New legal requirements for submission of product information to poisons centres in EU member states

Introduction: In the past eight years, the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) has been intensively involved in a European Commission led process to develop EU legislation on the information of hazardous products that companies have to notify to EU Poisons Centres (or equivalent “appointed bodies”). As a result of this process, the Commission adopted Regulation (EU) No 2017/542, amending the CLP Regulation by adding an Annex on harmonised product submission requirements.

Harmonised mixture information requirements: Detailed and consistent information on the composition of the hazardous product will become available to EU Poisons Centres (PC). The information will be submitted by companies to PCs (or equivalent “appointed bodies”) using a web-based software application or in-house software. Two new important features are introduced. Firstly, to be able to rapidly identify the product formula, a Unique Formula Identifier (UFI) on the product label links to the submitted information. Secondly, for better comparability of reports on poisonings between EU member states, a harmonised Product Categorisation System will specify the intended use of a product. Rapid product identification and availability of detailed composition information will lead to timely and adequate medical intervention. This may lead to considerable reduction in healthcare costs.

Additionally, for companies trading across the EU, costs of submission of this information will be reduced significantly.

Next steps: From 2017, an implementation period has started, consisting of a three-year period for stakeholders to implement the new requirements, followed by a gradual applicability for consumer products (2020), professional products (2021) and industrial use-only products (2024). Technical tools to generate the electronic format and the UFI together with guidance documents are expected to be made available by the end of 2017 by the European Chemicals Agency (ECHA). Guidance on interpretation of legal text and ECHA helpdesk support are planned to be ready at the end of 2018.     

Safety assessment for octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate (CAS Reg. No. 2082-79-3) from use in food contact applications

Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate (CAS Reg. No. 2082-79-3), currently marketed as Irganox 1076 (I-76), is a sterically hindered phenolic antioxidant used in a variety of organic substrates, including those used in the manufacture of food contact articles. In 2012, the US Food and Drug Administration (USFDA), Office of Food Additive Safety (OFAS), initiated a post-market re-evaluation of the food contact applications of I-76. This project aimed to ensure that current dietary exposures from the use of I-76 in food contact articles are accurately captured and the safety assessment considered all relevant and available toxicological information. To accomplish these aims, the USFDA reviewed the available toxicological studies and chemistry information on food contact applications of I-76. Based on this in-depth analysis, a NOAEL of 64 mg/kg-bw/d (female rats) from a chronic rat study and a cumulative estimated dietary intake (CEDI) of 4.5 mg/p/d, was used to calculate a margin of exposure (MOE) of ∼850. We concluded that the previous and current exposure levels provide an adequate margin of safety (MOS) and remain protective of human health for the regulated uses.     

Breast Density Knowledge in a Screening Mammography Population Exposed to Density Notification

ObjectiveWomen are increasingly informed about their breast density due to state density reporting laws. However, accuracy of personal breast density knowledge remains unclear. We compared self-reported with clinically assessed breast density and assessed knowledge of density implications and feelings about future screening.MethodsFrom December 2017 to January 2020, we surveyed women aged 40 to 74 years without prior breast cancer, with a normal screening mammogram in the prior year, and ≥1 recorded breast density measures in four Breast Cancer Surveillance Consortium registries with density reporting laws. We measured agreement between self-reported and BI-RADS breast density categorized as “ever-dense” if heterogeneously or extremely dense within the past 5 years or “never-dense” otherwise, knowledge of dense breast implications, and feelings about future screening.ResultsSurvey participation was 28% (1,528 of 5,408), and 59% (896 of 1,528) of participants had ever-dense breasts. Concordance between self-report versus clinical density was 76% (677 of 896) among women with ever-dense breasts and 14% (89 of 632) among women with never-dense breasts, and 34% (217 of 632) with never-dense breasts reported being told they had dense breasts. Desire for supplemental screening was more frequent among those who reported having dense breasts 29% (256 of 893) or asked to imagine having dense breasts 30% (152 of 513) versus those reporting nondense breasts 15% (15 of 102) (P = .003, P = .002, respectively). Women with never-dense breasts had 6.3-fold higher odds (95% confidence interval:3.39-11.80) of accurate knowledge in states reporting density to all compared to states reporting only to women with dense breasts.DiscussionStandardized communications of breast density results to all women may increase density knowledge and are needed to support informed screening decisions.     

