Basic Conditions for Consumer Reporting of Adverse Drug Reactions in Sweden - a Pilot Study

The proportion of patient reports of suspected ADRs to signal detection in the Netherlands: case–control study

“…The percentage of patient reports for other countries which have been published range between 7 and 15% of the total number of reports 4. Although some countries have published their experiences with patient reporting over the past few years,4, 6–19 the contribution of reporting by patients to the detection of signals has not been quantified and it is not clear to what extend the source of the reports influences the selection of signals. Recently, potential signals of adverse drug reactions generated by patients compared to healthcare professionals were described in an abstract from UK 14…”

“…They found that part of the reports by patients concerned unlabelled reactions with a possible value to signal detection. They concluded that signals with impact on regulatory actions were received by consumers 12. In the first 2000 calls to the Australian Adverse Medicine Events (AME) line, 5% of ADR reports were not listed in the SmPC 13.…”

“…A report having a patient as its source could be hampering factor in the selection of signals. On the other hand, there is also some evidence that new ADRs are reported by patients9, 12 so the reporter being a patient could also be a positive factor in signal detection.…”