Overview on haemovigilance about delayed transfusions in the UK and blood shortage in the USA / 中国输血杂志

Serious hazards of transfusion(SHOT)in the United Kingdom has been received reporting of the adverse events of delayed transfusion for more than ten years. Hemovigilance Module Surveillance Protocol in Biovigilance Component in National Healthcare Safety Network in the United States updated the incident codes to include under-transfusion with the creation of a new process code: no blood (NB) and four incident codes in October 2022. This review introduces the monitoring practice of delayed transfusion/under-transfusion in the UK and the USA, makes a suggestion to incorporate delayed transfusion/under-transfusion due to blood shortage into the national health standard on the classification of transfusion reactions and haemovigilance protocol in China, and to do a national survey as well, therefore the real world data and evidences would be obtained and used for further policy making.

Systemic infection caused by the methicillin-resistant Staphylococcus aureus USA300-LV lineage in a Brazilian child previously colonized

ABSTRACT The methicillin-resistant Staphylococcus aureus (MRSA) USA300-Latin American variant (USA300-LV) lineage is well documented in northern Latin American countries. It has replaced established clones in hospital environments. We herein report a systemic infection caused by a USA300-LV isolate in a 15-year-old boy, from a low-income area of Rio de Janeiro, previously colonized by the same strain. During hospital stay, seven pvl-positive MRSA USA300-LV isolates were recovered by nasal swab, blood and abscess secretion. The patient underwent intravenous vancomycin, daptomycin, and oral sulfamethoxazole/trimethoprim, and was discharged after 45 days after full recovery. This is the first documented case of a community-acquired MRSA infection caused by the USA300-LV variant in Brazil in a previously colonized adolescent with no history of recent travel outside of Rio de Janeiro. The need for improved surveillance programs to detect MRSA colonization in order to control the spread of hypervirulent lineages among community and hospital settings is highlighted.

First national record of Aedes melanimon (Diptera: Culicidae) in Mexico

Aedes (Ochlerotatus) melanimon Dyar 1924 has been considered an important pest in agricultural and rural communities. Aedes melanimon is a vector of WEEV and CEV and is a competent laboratory vector of WNV. The known range of Ae. melanimon extends throughout Southwest Canada, part of Central and most of Western USA. Here we report the first record of Ae. melanimon in Mexico, at Ciudad Juárez, Chihuahua. The collect represents the southernmost distributional record for this species. Its indigenous presence in a highly urbanized and dry area was not expected. A permanent surveillance program to detect and determine the species in border-crossing cities is encouraged.

Roll Back Stroke: The Way Forward for Physicians and Patients

The 6-lettered word "Stroke" is an ancient disease, likened Biblicallyto "666" in Revelation 13 verse 18. Globally, it is the commonestcause of acquired long-term disability. While its incidence has beendeclining in high-, low/middle-income countries (LMICs) have witnessed an increase. This increase is driven byepidemiologic-transition/modernizatio n-complex, healthcaredisparities, and increasing prevalence of vascular risk-factors. Despitethe disproportionate burden of stroke in LMICs, these countrieshave the lowest rate of access to acute reperfusion-interventions leadingto greater stroke-related morbidity /mortality. Effective primordial,primary, secondary, and quaternary prevention-strategies coordinated at all levels of care are needed to reduce stroke incidenceand poor outcomes. The World Stroke Organization (WSO) hasproposed achieving global primary prevention through 1) Population-wide approach to limiting stroke risk-factors exposure, 2) App-basedmotivational population-wide approach to mitigating stroke risk-fa cto rs, 3 ) u se of lo w-co st co mbi n at io n /po ly- p il l to tre at hypertension/dyslipidemia and 4) addressing behavioural risk-factorsthrough interventions by community health-workers.The need to set-up stroke-units, post-hospitalisation rehabilitation-centres, stroke-registers/registries, stroke-clubs, and encouragecommunity health-education, must be emphasised for optimal care inLMIC.13 Community Health Empowerment (CHE) withthe AcronymBE FAST / STRoke as warning signs of stroke must be emphasised(B: Balance-loss; E: Eye vision-loss; F: Facial Asymmetry; A: Armweakness; S: Speech difficulties; T: Time is brain; Or first 3-lettersof STRoke ­ Can Patient Smile? Talk? Or Raise-arm?). Strokehemorheology/blood-flow and treatment involve 3Ps' of pathogenicprinciples/strategies (Passenger, Passage, Power). Its complicationsinclude the 10D's: Death, Disability, Depression, Dementia, Delirium,Dysphagia, Dehydration, Deep-Venous Thrombosis, Decubitus-ulcers, Dysphasia, Seizures.

