Decisions regarding public health safety rely on scientific expertise, yet their impact hinges on how well they are understood and accepted by society as a whole. This article, drawn from the work of the Scientific Council (CS) of the ANSM, examines the conditions that facilitate better public engagement with these decisions. It highlights the tensions between knowledge production, its synthesis, political demands, and social expectations, particularly in the context of health crises that may amplify uncertainties and public perception of them. The analysis underscores that transparency alone is insufficient; it must be accompanied by clear communication about the inherent uncertainty in scientific data. Two key areas of reflection are thus proposed: enhancing the visibility and credibility of scientific discourse in the public sphere, and improving our understanding of citizens' perceptions. The article also emphasizes the value of an earlier and more collaborative dialogue between scientific expertise and society, supported by social sciences and an education in scientific knowledge.

Drug shortages are a growing public health issue, unevenly impacting therapeutic classes. Despite variations in drug consumption across populations, the consequences of these shortages on different patient groups remain insufficiently characterized. This study investigated age and sex profiles of patients consuming the therapeutic classes most commonly affected by drug shortages in France. The age and sex risk of shortage exposure were estimated in a nationwide retrospective study of French patients between 2014 and 2023, using data from the French drug shortage notification system and the national health insurance for the entire French population. Over 10 years, 17 505 drug shortage reports were recorded, 60.8% involving cardiovascular, nervous system, and anti-infective agents. Significantly higher mean percentages of consumers for drugs concerned by shortage reports per 1000 were observed in ≥60-year-old patients for 12 of the 14 therapeutic classes, compared to 20-59-year-old patients (P = .002). Younger population was more significantly concerned by anti-infective agents (11.2 vs 9.2, P = .002), respiratory system (1.8 vs 1.5, P = .002), and sensory organ (0.7 vs 0.6, P = .002) classes. Significantly higher mean percentages of consumers for drugs concerned by shortage reports per 1000 were observed for all Anatomical Therapeutic Chemical 1st level classes in women (P = .002), but agents acting on the renin-angiotensin system were higher for men (2.32 vs 2.02; P = .002). Our exploratory results suggest that a population-level approach is essential to understand how shortages affect different groups and exacerbate health inequalities.

The emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the subsequent coronavirus disease 2019 (COVID-19) pandemic with the continuous evolution of the virus into variants such as Alpha, Beta, Delta, Omicron and others necessitates an on-going surveillance and evaluation of vaccine effectiveness (VE).This study focuses on assessing the real-world performance of the Pfizer-BioNTech (BNT162b2) vaccine against the Omicron variant. This study employs a test-negative, case-control design, a methodology commonly utilized for estimating the VE in influenza studies. It evaluates SARS-CoV-2 test results in individuals aged 50 and older who had influenza-like illness (ILI) or COVID-like illness (CLI) symptoms and presented to the sentinel sites, classifying positive cases as "cases" and negative as "controls." Data collection was done through a standardized questionnaire administered by the Epidemiological Surveillance Unit (ESU) COVID-19 team via phone interviews. Logistic regression analysis was performed to measure the association, taking into account all confounding factors. The results indicate a 14% VE against contracting the disease among fully vaccinated individuals. Factors such as age and underlying conditions significantly influenced VE. The findings of this study highlight the effectiveness of the Pfizer-BioNTech (BNT162b2) vaccine in reducing the odds of symptomatic COVID-19, particularly by decreasing the prevalence of key symptoms such as fever, cough, myalgia, and loss of taste or smell. Breakthrough infections still occurred, indicating that while the vaccine reduces symptom severity, it may not fully prevent infection This VE is lower compared to previous variants, indicating potential challenges in vaccine efficacy. The study underscores the need for an on-going monitoring and potential booster doses to enhance protection, especially against evolving variants like Omicron.

Les décisions en matière de sécurité sanitaire reposent sur l’expertise scientifique, mais leur impact dépend de leur compréhension et de leur acceptation par l’ensemble de la société. Cet article, issu des travaux du Conseil scientifique (CS) de l’ANSM, examine les conditions qui favorisent une meilleure appropriation de ces décisions par le public. Il met en lumière les tensions entre la production de connaissances, leur synthèse, les exigences politiques et les attentes sociales, notamment dans les contextes de crises sanitaires qui peuvent exacerber les incertitudes et leur perception. La transparence ne suffit pas par elle-même. Elle doit être accompagnée d’une communication claire sur l’incertitude inhérente aux données scientifiques. Deux axes de réflexion sont ainsi proposés: renforcer la visibilité et la crédibilité de la parole scientifique dans l’espace public, et mieux comprendre les perceptions citoyennes. L’article insiste également sur l’intérêt d’un dialogue plus précoce et étroit entre expertise scientifique et société, appuyé sur les sciences sociales et une éducation aux savoirs scientifiques.

