Social change and Pharmaceutical Affairs Law (PAL)

Former Japanese pharmaceutical laws, originally based on the Pharmaceutical Marketing and Handling Regulations enacted in 1874 were in operation for many years before World War II. However, in order to address several drug issues, such as poor drug quality and insufficiences regarding the role of pharmacists during the War, the laws needed to be unified and revised. In this paper, we analyzed the record of discussions held by the Imperial Diet on the bill for the Pharmaceutical Affairs Law (PAL) in 1943. This is also regarded as the origin of the current PAL (LawNo.145 in 1960). Through this analysis, we tried to clarify the relationship between the social change and the role of PAL in society. During the War, the bill was discussed, aiming at the improvement of both human resources who treated drugs, and the quality of drug materials. Diet members discussed three main points, namely, "the duty of pharmacists", "the mission of the Japan Pharmaceutical Association" and "the quality control of pharmaceutical products". Notably, the bill pharmacists are required not only to dispense drugs, a role they had previously, but also to manage drug and food hygiene through the quality control of pharmaceutical products and the inspection of food and drink, in order to improve the public health in Japan. Originally, the law was passed to deal with the extraordinary circumstances during the War, but through our analysis, we found that they proactively improved the role of the law to comply with various drug issues raised during the War, the rapid change of the pharmaceutical hygiene concept and the social transformation.     

The law of patent medicine and the separation of drug dispensaries from medical practice

On March 30, 1914, the law of patent medicine was enacted in Japanese, though it took three years for this to be accomplished. One reason why it took such a long time for enactment is because the doctors and drugstore owners raised strong objections to the law. They feared that pharmacists might try to take over all rights to sell drugs. The pharmacists, however, believed this law to be very important, making it possible for them not only to expand the business rights and the establishment of their status, but also to hold exclusive rights to the sales of drugs. On the other hand, doctors were very cautious about this law. They considered it to be a preliminary stage toward the enactment of the separation of drug dispensing by the medical practice. On March 19, 1914, Dr. Miyake former dean of the School of Medicine, University of Tokyo, and a member of the House of Lords, delivered his opinion on the "needlessness of pharmacists" by quoting European cases in the House of Lords, to members of the Special Committee of the Drug Trade Bill. He stated that a separation of the dispensary from the medical practice was a turning point in the field of medicine that should be reconsidered, and he tried to suppress the pharmacists' movements to pursue this issue. Probably Dr. Miyake was afraid that someone might submit a bill calling for dispensary separation. The proceedings of the Imperial Diet revealed a close relation between the law and the separation of dispensaries.     

Doctors and jurists who objected to the separation of drug dispensaries from the medical practice in the Taisho Era

Doctors were very nervous about the movements of pharmacists toward achievement of the separation of drug dispensaries in the medical practices and drug dispensation in 1914 and 1915. They specifically blamed one person, Professor Tokichiro Niwa of Tokyo Imperial University who strongly advocated the separation of dispensaries in the medical practices. Furthermore, they were also very anxious that the Japan Pharmacists Association had supported legislators who had stood by the separation of dispensaries from medical practice at the twelfth general election held on March 25, 1915. They were concerned that the domain of doctors' activities would be narrowed by such a separation. Professor Kunika Katayama of the Tokyo Imperial University School of Medicine published a thesis at his own cost advocating a modification of the doctor's law to prohibit the separation of dispensaries be legislation and insisting that the right prescribe a drug to a patient must remain with the doctor. Moreover, Professor Mitsue Ichimura of Kyoto Imperial University also insisted that a doctor has the right to give drugs to patients, and that as a jurist he disagreed with the separation of dispensaries from medical practice.     

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。     

The community pharmacist as a member of a primary health care team in South Africa — perceptions of pharmacists,doctors and nurses

The growing emphasis on primary health care (PHC) has drawn increased attention to disease prevention and health promotion activities from many health professionals, among them pharmacists. This paper explores the role of the community pharmacist as a member of the PHC team in South Africa, through the perceptions of pharmacists, nurses and doctors. Data were collected by survey and interviews. The results reveal a scenario where pharmacists are eager to engage in PHC activities, whereas nurses and doctors are more cautious in their support. Although they see pharmacists as health professionals, and are of the opinion that they should play a part in the PHC team, doctors and nurses strongly protect their own domains when it comes to allocation of potential tasks. This raises some difficulties with regard to the effective implementation of PHC. Based on the South African reality and a literature review, suggestions are made to develop models of PHC centres which would potentially overcome some of the problems raised.     

