Andreas Vilhelmsson

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

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.

Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012

Background European Union law prohibits companies from marketing drugs off-label. In the United Kingdom—as in some other European countries, but unlike the United States—industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion. Methods and Findings We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%), using print material (70/72, 97%), for example, advertisements (21/70, 30%). Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%). Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%), payers (n = 2, 3%), or company staff (n = 2, 3%). Eight UK rulings (11%) pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US. However, while the UK cases typically related to only one or a few claims made in printed material, several complaints in the US alleged multifaceted and covert marketing activities. Because this study is limited to PMCPA rulings and whistleblower-initiated federal cases, it may offer a partial view of exposed off-label marketing. Conclusion The UK self-regulatory system for exposing marketing violations relies largely on complaints from company outsiders, which may explain why most off-label promotion rulings relate to plainly visible promotional activities such as advertising. This contrasts with the US, where Department of Justice investigations and whistleblower testimony have alleged complex off-label marketing campaigns that remain concealed to company outsiders. UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions. UK prescribers should be attentive to, and increasingly report, off-label promotion.

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

BackgroundThe 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.MethodsAll 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.ResultsThree 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.ConclusionsThe 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.

Depression and antidepressants: a Nordic perspective

The Nordic countries are all established welfare states, and there has for some time existed a notion of a distinctive Nordic or Scandinavian welfare state. Considerable differences seem to exist between for example the psychiatric services within, as well as between, the Nordic countries when it comes to history, mental health acts and allocation of resources. Some argue that it is not even possible to speak of a common Nordic political approach to public health, since all programs contain contradictory policies and ideological statements regarding the emphasis on individual behavior versus choice and living conditions and political responsibilities. Lately, the Nordic countries have performed well in comparative research of health policy in European countries but also regarding health care system in OECD countries. While it appears that the case for the existence of a Nordic model is strong there is actually no consensus of the precise specification of the feature that defines the model. Despite similarities in health care and health policy performance the Nordic countries seem to be quite diverse regarding the prevalence of depression (and the information provided) and sales of antidepressants. (Less)

The devil in the details: public health and depression.

Background: Mental disorders, especially depression, have been increasingly described as a growing burden to global public health. This description is, however, not without controversy, and some scholars are skeptical of how, for instance, depression is viewed as an increasing widespread ill health problem. Discussion: While public health medicine has long engaged in strategies of disease prevention and health promotion, more individualized practices of risk are argued to have become a central dimension of the politics of life in the twenty-first century. By trying to assess potential risk factors for disease and disorders at earlier stages, the concepts of illness and risk may become increasingly blurred. Non-medical problems have become medical ones with risking leading to overdiagnosis and overtreatment as the definition of what constitutes an abnormality gets increasingly broader. If normal events are misdiagnosed as depression, this will risk leaving those who are depressed untreated (extended waiting lists to health care, wrong medications or lack of resources) and thereby create undertreatment and overtreatment simultaneously. Summary: For the sake of public health, arguments for increased diagnosis must therefore be related to a possible danger of medicalizing social problems and life crises. By including people with mild problems in estimates of mental illness, we risk losing support for treating those people who have legitimate disorders. (Less)

A Pill for the Ill? Patients’ Reports of Their Experience of the Medical Encounter in the Treatment of Depression

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.

Consumer Narratives in ADR Reporting: An Important Aspect of Public Health? Experiences from Reports to a Swedish Consumer Organization.

Harms of drugs are an important cause of mortality and morbidity. The use of pharmaceuticals always entails a risk of adverse events, often to an unknown extent, and increased drug utilization has made drug-related problems a common occurrence (1). It is, for instance, estimated that adverse drug reactions (ADRs) cause the European Union almost 200,000 deaths annually (2) and cost approximately €79 billion (3). n nThe World Health Organization (WHO) clearly recognizes the need for prescribed medicines to be of good quality, safe, effective, and used by the right patient in the right dose at the right time in order to minimize the risk of harm (4). The thalidomide disaster around 1960 underscored the necessity of systems to monitor medicines safety after marketing. As a consequence, governments developed systems in order to affirm that drug products are safe and efficacious enough to be permitted on the market and that the pharmaceutical industry needed to be regulated since these companies have a responsibility to protect public health (5). This concern with patient safety and the rational usage of drugs is often referred to as pharmacovigilance (PV) (6), which can be defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse events or any other possible drug-related problems” (7). It is however well established that knowledge about medicines safety is limited at the time of licensing of a new product and spontaneous reporting of ADRs to regulatory authorities and drug manufactures is perhaps the most important way of monitoring the post-market safety of medicines (8). National databases to collect signals of ADRs from health care professionals (HCPs) were established already from the late 1960s and a WHO international collaboration started in 1968. With their Drug Monitoring Program, WHO supports the reporting of potential ADRs by HCPs (9), but it is a well-recognized problem by the Organization, that this group under-report serious and fatal reactions (4). Unexpected ADRs are, for instance, seldom reported.

