Annales pharmaceutiques francaises最新文献

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Topical formulation for wound management in animals: A paradigm shifts from conventional to advance.
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-02-26 DOI: 10.1016/j.pharma.2025.02.008
Sunita Nirban, Manisha Pandey, Sumit Kumar
{"title":"Topical formulation for wound management in animals: A paradigm shifts from conventional to advance.","authors":"Sunita Nirban, Manisha Pandey, Sumit Kumar","doi":"10.1016/j.pharma.2025.02.008","DOIUrl":"10.1016/j.pharma.2025.02.008","url":null,"abstract":"<p><p>Chronic wounds are a significant clinical problem for the healthcare system and require several intensive efforts to improve alternative drug delivery systems for wound care. Sometimes, this is insufficient to support the healing process. There are several obstacles to effective wound therapy, such as poor healing, off-targeting, non-compliance, and frequent dosage. Animal healthcare is a much-needed service for pet owners, farmers, and government agencies. However, the varied physiology of animals presents a challenge in producing effective medicines for animal health. To improve drug therapeutic performance, reduce animal stress, and minimize adverse effects, the industry focuses on current developments in technology for wound management in animals. The literature search utilized various reviews, research articles, clinical trials, case reports, etc. Search engines like Google Scholar, PubMed, and ScienceDirect were used to retrieve data. Various keywords such as \"wound dressing and animals\", \"antimicrobials and animal wounds\", \"wound healing and animals\" etc. were used to search the literature. Different formulation avenues are being explored, including hydrogels, wafers, and nanoemulsions. Therefore, further research is necessary to explore wound healing techniques. Utilising various advanced drug delivery systems for veterinary medicine has significantly reduced adverse effects, the frequency of doses, and stress on animals, resulting in increased profits for the industry. However, this also requires investment in research to ensure the safety, quality, and effectiveness of drugs, and delivery systems. This article reviews the various phases involved in wound healing, multiple factors affecting wound healing, different wound healing approaches, clinical trials, and case studies.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530960","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}
引用次数: 0
Photodynamic anti-cancer therapy and arachidonic acid metabolism: State of the art in 2024. 光动力抗癌疗法与花生四烯酸代谢:2024 年的技术水平。
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-02-26 DOI: 10.1016/j.pharma.2025.02.010
Hicham Wahnou, Youness Limami, Raphaël Emmanuel Duval, Bassel Ismail, David Yannick Léger, Vincent Sol, Bertrand Liagre
{"title":"Photodynamic anti-cancer therapy and arachidonic acid metabolism: State of the art in 2024.","authors":"Hicham Wahnou, Youness Limami, Raphaël Emmanuel Duval, Bassel Ismail, David Yannick Léger, Vincent Sol, Bertrand Liagre","doi":"10.1016/j.pharma.2025.02.010","DOIUrl":"10.1016/j.pharma.2025.02.010","url":null,"abstract":"<p><p>Photodynamic therapy (PDT) has emerged as a promising and evolving modality in cancer treatment leveraging light-sensitive compounds known as photosensitizers to selectively induce cell death in malignant tissues through the generation of reactive oxygen species (ROS). This review delves into the intricate mechanisms of PDT highlighting the pivotal role of photosensitizers and the resultant oxidative stress that damages cancer cells. It explores the versatile applications of PDT across various cancer types alongside the advantages and limitations inherent to this therapy. Recent technological advancements including improved photosensitizers and novel light delivery systems are also discussed. Additionally the review examines the critical role of arachidonic acid (AA) metabolism in cancer progression detailing the cyclooxygenase, lipoxygenase and cytochrome P450 pathways and their contributions to tumor biology. By elucidating the interplay between PDT and AA metabolism the review underscores the potential of targeting AA metabolic pathways to enhance PDT efficacy. Finally it provides clinical and translational perspectives highlighting ongoing research and future directions aimed at optimizing PDT for improved cancer treatment outcomes.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530955","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}
引用次数: 0
[Training healthcare teams of a multi-site university hospital on high-alert medication issues: Using an escape room].
