Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR

Abstract

Over a period of 3 years, the European Union’s Innovative Medicines Initiative WEB-RADR (Recognising Adverse Drug Reactions; https://web-radr.eu/ ) project explored the value of two digital tools for pharmacovigilance (PV): mobile applications (apps) for reporting the adverse effects of drugs and social media data for its contribution to safety signalling. The ultimate intent of WEB-RADR was to provide policy, technical and ethical recommendations on how to develop and implement such digital tools to enhance patient safety. Recommendations relating to the use of mobile apps for PV are summarised in this paper. There is a presumption amongst at least some patients and healthcare professionals that information ought to be accessed and reported from any setting, including mobile apps. WEB-RADR has focused on the use of such technology for reporting suspected adverse drug reactions and for broadcasting safety information to its users, i.e. two-way risk communication. Three apps were developed and publicly launched within Europe as part of the WEB-RADR project and subsequently assessed by a range of stakeholders to determine their value as effective tools for improving patient safety; a fourth generic app was later piloted in two African countries. The recommendations from the development and evaluation of the European apps are presented here with supporting considerations, rationales and caveats as well as suggested areas for further research.

Optimizing spontaneous adverse drug reaction reporting in public healthcare setting in Namibia

“…This may include ongoing training and education at pre-service and in-service levels, involvement of Therapeutic Committees at facility and regional levels and introduction, for example, of innovative electronic reporting to improve efficiency and boost the response rate among healthcare workers. [19][20][21][22] In conclusion, the study revealed a high level of knowledge of pharmacovigilance and ADR reporting system among the healthcare workers, though this has informed neither their attitude nor their practice of ADR reporting as seen in their reported attitude and practice. In other to optimize the current system, there is a need for effective communications between TIPC and the healthcare workers; this may be in the form of feedback, continuing professional development (CPD) lectures, advocacy within the health sector and community engagement.…”

“…Depending on the setting, centralized, national reporting systems may not always be the solution to pharmacovigilance but if they are adopted—as is the case in Namibia—there is a need to continually support their function and improvement. This may include ongoing training and education at pre‐service and in‐service levels, involvement of Therapeutic Committees at facility and regional levels and introduction, for example, of innovative electronic reporting to improve efficiency and boost the response rate among healthcare workers …”

Consumer reporting of suspected adverse drug reactions: modelling the acceptance of mobile phone caller tunes to raise awareness

“…Barriers to patient reporting of ADRs include poor awareness and confusion as to who reports ADRs, and to whom . These barriers could be addressed through the use of mobile phone‐based technologies including apps . Recent developments in mobile penetration worldwide have led to increased number of mobile health (mHealth) interventions.…”

“…[17,23,24] These barriers could be addressed through the use of mobile phone-based technologies including apps. [25,26] Recent developments in mobile penetration worldwide have led to increased number of mobile health (mHealth) interventions. For example, a review of mobile health (mHeath) interventions in Africa identified several projects, including one that focused on reporting of drugs' secondary effects.…”

Analysis of Access to Medical Information of Residents of Different Ages in Guangzhou

“…Real and effective medical information and medical information are often not very easy to sought, which significantly reduces the efficiency of hospital management and medical work [2]. With the advent of the information age, the way for patients to obtain medical information has become diversified, partially solving the problem of difficult medical treatment caused by lack of information sources [3]. However, due to the professionalism of medical knowledge, it is often difficult for non-professionals to judge the authenticity of information, which leads to many problems for patients such as overwhelming fake medical advertisements on the Internet, informal and illegal medical institution websites, etc.…”