Annales pharmaceutiques francaises最新文献

{"title":"Formulation and evaluation of a smart mucoadhesive nasal gel containing oregano, chamomile, and lavender for seizure control in PTZ-induced seizure model in rats","authors":"Samin Sheikholeslami , Amir Baghaei , Marziyeh Amiri-Andebili , Faranak Salmannejad , Mohammad Mahdi Ahmadian-Attari","doi":"10.1016/j.pharma.2025.03.004","DOIUrl":"10.1016/j.pharma.2025.03.004","url":null,"abstract":"<div><h3>Background</h3><div>Epilepsy is a prevalent neurological disorder characterized by recurrent seizures, affecting approximately 1% of the global population. Despite the availability of antiepileptic drugs, a significant proportion of patients experience uncontrolled seizures, which necessitates the development of alternative therapeutic strategies. Herbal medicine has gained attention due to its potential anticonvulsant properties.</div></div><div><h3>Objectives</h3><div>This study aimed to assess the anticonvulsant effects of hydroalcoholic extracts of oregano, chamomile, and lavender in rats’ pentylenetetrazol (PTZ)- induced seizure model. Furthermore, it sought to formulate and evaluate a mucoadhesive nasal hydrogel containing these extracts.</div></div><div><h3>Methods</h3><div>The herbal extracts were prepared using ethanol (70%) through maceration and analyzed based on the Iranian Herbal Pharmacopeia standards. Total phenolic content (TPC) was quantified using the spectrophotometric method to standardize the extracts. Using various gelling agents, the nasal hydrogel formulation was optimized for mucoadhesion and gelation properties. The anticonvulsant activity was evaluated in vivo using seizure models induced by pentylenetetrazol (PTZ).</div></div><div><h3>Results</h3><div>The herbal extracts met the pharmacopeial standards, and the nasal hydrogel formulation demonstrated favorable physicochemical properties, including optimal pH and mucoadhesive strength. In vivo studies showed that intranasal administration of the herbal extracts significantly delayed seizure onset and reduced seizure intensity at a dose of 34<!--> <!-->mg/kg, compared to the negative control group (<em>P</em> <!--><<!--> <!-->0.001).</div></div><div><h3>Conclusion</h3><div>The smart mucoadhesive nasal hydrogel containing oregano, chamomile, and lavender extracts exhibited promising anticonvulsant activity, suggesting its potential as a novel, non-invasive alternative for epilepsy management.</div></div><div><h3>Contexte</h3><div>L’épilepsie est un trouble neurologique répandu caractérisé par des crises récurrentes, touchant environ 1 % de la population mondiale. Malgré la disponibilité des médicaments antiépileptiques, une proportion importante de patients souffrent de crises incontrôlées, ce qui nécessite le développement de stratégies thérapeutiques alternatives. La phytothérapie a attiré l’attention en raison de ses propriétés anticonvulsivantes potentielles.</div></div><div><h3>Objectifs</h3><div>Cette étude visait à évaluer les effets anticonvulsivants des extraits hydroalcooliques d’origan, de camomille et de lavande dans le modèle de crise induite par le pentylènetétrazole (PTZ) chez le rat. De plus, elle visait à formuler et à évaluer un hydrogel nasal mucoadhésif contenant ces extraits.</div></div><div><h3>Méthodes</h3><div>Les extraits de plantes ont été préparés à l’éthanol (70 %) par macération et analysés selon les normes de la pharmacopée iranie","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 852-861"},"PeriodicalIF":1.1,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673408","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":"Le biologiste médical sous la loupe sémiotique","authors":"Bertrand Lefrère ,&nbsp;Lionel Barrand ,&nbsp;Jean-Louis Beaudeux","doi":"10.1016/j.pharma.2025.03.003","DOIUrl":"10.1016/j.pharma.2025.03.003","url":null,"abstract":"<div><div>En France, l’exercice de la biologie médicale suscite, depuis une dizaine d’année, un certain désamour des étudiants en médecine. Malgré son intrication et son importance dans le parcours de soin, l’univers du laboratoire clinique manque de visibilité pratique dans les études médicales. Si la désaffection ne peut être directement imputée à ce phénomène structurel, au regard de phénomènes plus