Journal of Pharmaceutical Policy and Practice最新文献

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Community pharmacy based point-of-care testing for early detection of undiagnosed type 2 diabetes mellitus: a study protocol. 基于社区药房的点护理检测早期发现未确诊的2型糖尿病:研究方案。
IF 2.6
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-04-22 eCollection Date: 2026-01-01 DOI: 10.1080/20523211.2026.2654489
Khaled Alshorman, Rabia Hussain
{"title":"Community pharmacy based point-of-care testing for early detection of undiagnosed type 2 diabetes mellitus: a study protocol.","authors":"Khaled Alshorman, Rabia Hussain","doi":"10.1080/20523211.2026.2654489","DOIUrl":"10.1080/20523211.2026.2654489","url":null,"abstract":"<p><strong>Background: </strong>Type 2 diabetes mellitus (T2DM) remains substantially underdiagnosed worldwide, contributing to delayed treatment and increased risk of long-term complications. Community pharmacies are highly accessible healthcare settings and may play a critical role in early case detection through structured screening programs. This study protocol aims to evaluate the implementation of point-of-care testing (POCT) for diabetes screening in community pharmacies and its potential to identify undiagnosed T2DM among adult pharmacy visitors in Irbid Governorate, Jordan.</p><p><strong>Methods: </strong>This study will employ a two-phase design. In phase one, a cross-sectional screening will be conducted among adults without a prior diagnosis of diabetes visiting selected community pharmacies. Participants will be assessed using the Finnish Diabetes Risk Score (FINDRISC). Individuals classified as high or very high risk will proceed to phase two, which involves glycated haemoglobin (HbA1c) measurement using a National Glycohemoglobin Standardization Program (NGSP)-certified point-of-care analyzer. Participants with abnormal HbA1c results will be referred to general practitioners (GPs) for diagnostic confirmation. They will be followed for six months to assess referral outcomes, treatment initiation, and changes in glycemic control. Descriptive, inferential, and multivariate regression analyses will be conducted.</p><p><strong>Results: </strong>The study is expected to determine the proportion of individuals at high risk for T2DM and the prevalence of previously undiagnosed dysglycaemia detected through pharmacy-based POCT. It will also describe referral patterns, confirmation rates of T2DM diagnosis, treatment initiation, and glycaemic outcomes over a six-month follow-up period.</p><p><strong>Conclusion: </strong>Community pharmacy - based diabetes screening integrating FINDRISC assessment and POCT HbA1c testing has the potential to enhance early detection of undiagnosed T2DM and improve referral pathways within primary healthcare systems. Findings from this study may inform future large-scale implementation of pharmacist-led screening programs and contribute to national diabetes prevention strategies.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2654489"},"PeriodicalIF":2.6,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13107482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147774616","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}
引用次数: 0
Effectiveness and safety of ceftazidime/avibactam versus polymyxin B in liver transplant recipients with carbapenem-resistant organism infections: a real-world cohort study. 头孢他啶/阿维巴坦与多粘菌素B对碳青霉烯耐药菌感染肝移植受者的有效性和安全性:一项真实世界队列研究
IF 2.6
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-04-20 eCollection Date: 2026-01-01 DOI: 10.1080/20523211.2026.2641111
Weiwei Zhang, Chuanlin Chen, Desheng Li, Zhengdon Zhou, Bo Sheng, Yongfang Hu, Zhenyu Zhang
{"title":"Effectiveness and safety of ceftazidime/avibactam versus polymyxin B in liver transplant recipients with carbapenem-resistant organism infections: a real-world cohort study.","authors":"Weiwei Zhang, Chuanlin Chen, Desheng Li, Zhengdon Zhou, Bo Sheng, Yongfang Hu, Zhenyu Zhang","doi":"10.1080/20523211.2026.2641111","DOIUrl":"10.1080/20523211.2026.2641111","url":null,"abstract":"<p><strong>Background: </strong>Treatment options for carbapenem-resistant organism (CRO) infections remain limited, with ceftazidime/avibactam (CAZ/AVI) and polymyxin B (PMB) being the main therapeutic choices. However, comparative evidence regarding the efficacy and safety of liver transplant (LT) recipients is scarce.</p><p><strong>Methods: </strong>This single-center retrospective cohort study was conducted in the liver intensive care unit of Beijing Tsinghua Changgung Hospital from January 2018 to December 2024. Adult LT recipients with CRO infections who received intravenous CAZ/AVI or PMB for > 48 h were included. Propensity score matching (PSM) was performed at a 1:1 ratio to balance baseline variables. Logistic regression analyses were used to evaluate microbial clearance, clinical success, and acute kidney injury (AKI). Cox proportional hazards models assessed the 90-day all-cause mortality and factors associated with survival outcomes.