Managing seen and unseen blood associated with drug injecting: implications for theorising harm reduction for viral risk

This paper addresses blood management in injecting drug use through a thematic analysis of 59 qualitative interviews about HCV and HIV. Blood management is rarely considered in the drug policy literature, particularly from the perspective of people who inject drugs and in connection with social theory. The analysis draws on the risk governance literature, in particular the idea of altruistic conduct and utopian visions of perfect risk management. Interviewees made a distinction concerning seen and unseen bleeding in injection situations. Bleeding was either ordinary or exceptional, but in either case open to direct surveillance. Unseen blood in injecting settings was a new and anxiety-provoking idea, partly because it undermined blood management. A related concern of blood management is containing blood through competent drug injection. Cleanliness also figured in blood management in terms of cleaning the self and injection settings and injecting with clean people. Implications for harm reduction include the need to address awareness of the possible presence of unseen blood in injecting settings without undermining security or furthering a sense of fallibility on the part of injecting drug users in blood management practice.     

规范药品调配,打牢风险防范基础

目的:正确认识药品调配工作特点,探讨促进安全用药措施。方法:借助文献归纳并结合作者的工作实践,分析药品调配过程中的风险应对措施。结果:减少或规避用药错误,药品调剂、配制、使用等环节的规范化管理是基础;提升药学人员专业素养,切实发挥审核把关与干预作用是关键;加强工作质量的持续完善与改进是重点;而信息化、自动化的药房建设使风险防范更有效。结论:基本配置应与规范管理更适宜,强化业务培训、实施ME报告鼓励制度、信息化自动化建设有助于药品调配工作发展。     

国家药品抽检药品质量风险排查处置机制分析与探讨

药品抽检是中国以及欧美等发达国家和地区重要的药品监管手段之一。我国药品监管部门颁布了一系列政策,建立了药品质量风险排查处置机制,对探索性研究中发现严重药品质量风险进行控制,取得了良好的成效。通过对国家药品抽检探索性研究概况、药品质量风险排查处置机制基本情况、政策法规、发挥的作用等方面的介绍,对国家药品抽检药品质量风险排查处置机制进行分析与探讨,建议在今后的工作中进一步提高探索性研究的科学性,加强探索性研究方法的转化,提高现场检查的针对性,提高该机制的法律效力。     

Multiple routes of drug administration and HIV risk among injecting drug users

This study assesses relationships between drug administration routes and HIV serostatus, drug use, and sexual behaviors among current injecting drug users (IDUs) in Tallinn, Estonia. We recruited 350 IDUs for a cross-sectional risk behavior survey. Adjusted odds ratios (AORs) were calculated to explore injection risk behavior, sexual behavior, and HIV serostatus associated with multiple route use. Focus groups explored reasons why injectors might use non-injecting routes of administration. Those reporting multiple drug administration routes were less likely to be HIV seropositive (AOR = 0.49, 95% confidence interval [CI] = 0.25-0.97) and had almost twice the odds of having more than one sexual partner (AOR = 1.90, 95% CI = 1.01-3.60) and of reporting having sexually transmitted diseases (AOR = 2.38, 95% CI = 1.02-5.59). IDUs who engage in noninjecting drug use may be reducing their risk of acquiring HIV though sharing injection equipment, but if infected may be a critical group for sexual transmission of HIV to people who do not inject drugs.     

中国药品不良反应成因分析及预防措施

目的:探讨和分析我国药品不良反应发生的各种因素,为减少和避免药品不良反应的发生提供参考。方 法:分析2006年我国严重药品不良反应数据并辅以相关文献,对8 128例严重病例从涉及的药品、不良反应临床表现等方 面进行回顾性分析,并对我国药品不良反应的成因进行分析归纳。结果:2006年我国严重药品不良反应报告涉及的药品 以抗微生物药物为多,不良反应累及的系统-器官以全身性损害为多。药品不良反应的成因复杂,与药物因素、机体因 素、不合理用药等相关。结论:应加强药品研究、生产、流通、使用、监管等各环节工作,预防和减少药品不良反应的 发生。     

