Annales pharmaceutiques francaises最新文献

Management of Asthma and COPD: Analysis of Clinical Profiles, Post-Hospitalization Trajectories, and Therapeutic Interventions.

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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":"https://doi.org/10.1016/j.pharma.2025.02.003","url":null,"abstract":"Objectives: 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.Methods: Data from the University Hospital for January-December 2019 on adult admissions for asthma/COPD were analyzed, focusing on demographics, hospitalization, and clinical outcomes.Results: 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 rehospitalisation-free survival between patients with asthma and those with COPD, identifying COPD patients as having a higher susceptibility to rehospitalisation.Conclusion: The study found COPD patients at greater risk but didn't specify a priority profile, suggesting the necessity for broad, customized interventions to improve outcomes and reduce healthcare strain.","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.

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Annales pharmaceutiques francaises Pub Date : 2025-01-30 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":"https://doi.org/10.1016/j.pharma.2025.01.013","url":null,"abstract":"Objectives: 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.Methods: 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.Results: 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 euro 5.6 million. If the HSC used in leukemia indication were under the medicinal product status of ATMP, the cost would rise to approximately euro 9.9 million, without accounting for expenses related to facilities, which are much higher for ATMP than for CT.Conclusion: 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.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-30","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}

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Impact of antioxidant excipients on N-nitrosamine formation and bioequivalence in metformin formulations (review article).

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Annales pharmaceutiques francaises Pub Date : 2025-01-30 DOI: 10.1016/j.pharma.2025.01.012

Güler Yağmur Akyüz

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First international guidelines on glucocorticoid-induced adrenal insufficiency: When and how manage glucocorticoid tapering and discontinuation?

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Annales pharmaceutiques francaises Pub Date : 2025-01-30 DOI: 10.1016/j.pharma.2025.01.014

Damien Denimal

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[Reprocessing of single-use medical devices: Viewpoints and perceptions of cardiologists and hospital pharmacists].

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Annales pharmaceutiques francaises Pub Date : 2025-01-29 DOI: 10.1016/j.pharma.2025.01.011

Samantha Huynh, Adeline Bonan, Judith Pineau, Eloi Marijon, Brigitte Sabatier, Nicolas Martelli

{"title":"[Reprocessing of single-use medical devices: Viewpoints and perceptions of cardiologists and hospital pharmacists].","authors":"Samantha Huynh, Adeline Bonan, Judith Pineau, Eloi Marijon, Brigitte Sabatier, Nicolas Martelli","doi":"10.1016/j.pharma.2025.01.011","DOIUrl":"10.1016/j.pharma.2025.01.011","url":null,"abstract":"A pilot initiative on the reprocessing of medical devices (MD), particularly in electrophysiology, is expected to be launched in France in 2025. Reprocessing single-use medical devices (SUDs) presents potential benefits and challenges, with differing perspectives among healthcare professionals. This study aims to compare the knowledge and positions of hospital pharmacists (HP) and cardiologists (CA) regarding the use of reprocessed single-use devices (R-SUDs), in order to identify their concerns as well as points of convergence and divergence. A directive and mixed electronic questionnaire consisting of 27 questions was sent to HPs and CAs from the Assistance publique-Hôpitaux de Paris (AP-HP). Responses from 32 HPs and 30 CAs were analyzed using statistical methods via R software. The results revealed that CAs overwhelmingly support reprocessing, while HPs show significantly more reservations (P<0.0001). Among HPs, 56% (n=18) favored an \"open\" supply chain model for reprocessing, compared to 28% (n=9) who preferred a \"closed\" one. CAs show a more balanced distribution of their preferences, with 30% (n=9) favoring the \"open\" chain and 40% (n=12) the \"closed\" model. Both groups raised concerns about the safety and quality of reprocessed devices, but the majority would accept R-SUDs if clinical trials validated their safety and effectiveness compared to original SUDs. Reprocessing is nevertheless seen as a means to reduce hospital costs and carbon footprint in hospitals.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143073795","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 the European Medical Device Regulation on the availability of medical devices: Scoping review and two-year analysis on the risk for patients in the cardiovascular field].

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Annales pharmaceutiques francaises Pub Date : 2025-01-28 DOI: 10.1016/j.pharma.2025.01.008

Adeline Bonan, Samantha Huynh, Judith Pineau, Brigitte Sabatier, Nicolas Martelli

{"title":"[Impact of the European Medical Device Regulation on the availability of medical devices: Scoping review and two-year analysis on the risk for patients in the cardiovascular field].","authors":"Adeline Bonan, Samantha Huynh, Judith Pineau, Brigitte Sabatier, Nicolas Martelli","doi":"10.1016/j.pharma.2025.01.008","DOIUrl":"10.1016/j.pharma.2025.01.008","url":null,"abstract":"The implementation of the Medical Devices Regulation (MDR) 2017/745/EU leaves manufacturers facing new requirements to certify their medical devices (MDs). Our objective is to accurately assess the impact of regulation on the availability of cardiovascular MDs in healthcare facilities. High-risk cardiovascular MDs appear to be heavily impacted by the regulation, with reclassification leading to mandatory clinical investigations. Access to new MDs could be restricted by the increase in clinical evidence that must be provided. However, our analysis has shown that some manufacturers are focusing on innovative cardiovascular MDs, at the expense of marketing existing product lines. The unavailability of MDs has impacted the practice of physicians in patient care. Healthcare professionals are requesting exceptional exemptions from national authorities to use the MDs. To combat these shortages, amendments to the MDR have been introduced, such as the extension of the MDs recertification deadline and the introduction of a reporting system to anticipate shortages. European and national institutions are becoming aware of the supply difficulties associated with the regulation. A tool for sharing information and proposing alternatives would simplify the management of these shortages.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143062883","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

[Development and validation of a conductimetric method for determining traces of detergent in final rinse water].

