Inconsistency Between Pictures on Baby Diaper Packaging in Europe and Safe Infant Sleep Recommendations.

OBJECTIVE: To describe the level of inconsistency between pictures on baby diaper packaging and safe infant sleep recommendations (SISRs) in Europe. STUDY DESIGN: We attempted to identify all packaging of baby diapers sold in 11 European countries for infants weighing less than 5 kg through internet searches from July 2022 through February 2023. For each type of package, we extracted whether there was a picture depicting a baby, whether the baby was sleeping, and whether the picture of the sleeping baby was inconsistent with ≥1 of 3 SISRs: (i) nonsupine sleeping position, (ii) soft objects or loose bedding, or (iii) sharing a sleep surface with another person. Data were aggregated at the country level, and a random-effects meta-analysis of proportions was used to obtain summary estimates. The outcome was the summary estimate of the proportion of pictures that were inconsistent with SISRs. RESULTS: We identified 631 baby diaper packaging types of which 49% (95% CI: 42-57; n = 311) displayed a picture of a sleeping baby. Among those 311 packages, 79% (95% CI 73-84) were inconsistent with ≥1 SISR, including a nonsupine sleeping position, 45% (95% CI 39-51), soft objects or loose bedding such as pillows or blankets, 51% (95% CI 46-57), and sharing a sleep surface with another person, 10% (95% CI 4-18). CONCLUSIONS: Pictures on baby diaper packaging in Europe are often inconsistent with SISRs. The prevention of sudden unexpected death in infancy requires action from manufacturers and legislators to stop parents' exposure to misleading images that may lead to dangerous practices.

Survey on ART and IUI: legislation, regulation, funding, and registries in European countries-an update.

STUDY QUESTION: How are ART and IUI regulated, funded, and registered in European countries, and how has the situation changed since 2018? SUMMARY ANSWER: Of the 43 countries performing ART and IUI in Europe, and participating in the survey, specific legislation exists in only 39 countries, public funding varies across and sometimes within countries (and is lacking or minimal in four countries), and national registries are in place in 33 countries; only a small number of changes were identified, most of them in the direction of improving accessibility, through increased public financial support and/or opening access to additional subgroups. WHAT IS KNOWN ALREADY: The annual reports of the European IVF-Monitoring Consortium (EIM) clearly show the existence of different approaches across Europe regarding accessibility to and efficacy of ART and IUI treatments. In a previous survey, some coherent information was gathered about how those techniques were regulated, funded, and registered in European countries, showing that diversity is the paradigm in this medical field. STUDY DESIGN, SIZE, DURATION: A survey was designed using the SurveyMonkey tool consisting of 90 questions covering several domains (legal, funding, and registry) and considering specific details on the situation of third-party donations. New questions widened the scope of the previous survey. Answers refer to the situation of countries on 31 December 2022. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: All members of the EIM were invited to participate. The received answers were checked and initial responders were asked to address unclear answers and to provide any additional information considered relevant. Tables resulting from the consolidated data were then sent to members of the Committee of National Representatives of ESHRE, requesting a second check. Conflicting information was clarified by direct contact. MAIN RESULTS AND THE ROLE OF CHANCE: Information was received from 43 out of the 45 European countries where ART and IUI are performed. There were 39 countries with specific legislation on ART, and artificial insemination was considered an ART technique in 33 of them. Accessibility is limited to infertile couples only in 8 of the 43 countries. In 5 countries, ART and IUI are permitted also for treatments of single women and all same sex couples, while a total of 33 offer treatment to single women and 19 offer treatment to female couples. Use of donated sperm is allowed in all except 2 countries, oocyte donation is allowed in 38, simultaneous donation of sperm and oocyte is allowed in 32, and embryo donation is allowed in 29 countries. Preimplantation genetic testing (PGT)-M/SR (for monogenetic disorders, structural rearrangements) is not allowed in 3 countries and PGT-A (for aneuploidy) is not allowed in 10; surrogacy is accepted in 15 countries. Except for marital/sexual situation, female age is the most frequently reported limiting criterion for legal access to ART: minimal age is usually set at 18 years and the maximum ranges from 42 to 54 with some countries not using numeric definition. Male maximum age is set in very few countries. Where third-party donors are permitted, age is frequently a limiting criterion (male maximum age ranging from 35 to 50; female maximum age from 30 to 37). Other legal restrictions in third-party donation are the number of children born from the same donor (or, in some countries, the number of families with children from the same donor) and, in 12 countries, there is a maximum number of oocyte donations. How countries deal with the anonymity is diverse: strict anonymity, anonymity just for the recipients (not for children when reaching legal adulthood age), a mixed system (anonymous and non-anonymous donations), and strict non-anonymity. Inquiring about donors' genetic screening showed that most countries have enforced either mandatory or scientific recommendations that exclude the most prevalent genetic diseases, although, again, diversity is evident. Reimbursement/compensation systems exist in more than 30 European countries, with around 10 describing clearly defined maximum amounts considered acceptable. Public funding systems are extremely variable. One country provides no financial assistance to ART/IUI patients and three offer only minimal support. Limits to the provision of funding are defined in the others i.e. age (female maximum age is the most used), existence of previous children, BMI, maximum number of treatments publicly supported, and techniques not entitled for funding. In a few countries reimbursement is linked to a clinical policy. The definitions of the type of expenses covered within an IVF/ICSI cycle, up to which limit, and the proportion of out-of-pocket costs for patients are also extremely dissimilar. National registries of ART are in place in 33 out of the 43 countries contributing to the survey and a registry of donors exists in 19 of them. When comparing with the results of the previous survey, the main changes are: (i) an extension of the beneficiaries of ART techniques (and IUI), evident in nine countries; (ii) public financial support exists now in Albania and Armenia; (iii) in Luxembourg, the only ART centre expanded its on-site activities; (iv) donor-conceived children are entitled to know the donor identity in six countries more than in 2018; and (v) four more countries have set a maximum number of oocyte donations. LIMITATIONS, REASONS FOR CAUTION: Although the responses were provided by well-informed and committed individuals and submitted to double checking, no formal validation by official bodies was in place. Therefore, possible inaccuracies cannot be excluded. The results presented are a cross-section in time, and ART and IUI frameworks within European countries undergo continuous modification. Finally, some domains of ART activity were deliberately left out of the scope of this survey. WIDER IMPLICATIONS OF THE FINDINGS: Our results offer a detailed updated view of the ART and IUI situation in European countries. It provides extensive answers to many relevant questions related to ART usage at the national level and could be used by institutions and policymakers at both national and European levels. STUDY FUNDING/COMPETING INTEREST(S): The study has no external funding, and all costs were covered by ESHRE. There were no competing interests.

