Exposure to Paracetamol in Early Pregnancy and the Risk of Developing Cerebral Palsy: A Case-Control Study Using Serum Samples.

OBJECTIVE: To investigate whether maternal paracetamol use in early pregnancy is associated with cerebral palsy (CP) in offspring. STUDY DESIGN: We conducted a registry and biobank-based case-control study with mother-child pairs. We identified CP cases (n = 322) born between 1995 and 2014 from a nationwide CP-registry. Randomly selected controls (n = 343) and extra preterm controls (n = 258) were obtained from a birth registry. For each mother, a single serum sample from early pregnancy (gestation weeks 10-14) was retrieved from a biobank and analyzed for serum concentrations of paracetamol, categorized into unexposed (<1 ng/ml), mildly exposed (1-100 ng/ml), and highly exposed (>100 ng/ml), and in quartiles. Analyses were performed using logistic regression and adjusted for potential confounders. Separate analyses were conducted including only those children born preterm and only those born term. RESULTS: Of the 923 participants, 36.8% were unexposed, 53.2% mildly exposed, and 10% highly exposed to paracetamol. Overall, prenatal exposure to paracetamol was not associated with CP. Sensitivity and subgroup analyses showed no clear associations between paracetamol and CP across strata of term/preterm birth as well as subtypes of CP. CONCLUSIONS: The present study does not support an association between intrauterine exposure to paracetamol in early pregnancy and the risk of CP. However, it is important to stress that the exposure estimate is based on a single serum sample.

Occupational risk of SARS-CoV-2 infection: a nationwide register-based study of the Danish workforce during the COVID-19 pandemic, 2020-2021.

OBJECTIVE: Most earlier studies on occupational risk of COVID-19 covering the entire workforce are based on relatively rare outcomes such as hospital admission and mortality. This study examines the incidence of SARS-CoV-2 infection by occupational group based on real-time PCR (RT-PCR) tests. METHODS: The cohort includes 2.4 million Danish employees, 20-69 years of age. All data were retrieved from public registries. The incidence rate ratios (IRRs) of first-occurring positive RT-PCR test from week 8 of 2020 to week 50 of 2021 were computed by Poisson regression for each four-digit Danish Version of the International Standard Classification of Occupations job code with more than 100 male and 100 female employees (n=205). Occupational groups with low risk of workplace infection according to a job exposure matrix constituted the reference group. Risk estimates were adjusted by demographic, social and health characteristics including household size, completed COVID-19 vaccination, pandemic wave and occupation-specific frequency of testing. RESULTS: IRRs of SARS-CoV-2 infection were elevated in seven healthcare occupations and 42 occupations in other sectors, mainly social work activities, residential care, education, defence and security, accommodation and transportation. No IRRs exceeded 2.0. The relative risk in healthcare, residential care and defence/security declined across pandemic waves. Decreased IRRs were observed in 12 occupations. DISCUSSION: We observed a modestly increased risk of SARS-CoV-2 infection among employees in numerous occupations, indicating a large potential for preventive actions. Cautious interpretation of observed risk in specific occupations is needed because of methodological issues inherent in analyses of RT-PCR test results and because of multiple statistical tests.

Using nudges to promote clinical decision making of healthcare professionals: A scoping review.

Nudging has been discussed in the context of policy and public health, but not so much within healthcare. This scoping review aimed to assess the empirical evidence on how nudging techniques can be used to affect the behavior of healthcare professionals (HCPs) in clinical settings. A systematic database search was conducted for the period January 2010-December 2020 using the PRISMA extension for Scoping Review checklist. Two reviewers independently screened each article for inclusion. Included articles were reviewed to extract key information about each intervention, including purpose, target behavior, measured outcomes, key findings, nudging strategies, intervention objectives and their theoretical underpinnings. Two independent dimensions, building on Kahneman's System 1 and System 2, were used to describe nudging strategies according to user action and timing of their implementation. Of the included 51 articles, 40 reported statistically significant results, six were not significant and two reported mixed results. Thirteen different nudging strategies were identified aimed at modifying four types of HPCs' behavior: prescriptions and orders, procedure, hand hygiene, and vaccination. The most common nudging strategy employed were defaults or pre-orders, followed by alerts or reminders, and active choice. Many interventions did not require any deliberate action from users, here termed passive interventions, such as automatically changing prescriptions to their generic equivalent unless indicated by the user. Passive nudges may be successful in changing the target outcome but may go unnoticed by the user. Future work should consider the broader ethical implications of passive nudges.

