Strategies for Success in Regulatory Readiness.

This article describes the formation of a Regulatory Advisory Council to address regulatory preparedness. The council used quality improvement methods to address data and findings from previous mock surveys and created 2 categories of work, an environment of care and clinical standards group, with checklists and work streams to improve organizational success with regulatory readiness.

Realizing the Value of Nursing Through Innovative Regulation.

Nursing regulation is a specialty area of nursing practice that some may perceive as only performing licensing and disciplinary functions. However, highly effective boards strive to meet their mission of public protection through continuous innovation. This article describes several innovative programs initiated by a board of nursing. Among the examples include regulatory waivers during the pandemic, collaborations with stakeholder organizations, a resource for nursing peer-review committees, and an alternative remediation option for practice breakdown. With strong leadership and committed teams, regulation can both protect the public and play a part in actualizing the value of nursing.

The red and the black: China's social credit experiment as a total test environment.

China's social credit system is an unusually explicit case where technology is used by multiple actors to turn human behavior into a test object on behalf of the state's goal of modifying the larger social environment, making it an intriguing setting for thinking about the new sociology of testing. This article considers how China's search for a usable "credit" score to both allocate financial resources and explicitly measure a citizen's trustworthiness creates an emergent experimental system of governance similar to, yet not quite captured by, the kinds of experimental processes observed in literature on the platform as a form of market-based governance. As a site where "seeing like a state" and "seeing like a market" converge, the social credit system is a vantage point for observing the changing relationship between moral and economic domains in an era of digital platforms. The article highlights the experimental quality of the system and its emerging system of governance structured around reward and punishment and argues that strategic ambiguity, institutionalized through the affordances of digital platforms, is an important part of the design of this large-scale social experiment.

The Response of Retailers in Scotland to the Standardised Packaging of Tobacco Products Regulations and Tobacco Products Directive.

INTRODUCTION: With most marketing channels prohibited, the retail environment has assumed greater importance for tobacco companies, even in markets with a ban on the open display of tobacco products. Research has yet to qualitatively explore how retailers respond to standardized packaging in a country where this has been introduced. METHODS: As part of the DISPLAY study, face-to-face interviews were conducted with 24 small retailers in Scotland between May 23 and June 26, 2017; the interviews were conducted after The Standardised Packaging of Tobacco Products Regulations and the Tobacco Products Directive were fully implemented. RESULTS: We found high retailer compliance with the legislation. With price-marked packs and packs containing less than 20 cigarettes and 30 g of rolling tobacco banned, retailers stated that this helped simplify ordering and stock management. The removal of price-marked packs also allowed them some flexibility to set their own prices, but many chose to stick closely to recommended retail price in order to remain competitive and avoid complaints from customers. In contrast to one of the tobacco industry's arguments against standardized packaging, most retailers suggested that transaction times had not increased, even though the changes had only recently come into force. CONCLUSIONS: This study challenges some of the arguments used against standardized packaging and provides an insight into the storage and pricing strategies adopted by retailers following the removal of price-marked packs. IMPLICATIONS: This study explores the response of the retailers to the introduction of standardized tobacco packaging and provides an insight into the storage and pricing strategies adopted by retailers following the removal of price-marked packs. It explores the importance of the retailer in tobacco companies' desire to maintain tobacco sales and challenges some of the arguments used against standardized packaging, such as an increase in transaction times. Countries seeking to introduce standardized packaging should monitor the experiences of retailers, preferably from preimplementation through to post implementation, to help understand how retailers respond to this policy and to inform compliance.

Methadone maintenance treatment as social control: Analyzing patient experiences.

Methadone maintenance treatment (MMT) is a harm reduction approach for persons who wish to stop using opioids and is rather effective if used for a minimum of 12 months. Notably, research demonstrates that many persons enrolled in MMT programs discontinue care before this time, limiting its effects. To better understand this process, we undertook an exploratory descriptive qualitative study and interviewed 12 men and women who were using MMT. Using the theoretical work of Foucault and Hardt and Negri, the interview data highlighted that MMT continues to be strongly stigmatized, and that it is a system of care that involves rewards and penalties, based on if patients behave according to prescribed norms. These results suggest that MMT is a disciplinary mechanism, albeit one that impedes its own access. We consequently recommend that healthcare providers work to facilitate access to MMT, which means altering care delivery.

