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Formulary Submissions: Value Claims, Protocols and Outcomes Based Contracting in Rare Disease. 提交处方集:罕见病的价值索赔、协议和基于结果的合同。
Pub Date : 2022-12-12 eCollection Date: 2022-01-01 DOI: 10.24926/iip.v13i3.5020
Paul C Langley

Outcomes based payments contracting is in its infancy. The increased attention being given to rare disease place a premium on the ability to engage with payers to ensure that there is an analytical framework relevant to value claims contracting. Rare disease is not, of course, alone; many other chronic disease states may be suitable candidates and have been over the past 10 years or more. Rare disease, however stands apart: (i) the evidence base at product launch is limited; (ii) the therapy costs are often considered prohibitive; and (iii) the target patient population is small. At the same time, those seeking to implement an evidence-based engagement with health systems to support innovative rare disease interventions face a substantive technology assessment barrier. The focus in health technology assessment on assumption driven modeled cost-effectiveness simulations that support imaginary recommendations for cost-effective pricing and access is, however, an avoidable barrier. In the US, this barrier is the business model of the Institute for Clinical and Economic Review (ICER) and one endorsed by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Rare disease can be better served with other tools at our disposal with a proposed new start analytical framework in health technology assessment. The purpose of this brief note is to make the case that this proposed new start focused on single attribute value claims that meet the standards of normal science and fundamental evidence can not only dispense with the ICER imaginary modeling but, with a new start formulary submission package, integrate value claims with assessment protocols to set the stage for effective outcome-based contracting as the default standard for future payer negotiations.

以结果为基础的支付合同尚处于起步阶段。罕见病日益受到重视,这就要求我们有能力与支付方合作,确保有一个与价值索赔合同相关的分析框架。当然,罕见病并非孤例;许多其他慢性病可能是合适的候选者,而且在过去 10 年或更长时间里一直是。然而,罕见病却与众不同:(i) 产品上市时的证据基础有限;(ii) 治疗费用通常被认为过高;(iii) 目标患者群体较小。与此同时,那些寻求与卫生系统开展循证合作以支持创新罕见病干预措施的人面临着实质性的技术评估障碍。然而,卫生技术评估的重点在于假设驱动的成本效益模拟模型,这些模型支持想象中的具有成本效益的定价和获取建议,这是一个可以避免的障碍。在美国,这一障碍是临床与经济审查研究所(ICER)的商业模式,也是国际药物经济学与结果研究学会(ISPOR)认可的商业模式。罕见病可以更好地利用我们所掌握的其他工具,在卫生技术评估中采用拟议的新启动分析框架。本摘要旨在说明,这一拟议的新起点侧重于符合正常科学和基本证据标准的单一属性价值诉求,不仅可以免除 ICER 想象中的建模,而且通过新起点处方集提交包,将价值诉求与评估规程相结合,为有效的基于结果的合同作为未来支付方谈判的默认标准奠定基础。
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引用次数: 0
Roles of Community Pharmacists in Cancer Management. 社区药剂师在癌症管理中的作用。
Pub Date : 2022-12-12 eCollection Date: 2022-01-01 DOI: 10.24926/iip.v13i3.4946
Oluwaseyi Muyiwa Egbewande, Muhsinah Adesewa Abdulwasiu, Rashidat Onyinoyi Yusuf, Aishat Bisoye Durojaye, Zainab Ikeoluwa Ashimiyu-Abdulsalam

Community pharmacists are among the most easily accessible healthcare practitioners and are usually the first point of contact with the public or community. This is often due to their accessibility, credibility, and widespread within the public sector making them essential members of the healthcare team with significant contributions to the delivery of public health care. Community pharmacists, in addition to their known educational and awareness-raising roles, may play an essential role in risk assessment and screening of patients, detection of symptoms of probable malignancy, and cancer treatments. The pharmacy profession has been evolving from dispensing roles into more patient-oriented outcomes and pharmacists are now participating in more clinical interventions. This places community pharmacists in the best position to provide the necessary knowledge and healthcare to benefit populations at risk of cancer. Active involvement of community pharmacists in the care and management of cancer will significantly contribute to screening and risk assessment, early detection, treatment and eradication of breast, cervical, lung, ovarian and other forms of cancer. As a result, the community pharmacy setting must the developed to maximize its full potential in cancer care.