Comparison of Shanghai water quality standard for drinking water with domestic and foreign standards and its influence after implementation / 上海预防医学

Objective:To explore the differences between shanghai water quality standards for drinking water （DB31/T 1091-2018） and domestic and foreign water quality standards， and to compare the improvement of water quality before and after the implementation of DB31/T 1091-2018. Methods:To compare shanghai water quality standard for drinking water with domestic and foreign standards in terms of index number， indicators of disinfectants and their by-products， increased indicators， and revised indicators， and the key water quality indicators before and after the standard implementation in Pudong New Area of Shanghai were investigated. Results:The number of new standard increased from one hundred and six to one hundred and eleven. Among them， the number of conventional indicators increased from forty-two to forty-nine， while the number of unconventional indicators decreased from sixty-four to sixty-two，seven new conventional indicators were added， and the limit value of seventeen conventional indicators was revised and so on. By analyzing water quality monitoring data of New standard before implementation （2017） and after implementation （2019） at water plants of Pudong New Area of Shanghai ， it is found that the total number of bacteria （Z=-2.772，P<0.01）， and carbon tetrachloride （Z=-5.570，P<0.01），trichloromethane （Z=-5.685，P<0.01）， turbidity （Z=-4.168，P<0.01）， total dissolved solids （Z=-7.061，P<0.01）， and total hardness （Z=-2.338，P<0.05）， oxygen consumption （Z=-2.580，P<0.05）， anion synthetic detergent （Z=-2.162，P<0.05）， total chlorine （Z=-2.826，P<0.01）， there were significant statistical differences between the two groups， while there were no statistical differences between the other indicators. Conclusion:The new standard refers to the domestic and foreign drinking water standards， tends to the high and strict requirements， and pushes the improvement water quality of the centralized water supply units， which need to carry out in-depth treatment process transformation， in order to further optimize the water quality.

Social distancing measures could have reduced estimated deaths related to COVID-19 in Brazil / Medidas de distanciamento social podem ter reduzido as mortes estimadas relacionadas à COVID-19 no Brasil

Social distancing was planned as a preventive measure to control the extensive spread of COVID-19. COVID-19-related deaths in Brazil were analyzed during the period of social distancing measures. Mortality data for COVID-19 was obtained from the Worldometer website (www.worldometer.info). Deaths were estimated up to the 31st day after the occurrence of the 5th COVID-19-related death in Brazil. Social distance was measured using Google's community mobility reports (https://www.google.com/covid19/mobility/). The Brazilian epidemic curves were interconnected, and mathematical models were evaluated to fit the mortality estimation curves. The optimistic model was defined in the opening period of social distancing and, therefore, in the lower mobility (40-60%). The realistic model was calculated according to relaxed social distance measures (<40%) and the pessimistic model was calculated based on the transmission rate between 2-3. Thus, the equations of the mathematical models provided the outcomes for the date of June 9, 2020, as follows: realistic model with 40,623 deaths, pessimistic model with 64,310 deaths and the optimistic model with a projection of 31,384 deaths. As a result of these analyzes, on May 24, 2020, there were a total of 22,965 deaths related to COVID-19, and those deaths included within the proposed mathematical models were 17,452 for the optimistic model, 22,623 for the realistic model and 32,825 for the pessimistic model. Thus, it is concluded that social distancing measures promoted by the Brazilian public managers contributes to the reduction in approximately ten thousand deaths related to COVID-19 in the current pandemic scenario.

