Journal of Pharmaceutical Policy and Practice最新文献

Background: Improper disposal of unused medicine can impact the environment causing significant healthcare and financial burdens. While the medicine take-back programme is an effective management strategy, its effectiveness differs across countries. This study aimed to systematically review the take-back programmes in various countries and to identify areas needing improvement for programme enhancement.

Methods: We conducted searches in Medline, EMBASE, CINAHL, Web of Science, Scopus, and Google Scholar, from database inception to June 2023.

Results: The review included 27 studies spanning 15 countries' medicine take-back programmes. While some programmes, mostly observed in the USA, were conducted at the local level with non-health-associated facilities, others were done at the national level within healthcare facilities. The cost of collected medicines ranged from US$7,416 to US$1,118,020, primarily involving medicines related to the nervous system, cardiovascular system, alimentary tract, and metabolism. Legislations pertaining to these programmes were available in the USA, most European countries, and Mexico, but unavailable in Spain, Austria, Australia, and New Zealand. However, despite this, the government or the industry in these countries managed the programmes.

Conclusion: Well-structured take-back programmes featuring easily accessible collection points, regular collection schedules, clear programme ownership, with legislation defining financial responsibilities, showed positive outcomes.

Introduction: Medication history errors at hospital admission are common and effective strategies to improve the quality of medication histories are still being researched. However, studies on new approaches regarding medication history taking are often time-consuming and resource-intensive. The gold standard when evaluating the quality of medication histories is the comparison of a Best Possible Medication History to the original. However, this double collection requires significant resources, disrupts clinical procedures, and places an additional burden on patients. Therefore, more efficient study designs need to be explored. We aimed to develop a design for future studies on medication history taking that uses fewer research resources and places less strain on patients and staff.

Discussion: We first identified shortcomings of the established study designs on medication history taking and subsequently defined requirements for a new design. A pragmatic study with an alternative endpoint was identified in a previous literature search. It served as the starting point from which we developed a new study design to assess the quality of approaches to medication history taking. Instead of taking a second medication history, a patient's pre-existing medication document can be used as comparator to determine the quality of the medication history. Furthermore, we defined a new primary endpoint, i.e. the number of updates per patient. Updates are differences between the newly acquired medication history and the comparator. They include discontinued, initiated, and changed medications. To enhance our proposed design, we recommend a preparatory phase to identify a suitable comparator document, and a baseline phase to assess the current process.

Conclusion: We propose a more resource-efficient study design with a new endpoint. We plan to test its feasibility and evaluate whether it could enhance the efficacy of research on medication history taking in a pilot project.

Background: Health systems worldwide are under pressure. Integration seems a possible solution to improve healthcare systems efficiency. This research aims to gather stakeholders' opinions on integrating community pharmacy and the primary healthcare system and secondly to explore and prioritise interventions for an initial integration plan.

Method: Using a constructivist qualitative research approach, a two-phase qualitative study was conducted in the Basque Country, Spain. Thematic analysis using NVivo® was undertaken on data gathered during focus groups and semi-structured interviews (phase 1). During phase 2, a nominal group prioritised potential integration interventions identified in phase 1.

Results: The study amalgamated findings from four focus groups and nine interviews, revealing six themes. Stakeholders had a diverse understanding of integration, associating the term mainly with collaboration, communication or cooperation. Community pharmacies were positively perceived; however, their commercial and privately owned nature was of concern. Remuneration methods for pharmacists were controversial, with a suggested shift to service-based remuneration. Information availability and barriers such as interprofessional communication gaps were highlighted. The nominal group prioritised, according to importance and feasibility, bidirectional communication development, coordination in using interprofessional protocols and community pharmacist participation in primary healthcare centre meetings as interventions for integrating community pharmacies and primary healthcare centres.

Conclusion: Based on the opinions of stakeholders, three interventions are proposed to initiate the integration process of community pharmacy and primary care. The implementation of these interventions will need to be negotiated with the relevant authorities and evaluated.

