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Table 5 Respondents’ comments on use of ADR reporting apps

From: Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience

 

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