社区药剂师是最容易接触到的医疗从业人员之一,通常是与公众或社区的第一接触点。这通常是由于他们的可及性、可信度和在公共部门的广泛分布,使他们成为医疗团队的重要成员,为提供公共医疗保健做出了重大贡献。社区药剂师除了他们已知的教育和提高认识的作用外,还可在风险评估和患者筛查、发现可能的恶性肿瘤症状以及癌症治疗方面发挥重要作用。药剂师职业已经从配药角色演变为更多以患者为导向的结果,药剂师现在正参与更多的临床干预。这使社区药剂师处于最有利的位置,能够提供必要的知识和医疗保健,使癌症高危人群受益。社区药剂师积极参与癌症的护理和管理,将极大地促进乳腺癌、宫颈癌、肺癌、卵巢癌和其他形式癌症的筛查和风险评估、早期发现、治疗和根除。因此,必须开发社区药房环境,以最大限度地发挥其在癌症护理方面的全部潜力。
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引用次数: 0
Exploratory Analysis of Survival and Mortality Rates among Older Lung Cancer Patients Utilizing Different Treatment Modalities. 对采用不同治疗方式的老年肺癌患者生存率和死亡率的探索性分析
Pub Date : 2022-12-12 eCollection Date: 2022-01-01 DOI: 10.24926/iip.v13i2.4346
Abdulmajeed Alotaibi, Askal Ali, Clyde Brown, Fatimah Sherbeny

Objective: To explore the impact of different lung cancer treatment modalities on survival time and mortality rates in older patients. Methods: The Surveillance Epidemiology and End Results (SEER) database was used to identify lung cancer patients aged ≥50 years old in the United States. Descriptive statistics and trend charts from 2000 to 2016 were generated. Regression analysis was performed among lung cancer patients to explore the association between survival time and treatment utilization (chemotherapy, radiation, and surgery). A regression model was also applied to explore the association between treatment modalities and odds of dying. Results: A total of 826,217 patients were diagnosed with lung cancer between 2000-2016. The number of lung cancer cases increased by 7%, and the average annual frequency was 48,529 cases per year. Survival, mortality, and treatment utilization varied over the years based on demographic, clinical characteristics, and social status. Five-year survival rate was less than 10% among the study population, and 84% of included lung cancer patients died. Chemotherapy was more commonly used (62%), followed by radiation (35%) and surgical interventions (22%). Chemotherapy and surgery showed a survival advantage. The odds of dying were two times higher among patients treated with surgery than those who were not (OR: 2.62, 95%Cl: 2.58-2.67). Conclusion: This study highlighted the importance of considering treatment modalities and individual patient characteristics, which may impact survival times and mortality rates among older lung cancer patients.

目的:探讨不同肺癌治疗方法对老年患者生存时间和死亡率的影响:探讨不同肺癌治疗方式对老年患者生存时间和死亡率的影响。方法使用监测流行病学和最终结果(SEER)数据库识别美国年龄≥50岁的肺癌患者。生成了 2000 年至 2016 年的描述性统计数字和趋势图。对肺癌患者进行了回归分析,以探讨生存时间与治疗利用率(化疗、放疗和手术)之间的关系。还应用回归模型探讨了治疗方式与死亡几率之间的关系。研究结果2000-2016年间,共有826217名患者被确诊为肺癌。肺癌病例数增加了 7%,年均病例数为 48529 例。根据人口统计学、临床特征和社会地位的不同,多年来的生存率、死亡率和治疗利用率也各不相同。研究人群的五年生存率不到 10%,84% 的肺癌患者死亡。化疗更常用(62%),其次是放疗(35%)和手术治疗(22%)。化疗和手术显示出生存优势。接受手术治疗的患者死亡几率是未接受手术治疗患者的两倍(OR:2.62,95%Cl:2.58-2.67)。结论这项研究强调了考虑治疗方式和患者个体特征的重要性,这可能会影响老年肺癌患者的生存时间和死亡率。
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引用次数: 0
The Evaluation of Pharmaceutical Packaging Pictograms via Eye Tracking Technique. 基于眼动追踪技术的药品包装象形图评价。
Pub Date : 2022-04-02 eCollection Date: 2022-01-01 DOI: 10.24926/iip.v13i1.4307
Merve Memişoğlu, Yener Girişken

