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M7 Designing around placebo inhaler device concerns and improving asthma healthcare professional patient training
  1. MJ Sanders,
  2. R Bruin
  1. Clement Clarke International Ltd, Harlow, UK

Abstract

Introduction Effective asthma control with drug therapy delivered via pressurised metered dose inhalers (pMDIs) is critically dependent on good inhaler technique. Healthcare professionals (HCPs) dedicate significant time and resources to patient education and review sessions, which tend to focus on the co-ordination of pMDI actuation with the slow inspiratory breath. Tools exist to facilitate this experience: dummy pMDIs, add-on devices which whistle at the ideal inspiratory flow rate and the highly valued but difficult-to-obtain placebo pMDIs. The latter currently offer the closest real-life training experience but are hampered by the multiple-use concerns of cross-infection (or confident decontamination), HCP-only demonstration, and unnecessary exposure to fluorocarbon propellants. The alternative of training with the active pMDI raises the issues of overdosing and drug wastage.

Methods Our self-imposed project brief was to design an improved low-cost solution to the placebo/drug pMDI training conundrum which included patient participation as an absolute, the ability of the HCP to visually assess technique, avoidance of contamination, and compatibility with different actuator formats; and specifically excluded, for example, validation and implementation of new decontamination techniques.

Results The solution is an add-on device, confirmed to fit all UK active and placebo pMDIs. The device (Figure 1, Flo-Checkä) is inserted into the pMDI actuator mouthpiece orifice and completely occludes the aerosol path. The lip-guard feature prevents mouth-contact contamination of the actuator and, when the patient inhales, inspiratory air is drawn in via side vents engineered to mimic the general resistance of a pMDI.

Conclusions A survey of manufacturer-supplied respiratory support devices in relation to all UK inhaled products (London Medicines Evaluation Network, 2013) revealed an almost universal lack of product specific devices with the exception of the Accuhalerâ (Glaxo Group Limited) and Symbicortâ (AstraZeneca AB) training whistles; neither of which addresses the issues raised above. Several specific placebo pMDIs are available but the pharmaceutical industry is cognizant of fluorocarbon use justification, the danger of misinterpretation as an active product, and manufacturing a low volume high unit-cost product. It is hoped that developments such as the Flo-Check address some of the issues: for manufacturer, patient and HCP.

Abstract M7 Figure 1

Flo-Check device

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