Annales pharmaceutiques francaises最新文献

Objectives: In recent years, the development of oral anticancer drugs has led to an increase in outpatient care for patients with cancer. This strategy brings many advantages but also entails major risks in securing the care pathway for patients undergoing oral chemotherapy in order to secure medication car, the pharmaceutical team, in collaboration with the medical team, has set up pharmaceutical consultations in the healthcare service. This work presents the process of setting up these consultations and produces a two years review.

Methods: The first step is the selection of the patient eligible for the pharmaceutical consultation. The pharmaceutical team has developed supports to harmonize practices, drawing in particular on the recommendations for good clinical practices from the Société française de pharmacie clinique (SFPC) and the implementation of pharmaceutical consultations from "la Société française de pharmacie oncologique (SFPO)". Initiation and follow-up pharmaceutical consultations could be carried out in person but also remotely (telephone and telepharmacy care), with an assessment of knowledge (rating grid out of 18) of compliance (according to the Girerd scale and feelings, associated with satisfaction questionnaire. The resources allocated for the activity were as follows: a pharmacist seconded to the care unit 0,8 full-time equivalent (FTE), a pharmacist 0,1 FTE, an intern in the care unit.

Results: Over two years (from 02/12/12021 to 02/12/2023), 271 consultations (203 initiations consultations and 68 follow-up consultations) were carried out, with 203 patients. One hundred and eighty-four patients benefited from knowledge assessment at initiation, 59,8% (n=110) had a score equal to 18/18 and 40,2% (n=74) a score lower than 18. Among the 74 patients who had a score below 18, 54% (n=40) had a follow-up consultation. From a statistical point of view, a significant improvement in knowledge was noted in these 40 patients (mean: 14 vs. 15.8; P<0.001). The average duration of consultations was 30minutes. Pharmaceutical interventions were carried out for 23% of patients. The latter were overall very satisfied with the consultations with the majority (61.3%) wishing to benefit from another consultation subsequently.

Conclusions: The implementation of initiation and follow-up pharmaceutical consultations within the healthcare service has made it possible to improve patient care. These consultations make it possible, on the one hand, to improve patients' knowledge of the oral anticancer drugs initiated, and on the other hand, to carry out a pharmaceutical analysis of the usual treatment with the new oral chemotherapy and possible associated treatments, while strengthening the link hospital city. One of the next objectives will be to monitor the evolution of compliance as follow-up consultations take place.

Objectives: Asthma and Chronic Obstructive Pulmonary Disease (COPD) are major global health issues, impacting morbidity, mortality, and healthcare costs. Despite the proven benefits of pharmacist involvement in managing these conditions, their potential in hospitals remains underused. This study aimed to identify patients at high risk of rehospitalization post-exacerbation of asthma or COPD, to target pharmaceutical interventions.

Methods: Data from the University Hospital for January-December 2019 on adult admissions for asthma/COPD were analyzed, focusing on demographics, hospitalization, and clinical outcomes.

Results: Among the 140 patients enrolled, a significant majority (91%) underwent adjustments in their treatment regimens during their hospital stay, and nearly 59% faced readmission within six months. A survival analysis highlighted a notable disparity in the rates of rehospitalisation-free survival between patients with asthma and those with COPD, identifying COPD patients as having a higher susceptibility to rehospitalisation.

Conclusion: The study found COPD patients at greater risk but didn't specify a priority profile, suggesting the necessity for broad, customized interventions to improve outcomes and reduce healthcare strain.

Objectives: The therapeutic promises of somatic cell and gene therapy (Advanced Therapy Medicinal Products - ATMP) and the significant current or future costs of such therapies raise questions about the impact of European health policy on these expenses. Regulation 1394/2007 currently imposes the medicinal product status on many treatments derived from cell therapy. This study aims to determine the impact of new regulations on manufacturing costs of cell therapy treatments, used as ATMP.

Methods: In our study, using counterfactual reasoning, we analyze the consequences that a change of status would have on the hematopoietic stem cells (HSC) used for treatment of leukemia.

Results: Under the existing status of cell transplantation (CT, Directive 2004/23/EC), the annual production cost of these cell therapy products (CTP) in France is estimated at €5.6 million. If the HSC used in leukemia indication were under the medicinal product status of ATMP, the cost would rise to approximately €9.9 million, without accounting for expenses related to facilities, which are much higher for ATMP than for CT.

Conclusion: This additional burden for manufacturers must be weighed against the theoretical benefits for patients, such as reduced contamination risk. Given the very low contamination levels reported by facilities using transplant standards, the extra cost seems excessive and could hinder the development of new advanced therapies. Furthermore, it raises the need to adapt existing Good Manufacturing Practice guidelines for autologous products or those made from a single donor for a single patient, ensuring safety and cost reduction, which should encourage further development of cell therapy.

The discovery of N-nitrosamine impurities in pharmaceutical products has raised serious quality concerns, particularly in metformin products, which are widely used in the treatment of type 2 diabetes mellitus. The detection of N-nitrosodimethylamine (NDMA) in metformin products has led to global recalls and increased regulatory investigations. Generic manufacturers face the challenge of balancing stringent bioequivalence requirements for Biopharmaceutical Classification System (BCS) Class III drugs, which require strict control of excipient composition while ensuring N-nitrosamine control and therapeutic equivalence. The use of antioxidants as a strategy to reduce N-nitrosamine formation requires careful consideration to maintain both bioequivalence and product safety. This article evaluates the use of antioxidants for the prevention of N-nitrosamine formation in metformin formulations, addressing the implications of this strategy on bioequivalence and its relationship with the regulatory framework.

