Arrêt de la valorisation humanitaire des médicaments non utilisés : enjeux et perspectives

Since the 1970s, drugs unused by French households have been collected for humanitarian aid. In 1993, the Cyclamed^® system was created by pharmacists in order to manage and collect unused drugs. However, experience has shown that in developing countries unused drugs caused more problems than they solved, including: poorly adapted to the needs of the population, poor quality of the collected medicines, interferences with local pharmaceutical policies, misappropriation… As recommended by the World Health Organisation, most of the humanitarian organizations stopped unused drug donations. In France this practice has been forbidden since the 1st of January 2009. Associations that still desire to send unused drugs to developing countries must develop other approaches, such as essential generic medicines or emergency health kits.     

Pourquoi des recommandations de vaccination généralisée contre le méningocoque C en France ?

In 2009, the French authorities have recommended the immunization against meningococcus C (MenC) of all infants between 1 and 2 years of age with a catch-up in children, adolescents and adults up to 24 years of age. The rationale of this decision relies on four major considerations: (1) after a peak in 2002, the incidence of invasive MenC disease remains stable at 0.3/100,000 in France and is henceforth, among the highest in Europe; (2) the recent evolution of circulating MenC strains shows the implantation of an hypervirulent strain C:2a:P1.7,1 belonging to the clonal complex E15/ST11; (3) meningococcal C conjugate vaccines are available and have demonstrated a good immunogenicity and tolerance in infants, children and adults; (4) some European countries have successfully experienced the implementation of universal MenC immunization targeting infants with an extensive catch-up program covering children and young adults. The choice of the strategy have been oriented by the results of a medico-economical study with modelisation and targets the infant between 1 and 2 years of age with transient extension to children, adolescents and adults up to 24 years of age. The success of such strategy is tightly linked to the ability to obtain rapidly high vaccination coverage levels in the whole target.     

Interactions entre les cyclodextrines et les triglycérides : de la stabilisation des émulsions à l’obtention d’un nouveau système galénique appelé « billes »

Natural cyclodextrins are cyclic oligosaccharides which can be modified to obtain more water soluble or insoluble derivatives. The main interest of cyclodextrins results from their ability to form an inclusion complex with hydrophobic molecules. Inclusion constitutes a true molecular encapsulation. This property is employed in pharmaceutical industry to facilitate the formulation of poorly water soluble and/or fragile drugs. A more recent application of cyclodextrins consists in their use in the preparation of dispersed systems such as micro- and nanoparticles or even liposomes. When incorporated in dispersed systems, cyclodextrin can enhance drug solubility, drug stability and drug loading. Interestingly, cyclodextrins themselves can also be employed to form or stabilise dispersed systems (material or emulsifying agent). For example, the interactions between cyclodextrins with components of the vegetable oils (more especially with triglycerides) allow to stabilise simple or multiple emulsions but also to form particles called “beads”. Very rich in oil, this novel lipid carrier presents an important potential for the encapsulation of highly lipophilic compounds and their delivery by topical and oral routes. These two applications are more particularly developed in the present paper.     

Caractéristiques des infections respiratoires basses chez les sujets âgés

Pneumonia is more frequent among the elderly and is associated with higher rates of hospitalization and death. The diagnosis of pneumonia in the elderly is a clinical challenge because of its non-typical symptoms and because of a poor diagnostic yield of microbiological analysis. Ageing is associated with specific pathogenesis, modifications in lung performance and modifications in oropharyngeal flora. The management relies on empirical therapy, which takes into account the severity of the infectious episode, the presence of additional risk factors, co-morbidities and institutionalization.     

2007年至2011年医务人员洗手效果的监测分析及对策

目的观察医护工作者洗手效果,以利于针对性的监测医务人员的手卫生。方法观察我院医务人员在2007年1月至2011年12月手卫生的情况。结果在这5年,共有1457人次医护人员监测手卫生,其合格率为91.4%。临床医师的手卫生监测合格率为89.3%,护士的手卫生监测合格率为98.2%。在Ⅱ类环境中,医护人员的手卫生监测合格率为96.5%,在Ⅲ类环境中,医护人员手卫生合格率为91.4%。医护人员手卫生监测合格率为91.9%;实习生与进修医护人员手卫生监测合格率为80.7%。结论落实各级规章制度,增强医护人员的手卫生的意识,提高洗手卫生设备的质量,从而可减少院内感染的发生。     

