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In preparation for a new version of the CRAT (Centre de référence sur les agents tératogènes) website, an evaluation of user satisfaction was carried out. An invitation to complete an online questionnaire covering the various dimensions of the website (appearance, content, interactivity, ease of use, technical performance) was sent in April 2022 to healthcare professionals who referred to CRAT for clinical expertise over the previous two years. After sending out 3224 individual e-mail invitations, 758 evaluators completed the questionnaire in full (response rate: 23...

INTRODUCTION: The coronavirus disease 2019 (COVID-19) vaccination campaign has resulted in numerous pharmacovigilance's safety reports which were recorded in the World Health Organization (WHO) pharmacovigilance database (VigiBase) and represent in July 2022 more than 10% of cases recorded. The information component (IC) is a statistical disproportionality measure based on the observed and expected numbers of case reports. A positive value of the lower endpoint of a 95% credibility interval for the information component (IC0...

BACKGROUND: Prognostic models have been developed using data from a multicentre noncomparative study to forecast the likelihood of a 50% reduction in prostate-specific antigen (PSA50), longer prostate-specific antigen (PSA) progression-free survival (PFS), and longer overall survival (OS) in patients with metastatic castration-resistant prostate cancer receiving [177 Lu]Lu-PSMA radioligand therapy. The predictive utility of the models to identify patients likely to benefit most from [177 Lu]Lu-PSMA compared with standard chemotherapy has not been established...

AIM OF THE STUDY: The past twenty years have seen a rise in cocaine-related statistics in France, including cocaine use in the general population, emergency ward presentations of acute cocaine intoxication, cocaine use disorders related outpatient appointments and cocaine-related deaths. This study's objectives were to describe trends in patients' admission for specific cocaine detoxification as well as changes in patients' characteristics in the Assistance publique-Hôpitaux de Paris (AP-HP) hospitals group located in Paris region, France...

We report our initial real-world experience with 177 Lu-PSMA-617 radioligand therapy. Methods: We performed a retrospective review of patients treated with 177 Lu-PSMA-617. Pretreatment PSMA PET, laboratory findings, overall survival, a fall in prostate-specific antigen by 50% (PSA50), and toxicities were evaluated. Results: Ninety-nine patients were included. Sixty patients achieved a PSA50. Seven of 18 (39%) patients who did not meet the TheraP PSMA imaging criteria achieved a PSA50. Nineteen of 31 (61%) patients who did not meet the VISION laboratory criteria achieved a PSA50...

Rare diseases are chronic, serious and generally genetic conditions affecting a small number of people, and their therapeutic management is a real challenge. They represent a considerable burden for patients, caregivers and society alike. Compared with existing symptomatic treatments, gene therapies represent a promising new approach aimed at treating these diseases by replacing a defective gene, or by abolishing or reviving a gene-derived function. France is considered one of the leading countries in the research and development of drugs for rare diseases, yet the position of French public and private stakeholders in the research and development of gene therapies for rare diseases at global and European level remains unclear...

BACKGROUND: Overusing medication for primary headaches or other medical conditions can lead to dependency and medication-overuse headache (MOH) as an adverse drug reaction (ADR). OBJECTIVES: To analyse reports of ADRs associated with MOH recorded in the French national pharmacovigilance database (FPVD). METHODS: This retrospective study selected all MOH cases reported in the FPVD from January 2000 to June 2023. A search of the High-Level Group Term "headache" was performed for drugs classified under ATC codes for the musculoskeletal and nervous systems...

INTRODUCTION: Bariatric surgery is the only treatment for severe obesity (BMI>35kg/m2 ) currently recognized as effective both in achieving tangible and lasting weight loss, and in improving obesity-related comorbidities such as type 2 diabetes, hypertension, and cardiovascular complications. Bariatric surgery, like any other surgery of the digestive tract, can have an impact on nutrient absorption, as well as on drug absorption. The literature on drug management in bariatric surgery patients concerned mainly of case reports and retrospective studies involving a small number of patients...

PURPOSE: The safety profile of methimazole (MMI) seems to be better than propylthiouracil in the management of hyperthyroidism. It is therefore advisable to use IMM as the first choice in Graves' patients. It is important to keep this drug in patients regardless of minor side effects. We report a case series of MMI-induced urticaria and provide a stepwise protocol for the safe re-administration of MMI. METHODS: It was a retrospective case series including all patients having manifested urticaria following MMI intake for hyperthyroidism; notified to the Pharmacovigilance Unit of the Clinical Pharmacology Department (March 2013-January 2022)...

In recent years, the increase in cannabidiol (CBD) sales in Europe has raised questions regarding the legal status of this product, as well as its safety of use. Consumers seem to be looking for solutions to various health issues. However, the scientific reality is much more nuanced. The European CBD market emerged in Switzerland in 2016 and subsequently expanded across the continent. This expansion has been facilitated by the establishment of delta-9-tetrahydrocannabinol (THC) concentration limits for these products...

