国家基本药物制度对中西部基层医疗机构合理用药的影响

??????? 目的 探讨国家基本药物制度的实施对中西部农村基层医疗机构合理用药产生的影响。方法 对中西部3省市6区县15家基层医疗机构进行处方抽样,用统计学方法分析抽取的2 630张处方,比较国家基本药物制度实施前后次均处方金额、处方药品品种数量均数以及使用抗生素、激素、注射剂处方的比例等指标的差异。结果 国家基本药物制度实施后,次均处方金额、处方药品品种数量均数、使用激素处方比例以及使用注射剂处方比例等指标均出现不同程度的下降,但使用抗生素处方比例未出现明显下降,甚至有所上升。结论 国家基本药物制度的实施能有效降低门诊处方费用,能有效促进基层医疗机构的合理用药,但促进作用具有一定的局限性;国家基本药物制度促进合理用药效果在我国存在地区差异。     

上海市高血压门诊处方用药合理性研究

目的 调查上海市各级医疗机构的高血压门诊用药合理性情况。方法 采用整群随机抽样的方法选取上海市8家医疗机构,对选定医疗机构2014年5月和11月的高血压门诊处方的合理用药相关指标进行统计分析。结果 平均药品种数为2.24种,基本药物使用率86.43%,平均每张处方基本药物种数1.94种,基药处方占比77.66%,注射剂使用率2.43%,平均药费198.54元。结论 上海市高血压门诊处方总体情况较为合理,二三级医疗机构需注重基本药物的使用,控制高血压门诊处方药费。     

门诊处方合理用药国际指标调研与分析

目的 根据合理用药国际指标和补充指标调研,分析门诊合理用药情况。方法 用合理用药国际指标和补充指标,对白银市第一人民医院2010年1—12月门诊处方进行调研,并统计、分析。结果 平均每张处方用药品种数为3.04种,抗菌药物使用率为25.82%,注射剂使用率为22.11%,通用名使用率为98.47%,抗菌药物的金额占处方总金额的百分率为28.81%,处方平均金额为47.65元。结论 采用合理用药国际指标评价医院门诊用药基本合理。     

基层医疗卫生机构基本药物制度实施现况调查分析

目的 对某县基层医疗卫生机构基本药物制度实施现况进行调查研究,为基本药物制度的推进提供借鉴。方法 对某县19家基层医疗卫生机构进行问卷调查,并对相关负责人进行非结构式访谈。结果 基本药物制度实施后药品销售额下降、门急诊人次增加,次均门诊费、次均住院费等下降,政府对机构的补偿逐渐加大。结论 基本药物制度实施后,基层医疗卫生机构要加大对国家基本药物的配备和使用,医生要转变用药观念,政府要制定出一套对机构合理补偿的措施。

     

循证医学视角下的超说明书用药分级管理研究

目的 为规范超说明书用药的管理,促进临床合理用药,保障患者用药安全,对超说明书用药进行分级管理。方法 以循证医学证据为分级管理依据,启动了全院临床科室超说明书用药备案评审工作。结果 在406条备案药物中,抗肿瘤药物超说明书用药占78.8%,依据国际指南用法的比例最高,占48.8%,其次为其他循证支持用法（包括文献报道）占36.4%,再次为国内指南用法占11.1%。结论 超说明书用药的管理应重点集中于证据等级较低、药物不良反应发生率较高,且曾发生过医患纠纷的药物。     

采用综合干预措施 加强抗菌药物使用管理

目的 通过采取综合干预措施,促进住院患者抗菌药物的临床合理应用。方法 采用抗菌药物合理使用国际指标进行基线调查后,进行多手段干预,用SPSS12.0软件进行统计分析调查结果,评价干预措施的有效性和可行性。结果 接受抗菌药物治疗的住院患者使用抗菌药物的平均品种数从干预前的2.06种降到干预后的1.78种,抗菌药物治疗的平均费用从干预前的1 038.26元降到干预后的696.21元,抗菌药物的平均使用天数从干预前的6.99 天下降到干预后的5.81天,接受抗菌药物治疗患者的平均住院日从干预前的13天下降到干预后的10天,其他多项指标均有改善。结论 综合干预措施对提高合理用药水平效果显著,促进了管理水平的提升。     

