Annales pharmaceutiques francaises最新文献

{"title":"First international guidelines on glucocorticoid-induced adrenal insufficiency: When and how to manage glucocorticoid tapering and discontinuation?","authors":"Damien Denimal","doi":"10.1016/j.pharma.2025.01.014","DOIUrl":"10.1016/j.pharma.2025.01.014","url":null,"abstract":"","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":"143073220","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":"Impact of antioxidant excipients on N-nitrosamine formation and bioequivalence in metformin formulations (review article).","authors":"Güler Yağmur Akyüz","doi":"10.1016/j.pharma.2025.01.012","DOIUrl":"10.1016/j.pharma.2025.01.012","url":null,"abstract":"<p><p>The discovery of N-nitrosamine impurities in pharmaceutical products has raised serious quality concerns, particularly in metformin products, which are widely used in the treatment of type 2 diabetes mellitus. The detection of N-nitrosodimethylamine (NDMA) in metformin products has led to global recalls and increased regulatory investigations. Generic manufacturers face the challenge of balancing stringent bioequivalence requirements for Biopharmaceutical Classification System (BCS) Class III drugs, which require strict control of excipient composition while ensuring N-nitrosamine control and therapeutic equivalence. The use of antioxidants as a strategy to reduce N-nitrosamine formation requires careful consideration to maintain both bioequivalence and product safety. This article evaluates the use of antioxidants for the prevention of N-nitrosamine formation in metformin formulations, addressing the implications of this strategy on bioequivalence and its relationship with the regulatory framework.</p>","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":"143073416","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":"[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":"<p><p>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.</p>","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}

{"title":"Impact du Règlement Européen sur les dispositifs médicaux sur leur disponibilité : scoping review et analyse sur deux ans du risque pour les patients dans le domaine cardiovasculaire","authors":"Adeline Bonan ,&nbsp;Samantha Huynh ,&nbsp;Judith Pineau ,&nbsp;Brigitte Sabatier ,&nbsp;Nicolas Martelli","doi":"10.1016/j.pharma.2025.01.008","DOIUrl":"10.1016/j.pharma.2025.01.008","url":null,"abstract":"<div><div>L’entrée en vigueur du Règlement Européen 2017/745 confronte les industriels à de nouvelles exigences pour certifier leurs dispositifs médicaux (DM). Notre objectif est d’évaluer précisément l’impact du règlement sur la disponibilité des DM du domaine cardiovasculaire (CV) dans les établissements de santé. Les DM à haut risque du domaine CV semblent très impactés par le règlement, avec la reclassification entraînant l’obligation d’effectuer des investigations cliniques. L’accès aux nouveaux DM serait freiné par l’augmentation des preuves cliniques à fournir. Toutefois, notre analyse montre la priorité de certains industriels à se consacrer aux DM innovants du domaine CV aux dépens de la commercialisation de gammes existantes chez d’autres. L’indisponibilité des DM modifie la pratique des médecins dans la prise en charge du patient. Les professionnels de santé ont dû demander des dérogations exceptionnelles auprès des instances nationales pour utiliser le DM. Pour lutter contre ces pénuries, des textes modificatifs du règlement ont été introduits, avec extension du délai de recertification des DM et introduction de systèmes de signalement pour anticiper les pénuries. Les institutions européennes et nationales prennent conscience de la difficulté d’approvisionnement liée au règlement. Un outil de partage d’informations et de proposition d’alternatives simplifierait la gestion de ces pénuries.</div></div><div><div>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.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 3","pages":"Pages 428-437"},"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}

{"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":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","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}

{"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":"<p><strong>Objective: </strong>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).</p><p><strong>Material and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","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}

{"title":"Investigating the binding dynamics and stability of bovine serum albumin with antibiotics with acridinedione dye.","authors":"Keerthiga Ravichandran, Rithika Kumaran, Kumaran Rajendran, Shoba Gunasekaran, Dhenadhayalan Namasivayam, Krishnan Anju","doi":"10.1016/j.pharma.2025.01.006","DOIUrl":"10.1016/j.pharma.2025.01.006","url":null,"abstract":"<p><p>Exploring the energetics and bimolecular interaction of bovine serum albumin (BSA) with various classes and generations of antibiotics in the absence and presence of a resorcinol based acridinedione dye (ADR1) were carried out. The binding stability of BSA-antibiotic complexes decreases on the introduction of ADR1 dye resulting in a positive value of free energy change, accompanied with several unfavourable interactions. Several polar amino acids contributed to the stability of the host-guest complex compared to that of non-polar amino acids, wherein BSA acts as the host, and antibiotics as the guest and ADR1 dye as the competing guest molecule. Hydrogen-bonding interactions govern the binding stability and energetics compared to that of hydrophobic interactions is elucidated in the present study.</p>","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":"143036276","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":"[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":"<p><strong>Introduction: </strong>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.</p><p><strong>Material and method: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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).</p>","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}

{"title":"Attentes des internes de médecine générale envers leur stage d’observation en pharmacie d’officine","authors":"Isabelle Bodein ,&nbsp;Nassir Messaadi ,&nbsp;Bertrand Décaudin ,&nbsp;Annie Standaert ,&nbsp;Antoine Telliez ,&nbsp;Anne Garat ,&nbsp;Anita Tilly-Dufour ,&nbsp;Sabine Bayen ,&nbsp;Matthieu Calafiore","doi":"10.1016/j.pharma.2025.01.005","DOIUrl":"10.1016/j.pharma.2025.01.005","url":null,"abstract":"<div><h3>Objectifs</h3><div>Ce travail avait pour objectif de recueillir les attentes des internes de médecine générale concernant leur stage d’observation en pharmacie d’officine pour contribuer à une nouvelle définition des objectifs de ce stage.</div></div><div><h3>Méthodes</h3><div>Le recueil des données a été réalisé selon la technique du groupe nominal. Les onze participants étaient des internes de neuvième année de médecine générale.</div></div><div><h3>Résultats</h3><div>Quarante-six propositions ont été émises et classées selon la priorité et la popularité pour en retenir au final quatorze.</div></div><div><h3>Conclusions</h3><div>Les quatorze propositions retenues peuvent être classées en 4 grandes catégories : l’acte pharmaceutique, les soins primaires et l’accompagnement du patient, le fonctionnement d’une pharmacie et la diversité des activités des pharmacies d’officine. Ces propositions soutiennent le développement de la communication interprofessionnelle et doivent permettre de faire évoluer le référentiel pédagogique du stage d’observation.</div></div><div><h3>Objectives</h3><div>The aim of this study was to collect the expectations of trainees in general practice towards their observation period in a community pharmacy, in order to contribute to a new definition of the objectives of this training period.</div></div><div><h3>Methods</h3><div>Data were collected using the nominal group technique. The eleven participants were ninth-year general medical students.</div></div><div><h3>Results</h3><div>Forty-six proposals were made and ranked according to priority and popularity, resulting in the selection of fourteen.</div></div><div><h3>Conclusions</h3><div>The fourteen proposals selected can be classified into 4 main categories: the pharmaceutical act, primary care and patient support, the operation of a pharmacy and the diversity of the activities of dispensing pharmacies. The proposals support the development of interprofessional communication and should make it possible to improve the teaching guidelines for observation periods.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 3","pages":"Pages 575-583"},"PeriodicalIF":1.0,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998885","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":"[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":"<p><strong>Objective: </strong>Our aim was to analyze pharmaceutical interventions related to heart failure (HF) outpatient treatment.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p>","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}