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Background In the strained actual economic context, all clinical pharmacy activities cannot be achieved for all patients of all care pathways. So finding a way to prioritize moments and patients needing those activities is essential. This is the challenge of the “5P project” (Patient personalized clinical pharmacy program integrated into care pathway). Objective To present adverse event (AE) risk management approach applied to develop clinical pharmacy programs integrated into care pathway, using two methods. Method Used as a priori AE risk management approach, the Delphi method and inductive approach analysis of semi-directed interviews were realized from April 1st to October 3rd, 2019, respectively in orthogeriatric (OG) and pediatric kidney transplantation (PKT) care pathways. Complementarily to bibliographic research, participants were medical and paramedical healthcare providers involved in the concerned care pathway. They have been interrogated regarding AE risks to identify the clinical pharmacy activities required, the patients who need them, and the appropriate steps of the care pathway. Results The Delphi method for OG care pathway has revealed: 1/. Patients were prioritized by the presence of at least 2 among the following 4 criteria: age ≥90 years old, cardiovascular diseases, prescribed potentially inappropriate medication for elderly patients, obesity or diabetes; priority steps were the post-operative and rehabilitation care steps. 2/. Prescription reviews, medication reconciliation and targeted pharmaceutical informative interview about oral anticoagulants were required. Nine semi-directed interviews used for PKT care pathway has revealed: 1/. Clinical pharmacy activities were carried out for all patients. Priority steps were pre-transplantation, immediate post-operative, and post-transplantation. 2/. Prescription reviews and educative interviews were required. Conclusions The two presented methods can be used to both develop patient prioritization and targeting steps for clinical pharmacy activities, and integrate it into care pathway. Today, those two developed programs have been executed in our teaching hospital.

In central sterile services departments (CSSD), the functionality of rigid endoscopes, which are complex and fragile reusable devices, is usually controlled visually and is considered a complex and subjective task. ScopeControl® was developed to provide an automated quality control of rigid endoscopes by measuring the value of six parameters: viewing angle (VA), field of view (FV), color correctness (CC), light transmission (LT), fibers transmission (FT), and focus (FC). The aim of the present study was to assess the ability of ScopeControl® to pre-emptively identify endoscope defects before the surgeon considers them as defective. The same endoscope was evaluated by surgeons during surgery using a scoring scale as well as the CSSD staff using the ScopeControl® during reprocessing. The ScopeControl® categorized the endoscope into 3 groups: “passed,” “in danger,” and “failed.” Correlations between the surgeon’s evaluation and results of the ScopeControl® were calculated. One hundred sixty-six controls were carried out concerning 51 different endoscopes. According to the surgeon’s evaluation, 78.9% and 80.7% of controls were considered as satisfactory for image and brightness quality, respectively. Results obtained using ScopeControl® found that 13.3% of controls were considered as “passed,” 31.3% “in danger,” and 55.4% “failed,” with poor correlation with the surgeons’ evaluation. LT and FT parameters represented 95.2% of the reasons for failures. The ability of the ScopeControl® to detect endoscope defects earlier than surgeons was validated by tracking the results of endoscopes used and controlled several times. The ScopeControl® achieved an objective and consistent quality control of endoscopes and showed poor correlation with the surgeon’s opinion. In practice, the ScopeControl® could avoid the use of defective endoscopes in the surgery unit and thus improve the quality of the surgical procedure.

International audience; Background Stroke represents a major Public Health issue in industrialized countries because of its frequency and severity. In secondary stroke prevention, treatment efficacy is correlated to medication adherence. However, it remains suboptimal in stroke patients. Community pharmacists, in light of their positioning in the care pathway and proximity to patients, can play an essential role in patient support and improving treatment adherence. However, it is currently unknown whether pharmacists are ready to perform this task. Objective Evaluate knowledge, practices and training needs for community pharmacists in therapeutic stroke management to improve long term care for stroke patients. Setting Community pharmacies in the Rhone Alpes region (France). Method We conducted a cross sectional study via a standardized self-assessment questionnaire consisting of 40 questions divided into three parts. The latter was designed by a multidisciplinary team and distributed electronically to community pharmacists of the Rhône-Alpes region (France). Main outcome measure (a) global knowledge score on the pathology, risk factors and clinical care management, (b) description of the support practices for stroke patients, (c) training needs for pharmacists. Results The 104 participants presented a moderate level of knowledge (global score: 12/20 ± 3). Topics best mastered were: pathophysiology, target blood pressure and place of antiplatelets in the therapeutic strategy. Knowledge items that needed improvement were: warning signs correctly identified by 44% of participants, time delay for thrombolysis for which 14% answered correctly, target glycated hemoglobin levels were correct for 41%, and the 3 recommended antihypertensive drug classes were only identified by 5% of participants. Patient education received from pharmacists concerned dosage (89%), treatment adherence (88%), benefits (66%) and administration modalities of medicines (64%), management of risk factors (75% for diet, 73% for physical activity, 70% for smoking and 53% for alcohol). All pharmacists wanted additional training on risk factors and clinical management guidelines. Conclusion Based on this small study, the fragmented knowledge and varied practices promote the need for further training for pharmacists to optimize support of stroke patients. This study promotes the elaboration of training systems adapted to pharmacists' needs. This will help support the development of a targeted pharmaceutical care approach for stroke patients.

Introduction: The risk of polypharmacy is on the rise in most industrialized countries, threatening to burden their health systems. Although many definitions exist and numerous concepts are found in literature as synonyms, the phenomenon of polypharmacy remains poorly defined. The aim of this literature review is to provide an overview of available definitions of polypharmacy, to analyse their convergences and divergences and to discuss the consequences on the assessment of the problem. Methods: A literature review was conducted to identify all published systematic reviews on definitions of polypharmacy available via Scopus and Pubmed databases. The Assessment of Multiple Systematic Reviews (AMSTAR) tool was used to appraise the methodological quality of the selected reviews. Available definitions and other characteristics were extracted; summarised in a table and analysed. Results: Six systematic reviews were identified. They were published between 2000 and 2018. Three focussed on definitions of polypharmacy in the elderly; two in the general population and one in children. The strategy adopted in reviews is more rigorous in the most recent ones. However, they remain, at best, partially exhaustive. The definitions found in the literature used two main approaches, either (i) quantitative, applying varying thresholds and types of polypharmacy based on the number of medications being taken by the patient (ii) qualitative, based on the clinical indications and effects of a given drug regimen, with a growing number of characteristics to describe polypharmacy. The term “inappropriate” is increasingly associated with polypharmacy especially in studies that aimed to use this definition to identify possible solutions for healthcare providers in the field related to aging. Conclusion: This review confirms a high variability and an evolution in the approaches defining “polypharmacy” in the absence of a consensus following standardized criteria. That makes it very difficult to estimate and measure the outcomes associated with this phenomenon.

