Reduction in the environmental exposure of pharmaceuticals through diagnostics,Personalised Healthcare and other approaches. A mini review and discussion paper

Pharmaceuticals enter the environment from production, through incorrect disposal as well as from patient use and excretion. Patients’ excretions into wastewater have been judged to form the highest fraction of pharmaceuticals released to the environment. There are concepts and technologies available to address pharmaceuticals emissions from production, incorrect disposal and patient excretion. However, while normal physiological excretion in patients cannot be prevented, there may still be ways to optimise the administration of pharmaceuticals with a view to reducing environmental exposure, while ensuring satisfactory pharmacologically active concentrations in the patient. Towards this goal, state-of-the-art diagnostics emerge as critically important. Describing different approaches for a reduction of environmental exposure, specifically addressing interindividual differences in drug metabolism and personalised healthcare, with recognising antibiotics administration as a related problem, this paper is not strictly speaking a scientific research article but is meant to be more of a compilation of existing and new ideas and a thought-starter.     

BOPPPS模式下大学生科研训练融入药剂学实验课程的教学改革与实践

目的：探讨BOPPPS教学模式及SRT理念在《药剂学实验》教学中的应用。方法：以平顶山学院2019级和2020级药学专业两个班级的230名本科生为研究对象,分为实验组和对照组。实验组采用基于BOPPPS的教学模式及SRT理念融入的教学方法,对照组采用传统教学方法,学期结束时使用SPSS24.0对实验操作成绩、小组设计成绩、教学满意度等结果进行检验。结果 教学结束时实验组的过程性评价和终结性评价的综合成绩及教学满意度均高于对照组,差异具有统计学意义(P<0.05)。结论 基于BOPPPS模式及SRT理念的《药剂学实验》教学方式比传统教学方式更加有利于提高学生的实验操作技能,并提升学生发散思维及综合运用知识和解决问题的能力。     

药品注册申报资料的现状与问题（三） ——中药、天然药物药学研究资料

 药品注册申请资料的完整性和研究数据的可溯源性,是开展药品技术审评的必要前提条件。通过对中药和化学药品的改剂型、仿制药注册申请资料的审查分析,从管理信息、药学、药理毒理、生物等效性研究等方面,对药品注册申报资料的现状与常见问题加以阐述,希望引起注册申请人的关注。     

药学监护技能评估标准的建立及在教学中的应用

目的: 构建药学监护技能评分标准并探索其在教学中的应用。方法: 基于药物治疗管理工作步骤,建立课程教学的评分标准,并采用专家咨询法对评分标准进行修订。对62名临床药学专业学生进行药学监护相关案例演练,按照评分标准对学生药学监护能力进行评估。结果: 从采集信息、药物治疗问题、拟定和执行药物监护计划、执业记录4个方面建立了评分标准。案例演练结果显示学生在药物治疗问题部分表现最佳(得分率为75.91%±12.76%),其次是采集信息和拟定和执行药学监护计划部分(得分率分别为72.45%±10.70%,71.02%±9.80%),在执业记录部分表现最差(62.50%±6.57%)。各部分的难度系数为0.63~0.76。结论: 评分标准能切实反映学生药学监护能力的具体情况,有助于改进教学手段,可作为药学监护教学的重要教学工具,并为其他高校药学监护教育评估提供参考。     

Pharmaceutical care of patients with gestational diabetes mellitus

Rationale, aims and objective To investigate whether the introduction of a programme of optimising drug treatment, intensive education and self‐monitoring of patients diagnosed with gestational diabetes mellitus (GDM) at an early stage (<20 gestational weeks), will improve management outcomes as determined by objective measures of patient knowledge about diabetes, glycaemia control, maternal/neonatal complications, and health‐related quality of life. Methods The study was a randomized, controlled, longitudinal, prospective clinical trial performed at Al‐Ain Hospital, Al‐Ain, United Arab Emirates. Over an 18‐month period, patients diagnosed with GDM were recruited and were randomly assigned to either an intervention or a control group, in a ratio of 3:2. Intervention patients received a structured pharmaceutical care service (including education and introduction of intensive self‐monitoring) while control patients received traditional services. Patients were followed up from time of recruitment until 6 months postnatally at scheduled outpatient clinics. A range of clinical and humanistic outcome measures, including maternal and neonatal complications, were used to assess the impact of the intervention. Results A total of 165 patients (99 intervention, 66 control) completed the study. The intervention patients exhibited a range of benefits from the provision of the programme when compared with control group patients. Statistically significant (P < 0.05) improvements were shown in the intervention group for knowledge of diabetes, health‐related quality of life (as determined by the SF36), control of plasma glucose and HbA_1c, maternal complications [e.g. decreased incidence of pre‐eclampsia (5.1% vs. 16.7%), eclampsia (1.0% vs. 7.6%), episodes of severe hyperglycaemia (3.0% vs. 19.7%) and need for Caesarean section (7.1% vs. 18.2%)], and neonatal complications [e.g. decreased incidence of neonatal hypoglycaemia (2.0% vs. 10.6%), respiratory distress at birth (4.0% vs. 15.2%), hyperbilirubinaemia (1.0% vs. 12.1%) and large for gestational age (9.0% vs. 22.7%)]. Conclusion The research provides clear evidence that provision of pharmaceutical care adds value to the management of GDM as exemplified by improved maternal and neonatal outcomes.     

