Introduction. Adverse drug reactions (ADRs) pose significant clinical and economic challenges, affecting healthcare quality and patient outcomes. A comprehensive analysis of these reactions is essential to develop effective management strategies and optimize healthcare resources.
Aims. To evaluate the clinical and economic implications of adverse drug reactions.

Methodology. A prospective, interventional study conducted over a six-month period in the departments of General Surgery, General Medicine, Medical Oncology, and Intensive Care Units. Patients aged 18 years and older who admitted due to an adverse drug reaction (ADR) or experienced an ADR during their hospital stay. Clinical outcomes of ADRs quantified using the Modified Hartwig and Siegel Scale, which assesses severity levels. Economic impacts evaluated through the direct medical costs associated with each ADR and the management strategies utilized.

Results. 218 adverse drug reactions (ADRs) were documented from 144 patients [84 (58.3%) males and 60 (41.6%) females], with an average of 1.5 ADRs per patient. Among 1509 administered medications, 92 elicited ADRs, averaging 2.3 ADRs per medication, predominantly involving antimicrobials [24 (26.1%)] and antineoplastics [19 (20.7%)]. The distribution of ADRs across formulations revealed intravenous solutions as most common [152 (69.7%)], followed by tablets [52 (23.8%)]. ADR severity was categorized as mild [66 (28.4%)], moderate [155 (71.1%)], and severe [1 (0.4%)]. These ADRs resulted in additional medications [133 (61.0%)], prolonged hospital stays [11 (5%)], and ICU admissions [11 (5%)]. Of all ADRs, 117 (54%) were resolved at the time of reporting, with 101 (86%) resolving in under five days and 16 (14%) in over five days. The total cost for managing these ADRs was US$ 6652.61, averaging US$ 30.5 per ADR.
Conclusion. In low- and middle-income countries, the clinical and financial burden of ADRs compromises patient's well-being and trust in Health care process. The early detection and prevention of the ADRs is vital in improving overall patient outcomes.

Introduction: The combination of nirmatrelvir and ritonavir has emerged as a promising antiviral treatment for COVID-19. Despite its approval and widespread use, real-world evidence of its effectiveness based on nationwide datasets remains limited.

Aims: This study aims to evaluate the effectiveness of nirmatrelvir plus ritonavir in preventing ICU admission, ventilatory support, hospitalization, and mortality within 30 days after the confirmed diagnosis of COVID-19.

Methods: This retrospective study examines the effectiveness of nirmatrelvir plus ritonavir in patients confirmed with COVID-19 between January 1, 2022, and December 31, 2022. Data were obtained from the Taiwan National Health Insurance Research Database, linked with the National Death Registry and the National Immunization Information System. Propensity scores were estimated based on age, gender, and risk factors associated with severe COVID-19, including age ≥ 65 years, smoking, obesity, pregnancy, and underlying comorbidities such as asthma, cancer, diabetes mellitus, chronic kidney disease, and cardiovascular disease. Multivariable logistic regression was used to compare clinical outcomes between patients prescribed nirmatrelvir plus ritonavir and those who were not, using cohorts matched through propensity score matching. The logistic models also controlled the vaccination status (none, one dose, and two or more).

Results: After 1:1 propensity score matching, the nirmatrelvir/ritonavir user and non-user groups comprised 824,134 patients each. Logistic regression analysis showed that, after controlling for demographics, vaccination status, and risk factors, patients prescribed nirmatrelvir plus ritonavir had significantly lower risks of hospital admission (OR: 0.707, 95% CI 0.696 -  0.719), ICU admission (OR: 0.349, 95% CI 0.336 - 0.362), invasive ventilatory support (OR: 0.324, 95% CI 0.304 - 0.345), and mortality (OR: 0.311, 95% CI 0.298 - 0.324).
Discussion: This nationwide, population-based study provides robust real-world evidence and hightlights the significant impact of nirmatrelvir plus ritonavir in reducing the risk of adverse clinical outcomes in COVID-19 patients.

Introduction: Potentially inappropriate medications (PIMs) have been associated with adverse outcomes such as increased risk of hospitalisation and mortality in older adults. However, there is currently a lack of national estimates of prevalence of PIMs defined using the latest list of PIMs.

Aim(s): To estimate the prevalence and factors associated with the use of PIMs in older adults living in Australia.

Method: This study utilised data from the Pharmaceutical Benefits Scheme and 2021 Census. PIMs were defined using the 2023 Beers Criteria and the 2024 list of Australian PIMs (AUSPIM). Users of PIMs were defined as having at least one dispensing of PIMs during the three-month study period following 2021 Census (August – October 2021). People aged 65 or above were included in the study. Prevalence was calculated for 5-year age strata. Patient sociodemographic factors were included in a multivariate logistic regression model to explore factors associated with the use of PIMs.

Results: Overall, 3.8 million Australians aged 65 or over in 2021 were included in this study, with a median age of 74 (interquartile range: 69-80) years, and half were female (54%). Overall, 38% and 41% of individuals were using at least one PIM according to the Beers Criteria and AUSPIM, respectively. The prevalence was highest among those aged 90 to 94 years old, with over half of the population using at least one PIM according to the Beers Criteria (50%), and AUSPIM (52%). Older age, requiring assistance with core activities, lower education level and living in a non-private dwelling were associated with increased likelihood of using a PIM.

Conclusion: Over half of older people living in Australia use PIMs, with risk highest in those from certain sociodemographic groups. Healthcare professionals should review the use of PIMs regularly to ensure equitable and quality use of medications.

Introduction: Monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor (anti-CGRP-mAbs) have emerged as promising treatment for migraine prevention. Yet, concerns remain regarding their cardiovascular safety related to blocking CGRP. There has been no comprehensive investigation into the cardiovascular safety of anti-CGRP-mAbs, particularly in high-risk populations such as the elderly and disabled.
Aims: To compare the incidence of cardiovascular diseases (CVD) between Medicare beneficiaries with migraine who initiated anti-CGRP-mAbs versus OnabotulinumtoxinA in the United States.
Methods: In this retrospective sequential cohort study, we examined a 15% national sample of fee-for-service beneficiaries in Medicare claims data from May, 2018 to December, 2020. The study included beneficiaries with migraine initiating anti-CGRP-mAbs or OnabotulinumtoxinA. We excluded those with pre-existing myocardial infarction (MI), stroke, cluster headache, or malignant cancer within the year prior to treatment initiation. To mitigate biases from new drug introductions and COVID-19 pandemic, we divided patients into five cohorts, each covering a sequential six-month period based on the treatment initiation date. We used inverse-probability-of-treatment-weighted Cox proportional hazards models to estimate the adjusted hazard ratio (aHR) of time to the first composite CVD event (MI or stroke). Secondary outcomes included hypertensive crisis, peripheral revascularization, and Raynaud’s phenomenon.
Results: The study identified 5,153 anti-CGRP-mAb initiators (mean±SD age=57.8±14.0 years; female=83.6%; White=82.2%) and 4,000 OnabotulinumtoxinA initiators (age=61.9±13.7 years; female=83.8%; White=83.8%). Covariates were well-balanced between the groups. Anti-CGRP-mAbs were not associated with increased risks of composite CVD events (aHR=0.88, 95%CI=0.44−1.77), hypertensive crisis (aHR=0.46, 95%CI=0.14−1.55), peripheral revascularization (aHR=1.50, 95%CI=0.48−4.73), or Raynaud’s phenomenon (aHR=0.75, 95%CI=0.45−1.24) compared to OnabotulinutoxinA. Subgroup analyses by age group or presence of established CVD (except MI and stroke) yielded consistent results.
Discussion/Conclusion: Despite initial concerns regarding the elevated CVD risk associated with CGRP blockade, our findings suggest no increased CVD risk among anti-CGRP-mAb users compared to OnabotulinumtoxinA users in Medicare beneficiaries with migraine.