International audience; Objectives: To determine if commercially available mouthwash with b-cyclodextrin and citrox (bio- flavonoids) (CDCM) could decrease the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) salivary viral load.Methods: In this randomized controlled trial, severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) PCR-positive patients aged 18e85 years with asymptomatic to mild coronavirus disease 2019 (COVID-19) symptoms for

Background In the recent decades, the number of apps promoting health behaviors and health-related strategies and interventions has increased alongside the number of smartphone users. Nevertheless, the validity process for measuring and reporting app quality remains unsatisfactory for health professionals and end users and represents a public health concern. The Mobile Application Rating Scale (MARS) is a tool validated and widely used in the scientific literature to evaluate and compare mHealth app functionalities. However, MARS is not adapted to the French culture nor to the language. Objective This study aims to translate, adapt, and validate the equivalent French version of MARS (ie, MARS-F). Methods The original MARS was first translated to French by two independent bilingual scientists, and their common version was blind back-translated twice by two native English speakers, culminating in a final well-established MARS-F. Its comprehensibility was then evaluated by 6 individuals (3 researchers and 3 nonacademics), and the final MARS-F version was created. Two bilingual raters independently completed the evaluation of 63 apps using MARS and MARS-F. Interrater reliability was assessed using intraclass correlation coefficients. In addition, internal consistency and validity of both scales were assessed. Mokken scale analysis was used to investigate the scalability of both MARS and MARS-F. Results MARS-F had a good alignment with the original MARS, with properties comparable between the two scales. The correlation coefficients (r) between the corresponding dimensions of MARS and MARS-F ranged from 0.97 to 0.99. The internal consistencies of the MARS-F dimensions engagement (ω=0.79), functionality (ω=0.79), esthetics (ω=0.78), and information quality (ω=0.61) were acceptable and that for the overall MARS score (ω=0.86) was good. Mokken scale analysis revealed a strong scalability for MARS (Loevinger H=0.37) and a good scalability for MARS-F (H=0.35). Conclusions MARS-F is a valid tool, and it would serve as a crucial aid for researchers, health care professionals, public health authorities, and interested third parties, to assess the quality of mHealth apps in French-speaking countries.

International audience; The aim of this study was to determine whether self-collected pure saliva (SCPS) is comparable to nasopharyngeal (NP) swabs in the quantitative detection of SARS-CoV-2 by RT-PCR in asymptomatic, mild patients with confirmed COVID-19. Thirty-one patients aged from 18 to 85 years were included between 9 June and 11 December 2020. A SCPS sample and a NP sample were taken for each patient. Quantitative PCR was performed to detect SARS-CoV-2 viral load. Results of SCPS vs NP samples testing were compared. Statistical analyses were performed. Viral load was significantly correlated (r = 0.72). The concordance probability was estimated at 73.3%. In symptomatic adults, SCPS performance was similar to that of NP swabs (Percent Agreement = 74.1%; p = 0.11). Thus, the salivary test based on pure oral saliva samples easily obtained by noninvasive techniques has a fair agreement with the nasopharyngeal one in asymptomatic, mild patients with a confirmed diagnosis of COVID-19.

Purpose Immunosuppressive therapy following pediatric hematopoietic stem cell transplantation is essential for the patient's prognosis, as the antibioprophylaxis and the isolation measures. But medication adherence is suboptimal for children and adolescents, from 52 to 73% in literature. The aim of this study is to provide an understanding of medication adherence after pediatric allogeneic stem cell transplantation (SCT), by identifying facilitators and barriers. Method Semi-structured interviews were conducted by a pharmacist with caregivers and healthcare providers in a pediatric centre . Four topics were discussed: transplantation, post-transplantation therapies, caregivers' experience and the healthcare system. Interviews were audiotaped, transcribed and analysed by inductive approach. Findings Semi-structured interviews with 15 caregivers and 21 healthcare providers identified factors of medication adherence and hygiene measures. The long-term nature of therapy and difficult transitions of care were identified as major barriers. Recognizing the benefits of medication and parental involvement are facilitators. Furthermore, caregivers expressed the need to take into consideration the family entity. They would like also to receive earlier information from healthcare providers before hospital discharge . Those needs were not always identified by healthcare providers. Conclusion This analysis revealed barriers and facilitators to the medication adherence and to the care. It demonstrated similarities and differences between caregivers and healthcare providers’ perceptions and has thereby initiated an improvement process of the healthcare system. As part of this process, medical and paramedical healthcare providers at this French pediatric centre are currently working on a support program for post-alloSCT hospital-home transition.

Ocrelizumab is the first approved drug for primary progressive multiple sclerosis. Following appraisal by health technology assessment (HTA) bodies, this medicine has not been widely covered across European countries. We have compared the HTA process in England and France.We undertook an analysis of relevant documents that were published by the two HTA bodies. We analyzed patients' availability of Ocrelizumab at the different stages of the process.We identified differences in the assessment, one being the use of a different population of the pivotal trial, which has resulted in the consideration of distinct clinical effectiveness estimates. Ocrelizumab became available earlier in France as part of an early access program. However, rapid access was discontinued for newly eligible patients following an opinion concluding that Ocrelizumab yielded no additional benefit over placebo. This opinion was not compatible with the criteria allowing reimbursement in France.In England, there was no early access program and following an appraisal that included cost-effectiveness evaluation combined with pricing agreements, medicine was finally recommended. In conclusion, differences in the HTA process may result in appreciable differences in timing and outcome from marketing authorization to the adoption of newly licensed drugs.

Nutrition is recognized as an essential component in the prevention of a number of chronic diseases, including periodontal disease. Based on these considerations, a better understanding is required regarding how the diet, and more particularly the intake of macronutrients and micronutrients, could impact the potential relationship between nutrition and periodontal diseases, periodontal diseases and chronic diseases, nutrition and chronic diseases. To overcome this complexity, an up-to-date literature review on the nutriments related to periodontal and chronic diseases was performed. High-sugar, high-saturated fat, low-polyols, low-fiber and low-polyunsaturated-fat intake causes an increased risk of periodontal diseases. This pattern of nutrients is classically found in the Western diet, which is considered as an &lsquo, unhealthy&rsquo, diet that causes cardiovascular diseases, diabetes and cancers. Conversely, low-sugar, high-fiber and high-omega-6-to-omega-3 fatty acid ratio intake reduces the risk of periodontal diseases. The Mediterranean, DASH, vegetarian and Okinawa diets that correspond to these nutritional intakes are considered as &lsquo, healthy&rsquo, diets, reducing this risk of cardiovascular diseases, diabetes and cancers. The role of micronutrients, such as vitamin D, E, K and magnesium, remains unclear, while others, such as vitamin A, B, C, calcium, zinc and polyphenols have been shown to prevent PDs. Some evidence suggests that probiotics and prebiotics could promote periodontal health. Periodontal and chronic diseases share, with a time delay, nutrition as a risk factor. Thus, any change in periodontal health should be considered as a warning signal to control the dietary quality of patients and thus reduce the risk of developing chronic diseases later on.

