Abstract
BackgroundAccording to the World Health Organization (WHO) the cost of adverse drug reactions (ADRs) in the general population is high and under-reporting by health professionals is a well-recognized problem. Another way to increase ADR reporting is to let the consumers themselves report directly to the authorities. In Sweden it is mandatory for prescribers to report serious ADRs to the Medical Products Agency (MPA), but there are no such regulations for consumers. The non-profit and independent organization Consumer Association for Medicines and Health, KILEN has launched the possibility for consumers to report their perceptions and experiences from their use of medicines in order to strengthen consumer rights within the health care sector. This study aimed to analyze these consumer reports.MethodsAll reports submitted from January 2002 to April 2009 to an open web site in Sweden where anyone could report their experience with the use of pharmaceuticals were analyzed with focus on common psychiatric side effects related to antidepressant usage. More than one ADR for a specific drug could be reported.ResultsIn total 665 reports were made during the period. 442 reports concerned antidepressant medications and the individual antidepressant reports represented 2392 ADRs and 878 (37%) of these were psychiatric ADRs. 75% of the individual reports concerned serotonin-reuptake inhibitor (SSRI) and the rest serotonin-norepinephrine reuptake inhibitor (SNRI). Women reported more antidepressant psychiatric ADRs (71%) compared to men (24%). More potentially serious psychiatric ADRs were frequently reported to KILEN and withdrawal symptoms during discontinuation were also reported as a common issue.ConclusionsThe present study indicates that consumer reports may contribute with important information regarding more serious psychiatric ADRs following antidepressant treatment. Consumer reporting may be considered a complement to traditional ADR reporting.
Highlights
According to the World Health Organization (WHO) the cost of adverse drug reactions (ADRs) in the general population is high and under-reporting by health professionals is a well-recognized problem
One important step towards consumer reporting of ADRs was recently taken by the European Parliament, who in September 2010 voted in favor for a new pharmacovigilance legislation to ensure greater patient safety and to improve public health [7,8]
Member States will have to adopt these changes in order to harmonize national adverse event systems, and one important change to the current law foresees the inclusion of direct patient reporting (DPR) of adverse events [10]
Summary
According to the World Health Organization (WHO) the cost of adverse drug reactions (ADRs) in the general population is high and under-reporting by health professionals is a well-recognized problem Another way to increase ADR reporting is to let the consumers themselves report directly to the authorities. One important step towards consumer reporting of ADRs was recently taken by the European Parliament, who in September 2010 voted in favor for a new pharmacovigilance legislation to ensure greater patient safety and to improve public health [7,8]. Member States will have to adopt these changes in order to harmonize national adverse event systems, and one important change to the current law foresees the inclusion of direct patient reporting (DPR) of adverse events [10] Some mean that this will mark the beginning of a new chapter in drug safety [11]. The organization proclaims consumer reporting to be of great importance in order to safeguard a pharmacovigilance that will help each patient to receive optimum therapy, and on a population basis will lead to ensure the acceptance and effectiveness of public health programmes [12]
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