Background: Many of the overseas qualified nurses educated work as health care assistants and support workers for a decreased wage without scope for professional advancement. There is an imperative to ease their entry to the nursing register.Aim: To gather and provide evidence to the regulatory bodies regarding the demographics of this cohort of nurses and the challenges they face in attempting to register as a nurse.Design: This study used a mixed-method explanatory sequential design. The survey was completed by 857 unregistered nurses followed by five in-depth interviews. Results from both phases were triangulated.Results: The results signpost to the characteristics and challenges of these nurses working as unqualified grades of staff for a decreased wage without scope for professional advance.Discussion and conclusion: The downward occupational spiral of internationally educated nurses underscores the paradoxical nature of the pedagogical application of transition theory, as these nurses are compelled to revert to a novice status.

The recent conflicting recommendations on coverage and use of monoclonal antibody treatments for Alzheimer\'s Disease (AD) in the United States provide an opportunity to better define the concepts of safety, efficacy, reasonableness, and necessity. The translation of current science into clinical practice may require additional studies that enroll patients like those seen by primary care providers. Regarding recently published clinical trials as a step forward toward an AD cure is critical, as is wide collaboration between researchers and clinicians, and public and private sectors, to ensure that new effective therapies can be easily provided in clinical practice settings.

For more than a decade, US laboratories have failed to implement solutions to help their clinicians in managing complex situations or patients on direct oral anticoagulants (DOACs). The problem may find different origins, among which is the position of the Food and Drug Administration, which categorized these drugs as monitoring- and measurement-free, whereas other regulatory bodies like the European Medicines Agency or the Therapeutic Goods Administration in Australia were more conservative on the principle that the absence of proof (of monitoring/measurement benefits) is not proof of an absence (of monitoring/measurement needs). Pivotal clinical studies that led to the approval of DOACs were presented as devoid of such testing, although some companies considered monitoring as a solution to improve their benefit/risk ratio. In this JTH In Clinics issue, we report more than a decade of development that has permitted the activation of smart laboratory solutions to qualify or quantify DOACs and discuss myths and misconceptions around technical and regulatory requirements that support the current reluctance of implementing these technologies in most US laboratories. Use of DOACs is ever expanding, with DOAC prescriptions now exceeding those of other anticoagulants, including vitamin K antagonists, in some geographies. As this use increases, the likely need to measure DOAC exposure will also increase. Measurement of DOACs does not represent any technical difficulty. That these laboratory tests are not available in some locations suggests disparities in patient care, and we suggest it is time to address such inequalities.

The aim of this chapter is to describe and give an overview of the steps from the conception of an idea in the lab to reaching the market. Starting from the early discovery in the lab environment (including reverse and classical pharmacology), and briefly going over the different phases of clinical trials: Phase I, first tests in humans; Phase II, safety and efficacy; Phase III, efficacy confirmation; and Phase IV, post-authorization, in which the investigation would focus on long-term effects, completion of technical and safety sheet. Finally, a short conclusion in regard to the continuous overview and revision of drugs in the market.

Undoubtedly, pharmacogenomics (PGx) aims in optimizing drug treatment responses whilst also improving the patients\' quality of life, either via a reduction of adverse drug reactions and/or an enhancement of drug treatment efficacy. To achieve this, PGx guidance is provided by the two major regulatory bodies in a worldwide level, specifically the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA), and occasionally some research consortia, such as the Clinical Pharmacogenetics Implementation Consortium (CPIC) or the Dutch Pharmacogenomics Working Group (DPWG). However, so far, there is a limited number of studies focusing on the delineation of the similarities and more importantly, the discrepancies in the PGx guidance by the different regulatory bodies and consortia. Herein, we use real-life clinical PGx data to highlight such discrepancies and similarities for genome-guided interventions in psychiatric disorders, thus demonstrating the need for harmonization of the guidelines and recommendations. More precisely, we used the PharmCAT genome-informed drug treatment reports from 304 Greek individuals with psychiatric disorders in order to emphasize on the discrepancies in the PGx guidance/guidelines between FDA vs EMA and CPIC vs DPWG, respectively. For example, CYP2D6-pimozide pair is characterized as \'Testing Required\' according to FDA and is accompanied by a DPWG PGx guideline, whilst no EMA or CPIC PGx guidance is found for this drug-gene pair. Moreover, discrepancies are observed regarding the type of PGx guidance for CYP2C19-doxepin pair, with 89 individuals from our study cohort requiring a dose prescribing change based on FDA, whilst only 5 individuals have to receive genome-guided treatment adjustment according to CPIC. To our knowledge, this is the first study, in which discrepancies regarding the type of PGx guidance and the number of actionable drug-gene pairs amongst FDA and EMA, as well as CPIC and DPWG, are brought to light with an emphasis on psychiatric disorders.

