Journal of Pharmaceutical Policy and Practice最新文献

The 1925 Brussels Pharmacopoeia Agreement and Geneva Opium Convention were foundational in shaping international pharmaceutical regulation. The former sought to standardise potent medicines, while the latter established controls over psychoactive substances. Despite differing objectives, both treaties influenced global pharmaceutical governance, contributing to modern regulatory frameworks and standards such as those of WHO or the European Pharmacopoeia. A century later, the year 2025 is witness to turbulent shifts in geopolitics and global health governance, but also revived contemporary debates on drug policy and traditional medicines. This letter revisits the seldom-documented history and impact of international pharmacy law, highlighting the relevance of these two pioneering treaties to evolving pharmaceutical governance and international health law.

Background: Off-label and contraindicated prescription drug use can result in adverse health outcomes. Despite concerns, the extent and characteristics of such usage patterns remain underexplored in the American population. We conducted a cross-sectional study analysing outpatient prescription data between 2016 and 2021 to determine the prevalence of off-label and contraindicated drug use.

Methods: The study used labelling information from DrugCentral and the Medical Expenditure Panel Survey, focusing on the American non-institutionalised population. We analysed 9872 drug-indication and 34,138 drug-contraindication pairs among 46,770 patients and 1,596,753 prescriptions. Linear and probit regressions, and a double machine learning approach, were employed to assess associations between off-label/contraindicated use, health status, and healthcare utilisation, adjusting for demographic and health-related factors.

Results: Overall, 75% of prescriptions were for labelled indications, while 25% were off-label; 54% were contraindicated. Only 33% of prescriptions were both indicated and not contraindicated. Off-label prescriptions had a lower contraindication rate (48.8%) compared to indicated prescriptions (56.2%). Improved health status and reduced medical expenditure correlated with lower off-label prescription rates. Notably, newer drugs (post-1997) had a higher rate of prescriptions that were both indicated and not contraindicated (43%) compared to older drugs (pre-1979, 21%). Patterns of off-label and contraindicated use were consistent across racial and educational demographics.

Conclusion: Off-label and contraindicated drug use is prevalent in outpatient prescriptions and is associated with worse health outcomes and increased healthcare utilisation. These findings suggest a need for enhanced monitoring and regulatory measures to minimise risks associated with inappropriate prescription practices.

Background: Acute coronary syndrome is a major global disease burden with high morbidity and mortality. This study aims to assess the impact of clinical pharmacy interventions on improving the quality use of medicines and drug-related problems in acute coronary syndrome patients.

Methods: An open, prospective, controlled, nonrandomised clinical trial was conducted at the Teaching Hospital, Peradeniya, Sri Lanka. Consenting patients were recruited and divided into control and intervention groups. Medication history, medication adherence and drug-related problems were assessed. The intervention group received clinical pharmacy interventions for six months. Improvements in medication adherence, discharge medication appropriateness, reduction of hospital readmissions for six months, and responses from the healthcare team's awareness and perception on clinical pharmacy services were recorded.

Results: Both groups (control - 180 patients, intervention - 185 patients) showed poor medication adherence at baseline. Medication adherence improved significantly after 6-months post-discharge in the intervention group compared to the control group (49.3% vs 18.8%). The clinical pharmacists successfully identified drug-related problems and provided suggestions for resolving them. The treating team accepted the majority (60%) of these suggestions. Discharge medication appropriateness in the intervention group was significantly higher compared to the control group. There was no significant difference in hospital readmissions related to cardiovascular disorders between the groups. Most doctors and nurses were aware of clinical pharmacists but none of them had previously worked with one.

Conclusion: Clinical pharmacist-led interventions significantly improved medication adherence and appropriateness, underscoring the added value of clinical pharmacists in a multidisciplinary healthcare team. While most doctors and nurses were aware of clinical pharmacists, none of them had prior experience working with them, emphasising an opportunity to foster greater multidisciplinary integration for improved health outcomes. Overall findings highlight the potential role of clinical pharmacists in enhancing good patient outcomes and improving real-world patient care.

Background: Critical illness can affect antimicrobial pharmacokinetics and pharmacodynamics. Antimicrobial stewardship programs promote appropriate antimicrobial usage. This study aimed to compare the appropriateness of antibiotic dosing, therapeutic drug monitoring, and ICU mortality before and after antimicrobial stewardship program implementation in medical intensive care units.

Methods: This retrospective study was conducted at King Chulalongkorn Memorial Hospital, Thailand. Adults admitted to medical intensive care units from August 1, 2019, to July 31, 2021, who received selected antibiotics in the antimicrobial stewardship program were included. During the intervention period, general education as well as prospective audit with intervention and feedback were implemented by infectious disease pharmacist and clinical pharmacists. The appropriateness of dosing, therapeutic drug monitoring, and ICU mortality were compared before and after antimicrobial stewardship program implementation.