récents, l’accès et la qualité de l’information pour l’orientation vers les études conduisant à la biologie médicale apparaissent essentiels. Ceci nous a conduit à interroger l’image, au sens iconographique du terme, associée au métier, via une analyse sémiotique. En dépit de quelques fantaisies, le corpus iconographique obtenu, composé d’images numériques éditées depuis dix ans, offre une vision consensuelle, assez raisonnable, centrée sur la phase analytique ; cet aperçu tronqué du métier reflète de manière très imparfaite la richesse d’exercices, de spécialités, la complexité technologique de l’analyse biologique et la relation avec les patients et l’équipe soignante. À ce titre, l’interaction clinique, avec le patient ou le clinicien, demeure, sauf exception, absente, interrogeant l’impact sur la perception du métier suscitée chez les étudiants.</div></div><div><div>In France, the practice of laboratory medicine has, over the past ten years or so, met with a certain amount of disenchantment from medical students. Despite its intricacy and importance to healthcare, the world of the clinical laboratory lacks visibility in medical studies. While other phenomena can explain this disenchantment, our belief in the importance of promoting greater visibility of laboratory medicine in medical studies led us to examine for this article the images and symbols associated with the profession, based on a semiotic analysis. We created a collection of digital images published over the last ten years and found that these images, aside from a few outliers, offer a fairly reasonable representation of the analytical dimension of laboratory medicine. However, we found that this collection of images does not reflect the wealth of specialities, technological complexity and other important aspects of the practice of laboratory medicine especially regarding the clinical staff. Furthermore, we found that clinical interactions (i.e., interactions with patients or doctors) remain, with a few exceptions, absent from most of the images, raising questions about the impact of the images on medical students’ perceptions of the profession.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 819-824"},"PeriodicalIF":1.1,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639491","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":"Pharmacological and herbal approach to diabetes mellitus type 2 management: A comparative analysis of conventional therapy and alternative remedy","authors":"Zahra Shareef ,&nbsp;Afsana Murtaza ,&nbsp;Ghousia Fatima ,&nbsp;Amjad Islam Aqib ,&nbsp;Zahid Manzoor ,&nbsp;Muhammad Sibghat Ullah Malik ,&nbsp;Hafiz Iftikhar Hussain","doi":"10.1016/j.pharma.2025.03.002","DOIUrl":"10.1016/j.pharma.2025.03.002","url":null,"abstract":"&lt;div&gt;&lt;div&gt;&lt;span&gt;Diabetes mellitus is a heterogeneous metabolic disorder that affects the metabolism of protein, fats, and carbohydrates due to the destruction of beta-cells resulting disruptions in insulin action/insulin secretion. According to International Diabetes Federation (IDF) prevalence of 90% people with diabetes has type 2 diabetes is driven by socio-economic, demographic, environmental, and genetic factors. DM type 2 sparks myriad of debilitating disease needs management to cure it. Management needs multifactorial authentication including diet, lifestyle and pharmacotherapy. Literature reveals, metformin is the first line of medication used to cure diabetes Mellitus type 2, also associated with contraindications and adverse effects which spark the interest in alternative herbal remedies. This review will compare pharmacological therapy (metformin) with alternative herbal remedies (&lt;/span&gt;&lt;em&gt;Moringa oleifera&lt;/em&gt;) in the management of diabetes mellitus type 2 including in mechanism, dosing relationship consequential effect. According to various guidelines and recommendations, &lt;em&gt;Moringa oleifera&lt;/em&gt; is herbal remedy to exhibit anti-diabetic properties by enhancing insulin sensitivity and glucose regulation, reducing oxidation stress and inhibiting free radicals. Significant outcomes suggest that moringa leaf extract is a valuable adjoining therapy with safety high profiling with fewer or no side effects as compared to metformin. There is a need for alternative approaches to diabetes management due to side effects of pharmacological therapies. This review paper will also demonstrate the potential of alternative remedy (&lt;em&gt;Moringa oleifera&lt;/em&gt;) in the management of DM type 2 and to what extent its dosing is related to efficacy and safety as compared to the pharmacological approach (Metformin).