北京市医药分开改革对临床医师用药行为的影响研究

目的 探讨北京市“医药分开”改革对临床医师用药行为的影响。方法 以北京市试行“医药分开”的部分医院为研究现场,随机抽取800名临床医师进行问卷调查,分析该项改革对临床医师用药行为的影响。结果 临床医师对“医药分开”改革的知晓率为99.5%。“医院宣传”、“专项培训”、“电视广播”为临床医师了解政策的三大主要途径。改革后,92.1%的临床医师更加重视规范诊疗、合理用药;94.4%的临床医师控制大处方,减少开方用药的数量、金额;89.9%临床医师受开药收入、提成、回扣的影响降低。结论 “医药分开”改革对试点医院临床医师的用药行为产生积极影响,规范医师处方行为,加强合理用药,基本实现了改革预期目标。     

上海市某区社区卫生服务中心门诊用药合理性评价

利用6个合理用药国际指标以及TOPSIS法,综合分析和评价了2009年上海市某区12所社区卫生服务中心门诊用药状况。12种社区卫生服务中心门诊处方分析显示：平均药费为77.11元/张,平均药物数为2.30种,抗菌药物费用比例为12.02%,针剂费用比例为12.95%,抗菌药物处方比例为26.27%,国家基本药物使用比例为56.45%。根据C _i值分析,社区卫生服务中心的门诊用药基本合理,部分医疗机构门诊用药合理性有待提高。     

基于知识库和商业智能的临床用药指引及监测系统

目的 有效规范临床用药，进行合理用药指标的监控，降低临床用药风险。方法 依据临床用药知识库，将用药规范和制度与医嘱系统流程融合；采用商业智能技术，抽取医院管理、医嘱、检验等临床业务数据库，建立主题模型，监测临床用药的各项指标。结果 软件化定制了临床用药规范和制度，在医嘱系统中实现提醒和审批流程。实时、精细化展示合理用药指标报表，并能进行潜入分析。结论 减少不合理用药医嘱，同时极大提高了合理用药数据统计、分析的效果和效率。     

多维度视角下关于基层版基本药物流通障碍的循证研究

目的 从多维度分析基层版基本药物流通的障碍，在此基础上得出相关结论和建议。方法 定量描述，定性分析。结果及结论 通过定量研究发现，基层医务人员对基本药物的认知度较低；患者对基本药物的可获得性低；现有基本药物品种满足患者基本用药需求受到质疑；政府财政投入力度不一，补贴机制不到位；政府机构对基本药物的定位需明确。解决上述问题是保障基本药物基层版顺利流通，提高患者对基本药物可获得性，保证卫生公平，降低群众基本用药费用的关键。     

甘肃省某县级医院基本药物政策实施效果研究

目的 了解甘肃省某县级医院基本药物政策实施过程中存在的问题及实施的效果。方法 对甘肃省永昌县人民医院院长进行结构化访谈,对2009年12月和2012年12月该医院的用药记录进行调查,对2009年、2012年该医院的统计报表进行调查。结果 基本药物采购及配送过程中存在问题,招标监督管理存在缺陷;基本药物的价格有所降低,非基本药物的价格明显升高;医院发展正常,以药养医的现象仍然很严重。结论 甘肃省县级医院基本药物政策需要进一步完善。     

WHO Essential Medicines Policies and Use in Developing and Transitional Countries: An Analysis of Reported Policy Implementation and Medicines Use Surveys

Background

Suboptimal medicine use is a global public health problem. For 35 years the World Health Organization (WHO) has promoted essential medicines policies to improve quality use of medicines (QUM), but evidence of their effectiveness is lacking, and uptake by countries remains low. Our objective was to determine whether WHO essential medicines policies are associated with better QUM.

Methods and Findings

We compared results from independently conducted medicines use surveys in countries that did versus did not report implementation of WHO essential medicines policies. We extracted survey data on ten validated QUM indicators and 36 self-reported policy implementation variables from WHO databases for 2002–2008. We calculated the average difference (as percent) for the QUM indicators between countries reporting versus not reporting implementation of specific policies. Policies associated with positive effects were included in a regression of a composite QUM score on total numbers of implemented policies. Data were available for 56 countries. Twenty-seven policies were associated with better use of at least two percentage points. Eighteen policies were associated with significantly better use (unadjusted p<0.05), of which four were associated with positive differences of 10% or more: undergraduate training of doctors in standard treatment guidelines, undergraduate training of nurses in standard treatment guidelines, the ministry of health having a unit promoting rational use of medicines, and provision of essential medicines free at point of care to all patients. In regression analyses national wealth was positively associated with the composite QUM score and the number of policies reported as being implemented in that country. There was a positive correlation between the number of policies (out of the 27 policies with an effect size of 2% or more) that countries reported implementing and the composite QUM score (r = 0.39, 95% CI 0.14 to 0.59, p = 0.003). This correlation weakened but remained significant after inclusion of national wealth in multiple linear regression analyses. Multiple policies were more strongly associated with the QUM score in the 28 countries with gross national income per capita below the median value (US$2,333) (r = 0.43, 95% CI 0.06 to 0.69, p = 0.023) than in the 28 countries with values above the median (r = 0.22, 95% CI −0.15 to 0.56, p = 0.261). The main limitations of the study are the reliance on self-report of policy implementation and measures of medicine use from small surveys. While the data can be used to explore the association of essential medicines policies with medicine use, they cannot be used to compare or benchmark individual country performance.