Nudging healthcare professionals in clinical settings: a scoping review of the literature.

BACKGROUND: Healthcare organisations are in constant need of improvement and change. Nudging has been proposed as a strategy to affect people's choices and has been used to affect patients' behaviour in healthcare settings. However, little is known about how nudging is being interpreted and applied to change the behaviour of healthcare professionals (HCPs). The objective of this review is to identify interventions using nudge theory to affect the behaviour of HCPs in clinical settings. METHODS: A scoping review. We searched PubMed and PsycINFO for articles published from 2010 to September 2019, including terms related to "nudging" in the title or abstract. Two reviewers screened articles for inclusion based on whether the articles described an intervention to change the behaviour of HCPs. Two reviewers extracted key information and categorized included articles. Descriptive analyses were performed on the data. RESULTS: Search results yielded 997 unique articles, of which 25 articles satisfied the inclusion criteria. Five additional articles were selected from the reference lists of the included articles. We identified 11 nudging strategies: accountable justification, goal setting, suggested alternatives, feedback, information transparency, peer comparison, active choice, alerts and reminders, environmental cueing/priming, defaults/pre-orders, and education. These strategies were employed to affect the following 4 target behaviours: vaccination of staff, hand hygiene, clinical procedures, prescriptions and orders. To compare approaches across so many areas, we introduced two independent dimensions to describe nudging strategies: synchronous/asynchronous, and active/passive. CONCLUSION: There are relatively few studies published referring to nudge theory aimed at changing HCP behaviour in clinical settings. These studies reflect a diverse set of objectives and implement nudging strategies in a variety of ways. We suggest distinguishing active from passive nudging strategies. Passive nudging strategies may achieve the desired outcome but go unnoticed by the clinician thereby not really changing a behaviour and raising ethical concerns. Our review indicates that there are successful active strategies that engage with clinicians in a more deliberate way. However, more research is needed on how different nudging strategies impact HCP behaviour in the short and long term to improve clinical decision making.

Revisiting the pharmaceuticalisation of pandemic influenza using Lukes' framework of power.

The power of social actors to drive or block pharmaceutical uptake has been a concern in sociological debates on pharmaceuticalisation, including in the case of pandemic vaccination. We build on Steven Lukes' three-dimensional view of power to explore the 2009 H1N1 pandemic vaccination in Sweden and Denmark - two similar countries that arrived at conflicting vaccination strategies. Drawing on interviews with members of each country's pandemic steering group and on document analysis, we explore three consecutive stages of pandemic vaccination response: planning, vaccine procurement and the vaccination campaign. The paper makes two contributions to studies of pharmaceuticalisation and pandemics. Conceptually, we advocate the suitability of Lukes' framework over the 'countervailing powers' framework repeatedly used to model power in the pharmaceutical field. Empirically, our study confirms that government-appointed experts steered pandemic planning in both countries, but we show that the state, industry and the WHO also exerted power by enabling and constraining experts' decision-making, including by keeping some information secret. Furthermore, we argue that mass vaccination in Sweden was a pervasive expression of state power, in Lukes' sense, since it rested on keeping latent the tension between many individuals' health interests and the state's interests in protecting social and economic functioning.

'So, the circle has grown' - Child Health Services nurses' experiences of giving parental interviews with nonbirthing parents.

BACKGROUND: Lately, greater focus has been given to the mental health of nonbirthing parents postpartum. However, mothers, but not nonbirthing parents, are routinely screened for postpartum depression, and until recently, nonbirthing parents have not been given the same opportunity as mothers to discuss their parental role without the other parent present. To strengthen the parental role, a separate parental interview with the nonbirthing parent began to be offered as part of the Swedish Child Health Service's (CHS) general programme. AIM: This study aimed to explore CHS nurses' experiences of performing parental interviews with nonbirthing parents. METHODS: Content analysis was used when analysing data from six research interviews, of which half were focus group interviews. In total, 11 CHS nurses were interviewed. RESULTS: Child Health Service nurses reported that although the interview with the nonbirthing parent was a positive experience and that a more family-oriented perspective was something many of them had been longing for, they could also feel that it demanded a lot from them, including things they had perhaps not previously considered. CHS nurses reported difficulties with having such close contact with both parents, and they also described feeling worried about the information that could come up in a standardised conversation and the knowledge provided. CONCLUSION: There are both possibilities and challenges in widening the responsibilities of the CHS nurse to include the nonbirthing parent by offering a postpartum interview. IMPLICATIONS: This study provides information to healthcare professionals about the importance of providing proper guidance and education when broadening the duties and responsibilities for CHS nurses to include nonbirthing parents in mental health screening. CHS nurses must be given the resources needed to deal with the challenges they encounter and sufficient time for the interviews to be possible and meaningful.