</p><p><strong>Results: </strong>Among the 106 LT recipients with postoperative CRO infections, 45 received CAZ/AVI (n = 23) or PMB (n = 22). After PSM, 22 patients were included in each group. The rates of microbial clearance (59.1% vs. 63.6%), clinical success (54.6% vs. 54.6%), and 90-day all-cause mortality (22.7% vs. 27.3%) were comparable between the CAZ/AVI and PMB (<i>p</i> > 0.05). However, AKI occurred significantly more frequently in the PMB group than in the CAZ/AVI group (81.8% vs. 50.0%, <i>p</i> = 0.026). Complete withdrawal of immunosuppressive therapy was independently associated with increased 90-day mortality (hazard ratio [HR] = 4.46, 95% CI 1.29-15.35, <i>p</i> = 0.018).</p><p><strong>Conclusion: </strong>CAZ/AVI and PMB achieved similar clinical effectiveness and survival outcomes in LT recipients with CRO infections; however, PMB carries a higher risk of nephrotoxicity. Discontinuation of immunosuppressive therapy during infection significantly affects patient survival. These findings highlight the importance of individualised antimicrobial selection, renal safety monitoring, and pharmacist-led stewardship in managing CRO infections in liver transplant patients.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2641111"},"PeriodicalIF":2.6,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13097177/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147774590","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}
引用次数: 0
Enhancing access to treatment and programmes for viral hepatitis in an endemic country: a narrative review of literature from 2000 to 2025 (Mongolia). 在一个流行国家加强病毒性肝炎治疗和规划的可及性:2000年至2025年文献综述(蒙古)。
IF 2.6
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-04-17 eCollection Date: 2026-01-01 DOI: 10.1080/20523211.2026.2650542
Gantuya Dorj, Undram Lkhagva, Gereltuya Dorj, Batsukh Badamnachin, Unenbat Gurbadam, Oidov Baatarkhuu, Javkhlan Jargalsaikhan, Baasandorj Erdenetsetseg, Amarjargal Choijoo
{"title":"Enhancing access to treatment and programmes for viral hepatitis in an endemic country: a narrative review of literature from 2000 to 2025 (Mongolia).","authors":"Gantuya Dorj, Undram Lkhagva, Gereltuya Dorj, Batsukh Badamnachin, Unenbat Gurbadam, Oidov Baatarkhuu, Javkhlan Jargalsaikhan, Baasandorj Erdenetsetseg, Amarjargal Choijoo","doi":"10.1080/20523211.2026.2650542","DOIUrl":"10.1080/20523211.2026.2650542","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Mongolia continues to experience the world's highest incidence of hepatocellular carcinoma (HCC), driven by chronic hepatitis B (HBV) and hepatitis C (HCV) infections. In response, the Mongolian Government has implemented comprehensive public health interventions, including the national 'Healthy Liver Programme,' to reduce viral hepatitis transmission and liver-related morbidity. This narrative review aims to evaluate national strategies, progress, and ongoing challenges in HBV and HCV control.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Policy documents from government agencies, WHO, and NGOs were reviewed, along with scientific publications retrieved from PubMed, and Embase using terms such as 'HBV,' 'HCV,' and 'treatment access.' Grey literature was also analysed. The review focused on (i) national strategies and action plans; (ii) programmatic interventions, vaccination, screening, and treatment scale-up; and (iii) reported trends in coverage, treatment uptake, and progress towards WHO 2030 elimination targets. Findings were synthesised by comparing policy commitments with implementation outcomes and triangulating evidence across multiple sources.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Forty-four peer-reviewed articles and 12 policy documents were included. Mongolia has achieved &gt;95% infant HBV vaccination and 93.9% hepatitis A coverage, reducing HBsAg prevalence among children under five to 0.3% by 2023. Among adults, HBsAg prevalence declined from 6.9% in 2015 to 5.5% in 2023, while HCV prevalence decreased from 6.7% to 3.7%. More than 120,000 HCV infections have been diagnosed, with over half treated through national initiatives; by 2023, 4,700 HBV and 66,959 HCV patients had initiated therapy. Liver cancer incidence decreased from 39.1% in 2016 to 32.7% in 2021, and annual HCC cases fell from 857 in 2015 to 567 in 2022.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;Mongolia aims to reduce viral hepatitis prevalence by 90% and liver-related mortality by 85% in the coming decade.