Patient reporting of suspected adverse drug reactions: a review of published literature and international experience


Alison Blenkinsopp, Professor of the Practice of Pharmacy, Department of Medicines Management, Keele University, Keele, Staffs ST5 5BG, UK.
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To synthesize data from published studies and international experience to identify evidence of potential benefits and drawbacks of direct patient reporting of suspected adverse drug reactions (ADRs) by patients.


Structured search of MEDLINE, CINAHL and PsycINFO supplemented by internet searches and requests for information to key contacts.


Seven studies (eight papers) were included in the review. None of the studies concerned spontaneous reporting by patients. Information on patient reporting systems was obtained for six countries, with summary data reported by four. Patient reports identified possible new ADRs that had not previously been reported by health professionals. The quality of patient reports appears to be similar to that of health professional reports. There is some evidence that patients report an ADR when they consider their health professional has not paid attention to their concerns. Patient reports may, at least initially, be more time consuming to process.


Overall, the evidence indicates that patient reporting of suspected ADRs has more potential benefits than drawbacks. Evaluation of patient reporting systems is needed to provide further evidence.