INTRODUÇÃO: O distanciamento social foi planejado como uma medida preventiva para controlar a disseminação extensiva da COVID-19. Nós analisamos as mortes relacionadas à COVID-19 no Brasil durante o período de medidas de distanciamento social. Os dados de mortalidade do COVID-19 foram obtidos no site da Worldometer (www.worldometer.info). As mortes foram estimadas até o 31º dia após a 5ª morte. O distanciamento social foi medido por meio dos relatórios de mobilidade comunitária COVID-19; Google (https://www.google.com/covid19/mobility/). As curvas epidêmicas brasileiras foram interligadas e os modelos matemáticos foram avaliados para se ajustarem às curvas de estimativa de mortalidade. O modelo otimista foi fundado no período de abertura da distância social e, portanto, na menor mobilidade (40-60%). O modelo realista foi calculado de acordo com medidas de distanciamento social relaxado (<40%) e o modelo pessimista foi calculado com base em R0 entre 2-3. Sob essa situação, o modelo matemático realista estimou 40.623 mortes em 9 de junho de 2020, enquanto o modelo pessimista antecipou 64.310 mortes e o modelo otimista projetou 31.384. Até hoje (24 de maio de 2020), um total de 22.965 foram relatadas, enquanto nosso modelo projetou 17.452 para o modelo otimista, 22.623 para o modelo realista e 32.825 para o modelo pessimista. Observamos movimento reduzido ao longo deste período. Em resumo, o modelo matemático sugere que a mobilidade reduzida da comunidade diminuiu o total estimado de mortes relacionadas à COVID-19 no Brasil. Enfatizamos que mais procedimentos metodológicos serão necessários para confirmar esta teoria

Introduction of OTC Monograph System in USA and Its Enlightenment to China / 中国药房

OBJECTIVE：To put forward some suggestions for the implementation of OTC monograph in China. METHODS ： Literature research was used to comprehensively review the concept ，emergence and development ，function of OTC monograph in USA；referring to experience in USA ，the necessity and feasibility of monograph system for OTC registration and evaluation in China were explored ，and some suggestions were put forward to the implementation of OTC monograph in China. RESULTS & CONCLUSIONS：OTC monograph in USA refers to the regulatory standards that should be followed when selling OTC products not included in new drug applications. The monograph originates from the re-evaluation project of the effectiveness of OTC drugs ， which plays a special role in accelerating the drug marketing and promoting product innovation. The OTC monograph system is necessary to help to optimize the OTC registration and evaluation ，but at present ，the conditions to establish and implement OTC monograph are not yet ripe in China. Based on the optimization of resource allocation and infrastructure construction ，national OTC drug management experience ，OTC monograph can play a full part in OTC registration and evaluation ，in terms of carrying out in-depth research ，taking pilot test ，improving risk management system and enhancing drug review resource allocation ability.

Review of new medical devices approvals by USFDA during the period of 2010 to 2014

Medical devices are health care products distinguished from drugs for regulatory purposes in most countries based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect. Developing new medical devices requires clinical investigations and approval process goes through similar process like drugs. Medical device approvals in the period of 2010 to 2014 were searched from USFDA website. Diseaseburden data in the similar period was searched from centers for disease control and prevention website. Collected data was analyzed to know number of approved devices, top therapy areas, and mechanism of action of these devices. Out of a total of 200 medical devices approvals in the time period of 2010 to 2014,maximum number of devices (51; 25.5%) were approved in the year 2011, cardiovascular (78; 39%) was the top therapy area. Highest number (180; 90%) of approved medical devices belonged to the category III and maximum number (73; 36.5%) of approved medical devices had ?mechanical? mechanism of action. The top 3 causes of deaths in USA during 2010 to 2014 were heart disease, cancer and followed by respiratory infection. There was a match between the topdiseases and the medical device approvals for top 2 diseases in USA i.e. heart disease, and cancer. With respect to respiratory infections and ailments which was the 3rd leading cause of death only one device was approved out of 200 approvals in total.

