Opportunities and responsibilities for pharmacists on short-term medical mission teams

BackgroundAmerican medical mission teams commonly travel to developing countries for short-term provision of clinical services. Although medications play an important role in the work of these teams, how to plan and organize a mission field pharmacy has been seldom described in the literature.ObjectiveTo describe pharmacist participation in medical mission work.SummaryGlobal standards and policies, as well as traditional best practices, should be applied to the selection, acquisition, use, and disposition of medications taken into a host country. This report describes the roles and responsibilities of pharmacists in planning and organizing a mission pharmacy and in delivering quality pharmacy services in the field.ConclusionPharmacists have an important contribution to make to medical mission teams. Pharmacist knowledge of drug products, regulatory issues, medication storage, dispensing, patient consultation, therapeutic substitution, and pharmacy organization and workflow is ideally suited for mission field work.     

ISO9001质量管理标准在药物临床试验机构建设中的应用

目的:保证药物临床试验的质量和保障受试者的权益。方法:将ISO9001质量管理标准的基本原则、程序和方法,贯穿于我院国家药物临床试验机构的建设中。结果与结论:以ISO9001质量管理体系为铺垫,进行药物临床试验机构的建设,符合《药物临床试验质量管理规范》的要求,有利于保证药物临床试验的质量和保障受试者的权益。     

How a longstanding P & T Committee identifies and meets current therapeutic challenges

The P & T Committee at the University of Michigan, Ann Arbor, has run smoothly for some time. Nevertheless, it is not immune to today's fiscal and drug therapy challenges. In this exclusive Hospital Formulary interview, Dr. Jeoffrey Stross, chairman; Dr. Richard deLeon, secretary; and Dr. Burgunda Volger, a key University Hospital P & T Committee member, candidly describe their committee's philosophy and the mechanics by which it functions. This committee uses restriction to modify inappropriate prescribing, but it also carries out educational activities. As newer, more expensive, therapies become available, the responsibility to ensure efficacious, safe, economical therapy becomes increasingly complex. The following discussion highlights some of their strategies for success.     

全国各省基本药物“双信封”招标中经济技术标评审标准比较研究

目的:为各地完善基本药物集中招标制度提供参考。方法:通过各省政府办公厅、卫生厅、药品集中交易监管平台等相关官方机构及网站收集各省基本药物经济技术标评审标准,并进行汇总、分析及比较研究。结果与结论:全国各省经济技术标评审标准中主客观标准比重、评审指标内容等差异较大,部分地方指标设置值得商榷。建议提高客观评价指标比重,优化药品质量类型评价指标,取消药品剂型指标。     

Reducing prophylactic antibiotic costs in cardiovascular surgery: the role of the clinical pharmacist

A project was undertaken to demonstrate significant drug cost savings from clinical pharmacy services. The method of identifying and documenting the problem and the presentation and implementation of the project are discussed. The cost savings of the project are presented, including the economic impact on the patient and institution. The clinical pharmacist, the key figure in the success of the project, presented a complete pharmacological and financial analysis of the project to the medical staff. The project resulted in a financial savings of approximately $600 000/yr to patients in decreased drug charges, $200 000/yr in decreased drug purchases/inventory, and $105 000/yr to the hospital in an improved revenue/expense statement. This project represents an example of the important role of the clinical pharmacist in helping a hospital identify areas to reduce drug therapy costs. A future role for clinical pharmacists will be to work closely with the director of pharmacy, hospital administration, and medical staff in identifying and implementing cost-effective drug therapy.     

如何保障药物临床试验机构高效有序运行

药物临床试验机构是进行药物临床试验的主要执行单位,药物临床试验机构的规范化管理及高效有序运行对确保高质量完成新药的临床试验具有重要作用。结合湖北省中医院药物临床试验机构建设情况、药物临床试验机构资格认定的准备以及药物临床试验机构日常管理的实际情况,试述如何保障药物临床试验机构高效有序运行,以期为国内同行提供参考。     

Drug-usage evaluation: traditional versus outcome-based approaches

The use of outcome assessment with DUE can provide more detailed information on the impact of drug therapy on the overall health status of the patient, rather than just the narrow view of the drug-prescribing process within the institution. These studies may justify additional pharmacists to help in the selection of drugs and their potential to affect overall quality patient care. In addition, the Joint Commission is recommending that measurement of health outcomes is important in QA. The Joint Commission has stated in their Agenda for Change program "that patient outcomes are influenced by all activities of a health care program." The Joint Commission plans to develop standards that "describe in functional terms what the key jobs are that need to be done to produce good patient outcomes." The major problem with adding outcome measures in the assessment of DUE programs is the evolutionary nature of the available technology to measure these patient outcomes. Incorporation of outcome measures into DUE programs can provide measures of the impact of drug therapy on the patients' HQOL. This HQOL is potentially a better reflection of patient outcomes and the assessment of quality of care.     