Ready for polygenic risk scores? An analysis of regulation of preimplantation genetic testing in European countries.

STUDY QUESTION: Would the different regulatory approaches for preimplantation genetic testing (PGT) in Europe permit the implementation of preimplantation genetic testing using polygenic risk scores (PGT-P)? SUMMARY ANSWER: While the regulatory approaches for PGT differ between countries, the space provided for potential implementation of PGT-P seems limited in all three regulatory models. WHAT IS KNOWN ALREADY: PGT is a reproductive genetic technology that allows the testing for hereditary genetic disorders and chromosome abnormalities in embryos before implantation. Throughout its history, PGT has largely been regarded as an ethically sensitive technology. For example, ethical questions have been raised regarding the use of PGT for adult-onset conditions, non-medical sex selection, and human leukocyte antigen typing for the benefit of existing siblings. Countries in which PGT is offered each have their own approach of regulating the clinical application of PGT, and a clear overview of legal and practical regulation of PGT in Europe is lacking. An emerging development within the field of PGT, namely PGT-P, is currently bringing new ethical tensions to the forefront. It is unclear whether PGT-P may be applied within the current regulatory frameworks in Europe. Therefore, it is important to investigate current regulatory frameworks in Europe and determine whether PGT-P fits within these frameworks. STUDY DESIGN, SIZE, DURATION: The aim of this study was to provide an overview of the legal and practical regulation of the use of PGT in seven selected European countries (Belgium, France, Germany, Italy, the Netherlands, Spain, and the UK) and critically analyse the different approaches with regards to regulatory possibilities for PGT-P. Between July and September 2023, we performed a thorough and extensive search of websites of governments and governmental agencies, websites of scientific and professional organizations, and academic articles in which laws and regulations are described. PARTICIPANTS/MATERIALS, SETTING, METHODS: We investigated the legal and regulatory aspects of PGT by analysing legal documents, regulatory frameworks, scientific articles, and guidelines from scientific organizations and regulatory bodies to gather relevant information about each included country. The main sources of information were national laws relating to PGT. MAIN RESULTS AND THE ROLE OF CHANCE: We divided the PGT regulation approaches into three models. The regulation of PGT differs per country, with some countries requiring central approval of PGT for each new indication (the medical indication model: the UK, the Netherlands), other countries evaluating each individual PGT request at the local level (the individual requests model: France, Germany), and countries largely leaving decision-making about clinical application of PGT to healthcare professionals (the clinical assessment model: Belgium, Italy, Spain). In the countries surveyed that use the medical indication model and the individual requests model, current legal frameworks and PGT criteria seem to exclude PGT-P. In countries using the clinical assessment model, the fact that healthcare professionals and scientific organizations in Europe are generally negative about implementation of PGT-P due to scientific and socio-ethical concerns, implies that, even if it were legally possible, the chance that PGT-P would be offered in the near future might be low. LIMITATIONS, REASONS FOR CAUTION: The results are based on our interpretation of publicly available written information and documents, therefore not all potential discrepancies between law and practice might have been identified. In addition, our analysis focuses on seven-and not all-European countries. However, since these countries are relevant players within PGT in Europe and since they have distinct PGT regulations, the insights gathered give relevant insights into diverse ways of PGT regulation. WIDER IMPLICATIONS OF THE FINDINGS: To the best of our knowledge, this is the first paper that provides a thorough overview of the legal and practical regulation of PGT in Europe. Our analysis of how PGT-P fits within current regulation models provides guidance for healthcare professionals and policymakers in navigating the possible future implementation of PGT-P within Europe. STUDY FUNDING/COMPETING INTEREST(S): This project has received funding from the European Union's Horizon 2020 research and innovation program under the Marie Sklodowska-Curie grant agreement no. 813707. The authors declare no conflict of interest. TRIAL REGISTRATION NUMBER: N/A.