中国药品不良反应成因分析及预防措施

目的:探讨和分析我国药品不良反应发生的各种因素，为减少和避免药品不良反应的发生提供参考。方 法:分析2006年我国严重药品不良反应数据并辅以相关文献，对8 128例严重病例从涉及的药品、不良反应临床表现等方 面进行回顾性分析，并对我国药品不良反应的成因进行分析归纳。结果:2006年我国严重药品不良反应报告涉及的药品 以抗微生物药物为多，不良反应累及的系统-器官以全身性损害为多。药品不良反应的成因复杂，与药物因素、机体因 素、不合理用药等相关。结论:应加强药品研究、生产、流通、使用、监管等各环节工作，预防和减少药品不良反应的 发生。     

中国药品不良反应成因分析及预防措施

目的:探讨和分析我国药品不良反应发生的各种因素，为减少和避免药品不良反应的发生提供参考。方 法:分析2006年我国严重药品不良反应数据并辅以相关文献，对8 128例严重病例从涉及的药品、不良反应临床表现等方 面进行回顾性分析，并对我国药品不良反应的成因进行分析归纳。结果:2006年我国严重药品不良反应报告涉及的药品 以抗微生物药物为多，不良反应累及的系统-器官以全身性损害为多。药品不良反应的成因复杂，与药物因素、机体因 素、不合理用药等相关。结论:应加强药品研究、生产、流通、使用、监管等各环节工作，预防和减少药品不良反应的 发生。     

中国药品不良反应成因分析及预防措施

目的:探讨和分析我国药品不良反应发生的各种因素，为减少和避免药品不良反应的发生提供参考。方 法:分析2006年我国严重药品不良反应数据并辅以相关文献，对8 128例严重病例从涉及的药品、不良反应临床表现等方 面进行回顾性分析，并对我国药品不良反应的成因进行分析归纳。结果:2006年我国严重药品不良反应报告涉及的药品 以抗微生物药物为多，不良反应累及的系统-器官以全身性损害为多。药品不良反应的成因复杂，与药物因素、机体因 素、不合理用药等相关。结论:应加强药品研究、生产、流通、使用、监管等各环节工作，预防和减少药品不良反应的 发生。     

Alcohol and other drug prevention for older adolescents: It's a no brainer

Older adolescence represents a critical period of brain development whereby the prefrontal cortex, responsible for higher level thinking and emotional regulation, is under construction. During this period, the brain is wired to underestimate risk and overestimate pleasure, which primes young people towards risky, pleasure‐oriented experiences. Substance use during this time can hinder brain maturation and lead to development related disorders. However, young people are the most likely to drink at risky quantities, use cannabis, MDMA and cocaine in the previous 12 months than any other age group. Despite this, there are no validated, age‐appropriate prevention programs targeting school leavers, which leaves a group of young people to navigate a landscape where drug use is the most common, without formal support. Drug and alcohol prevention programs should be developed for this age group that combine features of universal prevention programs and targeted intervention programs to support the wider range of drug use behaviours relevant to this older audience. This article outlines potential evidence‐based strategies that programs could focus on in the future.     

儿童用药风险因素分析及应对体系探析——基于患儿家长的调查研究

目的：为完善儿童用药风险防范体系提供建设性意见。方法：结合文献研究法和实践调研法。围绕患儿就医整个流程和终端用药环节中存在的问题开展针对患儿家长的调研，并结合文献研究回溯各风险主体的风险因素及其产生的原因。结果：各主体风险因素产生的原因主要有儿科高素质人才匮乏，药师技术水平较低，难以满足需求；医生、药师、患者三方之间缺乏有效的沟通交流机制，院内院间信息系统不完善；药师的权、责、利、地位不明确，儿童用药监管制度不完善等。结论：儿童用药风险因素具有相通性，风险防范需要各风险主体的共同努力。最终从人、制度、信息三个方面来优化儿童用药风险防范体系。     

医院药品风险管理情况分析及防范措施

目的 分析医院药品的风险管理情况.方法 对北京世纪坛医院2010年1月至2012年12月药品采购、入库验收、药品调剂、药品保管及使用过程药品质量问题进行统计分析.结果 2010年1月至2012年12月入库验收存在问题47种[2010年12种,检验报告0种（0.0％）、药品外观6种（50.0％）、标签1种（8.3％）、5种（41.7％）;2011年21种,检验报告2种（9.5％）、药品外观4种（19.0％）、标签2种（9.5％）、发票信息9种（61.7％）;2012年14种,检验报告1种（7.1％）、药品外观7种（50.0％）、标签0种（0.0％）、发票信息6种（42.9％）],调剂和临床使用中药剂出现问题49种（2010年15种、201 1年12种、2012年22种）,召回药品11种（2010年3种、2011年4种、2011年4种）.结论 医院存在不同程度的药品管理风险,需要加强防范措施.     

