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Patients’ perceptions of community pharmacists’ role: A cross-sectional study in Lebanon 患者对社区药剂师作用的看法:黎巴嫩横断面研究
Ali Kalash, Georges Hatem, Mohammad Chaheen, S. Awada, S. Rachidi, Roula Ajrouche
Recognizing, fostering, and maintaining a favorable public image is crucial for developing strong connections between patients and pharmacists, ultimately enhancing the pharmacist’s influence on healthcare results. Consequently, this research seeks to evaluate how the community perceives the role of pharmacists in Lebanon. A cross-sectional study was conducted among the Lebanese residents over 2 months. One-way analysis of variance assessed the relationship between the perception score and the general characteristics of the study sample. A multivariate analysis was performed using linear regression models to evaluate the combined effect of predictors on the perception score. The study comprised exclusively Lebanese participants, with a slightly higher proportion of males (53.4%) than females (46.6%) and a diverse age distribution, ranging from 18 to 65 years old, with 9.1% being 65 years or older. After adjusting for covariates, females scored 0.25 points lower than males (CI (−0.65, 0.15); p = .217), while individuals aged 40–49 and 50–65 had perception scores of 0.18 and 0.55 points lower than those aged 18–29, respectively (CI (−0.83, 0.48); p = .595 and CI (−1.29, 0.20); p = .153, respectively). Participants from Nabatiyeh had a perception score increase of 0.82 compared to those in Beirut (CI (0.15–1.49); p < .017), and those working in non-medical fields scored 0.90 points lower than others (CI (−1.49, −0.32); p = .002). Individuals with at least one comorbidity scored 0.83 points lower (CI (−1.44, −0.21); p = .008), while patients with public insurance and those with a treatment duration of 6 months had perception scores 0.57 and 0.66 points lower, respectively, compared to their counterparts (CI (−1.12, −0.03); p = .039 and CI (−1.29, −0.03); p = .040). Findings stress the significance of tailored healthcare and consistent patient-pharmacist relationships, especially for managing complex conditions, underscoring the importance of understanding these dynamics to bolster trust and appreciation for community pharmacists in Lebanon.
认识、培养和保持良好的公众形象对于发展患者与药剂师之间的紧密联系,最终提高药剂师对医疗保健结果的影响力至关重要。因此,本研究试图评估黎巴嫩社会如何看待药剂师的作用。本研究对黎巴嫩居民进行了为期两个月的横断面研究。单向方差分析评估了感知得分与研究样本一般特征之间的关系。使用线性回归模型进行了多变量分析,以评估预测因素对感知得分的综合影响。研究对象全部为黎巴嫩人,男性比例(53.4%)略高于女性(46.6%),年龄分布多样,从 18 岁到 65 岁不等,其中 9.1% 为 65 岁或以上。在对协变量进行调整后,女性的得分比男性低 0.25 分(CI (-0.65, 0.15); p = .217),而 40-49 岁和 50-65 岁人群的感知得分分别比 18-29 岁人群低 0.18 分和 0.55 分(CI (-0.83, 0.48); p = .595 和 CI (-1.29, 0.20); p = .153)。与贝鲁特的参与者相比,来自纳巴提耶的参与者的感知得分增加了 0.82 分(CI (0.15-1.49); p < .017),而在非医疗领域工作的参与者的得分比其他人低 0.90 分(CI (-1.49, -0.32); p = .002)。至少有一种合并症的患者得分比其他人低 0.83 分(CI (-1.44, -0.21); p = .008),而与同类患者相比,公共保险患者和疗程为 6 个月的患者的感知得分分别低 0.57 分和 0.66 分(CI (-1.12, -0.03); p = .039 和 CI (-1.29, -0.03); p = .040)。研究结果表明,量身定制的医疗保健服务以及患者与药剂师之间始终如一的关系非常重要,尤其是在处理复杂病情时。
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引用次数: 0
Impact of the economic crisis on the health-related quality of life of adults in Lebanon: An observational cross-sectional study 经济危机对黎巴嫩成年人健康相关生活质量的影响:观察性横断面研究
Rand Sukarieh, Georges Hatem, Nisrine Hajar, Amal Al-Hajje, Mouna Chehabeddine, Mohamad Bassam Sukarieh, S. Awada