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-02-25 DOI: 10.1016/j.pharma.2025.02.006
Pierre Leroux, Caroline Castera-Ducros, Laurence Conreur, Said Ait Taleb, Adja Fatou Diack, Louise Cayez, Romain Paoli-Lombardo, Édouard Lamy, Nicolas Primas, Christophe Curti, Patrice Vanelle, Pascal Rathelot
{"title":"[Training healthcare teams of a multi-site university hospital on high-alert medication issues: Using an escape room].","authors":"Pierre Leroux, Caroline Castera-Ducros, Laurence Conreur, Said Ait Taleb, Adja Fatou Diack, Louise Cayez, Romain Paoli-Lombardo, Édouard Lamy, Nicolas Primas, Christophe Curti, Patrice Vanelle, Pascal Rathelot","doi":"10.1016/j.pharma.2025.02.006","DOIUrl":"10.1016/j.pharma.2025.02.006","url":null,"abstract":"<p><strong>Objectives: </strong>High-Alert Medications represent a significant concern in clinical practice. The importance of raising awareness and training healthcare professionals appears essential for improving the quality and safety of care. Thus, an interactive and participatory educational format named escape room was employed in a multi-site University Hospital Center.</p><p><strong>Methods: </strong>The escape room 'Never Events Enigma' was implemented across 4 hospitals. Collaboration between our department and quality unit of each hospital facilitated the determination of organizational modalities regarding registration and session scheduling, which were carried out by our mobile team. Each session included: initial knowledge assessment, gameplay, formative debriefing and satisfaction survey. Two months later, a follow-up knowledge assessment was conducted.</p><p><strong>Results: </strong>The completion of 83 sessions enabled the training of 495 participants (average of 6 per team; minimum 2 and maximum 13). The average duration of a session was 1hour. The initial knowledge assessment revealed gaps among the various represented professions (average score 11.8/20). The satisfaction survey highlighted the relevance of this educational format. The post-training knowledge assessment demonstrated an improvement in the average score (17.2/20, gain of +5.4 points), but also its limitations, with a low response rate (25.7%).</p><p><strong>Conclusion: </strong>The escape room proved effective for the desired pedagogical objectives. This playful format offers numerous advantages to engage a diverse audience, although it represents a time-consuming method for large-scale training in small groups and requires thorough organization and communication beforehand for the smooth running of sessions.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522571","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}
引用次数: 0
Sommaire / Contents
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-02-16 DOI: 10.1016/S0003-4509(25)00024-0
{"title":"Sommaire / Contents","authors":"","doi":"10.1016/S0003-4509(25)00024-0","DOIUrl":"10.1016/S0003-4509(25)00024-0","url":null,"abstract":"","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 2","pages":"Pages iii-iv"},"PeriodicalIF":1.0,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143421943","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}
引用次数: 0
[Regulatory non-compliance of medical prescriptions: Implications for the dispensing of health products in pharmacies in the wilayas of Nouakchott].
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-02-13 DOI: 10.1016/j.pharma.2025.02.005
Eby Cheikh El Khou, Mohamed Ali Yousfi, Sid'El Wafi Baba, Raafa Ben Saada
{"title":"[Regulatory non-compliance of medical prescriptions: Implications for the dispensing of health products in pharmacies in the wilayas of Nouakchott].","authors":"Eby Cheikh El Khou, Mohamed Ali Yousfi, Sid'El Wafi Baba, Raafa Ben Saada","doi":"10.1016/j.pharma.2025.02.005","DOIUrl":"10.1016/j.pharma.2025.02.005","url":null,"abstract":"<p><p>Dispensing in a pharmacy is an important pharmaceutical act in order to deliver medicines safely. The aim of our study was to assess the compliance of prescriptions with the regulatory requirements and the consequences of non-compliance on the dispensing of medicines. The study collected 768 medical prescriptions from 16 pharmacies in 5 Moughataas in the 3 Wilayas of Nouakchott. The results show that the surname and first name of the prescriber (87.9%), the professional address (92.4%), the date of the prescription (95.1%), the signature and stamp (84.6%) were the most respected details. The study showed that 99.6% of prescriptions collected were written in French. Also, 76% of medicines were prescribed in the form of specialities. About 90% of prescriptions were handwritten. The non-conformities observed prevented the entire prescription from being dispensed (38.5%) and had consequences on the quality of the advice given to the patient (56.8%). In conclusion, the legal information on prescriptions were not respected, hence the need to rethink the regulatory information, to introduce a single model prescription for the public and private sectors, and to enforce the prescription of essential generic medicines in order to promote rational use and improve the affordability of medicines.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424561","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}
引用次数: 0
[Point of view on shared decision making: A territorial survey of healthcare professionals].