Introduction:
China's vast geographical landscape has led to significant regional disparities in economic development and healthcare resource distribution. In economically disadvantaged or remote areas, reduced insulin prices have not effectively increased accessibility due to high transportation costs and limited healthcare services, exacerbating health inequalities between urban and rural regions. Thus, the spatial accessibility of insulin is crucial for achieving healthcare equity.

Aims:
This study aims to assess the spatial accessibility of insulin across approximately 361 cities in China, analyzing travel times and accessibility inequalities. It evaluates how regional variations affect equitable access to insulin.

Methods:
The study utilizes pharmaceutical procurement data from 2017 to 2023, with geographical information on healthcare facilities sourced from Amap. We employed 1×1 km² scale friction maps for driving, obtained from the China National Geomatics Center, which includes detailed road networks and administrative boundaries. The analysis focuses on travel times and utilizes Gini and Theil indices to quantify spatial inequalities in insulin accessibility.

Results:
The implementation of the Volume-based Procurement (VBP) policy in 2021 significantly reduced travel times to healthcare facilities across China, with notable reductions in provinces like Beijing and Jiangsu by over 50%. Concurrently, Gini and Theil indices, indicating inequality in accessibility, substantially decreased. For instance, Shanghai’s Gini index reduced from 0.0177 pre-VBP to 0.0044 post-VBP. However, regions like Qinghai saw increases in travel times, indicating uneven benefits across the country.

Discussion:
The reduction in travel times and inequality indices post-VBP implementation highlights the policy’s effectiveness in enhancing insulin accessibility, particularly in regions with previously high disparities. However, the persistence of accessibility challenges in remote areas like Tibet suggests the need for targeted interventions to bridge remaining gaps. This may include the development of mobile healthcare services and improved transportation infrastructure to ensure comprehensive improvements in insulin accessibility nationwide.

Introduction
Despite evidence from clinical trials, real-world clinical evidence on the effects of PCSK9 inhibitors on LDL-C and cardiovascular events is lacking.
Aims
To investigate the impact of PCSK9 inhibitors compared with other lipid-modifying drugs on LDL-C changes and MACE in patients with ASCVD.
Methods
A retrospective cohort study using electronic health records from The Hong Kong University - Shenzhen Hospital identified ASCVD patients with high LDL-C levels (≥2.6 mmol/L) on PCSK9 inhibitors, statins, or ezetimibe between 2015 and 2023. Using a prevalent new-user cohort design, PCSK9 inhibitor and other lipid-modifying drug users (statin or ezetimibe) were matched 1:2 based on time-conditional propensity scores. Entry into the study cohort was the date of the first PCSK9 inhibitor prescription or the corresponding physician visit for the reference group. Patients were followed for mortality and MACE (composite of cardiovascular mortality, myocardial infarction (MI), stroke, and heart failure (HF) hospitalization). LDL-C levels before and after the entry date were analyzed, and associations between PCSK9 inhibitors and MACE were assessed using adjusted Cox regression analyses.
Results
A total of 1,305 PCSK9 inhibitor users and 65,156 on statin or ezetimibe users were identified. Mean LDL-C levels in the PCSK9 inhibitor users changed from 3.10 (IQR: 2.23 to 3.85) to 1.48 (IQR: 0.79 to 1.95), while in the statin/ezetimibe users, levels changed from 3.26 (2.54 to 3.99) to 2.06 (1.41 to 2.52). 57% of PCSK9 inhibitor users and 32% of statin/ezetimibe users had an LDL-C reduction of 50% or more. Hazard ratios (HR) for the PCSK9 inhibitors users were: MACE, 0.848 (0.406–1.773); MI, 1.200 (0.200–7.188); stroke, 0.341 (0.058–2.012); HF, 0.557 (0.150–2.073); and all-cause mortality, 0.424 (0.078–2.309).
Conclusions
Patients on PCSK9 inhibitors had a greater reduction in LDL-C levels compared to those on statin or ezetimibe therapy. Effects on MACE, MI, stroke, HF, and mortality were nonsignificant.

Introduction: Lyumjev is a new drug formulation for patients with diabetes. Hypoglycemia is one of the major concerns in insulin therapy for patients with diabetes.
Aims: To describe the incidence proportion and rate of the first severe hypoglycemia event requiring any hospital visit, and to estimate the risk of severe hypoglycemia among adult patients with diabetes treated with Lyumjev compared to patients treated with other rapid-acting insulin analogs under routine care in Japan.
Methods: The Medical Data Vision database, a nationwide hospital-based administrative database in Japan from 1 December 2019 through 31 May 2023, was used. A comparative analysis to estimate the risk of hypoglycemia among adult patients diagnosed with diabetes who were newly treated with Lyumjev (Lyumjev cohort) or with rapid-acting insulin analogs other than Lyumjev (comparator cohort) was performed using propensity score matching method (1:5) to control for potential baseline confounding.
Results: There were 10 592 patients in Lyumjev cohort and 52 917 patients in comparator cohort after propensity score matching. The total duration of follow-up period was 2 613.8 person-years and 15 565.7 person-years for the Lyumjev cohort and the comparator cohort, respectively.The incidence proportion and rate of the first severe hypoglycemia in the matched cohort (comparative analysis) were 0.32% (95% confidence interval [CI]: 0.23, 0.45) and 1.3 per 100 person-years (95% CI: 0.2, 7.9) for the Lyumjev cohort and 0.45% (95% CI: 0.40, 0.51) and 1.5 per 100 person-years (95% CI: 0.8, 2.9) for the comparator cohort. The hazard ratio was 0.76 (95% CI: 0.53, 1.09; p-value: 0.1324).
Discussion: There was no statistically significant increased incidence or risk of severe hypoglycemia with Lyumjev compared to other rapid-acting insulin analogs among adult patients who are naive to rapid-acting insulin analogs and initiating treatment. This study did not impact the benefit-risk balance of Lyumjev.

Introduction: Pharmacoepidemiological studies provide valuable insights into real-world usage of medications. However, in the case of rare diseases, limited disease prevalence, insufficient data collection and assessment challenges, and varying disease classifications make drug utilization studies challenging. Proper collection and analysis of pharmacoepidemiological data can provide important insights into treatment patterns, drug safety, and effectiveness in countries like India with a substantial burden of rare diseases.

