Pharmaceutical Medicine最新文献

{"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":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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}

{"title":"European Pharmaceutical Industry Medical Information: A Role to Play in the Provision of Medicine-Related Information to Patients.","authors":"Ana Barrias, Esther Di Lauro, Sarah Dunnett, Franziska Flick, Patricia Smerdka, Fiona Wardle, Jill Voss","doi":"10.1007/s40290-024-00534-x","DOIUrl":"10.1007/s40290-024-00534-x","url":null,"abstract":"<p><p>European pharmaceutical companies have a professional and legal obligation to provide objective, factual and non-promotional medicine-related information to both healthcare professionals (HCPs) and patients on request and have established Medical Information services to fulfil this need. Also, medicines are supplied with a package leaflet for patients and/or users-this usually includes the contact details for the company's Medical Information service. There is a large scale of patient enquiry interactions across the European region. A survey conducted in 2021 by the Medical Information Leaders in Europe (MILE) association revealed that 21% of all enquiries managed by Medical Information services in 2020 were from non-HCPs. Eighteen companies collectively managed over 140,000 non-HCP enquiries-while supporting so many patients, this is also a potentially rich source of insights to real-life patient experiences. When interacting with patients, companies are cautious not to interfere with the relationship between the patient and their HCP. This can limit the information provided, with many being referred to their busy treating physicians. Unfortunately, this approach can fall short of patients' expectations or needs. MILE recognises the potential to be more helpful and companies are keen to evolve to deliver more patient-centric support. MILE member companies have collaborated in the collation and publication of best-practice principles for handling unsolicited requests for medicine-related information from patients, caregivers and members of the general public (MOPs). This will help improve accessibility to quality information support, harmonise the patients' experience and build confidence in the pharmaceutical industry services. MILE continues to invite stakeholders, including patient associations, HCPs, pharmaceutical companies, regulators and national industry associations to engage and help advance these core principles for handling patient enquiries. This publication does not constitute legal advice; decision making and accountability remains with each pharmaceutical company.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"399-405"},"PeriodicalIF":3.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11625064/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142625725","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":"Addressing Challenges in Antibiotic Access: Barriers, Implications and Strategies for Solution.","authors":"Ritika Kondel Bhandari, Avaneesh Kumar Pandey, Samir Malhotra, Ashish Kumar Kakkar, Sanjeev Singh, Jennifer Cohn, Alison Holmes, Esmita Charani, Nusrat Shafiq","doi":"10.1007/s40290-024-00538-7","DOIUrl":"10.1007/s40290-024-00538-7","url":null,"abstract":"<p><p>Antimicrobial resistance (AMR) poses a significant threat to global public health, disproportionately affecting low- and middle-income countries (LMICs). While excessive antibiotic use is often discussed, the issue of access to antibiotics demands attention. This viewpoint explores the multidimensional nature of the issue of access to antibiotics. We have examined the issue through the lens of social, economic, healthcare structures, manufacturing and supply chain, policy and practices. Inter-relatedness of these issues has also been explored. The review further discusses potential solutions involving but not limited to increased awareness, improvement in healthcare infrastructure, models for sustained manufacturing and supply chains. Additionally, enhancing antimicrobial stewardship at hospital and community levels, empowering healthcare professionals, and emphasizing infection prevention are crucial. Global initiatives that aim to address access challenges, emphasizing collaboration and innovation are important to foster for a sustained response to the issue of antibiotic access.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"387-397"},"PeriodicalIF":3.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471877","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":"Transdermal Drug Delivery Systems: Different Generations and Dermatokinetic Assessment of Drug Concentration in Skin.","authors":"Rahul Kushwaha, Narahari N Palei","doi":"10.1007/s40290-024-00537-8","DOIUrl":"10.1007/s40290-024-00537-8","url":null,"abstract":"<p><p>Transdermal drug delivery systems (TDDS) are a highly appealing and innovative method of administering drugs through the skin, as it enables the drugs to achieve systemic effects. A TDDS offers patient convenience, avoids first-pass hepatic metabolism, enables local targeting, and reduces the toxic effect of drug. This review details several generations of TDDS and the advancements made in their development to address the constraints associated with skin delivery systems. Transdermal delivery methods of the first generation have been consistently growing in their clinical application for administering small, lipophilic, low-dose drugs. Second-generation TDDS, utilizing chemical enhancers and iontophoresis, have led to the development of clinical products. Third-generation delivery systems employ microneedles, thermal ablation, and electroporation to specifically target the stratum corneum, which is the skin's barrier layer. Dermatokinetics is the study of the movement of drugs and formulations applied to the skin over a period of time. It provides important information regarding the rate and extent to which drugs penetrate skin layers. Several dermatokinetic techniques, including tape stripping, microdialysis, and laser scanning microscopy, have been used to study the intricate barrier properties and clearance mechanisms of the skin. This understanding is essential for developing and improving effective TDDS.