品管圈在提高CCU医护人员手卫生依从性中的应用

目的探讨品质管理对提高CCU医护人员手卫生依从性中的应用。方法在开展品管护理活动前组织理论知识的学习,对CCU医护人员手卫生的现状进行调查,分析CCU医护人员手卫生依从性差的原因,采取有效措施进行持续质量改进。结果品管圈活动的开展使CCU医护人员的洗手率得到显著提高。结论品管圈活动有效提高了CCU医护人员的手卫生依从性,不仅保护了自身的健康,也大大降低了CCU医院感染的发生率。     

Handiness and acceptability of the new Abak bottle in chronically treated patients. A cross-sectional, retrospective and multicentre study

Background

Difficulty of use of eyedrops is a factor associated with poor patient compliance that reduces treatment efficacy. The aim of this study was to evaluate the handiness and global acceptability of the new Abak^® timolol bottle (multidose preservative-free eyedrops) in comparison with that of other administration systems (classical multidose eyedrops or single-doses) in patients treated for glaucoma or ocular hypertension.

Methods

Cross-sectional, retrospective and multicentre study involving 41 ophthalmologists in France. Selected patients were those who had been treated with the new Abak^® bottle since at least two months, as a replacement for other beta-blocker eyedrops. Handiness and acceptability of the new Abak^® bottle in comparison with other delivery systems were evaluated using a questionnaire filled by the investigator.

Results

Almost all the patients were unanimous regarding the handiness of the new Abak^® bottle: easy to open for 96.5% of them, easy to handle for 96.0%, and easy to get drops for 91.1%. For all these criteria and in a general manner, patients preferred the new Abak^® bottle in comparison with the previous eyedrop container. These results were confirmed in the oldest patients.

Conclusion

The new Abak^® bottle had a greater acceptability compared to preserved multidose eyedrops or to single-doses. Its handiness and the absence of preservative which may improve local tolerance are in favor of a greater compliance in chronically treated patients.     

Réévaluation de la colistine

Colistin (polymyxin E) designates two different drugs, colistin sulfate, an oral digestive decontaminant, and colismethate sodium (CMS) intended for intravenous, intrathecal/intraventricular, or inhaled therapy. Colistin interferes with bacterial membranes creating cytoplasmic leaks lethal to bacteria through interactions with membrane proteins and phospholipids (including LPS). This mechanism of action confers bactericidal activity to colistin on frequently multiresistant pathogens such as Acinetobacter spp., P. aeruginosa, and Klebsiella spp. It also leads to specific resistance mechanisms, which arise from modifications in bacterial membrane proteins. New methods applied to pharmacokinetic studies of colistin take into account the in-solution and plasmatic hydrolysis of CMS, the inactive prodrug, into active compounds among which colistin. These studies show that current therapeutic regimens may be optimized. Colistin being a concentration dependent bactericidal antibiotic, the area under the curve (AUC)/MIC was proven the best PK/PD parameter associated with in vivo efficacy, opening new perspectives in alternate dosing regimens. Nephrotoxicity occurs at a rate comparable to aminoglycosides and neurotoxicity is more often benign; both being reversible upon discontinuation of therapy. In multiresistant Gram negative, mostly A. baumanii or P. aeruginosa, nosocomial infections as well as in chronic P. aeruginosa infections and exacerbations in cystic fibrosis patients, the efficacy of colistin has been demonstrated within the limitations inherent to studies of an antibiotic which can only be used after determination of susceptibility in severe infections nonetheless requiring urgent adequate therapy. Further clarifications are required concerning the added benefit of combination with antibiotics considered as synergistic such as rifampicin and carbapenems.     

Vaccination antigrippe A (H1N1) : analyse rétrospective 2009

The occurrence of the influenza A (H1N1) pandemic was the opportunity to set an appropriate vaccination campaign, effective and well tolerated within the shortest period of time. Thanks to a strong experience in the development of seasonal influenza vaccines and recent experimental knowledge on potential vaccines against H5N1 strain, pharmaceutical companies developed a new vaccine suited for the pandemic A H1N1 California July 2009 strain. This vaccine was produced with and without adjuvant, taking into account safety controls and evolution of scientific knowledge. Nevertheless, this campaign got a poor reception from the general and medical population due to the concomitant spread of the pandemics, an insufficient communication program, organization that was felt as unsuited, too complex and not well understood. Despite that, effectiveness and tolerance of the vaccination campaign have been observed with may be a positive effect on the epidemic.     