Karen Beny,1,2 Benjamin du Sartz de Vigneulles,1 Valerie Chamouard,3,4 Ronald Guilloux,5 Valérie Gay,6 Claude Negrier,3 Claude Dussart1,2 1EA 4129 Laboratory P2S (Health Systemic Process), University of Lyon, University Claude Bernard Lyon 1, Lyon, France; 2Central Pharmacy, Hospices Civils de Lyon, Lyon, France; 3Reference center on hemophilia and other constitutional hemorrhagic diseases, Groupement Hospitalier Est, Hospices Civils de Lyon, Lyon, France; 4Pharmacy, Groupement Hospitalier Est, Hospices Civils de Lyon, Lyon, France; 5Laboratory S2HEP, University of Lyon, University Claude Bernard Lyon 1, Lyon, France; 6Hemophilia Care Center, Centre hospitalier Métropole Savoie, Chambéry, FranceCorrespondence: Karen BenyCentral Pharmacy, Hospices Civils de Lyon, 57 rue Francisque Darcieux, CS 60004, 69563 Saint Genis Laval Cedex, Lyon, FranceTel +33 4 78 86 66 92Fax +33 4 72 67 88 74Email karen.beny@chu-lyon.frBackground: New therapies provide a favorable evolution in the care management of persons with hemophilia. However, the impact of these new therapies on patient care organization remains to be determined. A qualitative study will be implemented to analyze patients’ perception regarding the impact of innovation on the organization of their care management. Secondary objectives will include refining specific factors related to persons with hemophilia (barriers or facilitators, especially the place of treatment) to consider within an organizational impact analysis.Patients and Methods: Semi-structured individual interviews will be conducted via videoconferencing or by phone by two researchers using an interview guide. Participants will be recruited from the Rhône-Alpes region, in France. Physicians from two hemophilia treatment centers will identify eligible patients. Moreover, a call for volunteers will be launched by the Rhône-Alpes committee of the French hemophilia association. Interviews will be conducted with adult patients, adolescent patients or parents of a minor with hemophilia regularly treated prophylactically or on demand. Data analysis will be performed with NVivo® software. Each interview will be analyzed by two researchers using an inductive content analytic method.Discussion: The INNOVHEMO study is an original study analyzing the way patients perceive the impact of an innovation on their care management organization. The resulting patient-specific factors, identified as barriers or facilitators, will need to be integrated into a more comprehensive analysis of the impact of innovation on care management organization.Keywords: therapeutic innovation, hemophilia, care pathway, qualitative research, organizational aspect, patient experience data

International audience; Background: Healthcare systems worldwide adapt to patients' needs and expectations, following social evolutions. Pharmaceutical practice has shifted towards activities such as therapeutic education. Such new missions require to prioritize human and social sciences, which now play a predominant role in training. Objective: This work consists of assessing the contribution of human and social sciences to the field of pharmacy, with a twofold focus on practice and training. Method: A literature review was carried out according to the PRISMA guidelines focusing on the last 10 years. Selected full texts were read and analyzed to elicit the contribution of human and social sciences to pharmacy. Results: Overall 36 articles were included. Three specific topics were identified during an inductive process of full text analysis: public health policy, patient care, and interprofessional collaboration. Conclusions: Although human and social sciences are essential to the evolution of the pharmacist profession, their impact on health care costs remains difficult to evaluate. Moreover, teaching human and social sciences can prove difficult to standardize. Such approaches must be supported and organized by governments and universities with a view of upscaling practices.

Objectives - To describe the evolution of the SARS-CoV-2 salivary viral load of patients infected with Covid-19, performing 7 days of tri-daily mouthwashes with and without antivirals. - To compare the evolution of the SARS-CoV-2 nasal and salivary viral load according to the presence or absence of antivirals in the mouthwash. Trial design This is a multi-center, randomised controlled trial (RCT) with two parallel arms (1:1 ratio). Participants Inclusion criteria - Age: 18-85 years old - Clinical diagnosis of Covid-19 infection - Clinical signs have been present for less than 8 days - Virological confirmation - Understanding and acceptance of the trial - Written agreement to participate in the trial Exclusion criteria - Pregnancy, breastfeeding, inability to comply with protocol, lack of written agreement - Patients using mouthwash on a regular basis (more than once a week) - Patient at risk of infectious endocarditis - Patients unable to answer questions - Uncooperative patient The clinical trial is being conducted with the collaboration of three French hospital centers: Hospital Center Emile Roux (Le Puy en Velay, France), Clinic of the Protestant Infirmary (Lyon, France) and Intercommunal Hospital Center (Mont de Marsan, France). Intervention and comparator Eligible participants will be allocated to one of the two study groups. Intervention group: patients perform a tri-daily mouthwash with mouthwash containing antivirals (β-cyclodextrin and Citrox®) for a period of 7 days. Control group: patients perform a tri-daily mouthwash with a placebo mouthwash for a period of 7 days. Main outcomes Primary Outcome Measures: Change from Baseline amount of SARS-CoV-2 in salivary samples at 4 and 9 hours, 1, 2, 3, 4, 5 and 6 days. Real-time PCR assays are performed to assess salivary SARS-CoV 2 viral load. Secondary Outcome Measures: Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 6 days. Real-time PCR assays are performed to assess nasal SARS-CoV-2 viral load. Randomisation Participants meeting all eligibility requirements are allocated to one of the two study arms (mouthwash with β-cyclodextrin and Citrox® or mouthwash without β-cyclodextrin and Citrox®) in a 1:1 ratio using simple randomisation with computer generated random numbers. Blinding (masking) Participants, doctors and nurses caring for participants, laboratory technicians and investigators assessing the outcomes will be blinded to group assignment. Numbers to be randomised (sample size) Both the intervention and control groups will be composed of 103 participants, so the study will include a total of 206 participants. Trial Status The current protocol version is 6, August 4th, 2020. Recruitment began on April 6, 2020 and is anticipated to be complete by April 5, 2021. As of October 2, 2020, forty-two participants have been included. Trial registration This trial was registered on 20 April 2020 at www.clinicaltrials.gov with the number NCT04352959. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.” The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).”

Objectives: Inclusion of patient preference (PP) data in decision making has been largely discussed in recent years. Healthcare decision makers-regulatory and health technology assessment (HTA)-are more and more conscious of the need for a patient-centered approach to decide on optimal allocation of scarce money, time, and technological resources. This literature review aims to examine the use of and recommendations for the integration of PP in decision making. Methods: A literature search was conducted through PubMed/Medline in May 2019 to identify publications on PP studies used to inform benefit-risk assessments (BRAs) and HTAs and patient-centered projects and guidelines related to the inclusion of PPs in health policy decision making. After title and abstract screening and full-text review, selected publications were analyzed to retrieve data related to the collection, use, and/or submission of PPs informing BRA or HTA as well as attempts and initiatives in recommendations for PPs integration in decision-making processes. Results: Forty-nine articles were included: 24 attempts and pilot project discussions and 25 PP elicitation studies. Quantitative approaches, particularly discrete choice experiments, were the most used (24 quantitative elicitation studies and 1 qualitative study). The objective of assessing PPs was to prioritize outcome-specific information, to value important treatment characteristics, to provide patient-focused benefit-risk trade-offs, and to appraise the patients' willingness to pay for new technologies. Moreover, attempts and pilot projects to integrate PPs in BRAs and HTAs were identified at the European level and across countries, but no clear recommendations have been issued yet. No less than seven public and/or private initiatives have been undertaken by governmental agencies and independent organizations to set guidance targeting improvement of patients' involvement in decision making. Conclusion: Despite the initiatives undertaken, the pace of progress remains slow. The use of PPs remains poorly implemented, and evidence of proper use of these data in decision making is lacking. Guidelines and recommendations formalizing the purpose of collecting PPs, what methodology should be adopted and how, and who should be responsible for generating these data throughout the decision-making processes are needed to improve and empower integration of PPs in BRA and HTA.

