Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 May 2;22(1):118.
doi: 10.1186/s12911-022-01832-7.

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

Ayako Fukushima  1 , Noha Iessa  1 , Madhava Ram Balakrishnan  1 , Shanthi Narayan Pal  2
Affiliations

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

Ayako Fukushima et al. BMC Med Inform Decis Mak. .

Abstract

Background: Smartphone technology can support paperless reporting of adverse drug reactions (ADRs). The aims of this study were to systematically assess smartphone ADR-reporting applications, understand their qualitative and quantitative impact on ADR reporting, and garner key lessons from owners and developers.

Methods: This study had three components: (1) An assessment of ADR-reporting apps, (2) an online survey on the impact of app implementation on ADR reporting and the experiences of app developers and owners, and (3) a search of VigiBase, the World Health Organization global database of individual case safety reports (ICSRs), to observe trends in the number of ADR reports targeting countries where the apps were implemented.

Results: Twenty-two apps were included. Eight out of the 22 apps were for countries in the WHO African region. Features observed included E2B data elements (E stands for efficacy) and functions supporting reporting and user engagement. Seventeen app developers and owners answered to the survey and reported overall positive experiences with app features, and post-launch increases in the total number of ICSRs. User type and user environment were cited as factors influencing app use: Respondents said younger people and/or those with an inclination to use technology were more likely to use apps compared to older or more technology-averse people, while respondents in countries with limited internet connectivity reported persistent difficulties in app use.

Conclusions: Smartphone apps for reporting ADRs offer added value compared to conventional reporting tools. Reporting tools should be selected based on interface features and factors that may influence app usage.

Keywords: Adverse drug reactions (ADRs); Drug safety; Pharmacovigilance; Regulatory system; Reporting of ADRs; Smartphone apps; VigiBase.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1
PRISMA flow chart of the app selection process
Fig. 2
Fig. 2
Number of apps offering each feature. Feature item No. 1 was present in the following apps: 1, 3, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 18, 19, 20, 21, 22. Feature item No. 2 was present in the following apps: 1, 2, 17, 18, 19, 20. Feature item No. 3 was present in the following apps: 2, 4, 19, 20 (While not having a laboratory field by default, there were apps which automatically displayed supplementary fields and questions in response to an answer to certain conditions such as pregnancy). Feature item No. 4 was present in the following apps: 2, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 21, 22. Feature item No. 5 was present in the following apps: 1, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 21, 22. Feature item No. 6 was present in the following apps: 17. Feature item No. 7 was present in the following apps: 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 21, 22. Feature item No. 8 was present in the following apps: 1, 3, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 21, 22 (Apps were also counted if contact was included in an acknowledgment message or in an introduced website)
Fig. 3
Fig. 3
Comparison of essential elements* appropriately filled in for ADR reports on apps and in paper form. *Elements making up the “minimum information for valid safety report” as defined by the ICH
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2D. https://database.ich.org/sites/default/files/E2D_Guideline.pdf.
    1. World Health Organization: Safety monitoring of medical products: reporting system for the general public; 2012.
    1. Avong YK, Jatau B, Gurumnaan R, et al. Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, Tuberculosis and Malaria: a prospective cohort study. PLoS ONE. 2018;13(8):e0200810. doi: 10.1371/journal.pone.0200810. - DOI - PMC - PubMed
    1. Gony M, Badie K, Sommet A, et al. Improving adverse drug reaction reporting in hospitals: results of the French Pharmacovigilance in Midi-Pyrenees region (PharmacoMIP) network 2-year pilot study. Drug Saf. 2010;33(5):409–416. doi: 10.2165/11319170-000000000-00000. - DOI - PubMed
    1. Potlog Shchory M, Goldstein LH, Arcavi L, et al. Increasing adverse drug reaction reporting—how can we do better? PLoS ONE. 2020;15(8):e0235591. doi: 10.1371/journal.pone.0235591. - DOI - PMC - PubMed