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;Le diabète sucré est un trouble métabolique hétérogène qui affecte le métabolisme des protéines, des graisses et des glucides en raison de la destruction des cellules bêta, entraînant des perturbations de l’action/sécrétion d’insuline. Selon la Fédération internationale du diabète (FID), la prévalence de 90 % des personnes diabétiques atteintes de diabète de type 2 est déterminée par des facteurs socioéconomiques, démographiques, environnementaux et génétiques. Le diabète de type 2 déclenche une myriade de maladies débilitantes qui doivent être prises en charge pour être guéries. La prise en charge nécessite une authentification multifactorielle incluant l’alimentation, le mode de vie et la pharmacothérapie. La littérature révèle que la metformine est la première ligne de médicaments utilisée pour guérir le diabète sucré de type 2, également associée à des contre-indications et à des effets indésirables qui suscitent l’intérêt pour les remèdes alternatifs à base de plantes. Cette revue comparera la thérapie pharmacologique (metformine) avec des remèdes alternatifs à base de plantes (&lt;em&gt;Moringa oleifera&lt;/em&gt;) dans la prise ","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 796-809"},"PeriodicalIF":1.1,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630121","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":"Regulatory frameworks and filing discrepancies in generic drug approvals: A cross-regional study with analysis of FDA ANDA deficiencies","authors":"Jyoti Pawar,&nbsp;Namita Hegde,&nbsp;Sanjay Sharma","doi":"10.1016/j.pharma.2025.03.001","DOIUrl":"10.1016/j.pharma.2025.03.001","url":null,"abstract":"<div><h3>Objectives</h3><div>This research aims to analyse the regulatory frameworks for generic drug applications in the U.S., EU, India, Japan, and China comparing their filing requirements to identify gaps and areas for harmonization. Additionally, it focuses on examining common deficiencies in ANDA from FDA submissions in 2014–2023 to address issues, facilitating more efficient approvals and minimizing delays.</div></div><div><h3>Material and methods</h3><div>The research involved analysing regulatory documents available on official websites, including the FDA, EMA, CDSCO, PMDA, and NMPA to achieve first objective. For second objective, a recurring common deficiency across key review disciplines such as bioequivalence, labelling and chemistry was identified through a detailed analysis of deficiency letters available on the FDA website. A targeted analysis was conducted on ANDA submissions filed between 2014 and 2024.</div></div><div><h3>Results</h3><div>A total of 172 deficiencies were identified, with bioequivalence (35%), chemistry (34%), and labelling (31%). Method validation had the most deficiencies, especially non-compliance with FDA guidelines. In the labelling discipline, the most common deficiency was non-compliance with reference listed drug (RLD) labelling. Comparisons with EMA and WHOPQTm revealed similarities in common deficiencies.</div></div><div><h3>Conclusion</h3><div>This descriptive study highlights regulatory frameworks for generics share significant differences in practical requirements. A harmonized approach could enhance efficiency and standardized submissions. Bioequivalence issues were the most prevalent, with chemistry-related deficiencies, while labelling issues were the least common seen in ANDA applications. This offer concerns to manufacturers for dossier compilation, aiming to accelerate generic drug registration.</div></div><div><h3>Objectifs</h3><div>Cette recherche vise à analyser les cadres réglementaires pour les demandes de médicaments génériques aux États-Unis, dans l’UE, en Inde, au Japon et en Chine en comparant leurs exigences de dépôt afin d’identifier les lacunes et les domaines d’harmonisation. De plus, il se concentre sur l’examen des lacunes courantes de l’ANDA dans les soumissions à la FDA de 2014 à 2023 afin de résoudre les problèmes, de faciliter des approbations plus efficaces et de minimiser les retards.