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"407-427"},"PeriodicalIF":3.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471879","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 Pharmaceutical Year that was, 2024.","authors":"Anthony W Fox","doi":"10.1007/s40290-024-00540-z","DOIUrl":"10.1007/s40290-024-00540-z","url":null,"abstract":"","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"381-385"},"PeriodicalIF":3.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471878","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":"Cultivating Excellence: Future-Proofing Medical Affairs with Tailored Talent Programs.","authors":"Florian Reis, Neda Rajaeean, Reyhan Rose Divarci, Veit Sollacher, Elke Dworatzek, Daniela Fliegner, Hagen Krüger, Christian Lenz, Clara Craesmeyer","doi":"10.1007/s40290-024-00532-z","DOIUrl":"10.1007/s40290-024-00532-z","url":null,"abstract":"<p><p>In today's rapidly growing healthcare landscape, the role of Medical Affairs within pharmaceutical companies has transitioned from a traditional support function into a strategic one. Amidst acute challenges such as evolving globalization, digitization, and healthcare trends, effective talent development and professional standards in Medical Affairs emerge as a pivotal cornerstone to future-proof pharmaceutical companies. This article explores strategies, perspectives, and best practices for enhancing talent development with medical or natural sciences background in the field of Medical Affairs. From the historical development of Medical Affairs, we cover current challenges and provide a comprehensive approach to talent development strategies of next-generation talents in Medical Affairs. Drawing upon current literature and personal experiences, we discuss various aspects relevant for designing targeted training programs, fostering interdisciplinary collaboration, and enhancing both technical and soft skills essential for success in Medical Affairs roles. Furthermore, we highlight the significance of company-internal rotational programs in exposing talents to different facets of Medical Affairs. We advocate for a flexible and individualized approach to talent development, allowing next-generation talents to pursue personal interests and contribute to innovative projects. Overall, this article offers practical recommendations for pharmaceutical companies aiming to optimize their local talent development initiatives in Medical Affairs and align them with the evolving needs of the healthcare landscape.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"355-363"},"PeriodicalIF":3.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875554","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":"P.O.L.A.R. Star: A New Framework Developed and Applied by One Mid-Sized Pharmaceutical Company to Drive Digital Transformation in R&D.","authors":"Riccardo Mariani, Maria Carmela De Vuono, Elena Businaro, Silvia Ivaldi, Tina Dell'Armi, Michele Gallo, Diego Ardigò","doi":"10.1007/s40290-024-00533-y","DOIUrl":"10.1007/s40290-024-00533-y","url":null,"abstract":"<p><p>Digital transformation has become a cornerstone of innovation in pharmaceutical research and development (R&D). Pharmaceutical companies now have an imperative to embrace transformation, including mid-sized and small-sized companies despite resource limitations that do not allow economies of scale compared with larger organizations. This article describes the journey undertaken by Chiesi to develop an efficient framework to drive digital transformation along its R&D value chain with the objective of building and refreshing a clear roadmap and relevant priorities, together with identifying and enabling new digital capabilities and skills within R&D, defining tools and processes that will guide Chiesi activities in the space up to mid-long term. This work has led so far to five main achievements, which align with the steps in the framework: a strategically aligned roadmap with key focus areas for digital transformation and a dedicated team to lead the effort; a common language for data across the R&D value chain; an internal mindset that's open to innovation and participation in key external networks and consortia; a set of quick-win use cases for the new framework; and a defined set of Key Performance Indicators (KPIs) and monitoring tools for digital transformation. The work presented here demonstrates that R&D digital transformation should represent an ongoing process to enable cross-functional collaboration and integration within complex corporate environments that face an ever-growing volume of diverse data, to efficiently support business needs, and to ensure a positive impact on patient care.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"343-353"},"PeriodicalIF":3.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11473631/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141907341","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":"Evaluation of the Effectiveness of Additional Risk Minimization Measures for Ixazomib Citrate for Relapsed/Refractory Multiple Myeloma in Japan: A Web-Based Survey Among Pharmacists.","authors":"Yoshiko Maeda, Akihito Abe, Seigo Seki, Nobuhiro Narii, Yasuhiro Katsura, Yukiko Muramatsu, Motonobu Sakaguchi","doi":"10.1007/s40290-024-00535-w","DOIUrl":"10.1007/s40290-024-00535-w","url":null,"abstract":"<p><strong>Background: </strong>Ixazomib citrate (IXA) in combination with lenalidomide and dexamethasone (IRD therapy) has been approved for the treatment of relapsed or refractory multiple myeloma. In Japan, as these three drugs have different dosing schedules, dosing instructions for patients have been prepared and distributed to patients via healthcare professionals to promote an understanding of the appropriate dosing regimen, as an additional risk minimization measure (aRMM).</p><p><strong>Objectives: </strong>This survey aimed to investigate whether the aRMM material is being utilized for the adequate use of IXA.