Pharmacy最新文献

{"title":"Access to Medicines in Bulgaria and North Macedonia: Legislative, Pricing, and Reimbursement Perspectives.","authors":"Anna Todorova, Dijana Miceva, Mariya Ivanova, Tanya Kazakova, Bistra Angelovska","doi":"10.3390/pharmacy14020052","DOIUrl":"https://doi.org/10.3390/pharmacy14020052","url":null,"abstract":"<p><p>National legislative frameworks governing prescribing, pricing, reimbursement, and dispensing play a decisive role in shaping access to medicines. This study examines the financial availability of medicines in Bulgaria and North Macedonia through a comparative review of national pharmaceutical legislation, pricing mechanisms, reimbursement models, and digitalisation policies, assessed in relation to European Union standards. The findings indicate that access to medicines in both countries is shaped by the combined effects of multiple regulatory and financial instruments rather than by individual policy measures. Both systems apply strict control of prescribing and dispensing, external reference pricing, and positive reimbursement lists, reflecting alignment with international recommendations. However, significant differences in policy design lead to divergent access outcomes. Bulgaria's more advanced digitalisation of prescribing and reimbursement, including mandatory electronic prescribing for selected therapeutic groups, enhances regulatory oversight and expenditure control but is associated with higher patient out-of-pocket expenditure, partly due to the application of the standard value-added tax on medicines. In contrast, North Macedonia combines lower taxation with capped patient co-payments, higher regulated pharmacy margins, and fixed pharmacy remuneration per prescription, contributing to improved financial affordability for patients while supporting pharmacy sustainability. Additional instruments, such as the Generics without Co-Payment List, further strengthen patient financial protection. The study provides comparative evidence relevant to pharmaceutical policy reforms and highlights the importance of balanced regulatory approaches that promote affordability, system sustainability, and equitable access to medicines.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"14 2","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13119055/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147783450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of Potential Exposure to Pregnancy-Contraindicated Medications Among Women of Reproductive Age in Japan: A Retrospective Database Study.","authors":"Hiroyuki Ura, Noriko Matsuoka","doi":"10.3390/pharmacy14020051","DOIUrl":"10.3390/pharmacy14020051","url":null,"abstract":"<p><p>Preconception care is globally recognized as essential for optimizing pregnancy outcomes; however, in Japan, comprehensive data on medication-related potential exposure to pregnancy-contraindicated medications among women of reproductive age remain limited. We conducted a retrospective cross-sectional descriptive study using data from Japan's National Database of Health Insurance Claims (fiscal year 2022) to assess the potential exposure to pregnancy-contraindicated medications among women of reproductive age. Outpatient prescriptions for oral medications dispensed to women aged 15-49 years were analyzed. In total, 270 medications classified as contraindicated during pregnancy were identified, of which 75 were also contraindicated for women planning pregnancy. Of these, 58 active ingredients were restricted in both phases. Notably, 212 medications were uniquely contraindicated during pregnancy, highlighting the broader contraindication profiles during fetal development than during the preconception period. Despite these contraindications, high prescription volumes were observed for medications such as loxoprofen sodium hydrate, sodium valproate, and metformin hydrochloride among women of reproductive age. These findings illustrate a high baseline utilization of pregnancy-contraindicated medications among women of reproductive age. As most women in this demographic are neither pregnant nor actively planning conception, these volumes primarily reflect standard care rather than inappropriate prescribing. In conclusion, pharmacists serve as an important supplementary safety net by routinely confirming pregnancy status to prevent inadvertent exposure.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"14 2","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13010656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147505031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Global Pharmaceutical Regulation: Comparative Frameworks and Operations.","authors":"Omolayo Tinuke Umaru, Adebowale Sylvester Adeyemi, Olajumoke Aderonmu, Balyodh Singh Bhangu, Harjot Singh Dhaliwal, Hae Lim, Taiwo Opeyemi Aremu","doi":"10.3390/pharmacy14020050","DOIUrl":"10.3390/pharmacy14020050","url":null,"abstract":"<p><p>Pharmaceutical regulation plays a central role in protecting public health by governing clinical trials, market authorization, and post-marketing safety monitoring throughout the medicine life cycle. While substantial literature describes established systems, particularly the United States Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and the European medicines regulatory network coordinated by the European Medicines Agency (EMA) together with national