Annales pharmaceutiques francaises最新文献

{"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}

{"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}

{"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 2.84×10⁴, 5.32×10⁴, and 3.06×10⁴L/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}

{"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}

{"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}

{"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}

{"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 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":"<p><p>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.</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":"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}