Background: The economic crisis imposed changes to afford necessities like food, housing, and healthcare, leading to a decline in the physical and mental health of the population. Objectives: This study assessed the impact of the economic crisis on Lebanese adults’ health-related Quality of Life (QoL) and the predictors of lower scores. Methods: A cross-sectional study targeted 561 adults using a uniform questionnaire for data collection and a Short Form 8-item survey. Results: The sample comprised 77.9% females and 22.1% males. More than half of the sample reported a decrease in their income compared to the period before the crisis, and most participants reported that the economic turmoil highly impacted their access to healthcare services (63.0%), medication (51.5%), and food (56.5%) in addition to other necessities. Participants had lower Mental Component (MC) than Physical Component (PC) scores (55.5 and 69.0, respectively). Those highly impacted by the economic crisis in accessing medication had 1.76 times higher odds of lower PC scores than others (OR 1.76, 95% CI: 1.07–3.21). As regards the impact of the economic crisis on the MC scores, significantly higher odds of a lower MC score were noted among those highly impacted by the economic crisis in terms of access to medication (OR 2.12, 95% CI: 1.14–3.95), to food (OR 1.79, 95% CI: 1.1.12–2.87), and encountering water shortage (OR 1.65, 95% CI: 1.01–2.71). Conclusion: Lebanese adults’ QoL suffered physically and psychologically amid the economic crisis. The study underscores the need for accessible and affordable essential healthcare services and necessities.
背景:经济危机改变了人们对食品、住房和医疗保健等必需品的承受能力,导致人们的身心健康水平下降。研究目的本研究评估了经济危机对黎巴嫩成年人与健康相关的生活质量(QoL)的影响,以及预测较低分数的因素。研究方法以 561 名成年人为对象进行横断面研究,使用统一的问卷收集数据,并进行 8 个项目的简表调查。结果样本中女性占 77.9%,男性占 22.1%。半数以上的样本表示,与危机前相比,他们的收入有所减少,大多数参与者表示,经济动荡严重影响了他们获得医疗服务(63.0%)、药物(51.5%)和食物(56.5%)以及其他必需品。参与者的心理成分(MC)得分低于身体成分(PC)得分(分别为 55.5 分和 69.0 分)。在获得药物方面受经济危机影响较大的人,其 PC 分数较低的几率是其他人的 1.76 倍(OR 1.76,95% CI:1.07-3.21)。至于经济危机对 MC 评分的影响,受经济危机影响较大的人群在获得药物(OR 2.12,95% CI:1.14-3.95)、食物(OR 1.79,95% CI:1.1.12-2.87)和缺水(OR 1.65,95% CI:1.01-2.71)方面的 MC 评分较低的几率明显较高。结论在经济危机中,黎巴嫩成年人的身体和心理质量都受到了影响。这项研究强调了提供方便且价格合理的基本医疗保健服务和必需品的必要性。
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引用次数: 0
Comparison of a brand-name drug and its generic drugs - Impact of anti-human immunodeficiency virus drug exposure on the intestinal epithelial barrier 一种品牌药物及其仿制药的比较 - 抗人类免疫缺陷病毒药物暴露对肠上皮屏障的影响
Yusuke Takizawa, Yuka Nagai, Miho Ishii, Satoshi Yasunaga, Yuki Aizawa, Takahito Furuya, Takuro Kurita, Junichi Masuda, Takanori Nakajima
The use of unapproved anti-human immunodeficiency virus (HIV) drugs for its treatment and prevention has recently increased in Japan. Our research group investigated generic drugs of the Truvada combination tablet (TVD) that have not been approved in Japan, and reported differences in the pharmaceutical properties of their formulations. We also demonstrated that the pharmaceutical excipients in generic drugs may differ from those in TVD, and showed that some pharmaceutical excipients may affect epithelial cell barrier function. The present study investigated differences in the effects of TVD and its generic drugs (Generic A and Generic B) on epithelial cell barrier function. No significant differences were observed in epithelial cell barrier function following exposure to TVD, Generic A, and Generic B. However, significant increases in the mRNA levels of ABCB1 and Occludin, which regulate the epithelial cell barrier, were detected following exposure to Generic B. Therefore, the administration of Generic B for a longer duration or at a higher concentration may lead to changes in epithelial barrier function. Since the treatment and prevention of HIV requires the long-term (chronic) administration of drugs, the drugs used may change, such as from a brand-name drug to a generic drug and also from one generic drug to another. The present results suggest that the effects of brand-name and generic drugs, such as on intestinal epithelial barrier function, may differ with changes in the drugs being administered.