细节管理与风险防范式护理在儿科护理中的应用与效果比较

目的 探讨和比较细节管理和风险防范式护理在儿科护理管理中的应用效果.方法 选取本院2013年6月至2015年6月收治的患儿440例,进行随机分组,分别为对照组(n=110)和观察组(n=330),其中观察组又分为A、B、C三组,分别为风险防范式护理组(n=110)、细节管理组(n=110)、细节管理加风险防范护理组(n=110).对照组给予常规护理,观察组给予相应的风险防范式护理或细节管理或细节管理加风险防范式护理干预.观察各组患儿的护理情况、家属满意度情况等,并进行对比.结果 通过采用不同的护理方式,对照组、A组、B组、C组并发症发生率分别为:18.31％、5.26％、5.51％、1.95％,客户评分护理非常不满意率分别为8.51％、4.34％、4.17％、1.68％, A、B、C三组与对照组相比差异均有统计意义(P＜ 0.05),C组与A、B组相比差异也有显著意义(P＜0.05).各个观察组护理质量明显优于对照组,并发症较少,家长满意度高,结论 在儿科护理中,细节管理和风险防范式护理均能显著提高儿科护理质量,降低风险事件发生率,提高患者满意度,且细节管理联合风险防范式护理的护理模式要优于单独的细节管理和风险防范式护理.     

Human carcinogenic risk evaluation, Part III: Assessing cancer hazard and risk in human drug development.

Assessing cancer risk for human pharmaceuticals is important because drugs are taken at pharmacologically active doses and often on a chronic basis. Epidemiologic studies on patient populations have limited value because of the long latency period for most cancers and because these studies lack sensitivity. The Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration relies on short-term surrogate assays (genetic toxicology studies) to assess risk to patients involved in clinical trials and on rodent carcinogenicity studies to assess cancer risk for drug approval. Unlike some other agencies that typically perform quantitative risk assessments on chemical pollutants or pesticide products, CDER does not perform such quantitative extrapolations. Rather, the evaluation of risk is the result of an integrated assessment of what is known about the drug, and risk is considered in the context of the clinical benefit. Mode of action of carcinogenesis and thresholds for effects are important considerations. The results of carcinogenicity studies of approved products are published in the drug labeling and individual clinicians balance risk and benefit in making prescribing decisions.     

青光眼患者用药风险防范与干预策略研究

目的建立青光眼患者用药风险防范计划与干预策略,保障患者用药安全。方法归纳我院药品说明书中禁忌项内明确注明青光眼患者禁用的药品。通过统计2014年门诊青光眼患者用药处方数据库,发现多个科室医生为青光眼患者处方不适宜的药物。为患者编写教育材料及开展面对面患者教育,为医生和药师分别编写了青光眼患者禁忌药品的品种,分别对医生、药师和患者进行问卷调查与用药教育。完善医院信息系统,增加对青光眼用药的提示信息。结果医生为16.2%的青光眼患者使用了不适宜的药物。88%的医生在处方前会询问患者青光眼病史,78%的医生了解青光眼禁忌药物的品种,98%的医生希望借助医院信息系统提示;29%的药师在审核处方时会询问青光眼患者病史,80%的药师了解青光眼禁忌药物的品种,51%的药师会主动告知患者使用禁忌用药的风险;30%的患者会主动告知医生青光眼病史,11%的患者了解青光眼禁忌用药的品种,72%的患者坚持青光眼药物治疗。结论无论是医生、药师还是青光眼患者,对青光眼患者禁忌用药品种的认知水平不高,制定青光眼患者用药风险防范计划与干预策略,具有必要性和有效性。     

Getting the mix right: family, community and social policy interventions to improve outcomes for young people at risk of substance misuse