Conclusions

WHO essential medicines policies are associated with improved QUM, particularly in low-income countries. Please see later in the article for the Editors'' Summary     

The Impact of WHO Essential Medicines Policies on Inappropriate Use of Antibiotics

Background

Inappropriate overuse of antibiotics contributes to antimicrobial resistance (AMR), yet policy implementation to reduce inappropriate antibiotic use is poor in low and middle-income countries.

Aims

To determine whether public sector inappropriate antibiotic use is lower in countries reporting implementation of selected essential medicines policies.

Materials and Methods

Results from independently conducted antibiotic use surveys in countries that did, and did not report implementation of policies to reduce inappropriate antibiotic prescribing, were compared. Survey data on four validated indicators of inappropriate antibiotic use and 16 self-reported policy implementation variables from WHO databases were extracted. The average difference for indicators between countries reporting versus not reporting implementation of specific policies was calculated. For 16 selected policies we regressed the four antibiotic use variables on the numbers of policies the countries reported implementing.

Results

Data were available for 55 countries. Of 16 policies studied, four (having a national Ministry of Health unit on promoting rational use of medicines, a national drug information centre and provincial and hospital drugs and therapeutics committees) were associated with statistically significant reductions in antibiotic use of ≥20% in upper respiratory infection (URTI). A national strategy to contain antibiotic resistance was associated with a 30% reduction in use of antibiotics in acute diarrheal illness. Policies seemed to be associated with greater effects in antibiotic use for URTI and diarrhea compared with antibiotic use in all patients. There were negative correlations between the numbers of policies reported implemented and the percentage of acute diarrhoea cases treated with antibiotics (r = -0.484, p = 0.007) and the percentage of URTI cases treated with antibiotics (r = -0.472, p = 0.005). Major study limitations were the reliance on self-reported policy implementation data and antibiotic use data from linited surveys.

Conclusions

Selected essential medicines policies were associated with lower antibiotic use in low and middle income countries.     

6000张抗菌药物处方专项点评分析及监管措施的探讨

目的:对我院门诊不合理使用抗菌药物处方进行分析,提高我院合理使用抗菌药物水平,探讨不合理使用抗菌药的原因及合理使用抗菌药的监管措施。方法:利用本院抗菌药处方信息系统,抽取2016年1月~12月抗菌药物处方,每月抽查抗菌药处方500张,包括16个科室共6000张进行处方点评,将药物选择不适宜;药物选择起点高,用法用量不适宜;溶液的浓度不适宜;溶媒量不适宜;联合用药是不适宜,诊断不规范,无适应症用药,重复用药,疗程偏长汇总分析。结果:不合理处方涉及16个科室,1160张不合理抗菌药处方,占抽取处方的19.33%,不合理处方包括十方面的内容,共1340处,占总抽查处方的22.33%。结论:我院门诊抗菌药物使用存在不合理性,不合理抗菌药处方占总抽查处方的百分率偏高,抗菌药物专项点评有利于发现科室存在的普遍问题,提出干预措施为持续改进提供参考。     

Selection of Essential Medicines for Diabetes in Low and Middle Income Countries: A Survey of 32 National Essential Medicines Lists

Aim

Diabetes is a growing burden especially in low and middle income countries (LMICs). Inadequate access to diabetes care is of particular concern and selection of appropriate diabetes medicines on national essential medicines lists (NEMLs) is a first step in achieving adequate access. This selection was studied among LMICs and influences of various factors associated with selection decisions were assessed.

Methods

Countries were studied if they employed NEMLs for reimbursement or procurement purposes. Presence and number of essential diabetes medicines from different classes, both insulins and oral blood glucose lowering medicines, were surveyed and calculated. Data were also analyzed by country income level, geographic region, year of last update of the NEML and purpose of NEML employment. The effect of prevalence and burden of disease on the number of essential diabetes medicines was also studied. Non parametric tests and univariate linear regression analysis were used.

Results

Nearly all countries (n = 32) had chosen fast (97%) and intermediate acting insulin (93%), glibenclamide and metformin (100% both) as essential medicines. The median number of essential diabetes medicines was 6, equally divided between insulins and oral medicines. 20% of the countries had selected insulin analogues as essential medicines. Among all the studied factors, an increase in burden of diabetes and wealth of countries were associated with selection of higher numbers of essential diabetes medicines (p = 0.02 in both cases).