Perspectives on educational reform of pharmaceutical science

The six-year system of pharmaceutical education in Japan has started this fiscal year, based on the amendment to the two related laws, namely "The Pharmacist Law" and "The Fundamental Law of Education". This new system is expected to produce future pharmacists who will be able to contribute to raising the level of pharmaceutical care in the national medical care system. The practical training for pharmaceutical care that future pharmacists will have is an important safety measure for pharmaceuticals in the medical care system, so that producing qualified pharmacists would be supported by the people. For this purpose we will help to improve the training system, and the circumstances where future pharmacists will be able to realize their ideal pharmaceutical care.     

临床药师对优化治疗方案的作用分析

目的为了促进临床的合理用药,临床药师对医嘱审核情况进行分析,发现临床用药中可/或需优化医嘱,及时与临床沟通,降低临床用药风险,优化治疗方案。方法临床药师参照住院患者医嘱审核流程图对2009年3～9月所在病区（呼吸、心内、内分泌、肿瘤科）医嘱进行审核,结合每日查房了解患者病情,发现可/需优化医嘱并提出治疗方案优化建议,填写医嘱审核登记表,根据登记表对治疗方案优化建议进行汇总分析。结果临床药师建议优化治疗医嘱185条,医生采纳108条,表示关注31条,未采纳46条,采纳率为58.38%。建议的内容主要为给药方法、药物选择、药品不良反应相关问题、药物相互作用、疗程、重复用药、适应证等方面,优化方案涉及药品品种主要为循环系统药物、抗微生物药物、呼吸系统药物及激素及其有关药物等。结论临床药师通过开展医嘱审核,对提高临床合理用药水平,降低临床用药风险和优化给药方案起到了一定的作用,有利于临床药师之间的经验共享和相互学习。     

Student-Peer Mentoring on a Drug Information Response

Objective. To implement a student peer-mentoring program with a drug information response assignment in an introductory pharmacy practice course.Design. Second-year student pharmacists (P2 mentors) enrolled in an independent study course were randomly assigned first-year student pharmacists (P1 mentees) to mentor on a drug information assignment. The P2 mentors provided feedback to P1 mentees'' assignment drafts. The P1 mentees had the opportunity to revise the draft prior to turning in the completed assignment to course faculty members for grading.Assessment. Both P1 mentees and P2 mentors agreed the mentorship improved their ability to prepare a drug information response (76% and 100%, respectively). A majority of the student pharmacists would choose to be involved in the program again.Conclusion. The student peer-mentoring program was successful in improving student pharmacists'' perceptions of ability to compose a drug information response.     

1例肺癌合并侵袭性肺真菌感染与多种并发症患者的药学监护与分析

目的 通过对1例肺癌合并侵袭性肺真菌感染患者的药学监护及用药分析,探讨临床药师进行药学监护工作的具体方法.方法 临床药师对患者进行全程药学监护,分别对抗真菌药、抗肿瘤药、降糖药和降压药的应用加以分析,探讨药师参与临床药物治疗方案的切入点.结果 医师采纳药师部分用药建议,患者病情得到缓解.结论 临床药师对患者进行药学监护,与临床医师密切合作,可进一步优化治疗方案,确保临床合理用药.     

The proposal for community pharmacist activity from a viewpoint of science history

Community pharmacists have many kinds of problems for demonstrating their ability and activity. One of them is to realize the professional activity. At present, I am afraid that such community professional activities might be for now confined to legal extension. I would therefore like to discuss the aspect of professional centrifugal practice in community health care system under the pharmaceutical law system. Secondly, the role of pharmacists in drug sale comprises advising and controlling medication that we call "Application Pharmacy" in which individual pharmacokinetics and susceptivities have to be considered. The Application Pharmacy will be established in the community medical health care system for new pharmacist's activity. The Application Pharmacy should be a requirement for community pharmacists and lead to a notion of "Community Pharmacy Therapeutics."].     

