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

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

Vilhelmssonetal.BMCPharmacologyandToxicology2012,13:19 /2050-6511/13/19 RESEARCH ARTICLE OpenAccess Experiencesfromconsumerreportsonpsychiatric adversedrugreactionswithantidepressant medication:aqualitativestudyofreportstoa consumerassociation AndreasVilhelmsson1*,TommySvensson1,2,AnnaMeeuwisse3andAndersCarlsten4 Abstract Background:ThenewEuropeanpharmacovigilancelegislationhasbeensuggestedasmarkingthebeginningofa newchapterindrugsafety,makingpatientsanimportantpartofpharmacovigilance.InSwedensince2008ithas beenpossibleforconsumerstoreportadversedrugreactions(ADRs)totheMedicalProductsAgency(MPA),and thesereportsarenowunderstoodasanincreasinglyvaluablecontributioninthemonitoringofsafetyaspectsin medicines.Alreadyin2002itwaspossibletoreportexperienceswithmedicinestothenon-profitandindependent organizationConsumerAssociationforMedicinesandHealth(KILEN)throughaweb-basedreportformwithan opportunitytodescribeADRexperiencesinfreetextcomments.Theaimofthisstudywastoqualitativelyanalyze thefreetextcommentsappendedtoconsumerreportsonantidepressantmedication. Methods:AllreportsofsuspectedadversereactionsregardingantidepressantmedicationssubmittedfromJanuary 2002toApril2009toKILEN’sInternet-basedreportingsysteminSwedenwereanalyzedaccordingtoreported narrativeexperience(s).Contentanalysiswasusedtointerpretthecontentof181reportswithfreetextcomments. Results:Threemaincategoriesemergedfromtheanalyzeddatamaterial:(1)Experiencesofdrugtreatmentwith subcategories(a)Severepsychiatricadversereactions,and(b)Discontinuationsymptoms;(2)Lackofcommunication and(3)Trustanddistrust.AmajorityofthereportstoKILENwerefrompatientsexperiencingsymptomsofmental disturbances(sometimessevere)affectingtheminmanydifferentways,especiallyduringdiscontinuation.Several reportincludednarrativesofpatientsnotreceivinginformationofpotentialADRsfromtheirdoctor,butalsothat therewerenofollow-upsofthetreatment.Trustwashighlightedasespeciallyimportantandsomepatients reportedlosingconfidenceintheirdoctorwhentheywereno