| The U.S. has been accepting consumer adverse drug reaction (ADR) reports within its Adverse Event Reporting System (AERS) since 1993. However, it is unknown if there are significant differences in ADR reports between physicians and consumers. To date, no published studies have been found analyzing the reports from the two sources in AERS and evidence is needed to determine whether consumer reports should be widely accepted as part of good pharmacovigilance practices. Guided by the risk perception theory, this cross-sectional study attempted to assess the differences by reporter based on the following factors: the distribution of ADRs based on seriousness, distribution of ADRs for system organ class (SOC), and anatomical therapeutic chemical (ATC). The Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug Dictionary were used for coding; statistical analysis was conducted using SAS Version 9.2. The chi-squared test for independence was used to test for relationship between reporter (physician and consumer) and the dependent variables of seriousness, SOC, and ATC. Results showed that compared to physicians, consumers tended to report more serious ADRs for the following SOCs: Cardiac Disorders, Ear and Labyrinth Disorders, Eye Disorders, GI Disorders, General Disorders and Administration Site Conditions, Injury, Poisoning and Procedural Complications, Nervous System Disorders, and Psychiatric Disorders. Consumers reported more serious ADRs for the ATC Group N (Nervous System) than physicians. The implications for positive social change include worldwide acceptance of consumer ADR reports within safety surveillance databases resulting in earlier signal detection and stronger pharmacovigilance practices. |
