Annales pharmaceutiques francaises最新文献

{"title":"Covid-19 psychological distress: Analysis of antipsychotic drugs’ use in an Italian population sample","authors":"","doi":"10.1016/j.pharma.2024.04.007","DOIUrl":"10.1016/j.pharma.2024.04.007","url":null,"abstract":"<div><h3>Background</h3><p>The current pandemic, in addition to putting a strain on healthcare systems and global economies, has exacerbated psychiatric problems and undermined the mental health of many individuals. In an Italian cohort, this phenomenon has been assessed through a retrospective study aimed at evaluating the consumption and costs of antipsychotic drugs between 2020 and 2022.</p></div><div><h3>Methods</h3><p>All dispensations made in local pharmacies accessible to the public have been extracted from a database called ‘Sistema Tessera Sanitaria’, which covers a population of approximately one million people residents in the ASL Napoli 3 Sud. Consumption data expressed in defined daily dose (DDD) and expenditure data expressed in Euro have been extrapolated.</p></div><div><h3>Results</h3><p>The results in the years 2020–2021 were relatively consistent, with consumption and expenditure decreasing slightly from 2020 to 2021. In 2022, the results showed a decrease in consumption and expenditure (2,706,951.07 DDD and €1,700,897.47) representing the reduced accessibility of patients to the healthcare facilities due to the pandemic. However, it should be noted that the antipsychotic drug aripiprazole showed an upward trend, registering an increase in consumption.</p></div><div><h3>Conclusion</h3><p>Despite expectations of increased consumption of antipsychotic medications, real-world evidence indicated a different phenomenon, with the pandemic seemingly not affecting the consumption of these drugs. The difficulty in accessing care and medical appointments has probably influenced this data, masking the therapeutic needs of citizens. It will be necessary to assess in the coming years, as normal clinical activity resumes, whether there will be a growing consumption of these medications, which represent one of the main expenditure categories for the National Healthcare System.</p></div><div><h3>Contexte</h3><p>La pandémie actuelle, en plus de mettre à rude épreuve les systèmes de santé et les économies mondiales, a exacerbé les problèmes psychiatriques et miné la santé mentale de nombreux individus. Il est bien connu que les événements épidémiques, en particulier les périodes de confinement, augmentent le risque de développer des troubles anxieux, des dépressions et des comportements agressifs.</p></div><div><h3>Méthodes</h3><p>Dans une cohorte italienne, ce phénomène a été évalué par le biais d’une étude rétrospective visant à évaluer la consommation et les coûts des médicaments antipsychotiques pendant et après la pandémie de Covid-19 dans les années 2020–2022. Toutes les ordonnances délivrées dans les pharmacies locales accessibles au public ont été extraites d’une base de données appelée Health Card System, couvrant une population d’environ un million de personnes.</p></div><div><h3>Résultats</h3><p>Les résultats pour les années 2020 à 2021 sont relativement cohérents, la consommation et les dépenses ayant légèrement diminué entre 2020 et ","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 5","pages":"Pages 840-847"},"PeriodicalIF":1.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140780545","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":"Glycemic and lipid control in patients with diabetes at time of myocardial infarction","authors":"","doi":"10.1016/j.pharma.2024.04.010","DOIUrl":"10.1016/j.pharma.2024.04.010","url":null,"abstract":"<div><h3>Objective</h3><p>Cardiovascular risk is increased in patients with diabetes. Little is known about glycemic and lipid control in patients with diabetes. We aimed to assess glycemic and lipid controls in patients with diabetes at time of their myocardial infarction.</p></div><div><h3>Method</h3><p>All known patients with type 2 diabetes consecutively admitted for a myocardial infarction in our coronary care unit between March 1<sup>st</sup> and December 31<sup>st</sup>, 2021 were included in this retrospective study. Glycemic and lipid control was assessed through individualized target of glycated haemoglobin (HbA<sub>1c</sub>) and low-density lipoprotein cholesterol (LDL-c), respectively. At admission, the comprehensive list of chronic medications was obtained through medication reconciliation.</p></div><div><h3>Results</h3><p>This study included 112 patients with a median age of 72 years. Most of patients had an individualized target of HbA<sub>1c</sub> and LDL-c of 7.0% (67%) and 0.55<!