BACKGROUND: There have been no studies, monitoring programs, or data about phthalate levels made available to the public on the safety of residential drinking water in Lagos, Nigeria.
OBJECTIVE: The present study aimed to assess the concentrations of dimethyl phthalate (DMP), diethyl phthalate (DEP), dibutyl phthalate (DBP), and zinc (Zn), lead (Pb), chromium (Cr), and cadmium (Cd) in drinking water drawn from taps in three residential areas of the state.
METHODS: High performance liquid chromatography and atomic absorption spectroscopy were used to determine the concentrations of phthalates and metals, respectively.
RESULTS: All of the water samples collected throughout the sampling period contained DMP, while DEP and DBP were present in only some of the samples. The highest mean DMP, DEP, and DBP concentrations of 1.15±0.28 mg/l, 0.09±0.16 mg/l, and 0.28±0.33 mg/l, respectively, were found in water samples collected from Lagos Street (Ebute-metta East). In addition, the trace/toxic metal concentrations in the water samples were found to be low for Cr, but high for Cd, Pb, and Zn, especially when compared with World Health Organization (WHO) limit values for drinking water. Lead recorded the highest mean concentration of 0.087±0.021 mg/l in the water samples obtained from Apapa Road (Ebute-Metta West). In the same vein, the highest significant (P < 0.01) mean Cr concentration of 0.047±0.012 mg/l was found in the water samples obtained from Apapa Road (Ebute-Metta West).
CONCLUSIONS: In view of the high concentrations of phthalates and metals in the water sampled in this study, and the potential adverse health effects of these contaminants, especially on children and women of child-bearing age, the Lagos State Government of Nigeria and the state water corporation are called upon to immediately institute a monitoring program to identify the sources of contaminants and take appropriate intervention measures.
UNASSIGNED: The authors declare no competing financial interests.

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Hypertension is now recognized as a major global cause of morbidity and death. All decisions relating to the epidemiology, diagnosis, and management of hypertension are dependent on being able to measure blood pressure accurately. Scientists have developed protocols to assess the accuracy of blood pressure-measuring devices, but little attention has been given to informing users which devices are accurate and inaccurate. This article identifies a recipient audience of researchers, clinicians, and scientists, the public, healthcare executives and administrators, and consumer and regulatory bodies, and discusses how best to communicate the results of device accuracy to these groups with the aim of improving the accurate measurement of blood pressure.

The importance of demonstrating adherence to good practice in the provision of clinical services is well recognised, and there are many legislative and regulatory requirements that aim to ensure that services are appropriately reviewed and certified. Therefore, for regulatory purposes, laboratories must provide assurance of the quality of the services they provide. Additionally in the field of transplantation, where donor organs and stem cells are exchanged across national boundaries, adoption of a common set of standards by laboratories across many different countries is an important factor. The European Federation for Immunogenetics (EFI) Accreditation Programme was established to provide assurance that Histocompatibility & Immunogenetics laboratories providing services for transplantation, transfusion, and disease association testing meet the requirements of the specialty specific EFI standards. The first H&I laboratories achieved EFI accreditation in 1995, and currently there are over 260 EFI accredited laboratories in 36 countries. The programme depends on the voluntary participation of the inspectors, who are all experts in the field of H&I, and who, over the last 22 years, have performed over 1400 onsite inspections of laboratories. Inspection findings show the areas that are most frequently found to be deficient in meeting the requirements of the standards, and this can be used to inform educational and other activities with the aim of improving laboratory compliance with the standards. The EFI standards have been regularly updated to reflect the changes in the field with 19 versions over the last 22 years, and the data from the accreditation programme show how laboratories have changed their practices to incorporate new techniques that support patient care.

The benefit-risk balance of vaccines is regularly debated by the public, but the utility of media monitoring for regulatory bodies is unclear. A media monitoring study was conducted at the European Medicines Agency (EMA) concerning human papillomavirus (HPV) vaccines during a European Union (EU) referral procedure assessing the potential causality of complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) reported to the authorities as suspected adverse reactions.
To evaluate the utility of media monitoring in real life, prospective real-time monitoring of worldwide online news was conducted from September to December 2015 with inductive content analysis, generating \'derived questions\'. The evaluation was performed through the validation of the predictive capacity of these questions against journalists\' queries, review of the EMA\'s public statement and feedback from EU regulators.
A total of 4230 news items were identified, containing personal stories, scientific and policy/process-related topics. Explicit and implicit concerns were identified, including those raised due to lack of knowledge or anticipated once more information would be published. Fifty derived questions were generated and categorised into 12 themes. The evaluation demonstrated that providing the media monitoring findings to assessors and communicators resulted in (1) confirming that public concerns regarding CRPS and POTS would be covered by the assessment; (2) meeting specific information needs proactively in the public statement; (3) predicting all queries from journalists; and (4) altering the tone of the public statement with respectful acknowledgement of the health status of patients with CRSP or POTS.
The study demonstrated the potential utility of media monitoring for regulatory bodies to support communication proactivity and preparedness, intended to support trusted safe and effective vaccine use. Derived questions seem to be a familiar and effective format for presenting media monitoring results in the scientific-regulatory environment. It is suggested that media monitoring could form part of regular surveillance for medicines of high public interest. Future work is recommended to develop efficient monitoring strategies for that purpose.