Results: There were 269 patients (455 prescriptions) and 376 patients (604 prescriptions) in the pre- and post-antimicrobial stewardship program implementation groups, respectively. Meropenem was the commonly prescribed antibiotic in both groups. Overall, the appropriateness of dosing and therapeutic drug monitoring improved after antimicrobial stewardship program implementation (36% to 63.58%, p < 0.001). Infectious disease and clinical pharmacists provided 40 interventions with an 87.5% acceptance rate. The most common recommendation was maintenance dose adjustment (79.17% acceptance rate). ICU mortality (29.37% to 18.62%, p = 0.001) and length of hospital stay in the ICU (7 days to 5 days, p = 0.005) were lower in the post-antimicrobial stewardship program implementation group.

Conclusions: Pharmacist-led education and prospective audit and feedback on antibiotic dose optimization can improve appropriate antibiotic dosing and therapeutic drug monitoring with a high acceptance rate. We suggest implementing this strategy in other intensive care units such as surgical intensive care units. We still found some nonadherence to our dosing guidelines; additional strategies to optimize dosing should be evaluated.

Background: Pharmacy workforces are central to healthcare systems, yet the profession faces challenges in job satisfaction and retention due to evolving roles, workload pressures, and other issues. Understanding workforce stability is crucial for optimising pharmacy services.

Objective: This systematic review aimed to identify and analyze the critical factors impacting pharmacy staff job satisfaction and retention, providing actionable insights to improve workforce stability and long-term engagement in the profession.

Methods: A comprehensive search was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), covering broad academic databases including EMBASE, Web of Science, PubMed, International Pharmaceutical Abstracts, and the supplementary use of Google Scholar for studies published between 2019 and 2024. The quality of the included articles was evaluated, revealing a generally low to moderate risk of bias.

Results: The review synthesised findings from 81 studies and extracted ten relevant themes. Countries including the United States, Saudi Arabia, Nigeria, Pakistan, and Southeast Asia countries contributed most frequently, highlighting regional research diversity. Key factors influencing job satisfaction included burnout, stress, and workload (24%); work conditions and roles (22%); professional development (14%); earnings and benefits (10%); and leadership support (9%).

Conclusion: With a global perspective that travels across 36 countries in five continents, this study is the latest in-depth analysis of factors influencing job satisfaction in the pharmacy workforce. This review emphasises the need for policy reforms and further research on workplace conditions in different locations. It provides insights for policymakers and healthcare leaders to enhance the pharmacy workforce's strategic support and engagement initiatives.

Background: Osteoarthritis (OA) is a prevalent disabling joint disease affecting more than 300 million people globally and knees are most commonly affected. It is associated with pain and functional limitation that adversely affect mental well-being and compromise quality of life. Analgesic use is common among patients with knee osteoarthritis (KOA), however, data on patterns of analgesics use at an individual patient level are sparse. The present study describes patterns of analgesic use, by determining the proportion of persistent users within one year of therapy initiation in patients with KOA.

Methods: A retrospective cohort study using the clinical practice research datalink. Analgesic prescriptions for adults with an incident KOA diagnosis were captured and grouped into five exposure groups including: antidepressants, antiepileptic drugs (AEDs), opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol. A persistent user was a person who used >180 defined daily doses (DDDs) per year and had prescriptions in at least three out of the four quarters of the year.

Results: Variable proportions of patients used respective analgesic classes persistently during the first year after prescribing; 36.8% of antidepressant users, 27.0% of NSAIDs, 23.8% of AEDs, 17.5% of paracetamol and 14.9% of opioid users were persistent users. Across classes, persistent users were slightly younger, were issued more prescriptions and used higher doses of analgesics compared to non-persistent users.

Conclusion: Between 14.9% and 36.8% became persistent analgesic users by the end of the first year after their initial prescription. The study applied meaningful clinical attributes to define persistence. This informs future research on clinical and adverse drug outcomes in persistent users compared to non-persistent users across five separate analgesic classes.

Background: Community pharmacies in England and Wales are taking on a broader range of primary care responsibilities in order to ease pressure on other health services. 'Pharmacy First', launched in 2024, allows patients to access treatment for a range of common conditions directly from a pharmacy without the need to consult a GP. However, funding and workforce pressures have resulted in a number of pharmacy closures in recent years. This study assesses the geographical accessibility of community pharmacies in England and Wales and identifies the impact of these recent closures.

Methods: Using open data on pharmacy locations and opening hours this study calculates a Spatial Accessibility Index (SPAI) for access to pharmacies by car in 2022 and 2024. We use a Modified Huff Variable Three Step Floating Catchment Area (MHV3SFCA), a variant of the Floating Catchment Area (FCA) technique.

Results: Suburban and rural neighbourhoods tend to have poorer access to community pharmacies, whilst more deprived neighbourhoods generally have comparatively better access. We identify neighbourhoods which could be classed as 'pharmacy deserts', which are primarily located in rural areas. We identify that all neighbourhood area types witness a reduction in overall accessibility to community pharmacies between 2022 and 2024. In total these result in a 10% reduction in the SPAI.