Pharmaceutical lobbying and pandemic stockpiling of Tamiflu: a qualitative study of arguments and tactics.

Background: Little is known about how pharmaceutical companies lobby authorities or experts regarding procurement or the use of vaccines and antivirals. This paper investigates how members of Denmark's pandemic planning committee experienced lobbying efforts by Roche, manufacturer of Tamiflu, the antiviral that was stockpiled before the 2009 A(H1N1) pandemic. Methods: Analysis of interviews with six of seven members of the Danish core pandemic committee, supplemented with documentary analysis. We sought to identify (1) arguments and (2) tactics used in lobbying, and to characterize interviewees' views on the impact of (3) lobbying and (4) scientific evidence on the decision to stockpile Tamiflu. Results: Roche lobbied directly (in its own name) and through a seemingly independent third party. Roche used two arguments: (1) the procurement agreement had to be signed quickly because the drug would be delivered on a first-come, first-served basis and (2) Denmark was especially vulnerable to an influenza crisis because it had smaller Tamiflu stocks than other countries. Most interviewees suspected that lobbying had an impact on Tamiflu procurement. Conclusions: Our study highlights risks posed by pharmaceutical lobbying. Arguments and tactics deployed by Roche are likely to be repeated whenever many countries are negotiating drug procurements in a monopolistic market.

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.

Influence of the COVID-19 pandemic on births and induced abortions in Southern Sweden: a register-based study.

BACKGROUND: Pandemics are linked with declining birth rates, but little is known about how the COVID-19 pandemic has influenced childbearing decisions. We aimed to investigate the associations between the COVID-19 pandemic and reproductive decisions, specifically to identify potential changes in the frequency of deliveries and induced abortions in Skåne, Sweden. METHODS: Using the Skåne Healthcare Register, we identified women aged 15-45 years who had at least one pregnancy-related care visit registered between 1 January 2013 and 11 November 11 2021. Deliveries and induced abortions were identified, and changes in weekly delivery and abortion counts were assessed using an interrupted time series design. Relative risks (RRs) and 95% confidence intervals (CIs) were estimated from a Poisson regression model. RESULTS: During the study period we identified 129 131 deliveries and 38 591 abortions. Compared with the counterfactual (exposed interval assuming COVID-19 had not occurred), pandemic exposure was associated with fewer deliveries (RR 0.93; 95% CI 0.89 to 0.98). For abortions, pandemic exposure appeared to be associated with fewer abortions (RR 0.95; 95% CI 0.90 to 1.00); however, age-related differences were found. Among women aged 25 years and over, pandemic exposure was more strongly associated with fewer abortions. Contrastingly, among women aged under 25 years, abortions appeared to increase. CONCLUSIONS: The COVID-19 pandemic seemed to have contributed to a decline in births in Southern Sweden. During the same period, abortions declined in women in the older age range, but contrastingly increased among younger women.

Public health and nuclear winter: addressing a catastrophic threat.

Despite the end of the Cold War, the world still has thousands of nuclear weapons and adversarial relations between the countries that possess them. A nuclear war could cause large and abrupt global environmental change known as nuclear winter, with potentially devastating public health consequences. A significant line of natural science research characterizes nuclear winter and its potential effect on global food security, but less has been done on the human impacts and policy implications. Therefore, this Viewpoint proposes an interdisciplinary research and policy agenda to understand and address the public health implications of nuclear winter. Public health research can apply existing tools developed for the study of other environmental and military issues. Public health policy institutions can help build preparedness and community resilience to nuclear winter. Given the extreme potential severity of nuclear winter, it should be treated as a major global public health challenge to be addressed by public health institutions and researchers.

Exposure to per- and polyfluoroalkyl substances in early pregnancy and risk of cerebral palsy in children.