Background: Anticoagulation therapy is crucial for managing various cardiovascular and thrombotic conditions; however, optimal delivery remains challenging in primary care. Pharmacist-led anticoagulation services have emerged as a potential strategy for enhancing patient care and outcomes in such settings. Understanding the perspectives of key stakeholders is critical for successful implementation.

Objectives: This study aimed to explore the perceptions of key stakeholders involved in the implementation of pharmacist-led anticoagulation clinics in primary care settings.

Methods: A cross-sectional study was conducted using structured, pilot-tested questionnaires between August and October 2023. Patients receiving warfarin, pharmacists, and physicians working across various primary healthcare centres were invited to complete an online survey. Each group of stakeholders had individualised questionnaires to assess their perceptions and expectations with regard to developing pharmacist-led anticoagulation clinics in primary care. Descriptive statistics were used to analyze the data.

Results: The response rates for the survey were 29.4% for physicians, 10.4% for patients, and 48.6% for pharmacists. Participants expressed positive perceptions toward pharmacist-led anticoagulation clinics, acknowledging benefits such as improved access to care, enhanced medication management, and increased patient education. The respondents expressed confidence in the expertise and skills of pharmacists in this role. However, healthcare providers strongly agree that pharmacists should receive additional training specific to anticoagulation management. Establishing standardised protocols and fostering interprofessional collaboration were identified as the main facilitators for practical implementation.

Conclusions: Broad support exists for pharmacist-led anticoagulation clinics in primary care, though additional pharmacist training and accountability concerns need to be addressed for successful implementation.

Background: Several cross-sectional and longitudinal investigations have demonstrated a robust association between academic stress, physical activity, mental health history, and time management skills. However, the existing literature exhibits inconsistencies in the relationship between academic stress and its predictive effects on physical activity and mental health history. In addition, there is a scarcity of scholarly research that concentrates on the significance of time management skills within this particular context. Furthermore, limited research has investigated these variables' longitudinal associations and causal pathways. Therefore, the present research explores the longitudinal relationships among academic stress, physical activity, mental health history, and time management skills among university students.

Methods: The data were gathered from Wuhan University, China, employing a two-wave longitudinal survey methodology with an annual interval. A cohort of 980 university-level students engaged in the completion of questionnaires, which encompassed measures of academic stress via the Educational Stress Scale for Adolescents (ESSA), physical activity ascertained through Cho's five-item questionnaire, mental health history assessed by the Kessler Psychological Distress Scale, and time management skills evaluated using the Time Management Behaviour Scale (TMBS). Subsequently, a cross-lagged path model was utilised to examine the prospective associations among these constructs.

Results: The outcomes of the cross-lagged path analysis indicated the presence of significant bidirectional relationships between academic stress and physical activity, mental health history, and time management skills. In addition, bidirectional interconnections existed between physical activity and mental health history. Furthermore, unilateral correlations were detected between physical activity and time management skills.

Conclusions: These findings underscore the importance of an integrated approach to student health initiatives and highlight the need for comprehensive support systems that address student well-being's psychological and physical aspects.

Introduction: The East African Community (EAC) has been facing challenges in ensuring access to affordable and quality-assured medicines. To address these problems, the EAC Partner States have been working on implementing an inter-country pooled procurement mechanism since 2005. However, with limited progress to date. The aims of this study were to explore how the EAC pooled procurement mechanism has been developing over time, and to clarify the work and efforts made during this development process to draw lessons for enhancing such collaborative efforts.

Methods: For this study, we carried out a multi-method qualitative case study. We used the Pooled Procurement Guidance to collect and structure our data drawn from academic papers, grey literature documents, observations and field notes. For the analysis, we used an inductive thematic analysis approach.