A latent class analysis of cognitive empowerment and ethnic identity: An examination of heterogeneity between profile groups on dimensions of emotional psychological empowerment and social justice orientation among urban youth of color.

Psychological empowerment (PE) encompasses key aspects of youth development and civic engagement. Empowerment scholarship has largely focused on the intrapersonal or emotional component of PE, which considers perceptions of control and self-efficacy, specifically in the sociopolitical sphere. Fewer studies have assessed the interactional or cognitive component of PE. Even less have examined the empirical association aspects of PE, including cognitive empowerment, with conceptually related variables, such as ethnic identity. Those studies that are present have shown that the association between aspects of PE and ethnic identity are complex. The current study of urban high school students of color (N = 383; 53.1% female; 75% Hispanic/Latinx) investigates the heterogeneity present between cognitive empowerment and ethnic identity. Latent class cluster analyses were conducted and five distinct profile groups emerged. Differences were observed on the basis of profile groups of cognitive empowerment and ethnic identity on self-reported dimensions of emotional PE (e.g., leadership and policy control) and social justice orientation. The majority of study participants were clustered in groups that identified moderate to high levels of both cognitive empowerment and ethnic identity. Results provide useful insights for theory and programming.

Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective.

PURPOSE: This article describes preclinical development of cell-based medicinal products for European markets and discusses European regulatory mechanisms open to developers to aid successful product development. Cell-based medicinal products are diverse, including cells that are autologous or allogeneic, have been genetically modified, or not, or expanded ex vivo, and applied systemically or to an anatomical site different to that of their origin; comments applicable to one product may not be applicable to others, so bespoke development is needed, for all elements - quality, preclinical and clinical. METHODS: After establishing how the product is produced, proof of potential for therapeutic efficacy, and then safety, of the product need to be determined. This includes understanding biodistribution, persistence and toxicity, including potential for malignant transformation. These elements need to be considered in the context of the intended clinical development. RESULTS: This article describes regulatory mechanisms available to developers to support product development that aim to resolve scientific issues prior to marketing authorization application, to enable patients to have faster access to the product than would otherwise be the case. CONCLUSIONS: Developers are encouraged to be aware of both the scientific issues and regulatory mechanisms to ensure patients can be supplied with these products.

Identification of ethics committees based on authors' disclosures: cross-sectional study of articles published in the European Journal of Anaesthesiology and a survey of ethics committees.

BACKGROUND: Since 2010, the European Journal of Anaesthesiology has required the reporting of five items concerning ethical approval in articles describing human research: ethics committee's name and address, chairperson's name, study's protocol number and approval date. We aimed to assess whether this requirement has helped to identify and to contact the referenced ethics committees. METHODS: In this cross-sectional study, we analysed articles requiring ethical approval, according to the Swiss federal law for human research and published in the European Journal of Anaesthesiology in 2011. Ethics committees were searched through our institutional Internet access based on information provided in the articles. The last search was performed in November 2015. Numbers (%) of items reported, of ethics committees identified, and of those that confirmed having provided ethical approval are reported. RESULTS: Of 76 articles requiring ethical approval, 74 (97%) declared it. Ethics committees' names and addresses were mentioned in 63/74 (85%), protocol numbers in 51/74 (69%), approval dates in 48/74 (65%), and chairpersons' names in 45/74 (61%). We could identify 44/74 (59%) committees; 36/74 (49%) answered our inquiry and 24/74 (32%) confirmed their role. Thirty-four of 74 articles (46%) reported all five items; in 25/34 (74%), we were able to identify an ethics committee, 18/34 (53%) answered our inquiry, and 15/34 (44%) confirmed their role. Forty of 74 articles (54%) reported ≤4 items; in 19/40 (48%), we were able to identify an ethics committee, 18/40 (45%) answered our inquiry, and 9/40 (23%) confirmed their role. Reporting five items significantly increased identification of ethics committees (p = 0.023) and their confirmation of ethical approval (p = 0.048). Twelve of 74 ethics committees (16%) were unable to confirm their role in approving the study. CONCLUSIONS: Even when details concerning ethical approval were reported in these studies of human research, we were unable to identify almost half of the ethics committees concerned. The reporting of five items, compared with reporting ≤4, was associated with facilitated identification of ethics committees, and increased the likelihood that they would be able to confirm the study's approval. Future research should identify which information facilitates identification of, and contact with, ethics committees.

