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Low awareness of adverse drug reaction reporting systems: a consumer survey

Adverse drug reactions (ADRs) are a concern to patients, doctors and the Australian health care system, with high rates of medication misadventure,1 adverse events in general practice patients,2 and hospitalisations.3 There are limited data on the long-term safety of newly marketed medicines and their use in patient groups not included in early clinical trials.

Most reporting of ADRs to the Therapeutic Goods Administration (TGA) is done by health professionals (doctors and pharmacists), hospitals and pharmaceutical companies, through mandatory reporting obligations. Consumers have been able to directly report possible ADRs to the TGA since 1964. Since 1990, there have been fewer than 7000 consumer ADR reports; 4190 of 74 036 reports (5.7%) between 2003 and 2009 were made by consumers, including a surge in 2009 (1307/13 298 [9.8%]) associated with the pandemic H1N1 influenza vaccination.4 Consumer reporting rates fell to 3% in 2011.5 It is unclear if these rates are low because patients are unaware of ADRs or unaware of the processes by which reports can…