美国医疗保险与药物治疗管理服务

美国药物治疗管理服务在解决和预防药物相关问题、提高药物治疗质量、降低医疗成本等方面发挥了重要作用.该文简要介绍美国医疗保险与美国老年和残障健康保险(Medicare)D部分药物治疗管理服务的受益人资格标准、服务提供者、服务要求、标准化文件等内容,以期为推动我国将药物治疗管理服务纳入医疗保险提供借鉴.     

Implementation of standardized forms to increase pharmacist/physician communication.

This article reports on the development and use of carbonized, standard communication forms by pharmacists in a 150-bed osteopathic teaching institution. The use of these communication forms has resulted in increased physician awareness of the clinical services offered by pharmacy and standardized responses to recurring drug therapy recommendations. Communication between physicians and pharmacists has been expanded, and a cost savings in drug therapy has resulted.     

国家药包材标准物质的发展现状与展望

目的：介绍国家药包材标准物质的发展历程、现状，探究我国药包材标准物质的发展方向。方法：通过分析比对的方法，总结国家药包材标准物质现存的问题，为药包材标准物质的发展提出合理化建议。结果：国家药包材标准物质发布5年，在控制药包材质量和提升检测机构检验能力方面起到了很大的作用，但在覆盖面和推广度方面有待提高。结论：国家药包材标准物质是《中华人民共和国药典》 2020年版和《国家药包材标准》2015年版顺利实施的重要保障，需进一步发挥药包材标准物质在国家标准中起到的“砝码”作用。目前所发行的药包材标准物质涵盖添加剂品种较少，各品类不能全覆盖，在实际检测中有局限性，亟待更多品种的研制与开发。     

P & T Committee formulary requests: criteria for admission

The criteria for P & T Committee members to consider when adding or deleting a product to the formulary are discussed. Although each institution will require and develop different standards that reflect the characteristics of the patient population they serve, two general sets of factors should be studied. The anticipated needs of the institution and the therapeutic application of the medication in consideration must be identified. Furthermore, the characteristics of the drug, including pharmacokinetics, biopharmaceutics, and cost must be clearly defined. The P & T Committee formulary decisions are critical in ensuring high-quality, cost-effective health care.     

对我国药品管理使命的思考

目的:为明确我国药品管理使命提供参考,促进药品管理效益的提高。方法:运用系统观点和方法分析药品管理使命应具备的特质,借鉴美国药品管理的成功经验,对我国药品管理的应然使命进行逻辑推理分析。结果与结论:我国药品管理使命长期缺失。"保护和促进国民健康"应成为引领我国药品管理实践的使命。     

Antibiotic surveillance: the results of a clinical pharmacy intervention program

One of the major goals of any medical center is to provide safe, cost-effective drug therapy. To ensure rational antimicrobial therapy and control hospital drug costs, a criteria-based antibiotic surveillance program was developed. This method of antibiotic restriction provided exceptional cost savings in our institution. Clinical pharmacy interventions resulted in physician education and an 18% increase in compliance with the program criteria producing in a one-year period a $43,000 cost avoidance for antibiotic expenditures.     

团体标准在药品标准工作中的作用与展望

目的：分析团体标准在药品标准工作中的作用,提出药品标准领域内发展团体标准的建议。方法：对团体标准概念和法律地位进行深入分析,对国内外团体标准发展现状进行总结。结果：药品领域内发展团体标准具有积极意义,可培育完善的标准体系,提高企业竞争力,促进国家药品标准工作的发展。结论：药品标准领域内推动团体标准工作非常重要,但必须加强引导,确保团体标准和国家标准协调发展。     

Clinical research: ASHP guidelines and future directions for pharmacists.

ASHP guidelines on the pharmacist's role in clinical drug research and future directions for pharmacists in clinical drug research are described. Health-system pharmacists have a responsibility to the patient and to the institution to ensure that clinical research systems are sound, that patients are protected, and that research is conducted in a safe, effective way. ASHP guidelines list minimum standards that are essential for improving performance. The ASHP Guidelines on Clinical Drug Research, approved in November 1997, update information previously found in the ASHP Guidelines for the Use of Investigational Drugs in Organized Health-Care Settings, approved in 1990, but have an expanded focus. Additions include recognition of relevant business practices, implications of technology, and the expansion of clinical research beyond the academic health center. At a minimum, all pharmacists involved in clinical research should handle the record keeping for drug accountability, provide drug information to patients and to other health care providers, ensure the appropriate care of patients at sites not involved in the study, and provide accountability at nonpharmacy locations. Managing and coordinating clinical drug research is an area of growth that represents a great opportunity for clinical drug research. By providing baseline and higher-level pharmaceutical services for clinical research projects, pharmacists can help to ensure data accuracy and completeness and patient safety.     