Background: Various visual tools are used to improve medication adherence in communication with the patient. Pharmaceutical pictograms are one such tool utilized within this communication process. Objective: The aim of this study is to investigate the eye movement of the participants and to recommend the most suitable location of pictograms on pharmaceutical packaging accordingly. It also aims to show whether there is a significant correlation between the effectiveness of pictograms and the health literacy, age, and gender of the participant. Methods: Forty-two participants were exposed to sixty stimuli showing four different pharmaceutical packages as an on-screen slide show. Participants were asked what they understood from the pictograms on the packaging, and their eye movements were examined using eye tracking to determine heat maps and areas of interest, and to measure the time to first fixation, total fixation duration, and percentage fixated. Results: The study revealed that the understanding level of the pictograms was determined at between 11.9 % and 71.43 %. Among the pictograms, only a small percentage 13% - namely numbers 12 and 13 which were prepared and validated by the FIP, achieved a score of 67%, the minimum level of comprehension in accordance with ISO 3684. We observed that participants fixated at least once on the pictograms up to 95% of the time. The pictograms were found to be most easily noticed at the center with a secondary focus area towards center-right parts of the packaging. Vertical design was highly engaging for participants regardless of health literacy. The significant relationship was found between the understanding of the pictograms and gender when mean values are examined. However, no significant relationship was between health literacy and pictogram comprehension level. Conclusions: This is the first study to have used eye tracking to analyze pictograms added to real pharmaceutical packaging on the market. Its findings can guide pharmaceutical companies to design their packaging in a way that prioritizes patient safety, and to place critical pictograms more effectively. These results can be adapted medication label design in hospitals to promote appropriate use. Studies to improve patient adherence by using pictograms should be diversified.

背景:各种可视化工具被用来提高与患者沟通的药物依从性。医药象形图就是这种交流过程中使用的一种工具。目的:本研究的目的是研究参与者的眼球运动,并据此推荐药品包装上象形文字的最合适位置。它还旨在表明象形文字的有效性与参与者的健康素养、年龄和性别之间是否存在显著的相关性。方法:42名参与者暴露在60个刺激物中,在屏幕上放映四种不同的药物包装。参与者被问及他们从包装上的象形文字中理解了什么,他们的眼球运动通过眼动追踪来确定热图和感兴趣的区域,并测量第一次注视的时间,总注视时间和注视的百分比。结果:对象形文字的理解水平在11.9% ~ 71.43%之间。在这些象形文字中,只有一小部分(13%),即数字12和13,由FIP编制和验证,达到了67%的分数,符合ISO 3684的最低理解水平。我们观察到,参与者在95%的时间里至少盯着象形图看一次。人们发现,象形文字最容易被注意到的是在包装的中心,其次是包装的中右部分。无论参与者是否具有健康素养,垂直设计都具有很高的吸引力。当平均值被检查时,发现象形文字的理解和性别之间有显著的关系。健康素养与象形文字理解水平无显著相关。结论:这是第一个使用眼动追踪来分析市场上添加到真实药品包装上的象形文字的研究。其研究结果可以指导制药公司以优先考虑患者安全的方式设计包装,并更有效地放置关键的象形图。这些结果可以适应医院的药物标签设计,以促进适当的使用。使用象形文字提高患者依从性的研究应该多样化。
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引用次数: 0
Impact of a Pharmacist-Led Warfarin to Direct Oral Anticoagulant Conversion Initiative during the COVID-19 Pandemic. 药剂师主导的华法林对COVID-19大流行期间直接口服抗凝药物转换倡议的影响
Pub Date : 2022-04-02 eCollection Date: 2022-01-01 DOI: 10.24926/iip.v13i1.4491
Kelsey Mews, Audrey Umbreit, Emily Holm, Kelsie Davis, Ellen Kelly, Carson Reinhardt, Allison Young, Joseph Flynn