Aims: This review assesses the current landscape of orphan drug utilization studies in India. It aims to identify gaps, challenges, and opportunities in using pharmacoepidemiology to advance rare disease research for improving healthcare and reducing treatment costs.

Methods: A review of relevant literature, encompassing scientific publications, regulatory data, and policy documents was undertaken for this study. The search of the relevant literature focussed on works related to pharmacoepidemiological studies of orphan drugs, current challenges in conducting these studies, and opportunities in improving the design and conduct of these studies especially in the Indian context.

Results: The Central Drug Standards Control Organization (CDSCO) has approved 218 orphan drugs in India between 2000 and 2022. However, there is a lack of extensive pharmacoepidemiological studies focused on drug utilization. The National Registry for Rare and Other Inherited Disorders (NRROID) by the Indian Council of Medical Research has collected 12,790 records, but information usage is largely unknown. Challenges include limited data availability, infrastructure, expertise, and underreporting.

Discussion: Pharmacoepidemiology has immense potential in rare disease research in India by providing insights about drug utilization, predicting drug safety during development, drug repurposing, evaluating drug safety and effectiveness, identifying drug targets, and assessing economic burden of healthcare system. Solutions include leveraging national disease registries, electronic health records and claims databases and fostering collaboration between researchers, clinicians, and policymakers to support research and improve treatment availability.

Keyword: Rare Disease, Orphan Drugs, Pharmacoepidemiology, India

Introduction: Dipeptidyl peptidase-4(DPP-4) inhibitors are widely prescribed for managing type 2 diabetes mellitus (T2DM) despite safety concerns. However, studies on the prevalence and the factors contributing to these adverse drug reactions with DPP-4 inhibitors in South India are scarce.
Aim: This study assessed the prevalence and predictors of adverse events(AEs) associated with DPP-4 inhibitors in T2DM patients.
Methods: This retrospective cross-sectional study analysed data from medical records of T2DM patients on DPP-4 inhibitors admitted to the medicine department in a South Indian tertiary care hospital from 2019 to 2021. The causality of AEs was assessed using the Naranjo algorithm and WHO-UMC criteria, and severity using the modified Hartwig and Seigel scale. We applied a Generalized Linear Model with a binary response and logit-link function to understand the parameters that best explain the AE. The best-fit models were selected based on the lowest Akaike's Information Criterion and highest Pseudo R2 and presented the odds ratio(OR) with a 95% confidence interval. All the analyses were performed in R software version 4.2.1.
Results: Among the 796 patients included, AEs were observed among 26% of the study population. A total of 212AEs were observed, with saxagliptin-associated AEs being the most prevalent(66.6%). Hepatic AEs(37.7%) were predominant, followed by gastrointestinal events(16.5%) and electrolyte imbalance(12.3%). Most AEs were possible based on WHO-UMC criteria(78.7%) and the Naranjo scale(86.7%), with 58% being moderate severity and 42% mild. In the multivariate analysis, aspartate transaminase[OR:1.013(0.006-0.020)], alkaline phosphatase[OR: 1.004(0.001-0.007)], and patients already on DPP-4 inhibitor[OR 0.191(-2.126 - -1.215)] were significant predictors for AEs with DPP-4 inhibitors.
Conclusion: The study identified a high prevalence of AEs associated with DPP-4 inhibitors and highlighted significant factors contributing to these events. These findings underscore the necessity of vigilant monitoring and risk assessment while using DPP-4 inhibitors in the Indian population.
Keywords: adverse event, DPP-4 inhibitor, predictor

Introduction:

The COVID-19 pandemic has posed unprecedented challenges to global healthcare systems, with vulnerable populations such as patients with Chronic Lymphocytic Leukemia (CLL) experiencing heightened risks of infectious complications.
Aims:

To investigate the impact of the COVID-19 pandemic on the incidence of infectious events among patients with CLL in China.
Methods:

A retrospective cohort study was conducted using patient data from multiple healthcare centers across China. The study analyzed data on CLL patients during the COVID-19 pandemic (2020-2022) and a comparable pre-pandemic period (2017-2019). The primary outcome assessed was the incidence of infectious events (fungal, bacterial, and viral infections), including respiratory infections and COVID-19-related complications.
Results:

The study included 3,635 patients who had a confirmed diagnosis and met the specified inclusion/exclusion criteria (total follow-up time: 9,258 person-years), with 2,691 patients (6,032.5 person-years) before the COVID-19 pandemic and 1,937 patients (3,225.5 person-years) during the pandemic. Throughout the follow-up period, 1,026 (28.2%) patients experienced at least one infection event, resulting in a total of 4,900 infection events among CLL patients, with an incidence rate of 52.9 per 100 person-years. The most common types of infection were viral (incidence: 4.8%, incidence rate per 100 person-years: 5.0), respiratory (19.6%, 16.3), pneumonia (11.4%, 8.4), and gastrointestinal (5.1%, 5.3). Compared to the pre-pandemic period, the incidence rates of all infection events except for viral infections (pre-pandemic: 2.7%, 4.9 vs. pandemic: 4.5%, 5.1) decreased. This decrease was observed in bacterial infection (2.3%, 1.9 vs. 1.9%, 1.5), fungal infection (2.9%, 2.2 vs. 1.8%, 1.7), and respiratory infection (21.0%, 18.9 vs. 7.6%, 11.5).
Discussion:

The study highlights the need for enhanced infectious disease prevention strategies, including vaccination and infection control measures, for CLL patients during pandemic conditions.

Introduction: Chronic heart failure (HF) represents a spectrum of disease states, including periods of stability or worsening. Worsening chronic heart failure (WCHF) occurs when patients with HF experience deterioration marked by hospital readmissions, emergency department visits, or heightened treatment needs.
Aims: The study aimed to characterize the epidemiology, clinical features, and outcomes of Asian patients with WCHF, and to explore the heterogeneity within this group in terms of demographics, clinical parameters, and management.
Methods: From January 1, 2005 to September 30, 2022, adult patients with HF were included in the WCHF cohort due to HF-related hospital readmission, emergency department (ED) visits, or intravenous diuretic treatment at the outpatient department beyond a 90-day interval following index HF event. Baseline data including demographics, comorbidities, and medication were compared between WCHF and non-WCHF patients. Outcomes assessed included all-cause mortality, HF readmission, and acute care encounters.
Results: Among 12,637 HF patients, 2,326 were categorized into WCHF group. Patients with WCHF were older (77.7 vs. 74.8, P<0.001), with lower body mass index (23.2 vs. 23.6, P=0.003), and reduced left ventricular ejection fraction (57.4% vs. 58.9%, P<0.001). During a median follow-up of 1.5 years, WCHF patients had higher risks of all-cause death or HF readmission (adjusted hazard ratio [aHR], 4.64; 95% CI 4.29-5.02; P<0.001), first HF acute care encounter (aHR, 9.57; 95% CI 8.72-10.51; P<0.001) and first all-cause readmission (aHR, 2.14; 95% CI 2.03-2.26; P<0.001) compared to patients without WCHF. Among HF patients with reduced ejection fraction (HFrEF), WCHF subjects were more likely to received more guideline-directed medical therapy (GDMT) (75.8% vs. 47.6%, P<0.001).
Discussion: This population-based cohort study conducted in Asian patients demonstrated that patients with WCHF exhibited poorer prognosis and higher healthcare resource utilization. But there was a discernible deficit in the utilization of GDMT among all HFrEF patients.