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;While substantial progress has been made, strengthened health system capacity and improved monitoring mechanisms are essential to close remaining gaps and accelerate progress towards hepatitis elimination.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Summary: &lt;/strong&gt;&lt;b&gt;Policy implementation:&lt;/b&gt; Mongolia implemented several key policies, including the Targeted Prevention and Control Program to Eradicate Viral Hepatitis (1988-2000), mandatory HBV vaccination, and the Healthy Liver programmes (2016-2020 and 2022-2025).&lt;b&gt;Vaccination programmes:&lt;/b&gt; Mongolia was among the first to introduce hepatitis B vaccination for newborns in 1991 and added a pentavalent vaccine in 2005. The HAV vaccine was introduced in 2012, with high coverage rates for children under one year.&lt;b&gt;Healthy liver programme:&lt;/b&gt; This programme improved access to diagnostic and treatment options for viral hepatitis, including introducing antiviral medicines and reimbursement for antiviral the","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2650542"},"PeriodicalIF":2.6,"publicationDate":"2026-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13094295/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147774579","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}
引用次数: 0
Impact of PharmaTE trial on glycemic control, diabetes knowledge, medication adherence, and quality of life in type 2 diabetes patients: a mixed-methods study protocol. PharmaTE试验对2型糖尿病患者血糖控制、糖尿病知识、药物依从性和生活质量的影响:一项混合方法研究方案
IF 2.6
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-04-14 eCollection Date: 2026-01-01 DOI: 10.1080/20523211.2026.2645906
Nour Aymn Ahmad, Rabia Hussain
{"title":"Impact of PharmaTE trial on glycemic control, diabetes knowledge, medication adherence, and quality of life in type 2 diabetes patients: a mixed-methods study protocol.","authors":"Nour Aymn Ahmad, Rabia Hussain","doi":"10.1080/20523211.2026.2645906","DOIUrl":"10.1080/20523211.2026.2645906","url":null,"abstract":"<p><strong>Background: </strong>Diabetes mellitus (DM) is a significant public health issue that requires lifelong management. Effective management requires a comprehensive approach integrating technology and clinical pharmacists into the healthcare team to improve glycemic control, patient knowledge, medication adherence, and quality of life. This study aims to evaluate the impact of a clinical pharmacist-led tele-educational intervention (PharmaTE trial) on glycemic control and patients' outcomes among patients with type 2 diabetes at a secondary care hospital in Ras Al Khaimah, United Arab Emirates (UAE).</p><p><strong>Methods: </strong>A mixed-methods embedded design will be employed, consisting of a randomised controlled trial (RCT) as the quantitative phase and a prospective descriptive qualitative study, a total of 154 adult patients diagnosed with uncontrolled type 2 diabetes, will be recruited and randomly assigned to either the (PharmaTE trial) intervention group (IG), which will receive five tele-education sessions led by a clinical pharmacist, or a control group (CG) receiving standard care. The primary outcome will be improved glycemic control, specifically achieving a target HbA1c level < 6.5% for individuals aged 18-65. Secondary outcomes will include improved diabetes knowledge, medication adherence, and quality of life, assessed using a validated Arabic version of the questionnaires: the Michigan Diabetes Knowledge Tool (MDKT), Morisky Medication Adherence Scale (MMAS), and Diabetes Quality of Life (DQOL). Moreover, the glycemic control will be evaluated by measuring HbA1c levels.</p><p><strong>Discussion: </strong>Compared to the control group, participants with uncontrolled glycemic levels are anticipated to show improvements in glycemic control, disease knowledge, medication adherence, and quality of life upon completion of the PharmaTE trial. These expected outcomes highlight the importance of adopting innovative, technology-based strategies and integrating clinical pharmacists into multidisciplinary care teams to enhance diabetes management. The PharmaTE intervention may offer an effective model for improving patient engagement, optimising treatment adherence, and ultimately advancing overall diabetes care and outcomes among patients with type 2 diabetes. The study protocol was registered as a clinical trial on ClinicalTrials.gov with the identifier NCT07043816 on June 20, 2025, and it was registered prospectively.<b>Trial registration:</b> ClinicalTrials.gov identifier: NCT07043816.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2645906"},"PeriodicalIF":2.6,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13101829/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147774676","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}