Permanently infertile couples and family building-a cross-sectional survey in Denmark.

STUDY QUESTION: Which decision-making factors influence family building among permanently infertile couples? SUMMARY ANSWER: Ethical, legal, and financial considerations outweigh genetic relatedness in decision-making, favouring domestic gestational surrogacy, if this were possible, over international options. WHAT IS KNOWN ALREADY: Permanent infertility affects 4-5% of people in the fertile age. Their family-building options include adoption, surrogacy, uterus transplantation, foster care, and intentional multiple parenthood. However, in most countries, including Denmark, legal barriers constrain these methods due to surrogacy restrictions, suspended international adoptions, and the experimental status of uterus transplantation. Despite existing research on surrogacy, adoption, and specific causes of permanent infertility, a significant gap remains in our understanding of how couples with permanent infertility make family-building decisions within these limited frameworks. STUDY DESIGN, SIZE, DURATION: This cross-sectional study with 150 permanently infertile Danish participants was conducted from June to November 2023 using an online questionnaire. Multiple strategies, such as online forums, fertility clinics, hospital departments, and snowballing, were used to recruit a diverse sample. PARTICIPANTS/MATERIALS, SETTING, METHODS: The study included couples aged 26-50 years facing permanent infertility due to the following primary causes: women without a uterus (15%), women with a non-functional uterus (47%) or women for whom pregnancy would be life-threatening (9%), male couples (16%), transgender partner couples (2%), and other causes (11%). The survey collected data on demographics, reproductive history, family-building choices, and communication strategies. Closed questions were analysed using descriptive statistics. MAIN RESULTS AND THE ROLE OF CHANCE: Among 150 respondents, 41% had used transnational surrogacy, 27% adoption, 14% chose to remain childless, and 19% were undecided. Critical factors on family-building decisions were ethical, legal, and financial concerns which ranked higher than genetic relatedness. Despite the complexity of family building, most participants were open about their child's origin and received social support. If all family-building methods were legal and available in Denmark, domestic gestational surrogacy would be the preferred method, with uterus transplantation and remaining childless being least popular. LIMITATIONS, REASONS FOR CAUTION: The sample size is relatively small, despite the use of a variety of recruitment strategies. Nevertheless, this has ensured a diverse cohort representing the different reasons for infertility and family-building choices. It is important to note that the strategies may have favoured individuals achieving parenthood. WIDER IMPLICATIONS OF THE FINDINGS: The finding of our study reveals a notable gap between available family-building options in Denmark and the preferences of couples facing permanent infertility. These insights could be instrumental for organizations reviewing and developing family-building frameworks. Furthermore, for healthcare professionals guiding couples experiencing infertility issues in their attempts to build a family, an understanding of these preferences is essential to facilitate informed decisions about their future family plans. STUDY FUNDING/COMPETING INTEREST(S): The project was financed by the Independent Research Fund Denmark. The authors have no conflict of interest to declare. TRIAL REGISTRATION NUMBER: N/A.