To provide an understanding of medical care adherence factors as reported by caregivers, adolescent, and adult patients with sickle cell disease and to analyse those concerns to identify barriers and facilitators about medical care adherence. Three topics influenced medical care adherence: the disease itself, therapeutics, and the healthcare system. This study will focus on the first topic.Qualitative explorative study, using semi-structured and life-experience interviews and manual inductive content analysis.From December 2016 - March 2017, one semi-structured interview was conducted by a researcher with each of the 15 adolescent patients, 10 adult patients, and 19 caregivers in a French public hospital. Interviews were audio-taped and transcribed before a content analysis. Perceptions were classified into barriers and facilitators of medical care adherence.This article presents disease perceptions of caregivers and patients (adolescents and adults): daily management and social representations. These perceptions differ among parents, adolescent patients, and adult patients. However, all report important disease-related "limitations" in their lives. The objective for adults (parents and patients) is to "live with the disease" and to achieve this, they find coping resources. Two major resources expressed by adults emerged: social resources (support from friends, patients' association, and social visibility) and disease knowledge (theoretical and derived from experience). This is not the case of adolescents for whom social normality was the main concern.Care management adherence is partly based on coping with the disease. Given the lower number of facilitators expressed by adolescents, it is essential to propose interventions in this population. It will help them cope with the disease and, consequently, optimize care management adherence.Showing differences among caregivers, adult, and adolescent patient perceptions, this study impact future care practices. It revealed needs of intervention for adolescents.目的: 了解医护人员、青少年和成年镰状细胞病患者所报告的医疗护理依从性因素,并对此类因素进行分析,以确定相关医疗护理的障碍和促进因素。 医疗护理依从性主要与三大主题相关:疾病本身、疗法和医疗系统。本研究将围绕第一个主题展开。 设计: 定性探索性研究,采用半结构化和生活经验访谈和手动归纳分析法。 方法: 研究人员在2016年12月至2017年3月间,对法国一家公立医院的15名青少年患者、10名成年患者和19名医护人员进行了一次半结构化访谈。该访谈内容在分析之录音和转录。此类人员的认知均可划分为医疗护理依从性的障碍和促进因素。 结果: 本文主要介绍医护人员和患者(青少年和成人)对疾病的认知,即:日常管理和社会表征。父母、青少年患者和成年患者对此观念的看法各异。然而,所有人都对其生活中疾病相关问题的“局限性”进行报告。成人(父母和患者)的目标是“与疾病抗争到底”,为实现此目标,其找到对应资源。成人主要需要两大资源,分别是:社会资源(朋友、患者协会和社会知名人士的支持)和疾病知识(理论和经验)。然而,这并不是青少年的关注点,对他们而言,社会常态更为重要。 结论: 护理管理依从性部分是以疾病对抗对基础。鉴于青少年所述促进者人数较少,有必要对此人群提出干预措施。此类措施的提出有助于其应对疾病,从而优化护理管理的依从性。 影响: 本研究显示护理人员、成人和青少年患者的认知差异,对未来护理实践有一定影响。本研究同样揭示青少年的干预需求。.

Considered to be a major portal of entry for infectious agents, the oral cavity is directly associated with the evolutionary process of SARS-CoV-2 in its inhalation of ambient particles in the air and in expectorations. Some new generations of mouth rinses currently on the market have ingredients that could contribute to lower the SARS-CoV-2 viral load, and thus facilitate the fight against oral transmission. If chlorhexidine, a usual component of mouth rinse, is not efficient to kill SARS-CoV-2, the use of a mouth rinses and/or with local nasal applications that contain β-cyclodextrins combined with flavonoids agents, such as Citrox, could provide valuable adjunctive treatment to reduce the viral load of saliva and nasopharyngeal microbiota, including potential SARS-CoV-2 carriage. We urge national agencies and authorities to start clinical trials to evaluate the preventive effects of βCD-Citrox therapeutic oral biofilm rinses in reducing the viral load of the infection and possibly disease progression.

Objectives\ud \ud Nusinersen (Spinraza®, Biogen) and onasemnogene abeparvosec (Zolgensma®, Novartis) are novel gene-based therapies for the orphan disease Spinal Muscular Atrophy. Onasemnogene abeparvosec has been allocated an acquisition cost of up to US$5 million per patient. We undertook a rapid inquiry to evaluate if onasemnogene abeparvosec is likely to be cost effective for the UK NHS.\ud \ud Methods\ud \ud We used publicly available cost effectiveness data and recommended methodology to perform cost utility evaluation of onasemnogene abeparvosec versus best supportive care and nusinersen.\ud \ud Results\ud \ud Our evaluations highlight wide variations in cost and benefit estimates of nusinersen and indicate that onasemnogene abeparvosec is unlikely to represent value for money according to current standards of reimbursement. Results are discussed in the context of reimbursement decisions for orphan diseases.\ud \ud Conclusion\ud \ud Commonly implemented commercial confidentiality practices combined with uncertain data obscure scrutiny and justification of past and present reimbursement decisions for orphan drugs. Future cutting edge expensive therapies will be numerous, they will entail very substantial economic strains. We conclude that there is an urgent and increasing need for the development of improved procedures that can lead to equitable, consistent and transparent decision making.

Periodontal disease is clearly correlated with systemic disease. The presence of periodontal pathogens in interdental spaces in young, healthy adults is a strong indicator of the need to introduce daily interdental prophylaxis. Twenty-five subjects (aged 18–35 years), diagnosticated clinically as periodontally healthy, were enrolled in this study. One hundred interdental sites were included. Among these sites, 50 “test” sites were cleaned daily with calibrated interdental brushes (IDBs), whereas the other 50 sites were not cleaned and considered “controls”. The interdental biofilm at these interdental sites was collected at the beginning of the study (basal) and at 1 week, 2 weeks, 3 weeks, 4 weeks, and 3 months. Real-time polymerase chain reaction (PCR) methodology was used to quantify (i) 19 periodontal bacteria, including Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia, and (ii) total bacteria. In the test sites, the quantity of total bacteria decreased over time with the use of IDBs. The bacteria from the red and orange Socransky complexes, which are associated with periodontal disease, significantly decreased in the test sites but not in the control sites. Bacteria from the yellow, and purple Socransky complexes, which are associated with periodontal health, increased significantly in both groups whereas bacteria from the blue Socransky complex increased significantly only in the test sites. Furthermore, at basal, 66% of test sites and 68% of control sites bled during interdental brushing. These percentages decreased by 85% in 3 months for the test sites and by 27% in the control sites. In conclusion, the daily use of calibrated IDBs can reduce periodontal pathogens, reestablish symbiotic microbiota and, decrease interdental inflammation in interdental sites of healthy young adults.