引用次数: 0
Reconstructing the professional role of pharmacists in China from the perspective of public value theory: challenges and institutional pathways. 公共价值理论视角下中国药师职业角色的重构:挑战与制度路径。
IF 2.6
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-04-14 eCollection Date: 2026-01-01 DOI: 10.1080/20523211.2026.2654488
Kexin Han, Shushan Wu, Fanghui Lin, Xiaoyan Nie, Luwen Shi, Xiaodong Guan
{"title":"Reconstructing the professional role of pharmacists in China from the perspective of public value theory: challenges and institutional pathways.","authors":"Kexin Han, Shushan Wu, Fanghui Lin, Xiaoyan Nie, Luwen Shi, Xiaodong Guan","doi":"10.1080/20523211.2026.2654488","DOIUrl":"10.1080/20523211.2026.2654488","url":null,"abstract":"<p><strong>Background: </strong>China's transition toward people-centered health governance has highlighted the essential role of pharmacists in ensuring rational medication use and protecting public health. However, pharmacists' professional roles remain fragmented across institutional, social, and regulatory dimensions. Drawing on public value theory, this study examines the structural and cognitive misalignments constraining pharmacist professionalisation in China and situates these challenges within an international context.</p><p><strong>Methods: </strong>This study employed a literature-based conceptual analysis informed by public value theory. National laws, administrative regulations, policy documents, and scholarly studies were reviewed to examine how public value - specifically value consensus, legitimacy and support, and operational capacity - is reflected in pharmacist governance. Evidence from existing empirical studies was integrated to illustrate gaps in public cognition, administrative coordination, and professional self-identity, with their scope and limitations qualitatively appraised.</p><p><strong>Results: </strong>Three interrelated challenges were identified. First, fragmented administrative governance across regulatory bodies leads to inconsistent legal definitions, unclear role boundaries, and limited institutional authority for pharmacists, particularly in clinical decision-making and medication therapy management. Second, public awareness of pharmacists' professional value is insufficient; survey evidence indicates that patients largely associate pharmacists with dispensing or sales functions, leading to low social demand for pharmaceutical care and inadequate legitimacy for role expansion. Third, pharmacists demonstrate inconsistent professional self-identification: many hospital pharmacists prioritise logistical tasks, while most community pharmacists remain oriented toward commercial rather than patient-centered service roles. Together, these structural, cognitive, and professional gaps undermine value consensus, legitimacy, and operational capacity within the pharmacist ecosystem.</p><p><strong>Conclusion: </strong>Advancing pharmacist professionalisation in China requires integrated legislation and cross-sectoral governance, enhanced public communication and health literacy, and strengthened professional competencies supported by adequate incentives. These findings echo international experiences, highlighting pharmacist professionalisation as a shared global governance challenge rather than a China-specific issue.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2654488"},"PeriodicalIF":2.6,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13081338/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147699148","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}
引用次数: 0
Strengthening pharmacovigilance through patient reporting: a scoping review of awareness, barriers, and facilitators. 通过患者报告加强药物警戒:对意识、障碍和促进因素的范围审查。
IF 2.6
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-04-13 eCollection Date: 2026-01-01 DOI: 10.1080/20523211.2026.2651405
Adeel Aslam, Hafizah Abdul Majid, Nimra Muhammad Boota, Asma Ghulam Mustafa, Sumera Saeed Akhtar