The French National Agency for Health Products (ANSM) is a regulatory and public health agency. Its regulatory, health policing and public health protection activities require a perfect fit with the field and the various people involved in the use of health products. Since 2019, the ANSM has adapted its organisation, procedures and processes to encourage and improve interaction with its stakeholders, as part of its policy of openness towards civil society. To accompany this ambitious change and to support its staff, the Agency has recruited advisors corresponding to the main users of health products: prescribers (doctor's hospital and outpatient), pharmacists and patients. Working as a group or individually, they provide a "lived"user perspective on health products at each stage of the evaluation process. They may be involved in the assessment of dossiers, signals or applications received by the Agency, in the internal validation of reports or in discussions with stakeholders. They are particularly involved when the analysis requires expertise that goes beyond the technical, scientific or regulatory aspects. They may also work with ANSM staff to explain certain processes and difficulties in the field. Advisors help to ensure that regulatory and/or scientific expertise is clear and consistent with user experience. In addition to their scientific and therapeutic aspects, medicines are also economic, social and political issues. Their regulation is therefore particularly affected by the need for health democracy. This requires the active participation of health professionals, patients and, more broadly, civil society in the decision-making process. Civil society is a space occupied by a wide range of actors who exert pressure from different ideological positions to influence the regulation of health products. In this context, taking into account a plurality of viewpoints in the regulation of health products is necessary and complex, but its operation can be facilitated by the collective efforts of the actors and the adaptation of organisations, such as the integration of advisors. (c) 2024 Agence Nationale de Securite du Medicament. Published by Elsevier Masson SAS on behalf of Societe franc,aise de pharmacologie et de therapeutique. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

The most effective way to prevent influenza infection and its severe outcomes is through vaccination. Influenza vaccination is recommended for high-risk groups, including health care workers who have high occupational exposure. Hesitancy is a major challenge affecting vaccine uptake. This study aims to identify the determinants of seasonal influenza vaccine uptake, intention and recommendation to target groups of physicians in Lebanon. A cross-sectional study was conducted targeting physicians working in Lebanon. Data was collected on Kobo Toolbox using an online questionnaire developed based on the Health Belief Model. A random sample of physicians was selected from the Order of Physicians database. The link to the questionnaire was sent by email or message. Univariate, bivariate and multivariable analyses were performed using R software. The total number of responses was 1019. Half (49 %) of the participants received the vaccine in the 2022-2023 season, and 73 % intend to get it if recommended and offered for free. The perception of vaccine effectiveness was associated with vaccine uptake (adjusted OR = 2.54, 95 %CI = 1.98-3.31), intention to be vaccinated (adjusted OR = 17.5, 95 %CI = 7.21-50.5) and vaccine recommendation. Perception of vaccine safety, type of healthcare facility and physician's specialty were also associated with flu uptake. Other predictors for intention were: perception of disease severity and flu uptake during the previous season. Other predictors for flu vaccine recommendation were: province of residence, number of years in healthcare, specialty and intention to take the flu vaccine (adjusted OR = 21.0, 95 %CI = 7.58-71.3). Influenza vaccine uptake among participating physicians is suboptimal, yet intention to take the vaccine is higher. The study identified several factors associated with the vaccine uptake, intention and recommendation. A multifaceted approach and targeted education activities are needed in a sustainable vaccination program to increase physicians' influenza vaccine uptake.

Artificial intelligence tools promise transformative impacts in drug development. Regulatory agencies face challenges in integrating AI while ensuring reliability and safety in clinical trial approvals, drug marketing authorizations, and post-market surveillance. Incorporating these technologies into the existing regulatory framework and agency practices poses notable challenges, particularly in evaluating the data and models employed for these purposes. Rapid adaptation of regulations and internal processes is essential for agencies to keep pace with innovation, though achieving this requires collective stakeholder collaboration. This article thus delves into the need for adaptations of regulations throughout the drug development lifecycle, as well as the utilization of AI within internal processes of medicine agencies.