在日本,使用未经批准的抗人类免疫缺陷病毒(HIV)药物进行治疗和预防的情况最近有所增加。我们的研究小组调查了未在日本获得批准的特鲁瓦达复方片剂(TVD)的仿制药,并报告了其制剂药物特性的差异。我们还证明了仿制药中的药用辅料可能与 TVD 中的药用辅料不同,并表明某些药用辅料可能会影响上皮细胞屏障功能。本研究调查了 TVD 及其仿制药(仿制药 A 和仿制药 B)对上皮细胞屏障功能影响的差异。然而,在服用 B 类药物后,检测到调节上皮细胞屏障的 ABCB1 和 Occludin 的 mRNA 水平明显升高。由于艾滋病毒的治疗和预防需要长期(慢性)用药,所使用的药物可能会发生变化,如从品牌药变为非专利药,以及从一种非专利药变为另一种非专利药。本研究结果表明,品牌药和非专利药对肠道上皮屏障功能等的影响可能会随着用药的变化而不同。
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引用次数: 0
Factors influencing the creation of an industry 4.0 strategy in the generic pharmaceutical industry 影响仿制药行业制定工业 4.0 战略的因素
John Graham
This study aims to identify how technological, organizational, and environmental factors influence the creation of an Industry 4.0 (I4.0) strategy in the generic pharmaceutical manufacturing industry. In this study, the technology-organization-environment (TOE) framework is used to explore the factors that influence the creation of an I4.0 strategy in generic pharmaceutical manufacturing organizations. A semi-structured interview case study approach was used to gather data from a generic pharmaceutical company using the company’s creation of a digital strategy as the focus of analysis. The study identifies a paradox where Regulatory Compliance serves both as a driving force for I4.0 strategy creation, aligned with stakeholder pressure, and a potential barrier due to complexity and implementation costs. The impact of regulatory changes, such as those in environmental, social, and governance (ESG) reporting, also contributes to the adoption of I4.0 technologies. The importance of organizational executive leader alignment on the broader environmental context and technical benefits for creating an I4.0 strategy is a key driver to overcome the investment barriers and risks that come with I4.0 strategy implementation in the context of a generic pharmaceutical manufacturing organization.