{"title":"Strengthening pharmacovigilance through patient reporting: a scoping review of awareness, barriers, and facilitators.","authors":"Adeel Aslam, Hafizah Abdul Majid, Nimra Muhammad Boota, Asma Ghulam Mustafa, Sumera Saeed Akhtar","doi":"10.1080/20523211.2026.2651405","DOIUrl":"10.1080/20523211.2026.2651405","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug reactions (ADRs) significantly impact global healthcare systems, yet patient participation in pharmacovigilance remains underutilised. This scoping review synthesises evidence on patient awareness, barriers, and facilitators for ADR reporting to inform strategies for enhancing pharmacovigilance systems.</p><p><strong>Methods: </strong>Following the Arksey and O'Malley framework, we conducted a scoping review of studies published up to 2025 across PubMed, Scopus, Embase, Web of Science, Cochrane Library, and Google Scholar. Two independent reviewers screened titles, abstracts, and full texts, extracted data, and synthesised findings using thematic and descriptive analyses.</p><p><strong>Results: </strong>A total of 1,420 articles were identified, of which 42 studies from 25 countries met the inclusion criteria. Most employed quantitative descriptive designs (n = 27), followed by mixed-methods (n = 7) and qualitative approaches (n = 5). Sample sizes ranged from 15 participants to over 500,000 ADR reports from national databases. Data collection methods included questionnaires, interviews, and electronic surveys, while six studies analysed secondary data from pharmacovigilance systems such as VigiBase and the Yellow Card Scheme. Key barriers included limited knowledge, complex reporting processes, and a lack of feedback, whereas facilitators included healthcare professional support and simplified, user-friendly platforms.</p><p><strong>Conclusions: </strong>Patient reporting is hindered by systemic and educational gaps, especially in LMICs. Strategic interventions, such as simplified reporting mechanisms, nationwide awareness campaigns, digital tool integration, and healthcare provider training, are critical to empower patients as active pharmacovigilance contributors. Future efforts must prioritise culturally tailored approaches and equitable access to reporting infrastructure.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2651405"},"PeriodicalIF":2.6,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13072706/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690736","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}
引用次数: 0
Do conditional marketing authorisations actually accelerate patient access? Time-to-access of conditional vs. standard marketing authorisations in Italy, Spain, and Germany. 有条件的上市许可真的能加速患者获得么?在意大利、西班牙和德国,条件许可与标准许可的准入时间。
IF 2.6
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-04-13 eCollection Date: 2026-01-01 DOI: 10.1080/20523211.2026.2651404
Vittoria Ardito, Lasse Falk, Montserrat Gasol Boncompte, Caridad Pontes, James Robinson, Jonas Schreyögg, Oriana Ciani
{"title":"Do conditional marketing authorisations actually accelerate patient access? Time-to-access of conditional vs. standard marketing authorisations in Italy, Spain, and Germany.","authors":"Vittoria Ardito, Lasse Falk, Montserrat Gasol Boncompte, Caridad Pontes, James Robinson, Jonas Schreyögg, Oriana Ciani","doi":"10.1080/20523211.2026.2651404","DOIUrl":"10.1080/20523211.2026.2651404","url":null,"abstract":"<p><strong>Background: </strong>The European Medicines Agency (EMA) implemented 'fast-track' programmes, like conditional marketing authorisations (CMA), where the benefits of immediate drugs' availability outweigh the risks associated with incomplete evidence. However, payers in the European Union (EU) decide on medicines' coverage based on clinical benefits assessment, cost-effectiveness and/or budget impact. We investigated differences in the time-to-access of drugs approved via CMA vis-à-vis standard marketing authorisation (SMA) in Italy, Germany, and Spain.</p><p><strong>Methods: </strong>CMA-licenced drugs from 2006 to 2022 were retrieved and matched with comparable SMA drugs. Collected data were as follows: marketing authorisation details, drug characteristics, pivotal trials' characteristics and national reimbursement decision dates. Data sources included European Public Assessment Reports, and country-specific databases (Farmadati®, Lauer-Taxe®, BIFIMED).</p><p><strong>Results: </strong>CMA drugs take longer, in days, to reach reimbursement compared to SMA drugs both in Italy (CMA: median 523, mean 635, standard deviation (SD 364; SMA: median 455, mean 497, SD 242) and Spain (CMA: median 691, mean 779, SD 456; SMA: median 534, mean 568, SD 273). Cox regressions and Kaplan-Meier survival analyses corroborate these findings.</p><p><strong>Conclusions: </strong>The EMA's intent to accelerate access to promising medicines may be offset by longer timelines to secure national reimbursement in major EU nations.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2651404"},"PeriodicalIF":2.6,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13072672/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690739","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}
引用次数: 0
Digital health literacy as a predictor of patient safety culture: evidence from a multi-centre study of Jordanian nurses. 数字健康素养作为患者安全文化的预测因素:来自约旦护士多中心研究的证据。
IF 2.6
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-04-13 eCollection Date: 2026-01-01 DOI: 10.1080/20523211.2026.2650578
