Pharmaceutical Medicine最新文献

{"title":"The Value and Importance of a Professional Ethical Code for Medicines Development: IFAPP International Ethics Framework.","authors":"Sandor Kerpel-Fronius, Alexander L Becker","doi":"10.1007/s40290-024-00547-6","DOIUrl":"10.1007/s40290-024-00547-6","url":null,"abstract":"<p><p>Pharmaceutical medicine professionals have to face many ethical problems during the entire life span of new medicines extending from animal studies to broad clinical practice. The primary aim of the general ethical principles governing research conducted in humans is to diminish the physical and psychological burdens of the participants in human drug studies but overlooks many additional social and ethical problems faced by medicine developers. These arise mainly at the interface connecting the profit-oriented pharmaceutical industry and the healthcare-centered medical profession cooperating in medicines development. In 2002, the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine developed the International Code of Ethical Conduct for Pharmaceutical Physicians for providing ethical advice for their members to manage the frequently competitive goals characteristic for their specialty. The ethical framework compiled by the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine serves its members by presenting morally acceptable or inacceptable behaviors in frequently encountered controversies arising from competing industrial and healthcare interests in medicines development. The authors selected this format to encourage reflection and debate for finding optimal moral conclusions in specific issues. Many recent examples of serious scientific-ethical misconduct, such as the oxycodone tragedy, the recommendations of unproven useless occasionally dangerous therapies during the coronavirus disease 2019 pandemic, and the withdrawal of many papers containing non-reproducible results, contributed to the increasing loss of trust by the public in science including pharmaceutical medicine. We are convinced that the ethical guidance developed by the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine will encourage its members to reflect intensively on optimal ethical behavior in drug development for strengthening the trust of society in innovative new medicines. Finally, considering the increasingly active participation of non-medically trained scientists in producing and applying complex biological medicines, distant monitoring methods coupled together with artificial intelligence technology in innovative clinical trials, the Ethics Working Group recommended already in 2017 measures to optimize their smooth cooperation and underlined their joint ethical responsibilities in guarding the safety and human dignity of trial participants.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143053131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acknowledgement to Referees.","authors":"","doi":"10.1007/s40290-024-00548-5","DOIUrl":"https://doi.org/10.1007/s40290-024-00548-5","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143040668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Author's Reply to Pongpirul: \"The Pharmaceutical Year that was, 2024\".","authors":"Anthony W Fox","doi":"10.1007/s40290-024-00544-9","DOIUrl":"10.1007/s40290-024-00544-9","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"57-58"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment on: \"The Pharmaceutical Year that was, 2024\".","authors":"Krit Pongpirul","doi":"10.1007/s40290-024-00543-w","DOIUrl":"10.1007/s40290-024-00543-w","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"55-56"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Evolution of In-Field Medical Affairs: Introducing the Strategic Scientific Advisor.","authors":"Lucía Regadera Anechina, Inmaculada Iglesias, Jorge A Marinich, Jesús Diago, Ana Pérez Domínguez","doi":"10.1007/s40290-025-00551-4","DOIUrl":"10.1007/s40290-025-00551-4","url":null,"abstract":"<p><p>The evolving landscape of healthcare demands a transformation in Medical Affairs (MA) to address new challenges and opportunities. This article presents the Strategic Scientific Advisor (SSA) role as a critical innovation within our MA department, aimed at enhancing early engagement with stakeholders and strategically positioning assets within the healthcare ecosystem. The SSA role was developed following a comprehensive external assessment and an internal review of the MA department's structure to integrate the CARABELA methodology, which serves as the foundation for SSA activities. CARABELA is a joint initiative between AstraZeneca and key scientific societies to optimize clinical practices in specific chronic diseases using a holistic strategy, whose implementation is monitored in each hospital by applying specifically designed indicators. The SSA role design, guided by the Strategic Scientific Area Plan Framework, emphasizes early proactive engagement, evidence generation, and a multidisciplinary approach to optimizing clinical practices. By fostering collaboration across internal teams and external partners, the SSA supports activities throughout the entire lifecycle of the product, facilitating early access strategies, and building tailored plans to address unmet medical needs. In contrast to traditional Medical Science Liaisons (MSLs), SSAs play pivotal roles in driving long-term healthcare outcomes, aligning with the Medical Affairs 2030 vision. The SSA is trained and evaluated to catalyze a strategic shift, enabling MA to address the complexities of healthcare ecosystems, improve clinical practices, and contribute to patient-centered innovations. This transformation underscores the critical need for MA professionals to expand beyond traditional responsibilities and lead initiatives that shape the future of healthcare.