Introduction: Medical devices play a vital role in patient care, yet they carry inherent risks, underscoring the importance of materiovigilance in monitoring and preventing Medical Device Adverse Events (MDAEs). The occurrence of these reported events underscores the necessity for a regulated system to supervise medical device surveillance.
Aims: This study primarily aims to develop a Knowledge, Attitude and Practice (KAP) questionnaire and to assess the effectiveness of an awareness/sensitization program about medical devices among the community pharmacists.
Methods: A structured, self-administered questionnaire, derived from previous studies, was developed and validated consisting of 30 questions. The questionnaire was distributed to the community pharmacists, and their responses were collected. The normality of the data was assessed using the Kolmogorov–Smirnov test and Wilcoxon Signed Ranks test was utilized to compare pre- and post-scores of the participants.
Results: Out of 170 individuals surveyed, 150 responses were received, meeting the required sample size. Prior to the sensitization efforts, 96% of participants were unfamiliar with materiovigilance. The Kolmogorov-Smirnov test result for Knowledge, Attitude, Practice (pre-total) yielded a statistic of 0.444, 0.411 and 0.390 with 150 degrees of freedom and a significance level of 0.000 and post result are Knowledge, Attitude, Practice (post-total) yielded a statistic of 0.188, 0.354 and 0.233 with 150 degrees of freedom and a significance level of 0.000. Wilcoxon signed ranks test was conducted, revealing a statistically significant result with a p-value of <0.05.
Discussion: These changes underscore the effectiveness of educational initiatives in improving KAP related to medical device safety monitoring. By tracking changes in KAP over time, adjustments can be made to sensitization programs to ensure continuous improvement and relevance. By identifying areas of weakness or misunderstanding, interventions can be designed to address specific knowledge gaps, reshape attitudes, and promote best practices among community pharmacists.

Introduction: Real-world evidence (RWE) on drug effectiveness, i.e., understanding how drugs perform in actual clinical practice, is crucial. However, the specific methods applied in pharmacoepidemiological drug effectiveness studies, and whether these methods depend on the drug investigated, remain unclear.
Aims: This scoping review aims to collect pharmacoepidemiological studies evaluating drug effectiveness using real-world data (RWD) and to categorize them based on (i) the methods applied and (ii) the drugs and outcomes investigated.
Methods: We searched PubMed and Embase for studies published in English language in the six-month period from July 2019 to December 2019. Studies with the following characteristics were eligible for inclusion: (i) RWD-based studies investigating the exposure of one or more drugs in humans, and (ii) studies including at least one primary outcome that can be classified as an effectiveness outcome.
Results: Of 4,820 identified records, 1,129 continued from title-abstract screening. Of these, 200 were randomly selected for full text assessment, and 90 were finally included. The 90 studies used RWD from the US (n=45), European countries (n=22), Asian countries (n=14), other countries (n=5), and multiple countries (n=4). Across the studies, chemotherapy was the dominating drug exposure (n=32), and all-cause mortality/survival was the most frequent outcome of investigation (n=53). Looking at applied methods, cox regression (n=46), Kaplan-Meyer analysis (n=42), and logistic regression (n=15) were the most frequent statistical models. Moreover, 13 studies applied descriptive statistics only. To counter confounding, adjustment by multivariable models (n=55), stratification (n=38), and propensity score matching (n=23) were the dominating methods.
Discussion: Our findings indicate that pharmacoepidemiologists reach towards well-known methods in RWD-based drug effectiveness studies. To comply with the increasing need for high-quality RWE of drug effectiveness, we believe that a continued focus on suitable data sources, methods, and scientific reporting in such studies is needed.

Introduction
Duchenne muscular dystrophy (DMD) is a rare hereditary muscle disorder with poor prognosis and quality of life. However, the nation-wide real-world data on DMD is lack in Taiwan.

Aims
The study aimed to investigate the characteristics, treatment patterns and the healthcare resource utilization (HCRU) of patients with DMD in Taiwan.

Materials and Methods
The Taiwan National Health Insurance Research Database with a data period of 2012 to 2021 was used in this population-based cohort study. Patients with initial catastrophic illness certificate (CIC) of DMD during 2013 to 2020 were identified, and the date of CIC issued was defined as the index date. Patients were followed-up for systemic steroid use, ventilator initiation, mortality and HCRU until death or end of the data period (December 2021), which ever came first.

Results
A total of 134 newly-diagnosed DMD patients were included in the study cohort. Sixty-eight patients (50.7%) were diagnosed during 2012-2015 with a median age at index date of 7 years; while 65 (49.3%) were diagnosed during 2016-2020 (median age at index date: 5 years). With a mean follow-up period of 4.4 years, 70 (52.2%) patients received systemic steroid treatment and 19 (14.2%) patients received ventilator. The median age of initiating systemic steroid and ventilator support was 6 years and 20 years, respectively. During the follow-up period, there were 159 DMD-related hospitalization events, and the mean length of stay was 6.7 (SD: 7.9) days per event. A total of 11 death events were captured, and the average age of death was 22.6 (standard deviation [SD]: 4.6) years.

Discussion
In consistent with the epidemiology studies from other Asian countries, most of the DMD patients were diagnosed before 10 years. The current study implies the increased awareness of DMD in Taiwan in recent years and highlights the potential disease burden of DMD.

Introduction: Tardive dyskinesia (TD) is a movement disorder induced by dopamine receptor antagonist medications. Valbenazine represents a novel, highly selective vesicular monoamine transporter 2 inhibitor approved by the US FDA for the treatment of TD.
Aims: This study integrated safety data on valbenazine in TD from randomized controlled trials (RCTs) and the FDA Adverse Event Monitoring System.
Methods: We systematically reviewed RCTs reporting adverse events (AEs) of valbenazine in patients with TD applying search on databases like PubMed, EMBASE, and ClinicalTrial.gov. The quality assessment was done using the Cochrane Risk of Bias Tool. We utilized a random effect meta-analysis to calculate Peto odds ratio (OR) with 95% confidence intervals (CI). The Open Vigil 2.1 MedDRAv24 was used to search the FAERS database, with data available until September 2023.The disproportionality was calculated using the proportional reporting ratio (PRR) and the reporting odds ratio (ROR). Signal refinement was conducted by restricting the drug roles to ‘primary suspect’.
Results: For the safety meta-analysis, nine RCTs with available AEs were examined. A total of 240 AEs were found associated with the valbenazine group and 96 AEs with placebo. Valbenazine significantly increased the risk of somnolence (OR=3.42, 95% CI: 1.97-5.92, p: <0.0001) compared with the placebo. In FAERS, 1,443 patients were reported with AEs associated with valbenazine. Significant signal scores were observed in nervous system disorders, psychiatric disorders, musculoskeletal and connective tissue disorders and general disorders and administration site conditions. Few generated signals, failed to meet the signal criteria upon refinement.
Discussion/Conclusion: Despite an expanding amount of information on the novel valbenazine, there is relatively limited evidence defining the comprehensive safety profile of this medication. The current study has updated and refined the safety profile of valbenazine during its post-marketing phase, thereby aiding in the assessment and mitigation of risks to optimize patient healthcare outcomes.