坤泰胶囊联合药学服务治疗绝经期综合征的临床疗效观察

目的观察坤泰胶囊联合药学服务治疗绝经期综合征的临床疗效。方法2011年5月-2013年5月天津市中心妇产科医院妇科门诊确诊绝经期综合征患者78例,随机分成治疗组（39例）和对照组（39例）。对照组口服坤泰胶囊,4粒／次,3次／d;治疗组给予药学服务,其他同对照组,两组均治疗2个月。治疗结束后,比较治疗前后两组患者更年期Kupperman评分变化,同时计算两组的临床有效率。结果治疗组患者Kupperman评分为（14．38±3．43）分,对照组患者为（19．62±3．79）分,两组比较差异有统计学意义（P〈0．05）。治疗组临床总有效率为89．7％,对照组为79．5％,两组比较差异有统计学意义（P〈0．05）。结论坤泰胶囊联合药学服务治疗绝绎期综合征可以明显提高临床疗效,方傅实用。     

脑胶质瘤的中医辨证及用药分析

目的利用频度分析总结脑胶质瘤证候及用药特点,探讨脑胶质瘤的中医证型及用药规律。方法对1990—2013年中国期刊全文数据库（CNKI）收录的中医药治疗脑胶质瘤文献进行整理、分析并归类,总结脑胶质瘤的辨证分型及中药治疗规律。结果共纳入文献11篇,其中本虚属脾气虚6篇,肾阴虚3篇;标实属瘀血11篇,肝风8篇,痰浊7篇,癌毒6篇。脑胶质瘤主要证型为脾肾不足,风痰凝结,瘀毒内阻。临床用药80味,按功效归为8类,使用频次从高到低依次为活血类（100%）、熄风类（82%）、补气类（64%）、解毒类（64%）、利水类（55%）、化痰类（45%）、引经类（36%）、补肾类（27%）。单味中药使用频次前3位的为熄风类蜈蚣（64%）、补气类生黄芪（55%）和活血类川芎（45%）。结论脑胶质瘤中医证型及用药规律分析可为目前脑胶质瘤的临床辨证论治提供参考。     

木犀草素制剂的研究进展

木犀草素是一种具有多种药理活性的黄酮类化合物,但因其水溶性差及生物利用度低等限制了其临床应用.微粒给药系统、固体分散体、包合物、磷脂复合物、水凝胶等制剂技术的应用可提高木犀草素的生物利用度,综述了木犀草素制剂的研究进展,并阐述了其在细胞和动物实验中的应用,旨在促进其制剂开发及临床应用.     

Clinical implementation of systematic medication reconciliation and review as part of the Lund Integrated Medicines Management model – impact on all‐cause emergency department revisits

What is known and objective: Interventions involving medication reconciliation and review by clinical pharmacists can reduce drug‐related problems and improve therapeutic outcomes. The objective of this study was to examine the impact of routine admission medication reconciliation and inpatient medication review on emergency department (ED) revisits after discharge. Secondary outcomes included the combined rate of post‐discharge hospital revisits or death. Methods: This prospective, controlled study included all patients hospitalized in three internal medicine wards in a university hospital, between 1 January 2006 and 31 May 2008. Medication reconciliation on admission and inpatient medication review, conducted by clinical pharmacists in a multiprofessional team, were implemented in these wards at different times during 2007 and 2008 (intervention periods). A discharge medication reconciliation was undertaken in all the study wards, during both control and intervention periods. Patients were included in the intervention group (n = 1216) if they attended a ward with medication reconciliation and review, whether they had received the intervention or not. Control patients (n = 2758) attended the wards before implementation of the intervention. Results and Discussion: No impact of medication reconciliation and reviews on ED revisits [hazard ratio (HR), 0·95; 95% confidence interval (CI), 0·86–1·04]or event‐free survival (HR, 0·96; 95% CI, 0·88–1·04) was demonstrated. In the intervention group, 594 patients (48·8%) visited the ED, compared with 1416 (51·3%) control patients. In total, 716 intervention (58·9%) and 1688 (61·2%) control patients experienced any event (ED visit, hospitalization or death). Because the time to a subsequent ED visit was longer for the control as well as the intervention groups in 2007 than in 2006 (P < 0·05), we re‐examined this cohort of patients; the proportion of patients revisiting the ED was similar in both groups in 2007 (P = 0·608). What is new and conclusion: Routine implementation of medication reconciliation and reviews on admission and during the hospital stay did not appear to have any impact on ED revisits, re‐hospitalizations or mortality over 6‐month follow‐up.