The Overturning of Chevron Deference: Implications for the US Healthcare System.

In 1984, Chevron deference was established by the US Supreme Court in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., granting administrative agencies broad powers to interpret ambiguous laws passed by Congress. This landmark decision has fostered decades of controversy among legal scholars. Opponents argued it deprived courts of their constitutional duty and inappropriately expanded the power of the administrative state, while proponents claimed federal agencies, staffed by experts in their field, possess specialized knowledge to most effectively accomplish the goals of Congress. In June 2024, the Supreme Court's ruling in Loper Bright Enterprises v. Raimondo effectively ended Chevron deference, altering the judicial landscape with significant implications for US healthcare. In this commentary, we discuss the various potential benefits and challenges that the US healthcare system will face in a post-Chevron landscape while also considering the ways in which clinicians will be expected to help address these obstacles.

Assessing the Impact of the 340B Drug Pricing Program: A Scoping Review of the Empirical, Peer-Reviewed Literature.

Policy Points The 340B Drug Pricing Program accounts for roughly 1 out of every 100 dollars spent in the $4.3 trillion US health care industry. Decisions affecting the program will have wide-ranging consequences throughout the US safety net. Our scoping review provides a roadmap of the questions being asked about the 340B program and an initial synthesis of the answers. The highest-quality evidence indicates that nonprofit, disproportionate share hospitals may be using the 340B program in margin-motivated ways, with inconsistent evidence for increased safety net engagement; however, this finding is not consistent across other hospital types and public health clinics, which face different incentive structures and reporting requirements. CONTEXT: Despite remarkable growth and relevance of the 340B Drug Pricing Program to current health care practice and policy debate, academic literature examining 340B has lagged. The objectives of this scoping review were to summarize i) common research questions published about 340B, ii) what is empirically known about 340B and its implications, and iii) remaining knowledge gaps, all organized in a way that is informative to practitioners, researchers, and decision makers. METHODS: We conducted a scoping review of the peer-reviewed, empirical 340B literature (database inception to March 2023). We categorized studies by suitability of their design for internal validity, type of covered entity studied, and motivation-by-scope category. FINDINGS: The final yield included 44 peer-reviewed, empirical studies published between 2003 and 2023. We identified 15 frequently asked research questions in the literature, across 6 categories of inquiry-motivation (margin or mission) and scope (external, covered entity, and care delivery interface). Literature with greatest internal validity leaned toward evidence of margin-motivated behavior at the external environment and covered entity levels, with inconsistent findings supporting mission-motivated behavior at these levels; this was particularly the case among participating disproportionate share hospitals (DSHs). However, included case studies were unanimous in demonstrating positive effects of the 340B program for carrying out a provider's safety net mission. CONCLUSIONS: In our scoping review of the 340B program, the highest-quality evidence indicates nonprofit, DSHs may be using the 340B program in margin-motivated ways, with inconsistent evidence for increased safety net engagement; however, this finding is not consistent across other hospital types and public health clinics, which face different incentive structures and reporting requirements. Future studies should examine heterogeneity by covered entity types (i.e., hospitals vs. public health clinics), characteristics, and time period of 340B enrollment. Our findings provide additional context to current health policy discussion regarding the 340B program.

Regulating Laboratory Tests: What Framework Would Best Support Safety and Validity?

Policy Points With increasing public attention to cases of inaccurate and misleading laboratory-developed tests, there have been calls for regulatory reform. To protect patients from faulty laboratory tests, we need a framework that balances comprehensive test review with laboratory flexibility. The Verifying Accurate Leading-edge IVCT [In Vitro Clinical Test] Development (VALID) Act would have helped ensure laboratory test safety and validity through a much-needed expansion of Food and Drug Administration (FDA) oversight. However, Congress did not pass the VALID Act in 2022, forcing the FDA to start the regulatory reform process on its own.

A practical approach to screening for carbapenemase-producing Enterobacterales- views of a group of multidisciplinary experts from English hospitals.