Societal responses to the existence of substance misuse fluctuate between harm minimisation and prohibition. Both approaches are predominantly downstream reactions to substance misuse that focus on the supply of harmful substances and the containment of misuse through treatment, rehabilitation or punishment. Until recently, little attention has been paid to the upstream individual, family, relationship, community or societal antecedents of substance misuse (which often overlap with those for other adverse life outcomes, such as unemployment, antisocial personality disorder and mental health problems) that have operated during earlier life. A growing body of evidence highlights the overlapping biological and experiential antecedents for substance abuse and other poor outcomes as well as the trajectory-changing protective factors that can prevent risks being translated into destiny. Risk minimisation and protection enhancement embedded in family and social systems are the essential building blocks of a set of early intervention strategies that begin antenatally and continue through the developing years of childhood, adolescence and young adult life, that have been shown to be effective in improving many outcomes in development, health and well-being. Much remains to be done to enable the promise of effective universal and targeted early intervention to be translated into policies, programs and practices that could be life-changing for citizens bogged in the mire of substance misuse and their children. Realistic, timely investment, influenced by the best scientific evidence indicating what works, for whom, under what circumstances, an increased degree of collaboration within and between governments and their agencies to enable "whole of government" responses in partnership with community-based initiatives are essential along with investments in multidisciplinary program evaluation research that will enable evidence-informed policy decisions to be tailored to the needs of individual countries.     

Alcohol and young people: minimizing the harm

In this paper the literature on patterns of use of alcohol by teenagers is reviewed. The model as proposed by Thorley is used to describe the specific nature of alcohol problems experienced by young people. A systemic approach to prevention is explored and recommendations are made about ways to minimise the harm associated with alcohol use by young people.     

A review of drug prevention system development in Romania and its impact on youth drug consumption trends, 1995–2005

Issues. A tremendous growth occurred in the reported drug use and abuse in Romania from 1995 to 1999. Lack of concern by government and little policy attention contributed to the surprising delay of drug policy and drug prevention system development. General public stigmatize drug users and drug consumption is considered a matter of personal fault and responsibility. There is some but not sufficient research and evaluation on drug use, abuse problem. Approach. Drug use, abuse and prevention are discussed from research‐based, user‐focused and prevention system development perspectives. Prevalence and trends of drug use, abuse in the past decade (1995–2005) are summarized. Prevention issues are discussed based on research data from adolescents, parents and teachers. The Romanian primary drug prevention system has been evaluated based on our experiences in drug use prevention activities carried out in schools and recreational environments. Key Findings. Public and scientific perspectives on drug consumption in Romania, between 1995 and 1999, were dominated by an idealistic, non‐realistic perception. Since 1995, drug use among adolescents increased almost four times in less than 4 years. The first law against drug traffic and consumption was issued only in 2000. Now primary drug prevention strategies are in action, but in general they are lacking standard evaluation procedures. Implications/Conclusion. Conclusions are drafted for new perspectives in prevention activities. More long‐term, user‐focused, demand‐centred prevention activities should be carried out in more and more diversified settings and evaluation should be thoroughly considered.[Dégi CL. A review of drug prevention system development in Romania and its impact on youth drug consumption trends, 1995–2005. Drug Alcohol Rev 2009;28:419–425]     

药品经营质量风险防范的探讨

目的:引起我国药品经营企业对质量风险防范的重视,为有效防范各类药品质量风险提供建议。方法:运用质量风险管理的基本理论并结合我国药品经营的现状进行分析。结果与结论:药品经营的质量风险有多种形成因素,应从设立质量风险管理制度、强化风险管理责任和主动抑制风险传递等方面来进行防范。     

The creation of evidence in 'evidence-based' drug prevention: a critique of the Strengthening Families Program Plus Life Skills Training evaluation

School-based curricula have become a mainstay of drug prevention policy in the United States and are increasing in popularity in other parts of the world. The promotion and dissemination of these interventions has been driven in large part by the creation of lists of programmes which, it is claimed, are grounded in scientific evidence demonstrating their effectiveness. Recently concerns have been raised about the data analysis and presentation practices used in evaluations of a number of programmes that appear on these lists. Here we examine a series of papers from an evaluation of an intervention that combined the Strengthening Families Program 10 - 14 and Life Skills Training Program, each of which is among the most widely advocated universal drug prevention programmes. The data analysis and presentation practices employed in the evaluation of this combined programme include one-tailed significance testing, alpha levels of 0.10, changes in outcome variables across publications and use of the post-test data as the baseline when assessing change over time. Taken together, these practices severely limit the claims that can be made about the results presented in the evaluation. Specifically, we believe that far from supporting the evaluators' claims concerning the rigour of the findings and their generalisability and public health significance, the results are very fragile, of little practical significance and quite possibly analysis-dependent. [Gorman DM, Conde E, Huber JC Jr. The creation of evidence in 'evidence-based' drug prevention: a critique of the Strengthening Families Program Plus Life Skills Training evaluation. Drug Alcohol Rev 2007;26:585 - 593]