Conclusions

Nearly all the studied LMICs had included the minimum required medicines for diabetes management in their NEMLs. Selection can still be improved (e.g. exclusion of insulin analogues and replacement of glibenclamide by gliclazide). Nevertheless, the known suboptimal and inconsistent availability of essential diabetes medicines in LMICs cannot be explained by inadequate selection of essential medicines. Countries should therefore be encouraged to give precedence to implementation of NEMLs to make essential diabetes medicines more accessible.     

Characterization of Foam- and Emulsion-stabilizing Functions of Enzymatically Modified Proteins with Surfactancy

A papain-catalyzed reaction involving covalent incorporation of l-leucine n-alkyl ester is available for producing an enzymatically modified protein (EMP) with surfactancy [Agric. Biol. Chem., 45, 1621 (1981)]. In the present work we used gelatin as a starting material and incorporated l-leucine n-hexyl ester to produce a whippable EMP and l-leucine n-dodecyl ester to produce an emulsifiable EMP. A foam system formed with the whippable EMP was much stabler than that formed with sodium dodecylsulfate. The emulsifiable EMP also gave a much stabler oil-in-water emulsion than Tween-80 did. The stability of the emulsion formed with EMP was not affected by the presence of NaCl at a very high concentration. The observed foam and emulsion stabilities were well explained by the data for decreased mobility of the involved water protons. These results may indicate that EMP molecules, when arranged at the air/water or oil/water interface, can bind a part of the water to form thick barriers which prevent the air or oil particles from coalescing.     

Superoxide-scavenging and Tyrosinase-inhibitory Activities of the Extracts of Some Chinese Medicines

The superoxide-scavenging and the tyrosinase-inhibitory activities of 28 kinds of plants used as Chinese medicines were evaluated. Methanol/water extracts were used for the screening tests, and for those which represented high activities, other kinds of extracts were also studied. The extracts of Mallotus japonicus Muell. Arg. scavenged superoxide strongly; the half-inhibiting concentration (IC₅₀) of its 50% methanol/water extract was 10.57 μg of dried material in 1 ml of reaction mixture. The extracts of Fntillaria thunbergii Miq., Carthamus tinctorius L., and Prunus persica (L.) Batsch had strong tyrosinase-inhibitory activities, and the extracts of Scutellariu baicalensis Georgi represented both kinds of activities. These facts suggested that Chinese medicines may be a treasure house of chemical compounds that have the superoxide-scavenging and the tyrosinase-inhibitory activities.     

Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

Background

At the time of approval of a new medicine, there are few long-term data on the medicine''s benefit–risk balance. Clinical trials are designed to demonstrate efficacy, but have major limitations with regard to safety in terms of patient exposure and length of follow-up. This study of the number of patients who had been administered medicines at the time of medicine approval by the European Medicines Agency aimed to determine the total number of patients studied, as well as the number of patients studied long term for chronic medication use, compared with the International Conference on Harmonisation''s E1 guideline recommendations.

Methods and Findings

All medicines containing new molecular entities approved between 2000 and 2010 were included in the study, including orphan medicines as a separate category. The total number of patients studied before approval was extracted (main outcome). In addition, the number of patients with long-term use (6 or 12 mo) was determined for chronic medication. 200 unique new medicines were identified: 161 standard and 39 orphan medicines. The median total number of patients studied before approval was 1,708 (interquartile range [IQR] 968–3,195) for standard medicines and 438 (IQR 132–915) for orphan medicines. On average, chronic medication was studied in a larger number of patients (median 2,338, IQR 1,462–4,135) than medication for intermediate (878, IQR 513–1,559) or short-term use (1,315, IQR 609–2,420). Safety and efficacy of chronic use was studied in fewer than 1,000 patients for at least 6 and 12 mo in 46.4% and 58.3% of new medicines, respectively. Among the 84 medicines intended for chronic use, 68 (82.1%) met the guideline recommendations for 6-mo use (at least 300 participants studied for 6 mo and at least 1,000 participants studied for any length of time), whereas 67 (79.8%) of the medicines met the criteria for 12-mo patient exposure (at least 100 participants studied for 12 mo).

Conclusions

For medicines intended for chronic use, the number of patients studied before marketing is insufficient to evaluate safety and long-term efficacy. Both safety and efficacy require continued study after approval. New epidemiologic tools and legislative actions necessitate a review of the requirements for the number of patients studied prior to approval, particularly for chronic use, and adequate use of post-marketing studies. Please see later in the article for the Editors'' Summary