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-02-13 DOI: 10.1016/j.pharma.2025.02.004
Siméon Robin, Emmanuelle Cartron, Leïla Moret, Roxane Denis, Sonia Prot-Labarthe
{"title":"[Point of view on shared decision making: A territorial survey of healthcare professionals].","authors":"Siméon Robin, Emmanuelle Cartron, Leïla Moret, Roxane Denis, Sonia Prot-Labarthe","doi":"10.1016/j.pharma.2025.02.004","DOIUrl":"10.1016/j.pharma.2025.02.004","url":null,"abstract":"<p><strong>Background and objectives: </strong>$ Shared Decision-Making (SDM) is an intuitive approach among healthcare professionals, but one that is still little formalized or taught in practice in France. In 2022, we carried out a qualitative study on the perception of the PDP concept among a multi-professional panel. Several themes emerged, notably around knowledge of the concept, its implementation in practice and the need for training. The aim of this study is to compare the results obtained in our qualitative study with a larger number of professionals, using a questionnaire.</p><p><strong>Methods: </strong>Territorial distribution of a questionnaire to medical, paramedical and non-medical professionals and students during the second half of 2022. Quantitative variables are described in headcount proportions. Results from open-ended questions were analyzed by axial coding of verbatims, grouped into categories, themes and sub-themes.</p><p><strong>Results: </strong>A total of 381 responses were collected from 10 professions (including 41% doctors, 17% pharmacists, 15% nurses, 8% midwives and 8% physiotherapists). Less than a third of respondents (28%) claimed to be trained in therapeutic patient education (TPE). Only 6% of respondents claim to be fully familiar with PDP, while 53% are unfamiliar with the concept. When asked to define PDP, the answer was appropriate in 33% of cases. The majority (81%) of respondents would like to have specific training, and 84% believe there is a link between PDP and ETP. As for the limitations of the concept, 75% of respondents cited the urgency of decision-making, 72% the lack of time, 49% organizational difficulties and lack of knowledge of the concept, and 42% lack of knowledge of the available support tools. Among the levers mentioned by respondents were: strengthening the therapeutic alliance (67%), patient demand (60%), inter-professional support (56%), team motivation (53%) and improving the patient pathway (44%). From the 130 free responses on needs for implementing PDP, 6 themes emerged: needs oriented towards professionals and towards patients, deployment of material resources, adaptation to certain specialties, institutional responsibility and difficulty in finding downstream solutions.</p><p><strong>Conclusion: </strong>The construction of this questionnaire from the qualitative study allows us to continue our reflection. Implementation of the concept in practice still seems to be in the minority. The limitations and levers identified in the qualitative analysis are confirmed. The development of specific and adapted training seems necessary and desirable for the implementation of the PDP process, even among people trained in ETP.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424473","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}
引用次数: 0
Indirect spectrophotometric micro-determination of catecholamine drugs in dosage forms using safranin O dye and N-bromosuccinimide.
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-02-11 DOI: 10.1016/j.pharma.2025.02.001
Theia'a N Al-Sabha, Mohamed Y Dhamra
{"title":"Indirect spectrophotometric micro-determination of catecholamine drugs in dosage forms using safranin O dye and N-bromosuccinimide.","authors":"Theia'a N Al-Sabha, Mohamed Y Dhamra","doi":"10.1016/j.pharma.2025.02.001","DOIUrl":"10.1016/j.pharma.2025.02.001","url":null,"abstract":"<p><strong>Objectives: </strong>The present work aims to develop a simple, sensitive, and fast spectrophotometric method for the determination catecholamine drugs namely, adrenaline, methyldopa, and dopamine in pure and dosage forms.</p><p><strong>Method: </strong>The proposed method is based on the oxidation of the drug compounds by an excess amount of the oxidizing agent N-bromosuccinimide, the remainder of which bleaches the safranin O dye which is measured at 535nm.</p><p><strong>Results: </strong>The estimation limits were 0.1-16, 0.5-9, and 0.5-18μg/mL, with molar absorptivity values of 2.84×10<sup>4</sup>, 5.32×10<sup>4</sup>, and 3.06×10<sup>4</sup>L/mol.cm with good accuracy and precision, as the average recovery % was 100.55%, 102.04%, and 98.44% for adrenaline, methyldopa, and dopamine, respectively, and the relative standard deviation was better than 2.1 for all drugs. The standard addition method was applied for both adrenaline and dopamine, and the results indicated the method is free from additive interference. The method has been applied successfully for the determination of the above drugs in their pharmaceutical formulations.</p><p><strong>Conclusion: </strong>The method has been applied successfully for the determination of catecholamine drugs in their pharmaceutical formulations, with good accuracy and precision. The standard addition method was applied, and the results indicated the method is free from additive interferences.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143405372","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}
引用次数: 0
[Implementation of initial pharmaceutical consultations and follow-up in onco-hematology: Two years review and outlooks].