BACKGROUND: Most cerebral palsy (CP) cases have an unexplained etiology, but a role for environmental exposures has been suggested. One purported environmental risk factor is exposure to endocrine-disrupting pollutants specifically per- and polyfluoroalkyl substances (PFAS). OBJECTIVES: We investigated the association between prenatal PFAS exposures and CP in Swedish children. METHODS: In this case-control study, 322 CP cases, 343 population controls, and 258 preterm controls were identified from a birth registry in combination with a CP follow-up program from 1995 to 2014 and linked to a biobank which contains serum samples from week 10-14 of pregnancy. Maternal serum concentrations of four PFAS compounds: perfluorohexane sulfonate (PFHxS), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorooctane sulfonate (PFOS) were analyzed using liquid chromatography-tandem-mass-spectrometry. We estimated odds ratios (ORs) and 95 % confidence intervals (CIs) for CP and each PFAS in quartiles and as continuous variables controlling for various sociodemographic and lifestyle factors. RESULTS: In crude and adjusted analyses, we did not find consistent evidence of associations between serum PFHxS, PFOA, PFNA, PFOS and concentrations in early pregnancy and CP, except in preterm infants. The ORs comparing the highest PFAS quartiles to the lowest were 1.05 (95 % CI: 0.63-1.76), 0.96 (95 % CI: 0.55-1.68), 0.71 (95 % CI: 0.41-1.25), and 1.17 (95 % CI: 0.61-2.26), for PFHxS, PFOA, PFNA, and PFOS, respectively. Some positive associations were observed for preterm infants, but the results were imprecise. Similar patterns were observed in analyses treating PFAS as continuous variables. CONCLUSIONS: In this study, we found little evidence that early pregnancy prenatal exposure to PFHxS, PFOA, PFNA, or PFOS increases the risk of CP. However, some positive associations were observed for preterm cases and warrant further investigation.

Maternal Serum Concentrations of Per- and Polyfluoroalkyl Substances in Early Pregnancy and Small for Gestational Age in Southern Sweden.

Small for gestational age (SGA) is considered an adverse birth outcome. Per- and polyfluoralkyl substances (PFAS) have become increasingly investigated as contributing environmental factors, thus far with inconclusive results. The current study aimed to investigate the hypothesized association between increased maternal PFAS levels in early pregnancy and an increased risk for SGA birth. This population-based study used data from a sample of children born in Scania, Southern Sweden, between 1995 and 2009. Two groups were compared: cases born with SGA (n = 298) and non-SGA controls (n = 580). The cases consisted of two subgroups: one included women whose children's growth in late pregnancy was in the lowest quartile, and another included women from the remaining growth quartiles. Corresponding maternal serum samples were collected from a biobank and analyzed for concentrations of four types of PFAS: perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), perfluorohexane sulfonic acid (PFHxS), and perfluorooctane sulfonic acid (PFOS) using liquid chromatography-tandem mass spectrometry (LC/MS/MS). The results were combined with information from birth registers and analyzed using Mann-Whitney U-tests and logistic regression-unadjusted as well as adjusted for potential confounders. In conclusion, elevated maternal concentrations of PFAS were not associated with an increased risk of SGA birth. However, significant ORs were observed in a subgroup analysis restricted to women of Nordic origin (unadjusted OR 3.2 and adjusted OR 2.4) for PFHxS.

COVID-19-related hospital admission in spouses of partners in at-risk occupations.

OBJECTIVE: This study aimed to quantify the risk of COVID-19-related hospital admission in spouses living with partners in at-risk occupations in Denmark during 2020-21. METHODS: Within a registry-based cohort of all Danish employees (N=2 451 542), we identified cohabiting couples, in which at least one member (spouse) held a job that according to a job exposure matrix entailed low risk of occupational exposure to SARS-CoV-2 (N=192 807 employees, 316 COVID-19 hospital admissions). Risk of COVID-19-related hospital admission in such spouses was assessed according to whether their partners were in jobs with low, intermediate or high risk for infection. Overall and sex-specific incidence rate ratios (IRR) of COVID-19-related hospital admission were computed by Poisson regression with adjustment for relevant covariates. RESULTS: The risk of COVID-19-related hospital admission was increased among spouses with partners in high-risk occupations [adjusted IRR (IRRadj)1.59, 95% confidence interval (CI) 1.1-2.2], but not intermediate-risk occupations (IRRadj 0.97 95% 0.8-1.3). IRR for having a partner in a high-risk job was elevated during the first three pandemic waves but not in the fourth (IRRadj 0.48 95% CI 0.2-1.5). Sex did not modify the risk of hospital admission. CONCLUSIONS: SARS-CoV-2 transmission at the workplace may pose an increased risk of severe COVID-19 among spouses in low-risk jobs living with partners in high-risk jobs, which emphasizes the need for preventive measures at the workplace in future outbreaks of epidemic contagious disease. When available, effective vaccines seem essential.