Purpose: To assess the impact of a pharmacist-led warfarin to DOAC conversion initiative during the COVID-19 pandemic. Methods: Patients who were prescribed warfarin and followed with the anticoagulation clinic for INR monitoring were assessed by outpatient clinical pharmacists as potential candidates for transition to DOACs from March-August 2020. Results: 530 patients were assessed for transition to DOACs, of which 373 (70.4%) were deemed by clinical pharmacists to be candidates for DOACs. Of the patients who were candidates for DOACs, 66 (17.7%) were transitioned from warfarin to a DOAC. Of the patients who transitioned to a DOAC, 59 (89.4%) remained on a DOAC after one year. Conclusion: Outpatient clinical pharmacists are an effective resource to help identify patients who are candidates for DOACs and assist with transition from warfarin. Further, high persistence rates with DOAC therapy after one year demonstrate the positive impact of the clinical pharmacist on medication adherence.

目的:评估在COVID-19大流行期间药剂师主导的华法林对DOAC转换倡议的影响。方法:2020年3月至8月,门诊临床药师对处方华法林并在抗凝诊所进行INR监测的患者进行评估,作为过渡到doac的潜在候选人。结果:530例患者被评估为过渡到DOACs,其中373例(70.4%)被临床药师认为是DOACs的候选人。在DOAC候选患者中,66例(17.7%)从华法林过渡到DOAC。在过渡到DOAC的患者中,59例(89.4%)在一年后继续使用DOAC。结论:门诊临床药师是一种有效的资源,可以帮助确定doac候选患者,并协助从华法林过渡。此外,一年后DOAC治疗的高持续率表明临床药师对药物依从性的积极影响。
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引用次数: 0
An Evaluation of Local Pharmaceutical Manufacturing in Zimbabwe: How Prepared is Zimbabwe to Produce COVID-19 Vaccines? 对津巴布韦当地制药业的评估:津巴布韦生产 COVID-19 疫苗的准备情况如何?
Pub Date : 2022-04-02 eCollection Date: 2022-01-01 DOI: 10.24926/iip.v13i1.4656
Melody Okereke, Hope Mufaro Mashavakure, Muhsinah Adesewa Abdulwasiu

Globally, the COVID-19 pandemic has had a significant impact, given the rise in the demand for novel therapeutics such as vaccines that can be used in the treatment of COVID-19 patients. Compared to other regions of the world, gross vaccine inequity exists in Africa due to several factors tied to the acute lack of vaccines in the region. As a result, efforts are currently being made to ramp up the production of COVID-19 vaccines in the region. However, there are concerns that most countries in Africa lack the adequate pharmaceutical manufacturing capacity required to produce COVID-19 vaccines, and Zimbabwe is not an exception. This article, therefore, aims to evaluate the preparedness and readiness efforts of the Zimbabwean pharmaceutical industry in the production of COVID-19 vaccines.

在全球范围内,COVID-19 大流行产生了重大影响,对可用于治疗 COVID-19 患者的疫苗等新型疗法的需求也随之增加。与世界其他地区相比,由于非洲地区严重缺乏疫苗等多种因素,该地区存在严重的疫苗不公平现象。因此,该地区目前正在努力加强 COVID-19 疫苗的生产。然而,令人担忧的是,大多数非洲国家缺乏生产 COVID-19 疫苗所需的足够制药能力,津巴布韦也不例外。因此,本文旨在评估津巴布韦制药业在生产 COVID-19 疫苗方面所做的准备和准备工作。
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引用次数: 0
More than Our Enemy: Making Space for the Microbiome in Pharmacy Education. 不只是敌人:在药学教育中为微生物组留出空间》。
Pub Date : 2022-04-02 eCollection Date: 2022-01-01 DOI: 10.24926/iip.v13i1.4553
Sarah P Collier, Abby J Weldon, Jessica L Johnson

The microbiome is the collection of commensal microorganisms along with their genomes inhabiting the human body. Despite the many known beneficial effects of these microbes on human health, the 2016 ACPE Standards for Doctor of Pharmacy curricula describe Medical Microbiology in Appendix 1 with a pathogen-centered focus. Over the last twenty years, evolving biotechnology has enabled a deeper understanding of the microbiome in the context of both wellness and disease. Retail stores are allocating increasing shelf space to commercial probiotic products, while the approach to PharmD training on the selection and use of these natural care products remains static, creating a disproportionate footprint between PharmD curricula and consumer markets. Looking to the future of patient care, we brief pharmacy educators on the current evidence and invite discussion around a proposed revision to the 2025 ACPE Standards that would add language recognizing the beneficial role of the commensal microbiota and expanding therapeutic applications of microbiome supplementation. We suggest a variety of opportunities within Doctor of Pharmacy curricula as leverage points for including relevant aspects of the microbiome in the training of future pharmacists.