Nadia Al Mazrouei, Khalid Awad Al-Kubaisi, Derar H Abdel-Qader, Abduelmula R Abduelkarem, Karem H Alzoubi, Moh'D Ahmad Shara, Richard Mottershead
{"title":"Digital health literacy as a predictor of patient safety culture: evidence from a multi-centre study of Jordanian nurses.","authors":"Nadia Al Mazrouei, Khalid Awad Al-Kubaisi, Derar H Abdel-Qader, Abduelmula R Abduelkarem, Karem H Alzoubi, Moh'D Ahmad Shara, Richard Mottershead","doi":"10.1080/20523211.2026.2650578","DOIUrl":"10.1080/20523211.2026.2650578","url":null,"abstract":"<p><strong>Background: </strong>The digitalisation of healthcare requires nurses to possess strong Digital Health Literacy (DHL) to ensure patient safety. This study aimed to evaluate the relationship between DHL and perceptions of PSC among registered nurses in Jordan and to identify the demographic and professional factors associated with varying levels of DHL.</p><p><strong>Methods: </strong>A multi-center, cross-sectional survey was conducted from July to September 2025 across five public, private, and university-affiliated hospitals in Jordan. A sample of 500 registered nurses was recruited using stratified random sampling. Data were collected using a validated, seven-part composite questionnaire. Data were analyzed using descriptive statistics, reliability analysis (Cronbach's alpha), and structural equation modelling.</p><p><strong>Results: </strong>The results confirmed the study's primary hypothesis, revealing a significant and strong positive predictive relationship between DHL and PSC (<i>β</i> = 0.42, <i>p</i> < 0.001), with DHL explaining 28.1% of the variance in PSC. Nurses reported moderately high DHL overall (<i>M</i> = 3.28), with strengths in operational skills but lower confidence in evaluating information reliability. Perceptions of patient safety culture were positive (<i>M</i> = 3.71), with Teamwork Climate rated highest (<i>M</i> = 4.21) and Perceptions of Management lowest (<i>M</i> = 3.34). Significant disparities in DHL were found; higher levels of education (<i>p</i> < .001) and working in a university-affiliated hospital (<i>p</i> = 0.001) were associated with higher competency. Notably, no significant differences were observed based on age or years of experience. Lack of adequate training and insufficient time were identified as the primary organisational barriers to technology use.</p><p><strong>Conclusion: </strong>Digital health literacy was significantly associated with better patient safety culture among Jordanian nurses, driven more by organisational and educational factors than generational stereotypes. To realise the safety benefits of digital health investments, institutions should strengthen nurses' digital and critical appraisal skills and remove organisational barriers.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2650578"},"PeriodicalIF":2.6,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13072690/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690761","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}
引用次数: 0
The registration status of maternal, newborn, and child health medical products: evidence from 9 countries. 孕产妇、新生儿和儿童保健医疗产品的注册状况:来自9个国家的证据。
IF 2.6
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-04-13 eCollection Date: 2026-01-01 DOI: 10.1080/20523211.2026.2635754
Jane Briggs, Kate Kikule, Helena Walkowiak, Javier Guzman, Martha Embrey, Helen Petach, Jeremie Fikiri, John Patrick Mwesigye, Abul Kalam Azad, Juliet Sanyu Namugambe, Raphael Shedafa, Birna Trap, Abdoul Karim Goita, Eliangiringa Kaale
{"title":"The registration status of maternal, newborn, and child health medical products: evidence from 9 countries.","authors":"Jane Briggs, Kate Kikule, Helena Walkowiak, Javier Guzman, Martha Embrey, Helen Petach, Jeremie Fikiri, John Patrick Mwesigye, Abul Kalam Azad, Juliet Sanyu Namugambe, Raphael Shedafa, Birna Trap, Abdoul Karim Goita, Eliangiringa Kaale","doi":"10.1080/20523211.2026.2635754","DOIUrl":"10.1080/20523211.2026.2635754","url":null,"abstract":"<p><strong>Background: </strong>Registration challenges in resource-limited countries can compromise the availability of life-saving maternal, newborn, and child health (MNCH) medical products - quality-assured generic products may not be registered or renewed.</p><p><strong>Methods: </strong>To identify barriers, we assessed the registration status of MNCH tracer medicines in 9 countries through document review and interviewed country regulators and 11 pharmaceutical manufacturers using structured questionnaires.