Mobile Design For Adverse Event Reporting And Pharmacovigilance
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Patient safety is concerned with protecting patients from errors, injuries, accidents, and infections. It is also concerned with capturing adverse events and understanding their severity. Reporting of adverse events help prevent poor patient outcomes in their acute phase. Another way of dealing with adverse events is by preventing them through the practice of monitoring the effects of drugs, medical devices including the detection, assessment, and understanding of an adverse event; this approach is called pharmacovigilance. Design Science framework was used for creating two mobile design solutions in the field of arthroplasty: one for the adverse event reporting and the other one for the pharmacovigilance. User centered design was utilized to understand requirements, context, and possibilities of managing and retrieving information of relevance for patient safety. Firstly, a mobile design for reporting of adverse events has proposed user interface to enable entry of data specific for knee and hip implants. Besides that, the system supports entry of the adverse event, its classification (serious, non-serious), its follow-up. Safety reports can be initiated and retrieved on request and depending on the adjudication of the event. Suspected severe events should be followed up and reported internally as well as to the national regulatory authorities until they are resolved and concluded. Expert evaluation of the first design solution was performed using low fidelity prototype. It has shown that design was relevant, straightforward, done in a way that official reporting would commence. Some users were positive to the reporting; some felt it would demand more work. The second design was focused on pharmacovigilance which seemed to be more appealing to the target group. It deals with the safety of medical devices (implants) by understanding the risks and dangers already reported by other clinicians or researchers. Internet resources such as the Manufacturer And User Facility Device Experience (MAUDE) web-site are often retrieved due to the lack of internal, local safety databases. The designed mobile solution for pharmacovigilance was based on the web system called WebBISS (Web-based implant search system) using HCI approach. The goal was not only to improve usability, but also to stimulate physicians to enter their safety data and become contributors, and not only users of information. The expert evaluation has been positive and encouraged developing stronger help and error reporting functions regarding the mobile application.