Journal of Pharmaceutical Policy and Practice最新文献

Background: Substandard and falsified medicines in Africa are a major public health concern. Access to quality medical products in African countries is governed in large part by two major entities at the national level: the regulatory authority and the procurement agency. The importance of national regulators in ensuring quality medical products is well known. The interplay between the national regulator and the national procurement agency also has a significant impact on access to quality medicines but is less understood. This study's aim was to characterise the regulatory-procurement interface - the intersection of decision-making in these two spheres - using publicly available data from five African countries.

Methods: For the five target countries, we adapted criteria from WHO's 2018 Pharmaceutical System Transparency and Accountability Assessment Tool to identify key national policies and practices around the nexus of medicines regulation and procurement.

Results: Though legal and policy frameworks enabling best practices in procurement were often in place, implementation and enforcement of these practices appear to be key areas for strengthening. In addition, we documented a lack of publicly available information related to the role that quality plays in selecting medical products. Finally, none of the five countries have publicly published the results of their selection decisions with key product details, making it difficult to assess whether basic quality standards are being met.

Conclusion: Based on these findings, one of the most important next steps for improving the effectiveness and transparency of national procurement is for procurement agencies to publish detailed quality selection criteria and an up-to-date list of the medical products they have purchased, with key product information. We hope these findings can help inform the conversation about implementing and enforcing best practices at the regulatory-procurement interface, with the goal of improving access to quality versions of medical products in Africa and globally.

Objective: This pilot study evaluated the professional self-actualisation (PSA) of pharmacists in the United Arab Emirates (UAE) across various practice settings.

Methods: Our study was conducted in the UAE from February to May 2024 and targeted pharmacists in hospitals, community pharmacies, industry, and academia. A PSA questionnaire was developed using validated instruments and expert input, and included items on professional fulfilment (PF), societal acceptance (SA), work environment (WE), autonomy and professional opportunities (APO), involvement in professional advocacy (IPA), and the impact of work on personal relationships (IWPR).

Results: Sixty-eight responses were received from pharmacists working in the community, hospital, industry and academic sectors. No significant differences in self-actualisation were observed between genders. PF scores were consistent across age groups, and education level significantly impacted IPA scores, with MSc/PhD holders (mean = 3.6, SD = 0.7) scoring higher than Bachelor's degree holders (mean = 2.9, SD = 0.9; p = 0.008). Years of experience were significantly associated with SA scores (p = 0.046), with pharmacists having 5-10 years of experience (mean = 3.5, SD = 0.8) scoring higher than those with less than 5 years (mean = 3.1, SD = 0.9) or more than 10 years (mean = 2.9, SD = 0.7). PF showed a strong correlation with a supportive WE (r = 0.744), highlighting the crucial role of a positive work setting in professional self-actualisation.

Conclusion: This study identified key factors affecting pharmacists' self-actualisation in the UAE, emphasising the importance of a supportive work environment, recognition, and professional development for job satisfaction. Despite limitations such as low sample size and underrepresentation of certain sectors, the findings provide a basis for future research and inform strategies to enhance work environments, policies, and pharmacists' professional satisfaction.

Background: The increase in the consumption of herbal medicines and their documented adverse reactions (ARs) necessitate countries to have good pharmacovigilance (PV) systems at all levels. PV systems should be frequently assessed in a systematic manner with available harmonised tools to monitor the implementation of efforts, strengthen the systems and identify areas for improvement.

Objectives: This study aimed to assess the performance of pharmacovigilance and its quality systems for monitoring herbal medicine safety at the National PV Centre at the Tanzania Medicines and Medical Devices Authority (TMDA), manufacturers and herbal medicine marketing authorisation holders (MAHs) to identify gaps, challenges and opportunities for improvement.

Methods: A descriptive cross-sectional study was conducted using structured interviews with key informants, questionnaires administered by the researchers and document analysis. A retrospective study of suspected ARs to herbal medicines received via the TMDA was also performed.