--> <!-->g/L (96%), respectively. The rate of uncontrolled patients for HbA<sub>1c</sub> and LDL-c and both was 46%, 90%, and 42% respectively. The rate of patients with non-optimal glucose- and lipid-lowering medications in uncontrolled patients was 63% and 87%, respectively. The rate of inappropriate glucose- and lipid-lowering medications was 73% and 91%, respectively.</p></div><div><h3>Conclusion</h3><p>We highlighted the poor glycemic and lipid control in high-risk CV patients. There is an urgent need to develop multidisciplinary approaches to optimize CV risk factors control to reduce myocardial infarction and strokes.</p></div><div><h3>Objectif</h3><p>Les patients diabétiques présentent un haut risqué cardiovasculaire. Peu de données existent sur le contrôle glycémique et lipidique des patients diabétiques en vie réelle. Notre objectif était d’évaluer le contrôle glycémique et lipidique des patients diabétiques au moment de leu infarctus du myocarde.</p></div><div><h3>Méthode</h3><p>Tous les patients diabétiques connus admis dans notre unité de soins intensifs de cardiologie pour un infarctus du myocarde entre mars et décembre 2021 ont été inclus dans notre analyse rétrospective. Le contrôle glycémique et lipidique a été évalué à l’aide des valeurs cibles individualisées d’hémoglobine glyquée (HbA<sub>1c</sub>) et du cholestérol lipoprotéine de faible densité (LDL-c). À l’admission, un bilan médicamenteux optimisé a été effectué par le pharmacien.</p></div><div><h3>Résultats</h3><p>L’étude a inclus 112 patients d’âge médian 72 ans. La plupart des patients avait des valeurs de HbA<sub>1c</sub> et LDL-c cibles de 7,0 % (67 %) et 0,55 g/L (96 %), respectivement. Le taux de patients non contrôlés pour HbA<sub>1c</sub>, LDL-c et les deux était 46 %, 90 % et 42 %, respectivement. Le taux de patients avec un traitement antidiabétique et hypolipémiant non optimal était 63 % et 87 %, respectivement. Le taux de médicaments antidiabétiques et hypolipémiants ","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 5","pages":"Pages 865-872"},"PeriodicalIF":1.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140849298","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 of mucoadhesive microspheres for intranasal delivery of fluconazole as an alternative treatment of cryptococcal meningitis infection in patients with acquired immunodeficiency","authors":"","doi":"10.1016/j.pharma.2024.04.001","DOIUrl":"10.1016/j.pharma.2024.04.001","url":null,"abstract":"<div><h3>Introduction</h3><p>Cryptococcal meningitis is a deadly disease with few treatment options. Its incidence is still high and closely linked to the HIV/AIDS epidemic. This study aimed to develop a mucoadhesive microsphere delivery system for fluconazole for the intranasal route.</p></div><div><h3>Method</h3><p>Microspheres of mucoadhesive fluconazole formulation variables such as different amounts of drug concentration and polymer concentration were prepared by a simple emulsion-crosslinking method. The prepared microspheres’ surface was characterised by SEM (Scanning electron microscopy) and evaluated for particle size, entrapment efficiency, production yield, infrared spectroscopic study, in-vitro muco-adhesion, and in-vitro drug release.</p></div><div><h3>Results</h3><p>The results showed that formula 1 is the optimal mucoadhesive microsphere preparation, with a particle size of 56.375<!--> <!-->m, a spherical surface shape, an entrapment efficiency of 99.96%, and a greater mucoadhesive capability during 6-hour evaluation. Furthermore, wash-off examination revealed that the mucoadhesive ability of this delivery system has a long duration and may release the active material at the right time.</p></div><div><h3>Conclusion</h3><p>The result of the researches suggesting that the formulation of mucoadhesive microspheres of fluconazole could be used to treat cryptococcal meningitis infection in HIV/AIDS patients.</p></div><div><h3>Introduction</h3><p>La méningite à cryptocoque est une maladie mortelle avec peu d’options de traitement. Son incidence est encore élevée et étroitement liée à l’épidémie de VIH/sida. Cette étude visait à développer un système d’administration de microsphère muco-adhésif pour le fluconazole par voie intranasale.</p></div><div><h3>Méthode</h3><p>Des microsphères de variables de formulation de fluconazole mucoadhesives telles que différentes quantités de concentration de médicament et de concentration de polymère ont été préparées par une méthode simple de réticulation d’émulsion. La surface des microsphères préparées a été caractérisée par SEM (microscopie électronique à balayage) et évaluée pour la taille des particules, l’efficacité du piégeage, le rendement de la production, l’étude spectroscopique infrarouge, la muco-adhésion in vitro et la libération de médicaments in vitro.