Dubai Medical Journal

ISSN: 2571-726X

Pioneering research in medicine, health sciences, nursing, pharmaceuticals, and laboratory work

Public-focused Pharmacovigilance Mobile Software: Comparison and Evaluation

Published date:Mar 24 2025

Journal Title: Dubai Medical Journal

Issue title: Dubai Medical Journal (DMJ): Volume 8, Issue 1

Pages:96 - 109

DOI: 10.18502/dmj.v8i1.18319

Authors:

Mariam Saeed Al-AttarIndependent Researcher, Manama

Huda Jawad HabibUniversity of Bahrain, Manama

Fatemeh Asgari HosseinehIndependent Researcher, Tehran

Mohammad Al-AttarIndependent Researcher, Manama

Abstract:

Introduction: Medications can lead to severe health complications including adverse drug reactions, a major cause of mortality globally. Pharmacovigilance plays a critical role in identifying, evaluating, and mitigating these risks. While mobile medical apps present new opportunities for enhancing medication safety, there is a recognized need for better pharmacovigilance support within these applications. This study assesses the role of medical applications in pharmacovigilance and drug safety with the goal of enhancing these applications and bridging the gap between their current offerings and patient needs.

Methods: This mixed-methods study developed a pharmacovigilance concept specifically for public-use mobile applications, identifying six key aspects related to patient needs. These aspects guided the creation of an investigation form which was then used to evaluate nine selected apps.

Discussion: The findings showed a high degree of similarity among the apps, with significant gaps between their features and the actual needs of users. Most apps were limited to providing medication reminders, with only a few offerings information on safety alerts or drug interaction verification. The study recommends addressing these gaps and enhancing the capabilities of drug vigilance applications by providing comprehensive and credible information services tailored to patient needs, thus improving the effectiveness of health applications in drug vigilance.

Conclusion: Mobile applications have the potential to significantly improve pharmacovigilance and medication safety. However, existing apps have notable gaps. Collaboration between developers and healthcare professionals is essential to improve these apps and prioritize pharmacovigilance in all health-related mobile applications.

Keywords: E-health, mHealth, pharmacovigilance, health app

References:

[1] Nour S, Plourde G. Foreword. Pharmacoepidemiology and pharmacovigilance: Synergistic tools to better investigate drug safety. 1st ed. London: Academic Press; 2019. pp. xi–xiv.

[2] Parracha ER, Advinha AM, Lopes MJ, Oliveira-Martins S. Mobile apps for quick adverse drug reaction report: A scoping review. Pharmacoepidemiol Drug Saf. 2023 Jan;32(1):19–27. https://doi.org/10.1002/pds.5542 PMID:36125022

[3] WHO. Regulation and Prequalification [Internet]. 2004 [cited 2023 Sep 6]. Available from: https://www. who.int/teams/regulation-prequalification/pharmacovigilance

[4] Beninger P. Pharmacovigilance: An overview. Clin Ther. 2018 Dec;40(12):1991–2004. https://doi.org/10. 1016/j.clinthera.2018.07.012PMID:30126707

[5] Ting ting Zhou, Rui Wang, Si jia Gu, Li ling Xie, Qing hua Zhao, Ming zhao Xiao, et al. Effectiveness of mobile medical apps in ensuring medication safety among patients with chronic diseases: Systematic review and meta-analysis. JMIR mHealth and uHealth. 2022;10:e39819.

[6] Defer G, Le Caignec F, Fedrizzi S, Montastruc F, Chevanne D, Parienti JJ, et al. Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): Study protocol for a randomized controlled trial. Trials. 2018 Mar;19(1):174. https: //doi.org/10.1186/s13063-018-2560-4PMID:29523169

[7] Pinnow E, Amr S, Bentzen SM, Brajovic S, Hungerford L, St George DM, et al. Postmarket safety outcomes for new molecular entity (NME) drugs approved by the Food and Drug Administration between 2002 and 2014. Clin Pharmacol Ther. 2018 Aug;104(2):390–400. https://doi.org/10.1002/cpt. 944PMID:29266187

[8] Lavertu A, Vora B, Giacomini KM, Altman R, Rensi S. A new era in pharmacovigilance: Toward realworld data and digital monitoring. Clin Pharmacol Ther. 2021 May;109(5):1197–1202. https://doi.org/10. 1002/cpt.2172PMID:33492663