</div></div><div><h3>Matériels et méthodes</h3><div>La recherche a consisté à analyser les documents réglementaires disponibles sur les sites web officiels, y compris la FDA, l’EMA, le CDSCO, la PMDA et la NMPA pour atteindre le premier objectif. Pour le deuxième objectif, une lacune commune récurrente dans les principales disciplines d’examen telles que la bioéquivalence, l’étiquetage et la chimie a été identifiée grâce à une analyse détaillée des lettres de déficience disponibles sur le site web de la FDA. Une analyse ciblée a été menée sur les soumissions ANDA déposées entre 2014 et 2024.</","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 876-889"},"PeriodicalIF":1.1,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613233","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":"Pharmacovigilance européenne des médicaments de thérapie innovante","authors":"Nadine Petitpain ,&nbsp;Viktoryia Prontskus ,&nbsp;Mélanie Gauthier ,&nbsp;Lena Loutterbach ,&nbsp;Cécile Pochon ,&nbsp;Jean Hugues Dalle ,&nbsp;Danièle Bensoussan","doi":"10.1016/j.pharma.2025.02.011","DOIUrl":"10.1016/j.pharma.2025.02.011","url":null,"abstract":"<div><div>Les médicaments de thérapie innovante (MTI) prennent une place progressivement croissante en thérapeutique et représentent, parfois, le seul espoir d’amélioration, voire de guérison, de certaines pathologies. Leur origine biologique, leur composition, leur mode d’action et leur fréquente complexité technique sont générateurs de nouveaux risques. Par ailleurs, les essais cliniques ne portent généralement que sur un très faible nombre de patients. La pharmacovigilance des MTI doit s’adapter à ces contraintes et à ces nouveaux risques identifiés ou potentiels pour être autorisés en Europe selon une procédure centralisée. La conception et l’analyse du plan de gestion des risques sont essentielles pour permettre, en complément de la pharmacovigilance dite « de routine », de continuer l’évaluation de la sécurité du MTI en conditions réelles et d’adapter les mesures de surveillance si besoin. Cet article fait un état des lieux des MTI et des spécificités réglementaires en matière de pharmacovigilance, en détaillant le rôle des comités européens dont le <em>Committee for Advanced Therapies</em>, l’importance du plan de gestion des risques et en abordant la problématique des effets indésirables retardés. La pharmacovigilance des MTI préparés ponctuellement (MTI-PP), dans le cadre de l’exemption hospitalière, est également décrite en prenant l’exemple de MTI-PP d’immunothérapie adoptive.</div></div><div><div>Advanced therapy medicinal products (ATMPs) are playing an increasingly important role in therapeutics, and sometimes represent the only hope of improving or even curing some pathologies. Because of their biological origin, composition, mode of action, and their frequent technical complexity, ATMPs are potentially generating new risks. Moreover, clinical trial data generally concern only a very small number of patients. The pharmacovigilance of ATMPs must adapt to these constraints and to these new identified or potential risks to be authorized according to an European centralized procedure. The conception and the assessment of the Risk Management Plan are essential to complete routine pharmacovigilance with post-authorization studies and additional risk minimisation measures adapted to the identified safety concerns. This article provides an overview of existing ATMPs and their specific regulatory pharmacovigilance requirements, involving the role of the European committees. It aims to describe the essential elements of the risk management plan of ATMPS, with a focus on delayed adverse reactions. The particular case of ATMPs prepared in the context of « hospital exemption », is also addressed, with the example of ATMPs for adoptive immunotherapy.