INTRODUCTION: Carbapenemase-producing Enterobacterales (CPE) are an important public health threat, with costly operational and economic consequences for NHS Integrated Care Systems and NHS Trusts. UK Health Security Agency guidelines recommend that Trusts use locally developed risk assessments to accurately identify high-risk individuals for screening, and implement the most appropriate method of testing, but this presents many challenges. METHODS: A convenience sample of cross-specialty experts from across England met to discuss the barriers and practical solutions to implementing UK Health Security Agency framework into operational and clinical workflows. The group derived responses to six key questions that are frequently asked about screening for CPE. KEY FINDINGS: Four patient groups were identified for CPE screening: high-risk unplanned admissions, high-risk elective admissions, patients in high-risk units, and known positive contacts. Rapid molecular testing is a preferred screening method for some of these settings, offering faster turnaround times and more accurate results than culture-based testing. It is important to stimulate action now, as several lessons can be learnt from screening during the COVID-19 pandemic, as well as from CPE outbreaks. CONCLUSION: Further decisive and instructive information is needed to establish CPE screening protocols based on local epidemiology and risk factors. Local management should continually evaluate local epidemiology, analysing data and undertaking frequent prevalence studies to understand risks, and prepare resources- such as upscaled screening- to prevent increasing prevalence, clusters or outbreaks. Rapid molecular-based methods will be a crucial part of these considerations, as they can reduce unnecessary isolation and opportunity costs.

Inconsistent Regulatory Mapping Quietly Threatens Rivers and Streams.

Even the most stringent environmental law cannot protect a river if its tributaries remain exposed to pollution and other threats upstream. Excluding a subset of watercourses from legal protection therefore threatens to alter freshwater ecosystems across entire river networks and the services they provide, such as drinking water and flood regulation. Considerable attention has been devoted to defining the scope of environmental laws protecting watercourses. Yet how these definitions are implemented through regulatory mapping, the cartography of waterbodies that legally qualify as watercourses and are thus protected, has not been examined outside of the United States. Here, we demonstrate the consequences of regulatory mapping on the extent of river networks that are protected, using France as a case study. By assembling the first map of France's watercourses protected under the Water Law, we estimate that a quarter of previously mapped hydrographic segments were excluded from protection and found stark geographical variations in the extent of protected ecosystems. Headwater and nonperennial segments are disproportionately excluded by 28% compared to their prevalence (67%) in the overall hydrographic network, with potentially far-reaching implications for biodiversity and people. We expect regulatory frameworks in most countries to be equally susceptible to local interpretation of legal definitions.

Disparity in organ distribution in Gauteng province in South Africa: Challenges and solutions.

BACKGROUND: Despite South Africa's rich heritage as pioneers in organ transplantation, access to organs remains a major issue in the Gauteng province. This is secondary to an array of socioeconomic and political factors that have implications for organ distribution. Our aim was to assess the contribution of the public sector to solid organ transplantation in Gauteng province and compare the distribution of solid organs between the recipient groups. METHODS: This was a retrospective registry review of consented brain-dead donors from the public sector within Gauteng from January 1, 2016, to June 30, 2021, coordinated at Charlotte Maxeke Johannesburg Academic Hospital, a tertiary academic hospital. RESULTS: Records of 49 deceased donors were analyzed. Mean donor age was 31.5 years with the age group 30-39 years constituting the majority of deceased donors at 15/49 (30.6%); 10/49 (16%) were from pediatric donors. There was a significant discrepancy in allocation between public and private sector in cardiac (p = .012) and liver allocation (p < .001) and adult and pediatric recipients for all solid organs (p < .001). There was a significant increase in the rate and number (p = .0026) of pediatric kidney transplants occurring after March 1, 2020, when there was a transition to a public sector-mandated kidney transplant waitlist. CONCLUSION: Current disparities in organ distribution have a significant impact on public sector recipients, especially pediatric patients. This is likely secondary to paucity of legislation and resource limitations which would benefit from improved governmental policies and explicit pediatric prioritization policies in transplant units.

Diverse pharmacovigilance jurisdiction-The right way for global drug safety?

PURPOSE: The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how these impact the number of adverse drug reactions (ADRs) that are reported to national competent authorities. METHODS: Legislative and statistical data regarding ADR reporting from various national competent authorities' websites, databases, and pharmacovigilance centers were used. In combination with the WHO pharmacovigilance quantitative indicator that was applied to evaluate the effectiveness of particular national pharmacovigilance systems in our scope. RESULTS: The study compared pharmacovigilance systems in six countries, focusing on ADR reporting from 2010 onwards. All countries required MAHs to report ADRs, while healthcare professionals' obligations varied. Per-capita ADR reports increased in all countries with available data, with the United States having a significantly higher reporting rate, possibly due to FDA campaigns. Despite starting later, China's per-capita reporting rate surpassed that of the Czech Republic and Japan. The study highlighted various measures taken by countries to enhance ADR reporting systems since the inception of their programs, contributing to the overall increase in reporting rates. CONCLUSIONS: ADR reporting is a global priority, with efforts made by different countries to strengthen their pharmacovigilance systems. Some success can be seen in gradually improving per-capita ADR reporting rates. The varying reporting rates and measures taken by each country may serve as a basis for further research and exchange of best practices to improve drug safety monitoring worldwide.