Research on the Management System of Medical Device Recognized Consensus Standards in USA / 中国医疗器械杂志

This paper gives a brief introduction on the development of recognized consensus standards, the recognition working procedure and the overview of medical devices recognized consensus standards in USA, and analyzes the experience of the recognition management system in USA, aiming at providing a reference for the improvement of the medical device standard management system in China.

Application of electronic medical record data in clinical decisions in the United States :inspirations for China / 中华医院管理杂志

With three typical applications of the US Veterans Administration as an example ,the paper introduced the use by the Administration EMR data in clinical decision. The author held that China should build a professional EM R data clinical decision system ,establish professional third-party clinical decision organs ,leverage EMR data sharing in building medical alliances ,and normalize policies and decrees ,for the purposes of better assistance to clinical workers and better healthcare for the people .

Complete genome sequence of community-associated methicillin-resistant staphylococcus aureus (strain USA400-0051), a prototype of the USA400 clone

Staphylococcus aureus subsp. aureus, commonly referred as S. aureus, is an important bacterial pathogen frequently involved in hospital- and community-acquired infections in humans, ranging from skin infections to more severe diseases such as pneumonia, bacteraemia, endocarditis, osteomyelitis, and disseminated infections. Here, we report the complete closed genome sequence of a community-acquired methicillin-resistant S. aureus strain, USA400-0051, which is a prototype of the USA400 clone.

Participation of the arcRACME protein in self-activation of the arc operon located in the arginine catabolism mobile element in pandemic clone USA300

ABSTRACT Staphylococcus aureus pandemic clone USA300 has, in addition to its constitutive arginine catabolism (arc) gene cluster, an arginine catabolism mobile element (ACME) carrying another such cluster, which gives this clone advantages in colonisation and infection. Gene arcR, which encodes an oxygen-sensitive transcriptional regulator, is inside ACME and downstream of the constitutive arc gene cluster, and this situation may have an impact on its activation. Different relative expression behaviours are proven here for arcRACME and the arcACME operon compared to the constitutive ones. We also show that the artificially expressed recombinant ArcRACME protein binds to the promoter region of the arcACME operon; this mechanism can be related to a positive feedback model, which may be responsible for increased anaerobic survival of the USA300 clone during infection-related processes.

Molecular characterization of methicillin-resistant Staphylococcus aureus isolated from blood in Rio de Janeiro displaying susceptibility profiles to non-ß-lactam antibiotics

Abstract The distinction between healthcare-associated MRSA (HA-MRSA) and community-associated MRSA (CA-MRSA) infections has become increasingly blurred. We assessed the molecular characterization and antimicrobial resistance profile for MRSA isolates from blood. Most of all (81.9%) isolates are related to known HA-MRSA and CA-MRSA epidemic lineages, such as, USA300, USA400, USA600, USA800 and USA1100. This is the first multicenter study in Rio de Janeiro.

Complete substitution of the Brazilian endemic clone by other methicillin-resistant Staphylococcus aureus lineages in two public hospitals in Rio de Janeiro, Brazil

Abstract Staphylococcus aureus is an important cause of bloodstream infections. Therefore, the main purpose of this work was to characterize a collection of 139 S. aureus isolates from bloodstream infections in two public hospitals in relation to their antimicrobial susceptibility profile, staphylococcal cassette chromosome mec types, and clonal relationship. Methicillin resistance and resistance to other 12 agents were accessed by the disk diffusion test. Minimum inhibitory concentration to mupirocin was also determined. The SCCmec types were accessed by multiplex PCR, and the clonal relationship was determined by pulsed field gel electrophoresis method and restriction modification system characterization. Besides, multilocus sequence typing was performed for representative methicillin-resistant S. aureus isolates. The military hospital showed a dissemination of the New York/Japan (USA100/ST5/CC5/SCCmecII) lineage associated to multidrug resistance, including mupirocin resistance, and the teaching hospital presented polyclonal and non-multidrug resistant MRSA isolates. Complete substitution of the Brazilian endemic clone by other lineages was found in both hospitals. These findings can highlight differences in policy control and prevention of infections used in the hospitals and a change in the epidemiological profile of MRSA in Brazilian hospitals, with the replacement of BEC, a previously well-established clone, by other lineages.