competent authorities, comparative analyses that integrate both mature authorities, emerging regulators and transnational harmonization networks remain limited. This narrative review draws on primary regulator/network documentation and targeted peer-reviewed literature to compare core regulatory functions across jurisdictions, including approval pathways and evidentiary expectations, inspection and good manufacturing practice (GMP) oversight, transparency practices, and pharmacovigilance and risk-management approaches. Across regions, we observe increasing convergence in scientific expectations through initiatives such as the International Council for Harmonisation (ICH) and reliance and work-sharing models, alongside persistent differences in legal mandates, resourcing, timelines, and data requirements. These differences are most consequential for complex products (e.g., advanced therapies) and in crisis settings, where emergency or conditional authorizations amplify the need for strong lifecycle monitoring, real-world evidence governance, and cross-border communication. We conclude by outlining opportunities to strengthen regulatory resilience and equity through fit-for-purpose harmonization, investment in enabling infrastructure, and future work on interoperable data systems, signal detection, and coordinated post-marketing evaluation.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"14 2","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13010624/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147505029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-Induced Hyponatremia as a Cause of Emergency Department Attendance.","authors":"Joel Gené Grasa, Natalia Sanz López, Marta Docio Alfaya, Verónica Mate García, Alicia Serrano García-Calvo, Adrián Plaza Díaz, Jesús Ruiz Ramos","doi":"10.3390/pharmacy14020049","DOIUrl":"10.3390/pharmacy14020049","url":null,"abstract":"<p><strong>Background: </strong>Hyponatremia is one of the most common electrolyte disturbances in emergency departments. This study aimed to describe the characteristics of patients presenting with drug-induced hyponatremia and analyse factors associated with 30-day revisits.</p><p><strong>Methods: </strong>Retrospective observational study including adult patients who attended the emergency department for drug-induced hyponatremia between 2020 and 2024.</p><p><strong>Results: </strong>141 patients were analysed (mean age 80.5 years; 78% women). Thiazide diuretics were the most frequently implicated pharmacological class (50.3%). In univariable analyses, polypharmacy, dementia, and treatment changes at discharge were associated with a higher risk of revisit for hyponatremia. In the multivariable model, only polypharmacy remained significantly associated with 30-day revisits.</p><p><strong>Conclusions: </strong>Thiazide diuretics were the leading drug-related cause of hyponatremia in the emergency setting. Polypharmacy was identified as an independent factor associated with increased revisit risk, underscoring the need for systematic medication review and close clinical follow-up after hospital discharge.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"14 2","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13010667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147505007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Comparison of Intravenous vs. Oral Antimicrobial Therapy for Bone and Joint Infections.","authors":"Maura Kreiser, Sarah Al Mansi, Ismaeel Yunusa, Caroline Derrick, P Brandon Bookstaver, Majdi N Al-Hasan, Yorika Hammett, Morgan Pizzuti","doi":"10.3390/pharmacy14020048","DOIUrl":"10.3390/pharmacy14020048","url":null,"abstract":"<p><p>Well-designed randomized controlled trials (RCTs) have demonstrated safe and effective use of oral antimicrobial therapy for bone and joint infections. Application of data for implementation into real-world practice, however, has inherent challenges. This retrospective cohort study compared real-world use of intravenous versus oral antimicrobial therapy in bone and joint infections within a large healthcare system comprising both academic and community medical centers. The primary outcome was the proportion of treatment failure. Key secondary outcomes included the proportion of patients with logistical failure and risk factors associated with treatment and logistical failure. Among 166 patients included, 136 (82%) and 30 (18%) received predominantly intravenous and oral antimicrobial therapy, respectively. Treatment failure occurred in (77/121) 64% versus (18/25) 72% of patients in the intravenous and oral antimicrobial groups (<i>p</i> = 0.491; OR, 1.38; 95% CI, 0.56-3.33). Logistical failure occurred in 29% versus 47% of patients in the intravenous and oral antimicrobial groups (<i>p</i> = 0.150; OR, 1.93; 95% CI 0.79-4.70). Risk factors for treatment failure included peripheral vascular disease (OR, 2.61; 95% CI 1.02-7.80) and higher Charlson Comorbidity Index scores (OR, 1.18; 95% CI 1.04-1.36). Similar to previously published RCTs, treatment failure appeared comparable between groups; however, oral antimicrobial therapy was overall underutilized.