Journal of Pharmacy and Pharmaceutical Sciences最新文献

Introduction: Patient Support Programs (PSPs) are growing globally to support early reimbursement, disease and medication dosing management. In Canada, the lack of public health support has promoted the rapid expansion of company-supported disease-specific or drug-product-specific PSPs. Data collected from these programs generate unique Canadian data serving as a valuable source of real-world data (RWD), generally adopted in EU and US as a source of evidence generation. This review evaluates the suitability of PSP data for regulatory or reimbursement submissions, based on recently published Real World Evidence guidelines by the Canadian Drug Agency (CDA-AMC).

Methods: Peer-reviewed publications evaluating patients with chronic diseases enrolled in a PSP from 1 January 2020, to 31 March 2025, were selected for review. The checklist in the CDA-AMC RWE Guideline was used to measure the quality and suitability of the PSP data.

Results: Nine studies were reviewed against the checklist. Based on the criteria required to inform decision-making, most studies failed to meet key criteria for regulatory submissions. One recently published study, "Therapeutic Drug Monitoring of Infliximab" met most regulatory and reimbursement submission requirements.

Conclusion: Data quality validation, data source transparency, validated methodology to manage study bias, measured or unmeasured confounders, and robust outcome analysis, including sensitivity and quantitative bias analysis, are essential to ensure PSP data analysis results in successful decision-making.

Objective: To analyze the impact of a Transformative Learning Theory (TLT)-based toolkit on pharmacy students' self-evaluation of professional identity formation (PIF).

Methods: This prospective, interventional cohort study included pre-clinical pharmacy students in a hospital skills-based course. Study participants were included if they completed the Professional Self Identity Questionnaire (PSIQ-9) and Macleod Clark Professional Identity Scale (MCPIS-9) at baseline (week 1), midpoint (week 8), and endpoint (week 15) of the course. The primary outcome was to assess the mean change in PSIQ-9 and MCPIS-9 scores from baseline to endpoint; the outcome was analyzed using the Wilcoxon-Signed Rank Test. Secondary outcomes included assessing the mean difference in questionnaire scores from baseline to midpoint and midpoint to endpoint.

Results: Seventy-nine pharmacy students were eligible, with 11 (14%) completing both questionnaires at all time points and 39 (49%) completing them at baseline and midpoint. Comparing baseline and endpoint scores, there was an increase in the PSIQ-9 mean difference for teaching others and a decrease in the MCPIS-9 for feeling ashamed of the profession. No MCPIS-9 differences were found between baseline and midpoint. Three PSIQ-9 questions, communication, using patient records, and teaching others, were significant at baseline and midpoint.

Conclusion: The TLT-based toolkit had a minimal impact on students' self-evaluation of PIF based on the PSIQ-9 and MCPIS-9 questionnaires over a 15-week course. Studies with larger sample sizes and longer durations are needed to provide more conclusive results.

Objective: This study evaluated the use of stress ulcer prophylaxis (SUP), assessed the costs associated with inappropriate use, and highlighted the impact of clinical pharmacists on improving adherence to the SUP guidelines.

Method: A prospective, non-randomized controlled study was carried out in two intensive care units (ICUs) of a training and research hospital between 1 June 2023 and 1 December 2023. Routine care services were provided for the observation group (OG) patients. In the guideline group (GG) patients, SUP management and routine care were performed according to ASHP guidelines. The physician and clinical pharmacist jointly evaluated the patients to determine the suitability of their SUP indications. Adherence rates to ASHP guidelines and the costs associated with nonadherence were evaluated.

Results: A total of 196 patients were included in the study: 121 in the OG and 75 in the GG. A total of 54.6% of the patients were male, and the reason for hospitalization was mainly surgery (52.6%). SUP use was higher in OG (100%) than in GG (42.6%) (p < 0.001). The indication rate according to the ASHP guidelines was significantly higher in the GG group (100%) than in the OG group (54.5%) (p < 0.001). Dosage form adherence was significantly lower in the OG (0%) than in the GG (100%) (p < 0.001). The costs associated with proton pump inhibitor use for inappropriate indications and incorrect dosage forms were $60 versus $0 (p < 0.001) and $321 versus $0 (p < 0.001) in OG and GG, respectively. Overall, cost savings of $327 were achieved in the GG group.

Conclusion: Inappropriate SUP use is common in the ICUs. Adequate adherence to guidelines and proactive involvement of clinical pharmacists may reduce inappropriate SUP in ICUs and the associated costs.

This study focuses on implementing a composition of the natural flavonoid dihydroquercetin (DHQ) with L-lysine in the treatment of thermal burns. The wound-healing activity of DHQ is well-known. The addition of amino acid to the composition increases the water solubility of the flavonoids, providing an opportunity to develop a spray dosage form. The research involved 60 male Wistar rats divided into five treatment groups. Sea buck oil served as a positive control. On day 14, the composition treatment group showed significant progress in wound healing, being 9.6 ± 2.0% ahead of the other groups in absolute terms. On day 35, treatment with the composition resulted in a significant decrease in relative wound area to 1.9 ± 0.9%, while in the negative and positive control groups, it was 10.7 ± 7.8% and 8.4 ± 4.9%, respectively. At the same time, the epidermal and dermal layers were found to be clearly distinguished in the composition treatment according to histological analysis. Numerous collagen fibres were clearly visible, and the active process of keloid scar formation was observed. An additive effect of the combined use of DHQ and L-lysine was observed (F = 0.21, p = 0.649). A natural next step is to develop the dosage form for the DHQ-L-lysine composition.