美国医疗器械上市前通告制度的演变及启示

美国是最早立法管理医疗器械的国家,其监管模式的科学性和系统性已被世界上大多数国家和地区认可。本文以美国上市前通告制度为切入点,介绍各项法规的制修订对上市前通告制度带来的变革,以及种种变革对企业注册申请情况的影响,希望能够为我国医疗器械的监管提供启示。     

Impact of Breast Density Legislation on Breast Cancer Risk Assessment and Supplemental Screening: A Survey of 110 Radiology Facilities

Breast density notification laws, passed in 19 states as of October 2014, mandate that patients be informed of their breast density. The purpose of this study is to assess the impact of this legislation on radiology practices, including performance of breast cancer risk assessment and supplemental screening studies. A 20‐question anonymous web‐based survey was emailed to radiologists in the Society of Breast Imaging between August 2013 and March 2014. Statistical analysis was performed using Fisher's exact test. Around 121 radiologists from 110 facilities in 34 USA states and 1 Canadian site responded. About 50% (55/110) of facilities had breast density legislation, 36% of facilities (39/109) performed breast cancer risk assessment (one facility did not respond). Risk assessment was performed as a new task in response to density legislation in 40% (6/15) of facilities in states with notification laws. However, there was no significant difference in performing risk assessment between facilities in states with a law and those without (p < 0.831). In anticipation of breast density legislation, 33% (16/48), 6% (3/48), and 6% (3/48) of facilities in states with laws implemented handheld whole breast ultrasound (WBUS), automated WBUS, and tomosynthesis, respectively. The ratio of facilities offering handheld WBUS was significantly higher in states with a law than in states without (p < 0.001). In response to breast density legislation, more than 33% of facilities are offering supplemental screening with WBUS and tomosynthesis, and many are performing formal risk assessment for determining patient management.     

某三级甲等医院2008～2013年传染病疫情上报数据分析

目的研究某三级甲等传染病医院疫情网络直报数据,为制订医院突发公共卫生事件预警及应急决策提供依据。方法采用描述性分析方法对2008～2013年南通市第三人民医院各类传染病的发病率、构成比（包括传染病历年报告情况、分类构成、主要发病构成、发病序位）以及发病时间分布等进行统计分析。结果 2008～2013年共上报各类传染病24种、18 325例,年报告数由2 123例增长到3 788例;传染病发病报告数以丙类为主,其中手足口病增长尤为显著;5～6月为该院传染病报告高峰。结论传染病发病报告病例数近几年明显增长,手足口病成为今后该院传染病防控重点,医院传染病防控工作需根据各种传染病流行特征有序开展。     

Significant but weak spousal concordance of metabolic syndrome components in Japanese couples

Objective

This study was initiated to investigate if spousal concordance in metabolic syndrome (MS) components exist in Japan.

Methods

In all, 756 couples (mean age: 48.9 and 47.3 years for husbands and wives, respectively) were identified. Each subject was classified as an MS, MS reserves (MSRES) or no risk of MS (NonMS) case after Japanese Ministry of Health, Labour and Welfare (JMHLW) criteria. Criteria of the National Cholesterol Education Program and of the Joint Interim Statement were also applied.

Results

With Japanese Ministry of Health, Labor and Welfare (JMHLW) criteria, MS, MSRES and NonMS cases accounted for 11.9, 14.7 and 73.4 % in husbands and 1.6, 3.7 and 94.7 % in wives. Waist circumference (WC), body mass index (BMI), systolic blood pressure (SBP) and hemoglobin A1c (HbA1c) showed significant correlation (p < 0.01). Correlation was also significant (p < 0.05) for mean blood pressure (MBP) and fasting plasma glucose (FPG). When adjusted for age, correlations were significant only for WC, BMI and HbA1c. Furthermore, none of the correlation coefficients were greater than 0.2. Logistic regression analyses did not suggest significant mutual influence in MS status between the couples.

Conclusions

Spousal concordance in MS components was detected for WC, BMI, SBP, MBP, FPG and HbA1c, but the correlation was generally weak and modest in Japanese couples.     

基层网络直报工作相关人员对有效分析和利用直报数据的需求情况

目的了解目前我国基层疾病预防控制中心(CDC)传染病网络直报工作相关人员对有效分析和利用直报数据的需求情况,从而制定相应的措施,提高直报数据的分析和利用的程度。方法对北京市和浙江省的基层CDC的传染病网络直报工作的相关人员进行自填式问卷调查,并对直报工作相关的医疗机构及卫生行政人员进行了定性访谈。结果需求主要体现在接受培训,获得信息,调整人员、设备和资金结构以及政策法规保障等方面。81.0%的直报工作相关人员希望能够接受数据分析和利用的培训;不同的机构或人员对疫情信息的需求有所不同;大多数人员希望提高基层直报工作相关人员的素质,增加资金和设备投入,同时健全法制建设,保障数据质量,以此提高数据的分析和利用程度。结论基层CDC直报工作相关人员对有效分析和利用直报数据有各方面的需求,应尽力满足其需求,从而提高直报数据的分析和利用程度。