Background Urinary tract infections (UTIs) are among the most common bacterial infections, and appropriate antimicrobial therapy with agents that minimise resistance is crucial. Despite international concern, adherence to guidelines is still suboptimal. This study aims to determine the effect of the absence of national guidelines and the rate of conformity to international guidelines among physicians in antibiotic (ATB) prescriptions for the treatment of UTIs in adults and detect the factors that are associated with a higher rate of non-compliance.Methods Patient-related characteristics and the prescribed ATBs were gathered from patients' medical files, and a questionnaire was directed to physicians to elicit the factors involved in decision-making. Four criteria were evaluated: molecule conformity, daily dose conformity, duration conformity and global conformity.Results 37 Lebanese physicians and 185 prescriptions were included. The most prevalent class of ATBs was fluoroquinolones (30.3%). Global conformity to guidelines was 31.4%, while conformity on drug choice, daily dose and duration of treatment was 83.2%, 74.7% and 41.6%, respectively. There were no differences in conformity rates according to the physician’s specialty (p=0.135). Physicians who studied in an American-system university had an increased risk of non-conformity (adjusted OR (aOR=2.107, p=0.018). Patients with higher education levels, or presenting with fever or chills, were more likely to get a non-compliant prescription (aOR=2.140, p=0.032 and aOR=4.947, p=0.033, respectively).Conclusion In a country with no local guidelines, non-conformity to international guidelines is high. Larger national studies are needed with immediate interventions to enhance physicians’ prescribing practices. After local guidelines were established, it would be interesting to compare the rate of adherence to these guidelines.

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) est une agence réglementaire et de santé publique. Ses actions de régulation, de police sanitaire et de protection de la santé publique imposent une parfaite adéquation avec le terrain et les différents acteurs concernés par l’utilisation des produits de santé. Depuis 2019, l’ANSM a adapté son organisation afin de promouvoir et améliorer ses interactions dans le cadre de sa politique d’ouverture à la société civile. Afin d’accompagner cette ambitieuse mutation et soutenir ses agents, l’Agence a recruté des conseillers reflétant les principaux profils d’utilisateurs de produits de santé : médecins, pharmaciens et patients. En collège ou individuellement, ils apportent un regard du « terrain » à chaque étape des processus de décision. Ils peuvent participer à l’évaluation des signalements et demandes comme aux validations de rapports ou aux instances d’échanges avec les parties prenantes. Ils interviennent notamment lorsque l’analyse nécessite une expertise au-delà des aspects scientifiques ou réglementaires. Ils peuvent aider à prendre en compte certains aspects du soin et les difficultés de terrain. Les conseillers participent à la lisibilité et à l’adéquation entre l’expertise réglementaire et/ou scientifique et le vécu des utilisateurs. Au-delà de l’aspect scientifique et thérapeutique, le médicament est aussi un objet économique, social et politique. Ainsi, sa régulation est particulièrement concernée par le besoin de démocratie sanitaire dont les conseillers sont les facilitateurs. Celle-ci impose une participation active des professionnels de santé, des patients et plus largement de la société civile dans la prise de décision. Dans ce contexte, la prise en compte de la pluralité des points de vue dans la régulation des produits de santé est nécessaire mais complexe. Elle peut être facilitée par l’adaptation des organisations, comme l’intégration de conseillers.

IntroductionInfluenza epidemics cause around 3 to 5 million cases of severe illness worldwide every year. Estimates are needed for a better understanding of the burden of disease especially in low- and middle-income countries. The objective of this study is to estimate the number and rate of influenza-associated respiratory hospitalizations in Lebanon during five influenza seasons (2015-2016 to 2019-2020) by age and province of residence in addition to estimating the influenza burden by level of severity. MethodsThe severe acute respiratory infection sentinel surveillance system was used to compute influenza positivity from the influenza laboratory confirmed cases. The total of respiratory hospitalizations under the influenza and pneumonia diagnosis was retrieved from the Ministry of Public Health hospital billing database. Age-specific and province-specific frequencies and rates were estimated for each season. Rates per 100 000 population were calculated with 95% confidence levels. ResultsThe estimated seasonal average of influenza-associated hospital admission was 2866 for a rate of 48.1 (95% CI: 46.4-49.9) per 100 000. As for the distribution by age group, the highest rates were seen in the two age groups >= 65 years and 0-4 years whereas the lowest rate was for the age group 15-49 years. For the distribution by province of residence, the highest influenza-associated hospitalization rates were reported from the Bekaa-Baalback/Hermel provinces. ConclusionThis study shows the substantial burden of influenza in Lebanon mainly on high-risk groups (>= 65 years and <5 years). It is crucial to translate these findings into policies and practices to reduce the burden and estimate the illness-related expenditure and indirect costs.