Objective: This study aims to enhance adherence to the guideline through an educational program focused on reducing inappropriate use of stress ulcer prophylaxis (SUP) and cost savings in the intensive care unit (ICU).

Method: This study was designed as a nonrandomized, controlled, prospective study created according to the pre-education (PreEd) and post-education (PostEd) evaluation model and conducted between January and July 2024. The appropriateness of SUP uses for the indication was evaluated according to the Sociedade Portuguesa de Cuidados (SPC) SUP guideline. Adherence rates to the SPC SUP guideline and the costs associated with nonadherence were evaluated.

Results: 495 patients were included in the study, 244 in PreEd and 251 in PostEd. 58.2% of the patients were male, and the hospitalization was mainly for medical reasons (59.6%). The mean ± SD rate of patients with appropriate SUP indication was 38.3 ± 41.6% in PreEd and 47.8 ± 42.8% in PostEd (p = 0.005). The total costs of inappropriate indication and proton pump inhibitor use in PreEd and PostEd were 272 dollars and 246 dollars, respectively (p = 0.007). Accordingly, when inappropriate SUP agent use was calculated per patient in both periods, the total cost saving was 34 dollars.

Conclusion: Inappropriate SUP use is common in the ICU. Adequate adherence to guidelines and proactive involvement of clinical pharmacists may reduce inappropriate SUP use and associated costs.

[This corrects the article DOI: 10.3389/jpps.2024.12434.].

17β-estradiol (E2) is an endogenous steroid hormone pivotal for the development of female secondary sexual characteristics and the maintenance of the female reproductive system. Its roles extend beyond these physiological functions, as E2 is employed in hormone replacement therapy to alleviate symptoms associated with menopause. Furthermore, E2 exhibits therapeutic potential in the management of osteoporosis, breast cancer, and various neurological and cardiovascular conditions, partly due to its anti-inflammatory effects via modulation of the MAPK/NFκB signaling pathway. Notwithstanding, the hydrophobic nature of E2 significantly hinders the formulation of efficacious delivery systems for its clinical deployment. Recent advances have highlighted nano-based delivery systems for E2 as a promising solution to this solubility challenge. This review critically examines contemporary nano-delivery strategies for E2, particularly emphasizing lipid and polymeric nanoparticle-based systems. These nanostructures are designed to enhance stability, biocompatibility, controlled release, and targeted delivery of E2, yet the selectivity of E2 delivery for therapeutic purposes remains an ongoing challenge. The novelty of this review lies in its focus on the advances in nano-based E2 delivery systems over the past decade, a topic not extensively covered in prior literature. We present a comprehensive analysis of the encapsulation of E2 within polymeric and lipid nanoparticles, underscoring the untapped potential of these strategies. This review identifies a significant research gap, advocating for intensified experimental investigations that could pave the way for the translation of nano-based E2 therapies from bench to bedside.

The COVID-19 pandemic has raised concern regarding respiratory system diseases and oral inhalation stands out as an attractive non-invasive route of administration for pulmonary diseases such as chronic bronchitis, cystic fibrosis, COVID-19 and community-acquired pneumonia. In this context, we encapsulated azithromycin in polycaprolactone nanoparticles functionalized with phospholipids rich in dipalmitoylphosphatidylcholine and further produced a fine powder formulation by spray drying with monohydrated lactose. Nanoparticles obtained by the emulsion/solvent diffusion-evaporation technique exhibited a mean hydrodynamic diameter around 195-228 nm with a narrow monomodal size distribution (PdI < 0.2). Nanoparticle dispersions were spray-dried at different inlet temperatures, atomizing air-flow, aspirator air flow, and feed rate, using lactose as a drying aid, resulting in a maximal process yield of 63% and an encapsulation efficiency of 83%. Excipients and the dry powder formulations were characterized in terms of morphology, chemical structure, thermal analyses and particle size by SEM, FTIR, DSC/TGA and laser light diffraction. The results indicated spherical particles with 90% at 4.06 µm or below, an adequate size for pulmonary delivery. Aerosolization performance in a NGI confirmed good aerodynamic properties. Microbiological assays showed that the formulation preserves AZM antimicrobial effect against Staphylococcus aureus and Streptococcus pneumoniae strains, with halos above 18 mm. In addition, no formulation-related cytotoxicity was observed against the human cell lines BEAS-2B (lung epithelial), HUVEC (endothelial) and HFF1 (fibroblasts). Overall, the approach described here allows the production of AZM-PCL nanoparticles incorporated into inhalable microparticles, enabling more efficient pulmonary therapy of lung infections.