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 825-840"},"PeriodicalIF":1.1,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536558","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":"Solubility and thermodynamic properties of amlodipine besylate in two binary mixtures of n-methyl pyrrolidone + 1-propanol/2-propanol at different temperatures","authors":"Seyedmahdi Naghavi Kalajahi,&nbsp;Elaheh Rahimpour,&nbsp;Abolghasem Jouyban","doi":"10.1016/j.pharma.2025.02.009","DOIUrl":"10.1016/j.pharma.2025.02.009","url":null,"abstract":"<div><div>In this study, the solubility of amlodipine besylate in N-methyl-pyrrolidone/1-propanol and N-methyl-pyrrolidone/2-propanol binary mixture systems were measured using a common shake-flask method followed by spectroscopy analysis at temperature ranges from 298.2<!--> <!-->K to 313.2<!--> <!-->K. The generated data were fitted to some models, van’t Hoff, Jouyban–Acree, Jouyban–Acree–van’t Hoff, mixture response surface, and modified Wilson, to mathematical representation the solubility data. Finally, the apparent thermodynamics properties for the saturated mixtures were computed using van’t Hoff and Gibbs equations.</div></div><div><div>Dans cette étude, la solubilité du amlodipine bésylate dans les systèmes de mélange binaire N-méthyl-pyrrolidone/1-propanol et N-méthyl-pyrrolidone/2-propanol a été mesurée à l’aide d’une méthode commune shake-flask suivie d’une analyse spectroscopique à des températures allant de 298,2. K à 313,2<!--> <!-->K. Les données générées ont été ajustées à certains modèles, van’t Hoff, Jouyban–Acree, Jouyban–Acree–van’t Hoff, mixture response surface, et modified Wilson pour représenter mathématiquement les données de solubilité. Enfin, les propriétés thermodynamiques apparentes des mélanges saturés ont été calculées à l’aide des équations de van’t Hoff et Gibbs.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 841-851"},"PeriodicalIF":1.1,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530957","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":"Photodynamic anti-cancer therapy and arachidonic acid metabolism: State of the art in 2024","authors":"Hicham Wahnou ,&nbsp;Youness Limami ,&nbsp;Raphaël Emmanuel Duval ,&nbsp;Bassel Ismail ,&nbsp;David Yannick Léger ,&nbsp;Vincent Sol ,&nbsp;Bertrand Liagre","doi":"10.1016/j.pharma.2025.02.010","DOIUrl":"10.1016/j.pharma.2025.02.010","url":null,"abstract":"<div><div><span><span><span>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 </span>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 </span>cyclooxygenase<span>, lipoxygenase and </span></span>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.</div></div><div><div><span>La thérapie photodynamique (PDT) a émergé comme une modalité prometteuse et en évolution dans le traitement du cancer exploitant des composés photosensibles appelés photosensibilisateurs pour induire sélectivement la mort cellulaire dans les tissus malins par la génération d’espèces réactives de l’oxygène (ERO). Cette revue explore les mécanismes complexes de la PDT en mettant en évidence le rôle crucial des photosensibilisateurs et le stress oxydatif résultant qui endommage les cellules cancéreuses. Elle examine les applications variées de la PDT dans différents types de cancers ainsi que les avantages et les limitations inhérents à cette thérapie. Les avancées technologiques récentes y compris des photosensibilisateurs améliorés et de nouveaux systèmes de délivrance de la lumière sont également discutées. De plus, la revue analyse le rôle critique du métabolisme de l’acide arachidonique (AA) dans la progression du cancer détaillant les voies cyclooxygenase, lipoxygenase et </span>cytochrome P450 et leurs contributions à la biologie tumorale. En élucidant l’interaction entre la PDT et le métabolisme de l’AA, la revue souligne le potentiel de cibler les voies métaboliques de l’AA pour améliorer l’efficacité de la PDT. Enfin, elle fournit des perspectives cliniques et translationnelles en mettant en lumière les recherches en cours et les futures directions visant à optimiser la PDT pour de meilleurs résultats dans le traitement du cancer.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 785-795"},"PeriodicalIF":1.1,"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}

{"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}

{"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":"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}