Introduction: Although treatment strategies for myasthenia gravis (MG) have changed significantly in recent years, the real-world situation is not well understood.
Aims: To summarize treatment patterns focusing on dose of oral corticosteroids (OCS) over time in an observational study, using three database-derived cohorts: JMDC claims database covering the Social Health Insurances (JMDC) between 2005-2021; DeSC database covering the National Health Insurance (NHI) between 2014-2021; and DeSC database covering the Late-stage Elderly Medical Service System (LSE) between 2014-2021.
Methods: A cohort of patients with a record of MG (ICD-10 code: G70.0), starting immunotherapy at ≥16 years of age, with a serological test and having at least 180 days of MG-free baseline period was derived. Achievement of ≤5mg/day OCS was defined if at least 90 days of consecutive ≤5mg/day OCS were observed during the follow-up, without any gap longer than 60 days between two consecutive claims. The time to achieve ≤5mg/day OCS was estimated using Kaplan-Meier survival analysis.
Results: In total, 811 patients were included. Mean ages were 49 years for JMDC, 61 years in NHI, and 80 years in LSE. In JMDC, the median time to achieving ≤5mg/day OCS was significantly shorter (p = 0.042; log rank test) in patients included in 2015 or later (11.0 months) than in those included before 2015 (17.9 months). Among the three cohorts, median time to ≤5mg/day OCS was shorter in LSE (6.5 months) than JMDC (11.0 months) and NHI (11.7 months).
Discussion: Faster tapering of the OCS dose was observed in patients starting treatment after the publication of the 2014 Japanese clinical guidelines for MG, compared with patients starting treatment prior to this. The more cautious use of OCS in elderly MG patients in LSE may reflect awareness and perceptions of tolerability and side effects in the elderly.

Introduction: Subacute myelo-optico-neuropathy (SMON) is a neurological disorder associated with the administration of clioquinol. Although clioquinol has been used worldwide, there was an outbreak of SMON in the 1950s–1970s in which the majority of cases were in Japan, prompting speculation that the unique genetic background of the Japanese population may have contributed to the development of SMON. We compared the frequency of loss-of-function polymorphisms in ABCC4, ABCC11, SOD1, and NQO1, which we expected to be associated with development of SMON, between patients with SMON and healthy controls.
Aims: To elucidate the genetic background involved in the development of SMON.
Methods: We analyzed 125 Japanese patients with SMON. ABCC4 rs3765534 polymorphism, ABCC11 rs17822931 polymorphism, SOD1 loss-of-function polymorphisms (rs2070424, rs4998557 and rs4816405) and NQO1 loss-of-function polymorphisms (rs1800566, rs10517, rs689452, and rs689456) were evaluated. The allele frequency distribution of each polymorphism was compared between the patients and the healthy Japanese individuals (Human Genomic Variation Database and Integrative Japanese Genome Variation Database) as well as our in-house healthy controls.
Results: The frequencies of loss-of-function polymorphisms in ABCC4, ABCC11, SOD1, and NQO1, alleles in patients with SMON did not differ significantly from those in the normal control group.
Conclusion: The genetic background associated with development of SMON has not yet been identified. At the moment, we consider that drug-induced factors may be more likely to contribute to the development of SMON than the genetic factors. We plan to expand the target genes of our analysis in the future.

Introduction: Dose-response meta-analysis has been gaining prominence in pharmacoepidemiology and health technology assessments as a method to synthesize evidence of dose-response relationships from multiple studies.
Aims: In practice of dose-response meta-analysis, “outlying” studies possibly lead to serious biases and yield misleading results. Also, there might be influential studies that have notable impacts on the overall evidence. In this study, we propose new methods of outlier detection and influence diagnostics for dose-response meta-analysis.
Methods: We developed 3 new methods, and applied them to a dose-response meta-analysis that assessed the efficacy of selective serotonin reuptake inhibitors for treatment of major depression. These methods involve leave-one-out-type influential analyses based on (1) study-level studentized residual, (2) arm-level studentized residual, and (3) generalized variance ratio statistic for the grand mean parameters of pooling model. We also developed quantification methods for statistical errors of these influential statistic using bootstrap.
Results: Through the influential analyses, a clinical study assessing the efficacy of fluoxetine was detected as a potential outlier among the 17 studies involved in the dose-response meta-analysis. The study was a phase 3 study in Japanese adults with major depressive disorder, and the efficacy of fluoxetine was not clearly demonstrated in this study. Fluoxetine has not been approved in Japan. The other studies generally showed the efficacy, and fluoxetine has been approved in US and registered in WHO Model List of Essential Medicines. Thus, the Japanese study could be detected as an outlier and this study was also shown to be influential to the overall results of the dose-response meta-analysis.
Discussion: Our new methods can provide effective statistical outcomes to circumvent erroneous evidence. These methods would also provide new insights in evidence from dose-response meta-analysis as the antidepressant study.

Introduction: Logistic regression has been widely used for cohort studies with binary outcomes in pharmacoepidemiology. However, when the event frequency is not low (>10%), the odds ratios fail to approximate risk ratios, and risk ratios and risk differences are preferred epidemiologic effect measures because of their straightforward interpretations. The modified Poisson and least-squares regressions have been alternative standard methods to estimate these measures with adjusting potential confounding factors.
Aims: We develop the lasso estimation for these effective regression analyses, an efficient shrinkage machine learning method that enables variable selection simultaneously.
Methods: We developed the lasso-type shrinkage and variable selection methods for the modified Poisson and modified least-squares regressions, and applied these methods to a retrospective cohort study that investigated the effects of donor killer immunoglobulin-like receptors genotype on the reactivation of cytomegalovirus after a hematopoietic stem cell transplantation. The new methods can provide effective risk ratio and risk difference estimates under small and sparse data settings. We also provide a bootstrap method to calculate the confidence intervals of the effect measures. In addition, we developed a new R package, regconfint, to implement these methods with simple commands.
Results: Through application to the hematopoietic stem cell transplantation cohort study, we showed that the lasso-type shrinkage methods could provide stable shrinkage estimates and narrower confidence intervals generally, even under the small and sparse data settings. We also showed that the lasso estimation enables effective variable selection for the risk ratio and risk difference regression models.
Conclusion: The ordinary modified Poisson and modified least-squares regressions have limitations for the accuracy of estimation in the effect measures under ill conditions, but the lasso-type estimation possibly overcomes these difficulties. The new methods also enable effective variable selections for these multivariate analysis models.

Introduction: In observational studies estimating the association between treatment and time-to-event outcomes, time-related biases can significantly impact results. Immortal time bias is one of the such biases, and two types are known: misclassified immortal time bias and excluded immortal time bias (Suissa 2007). Misclassified immortal time bias is caused by misclassifying the period between the time of cohort entry and the treatment initiation as a treatment group, and excluded immortal time bias is caused by excluding the period between the time of cohort entry and the treatment initiation from the analysis. These biases often arise when we inadequately set the start of follow-up (time zero), especially when non-users are used as the control group.