PCSK9 inhibitors in the current management of atherosclerosis / Los inhibidores de la PCSK9 en el manejo clínico actualizado de la aterosclerosis

Abstract: The history of proprotein convertase subtilisin/kexin type 9 (PCSK9) in medical science is fascinating and the evolution of knowledge of its function has resulted in new medications of major importance for the cardiovascular (CV) patient. PCSK9 functions as a negative control or feedback for the cell surface receptors for low-density lipoprotein including its component of cholesterol (LDL-C). The initial and key findings were that different abnormalities of PCSK9 can result in an increase or a decrease of LDL-C because of more or less suppression of cell surface receptors. These observations gave hints and awoke interest that it might be possible to prepare monoclonal antibodies to PCSK9 and decrease its activity, after which there should be more active LDL-C cell receptors. The rest is a fascinating story that currently has resulted in two PCSK9 inhibitors, alirocumab and evolocumab, which, on average, decrease LDL-C approximately 50%. Nevertheless, if there are no contraindications, statins remain the standard of prevention for the high-risk CV patient and this includes both secondary and primary prevention. The new inhibitors are for the patient that does not attain the desired target for LDL-C reduction while taking a maximum statin dose or who does not tolerate any statin dose whatsoever. Atherosclerosis can be considered a metabolic disease and the clinician needs to realize this and think more and more of CV prevention. These inhibitors can contribute to both the stabilization and regression of atherosclerotic plaques and thereby avoid or delay major adverse cardiac events. (United States)

Resumen: La historia de la proproteína convertasa subtilisin/kexin tipo 9 (PCSK9) es fascinante y la evolución del conocimiento de su función ha resultado en nuevos fármacos de gran importancia para el paciente cardiovascular. La PCSK9 funciona como un control negativo de receptores en la superficie de células para la lipoproteína de baja densidad con su componente de colesterol (LDL-C). El hallazgo inicial y clave fue que anormalidades diferentes de la PCSK9 resultan en un aumento o una disminución de la LDL-C, relacionados en una mayor o menor supresión de los receptores. Fueron estas observaciones las que proporcionaron evidencias indirectas a la idea de preparar anticuerpos monoclonales de la PCSK9 que pudieran disminuir su actividad y que esto se reflejara en receptores más activos para disminuir la LDL-C. El resto es una historia fascinante que ahora ofrece 2 inhibidores de la PCSK9, alirocumab y evolocumab, los cuales disminuyen la LDL-C en un 50%. Sin embargo, si no hay una contraindicación, las estatinas son el estándar de prevención para el paciente cardiovascular de alto riesgo e incluyen la prevención secundaria y primaria. Estos nuevos inhibidores están indicados en aquel paciente en el que no se obtiene el objetivo de tratamiento con la dosis máxima de una estatina o que no tolera ninguna de ellas. Debemos pensar en la aterosclerosis como una enfermedad metabólica y el clínico necesita darse cuenta de esta realidad y considerar las posibilidades disponibles para la prevención cardiovascular. Estos inhibidores pueden contribuir a la estabilización y regresión de placas ateroscleróticas y evitar episodios cardiovasculares mayores. (Estados Unidos)

Comparative Study and Enlightenment of the R&D Incentive Policies for Orphan Drugs in USA and the EU / 中国药房