Previous estimates to meta-analyze administration error rates were limited by the high statistical heterogeneity, restricting their use. This study aimed to investigate sources of heterogeneity in pooled administration error rates in hospitalized adults. We systematically searched scientific databases up to November 2017 for studies presenting error rates/relevant numerical data in hospitalized adults. We conducted separate meta-analyses for the numerators: One Medication Error (OME) (each dose can be correct or incorrect) and Total Number of Errors (TNE) (more than one error per dose could be counted), using the generic inverse variance with a 95% confidence interval. Heterogeneity was assessed using the I-2 and Cochran's Q test. We meta-analyzed 33 studies. The global pooled analyses based on the OME and TNE numerators showed very high heterogeneity (I-2 = 100%; p < 0.00001). For each meta-analysis, subgroup analyses based on study characteristics (countries, wards, population, routes of administration, error detection methods, and medications) yielded results with consistently elevated heterogeneity. Beyond these characteristics, we stratified the studies according to the mean error prevalence level as the threshold. Based on the OME numerator, we identified two subgroups of low (0.15[0.13-0.17]; I-2 = 0%; p = 0.43) and high (0.26[0.24-0.27]; I-2 = 38%; p = 0.17) pooled prevalence rates, with controlled heterogeneity. Similarly, for the TNE numerator, we identified two subgroups of low (0.10[0.09-0.10]; I-2 = 0%; p = 0.76) and high (0.28[0.27-0.29]; I-2 = 0%; p = 0.89) pooled prevalence rates, with controlled heterogeneity. These subgroups differed regarding the denominators used: Total opportunities for errors versus others (doses, observations, administrations). Calculation methods, specifically the denominator, seem a primary factor in explaining heterogeneity in error rates. Standardizing numerators, denominators, and definitions is necessary.

Shortages of drugs and medical devices have tended to increase in France and worldwide, with consequences for patients and healthcare professionals. Preventing shortages of health products has become a priority for regulatory authorities, including the French National Agency for Medicines and Health Products Safety (ANSM). To highlight perspectives for a better prevention, we described and analyzed the management of shortages in the availability of health products in France over the last 10 years. The supply chain was mapped to identify the main causes of shortages and stakeholders involved in managing shortages throughout the supply chain. National and European initiatives and regulatory measures were reviewed. A retrospective nationwide data analysis from the French reporting system of health product shortage reports was conducted over 10 years for drugs (2013–2022) and over an 18-month period for medical devices, from 1st March 2022 to 31st August 2023. An increase in drug shortage reports was observed, rising from 404 in 2013 to 3,761 in 2022 for drugs, with a relatively constant distribution of affected therapeutic classes. In 2022, the main reported causes of drug shortage risk were insufficient production capacity (27.1%), increased sales volume (21.5%), or lack of supply (13.6%). Over half of the reports on medical devices (55.4%) were objectified as indispensable, and their causes were mainly due to a lack of supply (48.2%), discontinuation of marketing (14.9%), increased sales volume (13.2%), and regulatory reasons (9.6%). ANSM and French authorities have engaged a public health policy for prevention and management of health product shortages including financial penalties, minimum safety stocks for Major Therapeutic Interest drugs, and a shortage management plan. Based on 10 years of experience, four priority measures have been identified to anticipate the risk of heath products shortages based: the importance of a national coordination from raw materials to local market, the implementation of new prevention and management actions in the supply chain, strengthening European cooperation and regulation including the establishment of a list of critical drugs, and promoting transparency and information.

The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors. New criteria based on the time from the first request for authorisation to the first inclusion could be of particular interest to appraise the implementation of the European Clinical Trial Regulation.

Nanomaterials are present in a wide variety of health products, drugs and medical devices and their use is constantly increasing, varying in terms of diversity and quantity. The topic is vast because it covers nanodrugs, but also excipients (that includes varying proportions of NMs) and medical devices (with intended or not-intended (by-products of wear) nanoparticles). Although researchers in the field of nanomedicines in clinical research and industry push for clearer definitions and relevant regulations, the endeavor is challenging due to the enormous diversity of NMs in use and their specific properties. In addition, regulatory hurdles and discrepancies are often cited as obstacles to the clinical development of these innovative products. The scientific council of the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) undertook a multidisciplinary analysis encompassing fundamental, environmental and societal dimensions with the aim of identifying topics of interest for regulatory assessment and surveillance. This analysis allowed for proposing some recommendations for approximation and harmonization of international regulatory practices for the assessment of the risk/benefit balance of these products, considering as well the public expectations as regards efficacy and safety of nanomaterials used in Health products, in terms of human and environmental health.

