Accepted features | Opportunities for further consideration and improvement | |
---|---|---|
Simplicity of use | ADR reporting via app is simplified, easier and requires less time [than other reporting forms], contributing to the elimination of reporting delays Apps include functions that facilitate data entry, such as dropdown menus, lists of medicines, and a “save” option to continue reporting later Information can be further reported in detail through attachments Storage of apps requires a small amount of data memory Apps provide adequate space for case narrative compared to paper forms with limited space | App collects only limited ADR information and must be complemented by comprehensive reporting by an ADR monitoring centre App takes longer to fill in than paper forms. Difficult to fill in electronic forms on small mobile phone |
Quality of reports | Apps eliminate quality issues such as missing reporter names and drug names due to mandatory fields | No comments made |
Accessibility | Apps make ADR reporting more accessible to all segments of society, such as patients and healthcare professionals, as anyone with a smartphone can report Offline features allow users to use some functions even without an internet connection Translation of apps into local languages makes them more accessible | Healthcare professionals must sometimes download the app onto their personal phone, which they may deem inappropriate since the app is work-related App users need internet access to download and use the online functions Users may be reluctant to complete the full user registration process. Also, users may not have email addresses required for the registration |
Innovativeness | Apps enable us to keep up with the contemporary digital world | Apps are mostly suitable for the younger generation and users with an inclination to use technology. Technology-averse or older populations may be reticent about using them |
Data transferability and data sharing | ADR reports are received directly to NRAs in national ADR databases, which contributes to preventing the need for manual data entry, thus saving time. This also eliminates possible transcribing errors Apps are structured in the E2B format required for data processing | Apps do not allow reporters to save a copy of a report to refer back to once it has been sent and thus to share the report with multiple internal and external entities. This limits administrative reporting processes, which are routinely followed in some countries |
Two-way communication | Apps provide users with a range of information, such as safety data on medicines and other related news, in a timely manner Apps engage an audience interested in the safety of medicinal products Immediate acknowledgement messages after report submissions are appreciated by users | If apps do not display contact information, users cannot get in touch with regulators or relevant bodies for clarifications or questions concerning the reporting Users may fail to read news if the apps do not have a notification feature for the news of interest Only a limited audience is likely to download apps for regulatory purpose |
Costs | ADR reporting in free of charge for reporters (except the fee for data transfer) Cuts the cost of distributing reporting tools to the users | No comment made |
Data security | No comments made | In apps that save reports until they are deleted by users, apps may have no control over patient information being uploaded to the Cloud if the device is backed up there Users may not want to provide details, such as their name, institution and contacts |