Aims: This study aims to illustrate time-related bias when non-users are used as the control, using both mathematical formulas and simulated data.

Methods: For simplicity, our formulation is based on the situation that there is no confounding and no treatment effect. We compare three different settings of time zero for treatment and control groups: (1) cohort entry date (CED) vs CED, (2) treatment initiation date (TID) vs CED, and (3) TID vs matched, where time zero for the non-user control is defined as the corresponding date from CED to TID of their matched treatment patient.

Results: Our simulation shows that both methods (1) and (2) exhibit large apparent preventive effects of the treatment due to immortal time bias. The magnitude of the bias is greater for the method (1) (misclassified immortal time bias) than for the method (2) (excluded immortal time bias). Conversely, method (3) shows no bias.

Discussion/Conclusion: To minimize time-related biases, researchers should use an appropriate time zero, especially when using a non-user control group.

Keywords: excluded immortal time bias, misclassified immortal time bias, time zero

Introduction:Distributed learning in multicenter studies addresses the issue of small sample sizes inherent in single-center research, while ensuring data privacy. This approach enhances the representativeness and generalizability of results and is particularly suitable for studies involving rare events.
Aims:Evaluate the status and methodology of distributed learning in the medical field to provide references for multicenter medical research.
Methods:A systematic search was conducted in PubMed, Scopus, etc., using the keywords "EHR/EMR/Claim" AND "distributed/federated learning." Studies on distributed learning in effect estimation were included.
Results: A total of 31 studies were included, covering 25 iterative methods and 49 specific applications. The majority were published in or after 2019(27/31), mainly from the United States(23/31). The most common regression model used was logistic regression(16/31), followed by Cox regression(9/31), Poisson regression(3/31), and GLMM(3/31). (1)In iterative methods, the principles mainly include constructing surrogate likelihood functions(13/25) and iterative communication(7/25). 40%(10/25) used single-round communication, 12%(3/25) used 2-3 rounds, and 48%(12/25) required multiple iterations. Additionally, 56%(14/25) addressed data heterogeneity, and 32%(8/25) dealt with rare outcomes. Methods were evaluated using estimation bias and MSE, with centralized analysis as the gold standard. (2)Among the 49 applications, the most common scenario involved using artificially partitioned datasets (26/49). Research focused on COVID-19 patients(9/49) and cancer patients(9/49), with adverse drug reactions being a significant research theme(11/49). Distributed algorithms showed less estimation bias than meta-analysis, particularly in cases of high data heterogeneity or rare outcomes. CDM(7/49) or FAIR principles(3/49) are now mainstream for data standardization, but missing data is still predominantly handled by deletion(9/11). Most algorithms provided open-source code, with varying usability.
Conclusion:Distributed computing has been applied to various models for epidemiological effect estimation, demonstrating wide applications in the medical field. Recent efforts have focused on handling data heterogeneity and addressing rare outcomes. However, improvements in code usability and missing data handling are still needed.

Introduction: Clinical trial in Vaccine have been historically some difficulties on clinical trials, with data on the effectiveness and safety relying on observational research. Methodological concerns regarding the data sources, study designs, and outcomes used for estimating associations are still problematic in observational studies. Answering on causal inference is still more complex. Despite the increased interest in emulating target trials using observational data, little is known about this approach in vaccine.

Aims: This review aims to describe the methodology for assessing the available literature concerning emulating target trials for studying outcomes in vaccine.

Methods: We performed a systematic review. The literature search was conducted using MEDLINE, EMBASE, the Cochrane databases, and reference lists from previous related reviews. We summarized characteristics of these eligible studies. We used existing statements to identify quality gaps in the current literature. Variables related to the content for pharmacoepidemiologic research was included. The Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) guided the assessment of the target trial emulation.

Results: Our review of identified 46 studies reveals several unique considerations when leveraging target trial emulation for vaccine research. These challenges include aligning clinically relevant outcomes with the research questions, identifying etiologically relevant time windows, defining relevant treatment strategies, and fixing exposure, eligibility criteria, and follow-up initiation. Despite these challenges, the methodology is promising in that it bridges the gap between randomized clinical trials and observational studies by adopting a transparent and clearly defined approach.

Discussion/Conclusion: Data regarding the safety and effectiveness taken, prior to and during exposure and it was necessary to understand how we could answer these questions using rigorous methods in observational research. Through this scoping review, we intended to understand to what extent the target trial approach was used in vaccination and provide recommendations to improve its use in this field.

Introduction: Medication adherence is a common problem among type 2 diabetes (T2D) patients worldwide, including low- and middle-income countries. A recent study showed that a tailored pharmacist-led intervention improved medication adherence among T2D patients in Indonesia. Identifying the opportunities and challenges in practice is useful to increase the chance of interventions being successfully adopted widely in clinical practice.
Aims: To explore the context and perspectives for implementing a tailored pharmacist-led intervention to improve medication adherence to glucose-lowering medication among people with T2D in Indonesia.
Methods: Semi‑structured interviews were performed among community pharmacists (CPs) and T2D patients focusing on the context of medication adherence and perspectives regarding a proposed intervention. All interviews were audio recorded, transcribed verbatim, and coded independently by two researchers using directed content analysis guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
Results: Sixteen CPs and thirteen T2D patients were interviewed. Medication adherence was recognized as a problem by patients, which CPs could address. Most CPs and patients were positive about the proposed intervention. Applying the RE-AIM framework showed factors relevant for implementation of the intervention, from both the CP and the patient perspectives. For most domains, challenges were seen at the setting level, including insufficient management support and resources. At staff level, training of pharmacists was relevant, particularly to better counsel and motivate patients in taking their medication. At patient level, challenges were seen to support older adults having poor self-efficacy and for patients not having time for counseling by the CP.
Discussion: The proposed pharmacist-led intervention was considered relevant in the current healthcare context but several factors need to be addressed when planning further implementation of the intervention in Indonesia.
In further research,stakeholders at the macro level need to be involved to investigate how to address perceived barriers for implementation of the intervention.

Introduction:

The Saudi Food and Drug Authority (SFDA) conducted a project to improve the current Additional Risk Minimization Measures (aRMMs). To the end of 2023, the SFDA has approved 303 aRMMs. Therefore, gathering the perceptions of patients on aRMMs is very important to improve the implementation of aRMMs. Their feedback is utilized to enhance the safety of medicinal products and to improve the recognized gaps in the current aRMMs.

Aims:
To obtain patients’ feedback about three aRMMs, semaglutide, ranibizumab and mycophenolate in regards to design and content.