Correspondence to Dr Laëtitia Belgodère; laetitia. belgodere@ ansm. sante. fr © Author(s) (or their employer(s)) 2023. Reuse permitted under CC BYNC. No commercial reuse. See rights and permissions. Published by BMJ. INTRODUCTION In France and Europe, medicine and healthcare products regulatory agencies have been proactively engaging in health democracy for the last decade. Since 2002, the French legislation has evolved to guarantee the rights of healthcare system’s users. Thus, eligible patients and health system user organisations are systematically represented in French health agencies as in some other countries. Beyond the integration of their representatives as members of committees and as part of its transparency policy, the French National Agency for Medicines and Health Products Safety (ANSM) is striving to involve patients at the various stages of the assessment and decisionmaking processes, but also all people concerned with health products. These are members of the public having different profiles, such as patients, users of the health system, caregivers, victims, patient representatives, support organisations and patient partners. Regulatory agencies are responsible for the benefit–risk (BR) assessment associated with the use of health products throughout their life cycle, from clinical development to market approval and the continuous reassessment of the BR balance thereafter. The assessment processes are driven by patient risk management, enabling the Agency to make decisions in a public health policy. ANSM is particularly willing and attentive to health democracy following the crises it has had to face. The involvement of the public and patients in a scientific and medical approach raises questions about the necessary adaptation of the BR assessment processes. To improve the BR assessment according to the approach of health democracy, the ANSM’s Scientific Advisory Board has formalised an approach to strengthen ‘people concerned’ involvement in the activities of regulatory agencies SUMMARY BOX

The COVID-19 pandemic was immediately marked by strong clinical research activity. The French national competent authority presents the data on request for authorization during the first 2 years of COVID-19 pandemic to inform discussions on future clinical research issues. Applications for authorization of interventional COVID-19 trials submitted between March 2020 and February 2022 were analysed. Trials on medicinal products were classified according to market authorization status, mechanism of action of the investigational product, target population and clinical context. In 2 years, 208 clinical trials were submitted. 75% were authorized, 3% refused, 22% withdrawn by the sponsor. Among medicinal products trials, 6% were adaptative, 28% included outpatients and 2% were focused on post COVID-19 symptoms. Vaccines were evaluated in 9% of trials, antivirals in 38% and immunomodulators in 35%; 63% of antiviral and 60% of immunomodulation trials included a drug with a marketing authorization in another indication. The dynamics of authorization prove the involvement of stakeholders but also illustrates the risk of dispersion of research efforts and the risk of decorrelation between trials and the epidemic evolution. The high rate of withdrawal of applications could be explained by changes in the sanitary context and by the dropping of some therapeutic approaches. Most of clinical trials evaluate drugs authorized in another indication and assessment procedures by authorities have to mitigate between the knowledge of safety profile of those drugs and the uncertainty in a new clinical context with rapidly evolving knowledge. COVID-19 experience should now support future evolution in clinical research practices.

Apart from its traditional use in the post-authorization phase for safety assessment, risk management, and life cycle benefit-risk evaluation (Flynn et al., 2022), the interest in Real-World Evidence (RWE) in the pre-authorization phase of medicines development is increasing exponentially (Li et al., 2021; Leufkens et al., 2022; Purpura et al., 2022). In this context, regulatory agencies should adapt their strategy (Heads ofMedicines Agencies and European Medicines Agency, 2019a). RWE is defined as “the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RealWorld Data (RWD)”; the latter includes “big data”, i.e., “extremely large datasets which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly and which may be analyzed computationally to reveal patterns, trends, and associations” (Heads of Medicines Agencies and EuropeanMedicines Agency, 2019b). RWE has a great potential not only to complement evidence generated through randomized controlled trials (RCTs) (Eichler et al., 2021) but also to provide valuable opportunities unavailable through RCTs (Chodankar, 2021). RCTs rightfully remain the fundamental method to establish the safety and efficacy of drugs for licensure (Slattery and Kurz, 2020). Nevertheless, the growing production and accessibility of digital health data support RWE to close the evidentiary gap between clinical research and real-world practice for better disease management (Corrigan-Curay et al., 2018; Lasky et al., 2021). OPEN ACCESS