</p></div><div><h3>Résultats</h3><p>Les résultats ont montré que la formule (1) est la préparation optimale de la microsphère muco-adhésive, avec une taille de particule de 56,375<!--> <!-->m, une forme de surface sphérique, une efficacité de piégeage de 99,96 % et une plus grande capacité de muco-adhésive pendant 6<!--> <!-->h d’évaluation. De plus, l’examen de lavage a révélé que la capacité muco-adhésive de ce système d’administration a une longue durée et peut libérer le matériau actif au bon moment.</p></div><div><h3>Conclusion</h3><p>Le résultat des recherches suggère que la formulation de microsphères muco-adhésives du fluconazole pour","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 5","pages":"Pages 813-821"},"PeriodicalIF":1.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140776646","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":"Urinary cytomegalovirus excretion: The unresolved issues","authors":"","doi":"10.1016/j.pharma.2024.03.004","DOIUrl":"10.1016/j.pharma.2024.03.004","url":null,"abstract":"<div><p>Cytomegalovirus (CMV) excretion in urine is frequently observed in clinical practice. However, the specific circumstances and pathophysiological mechanisms underlying this shedding remain largely unknown. Here, we address some of the key questions regarding urinary CMV excretion, focusing on new hypotheses raised by recent advances in the field. Cellular origins of CMV shedding, clinical contexts of occurrence, systemic spread of the virus <em>versus</em> compartmentalization in the urinary tract, and clinical impact are successively discussed.</p></div><div><p>Le cytomégalovirus (CMV) est fréquemment détecté dans l’urine mais les circonstances cliniques et les mécanismes physiopathologiques qui sous-tendent cette virurie restent mal compris. Dans cette revue, nous cherchons à répondre aux principales questions soulevées par cette excrétion urinaire de CMV, en appréhendant successivement: l’origine cellulaire de l’excrétion virale au sein de l’arbre urinaire, le contexte clinique sous-jacent, la distinction entre diffusion systémique du virus et compartimentation et l’impact clinique de ces viruries à CMV.</p></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 5","pages":"Pages 755-761"},"PeriodicalIF":1.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140139838","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":"Therapeutic effects of stevia aqueous extract alone or in combination with metformin in induced polycystic ovary syndrome rats: Gene expression, hormonal balance, and metabolomics aspects","authors":"A. Saedi ,&nbsp;S. Zarei ,&nbsp;M. Vatanparast ,&nbsp;M.R. Hajizadeh ,&nbsp;R. Hosseiniara ,&nbsp;O.S. Esmaeili ,&nbsp;M. Mohammad-Sadeghipour ,&nbsp;Z. Mirzaei ,&nbsp;M. Mahmoodi","doi":"10.1016/j.pharma.2024.08.008","DOIUrl":"10.1016/j.pharma.2024.08.008","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;This study aimed to assess the individual and combined effects of SAE and Met on the expression of genes related to insulin signaling, oxidative stress, hormonal imbalance, insulin resistance, and dyslipidemia in rats with induced PCOS.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;The estrous cycle of 50 adult Wistar female rats was monitored through vaginal smears. Subsequently, the rats were randomly assigned into five groups of 10, including control (receiving 1&lt;!--&gt; &lt;!--&gt;ml of carboxymethyl cellulose for 49 days), induction (letrozole at 1&lt;!--&gt; &lt;!--&gt;mg/kg/d for 21 days), SAE, Met, and SAE/Met. SAE and Met were orally administered at doses of 400&lt;!--&gt; &lt;!--&gt;mg/kg/d and 250&lt;!--&gt; &lt;!--&gt;mg/kg/d on day 22 and continued for an additional 28 days. Vaginal smears were analyzed, and gene expression levels of GLUT4, SIRT1, TNF-α, and INSR were evaluated using RT-qPCR. Antioxidant parameters were assessed using detection kits.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Treatment with SAE and Met restored a regular estrous cycle pattern in PCOS rats. Furthermore, SAE and Met treatment improved hormonal balance, dyslipidemia, and hyperglycemia in the rats. Administration of SAE and Met significantly elevated levels of antioxidant enzymes SOD and GPx in ovarian tissue (&lt;em&gt;P&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0.001). Additionally, mRNA levels of GLUT4, SIRT1, and INSR were significantly increased in ovarian tissue following SAE and Met treatment, while TNF-α gene expression decreased significantly (&lt;em&gt;P&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0.0001).