Recommandations de bon usage des carbapénèmes

Carbapenems are being increasingly used because of the widespread dissemination of antibiotic resistance among Gram-negative bacilli, especially of extended-spectrum beta-lactamases; this increasing use raises the concern of loss of activity for this antimicrobial class following the emergence of carbapenemases. The current guideline from the Anti-infective drugs Committee of the Assistance publique-Hôpitaux de Paris (AP–HP) group emphasizes the careful and limited use of carbapenems, comparing the respective characteristics of the four available molecules, and specifies their indications in clinical hospital practice, with possible alternatives.     

What's wrong with the National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM(2.5))?

Associations between airborne concentrations of fine particulate matter (PM(2.5)) and mortality rates have been investigated primarily by ecologic or semiecologic epidemiology studies. Many investigators and regulatory agencies have inferred that the weak, positive association often observed is causal, that it applies to all forms of airborne PM(2.5), and that current ambient levels of PM(2.5) require reduction. Before implementing stringent regulations of ambient PM(2.5), analysts should pause to consider whether the accumulated evidence is sufficient, and sufficiently detailed, to support the PM(2.5) National Ambient Air Quality Standard. We take two tacks. First, we analyze the toxicologic evidence, finding it inconsistent with the notion that current ambient concentrations of all forms of fine particulate matter should affect pulmonary, cardiac, or all-cause mortality rates. More generally, we note that the thousands of forms of PM(2.5) are remarkably diverse, yet the PM(2.5) NAAQS presumes them to be identical toxicologically, and presumes that reducing ambient concentrations of any form of PM(2.5) will improve public health. Second, we examine the epidemiologic evidence in light of two related examples of semiecologic associations, examples that both inform the PM-mortality association and have been called into question by individual-level data. Taken together, the toxicologic evidence and lessons learned from analogous epidemiologic associations should encourage further investigation of the association between particulate matter and mortality rates before additional regulation is implemented, and certainly before the association is characterized as causal and applicable to all PM(2.5).     

皮肤病专科门诊护士手卫生依从性的现状及影响因素

目的 调查皮肤病专科门诊护士手卫生依从性现状,分析手卫生依从性的影响因素,提升门诊护士手卫生依从性.方法 采用问卷调查和观察记录法,调查72名门诊护士的手卫生执行情况.结果 门诊护士对手卫生知识知晓率为76.4％,手卫生方法知晓率为72.2％,手卫生依从性为65.8％;手卫生依从性的影响因素按照构成比排列依次有:工作繁忙,没有足够时间洗手(53.8％);担心患者抱怨(15.1％);洗手设施设计不合理(10.9％);认为皂液及手消毒剂会损害皮肤(10.1％);不良个人卫生习惯(10.1％)等.结论 手卫生依从性达不到国内水平,应从原因着手,合理调配医护人员工作时间,加强护士手卫生知识的培训,规范手卫生管理制度,进一步提高手卫生知识知晓和依从性水平.     

GLP实验室质量保证人员工作实践的体会与思考

GLP实验室的质量保证(QA)人员对非临床研究工作质量进行监督检查,确保GLP实验室的设施、仪器设备、人员、方法、操作、记录和对照品符合GLP要求,进而起到提高质量、确保安全和讲究效率的作用。文中总结归纳了我国GLP环境下QA人员该如何认清形势,转变观念,明确职责,提升自我,严格检查,保证质量,坚持原则,灵活把握,开展对专题研究和整体设施的核查,保证药物安全性评价的质量,以共同提高QA的核查水平,确保人民用药安全。     

多途径手卫生监测对提高医务人员手卫生依从性的影响

目的 探讨多途径手卫生监测对医务人员手卫生依从性的影响.方法 医院感染管理专职人员通过微生物培养监测法、直接观察法、手卫生用品监测、手卫生质量考核等方法对全院医务人员手卫生依从性进行监测,获得监测数据向临床反馈,同时配合创建院内手卫生文化宣传氛围、手卫生专题培训等方法促进医务人员手卫生依从性的提高.对干预措施实施前后医务人员手卫生合格率、依从率、速干手消毒液消耗量及医院例次感染率的变化进行比较分析.结果 医务人员手卫生合格率提高了39.28％;手卫生依从率医生由22.92％上升到47.73％,护士由47.22％上升到57.38％,医护总体依从率由37.50％上升到53.33％;全院速干手消毒液消耗总量较去年明显增加,每月每床消耗量呈稳中有升;医院例次感染率环比下降了21.83％,同比增加了1.5％.结论 多途径手卫生监测有助于医务人员手卫生依从性提高,手卫生文化氛围的创建、专题培训对医务人员手卫生依从性有协同促进作用,医务人员手卫生意识需要不断强化,手卫生促进工作应作为医院感染管理部门的一项基础工作.     