A pilot initiative on the reprocessing of medical devices (MD), particularly in electrophysiology, is expected to be launched in France in 2025. Reprocessing single-use medical devices (SUDs) presents potential benefits and challenges, with differing perspectives among healthcare professionals. This study aims to compare the knowledge and positions of hospital pharmacists (HP) and cardiologists (CA) regarding the use of reprocessed single-use devices (R-SUDs), in order to identify their concerns as well as points of convergence and divergence. A directive and mixed electronic questionnaire consisting of 27 questions was sent to HPs and CAs from the Assistance publique-Hôpitaux de Paris (AP-HP). Responses from 32 HPs and 30 CAs were analyzed using statistical methods via R software. The results revealed that CAs overwhelmingly support reprocessing, while HPs show significantly more reservations (P<0.0001). Among HPs, 56% (n=18) favored an "open" supply chain model for reprocessing, compared to 28% (n=9) who preferred a "closed" one. CAs show a more balanced distribution of their preferences, with 30% (n=9) favoring the "open" chain and 40% (n=12) the "closed" model. Both groups raised concerns about the safety and quality of reprocessed devices, but the majority would accept R-SUDs if clinical trials validated their safety and effectiveness compared to original SUDs. Reprocessing is nevertheless seen as a means to reduce hospital costs and carbon footprint in hospitals.

The implementation of the Medical Devices Regulation (MDR) 2017/745/EU leaves manufacturers facing new requirements to certify their medical devices (MDs). Our objective is to accurately assess the impact of regulation on the availability of cardiovascular MDs in healthcare facilities. High-risk cardiovascular MDs appear to be heavily impacted by the regulation, with reclassification leading to mandatory clinical investigations. Access to new MDs could be restricted by the increase in clinical evidence that must be provided. However, our analysis has shown that some manufacturers are focusing on innovative cardiovascular MDs, at the expense of marketing existing product lines. The unavailability of MDs has impacted the practice of physicians in patient care. Healthcare professionals are requesting exceptional exemptions from national authorities to use the MDs. To combat these shortages, amendments to the MDR have been introduced, such as the extension of the MDs recertification deadline and the introduction of a reporting system to anticipate shortages. European and national institutions are becoming aware of the supply difficulties associated with the regulation. A tool for sharing information and proposing alternatives would simplify the management of these shortages.

Objective: Accurate, precise and robust HPLC method was developed for the simultaneous estimation of long-acting β2 agonist drugs (formoterol fumarate, salmeterol xinafoate and vilanterol trifenatate) along with two organic counterparts (xinafoic acid and triphenyl acetic acid) and inhaled corticosteroids (fluticasone propionate and fluticasone furoate).

Material and methods: The separation was carried out using C₁₈ column (250×4.6mm, 5μ) with eluent comprising of 0.05% orthophosphoric acid: methanol: acetonitrile (40:30:30, v/v/v) at a 1mL/min flow rate.

Results: Linearity was observed in the concentration ranges of 1.5-12μg/mL for formoterol fumarate, 2.82-22.6μg/mL for xinafoic acid, 6.25-50μg/mL for vilanterol, 3.12-25μg/mL for salmeterol, 2.0-15.2μg/mL for triphenyl acetic acid, 62.5-500μg/mL for fluticasone propionate and 25-200μg/mL for fluticasone furoate.

Conclusion: The proposed method was accurate, precise and robust and results were within the limit as per the ICH (Q2R1) guidelines. Additionally, the proposed method was found to be green and sustainable when analysed by different green analytical tools namely GAPI, AGREE, AGREEprep and BAGI.

Objective: The aim of our work is to develop a simple, rapid and inexpensive method for the detection and quantification of a detergent (phosphoric acid) in final rinse water using conductivity.

Methods: The conductimetric method was used. A calibration curve was obtained by measuring the conductivity of successive dilutions of a stock solution of the detergent. The conductivity of the sample was measured using the water from the last rinse. Detergent concentration in the sample was calculated using the regression equation of the calibration curve. Analytical validation was carried out in accordance with international harmonization conference guidelines ICH Q2. Data analysis was performed using jamovi software version 2.3.28.

Results: Linearity was proved by the correlation between concentration and conductivity with r=0.98. The coefficient of variation for repeatability and intermediate precision were low, and the mean recovery rates ranged from 98 to 102%. Calculated sample concentrations were below 5ppm.

Conclusions: The conductimetric method proposed in our study has been validated for the determination of phosphoric acid. It has the advantage of being rapid, inexpensive and simple. This makes the method the first choice for the determination of trace amounts of detergent in the pharmaceutical and research laboratories.

Exploring the energetics and bimolecular interaction of bovine serum albumin (BSA) with various classes and generations of antibiotics in the absence and presence of a resorcinol based acridinedione dye (ADR1) were carried out. The binding stability of BSA-antibiotic complexes decreases on the introduction of ADR1 dye resulting in a positive value of free energy change, accompanied with several unfavourable interactions. Several polar amino acids contributed to the stability of the host-guest complex compared to that of non-polar amino acids, wherein BSA acts as the host, and antibiotics as the guest and ADR1 dye as the competing guest molecule. Hydrogen-bonding interactions govern the binding stability and energetics compared to that of hydrophobic interactions is elucidated in the present study.