[9] Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: Complementing spontaneous reporting systems. Drug Saf. 2013 Feb;36(2):75–81. https: //doi.org/10.1007/s40264-012-0014-6PMID:23329541

[10] Inácio P, Cavaco A, Airaksinen M. The value of patient reporting to the pharmacovigilance system: A systematic review. Br J Clin Pharmacol. 2017 Feb;83(2):227–246. https://doi.org/10.1111/bcp.13098PMID: 27558545

[11] Hazell L, Shakir SA. Under-reporting of adverse drug reactions: A systematic review. Drug Saf. 2006;29(5):385–396. https://doi.org/10.2165/00002018-200629050-00003PMID:16689555

[12] Global eHealth market size, share & industry trends analysis report by product, end user, regional outlook and forecast, 2022-2028 [Internet]. Marqual IT Solutions; 2023. Report No.: 5778946. Available from: https://www.researchandmarkets.com/reports/5778946

[13] Berrewaerts J, Delbecque L, Orban P, Desseilles M. Patient participation and the use of eHealth tools for pharmacoviligance. Front Pharmacol. 2016 Apr;7:90. https://doi.org/10.3389/fphar.2016.00090 PMID:27148052

[14] World Health Organization. The conceptual framework for the international classification for patient safety. 1st ed. Geneva: World Health Organization; 2009.

[15] Drug-related side effects and adverse reactions [Internet]. MeSH subject heading scope note. 2014. Available from: https://www.ncbi.nlm.nih.gov/mesh/?term=Adverse+drug+reactions

[16] Medication errors [Internet]. MeSH subject heading scope note. 1967. Available from: https://www.ncbi. nlm.nih.gov/mesh/?term=Medication+error

[17] Drug interactions [Internet]. MeSH subject heading scope note. 1972. Available from: https://www.ncbi.nlm.nih.gov/mesh/68004347

[18] World Health Organization. Promoting rational use of medicines: Core components. Geneva: World Health Organization; 2002.

[19] Pierce CE, de Vries ST, Bodin-Parssinen S, Härmark L, Tregunno P, Lewis DJ, et al. Recommendations on the use of mobile applications for the collection and communication of pharmaceutical product safety information: Lessons from IMI WEB-RADR. Drug Saf. 2019 Apr;42(4):477–489. https://doi.org/10. 1007/s40264-019-00813-6PMID:30911975

[20] de Langen J, van Hunsel F, Passier A, de Jong-van den Berg L, van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: Three years of experience. Drug Saf. 2008;31(6):515–524. https://doi.org/10.2165/00002018-200831060-00006 PMID:18484785

[21] Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, et al. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: Literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011 May;15(20):1–234. https://doi.org/10.3310/hta15200PMID:21545758

[22] Barnes J. Pharmacovigilance of herbal medicines: A UK perspective. Drug Saf. 2003;26(12):829–851. https://doi.org/10.2165/00002018-200326120-00001PMID:12959628

[23] Li A, Del Olmo MG, Fong M, Sim K, Lymer SJ, Cunich M, et al. Effect of a smartphone application (Perx) on medication adherence and clinical outcomes: A 12-month randomised controlled trial. BMJ Open. 2021 Aug;11(8):e047041. https://doi.org/10.1136/bmjopen-2020-047041PMID:34373299

[24] National Council for Prescription Drug Programs. Universal Medication Schedule white paper. National Council for Prescription Drug Programs; 2013.

[25] Wolf MS, Taitel MS, Jiang JZ, Curtis LM, Wismer GA, Wallia A, et al. Prevalence of Universal Medication Schedule prescribing and links to adherence. Am J Health Syst Pharm. 2020 Jan;77(3):196–205. https://doi.org/10.1093/ajhp/zxz305PMID:31974556

[26] Mira JJ, Guilabert M, Carrillo I, Fernández C, Vicente MA, Orozco-Beltrán D, et al. Use of QR and EAN-13 codes by older patients taking multiple medications for a safer use of medication. Int J Med Inform. 2015 Jun;84(6):406–412. https://doi.org/10.1016/j.ijmedinf.2015.02.001 PMID:25731975

[27] Belsky JA, Holmes C, Stanek J, Yeager ND, Audino AN. Evaluating perspectives of a smartphone medication application in the adolescent and young adult oncology population: A qualitative study. J Adolesc Young Adult Oncol. 2021 Jun;10(3):282–287. https://doi.org/10.1089/jayao.2020.0113PMID: 32960135

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