微生物组是栖息在人体中的共生微生物及其基因组的集合。尽管这些微生物对人体健康有许多已知的有益影响,但 2016 年 ACPE 药学博士课程标准在附录 1 中描述的医学微生物学却以病原体为中心。在过去的二十年中,生物技术的发展使人们能够更深入地了解微生物组对健康和疾病的影响。零售店将越来越多的货架空间分配给商业益生菌产品,而药学博士关于选择和使用这些天然保健产品的培训方法却一成不变,这就造成了药学博士课程与消费者市场之间的不相称。展望未来的患者护理,我们向药学教育者简要介绍了当前的证据,并邀请他们围绕 2025 年 ACPE 标准的拟议修订进行讨论,该修订将增加承认共生微生物群的有益作用和扩大微生物群补充剂的治疗应用的措辞。我们建议将药学博士课程中的各种机会作为杠杆点,将微生物组的相关方面纳入未来药剂师的培训中。
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引用次数: 0
Assessing Willingness of Patients with Diabetes to Attend Pharmacist-Led Structured and Patient Specific Diabetes Self-Management Education. 评估糖尿病患者参加药师主导的结构化和患者特异性糖尿病自我管理教育的意愿。
Pub Date : 2022-04-02 eCollection Date: 2022-01-01 DOI: 10.24926/iip.v13i1.4429
Miranda L Moore, Joseph Jadallah, Pramit A Nadpara, Jean-Venable Kelly R Goode

Background: The American Diabetes Association recommends that people with diabetes should participate in diabetes self-management education, however data shows that many patients do not attend educational classes. Objectives: To examine the views of patients with diabetes who utilize services at an independent pharmacy in Richmond, Virginia regarding their (1) interest in attending diabetes self-management education and support (DSMES) services, (2) perceptions of a pharmacist leading DSMES services, (3) willingness to pay for DSMES services, and (4) relationship between self-reported diabetes management status with their willingness to attend DSMES services. Methods: A qualitative survey was administered over five months to patients with diabetes at an independent community pharmacy in Richmond, VA. The survey included 35 questions in a mixed format of Likert scale, dichotomous, and fill in the blank. Survey data was analyzed using univariate, bivariate, and/or multivariate analysis using SAS 9.4. Results: Twenty seven surveys were completed, 15% response rate. Patients were female (56.7%) with an average age of 69 ± 10.8 years. Caucasian race accounted for 90% of patients, 6.7% reported Black or African American, the remainder responded "other". Patients agreed they were interested in attending individual virtual and in person DSMES sessions with a rate of 52% and 87%, respectively. When asked about the full service of 9 group sessions, 33% responded disagree and 30% reported agree. 52% of patients reported belief that pharmacists had the knowledge to lead sessions. When asked about willingness to pay, patients mostly selected the lowest cost option ($25 - $35). Conclusion: Patients with diabetes are willing to participate in DSMES services and believe pharmacists can lead the sessions. It is important to continue to advocate for DSMES services so patients can understand the full benefits of the program and receive the best possible care.