Results: Policies and a legal framework for regulatory control and safety monitoring of herbal medicines were in place with a well-established and functional PV system at the TMDA. However, some gaps and challenges in the safety monitoring of herbal medicines, such as underreporting, lack of training, and dissemination of PV information, have been identified. A total of 18 reports containing 40 suspected herbal medicine ARs were received at the TMDA. Among the MAHs, only 64% had PV systems, with only 29% having mechanisms for the collection of ARs from their products. Only a few MAHs (39%) had a qualified person in the PV. The majority of the MAHs (64%) had established a quality system for PV; however, the systems were inadequate.

Conclusion: Deliberate efforts need to be made to strengthen herbal medicine safety monitoring at the regulatory level. MAHs need to develop efficient PV systems and recruit qualified persons to identify safety issues related to herbal medicines.

Background: High prices and other access barriers have contributed to the rise of a market for compounded glucagon-like peptide-1 receptor agonists for weight loss in the United States. This market has not been systematically studied. We conducted a pilot study to assess the prevalence, characteristics, and advertising content of direct-to-consumer providers of compounded glucagon-like peptide-1 products for weight loss in Colorado.

Methods: We conducted a cross-sectional study of websites advertising compounded glucagon-like peptide-1 products for weight loss in Colorado. Websites were identified using Google searches focused on census-defined statistical areas. Searches were conducted between March 21 and April 12, 2024. Data collected from websites included physical addresses, business type, highest reported staff credential, advertised glucagon-like peptide-1 products, whether businesses referred to Food and Drug Administration approval when describing products, and whether businesses referred to products as 'generic'.

Results: We identified 93 business websites advertising compounded glucagon-like peptide-1 products for weight loss corresponding to 188 physical locations throughout Colorado. Most businesses were self-categorized as medical/health spas (33/93) or weight loss services (26/93). Advertised products included semaglutide (92/93), tirzepatide (40/93), liraglutide (2/93), and retatrutide (1/93). Advertised combination products included B vitamins (8/93), levocarnitine (1/93), mannitol (1/93), BPC-157 (1/93), and glycine (1/93). Seven websites advertised oral formulations. Additionally, 41/93 websites referred to Food and Drug Administration approval in their descriptions of compounded products and 5/93 referred to products as 'generic'.

Conclusion: This study identified several instances of unapproved glucagon-like peptide-1 products being compounded and advertised in Colorado. Additionally, 1 product was advertised as compounded with BPC-157, a substance determined by the Food and Drug Administration to be unsafe for compounding. This study also identified numerous examples of misleading claims regarding the regulatory status of compounded glucagon-like peptide-1 products. Regulatory action is needed to ensure the benefits of compounded GLP-1 products outweigh the risks.

Background: Chronic Kidney Disease (CKD) represents a significant worldwide health challenge, with far-reaching implications for both patients and healthcare systems. This study aimed to identify the incidence of CKD at stages 3-5, analyzed the impact of statin and other antihyperglycemic interventions, on the CKD progression in individuals with T2DM.

Methods: This was a single-center retrospective cohort study based on data derived from electronic medical records (EMR) of UAE populations with diabetes mellitus, registered at outpatient clinics at Tawam Hospital in Al Ain, UAE, between January 2011 and December 2021. T2DM patients aged ≥ 18 years who had serum HbA1c level ≥ 6.5% and using one of the statin therapies were inclusion criteria. Patients with T1DM, who had undergone permanent renal replacement therapy, with under 1 year of follow-up and missing or incomplete data were excluded from the study. The collected data encompassed socio-demographics, detailed medical history, anthropometric measurements, laboratory analyses, clinical parameters, disease characteristics, and medications.

Results: Our study included a cohort of 1,003 individuals. We observed 388 subjects developed CKD stages 3-5 across an average monitoring duration of 11.7 years. This resulted in a cumulative incidence of 38.7%, translating to an incidence rate of 38 cases per 1000 person-years. There was a statistically significant difference in the cumulative incidence of CKD stages 3 ± 5 according to statin therapy (P = 0.047). High intensity statin users are more likely to develop a CKD stage 3-5 compared to low/moderate intensity users and to no statin users respectively (44.3% vs 37.9%), (44.3% vs 30.9%). Conversely, the use of Biguanides was associated with a decreased probability of CKD progression (37.9% vs. 52.8%; P = 0.001), whereas Insulin users demonstrated a heightened risk (54.2% vs. 34.1%; P < 0.001).