Ocular toxicity of benzalkonium

In order to meet the requirements of the pharmacopeia, ophthalmic preparations have to be manufactured in conditions that can secure their sterility before use and can prevent the development of micro-organisms after opening of the vial. The addition of an appropriate preservative is a way to meet this requirement. However, in addition to their lack of efficacy in certain conditions, they can be problematic in terms of formulation, stability and interaction with the packagings. Furthermore, their daily and repeated use in chronic pathologies such as glaucoma, dry eye or allergy has revealed their nuisance. Moreover, the recognition of certain parameters such as life quality and therapeutic observance has strengthened the proofs that have already been clinically shown. The review of the experimental and clinical data already published about the toxicity of the preservatives shows that almost every ocular structure is affected to various extents. From the first assumption data to preclinical and clinical proofs, this article highlights the evolution of the understanding process towards the toxic role of preservatives.     

Prise en charge des méningites postopératoires

Postoperative meningitis are rare but severe complications of neurosurgery. Their incidence varies from 0.3 to 1.5% after craniotomy. Aseptic meningitis are twice as more frequent than bacterial meningitis and have a constantly favorable outcome without antibiotic treatment. Physiopathology of aseptic meningitis remains debated between a bacterial origin with a low inoculum or a local inflammatory reaction to blood breakdown products, sutures, tissue breakdown products, etc. Clinical presentation and characteristics of cerebrospinal fluid (CSF) are similar between the two entities. Only negative CSF direct examination and CSF culture in the absence of antibiotic exposure previous to lumbar puncture allows the diagnostic of septic meningitis. There now is a consensus to systematically treat with antibiotics according to local ecology any patient with symptoms suggestive of postoperative meningitis with a CSF yielding more than 100 leukocytes/mm³. Antibiotic should be stop after 72 hours if CSF cultures remain sterile; if culture is positive, empirical treatment should be adapted accordingly. The efficiency of this approach was demonstrated in a prospective study and allowed a significant reduction in the duration of antibiotic treatment in patients with postoperative meningitis with a favorable clinical outcome.     

探讨有效实施手卫生执行状况的调查干预

目的：通过了解临床医护人员手卫生知识掌握情况和手卫生执行状况,分析影响医护人员手卫生依从性的因素,预防院内交叉感染。方法通过问卷调查、现场观察等方式,对随机抽取的临床注册护士予以考查,考查的人数为100名临床一线护士,做好结果记录并进行统计分析。结果临床护士对肉眼看不见的细菌污染洗手执行差,各科临床护士之间洗手合格率有明显差异,细菌监测外科洗手合格率最高,急诊最低,且自评洗手合格率明显高于实际洗手合格率。结论临床护士对手卫生依从性认识不到位,并存在不规范洗手的状况,主要原因是因为洗手设施不完善,未养成良好的洗手习惯,管理人员监管不到位等,因而采取多模式干预措施提高临床护士的洗手依从性,改善手卫生状况,预防医院交叉感染。     

思维导图引导时间位点管理对医院门诊服务质量的影响

目的　研究思维导图引导时间位点管理对医院门诊服务质量的影响。方法　回顾性分析广州市第十二人民医院2020年6月至2022年6月收治的380例门诊患者临床资料，依照有无实施思维导图引导时间位点管理将其分为实施前组［男104例，女86例，年龄（57.85±6.02）岁］和实施后组［男101例，女89例，年龄（58.13±5.63）岁］，评价和比较实施思维导图引导时间点管理前后门诊服务质量、院内感染控制指标，患者满意度。计量资料采用独立样本t检验，计数资料采用χ²检验。结果　实施后组门诊就诊环境评分（96.51±7.33）分、门诊响应评分（96.35±2.14）分、患者秩序评分（97.28±4.22）分、满意度［97.89%（186/190）］，均高于实施前组，差异均有统计学意义（均P<0.05）。实施后医护人员抽检院内手卫生达标率［97.92%（47/48）］、器械消毒达标率［97.92%（47/48）］、环境卫生达标率［95.83%（46/48）］均高于实施前，差异均有统计学意义（均P<0.05）。结论　经过针对化、综合化的思维导图引导时间位点管理后，门诊患者服务质量明显提升，院内卫生情况显著改善，值得推广应用。