本研究旨在确定技术、组织和环境因素如何影响仿制药制造业创建工业 4.0(I4.0)战略。本研究采用技术-组织-环境(TOE)框架来探讨影响仿制药生产企业创建工业 4.0 战略的因素。本研究采用半结构式访谈案例研究法,以一家非专利制药公司创建数字化战略的过程为分析重点,从该公司收集数据。研究发现了一个悖论,即监管合规既是创建 I4.0 战略的推动力,与利益相关者的压力相一致,又因复杂性和实施成本而成为潜在障碍。监管变化的影响,如环境、社会和治理(ESG)报告的影响,也有助于 I4.0 技术的采用。在非专利药品生产企业的背景下,组织执行领导者必须在更广泛的环境背景和技术优势上保持一致,以创建 I4.0 战略,这是克服实施 I4.0 战略所带来的投资障碍和风险的关键驱动力。
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引用次数: 0
The Journal of Generic Medicines – Editorial March 2024 非专利药品杂志》--2024 年 3 月社论
B. Tempest
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引用次数: 0
Decoding the perception of prescribers towards generic medicine: A bibliometric study 解密处方者对仿制药的看法:文献计量学研究
Aditya Prasad T, Ashwani Panesar
2008 can be considered a watershed year for generic medicine in India, as it saw the launch of the Jan Aushadi scheme, to provide cost-effective quality medicines to its populace, through special stores called Jan Aushadi stores. With more than 8800 stores, the scheme is touted as one of the world’s largest pharmaceutical retail chains. Since then, many generic medicine start-ups have also launched operations in the country- Zeno Health, One India Pharmacy, Generic Aadhaar and StayHappi Generics. These supply side developments will however have to be complemented with commensurate demand side responses for it make a sustainable impact towards the push for affordable and accessible healthcare for all (Sustainable Development Goal 3). Many studies have established that, on the demand side, owing to the lack of requisite medical knowledge on part of the patients, there exists a strong agency relationship, where patients rely heavily on their physicians (prescribers) to make decisions on choice of treatments. Though promotion of generic medicines requires a coordinated effort from many stakeholders, analysis reveals that the prescribers, and hence their perception of generics, plays a pivotal role in their adoption. This study undertakes a bibliometric analysis of the top 100 most-cited research papers published between 2012 and 2022 on the perception of prescribers towards generic medicine from SCOPUS database. Suitable keywords have been incorporated to reach the relevant publications and VOSviewer (version 1.6.10) has been used for analysis. The findings of the study recommend further research on interventions aimed at improving prescriber’s perception towards generic medicines to enhance their adoption and promote cost effective healthcare delivery.
2008 年可以说是印度非专利药品的分水岭,因为这一年印度启动了 Jan Aushadi 计划,通过名为 Jan Aushadi 商店的特殊商店向民众提供具有成本效益的优质药品。该计划拥有 8800 多家商店,被誉为世界上最大的药品零售连锁店之一。此后,许多仿制药新创公司也在该国开展了业务--Zeno Health、One India Pharmacy、Generic Aadhaar 和 StayHappi Generics。然而,供应方的这些发展必须辅之以需求方的相应回应,才能对推动人人享有可负担得起和可获得的医疗保健(可持续发展目标 3)产生可持续的影响。许多研究表明,在需求方面,由于患者缺乏必要的医学知识,存在着很强的代理关系,即患者在很大程度上依赖医生(开处方者)做出选择治疗方法的决定。虽然推广非专利药品需要许多利益相关者的共同努力,但分析表明,处方者以及他们对非专利药品的看法在非专利药品的采用中起着关键作用。本研究对 SCOPUS 数据库中 2012 年至 2022 年间发表的关于处方者对仿制药的看法的前 100 篇被引用次数最多的研究论文进行了文献计量分析。研究采用了合适的关键词来检索相关出版物,并使用 VOSviewer(1.6.10 版)进行分析。研究结果建议进一步研究旨在改善处方者对仿制药认知的干预措施,以提高仿制药的采用率并促进具有成本效益的医疗服务的提供。
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引用次数: 0
Lebanese pharmacists’ knowledge of generic drugs and factors affecting their use and selection following the pandemic and the economic crisis: A pilot cross-sectional study 大流行病和经济危机后黎巴嫩药剂师对非专利药物的了解以及影响其使用和选择的因素:一项试验性横断面研究
Maribelle Mansour, Georges Hatem, S. Ballout, Sarah Tarhini, A. Henaine, S. Awada
