Independent Identification of Handling Errors for Dry Powder Inhalers, Spiromax® and Turbuhaler®, Using a Delphi Process Involving Respiratory Device Experts. Issue 1 (December 2015)

• Record Type: Journal Article
• Authors: Hewitt, Charlie; Heinzmann, Sebastian; Safioti, Guilherme; Gopalan, Gokul
• Is Part Of: Pulmonary therapy. Volume 1:Issue 1(2015)
• Page Start: 77
• Page End: 90
• Publication Date: 2015-12
• Subjects: Delphi process methodology -- Handling errors -- Inhalation devices -- Spiromax -- Turbuhaler; Respiratory organs -- Diseases -- Treatment -- Periodicals; Respiratory therapy -- Periodicals; 616.20046
• DOI: 10.1007/s41030-015-0008-5
• Languages: English
• ISSNs: 2364-1754

Abstract

Abstract Introduction Correct use of inhalation devices is critical for optimal drug delivery to the lower lung. This Delphi process was conducted to compile lists of potential handling errors when using a Spiromax® or Turbuhaler® inhalation device, as determined by an independent panel. Methods A Delphi process was used to obtain consensus on potential handling errors for each device from ten independent respiratory device experts. In Round 1, advisors listed potential errors with the devices. In Round 2, a severity rating was assigned to each error based on erroneous device handling negatively affecting functionality and treatment effectiveness (error [score 0–3]; potentially critical [4–7]; critical [8–10]). In Round 3, advisors revised their ratings based on the group scores and voted on whether to accept the median severity score as the consensus in Round 4. Results A total of 29 potential errors for Spiromax and 31 for Turbuhaler were identified in Round 1. After Round 4, consensus was reached for 69% of the Spiromax errors and 94% of the Turbuhaler errors. After completion of the Delphi process, some anomalies were identified in the list of handling errors, which were then investigated with the panel via teleconferences. After teleconferences to discuss discrepancies in the results, there were 22 errors for Spiromax (four critical, 12 potentially critical, and six errors) and 27 for Turbuhaler (nine critical, 14 potentially critical, and four errors). Not inhaling through the mouthpiece, exhaling into the device, and incorrect mouth positioning were identified as critical errors for both devices. Conclusion Through the Delphi process, advisors independently identified and reached consensus on handling errors for Spiromax and Turbuhaler. Fewer Spiromax errors were classified as critical or potentially critical than with Turbuhaler, indicating that there may be less potential for handling errors with Spiromax. Funding Teva Branded Pharmaceutical Products R & D, Inc.