Dental caries is a major oral disease resulting from a complex interaction between the commensal microbiota, host susceptibility (heredity, immunity, diseases, etc.) and environmental factors (diet, dental hygiene, etc.). To predict the patient's risk of new carious lesions or progression of existing lesions, the Caries Risk Assessment (CRA) takes account of clinical, biological and behavioural factors. Thus, the CRA can predict whether the patient is at high or low risk of developing caries. The practitioner can thus set up a follow-up adapted to the risk of the patient. However, although bacteria are the main etiological factor of carious lesions, the CRA does not consider bacterial quantification or just focus on the level of S. mutans in the saliva. As the majority of cavities are interproximal in adolescence, the aim of this trial is to identify and quantify the interdental microbiota of adolescents aged from 15 to 17 years with low or high carious risk. So, the quantification of new biomarkers associated with carious lesion could be added to the CRA to improve it. Keywords: Interdental microbiota, Adolescent, Dental caries, Carious risk

This study aims to evaluate the potential role of pillboxes used for the preparation and delivery of individual daily medical treatments in the drug circuit of the Military Instruction Hospital (France) as reservoirs of bacterial contaminants. Samples were obtained from 32 pillboxes after decontamination (T1), after preparation in the pharmacy (T2), after use in two different medical units (T3), and again after usual mechanical washing (T4). Qualitative (identification and antibiotic susceptibility) and quantitative (contamination rate and number of colony forming units&mdash, CFUs) bacteriological tests were performed. Susceptible and resistant strains of environmental saprophytes were identified. The pillbox contamination rate was relatively low at T1 (13%). It was significantly increased at T2 (63%, p = 0.001 vs. T1), again at T3 (88%, p &lt, 0.05 vs. T2, p &lt, 0.001 vs. T1), and finally decreased dramatically at T4 (31%, p &lt, 0.001 vs. T3, p &gt, 0.05 vs. T1). The number of CFUs was significantly increased at T2 compared with that of T1 (36.7 &plusmn, 13.4 and 5.36 &plusmn, 3.64, respectively, p &lt, 0.001) and again at T3 (84.4 &plusmn, 19.4, p &lt, 0.001 vs. T1 and T2) and was significantly reduced at T4 (7.0 &plusmn, 2.0 vs. T3, p &lt, 0.001) to a level that was not significantly different from that at T1. So, the use of pillboxes to deliver individual medications to patients in the hospital is a potential risk factor for bacterial cross-contamination.

International audience; Background: Pain management in emergency departments is a complex objective. The absence of a care pathway or a high level of activity complicates diagnostic or analgesic therapeutic strategies. Medical innovation can impact both individual practices and the functioning of an emergency department.Objective: We then wanted to understand how medico-economic studies on pain were carried out in an emergency department.Study design: We reviewed the literature of the last 20 years (between 1998 and 2018).Setting: Of 846 titles screened, a total of 268 abstracts qualified for further screening, and 578 titles were excluded. A total of 14 studies qualified for inclusion in the review. Studies on medico-economics in an emergency department are very diverse. None of the methods used are identical; the studies differ in their very nature (prospective, retrospective, cost-effectiveness, etc.) and the determination of emergency room costs differs according to the part of the world studied. In addition, organizational impact is rarely measured, although it is an essential dimension for choosing or not a medical innovation.

Objectives: Pain assessment is enigmatic. Although clinicians and researchers must rely upon observations to evaluate pain, the personal experience of pain is fundamentally unobservable. This raises the question of how the inherent subjectivity of pain can and should be integrated within assessment. Current models fail to tackle key facets of this problem, such as what essential aspects of pain are overlooked when we only rely on numeric forms of assessment, and what types of assessment need to be prioritized to ensure alignment with our conceptualization of pain as a subjective experience. We present the multimodal assessment model of pain (MAP) as offering practical frameworks for navigating these challenges. Methods: This is a narrative review. Results: MAP delineates qualitative (words, behaviors) and quantitative (self-reported measures, non–self-reported measures) assessment and regards the qualitative pain narrative as the best available root proxy for inferring pain in others. MAP offers frameworks to better address pain subjectivity by: (1) delineating separate criteria for identifying versus assessing pain. Pain is identified through narrative reports, while comprehensive assessment is used to infer why pain is reported; (2) integrating compassion-based and mechanism-based management by both validating pain reports and assessing underlying processes; (3) conceptualizing comprehensive pain assessment as both multidimensional and multimodal (listening/observing and measuring); and (4) describing how qualitative data help validate and contextualize quantitative pain measures. Discussion: MAP is expected to help clinicians validate pain reports as important and legitimate, regardless of other findings, and help our field develop more comprehensive, valid, and compassionate approaches to assessing pain.

cited By 0; Purpose: A first cost-effectiveness analysis has raised a strong concern regarding the cost of tumor treatment fields (TTF) added to maintenance temozolomide for patients with glioblastoma. This evaluation was based on effectiveness outcomes from an interim analysis of the pivotal trial, moreover it used a “standard” Markov model. Our objective was to update the cost-effectiveness evaluation using the more flexible potential of the “partitioned survival” model design and using the latest effectiveness data. Methods: We developed the model with three mutually exclusive health states: stable disease, progressive disease, and dead. Good fit parametric models were developed for overall survival and progression free survival and these generated clinically plausible extrapolations beyond the observed data. We adopted the perspective of the French national health insurance and used a 20-year time horizon. Results were expressed as cost/life-years (LY) gained (LYG). Results: The base case model generated incremental benefit of 0.604 LY at a cost of €453,848 which, after 4% annual discounting of benefits and costs, yielded an incremental cost effectiveness ratio (ICER) of €510,273/LYG. Using sensitivity analyses and bootstrapping methods results were found to be relatively robust and were only sensitive to TTF device costs and the modelling of overall survival. To achieve an ICER below €100,000/LYG would require a reduction in TTF device cost of approximately 85%. Conclusions: Using a different type of model and updated survival outcomes, our results show TTF remains an intervention that is not cost-effective, which greatly restrains its diffusion to potentially eligible patients. © 2019, Springer Science+Business Media, LLC, part of Springer Nature.

Clinical research on herbal-based dentifrice +/&minus, mouth rinse products is very limited compared with the plethora of research on conventional oral care products under normal oral hygiene conditions. The aim of this study was to determine the anti-inflammatory effects of a novel plant Carica papaya leaf extract (CPLE) on interdental bleeding in healthy subjects. In this randomized, single-blind parallel-design study, the eligible subjects were generally healthy non-smokers, aged 18&ndash, 26, who exhibited healthy periodontal conditions upon study entry. The participants were equally randomized into the following four groups: CPLE dentifrice, CPLE dentifrice and mouthwash, sodium lauryl sulfate (SLS)-free enzyme-containing dentifrice and SLS-free enzyme-containing dentifrice with essential oil (EO) mouthwash. Subjects were instructed to brush their teeth twice a day without changing their other brushing habits. Interdental bleeding (BOIP) was measured from inclusion (T0) until the fourth week (T4) of the study. Clinical efficacy was assessed after one, two, three and four weeks of home use. The analyses compared BOIP between groups and were then restricted to participants with &ge, 70% and then &ge, 80% bleeding sites at T0. Pairwise comparisons between groups were performed at T0 and T4, and a logistic regression identified correlates of gingival bleeding (T4). Among 100 subjects (2273 interdental sites), the median percentage of bleeding sites per participant at T0 was 65%. The bleeding sites dramatically decreased in all groups between T0 and T4 (relative variations from &minus, 54% to &minus, 75%, p &lt, 0.01 for all). Gingival bleeding did not significantly differ between the CPLE dentifrice and the SLS-free dentifrice +/&minus, EO mouthwash groups (from p = 0.05 to p = 0.86), regardless of the baseline risk level. Among the CPLE dentifrice users, fewer bleeding sites were observed when toothpaste and mouthwash were combined compared to bleeding sites in those who used toothpaste alone (21% vs. 32%, p = 0.04). CPLE dentifrice/mouthwash provides an efficacious and natural alternative to SLS-free dentifrice +/&minus, EO-containing mouthwash when used as an adjunct to mechanical oral care to reduce interdental gingival inflammation.