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"14 2","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13010755/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147504952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of SGLT2 Inhibitors in Type 2 Diabetes: A Systematic Integrative Review of Reviews and Comparative Effectiveness Studies (2020-2025).","authors":"Desislava Stanimirova, Guenka Petrova, Zornitsa Mitkova","doi":"10.3390/pharmacy14020047","DOIUrl":"10.3390/pharmacy14020047","url":null,"abstract":"<p><p>This systematic integrative review evaluates the effectiveness of SGLT2 inhibitors in relation to improving glycaemic control, reducing cardiovascular events, and preserving renal function based on the latest published evidence. Search for publications referenced in PubMed, from January 2020 to January 2025, was conducted; 48 abstracts were reviewed, and 27 full-text articles were included for analysis-systematic reviews, meta-analyses, narrative reviews and comparative effectiveness studies. SGLT2 inhibitors are effective in reducing glucose levels, but the magnitude of reduction varies compared to other classes of antidiabetics. A noticeable reduction in the risk of major cardiovascular events, cardiovascular and all-cause mortality was reported, particularly compared to DPP-4 inhibitors and placebo. SGLT2 inhibitors demonstrated the most pronounced and consistent benefits in reducing hospitalisation for heart failure among all other evaluated classes. However, outcomes like myocardial infarction and stroke results were inconsistent. Renal outcomes consistently favoured SGLT2 inhibitors in reducing the risk of acute kidney injury, slowing chronic kidney disease and lowering the risk of end-stage kidney disease. SGLT2 inhibitors provide consistent glucose-lowering, cardiovascular and renal benefits. However, heterogeneity in study designs, patient populations, and treatment durations does not allow drawing definitive conclusions and highlights the need for future research focused on conducting well-designed trials with standardised methodology.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"14 2","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13010735/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147504990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Older Adults' Access to Pharmacological Treatment, a Human Right to Health: Scoping Review (2020-2025).","authors":"Doris Cardona, Valeria Santacruz-Restrepo, Juliana Madrigal-Cadavid, Alejandra Rendón-Montoya, Angela Segura-Cardona, Jorge Iván Estrada-Acevedo, Marcela Agudelo-Botero","doi":"10.3390/pharmacy14020046","DOIUrl":"10.3390/pharmacy14020046","url":null,"abstract":"<p><strong>Background: </strong>Limitations in timely and equitable access to essential medicines among older adults not only constitute a clinical barrier to the effective management of chronic conditions, but also represent a violation of the fundamental right to life, health and the principles of dignity, equality and non-discrimination that safeguard this population within the framework of human rights.</p><p><strong>Objective: </strong>To examine access to essential medicines for older adults with high-cost chronic conditions as a constitutive dimension of the fundamental rights to health, life and human dignity, in accordance with international human rights standards.</p><p><strong>Design: </strong>A literature review was conducted of articles published between 2020 and March 2025 in five databases, using the search terms: \"pharmacological treatment,\" \"access to health,\" \"chronic diseases,\" and \"barriers to access.\" After evaluating the inclusion criteria (language and year) and exclusion criteria (case studies), 12 articles were selected. A narrative synthesis was performed on the following aspects: application of the principles of the right to health, barriers to access, and rights violated or at risk.</p><p><strong>Results: </strong>The expansion of health coverage faces several barriers that violate fundamental principles of the right to health: equity, accessibility to medical advances, and long-term, quality, and specialized services, thus limiting autonomy. In conclusion, guaranteeing access to pharmacological treatments in old age will contribute to building more just and humane societies through public policies on coverage and pharmaceutical education, the simplification of treatment regimens, and the implementation of programs that allow people to age with dignity, considering health a human right based on equality and non-discrimination, participation and transparency.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"14 2","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13010731/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147504936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intention/Reflection (I/R) Practice Creates a Deeper APPE Connection for Student Pharmacists After COVID-19.","authors":"Kerry K Fierke, Gardner A Lepp, Alina Cernasev","doi":"10.3390/pharmacy14020045","DOIUrl":"10.3390/pharmacy14020045","url":null,"abstract":"<p><p>(1) Background: In response to the educational challenges brought on by the COVID-19 pandemic, APPE preceptors implemented the Intention/Reflection (I/R) practice as a structured engagement tool. I/R is designed to promote engagement, motivation, metacognitive growth, and self-awareness among student pharmacists with the goal of enhancing learning experiences in diverse APPE settings. This project aimed to assess the impact of I/R strategies on student pharmacist engagement during APPEs in