What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? Experiences from reports to a consumer association

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.

Experiences from consumer reports on psychiatric adverse drug reactions with antidepressant medication: a qualitative study of reports to a consumer association

“…A previous study on the KILEN material indicated that adverse reactions in connection with discontinuation of antidepressant medication was often reported to KILEN but not always mentioned in the Swedish Physicians’ Desk Reference FASS, and when it was mentioned, it was generally regarded as rare [9]. This has also been shown in an evaluation of the UK patient reporting system ‘Yellow Card Scheme’ which identified new ‘serious’ reactions not previously included in the SPC [5].…”

“…In a previous study, it was indicated that women reported ADRs to KILEN in a much higher degree: between three and four times more often than men, and sometimes more within certain age groups [9]. This may also be true for the use of these drugs.…”

“…This feeling of distance was sometimes described in the KILEN narratives as a kind of depersonalization or of feeling a sensation of unreality. In a previous study on the KILEN consumer reports, feeling a sensation of unreality was a commonly reported mental disturbance, but was not listed at all as an adverse drug reaction or side effect in the Swedish Physicians’ Desk Reference FASS (building on the Summary of Product Characteristics SPC) [9]. …”

“…Since the reports to KILEN contained individual responses to a drug reported as severe and noxious we decided to use the latter. The KILEN compilation and coding system is described in a previous study [9]. As Figure 1 shows, of 442 individual antidepressant reports, 393 individuals also provided a longer description of the ADR experience as free text (89%).…”

“…Since 2002 it has also been possible to report suspected ADRs to this organization through a web-based report form with the opportunity to add free text comments of the experience(s) (http://www.kilen.org). Previous research on the KILEN material has shown that consumer reports may contribute important information regarding more serious psychiatric adverse reactions following antidepressant treatment [9]. However, the free text comments were not scrutinized or analyzed.…”