Job satisfaction and the association with involvement in clinical activities among hospital pharmacists in Hong Kong

Objectives To describe the relationship between job satisfaction of hospital pharmacists and the extent of their involvement in clinical pharmacy activities, and to examine if demographics and practice characteristics are associated with the extent of involvement in clinical pharmacy activities and job satisfaction. Methods A cross‐sectional study was conducted by surveying with a self‐administered questionnaire mailed to all full‐time pharmacists employed by the Hospital Authority, Hong Kong. Key findings Respondents reporting job and career satisfaction averaged near the neutral point. The results indicated an unmet expectation of work balance between clinical activities and drug distribution, with the majority of responding pharmacists desiring a shift of work balance from more drug distributive roles towards more clinical activities. The results also suggested that an unmet expectation in work balance affects job and career satisfaction, particularly in younger, frontline pharmacists. Conclusions Younger, frontline pharmacists reported lower job satisfaction and a greater gap of unmet expectations in their work balance. This study highlights the importance of pharmacists' involvement in clinical activities, as job enrichment would improve job satisfaction and maximise benefits towards patients and healthcare organisations.     

从合理用药谈医疗纠纷

合理用药是医院药事管理的核心内容之一,是衡量临床用药水平的重要标志。患者对药物治疗的要求越来越高,由此引发的医疗纠纷也越来越多。医院应从药物、临床医师、护士、药师、患者等多方面加强监管,提高业务水平,增强法律意识,重视患者知情同意权,促进合理用药,有效减少医疗纠纷的发生,建立和谐的医患关系。     

我院消化科临床药师查房工作实例与体会

目的:探讨临床药师在药物治疗中的作用。方法:介绍2008年3月～2009年3月我院消化科临床药师协助医师进行药物治疗的案例。结果与结论:临床药师基本能根据药物特性帮助医师选择合适的药物。临床药师将药学知识与临床知识相结合能促进临床合理用药。     

试论药品管理处罚的归责原则

药品管理处罚应适用过错责任原则,这有利于实现药品管理法的立法目的和药品管理罚处的双重作用,避免了无过失责任原则导致的道德与法律、药品管理法与其它有关法律之间的矛盾和冲突.并就查处药品违法事件过程中如何认定过错作了初步探讨.     

结合案例谈药师在临床工作中的体会

目的：定位临床药师在为医、护、患提供药学服务中的角色和作用。方法：以临床药师参与的具体案例,分析临床药师临床实践工作中发挥的角色和实际作用。结果和结论：临床药师应针对医、护、患对用药知识需求的不同．提供有针对性、差异化的药学专业知识,真正成为医生的参谋、护士的伙伴、患者的朋友。     

医药护一体化监管模式对我院TDM全过程实施的影响

目的:探讨医药护一体化监管模式对治疗药物监测(TDM)全过程实施的影响。方法:将我院2018年1-12月期间实施TDM的患者作为对照组,采用传统监管模式(即医师、药师、护士三方的工作相对独立);将2019年1-12月期间TDM监测患者作为观察组,采用医药护一体化监管模式(即医师、药师、护士三方相互合作,以患者和样本为中心,药师作为关键衔接,制订各环节的执行标准,明确各自职责)。比较两组患者药物浓度总体达标率、问题样本发生率、危急值通报率、临床满意度、用药建议反馈与采纳情况以及6种监测药物(丙戊酸钠、地高辛、他克莫司、环孢霉素、甲氨蝶呤、万古霉素)的药物浓度达标率。结果:观察组的药物浓度总体达标率、危急值通报率、临床满意度合格率分别为64.57%、99.39%、97.22%,均显著高于对照组的57.86%、96.80%、92.22%(P<0.05);而观察组的问题样本发生率为0.72%,显著低于对照组的3.09%(P<0.001)。观察组的个体化药师发出反馈率(89.19%)、医师反馈交流率(80.50%)、用药建议采纳率(69.98%),均显著高于对照组的50.34%、71.46%、55.36%(P<0.001)。观察组患者除他克莫司的药物浓度达标率略低于对照组外(73.40%vs.75.77%,P>0.05),其余5种监测药物的药物浓度达标率均高于对照组,其中丙戊酸钠、地高辛、万古霉素的药物浓度达标率差异有统计学意义(P<0.05)。结论:对TDM全过程实施医药护一体化监管模式,可有效提高药物浓度达标率,并实现个体化用药的全程动态监督和反馈,有利于保障临床用药安全。