Dataset: COVID-19 epidemic policy and events timeline (Sweden).

The Swedish approach to managing the 2020-2021 COVID-19 pandemic has received significant attention in international scholarly work and press. For this dataset, we have reviewed governmental and media archives to build a detailed timeline that chronicles significant policies, interventions, and events in the Swedish management of COVID-19. The dataset contains summary descriptions of what took place, when it happened, and who the principal actors involved were. Links to primary sources are provided for each entry. Because of the level of detail and saturation, the dataset offers a detailed account of Swedish pandemic governance and will benefit anyone working on Swedish pandemic management or doing comparative work between Sweden and other jurisdictions.

Health care professionals' experiences of screening immigrant mothers for postpartum depression-a qualitative systematic review.

INTRODUCTION: Postpartum depression is considered a major public health problem, which immigrant mothers are at particular risk of being affected by, but it can also have long-lasting traumatic effects on the child's health and development. The Edinburgh Postnatal Depression Scale is the world's most commonly employed screening instrument for postpartum depression, used in connection with a clinical interview to screen for symptoms of postpartum depression. The aim of this study was to synthesize health care professionals (HCPs) experiences of identifying signs of postpartum depression and performing screening on immigrant mothers, since previous research suggested that this task might be challenging. METHODS: The databases CINAHL, PubMed, PsycINFO, SocINDEX, Embase and Cochrane were searched for papers published January 2000-December 2020, reporting qualitative data on immigrants, postpartum depression and the Edinburgh Postnatal Depression Scale. Eight papers representing eight studies from four countries were included and the Critical Appraisal Skills Program was used to assess their quality. The synthesis of studies was guided by Noblit & Hare's seven-step method based on meta-ethnography. FINDINGS: The synthesis resulted in two final themes: "I do my best, but I doubt that it's enough" and "I can find no way forward". The themes convey the fear and frustration that health care professionals experienced; fear of missing mothers with signs of postpartum depression, related to feeling uncomfortable in the cross-cultural setting and frustration in handling difficulties associated with communication, translated versions of the Edinburgh Postnatal Depression Scale and cultural implications of postpartum depression. CONCLUSIONS AND CLINICAL IMPLICATION: By supporting HCPs' self-efficacy in handling cultural implications of postpartum depression and by developing evidence-based clinical guidelines for the use of interpreters and translated versions of the Edinburgh Postnatal Depression Scale the screening of immigrant mothers may be facilitated.

The making of a Swedish strategy: How organizational culture shaped the Public Health Agency's pandemic response.

Several suggestions have been made as to why Sweden's approach to managing the COVID-19 pandemic came to rely on a strategy based on voluntary measures. Two of the most prominent explanations for why the country chose a different strategy than many other countries have focused on micro- and macro-level factors, explaining the strategy either in terms of the psychologies of prominent actors or by pointing to particularities in Swedish constitutional law. Supported by a qualitative analysis using interviews and text analysis, we argue that the Swedish strategy cannot be understood without paying attention to the meso-level and the organizations that produced the strategy. Moreover, we argue that to understand why one of the central organizations in Swedish pandemic management, the Public Health Agency, came to favor certain interventions, one must investigate the culture of production inside the organization and how it created precedents that led the Agency to approach pandemic management with a focus on balancing current and future health risks.

Selling one's future: over-indebtedness and the risk of poor mental health and the role of precarious employment - results from the Scania Public Health Cohort, Sweden.

OBJECTIVES: The credit market has expanded rapidly, increasing the risk of over-indebtedness among those who lack secure employment or adequate income, an issue of concern in the COVID-19 aftermath. We investigated the role of over-indebtedness for developing poor mental health, and whether this impact is modified by age, gender, educational level or being in precarious employment. METHODS: This is a cohort study using data from the Swedish Scania Public Health Cohort, based on individuals randomly selected from the general adult population in Scania, southern Sweden, initiated in 1999/2000 (response rate 58%) with follow-ups in 2005 and 2010. Over-indebtedness was assessed by combining information on cash margin and difficulty in paying household bills. Mental health was assessed by General Health Questionnaire-12. Those with poor mental health at baseline were excluded, and the analyses were further restricted to vocationally active individuals with complete data on main variables, resulting in 1256 men and 1539 women. RESULTS: Over-indebtedness was more common among women, among persons with a low educational level, born abroad and with a precarious employment at baseline. The age-adjusted incidence rate ratio (IRR) for poor mental health in 2010 among individuals exposed to over-indebtedness in 1999/2000 or 2005 was 2.2 (95% CI 1.7 to 2.8). Adjusting for educational level, country of origin and precarious employment in 1999/2000 or 2005, yielded an IRR of 2.0 (95% CI 1.6 to 2.6). An interaction analysis indicated that a high level of education may act synergistically with over-indebtedness, regarding poor mental health among men. CONCLUSIONS: Over-indebtedness was related to unfavourable societal power relations, regarding social class, gender and foreign birth. Precarious employment was independently linked to poor mental health and may also mediate the effect by over-indebtedness. The COVID-19 pandemic might entail increased over-indebtedness, which should be acknowledged in policies aiming at buffering social effects of the pandemic.