OBJECTIVE:To provide references and suggestions for building and improving the R&D incentive policies for or-phan drugs in China. METHODS:The R&D incentive policies for orphan drugs in USA and the EU were compared in aspects of its legislative history,incentive measures and effects. And suggestions for improving related policies in China were put forward. RE-SULTS & CONCLUSIONS:The R&D incentive policies for orphan drugs in USA and the EU respectively started from Orphan Drug Act in USA(1983)and Orphan Drug Management Specification in the EU(1999),then formed relatively complete system by continuous improvement. The USA and the EU showed differences in its certification standard,procedure and specific incentives [R&D funding,tax deduction,fee reduction,additional incentives for micro and small and medium enterprises (SMEs),market exclusivity and special approval procedure],etc. In terms of fee reduction,for example,prescription application fee,production cost and drug confirmation fee were exempted in USA,while arrangement assist fee,initial and follow-up fee,checking fee before approval,initial listing type were reduced to a certain percentage in the EU. After developing incentive policies for orphan drugs, there is great increase in numbers of recognized qualifications and listing,SMEs have become new force in orphan drug R&D, R&D investment covers all types of diseases,orphan drug R&D are becoming the main direction of drug innovation and biotechnol-ogy development. China should determine the relevant legislation of R&D incentives for orphan drugs as soon as possible,set certi-fication and improve specific measures of R&D incentives for orphan drugs from multiple aspects,while strengthen the cooperation with other countries in qualification and R&D incentives.

Comparative Study on the Licensed Pharmacist System in China and the USA / 中国药房

OBJECTIVE:To compare the licensed pharmacist system in China and the USA,and to provide reference for im-proving pharmaceutical care and promoting public safety of drug use in China. METHODS:The relevant literatures in recent 10 years were retrieved from CJFD and Wanfang database. The differences of legal status,access qualification,legal obligations and responsibilities of licensed pharmacists in the USA and China were compared,and suggestions on improving the licensed pharma-cists system in China were put forward. RESULTS & CONCLUSIONS:At present,the problems of licensed pharmacist system in China are mainly that the legal status is not high,the access threshold is low,the legal obligations and responsibilities are not clear. However,the licensed pharmacist system in the USA has been developed for a century and formed a relatively strict legal sys-tem. Model State Pharmacy Act promulgated by National Association of Boards of Pharmacy in USA has clearly defined the access qualifications,legal obligations and responsibilities of licensed pharmacists. The pharmacy acts of the states were enacted on its blueprint. In view of current problems in China,it is necessary to learn from the above experience of the USA to improve the legal status,access qualification,legal obligations and responsibilities of licensed pharmacists and the quality of pharmaceutical care.

Informatization Construction of Disease Prevention and Control in the United States and Its Enlightenment to the People's Armed Police Forces / 医学信息学杂志

The paper sorts out the achievements in informatization construction of disease prevention and control in the United States,summarizes the construction features,and puts forward the objective,requirements,functions and contents of Informatization construction of disease prevention and control of People's Armed Police forces in China based on its current situations.

Reserch Progress of USA300 Clone of Community-Associated Methicillin-Resistant Staphylococcus Aureus / 现代检验医学杂志

Community associated methicillin-resistant Staphylococcus aureus is a human pathogen.It can cause a series of infections cause morbidity and mortality,including bacteremia,pneumonia and soft tissue infections.USA300 clone is highly toxic and contagious.Its prevalence in the United States continues to rise,and has begun to spread to the rest of the world.This article briefly reviews the recent research on relevant aspects of molecular epidemiological characteristics,grug resistance mechanisms and treatment of USA300 clone.

Practice of the Responsibility Development of Community Pharmacists in USA,UK,Australia and Its En-lightenment to China / 中国药房

OBJECTIVE:To provide reference for the development of community pharmacists in China. METHODS:Accord-ing to reviewing the practice in the responsibility development of community pharmacists in USA,UK,Australia,relevant experi-ence was summarized and relevant suggestions were put forward. RESULTS & CONCLUSIONS:Responsibility development of community pharmacists in USA,UK,Australia had made great progress,and their levels of practice and their own quality also made continuously improvement. Besides,they made certain achievements in prevention of chronic disease,minor illness manage-ment in community pharmacy,drug use review and prescription drug intervention,and health mission pharmacy,etc. In China, our government should promote the transforming of the responsibility of community pharmacists by considering the differences of re-gions in stage and step by step,encourage pharmacists actively and orderly expand the business scope,actively explore from sys-tem and develop multiple authentication,and steadily improve the service skills of pharmacists. Meanwhile,domestic pharmacies and pharmacists should take the initiative to change the concept to get ready for the coming changes.