Results: Over the past two decades of the EAC's pooled procurement journey, we have identified two developmental stages so far: the promise stage and the creation stage. The promise stage was characterised by initial engagement and alignment efforts between Partner States. However, the lack of dedicated funding and ownership to drive the project forward led to stagnation of the process for some years. Following the establishment of a dedicated organisation, the pooled procurement mechanism entered the creation stage. This stage has been characterised by continuous alignment work consisting of project management, efforts to build inter-personal relationships, and facilitation of negotiations to harmonise goals, needs and operations. This process has been aided by broad and recurring involvement of regional experts.

Conclusion: To successfully implement a pooled procurement mechanism, we suggest EAC Partner States to continue their alignment efforts, sustain political will and allocate sustainable funding using a phased implementation approach towards pooled procurement.

Background: Regulatory pathways adopted by the United States Food Drug and Administration (FDA) and Australian Therapeutic Goods Administration (TGA) enable expedited approval of medicines that are thought to offer significant clinical advantage over existing options for severe diseases.

Objectives: To review Australian accessibility to medicines approved through the FDA breakthrough therapy designation (BTD) process including timelines and approvals by the TGA and Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS).

Methods: Retrospective review of published reports from the FDA, TGA, PBAC and PBS for BTDs from 1 January 2013-31 August 2023. Uniform data about BTD and milestone dates were collected. Analysis included all BTDs approved by FDA until 31-August-2022. Main outcome measures: Rates of approval by TGA and PBAC, and PBS-listing; and median (interquartile range, IQR) time from FDA submission to FDA approval, and FDA approval to TGA approval, PBAC approval and PBS listing for cancer and non-cancer medicines.

Results: Of 237 BTDs across 156 medicines, 68% were approved by the TGA, and 37% were listed on the PBS. Median (IQR) time from FDA submission to FDA approval was shorter for cancer compared to non-cancer; 179 days (140-210) vs 232 days (181-245), p < 0.02. Time from FDA approval to PBS listing was similar for cancer and non-cancer; median 744 days (IQR, 549-1136) and 733 days (IQR 440-960) respectively, with improvements for cancer BTDs noted for 2018-2022 compared to 2013-2017; 566 days (IQR 319-831) vs 880 days (IQR 620-1362), p < 0.02 but not for non-cancer BTDs.

Conclusion: BTD medicines are accessible in Australia approximately 2 years after FDA approval. Since 2018, time to PBS listing for cancer therapies improved, mirroring shorter FDA approval times for this category. Further understanding of clinical studies and context by therapeutic area may improve timely and safe access to life-saving medicines.

Background: The clinical characteristics and associated risk factors for recipients who experience multidrug-resistant organism (MDRO) bloodstream infections after liver transplantation are poorly understood. This study aimed to analyse the clinical characteristics and epidemiology of pathogenic bacteria and identify associated risk factors in patients who underwent MDRO after liver transplantation.

Method: We retrospectively collected data on recipients who developed bloodstream infections after liver transplantation between 2018 and 2023. Recipients were divided into MDRO and non-MDRO groups based on blood culture results. We explored the risk factors for MDRO bloodstream infections post-transplantation and summarised the clinical features, pathogen epidemiology, and prognosis. A multivariate logistic regression analysis was conducted to identify significant risk factors.

Results: A total of 463 liver transplant recipients were studied, and 73 developed blood infections. There were 29 MDRO cases. The mean duration of the episodes was 26 days (range: 1-474 days). Among these patients, 22 (30.1%) developed blood infections without fever (temperature < 37.3°C), and 33 patients (45.2%) had a white blood cell count between 4 and 10 × 10⁹/L. Among the 108 positive blood cultures, 29 genera were detected, predominantly gram-negative bacilli (n = 64, 58.2%). The detection rate for multidrug-resistant bacilli was 31.8% (35/110), with the abdomen being the most common site of origin (21.3%). Factors such as a history of preoperative intensive care unit (ICU) hospitalisation (p < 0.001) and a preoperative international normalised ratio (INR) > 2 (p < 0.048) were identified as risk factors in multivariate regression analysis.