Pharmacists are crucial in lowering pharmaceutical expenditures by substituting brand-name drugs for generic drugs. They are expected to understand the principles and practices of generic drug substitution for high-quality patient care. Some key areas of knowledge include bioequivalence and therapeutic equivalence, regulatory requirements, drug interchangeability, and adequate patient counseling. This study aims to assess the knowledge, perception, and practice of generic drug substitution among pharmacists in Lebanon following the crises and the factors affecting the prescription and selection of generic drugs. A pilot descriptive cross-sectional study targeting 80 Lebanese pharmacists was conducted over 2 months (September-October 2022), in which data were collected using a uniform survey. Overall, pharmacists had a good knowledge of generic drugs in terms of active ingredients (97.5%), pharmaceutical form (85.0%), lower cost (88.7%), bioequivalence to the brand before (95.0%), and therapeutic equivalence. Nevertheless, 22.5% reported that generic drugs are less safe than brands, and 22.5% said they cause side effects or did not know. Among the possible factors that influence the prescription of generic drugs, 35.0% of pharmacists reported that the financial situation of the patient is among the least important factors, while the lack of possible alternatives (45.0%) and the difference in prices (40.0%) were the most important ones. The price of different generics on the market was among the most important factors (36.3%) affecting the selection of generic drugs, followed by the patient’s. preference (26.3%). Only 11.2% considered the information given by pharmaceutical firms could affect their choice, and 10.0% considered the presence or not of excipients with known effects in the formulation. Most pharmacists in Lebanon were familiar with generic drugs and supported generic drug substitution. Factors affecting generic drug use and prescription should be further explored to clarify misconceptions and reduce possible adverse events.
药剂师在通过用品牌药代替仿制药来降低药品支出方面起着至关重要的作用。他们应该了解仿制药替代的原则和实践,以提供高质量的患者护理。一些关键的知识领域包括生物等效性和治疗等效性、监管要求、药物互换性和充分的患者咨询。本研究旨在评估黎巴嫩危机后药师对仿制药替代的知识、认知和实践,以及影响仿制药处方和选择的因素。针对80名黎巴嫩药剂师进行了为期2个月(2022年9月至10月)的实验性描述性横断面研究,其中使用统一调查收集数据。总体而言,药师在活性成分(97.5%)、剂型(85.0%)、较低成本(88.7%)、与原品牌生物等效性(95.0%)和治疗等效性方面对仿制药有较好的了解。尽管如此,22.5%的人表示仿制药不如品牌药安全,22.5%的人表示有副作用或不知道。在可能影响仿制药处方的因素中,35.0%的药师认为患者的经济状况是最不重要的因素,而缺乏可能的替代品(45.0%)和价格差异(40.0%)是最重要的因素。市场上不同仿制药的价格是影响仿制药选择的最重要因素(36.3%),其次是患者的价格。偏好(26.3%)。只有11.2%的人认为制药公司提供的信息会影响他们的选择,10.0%的人认为配方中是否存在已知作用的赋形剂。黎巴嫩的大多数药剂师熟悉仿制药,并支持仿制药替代。应进一步探讨影响仿制药使用和处方的因素,澄清误解,减少可能发生的不良事件。
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引用次数: 0
Comparison of pharmaceutical characteristics and membrane permeability of truvada combination tablets and its generic drugs 特鲁瓦达联合片与仿制药的药效学特性及膜透性比较
Y. Takizawa, Naruya Kunii, Junya Oguri, Yuki Aizawa, Takahito Furuya, Takuro Kurita, J. Masuda, Takanori Nakajima
Pre-exposure prophylaxis (PrEP) prevents HIV infection through the daily administration of anti-HIV drugs, such as Truvada combination tablets (a combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)). However, since PrEP is not approved in Japan, generic drugs sold overseas are imported and used by individuals. Then, the present study investigated the pharmaceutical equivalence of two generic drugs of Truvada (Generic A and Generic B). Tablet properties were examined by X-ray diffraction and differential scanning calorimetry. The dissolution behaviors and membrane permeabilities of FTC and TDF were assessed by the dissolution test using the paddle method and a membrane permeation experiment using Caco-2 cell monolayers, respectively. The dissolution behaviors of FTC and TDF differed between Truvada and its generic drugs. Furthermore, the membrane permeation rates of FTC and TDF in Generic B were slower than those in Truvada, and the AUC of FTC in Generic B was significantly smaller than that in Truvada. Differences were observed in the dissolution behaviors and membrane permeabilities of FTC and TDF in generic drugs (particularly Generic B) from those in Truvada. Since there are concerns regarding the clinical implications of these results, further studies, including in vivo experiments, are needed to ensure the safety of generic drugs.
