Erratum to "Outbreak of New Delhi Metallo-Beta-lactamase Carbapenemase Producing Enterobacterales on a bone marrow transplant unit: Role of the environment" Infect Prev Pract, Vol. 3 (June 2021) Article Number: 100125.

[This corrects the article DOI: 10.1016/j.infpip.2021.100125.].

The Impact of Real-Time Whole-Genome Sequencing in Controlling Healthcare-Associated SARS-CoV-2 Outbreaks.

Nosocomial severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections have severely affected bed capacity and patient flow. We utilized whole-genome sequencing (WGS) to identify outbreaks and focus infection control resources and intervention during the United Kingdom's second pandemic wave in late 2020. Phylogenetic analysis of WGS and epidemiological data pinpointed an initial transmission event to an admission ward, with immediate prior community infection linkage documented. High incidence of asymptomatic staff infection with genetically identical viral sequences was also observed, which may have contributed to the propagation of the outbreak. WGS allowed timely nosocomial transmission intervention measures, including admissions ward point-of-care testing and introduction of portable HEPA14 filters. Conversely, WGS excluded nosocomial transmission in 2 instances with temporospatial linkage, conserving time and resources. In summary, WGS significantly enhanced understanding of SARS-CoV-2 clusters in a hospital setting, both identifying high-risk areas and conversely validating existing control measures in other units, maintaining clinical service overall.

Outbreak of New Delhi Metallo-Beta-lactamase Carbapenemase Producing Enterobacterales on a bone marrow transplant unit: Role of the environment.

BACKGROUND: Carbapenemase Producing Enterobacterales (CPE) are a global health concern. Nosocomial outbreaks have been reported globally with patient-to-patient transmission felt to be the most frequent route of cross-transmission. AIM: To describe the investigation and control of an outbreak of healthcare-associated New Delhi Metallo-beta-lactamase (NDM) CPE on a haematology ward, over 2 months. METHODS: Four patients acquired CPE; all had gastrointestinal tract colonisation with two subsequently developing bacteraemias. The outbreak team performed a retrospective review, prospective case finding and environmental sampling using swabs, settle plates, air and water sampling. Immediate control measures were implemented including appropriate isolation of cases and additional ward cleaning with chlorine disinfectant, ultra-violet light decontamination and hydrogen peroxide. FINDINGS: Following two cases of nosocomial acquired CPE prospective case finding identified two further cases. 4.6% of the initial environmental samples were positive for CPE including from waste water sites, the ward sluice and the ward kitchen. Three of the four CPE isolates were identical on pulse field gel electrophoresis (PFGE) typing. Detection of the CPE from the ward kitchen environmental samples suggests a possible role for cross transmission. CONCLUSION: This is the first CPE outbreak report to highlight the role of a ward kitchen as a possible source of cross-transmission. In view of this we suggest ward kitchens are reviewed and investigated in nosocomial CPE outbreaks.

A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme.

The acceptance of foreign comparator products is the most limiting factor for the development and regulatory assessment of generic medicines marketed globally. Bioequivalence studies have to be repeated with the local comparator products of each jurisdiction because it is unknown if the comparators of the different countries are the same product, with the consequent duplication of efforts by regulators and industry alike. The regulatory requirements on the acceptability of foreign comparator products of oral dosage forms differ between countries participating in the Bioequivalence Working Group for Generics of the International Pharmaceutical Regulators Programme. Brazil, Colombia, the European Union member States, Japan, Mexico, South Korea and the United States only accept bioequivalence studies with their local comparator. In contrast, Australia, Canada, New Zealand, Singapore, South Africa, Switzerland and Taiwan accept studies with foreign comparators under certain conditions. Canada limits its use to highly soluble drugs with a wide therapeutic range in immediate release products. Australia requires a comparison of the quantitative composition. In contrast, there are fewer restrictions on the acceptance of foreign comparators in New Zealand, Singapore, South Africa, Switzerland and Taiwan. For the WHO Prequalification of Medicines and for developing generics of the essential medicines the WHO lists comparators from different countries. In conclusion, there is currently no consensus amongst regulators on the acceptability of foreign comparator products.

A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme.

PURPOSE: The Biopharmaceutics Classification System (BCS) based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in vitro data as evidence of therapeutic equivalence subject to certain conditions. Despite being based on the same principles, BCS-based biowaivers are interpreted and regulated differently among international regulatory agencies. In this survey, the Bioequivalence Working Group (BEWG) of the International Generic Drug Regulators Programme (IGDRP) compared the criteria for BCS-based biowaivers applied by the participating regulators and organisations. METHODS: Differences and similarities regarding solubility, permeability, dissolution, excipients and fixed-dose combination products, were identified and compared in a detailed survey of each participant's criteria for BCS-based biowaivers. These criteria were determined based upon the participants' respective regulatory guidance documents, policies and practices. RESULTS: This review has, with the exception of two participants who do not accept BCS-based biowaivers, revealed that most IGDRP participants interpret the BCS principles and conditions similarly but notable differences exist in the application of these principles.  Conclusion: Although many similarities exist, this review identifies several opportunities for greater convergence of regulatory requirements amongst the surveyed jurisdictions. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

Infection control nurses' perceptions of the Code of Hygiene.

AIM: The aim of the study was to understand senior infection prevention and control nurses' experiences and perceptions of implementing the day to day aspects of the Code of Hygiene. BACKGROUND: The Code of Hygiene is legislative and sets out compliance standards in order to reduce infection rates. It details standards by which health-care providers failing to comply with infection control standards can be subject to improvement notices and actions. METHODS: Senior nurses from five infection prevention and control teams in England participated in taped, qualitative interviews which were analysed. FINDINGS: Two themes emerged from the data: 'Interventions' and 'Barriers to compliance'. Interventions were driven by senior NHS managers and necessitated organizational change. It was senior NHS managers who were considered as being the force for change and who intervened and took responsibility for implementation. Change was achieved by a top-down approach and was driven by senior managers' fear of external censure. At the same time, participants felt they had more authority as a consequence of these changes as they too, felt they could enforce change. Barriers to compliance were identified as: a lack of facilities, specifically a lack of side rooms and isolation facilities, and the non-engagement of medical staff. IMPLICATION FOR NURSING MANAGEMENT: Compliance was achieved by organizational change and senior managerial intervention. Barriers to compliance must be addressed to meet the Code of Hygiene's compliance criteria.