Conclusion: Multidrug-resistant bacterial bloodstream infections after liver transplantation tend to occur early in the postoperative period (<30 days) and are associated with high mortality and a lack of specific clinical manifestations. A history of preoperative intensive care unit (ICU) hospitalisation and an international normalised ratio (INR) > 2 may be risk factors for multidrug-resistant bacterial bloodstream infections after liver transplantation.

Background: In recent decades, there has been an interest in clinical pharmacy practice in Türkiye with emerging studies in this area. Despite the recent emergence of diverse pharmacy practice studies in Türkiye, a comprehensive assessment of overall typology of studies and impact has not been conducted thus far.

Objectives: This systematic review aims to document and assess pharmaceutical policy and practice literature published within the last 5 years in Türkiye. The other aim is to summarise the expected impact of published studies on policy and practice research.

Methods: The systematic review was conducted according to the guidelines described in the PRISMA Statement. A comprehensive search approach, incorporating Medical Subject Headings (MeSH) queries and free-text terms was employed to locate pertinent literature related to pharmacy practice and policy in Türkiye. The search covered the period from January 1, 2019, to January 1, 2024, and involved electronic databases including PubMed, Medline Ovid, Scopus, ScienceDirect, Springer Link, PlosOne, and BMC.

Results: In the final grouping, 73 articles met the inclusion criteria and were selected for this review. Among the quantitative studies, majority studies were cross-sectional survey studies. Through the rigorous thematic content analysis seven research domains were developed from the selected literature: drug utilisation and rational drug use, the emerging role of pharmacist, access to medicines and generic medicines, community pharmacy practice, pharmacovigilance/adverse drug reactions, and pharmacoeconomic studies.

Conclusions: The pharmacist role is evolving; however, several challenges remain in fully realising the potential of pharmacists. These include regulatory barriers, limited public awareness of pharmacists' expanded roles, workforce capacity issues, and the need for ongoing professional development and training. Research studies are needed in the areas of generic prescribing, medicine adherence, intervention studies in community and hospital pharmacy practice, and on pharmacoeconomics and pharmacovigilance.

Background: Over the past decade, Canada has witnessed a shift of several drugs from prescription-only to behind-the-counter (BTC) and over-the-counter (OTC) status. This work examined community pharmacists' agreement with the current scheduling of agents used in the management of allergic rhinitis, heartburn, and vulvovaginitis.

Methods: From September to October 2022, an online survey was administered to pharmacists practicing in in Ontario and Québec. The survey aimed to gather insights into their preferred scheduling for 15 medicines commonly used to manage the three selected conditions. Pharmacists were asked whether they agreed with the current scheduling status of each and, if not, how they feel it should be scheduled.

Results: 715 pharmacists completed the survey, 462 from Ontario and 253 from Québec. Most were staff pharmacists working 30 or more hours per week, having been a pharmacist for 1-10 years. Ontario pharmacists expressed a preference for scheduling change for five drugs (four prescription [terconazole for intravaginal use, famotidine, rupatadine, mometasone nasal spray] and one unscheduled [ranitidine 75 mg]), while Québec pharmacists expressed preference for scheduling change for three prescription drugs (terconazole for intravaginal use, famotidine, rupatadine).

Discussion: As pharmacy practice continues to evolve, pharmacists' comfort with initiating previously prescription-only therapy independently or assisting patients with self-selection may similarly evolve. Of the five drugs identified as having a discrepancy between current status and pharmacist preference, four are prescription and may be candidates to consider for prescription to OTC switch.

Conclusion: Pharmacists in Ontario and Québec have expressed preference for most products used in the treatment of allergic rhinitis, heartburn, and vulvovaginitis to be categorised as Schedule II (BTC) or Schedule III (OTC) available only in pharmacies.