Patient participation as discursive practice-A critical discourse analysis of Danish mental healthcare.

Patient participation is one of the most prevalent focus areas in the Danish healthcare debate. Patient participation is generally presented as a fundamental democratic right, and is stated in an objective language with legal requirements for healthcare professionals to ensure that patients systematically participate in their own courses of care and treatment. In the research literature, it is not clear what is meant by 'patient participation', and several discourses on patient participation exist side by side. This study explores how discourses of patient participation unfold and are at play in the articulations in official legal and political documents and patient records relating to a Danish psychiatric context. The documents and patient records have been analyzed using a Fairclough-inspired critical discourse approach which is concerned with how power is exercised through language. The research findings show that patient participation within Danish psychiatric healthcare is governed within a neoliberal discourse where underlying discourses; discourse of biomedicine, paternalism, management, evidence and ethics of care are embedded, and a discourse that seems to ascribe stigmatizing traits to mentally ill patients.

The Trans-Pacific Partnership Agreement and health: few gains, some losses, many risks.

BACKGROUND: In early October 2015, 12 nations signed the Trans-Pacific Partnership Agreement (TPPA), promoted as a model '21(st) century' trade and investment agreement that other countries would eventually join. There are growing concerns amongst the public health community about the potential health implications of such WTO+ trade and investment agreements, but little existing knowledge on their potential health impacts. METHODS AND RESULTS: We conducted a health impact review which allows for a summary estimation of the most significant health impacts of a set of policies, in our case the TPPA. Our analysis shows that there are a number of potentially serious health risks, with the following key pathways linking trade to health: access to medicines, reduced regulatory space, investor-state dispute settlement (ISDS), and environmental protection and labor rights. We also note that economic gains that could translate into health benefits will likely be inequitably distributed. CONCLUSION: Our analysis demonstrates the need for the public health community to be knowledgeable about trade issues and more engaged in trade negotiations. In the context of the COP21 climate change Agreement, and the UN Sustainable Development Goals, this may be an opportune time for TPPA countries to reject it as drafted, and rethink what should be the purpose of such agreements in light of (still) escalating global wealth inequalities and fragile environmental resources-the two most foundational elements to global health equity.

Addressing antimicrobial resistance in China: policy implementation in a complex context.

The effectiveness of antibiotics in treating bacterial infections is decreasing in China because of the widespread development of resistant organisms. Although China has enacted a number of regulations to address this problem, but the impact is very limited. This paper investigates the implementation of these regulations through the lens of complex adaptive systems (CAS). It presents the findings from reviews of relevant policy documents and published papers. The paper identifies different types of agent and explores their interaction with regard to the use of antibiotics and their responses to changes of the regulations. It focuses particularly on the impact of perverse financial incentives on overall patterns of use of antibiotics. Implications for the possibilities of nonlinear results, interactive relationships, and new pathways of policy implementation are discussed. The paper concludes that policy-makers need to better understand the objectives, incentives and potential adaptive behaviors of the agents when they implement interventions to improve antibiotic use and reduce the risk of emergence of resistant organisms.

Tobacco control laws in Pakistan and their implementation: A pilot study in Karachi.

OBJECTIVE: In order to limit the high prevalence of tobacco use in Pakistan various tobacco control laws have been implemented. The objective of this study is to serve as a pilot study to assess the implementation of these laws in the largest city of Pakistan, Karachi. METHODS: A cross-sectional study was conducted in Karachi. The implementation of tobacco control laws in 'smoke-free' places, the adherence of tobacco companies to these laws, the regulation of cigarette sale, and the awareness and views of the general public regarding tobacco control laws were assessed via direct observation by visits and through self-administered questionnaires. RESULTS: The implementation of tobacco control laws in 'smoke-free' public places was found to be poor. Out of 37, only 23(62%) brands displayed pictorial warnings on their packs. 3(8%) of the brands were available in two different kinds of packs, both with and without pictorial warnings. Cigarette sale to minors was taking place at 80(85%) of the visited cigarette outlets. 50(53%) of the outlets displayed cigarette advertisements in the form of posters. 46(40%) of the persons questioned had awareness regarding the existence of ban on smoking in public places and 126(90%) of these were in favour of it. CONCLUSIONS: The implementation of tobacco control law in Pakistan is poor. Non adherence to the law in public places was alarmingly high. Also, the study demonstrates the poor compliance to the tobacco control laws by tobacco companies. The sale of cigarettes is almost unregulated.