Reassessing the VaxTax.

To counter the imbalance in vaccine distribution during the COVID-19 pandemic, Albertsen and more recently Germani et al have suggested a new system of taxation coined as 'VaxTax' that would force higher-income countries to fund the access of low-income and middle-income countries (LMICs) to new vaccines in times of pandemic. I will argue that this idea faces numerous challenges of ethical, sociopolitical and economical nature that may hinder any effort to solve the numerous health challenges that LMICs face. I argue that while it is an interesting idea, it is neither sufficient nor will it ever be easily implemented because of socioeconomic or practical reasons.

Regulatory safeguards needed if preimplantation genetic testing for polygenic risk scores (PGT-P) is permitted in Singapore.

Singapore, a highly affluent island city-state located in Southeast Asia, has increasingly leveraged new assisted reproductive technologies (ART) to overcome its dismal fertility rates in recent years. A new frontier in ART is preimplantation genetic testing (PGT) for polygenic risk scores (PRS) to predict complex multifactorial traits in IVF (in vitro fertilisation) embryos, such as type 2 diabetes, cardiovascular diseases and various other characteristics like height, intelligence quotient (IQ), hair and eye colour. Unlike well-known safety risks with human genome editing, there are negligible risks with PGT-P, because there are no man-made genetic modifications that can be transmitted to future generations. Nevertheless, the current efficacy of using PGT-P to select IVF embryos for either increased or decreased probability of developing specific polygenic traits is still far from certain. Hence, the regulatory safeguards proposed here will be based on the assumption that the efficacy of this new technology platform has already been validated. These include: (1) restricting the application of PGT-P only for prevention of clinically relevant polygenic disease traits, (2) securely blocking patients' access to the raw genomic DNA sequencing data of their IVF embryos, (3) validating diagnosis of polygenic disease traits in the prospective parents/grandparents of IVF embryos, and restricting PGT-P only for preventing specifically diagnosed polygenic disease traits and (4) mandating rigorous and comprehensive genetic counselling for IVF patients considering PGT-P. There is an urgent and dire need to prevent abuse of the PGT-P technique, as well as protect the interests and welfare of patients if its clinical application is to be permitted in the country.

No consent for brain death testing.

The overwhelming weight of legal authority in the USA and Canada holds that consent is not required for brain death testing. The situation in England and Wales is similar but different. While clinicians in England and Wales may have a prima facie duty to obtain consent, lack of consent has not barred testing. In three recent cases where consent for brain death testing was formally presented to the court, lack of consent was not determinative, and in one case the court questioned whether the clinicians were even required to seek consent from the parents of a child at all.

Updated population-level estimates of child restraint practices among children aged 0-12 years in Australia, 10 years after introduction of age-appropriate restraint use legislation.

OBJECTIVE: Optimal child passenger protection requires use of a restraint designed for the age/size of the child (appropriate use) that is used in the way the manufacturer intended (correct use).This study aimed to determine child restraint practices approximately 10 years after introduction of legislation requiring correct use of age-appropriate restraints for all children aged up to 7 years. METHODS: A stratified cluster sample was constructed to collect observational data from children aged 0-12 years across the Greater Sydney region of New South Wales (NSW). Methods replicated those used in a similar 2008 study. Population weighted estimates for restraint practices were generated, and logistic regression used to examine associations between restraint type, and child age with correct use accounting for the complex sample. RESULTS: Almost all children were appropriately restrained (99.3%, 95% CI 98.4% to 100%). However, less than half were correctly restrained (no error=27.3%, 95% CI 10.8% to 43.8%, no serious error=43.8%, 95% CI 35.0% to 52.7%). For any error, the odds of error decreased by 39% per year of age (OR 0.61, 95% CI 0.46 to 0.81) and for serious error by 25% per year (OR 0.75, 95% CI 0.60 to 0.93). CONCLUSION: The findings demonstrate high levels of appropriate restraint use among children across metropolitan Sydney approximately 10 years after introduction of legislation requiring age-appropriate restraint use until age 7, however, errors in the way restraints remain common. IMPLICATIONS FOR PUBLIC HEALTH: Given the negative impact incorrect use has on crash protection, continuing high rates of incorrect use may reduce effectiveness of legislative change on injury reduction.