Objectives The aims of the study were to describe medication errors (MEs) involving older adults reported to the French Medication Error Guichet and to compare them with MEs in younger adults, in each of the hospital and community settings. Methods Retrospective secondary data analysis of MEs reported throughout 2013 to 2017 was performed. Descriptive and multivariate analyses were performed to compare actual and potential ME reports between older adults (aged ≥60 y) and younger adults (aged ≥18, <60 y). Results We analyzed 4979 reports. In older adults, both in hospital (n = 1329) and community (n = 1264) settings, antithrombotic agents were frequently reported in MEs and were significantly more likely to be associated with reported MEs in older adults compared with younger adults. In hospital setting, antibacterials for systemic use (adjusted odds ratio [aOR] = 1.87, 95% confidence interval [CI] = 1.19–2.93) and antineoplastic agents (aOR = 2.22, 95% CI = 1.34–3.69), whereas in community setting, psycholeptics (aOR = 1.43, 95% CI = 1.04–1.98) and drugs used in diabetes (aOR = 6.01, 95% CI = 3.21–11.2) were more likely to be associated with reported MEs in older adults. In both settings, wrong dose and wrong drug were the most frequently reported error types in older adults; however, wrong technique error type (aOR = 2.06, 95% CI = 1.30–3.28) in hospital setting and wrong patient (aOR = 2.17, 95% CI = 1.30–3.60) in community setting were more likely to be associated with reported MEs in older adults. Conclusions We identified specific ME patterns for older adults, including antithrombotic agents in both settings; antibacterials for systemic use, antineoplastic agents, and wrong technique in hospital setting; and psycholeptics, drugs used in diabetes, and wrong patient in community setting. These findings inform future studies investigating population-specific medication safety strategies.

OBJECTIVES:To evaluate antibiotic prescribing patterns and correlates among Lebanese dentists.METHODS:A descriptive observational study was conducted, from the first of April to the end of May 2017. Dentists who specialized in oral dental surgery or general dental practitioners were eligible to participate in this study. All patients who sought consultation with the selected dentists over a 1 month period were included.KEY FINDINGS:A total of 2323 oral and dental procedures were performed by 60 dentists; 553 antibiotic prescriptions were prescribed, representing 23.8% (52.35% for prophylactic purposes and 47.65% for curative purposes). Prophylactic indications were mainly for implant surgery (36.3%) with only 1% appropriate. Curative use was mainly for periodontal abscesses/abscesses (indeterminate) (22.8%), followed by pulpal diseases and periradicular complications (20.5%); it was appropriate in only 1.7 and 1.9% of cases respectively. Amoxicillin-clavulanic acid was the antibiotic that was mostly prescribed for both curative and prophylactic uses (57.6 and 55.9%, respectively), followed by amoxicillin for prophylactic purposes and a combination of spiramycin plus metronidazole for curative purposes. Adherence to guidelines was low for both curative and prophylactic purposes (17.4 and 21.8%, respectively), but was better in patients who were younger [adjusted odds ratio(aOR) = 0.96], male (aOR = 0.40), or had cardiac disease with moderate or high infective endocarditis risk (aOR = 21.72), and when prescribed by oral surgeons (aOR = 0.15).CONCLUSIONS:This study showed evidence of the overuse of antibiotics among Lebanese dentists. It can serve as a basis for future studies to optimize antibiotic use among dentists in Lebanon.

Background: Antibiotic consumption has been reported to be driven by the treatment of respiratory tract infections. Our objectives were to describe the trend of antibiotic consumption in France compared with that of other European countries; to describe the evolution of each antibiotic class in France; and to explore the relationship between antibiotic consumption and incidence of influenza-like illnesses. Methods: In this observational study, antibiotic consumption was reported as defined daily doses per 1000 inhabitants per day in the community and hospital sectors in descriptive and graphical formats, using data from the European Surveillance of Antimicrobial Consumption Network database. The total consumption and the consumption of different classes of antibiotics in France according to time and influenza-like illnesses were studied using multiple linear regression models. Results: The total consumption of antibiotics in France was constant over the 15 years. It was driven by the community sector (92.8%) and was higher than the consumption of other European Union countries (P-value< 0.001). The beta-lactam penicillins were the most consumed antibiotic class and the only class that increased with time. The multiple linear regression models showed a positive correlation between antibiotic consumption in the community sector and incidence of influenza-like illnesses [B = 0.170, 95% CI (0.088-0.252)]. Similar significant results were shown between other antibiotic classes used in the management of influenza-like illnesses (other beta-lactams, and macrolides, lincosamides and streptogramins) and influenza-like illnesses. Conclusion: Our results suggest that antibiotics used in the management of respiratory tract infections might be involved in the irrational use of antibiotics.