The sensory power of cameras and noise meters for protest surveillance in South Korea.

This article analyzes sensory aspects of material politics in social movements, focusing on two police tools: evidence-collecting cameras and noise meters for protest surveillance. Through interviews with Korean political activists, this article examines the relationship between power and the senses in the material culture of Korean protests and asks why cameras and noise meters appeared in order to control contemporary peaceful protests in the 2000s. The use of cameras and noise meters in contemporary peaceful protests evidences the exercise of what Michel Foucault calls 'micro-power'. Building on material culture studies, this article also compares the visual power of cameras with the sonic power of noise meters, in terms of a wide variety of issues: the control of things versus words, impacts on protest size, differential effects on organizers and participants, and differences in timing regarding surveillance and punishment.

Project NO REST: Addressing Human Trafficking in North Carolina.

Project NO REST (North Carolina Organizing and Responding to the Exploitation and Sexual Trafficking of Children) is a 5-year effort funded by the US Children's Bureau to address the trafficking of individuals age 25 years and younger in North Carolina. The project aims to increase awareness of human trafficking affecting children and youth, especially those in the child welfare system; to reduce the number of these youth who are trafficked; and to improve outcomes for those who are trafficked. In the project's first year, nearly 100 stakeholders statewide developed a comprehensive plan to address trafficking. Later, 5 communities were recruited to implement the plan at the local level. Their experiences will be used to develop a toolkit for future anti-trafficking efforts.

"What makes you think you have special privileges because you are a police officer?" A qualitative exploration of police's role in the risk environment of female sex workers.

Worldwide, female sex workers (FSWs) have high rates of HIV. Many factors that escalate their risk lay outside of their control, primarily in the environments in which they practice sex. An understudied yet powerful risk environment is that of police. We qualitatively explored sex workers' interactions with police in their personal and professional lives. Thirty-five FSWs were purposively sampled in Baltimore, MD, in 2012. Women discussed experiences of police verbal harassment, sexual exploitation, extortion, and a lack of police responsiveness to 911 calls in emergencies, largely partner violence. Women's mistrust of police was often developed at an early age and further reinforced by interactions in their personal and professional lives. The study underscores the need for targeting police in reducing sex workers' HIV and other risks. The case for police's role in generating risk is evident, which could be addressed through structural interventions targeting both police practices and policies.

The development and validation of the Youth Actuarial Care Needs Assessment Tool for Non-Offenders (Y-ACNAT-NO).

BACKGROUND: In The Netherlands, police officers not only come into contact with juvenile offenders, but also with a large number of juveniles who were involved in a criminal offense, but not in the role of a suspect (i.e., juvenile non-offenders). Until now, no valid and reliable instrument was available that can be used by Dutch police officers for estimating the risk for future care needs of juvenile non-offenders. In the present study, the Youth Actuarial Care Needs Assessment Tool for Non-Offenders (Y-ACNAT-NO) was developed for predicting the risk for future care needs that consisted of (1) a future supervision order as imposed by a juvenile court judge and (2) future worrisome incidents involving child abuse, domestic violence/strife, and/or sexual offensive behavior at the juvenile's living address (i.e., problems in the child-rearing environment). METHODS: Police records of 3,200 juveniles were retrieved from the Dutch police registration system after which the sample was randomly split in a construction (n = 1,549) and validation sample (n = 1,651). The Y-ACNAT-NO was developed by performing an Exhaustive CHAID analysis using the construction sample. The predictive validity of the instrument was examined in the validation sample by calculating several performance indicators that assess discrimination and calibration. RESULTS: The CHAID output yielded an instrument that consisted of six variables and eleven different risk groups. The risk for future care needs ranged from 0.06 in the lowest risk group to 0.83 in the highest risk group. The AUC value in the validation sample was .764 (95% CI [.743, .784]) and Sander's calibration score indicated an average assessment error of 3.74% in risk estimates per risk category. CONCLUSIONS: The Y-ACNAT-NO is the first instrument that can be used by Dutch police officers for estimating the risk for future care needs of juvenile non-offenders. The predictive validity of the Y-ACNAT-NO in terms of discrimination and calibration was sufficient to justify its use as an initial screening instrument when a decision is needed about referring a juvenile for further assessment of care needs.