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"19-27"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11880172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding the National Healthcare Ecosystem to Position Medical Affairs as a Strategic Element: Lessons Learned from AstraZeneca Spain.","authors":"Inmaculada Iglesias, Jorge A Marinich, Lucía Regadera Anechina, Marc Cortés, Ana Pérez Domínguez","doi":"10.1007/s40290-024-00542-x","DOIUrl":"10.1007/s40290-024-00542-x","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;The rapidly evolving healthcare landscape has prompted Medical Affairs (MA) departments within pharmaceutical companies to transition from their traditional role as information providers to becoming strategic partners in the healthcare ecosystem. Responding to the increasing complexity of patient needs and stakeholder dynamics within Spain's national health system, this shift emphasizes the importance of aligning MA functions with broader healthcare goals. Effective transformation requires in-depth assessments of stakeholder trends and expectations. The objectives of this study were to identify key stakeholders in the Spanish healthcare ecosystem, analyze their trends in detail, and evaluate ways in which our MA department should adapt to address them.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;To support this strategic transformation, we conducted a dual assessment focusing on the Spanish healthcare ecosystem. Using a combination of desk analysis and stakeholder research, we examined external and internal dynamics affecting the MA department's role. This approach identified the perspectives and needs of key stakeholders across three main communities: patients, healthcare professionals, and institutional bodies, offering insights into stakeholder-specific expectations and broader industry macrotrends.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The identification of 16 pivotal stakeholders in Spain's healthcare ecosystem underscores the complex array of needs and expectations that shape MA's evolving role. For the patient community, key trends include the demand for accessible information, emotional support resources, and tools to enhance treatment adherence and chronic disease management. Among clinicians and key external experts, there is an increasing need for current medical resources, digital integration in care processes, and collaborative research opportunities. Institutional stakeholders emphasize sustainable integration of therapeutic innovations, budget predictability, and public-private collaboration to enhance healthcare quality and access. Beyond these specific needs, transversal trends affecting all stakeholders were identified, including the acceleration of medical innovation, demand for value-added services, and the expansion of digital tools and data-driven decision making. Macrotrends within the pharmaceutical industry - such as patient-centric approaches, the growth of digital health, and data-focused business models - further shape the industry's response to evolving healthcare challenges. A unified organizational vision, reflected in shared objectives and priorities, is crucial for cohesive strategy implementation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;This research underscores the essential role of MA departments in redefining their influence within healthcare systems. By aligning MA activities with stakeholder trends, pharmaceutical companies can reposition MA as a central pillar within the healthcare ecosystem. Our","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"39-50"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11880095/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Knowing is Half the Battle: The Factors Leading to Efficient Recruitment of Representative Samples in Schizophrenia Research.","authors":"Joohyun Yoon, Megan R Mayer, Tala Berro, Stephanie Brazis, Joshua T Kantrowitz","doi":"10.1007/s40290-024-00545-8","DOIUrl":"10.1007/s40290-024-00545-8","url":null,"abstract":"<p><strong>Background and objectives: </strong>Drug development in schizophrenia is limited by the differential scaling of the active treatment and placebo arms of a study, such that, as the number of sites increases, the magnitude of placebo response disproportionately increases. The objective of this article was to identify factors conducive to efficient recruitment as a step towards trial designs allowing recruitment of more participants per site, leading to reduced variability, and potentially a smaller placebo effect.</p><p><strong>Patients and methods: </strong>Using the information of 554 individuals, we calculated the percentage of individuals who were screened, consented, and retained in our research, along with rationale for nonconsent. Independent t tests and Chi-squared tests were performed to compare participant characteristics.</p><p><strong>Results: </strong>Out of the 273 individuals who were fully screened, 84 did not progress to the consented stage owing to various reasons, leading to a total of 189 individuals who were screened and consented and a total of 365 individuals who were either incompletely screened or not consented into a study. Individuals with an externally validated medical history showed the highest yield in being consented and retained in research as new participants. In particular, chart reviews from clinics were highly efficient (25.8%) in facilitating new participants' enrollment, even when these individuals were not actively/prospectively seeking research. The most common reason for nonconsent was difficulty in telephone or email contact. Consenting and nonconsenting participants were similar in demographics, and recruitment sources only differed in their reported substance use.