ObjectivesWe hypothesised that patients having experienced one coronary event in their life were susceptible to present differences in their pathways of care and within 1 year of their life courses. We aimed to compare pathways between first-time ST-elevation myocardial infarction (STEMI) and STEMI with prior myocardial infarction (MI).DesignA retrospective observational study based on the Observatoire des Syndromes Coronariens Aigus du réseau RESCUe (OSCAR) registry collecting all suspected STEMI from 10 percutaneous coronary intervention centres in France.SettingAll patients with STEMI from 2013 to 2017 were included (N=6306 with 5423 first-time STEMI and 883 STEMI with prior MI). We provided a matching analysis by propensity score based on cardiovascular risk factors.ParticipantsWe defined first-time STEMI as STEMI occurring at the inclusion date, and STEMI with prior MI as STEMI with a history of MI prior to the inclusion date.ResultsPatients with first-time STEMI and patients with STEMI with prior MI were equally treated during hospitalisation and at discharge. At 12 months, patients with first-time STEMI had a lower adherence to BASIC treatment (ie, beta-blocker, antiplatelet therapy, statin and converting enzyme inhibitor) (48.11% vs 58.58%, p=0.0167), more frequently completed the cardiac rehabilitation programme (44.33% vs 31.72%, p=0.0029), more frequently changed their lifestyle behaviours; more frequently practiced daily physical activity (48.11% vs 35.82%, p=0.0043) and more frequently stopped smoking at admission (69.39% vs 55.00%, p=0.0524). The estimated mortality was higher for patients with STEMI with prior MI at 1 month (p=0.0100), 6 months (p=0.0500) and 1 year (p=0.0600).ConclusionsWe provided an exhaustive overview of the real-life clinical practice conditions of STEMI management. The patients with STEMI with prior MI presented an optimised use of prehospital resources, which was probably due to their previous experience, and showed a better adherence to drug therapy compared with patients with first-time STEMI.Trial registration numberCommission Nationale de l’Informatique et des Libertés (number 2 013 090 v0).

International audience; BACKGROUND:Acute trauma pain is poorly managed in the emergency department (ED). The reasons are partly organizational: ED crowding and rare trauma care pathways contribute to oligoanalgesia. Anticipating the organizational impact of an innovative care procedure might facilitate the decision-making process and help to optimize pain management.METHODS:We used a multiple criteria decision analysis (MCDA) approach to consider the organizational impact of methoxyflurane (self-administered) in the ED, introduced alone or supported by a trauma care pathway. A MCDA experiment was designed for this specific context, 8 experts in emergency trauma care pathways (leading physicians and pharmacists working in French urban tertiary hospitals) were recruited. The study involved four steps: (i) Selection of organizational criteria for evaluating the innovation's impact; (ii) assessment of the relative weight of each criterion; (iii) choice of appropriate scenarios for exploring the organizational impact of MEOX under various contexts; and (iv) software-assisted simulation based on pairwise comparisons of the scenarios. The final outcome measure was the expected overall organizational impact of methoxyflurane on a 0-to-100 scale (score >50: positive impact).RESULTS:Nine organizational criteria were selected. "Mean length of stay in the ED" was the most weighted. Methoxyflurane alone obtained 59 as a total score, with a putative positive impact for eight criteria, and a neutral effect on one. When a trauma care pathway was introduced concomitantly, the impact of methoxyflurane was greater overall (score: 75) and for each individual criterion.CONCLUSIONS:Our model highlighted the putative positive organizational impact of methoxyflurane in the ED-particularly when supported by a trauma care pathway-and the relevance of expert consensus in this particular pharmacoeconomic context. The MCDA approach could be extended to other research fields and healthcare challenges in emergency medicine.

Background Organizational aspect is rarely considered in healthcare. However, it is gradually seen as one of the key aspects of the decision-making process as well as clinical and economic dimensions. Our primary objective was to identify criteria already used to assess the organizational impact of medical innovations. Our secondary objective was to structure them into an inventory to support decision-makers to select the relevant criteria for their complex decision-making issues. Materials and methods A search using the Medline database was conducted in June 2019. The records published between January, 1990 and December, 2018 were identified. The publications cited by the authors of the included articles and the websites of health technology assessment agencies, units or learned societies identified during the search were also consulted. The identified criteria were structured in an inventory. Results We selected 107 records of a wide range of evidence mostly published after the 2000s. We identified 636 criteria that we classified into five categories: people, task, structure, technology, and surroundings. Conclusion Criteria selection is a crucial step in any multi-criteria decision analysis (MCDA). This work is the first step in the development of a validated MCDA method to assess the organizational impact of medical innovations.

INTRODUCTION The objective was to evaluate the quality of life of pregnant women with a full-term birth from the first trimester to the 9th month using the EQ5D-3L questionnaire, comparing physiological, simple pathological, or complex pathological pregnancies. MATERIAL AND METHODS A prospective cohort of 500 pregnant women over the age of 18 was monitored between 2015 and 2017 at the Toulouse University Hospital (France). The data were collected monthly with an online report. Given that the decrease in quality of life was not linear during pregnancy, unadjusted and adjusted piecewise linear regression models were performed, considering 3 periods of time during pregnancy: 3-4, 4-8, and 8-9 months. The 5 dimensions of the EQ5D-Index and perceived health status were also analyzed. RESULTS In total, 1847 questionnaires were collected. Between the 4th and 8th months, the quality of life was lower for pathological pregnancies (P

Background Pharmacists contribute to reduce the number of medication errors during medication review. Nevertheless, few French studies report the potential clinical impact of pharmacists' interventions performed after detecting drug-related problems. The objective was to evaluate the clinical relevance of pharmacists' interventions in a rheumatology ward from medical and pharmaceutical perspectives. Method The analysis was conducted on pharmacists' interventions performed between January 1 and December 31, 2015 in a French teaching hospital. Similar pharmacists' interventions were grouped in one item and they were analysed according to 11 drug categories. The clinical significance of pharmacists' interventions was considered independently by a pharmacist and a rheumatologist using a validated French scale that categorises drug-related problems from minor to catastrophic. The agreement between the two professionals was analysed using the weighted kappa coefficient. Results Of 1313 prescriptions reviewed, 461 pharmacists' interventions (171 items) were formulated for drug-related problems with an acceptance rate of 67.2%. Of the 418 interventions selected for clinical significance analysis, 235 interventions (56.2%) for the physician and 400 interventions (95.7%) for the pharmacist were at least significant. The two professionals evaluated equally the clinical relevance of 90 items (50.6%). The categories with the most similarities were the analgesics/anti-inflammatory drugs (78.1%), the antidiabetics (75.0%) and the anticoagulants (71.4%). The agreement was estimated by a weighted kappa coefficient of 0.29. Conclusion This work highlights the positive clinical relevance of pharmacists' interventions in rheumatology and the importance of medico-pharmaceutical collaboration to prevent medication errors.