The impact of recreational cannabis legalization on ED visit rates for acute cannabis intoxication.

BACKGROUND: In December 2018 the Michigan Regulation and Taxation of Marihuana Act legalized the recreational use of cannabis in Michigan. There are now high potency forms of cannabis readily available in the state, which could result in increased emergency department (ED) visit rates due to intoxication in adults and children. Although cannabis related visits account for a small percentage of all adult and pediatric ED visits, they impose a significant burden on the health care system's resources. This study aimed to assess the impact of the legalization of recreational marijuana on the rate of ED visits for acute cannabis intoxication. METHODS AND DESIGN: We utilized the legalization of marijuana in the state of Michigan to conduct a natural experiment utilizing a retrospective observational cohort design of ED visits for acute intoxication before and after legalization. The study was conducted at a health system composed of eight hospitals in southeast Michigan, including both academic and community hospitals serving a diverse patient population. We estimated monthly cannabis-related ED visits based on cannabis-related ICD-10 discharge codes and total ED visits using electronic health record data from 2016 to 2022. A negative-binomial (NB) regression model was used to estimate the immediate and cumulative changes in cannabis-related ED visit rate after legalization. RESULTS: There were a total of 2177 ED visits from 2066 patients for cannabis intoxication in our study cohort. Of the 2177 visits, 671 were before and 1506 were after legalization. In the univariate analysis, recreational cannabis legalization was associated with an increase in the average cannabis-related ED visit rate (Rate Ratio [RR]:1.70, 95% CI: (1.49, 1.94), p-value <0.001). In the multivariate analysis adjusting for age, results remain significant (RR 1.47, 95% CI (1.29, 1.70), p-value <0.001). The increased visit rate occurred in the first month after legalization; however, the slope of the increasing rate of ED visits were similar before and after cannabis legalization (RR, 1.28, 95% CI (1.07, 1.54), p-value <0.001). CONCLUSIONS: The legalization of recreational cannabis in Michigan was associated with an immediate increase in ED visit rates for acute cannabis intoxications across all ages, especially among middle-aged adults, in the context of an stably increasing ED visit rate.

Unlocking food safety: a comprehensive review of South Africa's food control and safety landscape from an environmental health perspective.

Food fraud (often called fake food in South Africa) the deliberate misrepresentation or adulteration of food products for financial gain, is a growing problem in South Africa (SA) with severe public health and financial consequences for consumers and businesses. The recent public outcry against food fraud practices especially in communities that have lost loved ones due to the consumption of allegedly adulterated foodstuffs, highlights the grave danger that food fraud poses to consumers and the potential for significant reputational damage to food manufacturers. Despite the risks, food fraud often goes undetected, as perpetrators are becoming increasingly sophisticated. The precise magnitude of food fraud remains obscure, as incidents that do not cause consumer illnesses are frequently unreported and, as a result, are not investigated. Food fraud costs the global economy billion annually. This cost is borne by consumers, businesses, and the government. Food fraud can occur at any stage of the food supply chain, from production to processing to retailing or distribution. This is due in part to the limitations of current analytical methods, which are not always able to detect food fraud. This review of food fraud in SA looks at several factors that may be contributing to epidemic of food fraud, including inadequate penalties, inadequate government commitment, a complex labelling regulation, emerging threats such as e-commerce, and shortage of inspectors and laboratories. The review recommends establishing a single food control/safety authority, developing more food safety laboratories, and adopting innovative technologies to detect and prevent food fraud. SA faces a serious food fraud crises unless decisive action is taken.

Coverage of policies to improve antimicrobial stewardship in human medicine in low and middle income countries: results from the Global Survey of Experts on Antimicrobial Resistance.

