomedical Technologies (KBT) will be able to inform clinicians and respiratory therapists about how a patient uses the inhaler and how drug absorption is impacted. With that data, clinicians, therapists, and parents or caregivers can decide if the patient needs assistance to perfect the dosing technique.
Until now, identifying patients that need extra support has been based primarily on self-reporting. Kyle Dolbow, CEO at HealthFactors, notes, “Even the best patients may not be able to self-assess their technique and the impact of that technique consistently or correctly. Quantitative information about successful inhalation usage can address that challenge … [and] can be used to intervene and guide … training efforts and adjust treatment protocols. The technology that we’re bringing to market will also help enable newer healthcare models like telemedicine and chronic care management.”
Key to the technology are algorithms based on measuring the flow waveform parameters of each inhalation. The algorithms support training in dosing technique and assessment of each dose. Work continues to correlate inhalation profiles with delivery of medication to the desired areas in the lungs.
Dan Spors, chief commercial officer at HealthFactors, reports, “Our Phase I pilot results showed positive outcomes for participants. More specifically, there was a statistically significant increase in the amount of medication that was aerosolized with each of five inhaler trials for 34 adult patients who were newly diagnosed with asthma or COPD, and who were unfamiliar with inhaler use. In addition, the device received positive feedback from five respiratory therapists and pulmonary function specialists who were involved with the trial.”
HealthFactors and KBT are working with leading research institutions and physicians in respiratory care to develop a clinical scale that can be used to go beyond adherence monitoring to therapeutic and diagnostic elements. Spors says, “Correct inhalation technique is critical for the successful use of inhaled medications. This new smart inhaler technology is envisioned to be part of an overall commercial platform whereby patients are first assessed and interactively trained on proper technique in a clinical setting for a prescribed inhaler. The patient continues to receive this technique feedback and reinforcement at home through the smart inhaler.”
“The technologies being developed will allow pharmaceutical companies to differentiate their products … by integrating clinically validated treatment management tools,” adds Dolbow. “Now that our initial collaborators are in place, we are actively looking to add one or two pharmaceutical partners in 2017 for this opportunity,” he concludes.
1. Gecko Health Innovations, “Asthma and COPD Management Made Simple,” www.caretrx.com, accessed June 16, 2017.
2. Adherium, “Adherium Wins 'Most Innovative Hi-Tech Hardware Product Award' at the 2017 NZ High Tech Awards,” Press Release, May 15, 2017.
3. Adherium, “Proven Results for Increasing Adherence and Improving Health,” http://smartinhaler.com/outcomes, accessed June 16, 2017.