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. 2017 May;40(5):443-455.
doi: 10.1007/s40264-016-0494-x.

Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study

Collaborators, Affiliations

Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study

Sieta T de Vries et al. Drug Saf. 2017 May.

Abstract

Introduction: A mobile app may increase the reporting of adverse drug reactions (ADRs) and improve the communication of new drug safety information. Factors that influence the use of an app for such two-way risk communication need to be considered at the development stage.

Objective: Our aim was to reveal the factors that may influence healthcare professionals (HCPs) and patients to use an app for two-way risk communication.

Methods: Focus group discussions and face-to-face interviews were conducted in the Netherlands, Spain and the UK. Patients with type 2 diabetes mellitus, patients with a rare disease or their caregivers and adolescents with health conditions were eligible to participate. HCPs included pharmacists, paediatricians, general practitioners, internists, practice nurses and professionals caring for patients with a rare disease. Patients and HCPs were recruited through various channels. The recorded discussions and interviews were transcribed verbatim. The dataset was analysed using thematic analysis and arranged according to the Unified Theory of Acceptance and Use of Technology.

Results: Seven focus group discussions and 13 interviews were conducted. In total, 21 HCPs and 50 patients participated. Identified factors that may influence the use of the app were the type of feedback given on reported ADRs, how ADR reports are stored and the type of drug news. Also mentioned were other functions of the app, ease of use, type of language, the source of safety information provided through the app, security of the app, layout, the operating systems on which the app can be used and the costs.

Conclusions: Further research is needed to assess associations between user characteristics and the direction (positive or negative) of the factors potentially influencing app use.

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Conflict of interest statement

Conflict of interest

Sieta T. de Vries, Lisa Wong, Alastair Sutcliffe, François Houÿez, Carmen Lasheras Ruiz, and Peter G.M. Mol declare that they have no conflicts of interest.

Ethical approval

All procedures performed in this study were carried out in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Ethical approval for this study was sought as determined by each country’s local ethics committee policy. In Spain, ethical approval was obtained from the Fundació Sant Joan de Déu. In the UK, ethical approval was obtained from the University College London. In the Netherlands, a waiver for full ethical approval was obtained from the University Medical Center Groningen (reference number M15.172178). Informed consent was obtained from all participants.

Funding

The Web-RADR project has received support from the Innovative Medicine Initiative Joint Undertaking (http://www.imi.europa.eu) under Grant Agreement no. 115632—resources of which are composed of financial contributions from the European Union’s Seventh Framework Programme FP7/2007–2013 and EFPIA companies in kind contribution, http://www.imi.europa.eu, UK.

Figures

Fig. 1
Fig. 1
Screenshots of the UK version of the prototype app for two-way risk communication. a Login screen, b first screen to report an adverse drug reaction (ADR), c example of news items, d overview of reported ADRs
Fig. 2
Fig. 2
Overview of the identified influencing factors and moderating variables of using an app for two-way risk communication

References

    1. Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005–2012. JAMA. 2014;311(4):368–377. doi: 10.1001/jama.2013.282034. - DOI - PMC - PubMed
    1. Raine J, Wise L, Blackburn S, Eichler HG, Breckenridge A. European perspective on risk management and drug safety. Clin Pharmacol Ther. 2011;89(5):650–654. doi: 10.1038/clpt.2011.28. - DOI - PubMed
    1. Stricker BH, Psaty BM. Detection, verification, and quantification of adverse drug reactions. BMJ. 2004;329(7456):44–47. doi: 10.1136/bmj.329.7456.44. - DOI - PMC - PubMed
    1. Segal ES, Valette C, Oster L, Bouley L, Edfjall C, Herrmann P, et al. Risk management strategies in the postmarketing period: safety experience with the US and European bosentan surveillance programmes. Drug Saf. 2005;28(11):971–980. doi: 10.2165/00002018-200528110-00001. - DOI - PubMed
    1. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63(2):148–156. doi: 10.1111/j.1365-2125.2006.02746.x. - DOI - PMC - PubMed

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