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-02-11 DOI: 10.1016/j.pharma.2025.02.002
Philippe Coulibaly, Baptiste Bazire, Julia Santucci, Rozenn Bougault, Chloé Fourage, Valérie Chedru, Antoine Alix, Baptiste Delapierre, Hippolyte Bardet, Margaret Macro, Gandhi Laurent Damaj
{"title":"[Implementation of initial pharmaceutical consultations and follow-up in onco-hematology: Two years review and outlooks].","authors":"Philippe Coulibaly, Baptiste Bazire, Julia Santucci, Rozenn Bougault, Chloé Fourage, Valérie Chedru, Antoine Alix, Baptiste Delapierre, Hippolyte Bardet, Margaret Macro, Gandhi Laurent Damaj","doi":"10.1016/j.pharma.2025.02.002","DOIUrl":"10.1016/j.pharma.2025.02.002","url":null,"abstract":"<p><strong>Objectives: </strong>In recent years, the development of oral anticancer drugs has led to an increase in outpatient care for patients with cancer. This strategy brings many advantages but also entails major risks in securing the care pathway for patients undergoing oral chemotherapy in order to secure medication car, the pharmaceutical team, in collaboration with the medical team, has set up pharmaceutical consultations in the healthcare service. This work presents the process of setting up these consultations and produces a two years review.</p><p><strong>Methods: </strong>The first step is the selection of the patient eligible for the pharmaceutical consultation. The pharmaceutical team has developed supports to harmonize practices, drawing in particular on the recommendations for good clinical practices from the Société française de pharmacie clinique (SFPC) and the implementation of pharmaceutical consultations from \"la Société française de pharmacie oncologique (SFPO)\". Initiation and follow-up pharmaceutical consultations could be carried out in person but also remotely (telephone and telepharmacy care), with an assessment of knowledge (rating grid out of 18) of compliance (according to the Girerd scale and feelings, associated with satisfaction questionnaire. The resources allocated for the activity were as follows: a pharmacist seconded to the care unit 0,8 full-time equivalent (FTE), a pharmacist 0,1 FTE, an intern in the care unit.</p><p><strong>Results: </strong>Over two years (from 02/12/12021 to 02/12/2023), 271 consultations (203 initiations consultations and 68 follow-up consultations) were carried out, with 203 patients. One hundred and eighty-four patients benefited from knowledge assessment at initiation, 59,8% (n=110) had a score equal to 18/18 and 40,2% (n=74) a score lower than 18. Among the 74 patients who had a score below 18, 54% (n=40) had a follow-up consultation. From a statistical point of view, a significant improvement in knowledge was noted in these 40 patients (mean: 14 vs. 15.8; P<0.001). The average duration of consultations was 30minutes. Pharmaceutical interventions were carried out for 23% of patients. The latter were overall very satisfied with the consultations with the majority (61.3%) wishing to benefit from another consultation subsequently.</p><p><strong>Conclusions: </strong>The implementation of initiation and follow-up pharmaceutical consultations within the healthcare service has made it possible to improve patient care. These consultations make it possible, on the one hand, to improve patients' knowledge of the oral anticancer drugs initiated, and on the other hand, to carry out a pharmaceutical analysis of the usual treatment with the new oral chemotherapy and possible associated treatments, while strengthening the link hospital city. One of the next objectives will be to monitor the evolution of compliance as follow-up consultations take place.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413275","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}
引用次数: 0
Management of asthma and COPD: Analysis of clinical profiles, post-hospitalization trajectories, and therapeutic interventions.