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;The findings suggest that SAE and Met aqueous extract exert protective effects on letrozole-induced PCOS in rats by modulating gene expression associated with insulin signaling and oxidative stress.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectifs&lt;/h3&gt;&lt;div&gt;Cette étude visait à évaluer les effets individuels et combinés du SAE et du Met sur l’expression de gènes liés à la signalisation de l’insuline, au stress oxydatif, au déséquilibre hormonal, à la résistance à l’insuline et à la dyslipidémie chez les rats atteints du SOPK induit.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthodes&lt;/h3&gt;&lt;div&gt;Le cycle œstral de 50 rats femelles Wistar adultes a été surveillé au moyen de frottis vaginaux. Par la suite, les rats ont été répartis au hasard en cinq groupes de 10, comprenant le contrôle (recevant 1&lt;!--&gt; &lt;!--&gt;ml de carboxyméthylcellulose pendant 49&lt;!--&gt; &lt;!--&gt;jours), l’induction (létrozole à 1&lt;!--&gt; &lt;!--&gt;mg/kg/j pendant 21&lt;!--&gt; &lt;!--&gt;jours), le SAE, le Met et le SAE/Met. SAE et Met ont été administrés par voie orale à des doses de 400&lt;!--&gt; &lt;!--&gt;mg/kg/j et 250&lt;!--&gt; &lt;!--&gt;mg/kg/j au jour 22 et ont été poursuivis pendant 28&lt;!--&gt; &lt;!--&gt;jours supplémentaires. Les frottis vaginaux ont été analysés et les niveaux d’expression génique de GLUT4, SIRT1, TNF-α et INSR ont été évalués par RT-qPCR. Les paramètres antioxydants ont été évalués à l’aide de kits de détection.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Le traitement par SAE et Met a rétab","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 2","pages":"Pages 297-310"},"PeriodicalIF":1.0,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142054789","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":"Risk analysis applied to the process of managing medical single use devices in a hospital pharmacy department","authors":"Aymen Ben Salem ,&nbsp;Fatma Sellami ,&nbsp;Ahlem Ben Cheikh Brahim ,&nbsp;Yosr Krichen ,&nbsp;Aimen Abbassi","doi":"10.1016/j.pharma.2024.08.006","DOIUrl":"10.1016/j.pharma.2024.08.006","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;During the COVID-19 pandemic, single use medical devices’ supply (SUMD) was marked by repetitive and unforeseen interruptions. The present study aimed to determine the risks related to the processes of management of medical devices in our CHU according to a method of failure mode, effect and criticality analysis (FMECA).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;Qualified healthcare professionals were recruited to form a multidisciplinary consensus committee. By analyzing the process map, all failure modes, causes and consequences were identified through brainstorming meetings. They were then classified taking into account the criticality index (CI) calculated according to three parameters: frequency, severity, and detectability. The prioritization was carried out by considering the mean and the median values of the CI as limits. Corrective and preventive actions were then proposed.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;A total of 49 failure modes were identified, accumulating 4466 criticality points. The most critical step is that relating to the inter-depot order with a CI equal to 783 points. An action plan was developed, allows us to control 64% of the overall criticality of the risks linked to the process. Three main lines of action have been proposed: continuous training, especially for managerial and administrative tasks, logistical improvement (architectural reorganization and implementation of systems for securing the circuit of SUMDs) and support for the digitization of hospital pharmacy.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;The FMECA is a consensual method, which makes it possible to propose actions in order to reduce the risks linked to the process of managing medical devices. Optimizing the estimation of needs, strengthening communication with stakeholders and securing the circuit are essential to guarantee the availability of SUMDs for the benefit of the patient.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Lors de la pandémie de COVID-19, l’apprivoisement en dispositifs médicaux (DM) a été marqué par des interruptions répétitives et imprévues. La présente étude visait à déterminer les risques liés aux processus de gestion des DM dans notre CHU selon une méthode d’analyse des modes de défaillance et de leurs effets (AMDEC).