Journal of Pharmaceutical Policy and Practice最新文献

Background: Anthropometry and biochemical parameters as diagnostic measures of metabolic syndrome (MetS) are of high repute in clinical settings. However, statistics capable of predicting MetS explicitly in young adults are the least discussed in the literature. We, therefore, aimed to establish the profile and identify the associated predictors of MetS among young adults enrolled in a public medical institute in Quetta city, Pakistan.

Methods: This was a cross-sectional study. Along with the demographics, anthropometric measures were examined as per World Health Organization' criteria. Biochemical measures were assessed using standardized protocols. In addition to the non-parametric tests, the binary logistic regression was used to identify the predictors of MetS. For all analyses, p < 0.05 was taken significantly.

Results: Three hundred and fifty-one young adults responded to the study with a response rate of 77.1%. Majority of the respondents were females (55%) with 19 years age (82.1%) dominating the cohort. Almost 50% of the respondents had higher triglyceride levels and high-density lipoproteins were below normal in 42.7%. Nearly 31% were obese and 25% had higher HbA1c. Logistic regression analysis revealed fourteen independent variables that accounted for 75.2% of the model explanation. Glycated haemoglobin and body mass index were identified as significant predictors of MetS (adjusted OR = 5.014, p < 0.001 and adjusted OR = 3.323, p < 0.042, respectively). An increase in HbA1c level and body mass index of one point was associated with the development of MetS by a factor of 5.014 and 3.323 respectively.

Conclusion: The prevalence of MetS was high, whereas HbA1c and BMI were shaped as predicting factors of MetS. Therefore, while addressing MetS-related issues among young adults, healthcare and preventive professionals, and policymakers should consider the identified factors while designing individualized or targeted interventions.

Introduction: The scope of the WHO Model Lists of Essential Medicines (EML) has evolved from a tool for resource-constrained countries to a global benchmark that includes several high-priced, patented medicines. The addition of high-priced medicines has sparked a recent debate about whether affordability should be more explicitly considered in WHO EML listing decisions.

Discussion and analysis: Currently, WHO must face the difficult task of balancing clinical benefits with the economic realities of the current pharmaceutical market. As such, a key question arises: Should the WHO EML consider prices at the time of listing, or does EML inclusion serve as a catalyst for price reductions through targeted mechanisms post-listing? This analysis explores the complexities of including high-priced medicines on the Model Lists.

Analysis: Challenges include market and regulatory exclusivities, marginal clinical benefits, difficulties with applying cost-effectiveness analyses globally, and the disconnect between production costs and market prices. Several mechanisms that could facilitate post-listing price reductions are reviewed, including voluntary and compulsory licenses, pooled procurement, WHO prequalification, price transparency, and political advocacy. These mechanisms are frequently referenced in EML recommendations and the academic literature but have not been examined together.

Conclusion: This analysis provides insights to inform ongoing WHO reforms and a foundation for future research evaluating the downstream economic impacts of the WHO EML on access to medicines worldwide.

Background: Voriconazole (VCZ) belongs to the class of broad-spectrum antifungal agents, and it is commonly used for the treatment of serious fungal infections. Safe and effective therapy with VCZ is a challenge due to the narrow therapeutic index and high variability in pharmacokinetics between patients. Age of the patients can be a significant factor for this variability. However, no prior study in Pakistan has compared the pharmacokinetics of VCZ among young and elderly patients.

Methods: A population pharmacokinetic model was developed on NONMEM software by using therapeutic drug monitoring (TDM) data from 51 cancer patients. Patients were divided into two age groups, that is ≤ 65 years and > 65 years. The covariate influence on CL of VCZ was assessed by stepwise covariate modelling. The predictive performance and stability of the final model were evaluated by using goodness-of-fit plots and bootstrap analysis, respectively.

Results: A one-compartment model with first-order elimination best described the data. The CL of VCZ in patients with age > 65 years was 3.11 L/h, which was significantly lower than the CL in patients with age ≤ 65 years, which was 6.46 L/h. No other covariate proved significant on CL and volume of distribution of VCZ. The final model demonstrated robust predictive performance and stability.

Conclusions: The reduced CL of VCZ in elderly patients might be due to compromised hepatic enzymes in elderly patients. The dose of VCZ should be reduced in patients aged > 65 years.

Background: Pharmacists' capacity to handle their workload and fulfil health service expectations affect their well-being. This study aimed to analyze and validate the second-order confirmatory factor analysis of pharmacists' well-being in the Eastern Economic Corridor (EEC) of Thailand and establish criteria for assessing pharmacists' well-being.

