Annales pharmaceutiques francaises最新文献_第3页

[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

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}

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":"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 5ppm.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

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

引用次数: 0

[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

[Expectations of trainees in general practice about their observation period (internship) in community pharmacy]. 全科医生实习生对药学实习的期望。

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Annales pharmaceutiques francaises Pub Date : 2025-01-17 DOI: 10.1016/j.pharma.2025.01.005

Isabelle Bodein, Nassir Messaadi, Bertrand Décaudin, Annie Standaert, Antoine Telliez, Anne Garat, Anita Tilly-Dufour, Sabine Bayen, Matthieu Calafiore

引用次数: 0

[Analysis of pharmaceutical interventions related to outpatient treatment of chronic heart failure]. 【慢性心力衰竭门诊用药干预分析】。

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Annales pharmaceutiques francaises Pub Date : 2025-01-10 DOI: 10.1016/j.pharma.2025.01.004

Elisée Doffou, Aminata Coulibaly, Pascal Danho Abrogoua

{"title":"[Analysis of pharmaceutical interventions related to outpatient treatment of chronic heart failure].","authors":"Elisée Doffou, Aminata Coulibaly, Pascal Danho Abrogoua","doi":"10.1016/j.pharma.2025.01.004","DOIUrl":"10.1016/j.pharma.2025.01.004","url":null,"abstract":"Objective: Our aim was to analyze pharmaceutical interventions related to heart failure (HF) outpatient treatment.Methods: An observationnal study was carried out over 6 months at the Abidjan Institute of Cardiology (ICA). Data were collected using a survey form that focused on therapeutic adherence, drugs related-problems (DRP) and pharmaceutical interventions (PI). DRP and PI coding tool of French Society of Clinical Pharmacy was used. Therapeutic adherence was assessed using the GIRERD tool. Prescription review made by Algorithm of Calop. Clinical, economic and organizational impacts of PI accepted by the physician were rated using the CLEO tool.Results: Study population had a mean age of 51.4 years. DRP prevalence was 59%. These DRP were essentially adherence problem (43%) and drug-drug interactions (39.7%). The PIs were mainly \"optimization of administration methods\" (43.6%) and \"therapeutic monitoring\" (38.1%). The acceptance rate of PIs intended for prescribers was 80.8%. Mainly of these PIs were rated \"PI with minor clinical impact\" (60.2%), \"PI without economic impact\" (83.8%) and PI with \"positive organizational impact\" (63.2%).Conclusion: DRPs and more specifically adherence problems and drug-drug interactions are common in HF outpatient management. The pharmacist can contribute to improve this care through regular assessment of therapeutic adherence and management of DRPs.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969369","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

Sustained release of Ambrisentan solid lipid nanoparticles for the treatment of hypertension: Melt emulsification method. 氨布里森坦固体脂质纳米颗粒治疗高血压的缓释：熔融乳化法。

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Annales pharmaceutiques francaises Pub Date : 2025-01-07 DOI: 10.1016/j.pharma.2025.01.003

Harshada Shewale, Abhishek Kanugo

{"title":"Sustained release of Ambrisentan solid lipid nanoparticles for the treatment of hypertension: Melt emulsification method.","authors":"Harshada Shewale, Abhishek Kanugo","doi":"10.1016/j.pharma.2025.01.003","DOIUrl":"10.1016/j.pharma.2025.01.003","url":null,"abstract":"Objective: The beneficial usefulness is limited because of its deprived solubility and bioavailability. The recent work deals with the advancement of solid lipid nanoparticles of Ambrisentan for the effective therapy of pulmonary hypertension intended for oral delivery.Material and methods: The solid lipid nanoparticles of Ambrisentan were developed using the melt emulsification method. The characterization of Ambrisentan was carried out with FTIR, DSC, and crystalline nature with XRD. The optimization was accomplished with the Box-Behnken design. The glyceryl monostearate (GMS), Tween 80, and sonication time were considered independent factors and the particle size, and entrapment efficiency were the critical quality attributes in the development of SLN.Results: The compatibility, thermal nature, and crystalline behavior were confirmed with FTIR, DSC, and XRD respectively. The preferred batch F10 indicated a particle size of 166.7nm and an entrapment efficiency of 83.96%. The cumulative percentage of drug dissolved from the optimized Ambrisentan-loaded SLN was 87.68% after 24h indicating a sustained release pattern. Furthermore, after lyophilization and estimated with scanning electron microscopy a particle size of 153.5 to 179.8nm was confirmed. The lyophilized powder is intended for oral delivery and has significant bioavailability, minimizing the chances of mortality due to its sustained release action.Conclusion: The significant improvement in solubility of Ambrisentan was achieved through solid lipid nanoparticles which facilitates greater efficacy.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142943404","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 of an e-learning training program for pharmacy technicians' authorization in non-sterile compounding unit]. 非无菌配药单位药学技术人员授权电子学习培训项目的开发

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Annales pharmaceutiques francaises Pub Date : 2025-01-07 DOI: 10.1016/j.pharma.2025.01.001

Mathilde Noguero, Aasfa Khan, Arnaud Venet

{"title":"[Development of an e-learning training program for pharmacy technicians' authorization in non-sterile compounding unit].","authors":"Mathilde Noguero, Aasfa Khan, Arnaud Venet","doi":"10.1016/j.pharma.2025.01.001","DOIUrl":"10.1016/j.pharma.2025.01.001","url":null,"abstract":"Objectives: Training of pharmacy technicians in non-sterile compounding unit must meet the requirements of the French Good Manufacturing Practices. Our current training program is composed of one week companionship preceded by a theoretical course and do not allow the acquisition of all the skills and knowledge required. The formation load over the pharmacist and technician also increase due to an important turnover among the technicians. The aim of this work is to improve the current training by the development and implementation of an e-learning training program.Methods: E-learning program was developed by a multidisciplinary team using the instructional system design model ADDIE. The first two levels of Kirkpatrick's evaluation model were assessed using a satisfaction survey and an evaluation conducted before and after the program by the agents who attended the course.Results: The online training program include 4 units divided into 10 sequences available in PowerPoint® format. Fifteen pharmacy technicians were able to test the course. Among them, 6 agents finished the program and were satisfied with the training. Evaluation grade improved after the course (18.33/25) compared with the first evaluation (10.25/25).Conclusion: The development of an e-learning course completed the existing training program by providing standardized knowledge that strengthens practical training. New modules on various topics can be added later to improve ongoing training of pharmacy technicians in the compounding unit.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142943400","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