</p><p><strong>Conclusions: </strong>Referrals and chart reviews from known clinics were the most efficient method in retaining new participants, highlighting the importance of external validation and communication between research and clinical staff within a system. Consenting participants showed no significant differences from the database as a whole, demonstrating that the study samples were representative. Future studies should aim to confirm the present findings at other academic and commercial research centers.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"29-38"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142966110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Contraception Requirements in Early Clinical Trials: Considerations Towards an Evidence-Based Approach.","authors":"Tatyana Dubich, Ad F Roffel","doi":"10.1007/s40290-025-00555-0","DOIUrl":"10.1007/s40290-025-00555-0","url":null,"abstract":"<p><p>Enrollment of women of childbearing potential in clinical trials from early stages of drug development allows the gathering of relevant safety and pharmacokinetics data in the representative disease population. However, risk mitigation strategies are needed to ensure the safety of the developing embryo in case of unintended pregnancy in female study participants or in female partners of male study participants. These risk mitigation strategies often include contraception requirements, however we observed that such requirements vary widely across sponsors and trials. Some sponsors and contract research organizations adhere to the strictest precautions by default, assuming a worst-case scenario for each new compound's risk assessment. In this review, we provide an overview of the risks addressed by and introduced by contraception requirements in clinical trials. We critically discuss the 'worst-case' approach, and we present a holistic, risk-based approach that takes into account all relevant data, the pros and cons of using hormonal contraceptives, and subject burden.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"5-17"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pricing and Impact: Understanding Sales Trends and Price-Volume Distributions of Antihypertensive Drugs in Europe, USA, and India.","authors":"Gautam Satheesh, Swagata Kumar Sahoo, Stephen Jan, Andrew E Moran, Anthony Rodgers, Abdul Salam","doi":"10.1007/s40290-024-00546-7","DOIUrl":"10.1007/s40290-024-00546-7","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"51-54"},"PeriodicalIF":3.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143009444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review.","authors":"Elif Car, Yannick Vandenplas, Teresa Barcina Lacosta, Steven Simoens, Isabelle Huys, Arnold G Vulto, Liese Barbier","doi":"10.1007/s40290-024-00541-y","DOIUrl":"10.1007/s40290-024-00541-y","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;In the context of biosimilar use and switching, a patient's negative perception of a biosimilar might trigger a nocebo effect, where negative expectations unrelated to its pharmacologic action may lead to worsened symptoms, resulting in less perceived therapeutic benefit or worsened adverse events. Considering the crucial role biosimilars have in reducing health care costs and expanding access to safe biologics globally, it is essential to develop and implement effective strategies to mitigate the possible occurrence of such nocebo effects.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this systematic literature review was two-fold: (i) to review strategies that have been applied and/or tested for minimising the nocebo effect in clinical practice, within and outside the context of biosimilar switching, and (ii) to propose recommendations on useful mitigation strategies to minimise the occurrence of the nocebo effect in the context of biosimilar switching.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Biomedical databases PubMed and Embase were screened up until the end of April 2023 with a search string consisting of the following search terms \"nocebo\", \"biosimilar\", \"mitigation\", \"strategy\", and \"prevention\" and related synonyms. The search strategy was supplemented by snowballing of the included studies. The quality of the studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses, the Scale for the Assessment of Narrative Review Articles, and the Mixed Methods Appraisal Tool.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of the 1617 identified and screened records, 60 met the inclusion criteria. Among these, 10 (17%) were conducted within the context of biosimilar switching, 7 of which specifically tested strategies to mitigate the nocebo effect. Among the remaining 50 studies conducted outside the biosimilar switching context, 46 tested mitigation strategies. Across the included studies, 13 distinct mitigation strategies were identified, which can be employed within the context of biosimilar switching: (i) open non-verbal communication, (ii) positive framing, (iii) empathic communication, (iv) validating communication, (v) shared decision making, (vi) self-affirmation, (vii) education of patients and health care professionals about the nocebo effect, (viii) education of patients and health care professionals about biosimilars, (ix) soft-skills training for health care professionals, (x) personalised information, (xi) supporting information, (xii) multidisciplinary approach, (xiii) organisation of the switch.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;This review has identified a set of strategies that have been tested to mitigate the nocebo effect, which can be applied by health care professionals in the context of biosimilar switching with the aim of mitigating the occurrence of a nocebo effect. We recommend implementing a combination of mitigation strategies for patients and ","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"429-455"},"PeriodicalIF":3.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11625068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142751372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}