暴露前预防(PrEP)通过每日服用抗艾滋病毒药物来预防艾滋病毒感染,例如特鲁瓦达联合片(恩曲他滨(FTC)和富马酸替诺福韦二氧吡酯(TDF)的组合)。然而,由于PrEP在日本不被批准,海外销售的仿制药是进口的,个人使用。然后对特鲁瓦达仿制药A和仿制药B的药物等效性进行了研究,并采用x射线衍射和差示扫描量热法对其片剂性质进行了表征。采用桨叶法溶出实验和Caco-2细胞单层膜透膜实验,分别对FTC和TDF的溶出行为和膜透性进行了评价。特鲁瓦达及其仿制药中FTC和TDF的溶出行为存在差异。此外,通用B组FTC和TDF的膜渗透速度比特鲁瓦达组慢,通用B组FTC的AUC明显小于特鲁瓦达组。在仿制药(尤其是仿制药B)和特鲁瓦达中,FTC和TDF的溶出行为和膜透性存在差异。由于对这些结果的临床意义存在担忧,需要进一步的研究,包括体内实验,以确保仿制药的安全性。
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引用次数: 0
EU Legal and Regulatory Update January 2023 欧盟法律法规更新2023年1月
R. Milchior, S. Charbonnel
Compiled and written by SCP Herald Herald Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies. This section is intended to be a synopsis of recent developments and is not intended to be all comprehensive. If any (issue) information referred to in this section is to be relied upon, specific advice should be sought. Please contact the Editor: Richard Milchior and Séverine Charbonnel SCP Herald 91 rue du Faubourg Saint Honore 75008 Paris France Tel: +33 (0)1 53 43 15 15 Fax: +33 (0) 1 53 43 15 00 Email: r.milchior@herald-avocats.com Email: s.charbonnel@herald-avocats.com
Herald Avocats是一家法国律师事务所,涉及知识产权法、制药法和欧盟法,为医疗保健、生物技术和制药公司提供服务。本节旨在简要介绍最近的发展情况,并不打算包罗万象。如果要依赖本节中提及的任何(问题)信息,应寻求具体建议。请联系编辑:Richard Milchior和ssamverine Charbonnel SCP Herald 91 rue du Faubourg Saint Honore 75008法国巴黎电话:+33(0)1 53 43 15 15传真:+33(0)1 53 43 15 15电子邮件:r.milchior@herald-avocats.com电子邮件:s.charbonnel@herald-avocats.com
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引用次数: 0
Considerations for filing U.S. patent applications in DOCX format 以DOCX格式提交美国专利申请的注意事项
J. Bousquet
Compiled and written by Greenblum & Bernstein PLC AUS intellectual property law firm which provides a full range of services in IP-related matters across all industries, including the biotech and pharmaceutical industries, including: Inter partes Review (IPR) and Post Grant Review (PGR) Abbreviated new drug applications (ANDAs) and Notice Letters Patent and trademark litigation Patent drafting and prosecution Patent infringement and validity opinions Patent reexamination proceedings and interferences New drug strategies Market entry strategies Joint venture strategies Licensing
由美国知识产权律师事务所Greenblum & Bernstein PLC编写,该律师事务所在所有行业(包括生物技术和制药行业)提供与知识产权相关的全方位服务,包括:专利和商标诉讼专利起草和起诉专利侵权和有效性意见专利复审程序和干扰新药战略市场进入战略合资企业战略许可
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引用次数: 0
期刊
Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector
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