Conclusion: The findings emphasise the pivotal role of personalised treatment strategies, particularly concerning statin therapy and other medications, in populations at high risk.

Background: Fluid administration is a critical component of perioperative management for liver transplant recipients, and excessive fluid infusion can lead to acute kidney injury (AKI) and poor patient outcomes.

Method: We conducted a cross-sectional survey on the fluid intake and output of adult liver transplant recipients over a 7-day period. The patients were divided into AKI and non-AKI groups. Multivariate logistic regression analyses were used to evaluate the association between fluid balance (FB) and AKI. A Kaplan-Meier survival analysis was performed to determine the survival of the recipient survival at 180 days.

Results: A total of 210 liver transplant recipients were included. The peak FB occurred on the second day after transplantation, which was higher than on the seventh day (0.3 [IQR, -0.2 to 0.8] L vs. -0.4 [IQR, -1.0 to 0.3] L, p < 0.001). The highest incidence of AKI was observed on the second day after transplantation and the lowest on the seventh day (52.4% vs. 15.4%, p < 0.001). Multivariate analysis showed that a cumulative FB > 1 L within the first 2 days postoperatively was an independent risk factor for AKI on the second day after liver transplantation (LT) (OR = 2.66, 95% CI, 1.31-5.41, p = 0.007). Survival analysis indicated significant differences in 180-day survival rates among patients with different grades of AKI [94.0% (grade 1) vs. 91.4% (grade 2) vs. 77.8% (grade 3), χ ²  = 12.93, p < 0.001].

Conclusion: There is a significant correlation between post-LT AKI and perioperative FB. Cumulative FB > 1 L in the first 2 days postoperatively is an independent risk factor for AKI on the second day after LT. AKI after LT is associated with a lower 180-day survival rate in patients.

Background: Beliefs about medicines, the need for drug therapy and patient willingness can influence medication adherence. The community pharmacist, through his skills as an expert in drug therapy, has the opportunity to promote medication adherence in everyday pharmaceutical practice. This study aims to assess beliefs about medicines and supplements and the need for drug therapy and medication adherence of the patients who visited community pharmacies.

Methods: 809 patient volunteers answered a 14-item online questionnaire using a 5-point Likert scale. Statistical analysis was done in SPSS 27.0.

Results: The validity indices of the questionnaire were acceptable; internal consistency was good; and the factor analysis indicated 3 factors (Eigen values > 1.0). The median scores were 3.33 regarding the beliefs about medicines and supplements; 2.75 regarding the beliefs about the need for therapy; and 2.71 on medication adherence. Beliefs about medicines and supplements, the need for drug therapy, and medication adherence varied according to patients' socio-demographic status, health status, and access to pharmacy services (p ≤ 0.05).

Conclusion: Patients' beliefs about medicines and supplements were moderate, patients' beliefs about the need for drug therapy were negative and patients' medication adherence was good.

Background: Potentially inappropriate medications (PIMs) are associated with adverse outcomes and higher healthcare costs in older adults. Explicit screening criteria like the Beers Criteria, STOPP criteria, and the Malaysian Potentially Inappropriate Prescribing (MALPIP) criteria served to identify PIMs, but comparative data are scarce. Aim: To evaluate the prevalence of PIMs identified by Beers 2019, STOPP version 2 and MALPIP criteria in Malaysian older adults and examine their predictive ability for adverse outcomes and cost-saving potential. Methods: A historical cohort study was conducted among older adults aged ≥ 60 years on five or more medications in four Malaysian tertiary hospitals. PIMs were identified using Beers, STOPP, and MALPIP criteria. Sensitivity, specificity and predictive abilities of these criteria were analysed against clinical outcomes. Monthly cost savings were calculated based on hypothetical deprescribing scenarios. Results: Among 1069 patients, the prevalence of PIMs was 89.1% using MALPIP, 51.3% with Beers, and 37.0% with STOPP criteria. A moderate concordance was seen between Beers and STOPP criteria (κ =  0.437), and the lowest agreement was observed between the STOPP and MALPIP (κ =  0.131). STOPP criteria significantly predicted hospital readmissions (p = 0.003), while Beers and MALPIP did not show significant predictive abilities across all outcomes. The most common PIMs identified were proton pump inhibitors (PPIs) and nonsteroidal anti-inflammatory drugs (NSAIDs). Deprescribing scenarios based on these criteria indicated potential monthly cost savings of MYR 4.83 to MYR 44.84 per patient, with the greatest savings associated with MALPIP criteria. Conclusion: MALPIP demonstrated the highest potential for cost savings, the highest sensitivity but the lowest specificity in PIM detection. Context-specific assessments and clinical judgment are crucial in optimising medication safety and efficacy in geriatric pharmacotherapy. Further research is needed to refine PIM criteria to better predict clinical outcomes and balance the benefits and risks of deprescribing in diverse healthcare settings.