Background: In France, a significant part of health expenditure is publicly funding. This put a heavy burden on society. In an economic context requiring tight control of public spending, it seems relevant to control the diffusion of medical innovations. That is why health technology assessment is subject to an increasing interest at national level for management and approval decisions. This article provides an overview of the assessment and diffusion of medical innovation in France. Method: The data are extracted from French authorities or organisations websites and documents and from French legislative texts. In addition, regarding discussion, a search in MEDLINE database was carried out. Results: An overview of the assessment and diffusion of medical innovation in France is given by presenting the different types of medical innovations according to French health system definition (I); introducing French authorities participating to health technology assessment and describe assessment procedures of medical innovations (II); and giving details about market access process of innovative health product in France (III). Key opportunities and challenges of medical innovation assessment and diffusion in France are discussed at the end of this article. Conclusion: In France, medical innovation is considered as a crucial component for quality of care and performance of healthcare system. The aim of health technology assessment is to promote a secure and timely access to innovation for patients. Nevertheless, it appears necessary to improve regulatory mechanisms.

International audience; Background: Claims included in package inserts (PIs) for medicinal products approved by the US Food and Drug Administration (FDA) constitute the regulatory definition of drugs' benefits and risks. Objective: We sought to assess the usage of patient-reported outcome (PRO) claims in a comprehensive set of US FDA orphan drug approvals dated between 1/1/2012 and 31/12/2016, and characterize them. Study design: Orphan drug approval documentation was obtained from the US FDA website. Drug Package Inserts (PI) were analyzed to extract information on PRO-related language. Results: Among 178 drugs that met inclusion criteria, 16 (9%) products approved for 16 orphan indications contained PRO language in the Clinical Studies section of the PI. All PRO instruments concerned disease symptoms, and two also referred to patient functioning. The most common PRO instrument was a bleed-specific rating scale for four products approved for the treatment or prevention of bleeding episodes in patients with genetic bleeding disorders. Conclusions: There is a need to implement public incentives for academic development of PRO instruments for rare conditions and for regulatory policies that mandate the collection of PRO endpoints in pivotal trials of orphan drugs.

In wealthy nations, non-profit drug RD has been proposed to reduce the prices of medicines. We sought to review the ethical and economic issues concerning non-profit drug RD companies, and the possible impact that their pricing strategy may have on the innovation efforts from for-profit companies targeting the same segment of the pharmaceutical market. There are two possible approaches to pricing drugs developed by non-profit RD programs: pricing that maximises profits and "affordable" pricing that reflects the cost of manufacturing and distribution, plus a margin that ensures sustainability of the drug supply. Overall, the non-profits face ethical challenges - due to the lack of resources, they are unable to independently commercialize their products on a large scale; however, the antitrust law does not permit them to impose prices on potential licensees. Also, reduced prices for the innovative products may result in drying the for-profit RD in the area.

BACKGROUND The addition of novel therapy “Tumor-Treating fields” (TTF) to standard radio-chemotherapy with Temozolomide (TMZ) has recently shown superiority over conventional TMZ regimen in patients with glioblastoma. Despite the clinical benefit of TTF, there is a strong concern regarding the cost of this new treatment. A first cost-effectiveness analysis, which was published in 2016, was based on effectiveness outcomes from an interim analysis of the pivotal trial and used a “standard” Markov model. Here, we aimed to update the cost-effectiveness evaluation using a partitioned survival model design and using the latest effectiveness data. MATERIAL AND METHODS A partitioned survival model was developed with three mutually exclusive health states: stable disease, progressive disease, and dead. Parametric models were fitted to the Kaplan-Meier data for overall and progression-free survival. These generated clinically plausible extrapolations beyond the observed data. The perspective of the French national health insurance was adopted and the time horizon was 20 years. Base case results were expressed as cost/life-years (LY) gained (LYG). Secondary analyses were undertaken, with the results presented as cost/per quality adjusted life years (QALY) gained. Last, we undertook deterministic and probabilistic sensitivity analyses. RESULTS After applying 4% annual discounting of benefits and costs, the base case model generated incremental benefit of 0.507 LY at a incremental cost of €258,695 yielding an incremental cost effectiveness ratio (ICER) of €510,273 / LYG. Secondary analyses yielded an ICER of €667,173/QALY. Sensitivity analyses and bootstrapping methods showed the model was relatively robust. The model was sensitive to TTF device costs and the parametric model fitted to the Kaplan-Meier data for overall survival. The cost-effectiveness acceptability curve showed TTF has 0% of being cost-effective under conventional thresholds. CONCLUSION Using a partitioned survival model, uprated costs and more mature survival outcomes, TTF when compared to standard radio-chemotherapy with TMZ is not likely to be cost-effective. This has major implications in terms of access of newly eligible patients

International audience

International audience; In Poland, two proposed amendments to the reimbursement act are currently in preparation ; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Proposed changes include: alignment of medical device reimbursement with that of pharmaceuticals; relaxing the strict reimbursement criteria for ultra-orphan drugs; establishment of an additional funding category for vaccines; introduction of compassionate use, and a simplified reimbursement pathway for well-established off-label indications; appreciation of manufacturers' innovation and research and development efforts by creating a dedicated innovation budget; introduction of a mechanism preventing excessive parallel import; prolonged duration of reimbursement decisions and reimbursement lists; and increased flexibility in defining drug programmes. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry in Poland. ARTICLE HISTORY

Objectives Phenylephrine, ephedrine and norepinephrine are the vasopressors most commonly used in the operating room to treat anaesthesia-induced hypotension. Two new diluted forms of phenylephrine were released in 2011 (500 μg/10 mL and 500 μg/5 mL). We initiated a study to evaluate trends in the use of vasopressors in the operating room in French hospitals over the period 2011–2014. Methods We conducted a longitudinal, retrospective, observational study between 2011 and 2014 in French teaching and military hospitals. A questionnaire was sent in February 2015 to hospital pharmacists of each centre to retrospectively collect the consumption of each type of vasopressor. Yearly numbers of vasopressor ampoules were divided by the yearly numbers of anaesthetics recorded. For each vasopressor, we calculated the number of ampoules per 100 anaesthetics recorded (/100A). Results Thirty-two hospitals (82%) completed the questionnaire. One hundred per cent of hospitals had registered the diluted form of phenylephrine (61% had chosen the dilution 500 μg/10 mL), whereas concentrated ampoules were available in 68% of hospitals. Over the period, an exponential increase in the use of diluted phenylephrine was observed (from 1.0 ampoule/100A in 2012 to 31.7 in 2014), the use of ephedrine remained stable (26 ampoules and 17 prefilled syringe/100A), and use of norepinephrine trended upwards (from 6.7 to 8.2 ampoules/100A). Conclusions The use of diluted phenylephrine has exponentially increased without reducing consumption of other vasopressors. This trend might be secondary to practice changes in hypotension treatment following the release of French guidelines in 2013 related to fluid management, the restriction of indications of hydroxylethyl-starch solutions in 2013, and a better knowledge of the benefit of blood pressure optimisation to reduce postoperative morbidity. © 2017 Academie Nationale de Pharmacie