Conclusion: The MHV3SFCA applied here is novel in its application to community pharmacy accessibility in a UK context. We demonstrate its utility as a tool to identify the impact of changes to the community pharmacy network on accessibility as experienced by different neighbourhoods. We find evidence of a 'positive pharmacy care law' and also the existence of some 'pharmacy deserts'.

Background: Following a 2007 report by the Thai Food and Drug Administration highlighting disparities in drug pricing across different sectors, there has been a concerted effort to establish and enforce a cohesive medicine pricing policy in Thailand. This study aims to explore the government interventions on medicine pricing in Thailand.

Methods: Employing a mixed-methods approach, this research included a literature review and a cross-sectional survey of medicine prices using the World Health Organization/Health Action International (WHO/HAI) methodology. Data were collected from both public and private sectors across six provinces in Thailand during April-May 2023. Additionally, international price comparisons were conducted with countries including Australia, Canada, Denmark, Malaysia, and New Zealand.

Results: The research identified a significant reduction in the median price ratios (MPRs) of medicines, closer alignment of prices with international benchmarks, and decreased variability in pricing between regions and sectors. These changes illustrated the positive effects of Thailand's pricing policies implemented over the past 16 years.

Conclusions: The strategic interventions implemented by the Thai government have markedly enhanced the regulation and affordability of medicine prices. However, to sustain these achievements and ensure the viability of the local pharmaceutical industry, ongoing efforts and policy adaptations are essential. This study emphasises the critical need for continuous evaluation of these policies to respond effectively to evolving healthcare and economic conditions.

Background: Pharmacists are key to China's healthcare system, balancing traditional Chinese medicine (TCM) and Western pharmaceuticals. The expanding pharmaceutical industry has increased their workload, contributing to work family conflict, which affects job satisfaction and performance and can lead to burnout. Psychological flexibility may alleviate the negative effects of work family conflict on job performance.

Method: This study used a cross-sectional quantitative approach to examine the relationships between work family conflict, psychological flexibility and job performance among 1,359 pharmacists in Shenzhen, China. Online questionnaires assessed work family conflict using the Work and Family Conflict Scale, psychological flexibility using the Acceptance and Action Questionnaire-2 and job performance using the Individual Work Performance Questionnaire.

Results: Correlation analyses revealed significant positive associations between work family conflict and psychological flexibility and between psychological flexibility and job performance. Regression analyses showed that work family conflict negatively predicted job performance, while psychological flexibility positively predicted it. Pharmacists in metropolitan areas reported higher psychological flexibility than those in rural areas, but there were no significant differences in job performance. Male pharmacists had higher psychological flexibility and job performance scores than females although the differences were not statistically significant.

Conclusion: This study underlines the importance of psychological flexibility in enhancing job performance amid work family conflict. The study suggests implementing stress reduction programmes, mindfulness training and workplace policies such as flexible working hours and childcare services to reduce work family conflict and foster psychological flexibility. Addressing these issues can significantly improve the well-being and job performance of pharmacists in China.

Background: The addition of cadonilimab to first-line platinum-based chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in patients with persistent, recurrent, or metastatic cervical cancer. However, the economic value of using this novel therapy for this indication is currently unknown. The aim of this study is to evaluate the cost-effectiveness of the addition of cadonilimab to first-line standard chemotherapy for patients with persistent, recurrent, or metastatic cervical cancer from the perspective of Chinese healthcare system.

Methods: A partitioned survival model was constructed to compare the cost-effectiveness of cadonilimab versus placebo in patients enrolled in the COMPASSION-16 trial. Cost, life-year, quality-adjusted life-year (QALY), incremental cost-effectiveness ratio (ICER), incremental net health benefit (INHB), and incremental net monetary benefit (INMB) were calculated for 2 treatment strategies. Sensitivity, scenario, and subgroup analyses, and value of information analysis (EVPI) were performed.

Results: Cadonilimab provided an additional 1.18 QALYs and $89,528.64 compared with placebo, which resulted in an ICER of $75,944.56/QALY. At the willingness-to-pay threshold of $38,042.49/QALY, INHB was estimated to be -1.17 QALYs, while INMB amounted to -$44,681.55 and EVPI was calculated as $71.40/person. Sensitivity analyses revealed that the model was most sensitive to hazard ratio (HR) for OS and PFS, and the probability of cadonilimab being cost-effective was 0.70%. To achieve cost-effectiveness, the price of cadonilimab must be reduced by approximately 50%. Subgroup analysis found that all subgroups unfavored cadonilimab by varying the HR for OS and PFS. Scenario analyses showed using life-year as effectiveness, altering time horizon and selection of survival analysis did not reverse results.

Conclusions: Although the use of cadonilimab resulted in clinical benefit, it was not deemed cost-effective as a first-line therapy for persistent, recurrent, or metastatic cervical cancer in China. Lowering the price of cadonilimab may enhance its cost-effectiveness.