Are patients ready to take part in the Pharmacovigilance system? a portuguese preliminary study concerning adr reporting

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

“…Many participants did not know that there was a national regulatory agency. In seven quantitative studies, 75% (range 44.1–93.8%) of participants were not aware of available ADR reporting systems .…”

“…Three quantitative and two qualitative studies indicated that judging the ADR as serious was the main motivation for patients to report . For example, in two UK surveys, the majority of respondents (62% and 86%, respectively) declared that only serious ADRs requiring hospital admission or affecting daily life were worthy of reporting .…”

“…For example, in two UK surveys, the majority of respondents (62% and 86%, respectively) declared that only serious ADRs requiring hospital admission or affecting daily life were worthy of reporting . Similarly, in Portugal, participants agreed or strongly agreed that severity was the primary reason for reporting ADRs .…”

Consumer reporting of suspected adverse drug reactions: modelling the acceptance of mobile phone caller tunes to raise awareness

“…Barriers to patient reporting of ADRs include poor awareness and confusion as to who reports ADRs, and to whom . These barriers could be addressed through the use of mobile phone‐based technologies including apps .…”

“…[13] However, a cross-sectional survey a few months after the launch showed that only 1.6% of patients were willing to report ADRs directly to the FDA's National Pharmacovigilance Centre because of lack of sustained awareness. [15] Barriers to patient reporting of ADRs include poor awareness [16][17][18][19][20][21][22] and confusion as to who reports ADRs, and to whom. [17,23,24] These barriers could be addressed through the use of mobile phone-based technologies including apps.…”