Correlation between patient Handling Errors and in-vitro Performance of Spiriva® Handihaler®   

Jetmir Xhema¹, Line Tschiember¹ & Yannick Baschung¹

¹ OINDP analytical services, Solvias AG, Kaiseraugst, Switzerland

Summary

Success of inhalation therapy highly correlates with appropriate and reproducible doses delivered to the lungs, and correct inhaler technique are key for successful treatment outcome. Lack of treatment adherence, incorrect breathing techniques and misuse of inhalers by patients are some of the parameters that lead to uncertainties about lung deposition and can have a significant impact on the dose delivered and on the success of the treatment. Several studies exist in which the prevalence of human error for each type of inhaler and each category are described. However, the impact of these errors on the dose delivered to the patient and on the aerodynamic size distribution of the particles delivered by the inhaler remains unclear.

In the present study, various commonly reported patient handling errors were reproduced in-vitro to identify their impact on the Emitted Dose (ED) and Aerodynamic Particle Size Distribution (APSD) performance of the device. We have highlighted that adapted in-vitro measurements may help to better understand the importance and interactions between human handling errors and device performance, and that a particular emphasis should be placed on the training of patients against critical inhaler handling errors, as some of the in-vitro reproduced errors have shown to lead to a drastic decrease of device performance, both on the Emitted Dose (ED) and on the Aerodynamic Particle Size Distribution (APSD) performance of the device, which can therefore significantly impact the success of the treatment.

Key Message

Frequent patients handling error such as incorrect DPI position, closure or manipulation can lead to a significant loss of up to 85% of the dose delivered by the device. Prescribers should ensure that the patient is properly trained on the use of the device and informed on the impact that device misuse can have on the success of the treatment.