</p><p><strong>Methods: </strong>A web-based questionnaire survey was conducted among in-hospital pharmacists in Japan who instructed patients on IXA dosing for IRD therapy. The primary endpoint was the proportion of pharmacists who provided patients with the contents of the aRMM material (i.e., how to take IXA). The secondary endpoints were the proportion of pharmacists who had obtained the aRMM material and the proportion of pharmacists who understood the importance of explaining how to take IXA to patients.</p><p><strong>Results: </strong>Of the 330 pharmacists who completed the questionnaire, 93.0% answered that they had explained how to take IXA to patients. Of those who answered that they had explained how to take IXA, 33.2% responded that they had experience in using the aRMM material. In addition, 37.6% of the pharmacists answered that they had obtained the aRMM material. Moreover, 95.8% stated that they knew how to take IXA, and 90.3, 9.1, 0.3, and 0.3% of pharmacists answered that the importance of explaining how to take IXA was \"very important,\" \"probably important,\" \"less important\" and \"not important,\" respectively.</p><p><strong>Conclusions: </strong>How to take IXA was explained to patients by pharmacists and the aRMM material was utilized at the time of the explanation, indicating that the aRMM material contributes to the promotion of the appropriate use of IXA.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"373-380"},"PeriodicalIF":3.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11473584/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142018263","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":"Artificial Intelligence in Medical Affairs: A New Paradigm with Novel Opportunities.","authors":"Emma Fröling, Neda Rajaeean, Klara Sonnie Hinrichsmeyer, Dina Domrös-Zoungrana, Johannes Nico Urban, Christian Lenz","doi":"10.1007/s40290-024-00536-9","DOIUrl":"10.1007/s40290-024-00536-9","url":null,"abstract":"<p><p>The advent of artificial intelligence (AI) revolutionizes the ways of working in many areas of business and life science. In Medical Affairs (MA) departments of the pharmaceutical industry AI holds great potential for positively influencing the medical mission of identifying and addressing unmet medical needs and care gaps, and fostering solutions that improve the egalitarian and unbiased access of patients to treatments worldwide. Given the essential position of MA in corporate interactions with various healthcare stakeholders, AI offers broad possibilities to support strategic decision-making and to pioneer novel approaches in medical stakeholder interactions. By analyzing data derived from the healthcare environment and by streamlining operations in medical content generation, AI advances data-based prioritization and strategy execution. In this review, we discuss promising AI-based solutions in MA that support the effective use of heterogenous information from observations of the healthcare environment, the enhancement of medical education, and the analysis of real-world data. For a successful implementation of such solutions, specific considerations partly unique to healthcare must be taken care of, for example, transparency, data privacy, healthcare regulations, and in predictive applications, explainability.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"331-342"},"PeriodicalIF":3.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11473552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142292831","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":"Automated Mass Extraction of Over 680,000 PICOs from Clinical Study Abstracts Using Generative AI: A Proof-of-Concept Study.","authors":"Tim Reason, Julia Langham, Andy Gimblett","doi":"10.1007/s40290-024-00539-6","DOIUrl":"10.1007/s40290-024-00539-6","url":null,"abstract":"<p><strong>Background: </strong>Generative artificial intelligence (GenAI) shows promise in automating key tasks involved in conducting systematic literature reviews (SLRs), including screening, bias assessment and data extraction. This potential automation is increasingly relevant as pharmaceutical developers face challenging requirements for timely and precise SLRs using the population, intervention, comparator and outcome (PICO) framework, such as those under the impending European Union (EU) Health Technology Assessment Regulation 2021/2282 (HTAR). This proof-of-concept study aimed to evaluate the feasibility, accuracy and efficiency of using GenAI for mass extraction of PICOs from PubMed abstracts.</p><p><strong>Methods: </strong>Abstracts were retrieved from PubMed using a search string targeting randomised controlled trials. A PubMed clinical study 'specific/narrow' filter was also applied. Retrieved abstracts were processed using the OpenAI Batch application programming interface (API), which allowed parallel processing and interaction with Generative Pre-trained Transformer 4 Omni (GPT-4o) via custom Python scripts. PICO elements were extracted using a zero-shot prompting strategy. Results were stored in CSV files and subsequently imported into a PostgreSQL database.</p><p><strong>Results: </strong>The PubMed search returned 682,667 abstracts. PICOs from all abstracts were extracted in < 3 h, with an average processing time of 200 s per 1000 abstracts. A total of 395,992,770 tokens were processed, with an average of 580 tokens per abstract. The total cost was $3390. On the basis of a random sample of 350 abstracts, human verification confirmed that GPT-4o accurately and comprehensively extracted 342 (98%) of all PICOs, with only outcome elements rarely missed.</p><p><strong>Conclusions: </strong>Using GenAI to extract PICOs from clinical study abstracts could fundamentally transform the way SLRs are conducted. By enabling pharmaceutical developers to anticipate PICO requirements, this approach allows for proactive preparation for the EU HTAR process, or other health technology assessments (HTAs), streamlining efficiency and reducing the burden of meeting these requirements.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"365-372"},"PeriodicalIF":3.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11473607/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142351507","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}