药物临床试验过程中试验用药品管理的若干问题

目的:为各医院临床试验用药品的管理提供参考。方法:总结现阶段试验用药品管理常见的问题并分析其危害性,针对问题提出解决措施。结果与结论:目前各药物临床试验机构试验用药品的管理尚未见统一的管理模式,对药品管理的重要性认识也各有差异。因而在实际操作中存在若干影响试验的因素,甚至造成不良后果。各机构应制定科学、有效、实用的管理规范及操作流程,提高药品管理质量,保障药物临床试验安全、科学、可靠。     

Alternating monotherapy is the preferred treatment

The choice of initial therapy of hypertensive patients may be critical in the long-term efforts to reduce premature cardiovascular morbidity and mortality. In the 1984 report of the third Joint National Committee (JNC), significant changes in the usual approach to initial therapy were suggested, including a more conservative approach toward the institution of drug therapy, more liberal use of nondrug therapies and broader choices for the initial drug. I support these changes and believe that even a greater number of choices for initial therapy should be considered. I am increasingly concerned about the hazards of diuretic therapy and believe that for most patients, an adrenergic inhibitor is preferable for first drug. Rather than limit the type of adrenergic inhibitor to a beta blocker as suggested in the JNC report, either an alpha blocker or a centrally acting drug may be preferable. In the near future, calcium antagonists will likely also become logical choices.     

基于层次分析法的药品标准实施评估研究

目的 为国家药品标准实施评估提供参考。方法 通过查阅文献、咨询专家等方式,确定药品标准实施评估指标。利用层次分析法,以金银花配方颗粒企业标准为例,评估其实施效果。结果 国家药品标准实施评估是药品标准生命周期中非常重要的一项工作,通过利用层次分析法,建立了药品标准实施评估模型,并对金银花配方颗粒标准进行了初步评估,利用价值较高。结论 该评估模型可以为其他药品标准实施评估起到一定参考作用。     

Consistent standards in medication use: the need to care for patients from research to practice.

OBJECTIVE: To propose adoption of practice standards for pharmacists based on the principles of pharmaceutical care that are parallel to internationally accepted ethical precepts governing clinical research. DATA SOURCES: Relevant literature selected by the authors. SUMMARY: Pharmaceutical care practice standards can create a continuum of high quality care for patients from research through practice and are presented as a rational solution to managing the benefits and risks of medication use. By implementing these practice standards, patients are empowered to become active participants in the treatment process, knowledge of drug effectiveness and safety is increased, and the pharmaceutical care practitioner's responsibilities are delineated. More than a quarter century ago, the research community adopted the ethical principles of respect for persons, beneficence, and justice, as outlined in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Under these guidelines, research subjects are considered participants, knowledge of medication efficacy and safety has increased, and investigator responsibilities have been defined. However, these guidelines only apply to the life cycle of a drug before approval by the Food and Drug Administration. Once the product is released for general use, fewer standards are applied. Pharmacy has the opportunity to establish parallel standards for the clinical use of medications in patients by establishing patient care practices in consonance with pharmaceutical care practice. CONCLUSION: Pharmaceutical care practitioners need to apply new practice standards that allow them to contribute meaningfully to appropriate, effective, safe, and convenient drug therapy for all patients. Such pharmaceutical care practice standards could ensure consistent vigilance throughout the life cycle of the drug product and result in rational, appropriate, effective, safe, and convenient drug therapy for all patients.     

关于国家药品标准提高工作的思考

目的 为国家药品标准提高工作提供参考。方法 通过查阅文献,结合药品标准管理工作实践,分析我国国家药品标准提高过程中存在的问题,并提出相应的管理建议。结果与结论 国家药品标准提高工作是药品上市后监管中极端重要的一项工作,对于保障人民群众安全用药发挥了重要作用。建议在国家药品标准提高立项阶段,应该充分调研药品临床应用情况以及标准存在问题,紧密与国家药品评价性抽验等部门互动,建立沟通机制,避免浪费资源,及时将可行建议转化为国家药品标准。此外,应当建立以国家药典委员会为核心的药品标准研究集群,制定鼓励药品生产企业参与国家药品准制修订工作的措施,通过绩效考核等方式提高国家药品标准提高工作完成质量和效率。