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1.
PLoS One ; 8(6): e66338, 2013.
Article in English | MEDLINE | ID: mdl-23823902

ABSTRACT

BACKGROUND: Starting in the 1960s, a broad-based patients' rights movement began to question doctors' paternalism and to demand disclosure of medical information, informed consent, and active participation by the individual in personal health care. According to scholars, these changes contributed to downplay the biomedical approach in favor of a more patient-oriented perspective. The Swedish non-profit organization Consumer Association for Medicines and Health (KILEN) has offered 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. METHODOLOGY: In this paper, qualitative content analysis was used to analyze 181 KILEN consumer reports of adverse events from antidepressant medications in order to explore patients' views of mental ill health symptoms and the doctor-patient interaction. PRINCIPAL FINDINGS: Overall, the KILEN stories contained negative experiences of the patients' medical encounters. Some reports indicated intense emotional outrage and strong feelings of abuse by the health care system. Many reports suggested that doctors and patients had very different accounts of the nature of the problems for which the patient was seeking help. Although patients sought help for problems like tiredness and sleeplessness (often with a personal crisis of some sort as a described cause), the treating doctor in most cases was exceptionally quick in both diagnosing depression and prescribing antidepressant treatment. When patients felt they were not being listened to, trust in the doctor was compromised. This was evident in the cases when the doctor tried to convince them to take part in medical treatment, sometimes by threatening to withdraw their sick-listing. CONCLUSIONS: Overall, this study suggests that the dynamics happening in the medical encounter may still be highly affected by a medical dominance, instead of a patient-oriented perspective. This may contribute to a questionable medicalization and/or pharmaceuticalization of depression.


Subject(s)
Antidepressive Agents/therapeutic use , Depression/drug therapy , Humans , Practice Patterns, Physicians'
2.
BMC Pharmacol Toxicol ; 13: 19, 2012 Dec 23.
Article in English | MEDLINE | ID: mdl-23259410

ABSTRACT

BACKGROUND: The new European pharmacovigilance legislation has been suggested as marking the beginning of a new chapter in drug safety, making patients an important part of pharmacovigilance. In Sweden since 2008 it has been possible for consumers to report adverse drug reactions (ADRs) to the Medical Products Agency (MPA), and these reports are now understood as an increasingly valuable contribution in the monitoring of safety aspects in medicines. Already in 2002 it was possible to report experiences with medicines to the non-profit and independent organization Consumer Association for Medicines and Health (KILEN) through a web-based report form with an opportunity to describe ADR experiences in free text comments. The aim of this study was to qualitatively analyze the free text comments appended to consumer reports on antidepressant medication. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.


Subject(s)
Adverse Drug Reaction Reporting Systems/organization & administration , Antidepressive Agents/adverse effects , Community Participation/methods , Pharmacovigilance , Adverse Drug Reaction Reporting Systems/legislation & jurisprudence , Adverse Drug Reaction Reporting Systems/trends , Community Participation/legislation & jurisprudence , Community Participation/trends , Sweden
3.
BMC Clin Pharmacol ; 11: 16, 2011 Oct 25.
Article in English | MEDLINE | ID: mdl-22026961

ABSTRACT

BACKGROUND: 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. 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. METHODS: All 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. RESULTS: In 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. CONCLUSIONS: The 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.


Subject(s)
Adverse Drug Reaction Reporting Systems , Antidepressive Agents/adverse effects , Community Participation , Consumer Organizations , Neurotoxicity Syndromes/epidemiology , Pharmacovigilance , Adolescent , Adrenergic Antagonists/adverse effects , Adult , Age Factors , Aged , Aged, 80 and over , Female , Humans , Internet , Male , Middle Aged , Neurotoxicity Syndromes/psychology , Selective Serotonin Reuptake Inhibitors/adverse effects , Severity of Illness Index , Sex Characteristics , Substance Withdrawal Syndrome/epidemiology , Substance Withdrawal Syndrome/psychology , Sweden/epidemiology , Young Adult
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