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Annales pharmaceutiques francaises Pub Date : 2025-01-28 DOI: 10.1016/j.pharma.2025.01.010

Safae Alaoui, Ismail Bennani, Sara Hajjaj, Abdeslam El Kartouti

{"title":"[Development and validation of a conductimetric method for determining traces of detergent in final rinse water].","authors":"Safae Alaoui, Ismail Bennani, Sara Hajjaj, Abdeslam El Kartouti","doi":"10.1016/j.pharma.2025.01.010","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.01.010","url":null,"abstract":"Objective: The aim of our work is to develop a simple, rapid and inexpensive method for the detection and quantification of a detergent (phosphoric acid) in final rinse water using conductivity.Methods: The conductimetric method was used. A calibration curve was obtained by measuring the conductivity of successive dilutions of a stock solution of the detergent. The conductivity of the sample was measured using the water from the last rinse. Detergent concentration in the sample was calculated using the regression equation of the calibration curve. Analytical validation was carried out in accordance with international harmonization conference guidelines ICH Q2. Data analysis was performed using jamovi software version 2.3.28.Results: Linearity was proved by the correlation between concentration and conductivity with r =0.98. The coefficient of variation for repeatability and intermediate precision were low, and the mean recovery rates ranged from 98 to 102%. Calculated sample concentrations were below 5 ppm.Conclusions: The conductimetric method proposed in our study has been validated for the determination of phosphoric acid. It has the advantage of being rapid, inexpensive and simple. This makes the method the first choice for the determination of trace amounts of detergent in the pharmaceutical and research laboratories.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143062880","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

Green approach for simultaneous determination of long-acting β-agonists, their organic counterparts and corticosteroids by HPLC coupled with PDA detector.

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Annales pharmaceutiques francaises Pub Date : 2025-01-28 DOI: 10.1016/j.pharma.2025.01.009

Sweta Gupta, Sonal Desai

{"title":"Green approach for simultaneous determination of long-acting β-agonists, their organic counterparts and corticosteroids by HPLC coupled with PDA detector.","authors":"Sweta Gupta, Sonal Desai","doi":"10.1016/j.pharma.2025.01.009","DOIUrl":"10.1016/j.pharma.2025.01.009","url":null,"abstract":"Objective: Accurate, precise and robust HPLC method was developed for the simultaneous estimation of long-acting β2 agonist drugs (formoterol fumarate, salmeterol xinafoate and vilanterol trifenatate) along with two organic counterparts (xinafoic acid and triphenyl acetic acid) and inhaled corticosteroids (fluticasone propionate and fluticasone furoate).Material and methods: The separation was carried out using C18 column (250×4.6mm, 5μ) with eluent comprising of 0.05% orthophosphoric acid: methanol: acetonitrile (40:30:30, v/v/v) at a 1mL/min flow rate.Results: Linearity was observed in the concentration ranges of 1.5-12μg/mL for formoterol fumarate, 2.82-22.6μg/mL for xinafoic acid, 6.25-50μg/mL for vilanterol, 3.12-25μg/mL for salmeterol, 2.0-15.2μg/mL for triphenyl acetic acid, 62.5-500μg/mL for fluticasone propionate and 25-200μg/mL for fluticasone furoate.Conclusion: The proposed method was accurate, precise and robust and results were within the limit as per the ICH (Q2R1) guidelines. Additionally, the proposed method was found to be green and sustainable when analysed by different green analytical tools namely GAPI, AGREE, AGREEprep and BAGI.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063183","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}

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Investigating the binding dynamics and stability of bovine serum albumin with antibiotics with acridinedione dye.

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Annales pharmaceutiques francaises Pub Date : 2025-01-22 DOI: 10.1016/j.pharma.2025.01.006

Keerthiga Ravichandran, Rithika Kumaran, Kumaran Rajendran, Shoba Gunasekaran, Dhenadhayalan Namasivayam, Krishnan Anju

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[Review of practices concerning the delivery of an international implant card following the implantation of a medical device].

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Annales pharmaceutiques francaises Pub Date : 2025-01-22 DOI: 10.1016/j.pharma.2025.01.007

Alexia Laflotte, Constance Bretagnolle, Agnès Henry

{"title":"[Review of practices concerning the delivery of an international implant card following the implantation of a medical device].","authors":"Alexia Laflotte, Constance Bretagnolle, Agnès Henry","doi":"10.1016/j.pharma.2025.01.007","DOIUrl":"10.1016/j.pharma.2025.01.007","url":null,"abstract":"Introduction: The European regulation 2017/745 requires the delivery of an international implant card to the patient following the implantation of implantable medical devices (IMD). Currently, there are no procedure to describe the process for providing traceability documents to patients in our institution. The objective of this work was to evaluate the practices of the various departments concerned in our institution and to think about actions to meet the current regulation.Material and method: The evaluation of practices concerning the delivery of traceability documents to patients was evaluated through a questionnaire with 13 departments. Then, for each specialty, three electronic patient record (EPR) were audited. Finally, IMD's suppliers were asked about their ability to provide an international implant card.Results: In total, 85% (11/13) of the departments sent an IMD traceability document to patients, and in 91% (10/11) of cases, this transmission was done with the international implant card or the operative report. However, 63% of the operative report analyzed did not contain the traceability data of the IMD. Finally, only 60% of the suppliers contacts accompanied their IMD with an international implant card.Conclusion: While waiting for the suppliers to send an international implant card, it was proposed to the departments to give patients the IMD traceability sheet from the IMD traceability software. However, this document does not allow us to be in full compliance with the European regulation to the absence of regulatory information (UDI, address and manufacturer's website).","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143036274","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