Methods:
A focus group discussion was conducted targeted patients who received patient guide of targeted medicines. These focus groups were conducted in collaboration with regional pharmacovigilance offices allocated in different hospital in Saudi Arabia. The questions were carefully designed to collect data on the effectiveness, clarity, design and content of the current aRMMs. Three medicines were selected based on specific criteria, which is Seriousness of risk and the number of Generic products marketed in Saudi Arabia. Descriptive statistics were performed to represent demographic characteristics and patients’ opinions using Microsoft Excel program

Discussion:

A total of 60 patients participated in three focus group discussion conducted in three hospitals. The majority around 90% found that the Patient Guide is excellent, appropriate, and agreed that its appearance was clear and all instructions are understandable. Also, the information provided can be followed easily. In addition, number of participants agreed that excess information is provided and briefing of information is preferable. However, 10% of participants stated that the medical terms were not clear. Also, more than 90% of participants agreed that the reporting of adverse drug reactions is clear and stated that the illustrations, size, font, and color were excellent, however, 7% of the participants stated that the font is small and reporting ADRs was not clear.

Introduction: Social media use was increasing, with 40% of university students found to be addicted, negatively affecting their health. A social media detox could reduce addiction.
Aim: This study compared the impact of social media detoxification between experimental and control groups, assessing SMAT scores and weekly social media usage among undergraduate pharmacy students before and after the intervention.
Method: Undergraduate pharmacy students were randomly assigned to experimental and control groups. The experimental group reduced screen time on mobile phones and tablets by 50%, while the control group continued normal usage. Both groups completed the SMAT questionnaire (0 = definitely not true to 3 = definitely true) before and after the 4-week intervention and recorded weekly social media usage. Data collection was from December 2023 to February 2024.
Results: Of 23 students, 12 were in the experimental group and 11 in the control group. Initial SMAT scores were similar (38.0±6.7 vs. 36.0±8.5; p=0.536). After 4 weeks, the study found a significant difference in the mean difference of SMAT scores between the experimental and control groups (16.8±4.9 vs. 8.5±7.3; p=0.004). Weekly social media usage decreased substantially more in the experimental group (2905.6±1608.8 to 1059.3±1591.9; p=0.012). Both groups showed significant decreases in SMAT scores pre- and post-study (experimental: 38.0±6.7 to 21.2±7.1, p<0.001; control: 36.0±8.5 to 27.4±10.1, p=0.003). Weekly social media usage decreased significantly in the experimental group (4208.8±1651.8 to 1303.2±702.5; p<0.001).
Discussion: Limiting screen time on mobile phones and tablets for social media detoxification significantly lowered SMAT scores and weekly social media usage compared to normal usage.

Background and objectives: We have constituted a National Task Force (NTF) in 2022 to explore possible solutions that could improve safe and rational use of medicines (SRUM). The objective was to identify research ideas in the field of SRUM through a survey of relevant stakeholders (Indian and International), and further to prioritize the research ideas using a pre-identified set of criteria.
Methods: This exercise was carried out using the CHNRI method which is an established research priority setting methodology. The NTF gathered research ideas from relevant Indian and global stakeholders. The ideas were checked for duplicates, re-phrased where necessary and classified into various sub-themes. Subsequently the research ideas were scored by Indian experts with relevant technical expertise.
Results and Interpretation: The final output of the prioritization process was a list of research ideas or questions, ranked by their scores. We received 852 ideas related to SRUM. After excluding ideas which were duplicate or unclassifiable, there were 209 ideas. 55 ideas were identified as priority by Indian researchers, which included ideas on rational use of antimicrobials, optimizing polypharmacy in elderly and measures to reduce environmental burden of pharmaceuticals.
Conclusion: The findings of the research priority setting exercise will help to improve SRUM in India. We will now work with partners in India to translate the prioritized research ideas into research questions, develop and test solutions that can be adopted by health systems in India. The NTF will identify policy, technological, or educational interventions that can improve SRUM.
Keywords: CHNRI, Safe and Rational Use of Medicines (SRUM), LMIC (Low-middle income countries), research priority setting exercise.

Introduction: Real-World Evidence (RWE) stands as a pivotal factor in augmenting regulatory decision-making within the healthcare sphere. This study scrutinizes the present landscape and future trajectories of RWE integration within the regulatory frameworks of the United States (US) and the European Union (EU).
Methods: A comparative analysis was conducted, delving into regulatory documents, guidelines, and pertinent literature sourced from the USFDA and the EMA. The review honed in on data infrastructure, methodological prowess, capacity-building endeavors, and the possible opportunities and challenges in integrating RWE.
Results: The US and EU have comprehensive initiatives integrating RWE, supported by extensive data infrastructure including Electronic Health Records (EHRs), registries, and claims databases. Sophisticated resources in pharmacoepidemiology and data science bolster these efforts. The EU actively broadens data accessibility through European Health Data Space (EHDS), addressing challenges of data quality, standardization, privacy, and interoperability.
Discussion: Prospective avenues for RWE integration encompass the development of robust methodologies and analytical tools, substantial investment in capacity building, and the assurance of transparency and active patient participation. Challenges encompass tackling causality and biases, fostering collaborative endeavors to establish best practices, building trust, and aligning stakeholder expectations.
Conclusion: The US and EU stand at the forefront of RWE integration, harnessing robust data infrastructure and proficiency in methodology. The effective assimilation of RWE necessitates concerted efforts aimed at addressing data accessibility, methodological advancements, capacity building, and stakeholder engagement. Collaborative ventures will underpin the global development and regulation of safe and efficacious healthcare products.

Introduction: Nowadays, there are more options for cancer treatment. Besides traditional chemotherapy, targeted therapy with monoclonal antibodies or orally administered small molecular drugs, as well as immunotherapy, have become the newest trends in cancer treatment.

Aims: With different types of side effects and self-care precautions, being educated by pharmacists may improve the understanding of drug-related problems.

Methods: We conducted a retrospective analysis of a questionnaire administered to patients undergoing their initial course of cancer treatment, which encompassed chemotherapy, targeted therapy, and immunotherapy. The questionnaire comprised 13 inquiries concerning fundamental self-care practices and the management of side effects. Additionally, we assessed medication adherence using the Morisky score. Data collection spanned from 2021 to April 2024.

Results: 608 patients were enrolled in this study. The predominant cancer types among these patients were breast cancer (62.1%), followed by gastric cancer (14.7%), head and neck cancer (8.5%), hepatic cancer (6.3%), and pancreatic cancer (4.4%). The remaining 4% consisted of urothelial cancer, blood cancer, and other types. The mean pre-test score prior to pharmacist education was 73.4. Following pharmacist intervention, the mean post-test score significantly increased to 94.3. While the majority of patients demonstrated good compliance, 21 patients exhibited poor medication adherence. Additional educational interventions will be provided for these individuals.

Discussion: Though cancer patients often receive education from doctors or nurses, the inclusion of pharmacists in the educational process can significantly enhance understanding of basic self-care and side effects management.