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthodes&lt;/h3&gt;&lt;div&gt;Des professionnels de la santé qualifiés ont été recrutés pour former une équipe d’étude multidisciplinaire. Après la rédaction de la cartographie du processus, les modes de défaillance ont été définis tout en indiquant les causes et conséquences à travers des réunions de brainstorming. Ensuite, ils ont été classés en tenant compte de l’indice de criticité (IC) calculé selon trois paramètres : la fréquence, la sévérité, et la détectabilité. La priorisation a été réalisée en considérant la moyenne et les valeurs médianes de l’IC comme limites. Des actions correctives et préventives ont alors été proposées.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Un tota","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 2","pages":"Pages 287-296"},"PeriodicalIF":1.0,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142046165","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":"Harmonization of regulatory frameworks for medical devices in BRICS countries: A path to enhanced trade and investment","authors":"Himanshu Pawar,&nbsp;Mital Patel","doi":"10.1016/j.pharma.2024.08.007","DOIUrl":"10.1016/j.pharma.2024.08.007","url":null,"abstract":"&lt;div&gt;&lt;div&gt;The study is designed to advocate for a harmonized medical device regulatory framework throughout the BRICS countries with a view to facilitating trade, attracting investments and safeguarding patients’ health. The development of the medical devices industry in BRICS countries is impeded by a lack of standardized regulation. A harmonized framework would facilitate the approval process, promotion of innovation and wider access for patients to modern medical technologies. The paper analyses existing regulatory frameworks for medical devices in BRICS countries and identifies their strengths and weaknesses. Specific measures to harmonize such as standardization of technology, interoperability and the implementation of transparent licensing procedures are also proposed. The study indicates that a joint committee should be set up to supervise legal harmonization, standardization of classification and development of specific technical specifications. It also provides information about the regulatory framework in different countries, such as Brazil, Russia, India, China and South Africa, on classification of medical devices. Report emphasizes the need for a harmonized regulatory framework to rapidly introduce new healthcare technologies. It suggests that the BRICS countries can create a more conducive environment for the medical device industry, ultimately benefiting patients, manufacturers and the overall healthcare system by aligning their legislation.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;L’étude vise à plaider en faveur d’un cadre réglementaire harmonisé sur les dispositifs médicaux dans l’ensemble des pays BRICS en vue de faciliter le commerce, d’attirer les investissements et de protéger la santé des patients. Le développement de l’industrie des dispositifs médicaux dans les pays BRICS est entravé par le manque de réglementation standardisée. Un cadre harmonisé faciliterait le processus d’approbation, la promotion de l’innovation et un accès plus large des patients aux technologies médicales modernes. Le document analyse les cadres réglementaires existants pour les dispositifs médicaux dans les pays BRICS et identifie leurs forces et leurs faiblesses. Des mesures spécifiques d’harmonisation, telles que la normalisation de la technologie, l’interopérabilité et la mise en œuvre de procédures d’autorisation transparentes, sont également proposées. L’étude indique qu’un comité mixte devrait être créé pour superviser l’harmonisation juridique, la normalisation de la classification et l’élaboration de spécifications techniques spécifiques. Il fournit également des informations sur le cadre réglementaire de différents pays, tels que le Brésil, la Russie, l’Inde, la Chine et l’Afrique du Sud, en matière de classification des dispositifs médicaux. Le rapport souligne la nécessité d’un cadre réglementaire harmonisé pour introduire rapidement de nouvelles technologies de soins de santé. Il suggère que les pays BRICS peuvent créer un environnement plus propice à l’in","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 2","pages":"Pages 272-286"},"PeriodicalIF":1.0,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142046204","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":"Évaluation de la faisabilité du dispositif d’auto-administration des