the post-pandemic landscape, with the overarching goal of identifying and advancing best practices in experiential pharmacy education. (2) Methods: This retrospective qualitative study included 20 student pharmacists from two U.S. colleges who participated in APPE elective rotations featuring I/R activities. Student pharmacists' responses to five structured I/R prompts were collected and thematically analyzed by two independent researchers using qualitative data analysis software. (3) Results: Four themes were identified in the I/R responses: two themes each from the intention and reflection responses. The intention themes \"Embracing Discomfort as a Catalyst for Confidence, Engagement, and Leadership Growth\" and \"Purposeful Precision: Growing into Adaptive Leadership\" both illustrate the students' journeys as they develop greater confidence and resilience in overcoming challenges. The reflection themes \"Reflection as a Catalyst for Professional Learning and Engagement\" and \"Reflection as a Tool for Focused Growth and Self-Awareness\" synthesized the evolution of the student pharmacist and forward thinking for future career. (4) Conclusion: Overall, participants perceived the I/R practice as transformative, citing benefits such as sustained learning, increased confidence, and continued professional development. These findings suggest that integrating I/R into experiential pharmacy education can significantly enhance student engagement and contribute to best practices for post-pandemic pharmacy training.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"14 2","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13010714/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147504978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Beta Blocker Intoxications in Belgium: A Data Analysis with Focus on Propranolol.","authors":"Brechje van den Boogaard, Maria van de Lavoir, Rani Robeyns, Celine Gys, Adrian Covaci, Hans De Loof","doi":"10.3390/pharmacy14020043","DOIUrl":"10.3390/pharmacy14020043","url":null,"abstract":"<p><p><b>Background:</b> The issue of beta blocker poisoning has received little attention, despite the widespread use of these compounds in cardiac and neuropsychiatric care. Safety profiles differ, and some beta blockers appear in poisonings far beyond what their usage rates imply. This study characterizes beta blocker intoxication patterns in Belgium, focusing on propranolol, by integrating national prescription data, poisoning reports, and adverse drug reaction records. <b>Methods:</b> Belgian prescription data, poison centre reports, and European ADR databases were analysed to identify intoxication patterns and demographic or clinical characteristics associated with these events. <b>Results:</b> Poisoning data revealed propranolol as markedly overrepresented compared to prescription rates and was the primary beta blocker implicated in self-harm-related overdoses. These cases occurred mainly in women, younger individuals, and patients with psychiatric or cardiovascular comorbidities. Co-exposures with benzodiazepines, antidepressants, and other psychoactive agents were frequent, and propranolol was linked to more complex intoxication patterns than other beta blockers. <b>Conclusions:</b> Propranolol shows a distinct toxicological profile and is disproportionately involved in intoxications, especially in vulnerable groups and in combination with psychoactive drugs. These findings highlight the need for greater awareness, targeted prevention, and careful monitoring.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"14 2","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13010693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147504982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Thickening Agents Used in Dysphagia on the In Vitro Dissolution of Gliclazide.","authors":"Ayman Allahham, Seerat Fatima, Ieva Stupans, Thilini Thrimawithana, Vivek B Nooney","doi":"10.3390/pharmacy14020044","DOIUrl":"10.3390/pharmacy14020044","url":null,"abstract":"<p><p>Dysphagia is common among older adults and frequently necessitates the use of thickening agents to facilitate safe swallowing of medicines, which may in turn alter their bioavailability. This study investigated the impact of two commercially available lubricants-Gloup^® Forte and extremely thick water-on the in vitro dissolution behaviour of immediate-release gliclazide tablets. Dissolution studies were conducted using crushed and whole tablets in different media consisting of reverse osmosis water, phosphate buffer (pH 6.8), and 0.1 N HCl at 37 °C. Dissolution profiles were compared using similarity factor (<i>f</i>₂) analysis and modelled using established kinetic equations. Gliclazide dissolution was significantly delayed in the presence of Gloup^® Forte across all media for both crushed and whole tablets, with <i>f</i>₂ values below 50, indicating dissimilar profiles. Dissolution kinetics confirmed that mixing the formulated gliclazide with Gloup^® Forte delayed the release and reduced the dissolution rate constant for drug from both crushed and whole gliclazide tablets in media studied.</p>","PeriodicalId":30544,"journal":{"name":"Pharmacy","volume":"14 2","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13010598/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147504957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}