CONTEXT: Patients with chronic obstructive pulmonary disease (COPD) experience pain as both symptom and comorbidity. There has been no evaluation of the recommendations for pain management in updated clinical practice guidelines (CPGs). OBJECTIVES: Update the evidence on pain management, determine alignment of pain management recommendations with best-practice, and advocate for optimal pain management in patients with COPD. METHODS: PubMed, Guideline International Network, Guideline Portal, Agency for Healthcare Research and Quality, National Institute for Healthcare Excellence, Scottish International Guidelines Network, Institute of Medicine, grey literature, national websites, and bibliographies were searched...

The number of elderly people with type 2 diabetes (T2D) is increasing worldwide. Community pharmacies, thanks to their proximity, provide more easy access to therapeutic education for rural patients. Populations living in isolated areas require specific educational resources related to their condition. The aim of this project was to perform a short (FLASH) educational intervention, coordinated by community pharmacists, and then evaluate the impact of this intervention on patient knowledge of their disease. The study was performed in Issoudun, a rural French town of approximately 10,000 inhabitants...

The main objectives of multidisciplinary clinical investigation center (CIC-P) are to facilitate the availability of new drugs for patients, to enhance the visibility and attractiveness of French clinical research, to improve the quality of early phase trials, and to enhance the value of academic research by evaluating molecules in rare diseases. Since 2017, the CIC-P has been committed to a quality approach process, launching in 2018 its first satisfaction survey on patient care and clinical trial management of all its employees...

The beginning of the 21st century has seen an increasing number of digital medical devices (DMDs) arrive on the European market, bringing major benefits and changes for society. DMDs are unique in that they bring intelligence to the organisation of care, and generate and collect a wealth of real-life data with ultra-fast life cycles. They have specific requirements, particularly in terms of data security and interoperability. In France and Europe, the construction of evidence, the assessment process and evaluation methodologies with a view to purchase or reimbursement must adjust to these changes, given the specific features of these technologies...

BACKGROUND: Considering data from the literature in favor of active educational intervention to teach pharmacovigilance, we describe an innovative model of distance learning clinical reasoning sessions (CRS) of pharmacovigilance with 3rd year medical French students. METHODS: The three main objectives were to identify the elements necessary for the diagnosis of an adverse drug reaction, report an adverse drug reaction and perform drug causality assessment. The training was organized in 3 stages...

OBJECTIVE: To estimate the prevalence of the paracetamol use for a reason other than pain (qualitative misuse) during the last 12 months in patients consulting their general practitioner, as well as the reasons for this misuse. METHODS: Descriptive cross-sectional analysis, with gender weighting to estimate the prevalence of paracetamol misuse. RESULTS: In total, data from 209 patients were included in the analysis. Among them, 11 patients declared having taken paracetamol for a reason other than pain, i...

177 Lu-labeled prostate-specific membrane antigen (PSMA) radioligand therapy effectively treats metastatic castration-resistant prostate cancer. Patients requiring treatment, and consequently the number of theranostic centers, are expected to increase significantly after Food and Drug Administration and European Medicines Agency approval. This requires standardization or harmonization among theranostic centers. The aim of this study was to assess operational differences and similarities among 177 Lu-PSMA treatment centers...

OBJECTIVE: Sjogren's syndrome (SS) is an autoimmune disease that mainly affects the salivary and lacrimal glands and further leads to dry mouth and eyes. In recent years, knowledge about the treatment of SS is developing rapidly. This study aims to assess research progress on SS treatment using a bibliometric approach and to identify research hotspots and emerging trends in this area. METHODS: The publications related to the treatment of SS were retrieved from the Science Citation Index Expanded (SCI-E) database...

OBJECTIVE: To evaluate the development of pharmaceutical interviews in pharmacies in France, in order to understand the organization implemented, any limitations and the expansion of eligible pathologies. METHOD: A dematerialized questionnaire was designed and distributed between November 2022 and February 2023 to pharmacists and pharmacy students in France (mainland and overseas) via a link to a Google Form. RESULTS: Ninety-four pharmacists from 8 different regions of France responded to the survey...

Acute generalized exanthematous pustulosis (AGEP) is a severe and life-threatening cutaneous adverse reaction. Drug-induced AGEP is mainly related to antibiotics. More recently, AGEP following spider bites has been increasingly described. Treatment includes withdrawal of the offending drug and supportive care. In Tunisia, data concerning severe cutaneous adverse reactions (SCARs) in general and especially AGEP is lacking. Herein, we conducted a retrospective study to investigate the epidemiological, clinical characteristics and etiologies of AGEP referred to the Dermatology department...