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-02-07 DOI: 10.1016/j.pharma.2025.02.003
Eric Barat, Elisa Dubec, Johanna Raymond, Luc-Marie Joly, Romain Léguillon, Rémi Varin
{"title":"Management of asthma and COPD: Analysis of clinical profiles, post-hospitalization trajectories, and therapeutic interventions.","authors":"Eric Barat, Elisa Dubec, Johanna Raymond, Luc-Marie Joly, Romain Léguillon, Rémi Varin","doi":"10.1016/j.pharma.2025.02.003","DOIUrl":"10.1016/j.pharma.2025.02.003","url":null,"abstract":"<p><strong>Objectives: </strong>Asthma and Chronic Obstructive Pulmonary Disease (COPD) are major global health issues, impacting morbidity, mortality, and healthcare costs. Despite the proven benefits of pharmacist involvement in managing these conditions, their potential in hospitals remains underused. This study aimed to identify patients at high risk of rehospitalization post-exacerbation of asthma or COPD, to target pharmaceutical interventions.</p><p><strong>Methods: </strong>Data from the University Hospital for January-December 2019 on adult admissions for asthma/COPD were analyzed, focusing on demographics, hospitalization, and clinical outcomes.</p><p><strong>Results: </strong>Among the 140 patients enrolled, a significant majority (91%) underwent adjustments in their treatment regimens during their hospital stay, and nearly 59% faced readmission within six months. A survival analysis highlighted a notable disparity in the rates of rehospitalization-free survival between patients with asthma and those with COPD, identifying COPD patients as having a higher susceptibility to rehospitalization.</p><p><strong>Conclusion: </strong>The study found COPD patients at greater risk but did not specify a priority profile, suggesting the necessity for broad, customized interventions to improve outcomes and reduce healthcare strain.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381418","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}
引用次数: 0
Impact of advanced therapy medicinal products status in European regulations on their production cost: The case of hematopoietic stem cells.
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-01-31 DOI: 10.1016/j.pharma.2025.01.013
Thibault Cousin, Frédéric Chantreuil, Eric Barat, Olivier Boyer, Françoise Norol, Rémi Varin, Isabelle Lebon, Camille Giverne
{"title":"Impact of advanced therapy medicinal products status in European regulations on their production cost: The case of hematopoietic stem cells.","authors":"Thibault Cousin, Frédéric Chantreuil, Eric Barat, Olivier Boyer, Françoise Norol, Rémi Varin, Isabelle Lebon, Camille Giverne","doi":"10.1016/j.pharma.2025.01.013","DOIUrl":"10.1016/j.pharma.2025.01.013","url":null,"abstract":"<p><strong>Objectives: </strong>The therapeutic promises of somatic cell and gene therapy (Advanced Therapy Medicinal Products - ATMP) and the significant current or future costs of such therapies raise questions about the impact of European health policy on these expenses. Regulation 1394/2007 currently imposes the medicinal product status on many treatments derived from cell therapy. This study aims to determine the impact of new regulations on manufacturing costs of cell therapy treatments, used as ATMP.</p><p><strong>Methods: </strong>In our study, using counterfactual reasoning, we analyze the consequences that a change of status would have on the hematopoietic stem cells (HSC) used for treatment of leukemia.</p><p><strong>Results: </strong>Under the existing status of cell transplantation (CT, Directive 2004/23/EC), the annual production cost of these cell therapy products (CTP) in France is estimated at €5.6 million. If the HSC used in leukemia indication were under the medicinal product status of ATMP, the cost would rise to approximately €9.9 million, without accounting for expenses related to facilities, which are much higher for ATMP than for CT.</p><p><strong>Conclusion: </strong>This additional burden for manufacturers must be weighed against the theoretical benefits for patients, such as reduced contamination risk. Given the very low contamination levels reported by facilities using transplant standards, the extra cost seems excessive and could hinder the development of new advanced therapies. Furthermore, it raises the need to adapt existing Good Manufacturing Practice guidelines for autologous products or those made from a single donor for a single patient, ensuring safety and cost reduction, which should encourage further development of cell therapy.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143073221","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}
引用次数: 0
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