médicaments par le patient dans un centre hospitalier universitaire : audits de pratique et recommandations pour une mise en œuvre sûre","authors":"Cyril Baudrier ,&nbsp;Victoire Petitcuenot ,&nbsp;Nacima Oussedik ,&nbsp;William Champeau ,&nbsp;Rouba Alarab ,&nbsp;Anne-Laure Lefebvre ,&nbsp;Yara Rahma ,&nbsp;Cecile Bottois ,&nbsp;Ornella Conort","doi":"10.1016/j.pharma.2024.08.004","DOIUrl":"10.1016/j.pharma.2024.08.004","url":null,"abstract":"&lt;div&gt;&lt;div&gt;En 2022, la HAS a émis des recommandations sur l’auto-administration des médicaments, destinée aux patients volontaires en hospitalisation, sous accord médical. L’objectif de notre étude est d’évaluer les pratiques liées à la gestion des médicaments dans notre établissement afin de proposer des recommandations pour une mise en œuvre sûre du dispositif d’auto-administration des médicaments. Une étude monocentrique prospective a été menée entre janvier et juin 2023. Deux audits ont été réalisés auprès des patients et des infirmier(e)s à l’aide de questionnaires basés sur les recommandations de la HAS. Sur un total de 207 patients, avec un âge moyen de 59,6 ans, 56 % étaient favorables à gérer les traitements initiés à l’hôpital. Parmi ceux ayant des traitements habituels, 62 % étaient favorables pour continuer à les gérer à l’hôpital. Dans les unités d’hospitalisation de semaine, 92 % des patients étaient favorables à la gestion de leurs traitements habituels, et 75 % à ceux initiés à l’hôpital. Parmi les 26 infirmier(e)s interrogé(e)s, 71 % ont noté l’autonomie des patients pour la prise médicamenteuse dans les transmissions narratives, 88 % ont vérifié la prise médicamenteuse en auto-administration, et 96 % l’ont tracée informatiquement. Le dispositif d’auto-administration des médicaments est envisageable dans notre établissement, notamment dans les unités d’hospitalisation de semaine avec des patients ayant une bonne connaissance de leurs traitements. Actuellement, les infirmier(e)s évaluent et assurent la traçabilité de l’autonomie du patient sans outils spécifiques. Pour garantir le succès de cette nouvelle approche, une collaboration entre les professionnels de santé est essentielle, avec un rôle central du pharmacien.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;The French Health Authority recently published guidelines about patient self-administration of medications for voluntary hospitalized patients under medical supervision. This study aimed to assess medication management practices in our hospital and provide recommendations for self-administration medication. A prospective monocentric study was performed from January to June 2023, involving patient and nurse surveys based on the guidelines from the French Health Authority. A total of 207 patients participated in the survey, with a mean age of 59.6&lt;!--&gt; &lt;!--&gt;years. Among them, 56% were inclined to self-manage treatments initiated during hospitalization. Among patients with regular treatments, 62% were inclined to self-manage them in the hospital. In weekday hospitalization units, 92% of patients were inclined to self-manage their regular treatments, and 75% of those initiated during hospitalization. Among the 26 surveyed nurses, 71% reported patient autonomy for taking drugs in narrative transmissions, and 88% verified medication intake through self-administration, while 96% digitally traced it. The concept of self-administration of medication appears promising, especially within weekday hospitalizat","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 1186-1200"},"PeriodicalIF":1.0,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999377","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":"Cardiovascular disease and thrombosis: Intersections with the immune system, inflammation, and the coagulation system","authors":"Shivam Rajput ,&nbsp;Rishabha Malviya ,&nbsp;Saurabh Srivastava ,&nbsp;Irfan Ahmad ,&nbsp;Safia Obaidur Rab ,&nbsp;Prerna Uniyal","doi":"10.1016/j.pharma.2024.08.005","DOIUrl":"10.1016/j.pharma.2024.08.005","url":null,"abstract":"&lt;div&gt;&lt;div&gt;The coagulation and immune system, both essential physiological systems in the human body, are intricately interconnected and play a critical role in determining the overall health of patients. These systems collaborate via various shared regulatory pathways, such as the Tissue Factor (TF) Pathway. Immunological cells that express TF and generate pro-inflammatory cytokines have the ability to affect coagulation. Conversely, coagulation factors and processes have a reciprocal effect on immunological responses by stimulating immune cells and regulating their