Following the dramatic death of a teenager from anaphylaxis - despite having used two adrenaline auto injectors (AAI) - on a flight, safety concerns have been raised in the UK coroner and others, regarding the effective use and design of AAIs and highlighted the importance of training materials for users. Following a review by the EU Pharmacovigilance Risk Assessment Committee (PRAC) June 25th, 2015, EU marketing authorisation holders were required to produce updated and improved training materials, in order to better communicate about risks and instructions for use of their products. Currently, there is no specific agreed process to evaluate the quality and effectiveness of these videos themselves. In addition, there is no published information about the effectiveness of these training material (You Tube videos) in communicating risks. Thus, we designed a questionnaire with open ended questions, taking a human factors approach based on a hierarchical task analysis called Systematic Human Error Reduction and Prediction Analysis. Information on the user’s perception and their appreciation of the videos were gathered anonymously and no identifiable data were obtained. Results collected through the questionnaire showed that many key points were lacking in each of the three videos including communication about risks and usability related to adrenaline auto injectors. Additionally, differences between these videos were raised, which highlighted the need for harmonizing the content of these videos to allow for interchangeability of AAIs and the implementation of a systematic process both to design and assess training materials. This may well have implications for assessment of risk communication using videos for all forms of products.

Creation of a process and questionnaire to assess video-based training materials for adrenaline auto-injectors

DIA Europe 2020 

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