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

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.

Is there evidence for the racialization of pharmaceutical regulation? Systematic comparison of new drugs approved over five years in the USA and the EU.

Recent decades have seen much interest in racial and ethnic differences in drug response. The most emblematic example is the heart drug BiDil, approved by the US Food and Drug Administration in 2005 for "self-identified blacks." Previous social science research has explored this "racialization of pharmaceutical regulation" in the USA, and discussed its implications for the "pharmaceuticalization of race" in terms of reinforcing certain taxonomic schemes and conceptualizations. Yet, little is known about the racialization of pharmaceutical regulation in the USA after BiDil, and how it compares with the situation in the EU, where political and regulatory commitment to race and ethnicity in pharmaceutical medicine is weak. We have addressed these gaps by investigating 397 product labels of all novel drugs approved in the USA (n = 213) and the EU (n = 184) between 2014 and 2018. Our analysis considered statements in labeling and the racial/ethnic categories used. Overall, it revealed that many labels report race/ethnicity demographics and subgroup analyses, but that there are important differences between the USA and the EU. Significantly more US labels specified race/ethnicity demographics, as expected given the USA's greater commitment to race and ethnicity in pharmaceutical medicine. Moreover, we found evidence that reporting of race/ethnicity demographics in EU labels was driven, in part, by statements in US labels, suggesting the spillover of US regulatory standards to the EU. Unexpectedly, significantly more EU labels reported differences in drug response, although no drug was restricted to a racial/ethnic population in a manner similar to BiDil. Our analysis also noted variability and inconsistency in the racial/ethnic taxonomy used in labels. We discuss implications for the racialization of pharmaceutical regulation and the pharmaceuticalization of race in the USA and EU.

Five years of pharmaceutical industry funding of patient organisations in Sweden: Cross-sectional study of companies, patient organisations and drugs.

BACKGROUND: Many patient organisations collaborate with drug companies, resulting in concerns about commercial agendas influencing patient advocacy. We contribute to an international body of knowledge on patient organisation-industry relations by considering payments reported in the industry's centralised 'collaboration database' in Sweden. We also investigate possible commercial motives behind the funding by assessing its association with drug commercialisation. METHODS: Our primary data source were 1,337 payment reports from 2014-2018. After extraction and coding, we analysed the data descriptively, calculating the number, value and distribution of payments for various units of analysis, e.g. individual companies, diseases and payment goals. The association between drug commercialisation and patient organisation funding was assessed by, first, the concordance between leading companies marketing drugs in specific diseases and their funding of corresponding patient organisations and, second, the correlation between new drugs in broader condition areas and payments to corresponding patient organisations. RESULTS: 46 companies reported paying €6,449.224 (median €2,411; IQR €1,024-4,569) to 77 patient organisations, but ten companies provided 67% of the funding. Small payments dominated, many of which covered costs of events organised by patient organisations. An association existed between drug commercialisation and industry funding. Companies supported patient organisations in diseases linked to their drug portfolios, with the top 3 condition areas in terms of funding-cancer; endocrine, nutritional and metabolic disorders; and infectious and parasitic disorders-accounting for 63% of new drugs and 56% of the funding. CONCLUSION: This study reveals close and widespread ties between patient organisations and drug companies. A relatively few number of companies dominated the funding landscape by supporting patient organisations in disease areas linked to their drug portfolios. This commercially motivated funding may contribute to inequalities in resource and influence between patient organisations. The association between drug commercialisation and industry funding is also worrying because of the therapeutic uncertainty of many new drugs. Our analysis benefited from the existence of a centralised database of payments-which should be adopted by other countries too-but databases should be downloadable in an analysable format to permit efficient and independent analysis.