Background: Hospital pharmacy services support quality use of medicines and medication safety through clinical pharmacy activities such as medication reviews and patient education. These activities can be measured and monitored using evidence-based and standardised key performance indicators (KPIs), which highlight the value of pharmacy services. Standardisation of KPIs supports long-term benchmarking and inter- and intra-site comparisons to target key areas for improvement in clinical pharmacy services. Aim: To describe the type and frequency of clinical pharmacy activity across five hospitals within one metropolitan hospital district. Methods: Key Performance Indicator data were collected by pharmacists from five hospital sites at one metropolitan hospital district, in Queensland Australia. Data were collected over one week for the following clinical settings: inpatient, discharge, outpatient clinic, and the dispensary. Data were collected using a manual, paper-based data collection tool previously developed using a co-design process. Results: Across 11,215 inpatient encounters, hospital pharmacy services provided: best possible medication history (BPMH) within 24 h of admission: 69.5%; daily medication chart review: 57.2%; discharge education: 82.7%, discharge reconciliation: 88.2%; and provision of discharge medication record: 82.4%. Across 1,092 outpatient encounters, pharmacists documented BPMH for 33.3% of patients. Pharmacists identified a total of 5,009 drug-related problems (DRPs) across the data collection period, with the rate of identification highest in the outpatient clinic setting (64.8 per 100 patient reviews) followed by discharge (52.6 per 100 patient reviews) and then inpatient (48.1 per 100 patient reviews). Almost 20% of DRPs identified (n = 975) were high risk. Conclusion: Reporting and benchmarking clinical pharmacy activity through standardised KPIs supports opportunities to identify service improvements. Future research should focus on larger scale studies using routinely recorded data to monitor clinical pharmacy KPIs across all care settings.

Background: National pharmaceutical services units (NPSUs) - organisational units within the central government usually responsible for pharmaceutical services and management - have an increasingly narrow mandate. Anecdotal evidence points to an increasing focus, almost exclusively, on logistics management, while pharmaceutical care and policy oversight have become fragmented. This study examined NPSUs' current functions and mandates, and proposed what should be the critical functions and roles of these units going forward.

Methods: Using case studies of Côte d'Ivoire, Kenya and Nepal, the study relied on a literature review and in-depth interviews. We triangulated and synthesised the findings to identify NPSUs by level in the health ministry's hierarchy and reporting line, mandate, and function.

Results: We identified medicine regulation, procurement and supply chain management, selection and rational use of medicines, and pharmacy practice regulation as four broad sets of functions that NPSUs commonly have as their mandate. A clear position in the Ministry of Health's hierarchical structure, the legal or administrative framework that mandates an NPSU's functions, and national pharmaceutical policies and regulations to guide the pharmaceutical sector are three critical factors for effective functioning. It is essential to have a legislative framework that at a minimum identifies one NPSU as responsible for pharmaceutical policy and governance, serving as the steward for the pharmaceutical system. This role encompasses pharmaceutical system coordination and administrative functions, formulating and implementing policies for organising, managing, financing, regulating, monitoring, and evaluating the pharmaceutical system. As such, we recommend that NPSUs should at a minimum have four broad sets of functions: pharmaceutical policy and governance, medicine regulation, pharmacy practice regulation and procurement and supply chain management.

Conclusion: The study substantiates the need for a pharmaceutical policy and governance unit that stewards the pharmaceutical system and is empowered to monitor and evaluate system performance and coordinate efforts for system strengthening.