BACKGROUND: Antimicrobial resistance (AMR) constitutes a major threat to global health. While antimicrobial misuse or overuse is one of the main drivers for AMR, little is known about the extent to which antibiotic misuse is due to a lack of national government-led efforts to enforce rational use in low and middle-income countries (LMICs). METHODS: To assess antimicrobial stewardship and national implementation measures currently in place for optimizing antimicrobial use and for slowing the spread of AMR, we invited public health experts from 138 LMICs to participate in a Global Survey of Experts on Antimicrobial Resistance (GSEAR). Key coverage measures, as reported by experts, were compared across countries and also juxtaposed with estimates collected in the 2020-21 World Health Organization-organized Tripartite AMR Country Self-Assessment Survey (TrACSS). RESULTS: A total of 352 completed surveys from 118 LMICs were analysed. Experts in 67% of the surveyed countries reported a national action plan (NAP) on AMR, 64% reported legislative policies on antimicrobial use, 58% reported national training programs for health professionals, and 10% reported national monitoring systems for antimicrobials. 51% of LMICs had specific targeted policies to limit the sale and use of protected or reserve antibiotics. While 72% of LMICs had prescription requirements for accessing antibiotics, getting antibiotics without a prescription was reported to be possible in practice in 74% of LMICs. On average, country efforts reported in TrACSS were substantially higher than those seen in GSEAR. CONCLUSIONS: In many LMICs, despite the existence of policies aimed at slowing down the spread of AMR, there are still significant gaps in their implementation and enforcement. Increased national efforts in the areas of enforcement and monitoring of antibiotic use as well as regular monitoring of national efforts are urgently needed to reduce inappropriate antibiotic use in LMICs and to slow the spread of AMR globally.

Asbestos ban policies and mesothelioma mortality in Greece.

BACKGROUND: Malignant mesothelioma is a rare form of cancer that mostly affects the pleura and has a strong link to asbestos exposure. Greece banned the use of asbestos in 2005, however, the public was already aware of this substance in the 1980s. This research aims to present an overview of Greece's mesothelioma age-standardized mortality rates (ASMR) from 1983 to 2019 by age, gender, and geographic region and to determine whether the actions to ban asbestos impacted these rates. METHODS: Data were retrieved by the Hellenic Statistical Authority (HSA) from death certificates that mentioned mesothelioma as the cause of death from 1983 to 2019 with details on the residence, gender, and age. Statistical analysis was performed using PRISM 6.0 software, a two-way ANOVA test, Trend analysis was conducted using Joinpoint Regression Program 5.0 software. The linear and non-linear model was used to calculate the age-standardized rates of annual percentage change (APC) and its 95% confidential interval (95% CI). RESULTS: From 1983 to 2019, 850 total mesothelioma deaths were recorded, the majority of whom were males (634). A rate of 74.6% accounts for males and 25.4% for females, and the ratio of Males: Females was 3:1. Males' ASMR and the whole population's ASMR reached their highest levels in 2011 (0.93/100000person-years and 0.53/100000person-years, respectively). To look for potential changes between the first two decades of the 21st century, we compared the mean ASMR of each geographic region in Greece between two different 10-year subperiods (2000-2009 and 2010-2019). Except for Epirus, all regions of Greece had elevated regional ASMRs, particularly in those with the highest asbestos deposits. Notably, the ASMR in Epirus decreased from 0.54/100000person-years (2000-2009) to 0.31/100000person-years (2010-2019). After 2011, the ASMR for men and the general population stabilized. This stability is important since mesothelioma in men is associated with occupational asbestos exposure. The intriguing discovery of a lower ASMR in Epirus emphasizes the need to raise awareness of the condition and implement effective public health measures. CONCLUSIONS: In Greece, the annual ASMR for males and the whole population reached its highest level in 2011, which is positive and encouraging and may be a sign that the rate will stabilize during the following years. Moreover, this study showed that the actions made in the 1980s regarding public awareness and surveillance directly impacted the decrease in Epirus rates. Future research, continual awareness, information, and recording are needed to monitor the mesothelioma epidemic. The possible benefit of a mesothelioma registry and the epidemiological surveillance of asbestos-related diseases, particularly mesothelioma mortality, need to be addressed. TRIAL REGISTRATION: Not applicable.

Do compulsory mental health patients have a right to receive a second opinion on their treatment under Australian mental health legislation?

We reviewed Australian mental health legislation to determine what obligations it places on psychiatrists to facilitate second opinions for compulsory patients who request them. Only four jurisdictions-Australian Capital Territory, Queensland, Victoria, and Western Australia-have legislated for 'patient-initiated' second opinions. Within these four regimes, there is variation in important aspects of the second opinion process, and there is a general absence of direction given to the second opinion providers. Based on research showing the variability of second opinion provision under New Zealand mental health legislation, we argue that this absence is likely to result in significant variation in the quality and depth of second opinions provided in Australia. We argue that New South Wales, the Northern Territory, South Australia, and Tasmania should consider formal provision for patient-initiated second opinions in their mental health legislation. We believe that such legislation ought to be aware of the barriers patients may face in accessing second opinions, and avoid exacerbating these barriers as Queensland's legislation appears to. Also, we argue that research on current practice in Australia should be conducted to better understand the effects of legislation on second opinions, and to help determine what amounts to best practice.