Annales pharmaceutiques francaises最新文献

Advanced Therapy Medicinal Products (ATMPs) are playing an increasingly important role in therapeutics, and sometimes represent the only hope of improving or even curing some pathologies. Because of their biological origin, composition, mode of action, and their frequent technical complexity, ATMPs are potentially generating new risks. Moreover, clinical trial data generally concern only a very small number of patients. The pharmacovigilance of ATMPs must adapt to these constraints and to these new identified or potential risks to be authorized according to an European centralized procedure. The conception and the assessment of the Risk Management Plan are essential to complete routine pharmacovigilance with post-authorization studies and additionnal risk minimisation measures adapted to the identified safety concerns. This article provides an overview of existing ATMPs and their specific regulatory pharmacovigilance requirements, involving the role of the European committees. It aims to describe the essential elements of the risk management plan of ATMPS, with a focus on delayed adverse reactions. The particular case of ATMPs prepared in the context of « hospital exemption », is also addressed, with the example of ATMPs for adoptive immunotherapy.

In this study, the solubility of amlodipine besylate in N-methyl-pyrrolidone/1-propanol and N-methyl-pyrrolidone/2-propanol binary mixture systems were measured using a common shake-flask method followed by spectroscopy analysis at temperature ranges from 298.2 K to 313.2 K. The generated data were fitted to some models, van't Hoff, Jouyban-Acree, Jouyban-Acree-van't Hoff, mixture response surface, and modified Wilson, to mathematical representation the solubility data. Finally, the apparent thermodynamics properties for the saturated mixtures were computed using van't Hoff and Gibbs equations.

Biosensors play a crucial role in the diagnosis and monitoring of diseases as therapeutic applications that come with ease through incorporation and collaboration with wearable medical devices. Various regulatory markets are implementing development and management strategies for this emerging medical device field. This paper provides regulatory navigation of biosensors in wearable diagnostic devices across the US, EU, and Indian markets. The regulatory structure of all three countries differs from their origination and management which is discussed in this article along with the regulatory requirements applicable to such devices. The study also focuses on areas such as Good Manufacturing Practices (GMP), risk-based device classification, validation, and post-market surveillance. Key highlights include understanding regulatory authorities, guidelines, rules, regulations, and standards; comparison of regulatory perspectives between the three markets; application of biosensors in medical devices; prospects and market size. The study identifies approval pathways, regulatory challenges, and harmonization efforts across the globe. The paper explores recent advancements in biosensors for health interventions, such as personalized medicine, collaboration with the IoT, biomedical applications, and their accessibility.

Chronic wounds are a significant clinical problem for the healthcare system and require several intensive efforts to improve alternative drug delivery systems for wound care. Sometimes, this is insufficient to support the healing process. There are several obstacles to effective wound therapy, such as poor healing, off-targeting, noncompliance, and frequent dosage. Animal healthcare is a much-needed service for pet owners, farmers, and government agencies. However, the varied physiology of animals presents a challenge in producing effective medicines for animal health. To improve drug therapeutic performance, reduce animal stress, and minimize adverse effects, the industry focuses on current developments in technology for wound management in animals. The literature search utilized various reviews, research articles, clinical trials, case reports, etc. Search engines like Google Scholar, PubMed, and ScienceDirect were used to retrieve data. Various keywords such as "wound dressing and animals", "antimicrobials and animal wounds", "wound healing and animals" etc. were used to search the literature. Different formulation avenues are being explored, including hydrogels, wafers, and nanoemulsions. Therefore, further research is necessary to explore wound healing techniques. Utilising various advanced drug delivery systems for veterinary medicine has significantly reduced adverse effects, the frequency of doses, and stress on animals, resulting in increased profits for the industry. However, this also requires investment in research to ensure the safety, quality, and effectiveness of drugs, and delivery systems. This article reviews the various phases involved in wound healing, multiple factors affecting wound healing, different wound healing approaches, clinical trials, and case studies.

Photodynamic therapy (PDT) has emerged as a promising and evolving modality in cancer treatment leveraging light-sensitive compounds known as photosensitizers to selectively induce cell death in malignant tissues through the generation of reactive oxygen species (ROS). This review delves into the intricate mechanisms of PDT highlighting the pivotal role of photosensitizers and the resultant oxidative stress that damages cancer cells. It explores the versatile applications of PDT across various cancer types alongside the advantages and limitations inherent to this therapy. Recent technological advancements including improved photosensitizers and novel light delivery systems are also discussed. Additionally the review examines the critical role of arachidonic acid (AA) metabolism in cancer progression detailing the cyclooxygenase, lipoxygenase and cytochrome P450 pathways and their contributions to tumor biology. By elucidating the interplay between PDT and AA metabolism the review underscores the potential of targeting AA metabolic pathways to enhance PDT efficacy. Finally it provides clinical and translational perspectives highlighting ongoing research and future directions aimed at optimizing PDT for improved cancer treatment outcomes.

Objectives: High-Alert Medications represent a significant concern in clinical practice. The importance of raising awareness and training healthcare professionals appears essential for improving the quality and safety of care. Thus, an interactive and participatory educational format named escape room was employed in a multi-site University Hospital Center.

