%0 Journal Article
%T Experiences from consumer reports on psychiatric adverse drug reactions with antidepressant medication: a qualitative study of reports to a consumer association
%A Andreas Vilhelmsson
%A Tommy Svensson
%A Anna Meeuwisse
%A Anders Carlsten
%J BMC Pharmacology and Toxicology
%D 2012
%I BioMed Central
%R 10.1186/2050-6511-13-19
%X All reports of suspected adverse reactions regarding antidepressant medications submitted from January 2002 to April 2009 to KILEN¡¯s Internet-based reporting system in Sweden were analyzed according to reported narrative experience(s). Content analysis was used to interpret the content of 181 reports with free text comments.Three main categories emerged from the analyzed data material: (1) Experiences of drug treatment with subcategories (a) Severe psychiatric adverse reactions, and (b) Discontinuation symptoms; (2) Lack of communication and (3) Trust and distrust. A majority of the reports to KILEN were from patients experiencing symptoms of mental disturbances (sometimes severe) affecting them in many different ways, especially during discontinuation. Several report included narratives of patients not receiving information of potential ADRs from their doctor, but also that there were no follow-ups of the treatment. Trust was highlighted as especially important and some patients reported losing confidence in their doctor when they were not believed about the suspected ADRs they experienced, making them attempt to discontinue their antidepressant treatment on their own.The present study indicates that free text comments as often contained in case reports directly submitted by patients can be of value in pharmacovigilance and provide important information on how a drug may affect the person using it and influence his or her personal life.The new European pharmacovigilance legislation (Directive 2010/84/EU) (Regulation 1235/2010) [1] that came into force in July 2012 has been suggested as marking the beginning of a new chapter in drug safety [2]. Its purpose is to further accentuate patient influence, and all EU countries are now obliged to introduce patient/consumer reporting to their spontaneous reporting systems, making patients an important part of pharmacovigilance. Since under-reporting by health professionals is a well-recognized problem by the World Health Org
%U http://www.biomedcentral.com/2050-6511/13/19