Factors affecting patient reporting of adverse drug reactions: a systematic review

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The aim of the present study was to determine the barriers and motives influencing consumer reporting of adverse drug reactions (ADRs).


A systematic review, guided by the Cochrane Handbook, was conducted. Electronic searches included MEDLINE, EMBASE, PsycINFO, CINAHL, PubMed and the Cochrane Database of Systematic Reviews from 1964 to December 2014. Eligible studies addressed patients' perceptions and factors influencing ADR reporting. Studies about healthcare professional (HCP) reporting of ADRs were excluded. Studies were appraised for quality, and results were analysed descriptively.


Of 1435 citations identified, 21 studies were eligible. Studies were primarily conducted in the UK, the Netherlands and Australia. The identified barriers to patient reporting of ADRs (n = 15 studies) included poor awareness, confusion about who should report the ADR, difficulties with reporting procedures, lack of feedback on submitted reports, mailing costs, ADRs resolved and prior negative reporting experiences. The identified motives for patients reporting ADRs (n = 10 studies) were: preventing others from having similar ADRs, wanting personal feedback, improving medication safety, informing regulatory agencies, improving HCP practices, responding to HCPs not reporting their ADRs and having been asked to report ADRs by HCPs.


Most patients were not aware of reporting systems and others were confused about reporting. Patients were mainly motivated to make their ADRs known to prevent similar suffering in other patients. By increasing patient familiarity and providing clear reporting processes, reporting systems could better achieve patient reporting of ADRs.

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