Methods: A mixed-methods explanatory sequential approach was employed in two phases. Phase 1: Quantitative study involving data collection from 400 pharmacists using a structured questionnaire with second-order confirmatory factor analysis (CFA). Phase 2: Qualitative study including in-depth interviews with seven key informants to refine assessment criteria and interpret quantitative results.

Results: The quantitative findings indicated that the second-order confirmatory factor analysis of pharmacists' well-being exhibited a good fit with the empirical data. The highest loading was observed for physical well-being (PWb), followed by occupational well-being (OWb), emotional well-being (EWb), social well-being (SWb), financial well-being (FWb), and spiritual well-being (SpWb). The qualitative findings provided robust support for the validity of the proposed factor structure. The pharmacists highlighted the significance of PWb, followed by OWb. They stated that the implementation of stress management strategies facilitated EWb. SWb was defined as the support received from colleagues, FWb was associated with the need for security, and SpWb was linked to the pursuit of meaning in one's work.

Conclusion: These findings advocate for the establishment of a programme for promoting well-being among pharmacists that focuses on their physical health, workplace enhancements, and increased professional recognition. Pharmacists' well-being in the EEC is influenced by various factors such as physical health, professional engagement, emotional resilience, organisational systems, and work context. These insights can guide policy development, human resource management, and organisational wellness initiatives that can enhance the quality of life of pharmacists.

Background: Assisted suicide is discussed in many countries to permit terminal-ill patients to die in dignity. Pharmacists often have the last interaction with the patients. This study aimed to explore Austrian pharmacists' perspectives on assisted suicide and to identify challenges and strategies for improving this service.

Methods: The study was a cross-sectional convergent parallel mixed-methods study. The quantitative component involved digital surveys distributed by the Austrian Board of Pharmacists. The qualitative phase included semi-structured interviews with pharmacists who had experience dispensing lethal drugs. Quantitative data were analysed using SPSS and qualitative data through Mayring's content analysis with MAXQDA. Findings were integrated through mixed-methods matrices for comparison and strategy development. The study was registered in the German Clinical Trials Register (DRKS00034077).

Results: A total of 324 pharmacists participated (193 enrolled and 131 non-enrolled) yielding a 5.11% total response rate. Over half of the enrolled pharmacists (52.8%) had dispensed the lethal drug, viewing their involvement as a responsibility (55.6%) and feeling mentally capable (44%). Nearly half of non-enrolled pharmacists (42%) opposed participation, citing safety concerns and fear of mental burden. In-depth interviews (n = 5) highlighted the emotional strain on patients and pharmacists. Older pharmacists felt more prepared than younger ones (ρ = -0.295, p = 0.001). Enrolled pharmacists viewed training as helpful, while non-enrolled saw it as a barrier, emphasising the need for better communication and support.

Conclusion: The study identified key issues and areas for improving care and pharmacist enrolment. Frameworks can assist pharmacists supporting patients facing their last destination, while also providing room for their own reflection.Trial registration: German Clinical Trials Register identifier: DRKS00034077.

Background: Access to unauthorized medicines in the EU is legally restricted, except in certain cases such as clinical trials, magistral preparations, hospital exemptions, and early access programs, including compassionate use programs (CUPs) and named patient use (NPU). CUPs, regulated under Article 83 of Regulation (EC) No 726/2004, are intended for a group of patients with an unmet medical need. Despite this EU-wide regulation, the implementation of CUPs varies among member states, and the factors driving pharmaceutical companies to pursue them are poorly understood.

Methods: This study conducted semi-structured interviews with pharmaceutical companies that had applied for CUPs in the Netherlands, as well as those with potentially eligible medicines that had not pursued CUPs. The interviews explored the decision-making processes and factors influencing CUP applications. Transcripts were analyzed using Atlas.ti software, with coding categories derived from the interview guide and emerging themes.

Results: Ten interviews were conducted. Factors influencing CUP applications were classified into four categories: regulatory, medical, operational, and financial. Regulatory factors included recommendations from the Health and Youth Care Inspectorate (IGJ) and European Medicines Agency (EMA), concerns about post-marketing authorization uncertainties, and timelines for CUP approval. Medical factors involved unmet medical needs, patient numbers, and the alignment of CUP indications with authorized indications. Operational factors included prior experience with CUPs, supply availability, and the appeal of NPU due to faster approval times. Financial factors centered on reimbursement expectations and decisions by company headquarters on the free provision of medicines.

Conclusion: The decision to pursue CUPs is influenced by multiple factors, with regulatory uncertainties and operational complexities playing significant roles. Improving clarity concerning CUP regulations, particularly data collection and the post-marketing phase, could encourage more pharmaceutical companies to apply for CUPs, which would provide patients with earlier access to potentially promising treatments.