Value-Based Health Care Delivery, Preventive Medicine and the Medicalization of Public Health

The real paradigm shift for healthcare is often stated to include a transition from accentuating health care production and instead emphasize patient value by moving to a ‘value-based health care delivery’. In this transition, personalized medicine is sometimes referred to as almost a panacea in solving the current and future health challenges. In theory, the progress of precision medicine sounds uncontroversial and most welcomed with its promise of a better healthcare for all, with real benefits for the individual patient provided a tailored and optimized treatment plan suitable for his or her genetic makeup. And maybe, therefore, the assumptions underpinning personalized medicine have largely escaped questioning. The use of personalized medicine and the use of digital technologies is reshaping our health care system and how we think of health interventions and our individual responsibility. However, encouraging individuals to engage in preventive health activities possibly avoids one form of medicalization (clinical), but on the other hand, it takes up another form (preventive medicine and ‘self-care’) that moves medical and health concerns into every corner of everyday life. This ought to be of little value to the individual patient and public health. We ought to instead demand proof of these value ideas and the lacking research. Before this is in place critical appraisal and cynicism are requisite skills for the future. Otherwise, we are just listening to visionaries when we put our future health into their hands and let personalized solutions reach into peoples everyday life regardless of patient safety and integrity.

Reducing health inequalities with interventions targeting behavioral factors among individuals with low levels of education - A rapid review

Individuals with low levels of education systematically have worse health than those with medium or high levels of education. Yet there are few examples of attempts to summarize the evidence supporting the efficacy of interventions targeting health-related behavior among individuals with low education levels, and a large part of the literature is descriptive rather than analytical. A rapid review was carried out to examine the impact of such interventions. Special attention was given to the relative impact of the interventions among individuals with low education levels and their potential to reduce health inequality. Of 1,365 articles initially identified, only 31 were deemed relevant for the review, and of those, nine met the inclusion and quality criteria. The comparability of included studies was limited due to differences in study design, sample characteristics, and definitions of exposure and outcome variables. Therefore, instead of performing a formal meta-analysis, an overall assessment of the available evidence was made and summarized into some general conclusions. We found no support for the notion that the methods used to reduce smoking decrease inequalities in health between educational groups. Evidence was also limited for decreasing inequality through interventions regarding dietary intake, physical activity and mental health. Only one study was found using an intervention designed to decrease socioeconomic inequalities by increasing the use of breast cancer screening. Thus, we concluded that there is a lack of support regarding this type of intervention as well. Therefore, the main conclusion is that solid evidence is lacking for interventions aimed at individual determinants of health and that more research is needed to fill this gap in knowledge.

Using Qualitative Content Analysis to Study Consumer Reports on Adverse Drug Reactions

Using qualitative content analysis on adverse drug reactions reports filed to an open Internet-based reporting system in Sweden, this study explored patients’ and consumers’ experiences of antidepressant treatment and the medical encounter. By scrutinizing free text comments in 181 individual consumer reports of adverse drug reactions, we could obtain important information about how people, as individuals and as a group, experience mental health problems, their diagnosis and treatment, and their relationships with the health care personnel. This research illustrated how a series of contextual factors (e.g., time pressure, inferior knowledge of adverse drug reactions, no follow-up meetings, and overall medical dominance) can risk medicalizing and thereby social problems resulting in overdiagnosis and overtreatment of mental ill health; something that could corrupt patients’ future trust in seeking help. By using qualitative content analysis to study free text comments in patient reports of adverse drug reactions, it is possible to broaden the understanding on how drugs affect the user in terms of treatment effects but also how the medicine is affecting the user in his or her daily life and identify new serious reactions. It can also be an important tool to analyze, for instance, sociological aspects in terms of what is going on in the medical meeting and how the doctor-patient interaction may look like from the patient’s point of view revealing power imbalance and inadequate care. We strongly recommend this qualitative approach for further research and within a clinical context to bring the patient perspective to the fore. (Less)