Methods: The escape room 'Never Events Enigma' was implemented across 4 hospitals. Collaboration between our department and quality unit of each hospital facilitated the determination of organizational modalities regarding registration and session scheduling, which were carried out by our mobile team. Each session included: initial knowledge assessment, gameplay, formative debriefing and satisfaction survey. Two months later, a follow-up knowledge assessment was conducted.

Results: The completion of 83 sessions enabled the training of 495 participants (average of 6 per team; minimum 3 and maximum 13). The average duration of a session was 1 hour. The initial knowledge assessment revealed gaps among the various represented professions (average score 11.8/20). The satisfaction survey highlighted the relevance of this educational format. The post-training knowledge assessment demonstrated an improvement in the average score (17.2/20, gain of +5.4 points), but also its limitations, with a low response rate (25.7%).

Conclusion: The escape room proved effective for the desired pedagogical objectives. This playful format offers numerous advantages to engage a diverse audience, although it represents a time-consuming method for large-scale training in small groups and requires thorough organization and communication beforehand for the smooth running of sessions.

Dispensing in a pharmacy is an important pharmaceutical act in order to deliver medicines safely. The aim of our study was to assess the compliance of prescriptions with the regulatory requirements and the consequences of non-compliance on the dispensing of medicines. The study collected 768 medical prescriptions from 16 pharmacies in 5 Moughataas in the 3 Wilayas of Nouakchott. The results show that the surname and first name of the prescriber (87.9%), the professional address (92.4%), the date of the prescription (95.1%), the signature and stamp (84.6%) were the most respected details. The study showed that 99.6% of prescriptions collected were written in French. Also, 76% of medicines were prescribed in the form of specialities. About 90% of prescriptions were handwritten. The non-conformities observed prevented the entire prescription from being dispensed (38.5%) and had consequences on the quality of the advice given to the patient (56.8%). In conclusion, the legal information on prescriptions were not respected, hence the need to rethink the regulatory information, to introduce a single model prescription for the public and private sectors, and to enforce the prescription of essential generic medicines in order to promote rational use and improve the affordability of medicines.

Background and objectives: Shared Decision-Making (SDM) is an intuitive approach among healthcare professionals, but one that is still little formalized or taught in practice in France. In 2022, we carried out a qualitative study on the perception of the PDP concept among a multi-professional panel. Several themes emerged, notably around knowledge of the concept, its implementation in practice and the need for training. The aim of this study is to compare the results obtained in our qualitative study with a larger number of professionals, using a questionnaire.

Methods: Territorial distribution of a questionnaire to medical, paramedical and non-medical professionals and students during the second half of 2022. Quantitative variables are described in headcount proportions. Results from open-ended questions were analyzed by axial coding of verbatims, grouped into categories, themes and sub-themes.

Results: A total of 381 responses were collected from 10 professions (including 41% doctors, 17% pharmacists, 15% nurses, 8% midwives and 8% physiotherapists). Less than a third of respondents (28%) claimed to be trained in therapeutic patient education (TPE). Only 6% of respondents claim to be fully familiar with PDP, while 53% are unfamiliar with the concept. When asked to define PDP, the answer was appropriate in 33% of cases. The majority (81%) of respondents would like to have specific training, and 84% believe there is a link between PDP and ETP. As for the limitations of the concept, 75% of respondents cited the urgency of decision-making, 72% the lack of time, 49% organizational difficulties and lack of knowledge of the concept, and 42% lack of knowledge of the available support tools. Among the levers mentioned by respondents were: strengthening the therapeutic alliance (67%), patient demand (60%), inter-professional support (56%), team motivation (53%) and improving the patient pathway (44%). From the 130 free responses on needs for implementing PDP, 6 themes emerged: needs oriented towards professionals and towards patients, deployment of material resources, adaptation to certain specialties, institutional responsibility and difficulty in finding downstream solutions.

Conclusion: The construction of this questionnaire from the qualitative study allows us to continue our reflection. Implementation of the concept in practice still seems to be in the minority. The limitations and levers identified in the qualitative analysis are confirmed. The development of specific and adapted training seems necessary and desirable for the implementation of the PDP process, even among people trained in ETP.

Objectives: The present work aims to develop a simple, sensitive, and fast spectrophotometric method for the determination catecholamine drugs namely, adrenaline, methyldopa, and dopamine in pure and dosage forms.

Method: The proposed method is based on the oxidation of the drug compounds by an excess amount of the oxidizing agent N-bromosuccinimide, the remainder of which bleaches the safranin O dye which is measured at 535nm.

Results: The estimation limits were 0.1-16, 0.5-9, and 0.5-18μg/mL, with molar absorptivity values of 2.84×10⁴, 5.32×10⁴, and 3.06×10⁴L/mol.cm with good accuracy and precision, as the average recovery % was 100.55%, 102.04%, and 98.44% for adrenaline, methyldopa, and dopamine, respectively, and the relative standard deviation was better than 2.1 for all drugs. The standard addition method was applied for both adrenaline and dopamine, and the results indicated the method is free from additive interference. The method has been applied successfully for the determination of the above drugs in their pharmaceutical formulations.

Conclusion: The method has been applied successfully for the determination of catecholamine drugs in their pharmaceutical formulations, with good accuracy and precision. The standard addition method was applied, and the results indicated the method is free from additive interferences.