Background: Self-medication is a widespread practice globally involving the use of medications without direct medical supervision. While it provides convenience and cost savings, it poses risks such as misdiagnosis, incorrect dosages, adverse drug interactions, and antibiotic resistance. This study assessed the prevalence, determinants, and perceptions of self-medication among adults in the United Arab Emirates (UAE), and evaluated the impact of a brief educational intervention on public awareness and attitudes.

Methods: A cross-sectional community-based study was conducted among 400 participants using structured, face-to-face surveys, followed by an educational intervention that included a targeted brochure. Post-intervention feedback was collected directly using an online survey. Descriptive and inferential analyses were performed using SPSS v. 29.

Results: Self-medication was reported by (78%) of participants, primarily for minor ailments, with key drivers including the perceived unimportance of the illness (79.3%), prior knowledge of drugs (61.3%), and accessibility to pharmacies (42.5%). Chronic illness was significantly associated with increased self-medication. Despite 47.8% reporting awareness of drug interactions, only 38.6% could identify examples. Antibiotic misuse was noted in (24.5%) of cases. Participant narratives revealed real-life harms, including pediatric dosing errors, herbal misuse during pregnancy, and delayed diagnosis due to symptom masking. The educational intervention improved understanding in 88.3% of respondents, and 79% expressed interest in further education. Self-medication was significantly associated with age, gender, education, and insurance status (p < 0.05).

Conclusion: Self-medication is highly prevalent in the UAE, influenced by demographic and access-related factors. Despite moderate awareness, critical knowledge gaps persist. Educational tools and stronger pharmacist engagement can enhance safe medication use. Targeted interventions are needed to promote responsible self-care and regulatory compliance.

Background: Medication reconciliation is a key responsibility of ward pharmacists, who work closely with doctors. However, little is known about doctors' practices in the administration of this service.

Methods: A cross-sectional survey was conducted with doctors from the medical wards of 14 Perak government hospitals. A validated self-administered questionnaire was used to assess doctors' demographics, experiences with pharmacist-led medication reconciliation services (13 items) and practices in administering medication reconciliation-related information (8 items). Responses were measured on a 5-point Likert scale.This study explored doctors' experiences with and utilisation of medication reconciliation services provided by pharmacists in medical wards. The independent t-test and Kruskal-Wallis test were performed to evaluate the associations between the doctor's sociodemographic backgrounds with their experiences and practices towards pharmacist-led medication reconciliation services.

Results: A total of 209 doctors responded, with more than half of them being female (60.8%) and medical officers (76.6%). Most respondents agreed that ward pharmacists play an integral role (97.6%), perform quality reconciliation (97.2%), and reduce medication errors (97.1%) during medication reconciliation. The majority frequently expected the pharmacists to provide medication history assessments (90.0%), relied on their medication history assessments during prescribing at admission (88.6%) and discharge (89.0%), and collaborated on reconciliation issues (91.8%). Higher practice scores were observed among medical officers (3.89 ± 0.63, p = 0.01) and those aged >30 years (3.9 ± 0.46, p = 0.04), and those working in wards with ≥30 beds (3.94 ± 0.48, p = 0.02).

Conclusion: Doctors demonstrated positive experiences and practices regarding pharmacist-led medication reconciliation services provided by ward pharmacists. These findings suggest that doctors acknowledge the role of pharmacists in medication reconciliation services.

Background: The perception of pharmacy policymaking among early-career pharmacists is crucial for developing and advancing the profession. This study aimed to construct and validate a new tool, the Pharmaceutical Policymaking Perception Scale (PPPS), and assess pharmacy students' and graduates' perceptions of pharmaceutical policymaking in Lebanon.

Methods: A standardized questionnaire was disseminated through electronic platforms. It included sociodemographic characteristics, education-related variables, and scales measuring leadership, general self-efficacy, strategic thinking, and public service motivation. The validity of the newly developed PPPS was confirmed, and concepts were linked through multivariate analyses.

Results: The PPPS tool exhibited excellent psychometric properties, with its items loading on two factors representing the positive and negative perceptions of pharmaceutical policymaking. The scale demonstrated excellent reliability as well as robust content, construct, structural, and concurrent validity. Only 4% of participants scored above 70, indicating relatively low perceptions of pharmaceutical policymaking in Lebanon. Higher PPPS scores were associated with higher self-efficacy and strategic thinking, while lower scores were linked to reduced public service motivation. No association was found between PPPS and leadership.

Conclusion: The novel PPPS scale offers valuable insights into pharmacists' views, enabling a more comprehensive assessment of policymaking perceptions. The potential disconnection between the studied concepts raises concerns. Further research is recommended to confirm these findings, and urgent action by educators and policymakers is essential to effectively engage with early-career pharmacists and enhance their motivation to serve the profession in challenging circumstances.