背景:美国糖尿病协会建议糖尿病患者应该参加糖尿病自我管理教育,然而数据显示许多患者不参加教育课程。目的:研究在弗吉尼亚州里士满一家独立药房使用服务的糖尿病患者的观点,包括:(1)参加糖尿病自我管理教育和支持(DSMES)服务的兴趣,(2)对药剂师领导DSMES服务的看法,(3)为DSMES服务付费的意愿,以及(4)自我报告的糖尿病管理状况与参加DSMES服务意愿之间的关系。方法:对弗吉尼亚州里士满一家独立社区药房的糖尿病患者进行为期5个月的定性调查,调查包括35个问题,采用李克特量表、二分法和填空法的混合格式。使用SAS 9.4对调查数据进行单因素、双因素和/或多因素分析。结果:共完成问卷调查27份,回复率15%。患者中女性占56.7%,平均年龄69±10.8岁。白种人占90%,黑人或非裔美国人占6.7%,其余为“其他”。患者同意他们有兴趣参加单独的虚拟和面对面的DSMES会议,比例分别为52%和87%。当被问及9个小组会议的全面服务时,33%的人表示不同意,30%的人表示同意。52%的患者报告认为药剂师有知识来领导会议。当被问及支付意愿时,患者大多选择了成本最低的方案(25 - 35美元)。结论:糖尿病患者愿意参与DSMES服务,并相信药师可以主导会议。重要的是继续倡导DSMES服务,以便患者能够了解该计划的全部好处并获得最好的护理。
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引用次数: 1
Assessment of Direct Oral Anticoagulant Use at a Community Teaching Hospital. 某社区教学医院直接口服抗凝血剂使用情况评价
Pub Date : 2022-04-02 eCollection Date: 2022-01-01 DOI: 10.24926/iip.v13i1.4459
Alaina Van Dyke, Doug Carroll

Direct oral anticoagulants (DOACs) have become popular choices for both the treatment and prevention of thromboembolic events. However, these agents pose additional risks to patients due to complex dosing, insufficient monitoring, and inconsistent patient compliance. This study evaluates the appropriateness of DOAC prescribing for patients who received an order for apixaban or rivaroxaban over a 6-month period. The primary outcome is percentage of inappropriately prescribed DOAC regimens. Secondary outcomes include an effectiveness endpoint of stroke or embolism and a safety endpoint of major bleeding documented during or within 60 days of the initial visit as well as number of pharmacist clinical interventions. DOAC orders were appropriate 73% of the time. Of the 27% of inappropriate orders, approximately half were apixaban and half were rivaroxaban. The most common reason for an inappropriate order for apixaban was due to atrial fibrillation dosing, and the most common reason for an inappropriate rivaroxaban order was due to dose-indication mismatch. There were 30 pharmacist clinical interventions on DOAC orders that were documented during the 6-month period, and the most common reason for a pharmacist intervention was duplication with another anticoagulant.

直接口服抗凝剂(DOACs)已成为治疗和预防血栓栓塞事件的流行选择。然而,由于给药复杂、监测不足和患者依从性不一致,这些药物给患者带来了额外的风险。本研究评估了接受阿哌沙班或利伐沙班处方超过6个月的患者DOAC处方的适宜性。主要结果是处方不当的DOAC方案的百分比。次要结局包括卒中或栓塞的有效性终点和初次就诊期间或60天内记录的大出血的安全性终点,以及药剂师临床干预的数量。DOAC的订单在73%的情况下是合适的。在27%的不适当的订单中,大约一半是阿哌沙班,一半是利伐沙班。阿哌沙班最常见的用药顺序是由于房颤剂量,利伐沙班最常见的用药顺序是由于剂量适应证不匹配。在6个月的时间里,有30名药剂师对DOAC订单进行了临床干预,药剂师干预的最常见原因是与另一种抗凝剂重复使用。
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引用次数: 1
A Portrait of the Pharmacy Profession Globally: Pharmacist Universal Professional Identity and Establishment of Global Pharmacy Council. 全球药学专业概况:药剂师的普遍职业认同与全球药学委员会的建立。
Pub Date : 2022-04-02 eCollection Date: 2022-01-01 DOI: 10.24926/iip.v13i1.4502
Muhammad Ahmer Raza, Shireen Aziz, Misbah Noreen, Irfan Anjum, Shahid Masood Raza

⮚ Professional identity is an important component of practice change.⮚ Research on professional identity in pharmacy is limited, and this needs to change if we are to truly move practice in the 21st century.⮚ A unified professional identity is crucial for society to see pharmacists as healthcare providers.

职业认同是实践变革的重要组成部分。对于药学专业认同的研究是有限的,如果我们要真正在21世纪的实践中移动,这需要改变。统一的职业身份对于社会将药剂师视为医疗保健提供者至关重要。
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引用次数: 7
期刊
Innovations in Pharmacy
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