functions. These interconnected pathways play a role in both preserving well-being and contributing to a range of pathological disorders. The close relationship between blood clotting and inflammation in the development of vascular disease has become a central focus of clinical study. This research specifically examines the crucial elements of this interaction within the contexts of cardiovascular disease and acute coronary syndrome. Tissue factor, the primary trigger of the extrinsic coagulation pathway, has a crucial function by inducing a proinflammatory reaction through the activation of coagulation factors. This, in turn, initiates coagulation and subsequent cellular signalling pathways. Protease-activated receptors establish the molecular connection between coagulation and inflammation by interacting with activated clotting factors II, X, and VII. Thrombosis, a condition characterised by the formation of blood clots, is the most dreaded consequence of cardiovascular disorders and a leading cause of death globally. Consequently, it poses a significant challenge to healthcare systems. Antithrombotic treatments efficiently target platelets and the coagulation cascade, but they come with the inherent danger of causing bleeding. Furthermore, antithrombotics are unable to fully eliminate thrombotic events, highlighting a treatment deficiency caused by a third mechanism that has not yet been sufficiently addressed, namely inflammation. Understanding these connections may aid in the development of novel approaches to mitigate the harmful mutual exacerbation of inflammation and coagulation. Gaining a comprehensive understanding of the intricate interaction among these systems is crucial for the management of diseases and the creation of efficacious remedies. Through the examination of these prevalent regulatory systems, we can discover novel therapeutic approaches that specifically target these complex illnesses. This paper provides a thorough examination of the reciprocal relationship between the coagulation and immune systems, emphasising its importance in maintaining health and understanding disease processes. This review examines the interplay between inflammation and thrombosis and its role in the development of thrombotic disorders.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;La coagulation et le système immunitaire, deux systèmes physiologiques essentiels du corps humain, sont étroitement liés et jouent","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 2","pages":"Pages 228-250"},"PeriodicalIF":1.0,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003492","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":"Aqueous eye drop formulations: Cyclodextrins as enabling excipients","authors":"Frédéric Pilotaz ,&nbsp;Thorsteinn Loftsson","doi":"10.1016/j.pharma.2024.08.003","DOIUrl":"10.1016/j.pharma.2024.08.003","url":null,"abstract":"<div><div>Cyclodextrins are enabling pharmaceutical excipients that solubilize and stabilize drugs in aqueous formulations. Cyclodextrins possess very favorable pharmacokinetic and toxicological profiles and are commonly used in marketed drug products for oral and parenteral administration. However, their use in ophthalmic products is still very limited. Cyclodextrins have a broad range of physical properties that are specifically appropriate for designing topical ophthalmic dosage forms. Additionally, both the regulatory and intellectual property environments have been cleared over the last years and should foster their use for designing new drugs for ophthalmic use.</div></div><div><div>Les cyclodextrines sont des excipients permettant la solubilisation et la stabilisation de médicaments dans les formes pharmaceutiques aqueuses. Les cyclodextrines possèdent des profils pharmacocinétiques et toxicologiques très favorables et sont couramment utilisées dans des médicaments commercialisés pour l’administration orale et parentérale. Toutefois, leur utilisation dans les produits ophtalmiques est encore très limitée. Les cyclodextrines possèdent un large spectre de propriétés physiques qui est particulièrement adapté pour la conception de formes pharmaceutiques à usage topique ophtalmique. Enfin, leur environnement réglementaire ainsi que celui de la propriété intellectuelle se sont éclaircis au cours des dernières années, ce qui devrait favoriser leur utilisation pour la conception de nouveaux médicaments à usage ophtalmique.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 994-1007"},"PeriodicalIF":1.0,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141911557","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}