Le service de Sante des Armees assure le soutien sanitaire des forces armees deployees en operation exterieure. Afin d'assurer la meme qualite de soin sur le theâtre et en Metropole, le Service de Sante des Armees realise la sterilisation des dispositifs medicaux reutilisables par ses propres moyens. Le pharmacien militaire en mission sur place provient de differents horizons: laboratoire de biologie medicale, recherche, ravitaillement sanitaire, pharmacie hospitaliere ou encore officine pour certains reservistes. Une formation a la pratique de la sterilisation en situation d'isolement est donc necessaire afin d'assurer une uniformite des connaissances. Notre travail s'est articule en deux temps: determination des besoins et des modalites de formation adaptes, puis construction de la formation proprement dite. Cette formation doit etre accessible a un public disperse geographiquement dont les niveaux d'expertise en sterilisation sont disparates. Le module « preparation operationnelle a la sterilisation en Operation Exterieure » realise permet d'actualiser et d'uniformiser les connaissances des pharmaciens deployes. Il est compose de 11 sous-modules couvrant les differents aspects de la sterilisation en Operation Exterieure. Une evaluation, a l'aide de questions a choix multiples (QCM), est necessaire pour verifier le niveau de connaissance et de comprehension a la fin de la formation. Un taux de bonne reponse de 75% est demande pour valider la formation. Le contenu de la formation a ete approuve par les referents nationaux en sterilisation et est d'ores et deja disponible sur la plateforme de formation e-learning de l'Ecole du Val de Grace.

Background: The Trump administration's 'American Patients First' blueprint proposes to reduce drug prices in the USA by increasing drug prices abroad, ex USA. The possibility of the Trump administration to raise drug prices ex USA through legal action via the WTO and bilateral negotiations with foreign trade partners was reviewed. Methods: A literature review was conducted through PUBMED, EMBASE, Media and grey literature to consolidate publications of the Trump administrations' policies and strategies towards foreign countries and drug prices. Results: The Trump administration has withdrawn from and halted major multilateral agreements including the TPP, Paris Agreement, TTIP, UNESCO, NAFTA (now USMCA), and NATO. The Trump administration has been successful in bilateral negotiations for pharmaceuticals' pricing, as seen with Japan, South Korea, Germany, and Mexico and Canada. Conclusion: The objective of raising prices abroad is attainable. Action through the WTO is unlikely, due to its nondiscriminatory principle. Bilateral trade negotiation have proven more promising. In this bilateral framework, financial security and military protection are strong assets for the USA to levy higher drug prices abroad. Although raising drug prices ex USA is possible, further questions as to whether this will directly translate into lower drug prices for American patients are raised. ispartof: J Mark Access Health Policy vol:7 issue:1 pages:1650596- ispartof: location:United States status: Published online

Introduction: The appraisal of medicines is often a complex and iterative process. We compared the health technology assessment (HTA) process in England and France taking as a case study the example of ixazomib for multiple myeloma.\ud \ud Methods: We undertook an analysis of eight relevant published documents identifed from the websites of the French and English HTA bodies (HAS and NICE, respectively). We analyse patients’ availability of ixazomib resulting in the different stages of the appraisal process.\ud \ud Results: We identified differences in the assessment, one of these being the use of an appraisal scope in England allowing the differentiation of populations and comparators according to previously approved treatments. Ixazomib became available earlier in France as part of an early access programme, but the availability was soon discontinued for newly eligible patients following an HAS determination that Ixazomib yielded no additional benefit. This opinion resulted in long pricing discussions. In England, despite the absence of an early access programme and following a process that included cost-effectiveness evaluation combined with pricing discussions, the medicine was fairly rapidly recommended for use.\ud \ud Conclusions: Differences in the HTA process may result in appreciable differences in time from marketing authorisation to health service adoption of newly licensed drugs

Purpose: We aimed to evaluate the rate of usage and the kind of patient-reported outcome (PRO) claims in orphan drug approvals from the European Medicines Agency (EMA) dated between 1/1/2012 and 31/12/2016 and to compare them to those from the US Food and Drug Administration (FDA). Methods: Orphan drug approval documentation was obtained from the EMA website. PRO-related language was extracted from the Summaries of Product Characteristics (SmPCs). Data were compared to a previously published analysis of the FDA approvals from the same time period. Results: Out of 60 approvals that met the inclusion criteria, 12 products approved by the EMA for 13 (21.7%) orphan indications contained PRO language in the Clinical Studies section of the SmPC. Twelve SmPCs contained PRO instruments based on symptoms, five of which also concerned patient functioning. Eight approvals included PRO claims related to quality of life (QoL) most commonly in cancer treatment. Conclusion: The rate of PRO claims was lower for orphan drugs specifically than for all drug approvals by the EMA. However, in accordance with previous findings, the EMA appeared more inclined to grant PRO claims including health-related QoL than the FDA.

The majority of medication errors that harm patients relate to the prescribing process. Our study aimed to identify the predictors of prescription errors involving anticancer chemotherapy agents.All consecutive antineoplastic prescriptions from June 2006 to May 2008 were analysed, with medication errors being captured. Potential risk factors for medication prescribing errors were defined in relation to the patient, chemotherapy regimen and hospital organisation. The relationship between these risk factors and observed medication errors or dose medication errors was assessed by univariate and multivariate logistic-regression analyses.Among the 17,150 chemotherapy prescriptions, 540 contained at least one error (3.15%). The following independent predictors of risk of medication errors were identified: patients with a body surface area2m(2) (odds ratio (OR): 1.3, 95% confidence interval (CI) 1.01-1.67, p=0.04), protocols with more than three drugs (OR: 1.91, 95%CI 1.59-2.31, p0.001), protocols involving carboplatin (OR: 2.33, 95%CI 1.85-2.95, p0.001), protocols requiring at least one modification by the physician (OR: 1.32, 95%CI 1.09-1.61, p=0.005), inpatient care (OR: 1.58, 95%CI 1.28-1.93, p0.001) and prescriptions by a resident physician (OR: 1.83, 95%CI 1.50-2.22, p0.001). The risk of medication dose prescribing errors was significantly associated with three independent factors: protocols involving carboplatin (OR: 4.47, 95%CI 3.45-5.79, p0.001), protocols with more than three drugs (OR: 2.4, 95%CI 1.92-3.00, p0.001) and protocols requiring at least one modification (OR: 1.33, 95%CI 1.04-1.69, p=0.02).In this epidemiologic study, the independent risk factors identified should be targeted for preventive measures in order to improve anticancer agent prescriptions and reduce the risk of medication errors.