</p><p><strong>Results: </strong>On average, 72% of the tracer medicines had at least one registered product across the 9 countries (ranging from 28% to 100%). Some countries only had one or two registered products for some MNCH tracer medicines. Five countries had not registered any of the four World Health Organization-prequalified products. The average registration timeline ranged from six months to four years due to national regulatory authority backlogs and complicated procedures. Only two countries officially recognised regulatory decisions from other countries' Good Manufacturing Practices inspections. No country had formal processes embedded in legislative provisions to prioritise and expedite registration of essential MNCH medical products.</p><p><strong>Discussion: </strong>Solutions to registration impediments involve legal, organisational, and procedural changes. MNCH medicines have specific challenges including low profit margins due to the ease of production and variety of manufacturers; additionally, an inconvenient registration process is a disincentive for manufacturers. Likewise, procurers who are more price than quality conscious may not procure costlier prequalified medicines. Registration catalysts include streamlining the process with electronic management information systems providing market information, maintaining qualified staffing, and emphasising reliance on and recognition of other regulatory authority decisions.</p><p><strong>Conclusion: </strong>Some life-saving MNCH products are not available because national registration processes are flawed. Consequently, governments and donors must invest in changes to streamline procedures to register vital medicines to protect the health of women and children. To maximise health outcomes, countries should prioritise the registration of products of public health importance, including MNCH medicines.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2635754"},"PeriodicalIF":2.6,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13072682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690758","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}
引用次数: 0
Rarely listed essential medicines in 158 national lists. 在158个国家清单中很少列出基本药物。
IF 2.6
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-03-31 eCollection Date: 2026-01-01 DOI: 10.1080/20523211.2026.2637398
Moizza Zia Ul Haq, Camila Heredia, Amal Rizvi, Aine Workentin, Nav Persaud
{"title":"Rarely listed essential medicines in 158 national lists.","authors":"Moizza Zia Ul Haq, Camila Heredia, Amal Rizvi, Aine Workentin, Nav Persaud","doi":"10.1080/20523211.2026.2637398","DOIUrl":"10.1080/20523211.2026.2637398","url":null,"abstract":"<p><strong>Background: </strong>Health needs are relatively similar across the planet as there are few conditions that are truly unique to one region or country, and most conditions are common around the world. Differences in health needs do not explain differences in national essential medicines lists. Factors other than health needs may well lead different countries to select different medicines. The purpose of this study is to identify and describe medicines listed by only a small number of countries.</p><p><strong>Methods: </strong>Using the Global Essential Medicines database of NEMLs that was updated in 2023 and 2025, we identified medicines listed by 2 or fewer countries that were not listed on the 2023 World Health Organization's Model List of Essential Medicines. We characterized these rare medicines and their indications based on information obtained from the NEMLs that listed them, and also performed literature searches for each rarely listed medicine. We also identified which countries listed many rare medicines (5 or more) and performed literature searches to explore possible explanations for them being rarely listed.</p><p><strong>Results: </strong>We identified 460 rarely listed essential medicines, including 317 medicines that were listed in the NEML of only one country, and 143 medicines that were listed by two countries. A total of 83 countries listed at least one rare medicine, including 30 countries that listed many (5 or more) rarely listed medicines and 53 that listed few rare medicines. Countries that listed many rare medicines included Greece, Australia, and the Russian Federation.</p><p><strong>Conclusion: </strong>Certain medicines are prioritized for access in just one or two countries, and some countries list many such medicines. Further work is needed to understand why certain medicines are rarely listed and whether changes to lists are needed.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2637398"},"PeriodicalIF":2.6,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13040568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147609288","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}
引用次数: 0
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