Introduction: Deprescribing is an essential practice in various fields of medicine, including
psychiatry. It involves reducing or discontinuation of medications with unfavorable risk-
benefit ratios, thus optimizing treatment, minimizing polypharmacy, improving patient safety
and treatment outcomes.
Aim: To identify and deprescribe medications that were being used inappropriately and drugs
that caused adverse outcomes among psychiatric patients.
Methods: It was a prospective interventional study conducted among inpatients at the
Department of Psychiatry of a tertiary care hospital in Southern India for 9 months. Data
regarding potentially inappropriate medication use and adverse drug reactions were identified
using tools such as the standard treatment guidelines, Beer’s criteria, and drug information
databases like UpToDate. Identified interventions were conveyed to the prescribing
psychiatrist and upon their acceptance, the process of deprescribing was initiated. Patient
satisfaction post deprescribing was assessed.
Results: A total of 170 psychiatric patients with mean age of 37.3±12.4 were enrolled in the
study of which 62.4% were males. The study identified 42 potentially inappropriate
medications, primarily D2 receptor antagonists (13, 28.2%) and atypical antipsychotics (7,
17.9%). The primary reason for their inappropriateness was lack of a valid indication.
Adverse drug reactions were associated with 28 medications, primarily involving atypical
antipsychotics (14, 50%) and benzodiazepines (7, 25%). A total of 70 medications were
targeted for deprescribing, out of which 24 deprescribing were initiated by the prescriber and
46 were initiated by the pharmacist. Pharmacist-initiated interventions had an acceptance rate
of 45.7%. Ultimately, 45 medications were successfully deprescribed. Patient satisfaction
post-deprescribing was assessed and majority of subjects expressed positive response
(61.5%).
Conclusion: Deprescribing in psychiatry proves effective in addressing inappropriate
medication use and adverse health outcomes. However, successful deprescription with the
involvement of both prescribers and pharmacists, emphasizes the importance of personalized
medication management in improving patient care.
Keywords: Deprescribing, Potentially-inappropriate medications, Adverse outcomes.

Introduction: Management of hematologic cancer encompasses multimodal therapeutic strategies ranging from chemotherapy to Hematopoietic Cell Transplantation (HCT). These therapeutic facets demand vigilant monitoring throughout its intricate course. As an integral part of the multidisciplinary healthcare team, onco-clinical pharmacists play a crucial role in optimising the therapeutic protocols.
Aims: This study applies the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to assess the scope of onco-pharmacists in HCT setting.
Methods: Medication management services offered by the onco-clinical pharmacist and HCT pharmacist was assessed in onco setting and HCT Unit. The drug-related problems and clinical interventions were documented on a pre-validated tool with additional focus on therapeutic drug monitoring of immunosuppressants. Data obtained was analysed using the PQA Medication Therapy Problem Categories Framework to estimate clinical outcomes. Finally, a survey was conducted in the patients/caretakers and healthcare professionals to assess the degree of satisfaction pertinent to the pharmaceutical care.
Results: Over a 9-month period, the HCT pharmacist monitored 15 allogeneic and 4 autologous patients, while 73 individuals with hematologic malignancies were cared for by onco-pharmacists. This included 72 HCT patient encounters and 219 hematology patient encounters/interactions, with an average follow-up duration of 90 days. The HCT pharmacist managed 128 medications, identifying 216 medication-related problems and providing 194 interventions, while the onco-pharmacist managed 84 medications, identifying 96 problems, and providing 108 interventions. The time in therapeutic range of immunosuppression was 67.9% under the HCT pharmacist's management. In the satisfaction survey, of the 70 patients/18 caregivers, 71(88%) were strongly satisfied with the pharmaceutical care and of the 28 health care professionals, 24(85%) were strongly supportive of the continued need of a HCT pharmacist.
Discussion: The RE-AIM framework provided a methodological approach for programmatic evaluation and generalizability. The implementation of an HCT pharmacist services and novel practice models positively enhanced the clinical and humanistic outcomes.

Introduction: Many patients need extensive aftercare & clinical follow-ups to manage their chronic illness. Significant gaps exist in outpatient care including poor communication, inadequate follow-up, insufficient patient education, medication management issues, and financial barriers. Ambulatory pharmacist-led telephonic intervention possesses huge potential to bridge these care gaps.

Aim: To assess the impact of ambulatory pharmacist-led telephonic intervention in patient’s health-related quality of life.

Methods: A pilot study is carried out in an ambulatory setting of a hospital for 6 months. Patients with atleast one chronic condition & visiting the study site are included, after obtaining written consent. The patient’s medical record data, contact details, and other necessary information were collected. The ambulatory pharmacist-initiated telephonic intervention every month after evaluating the patient’s needs. Under this initiative, various levels of preventive care services were delivered. Health-related quality of life assessments were performed using the EuroQoL® EQ-5D-3L instrument at baseline, 2nd month, and 4th month. The data obtained was analysed using descriptive statistics.

Results: 58 patients enrolled, among which 53% were above 50 years of age & 67% had preliminary education. Majority of them were suffering from hypertension (36%), diabetes (21%) and rheumatoid arthritis (26%). Under this initiative, 79% of patients received personalized counseling (primary-level preventive care). About 9% of patients received secondary-level preventive care in which disease & treatment-related complications were evaluated & addressed; Referrals were initiated for 3% of patients as a part of tertiary-level preventive care. The average HRQoL was 66.23±15.45 at baseline & follow-up HRQoL measures were 71.41±14.48 and 75±14.98. This initiative, enhanced patient’s self-care practices.

Conclusion: Ambulatory pharmacist-led telephonic intervention has positively impacted patient’s health-related quality of life.

Keywords: ambulatory pharmacist, preventive care, quality of life, telephonic interventions.

Aim/Objective: This study evaluates the evolution and resilience of South Africa's Central Chronic Medicine Dispensing and Distribution (CCMDD) program in improving healthcare accessibility for chronic patients amidst various challenges.
Methods: The study assesses CCMDD's operation within the National Health Insurance (NHI) framework, focusing on its expansion, patient retention strategies, and engagement with service providers. It employs gradual scaling and geographic information system (GIS) tools for targeted interventions.
Results: CCMDD significantly expands medication access, improves availability, reduces the burden on public healthcare, and enhances patient adherence. The program's vital role in managing chronic conditions is underscored, calling for further research to evaluate health outcomes and patient quality of life.
Conclusion: Clear contracts, service level agreements (SLAs), and standard operating procedures (SOPs) are crucial for scaling success. Ongoing private sector engagement, geographic diversification, and adaptability ensure patient well-being and system resilience, aligning with the goals of NHI and Universal Health Coverage (UHC).
Keywords:
1. CCMDD Program
2. Chronic Medication Distribution
3. Public-Private Collaboration

-Introduction: As of December 2023, more than 590,000 immigrants lived in Taiwan, with numbers increasing. Previous studies indicate that immigrants are at a higher risk of poor health literacy (HL). However, extrapolating these results may be problematic due to varying cultures and racial compositions across countries. Currently, research comparing HL between immigrants and natives in Taiwan is lacking.

-Aims: To compare the level of HL between immigrants and natives using the National Health Interview Survey (NHIS) of Taiwan.

-Methods: The 2017 Taiwan NHIS served as the data source for this study. We included individuals who aged ≥20 years old and completed the HL questionnaire. The key independent variable was nationality (natives and immigrants), and the dependent variable was HL. The total score of the HL questionnaire was calculated and divided into two categories: poor (scored 0-33) and good (scored 34-50) HL. Multivariable logistic regression was performed to evaluate the odds of being with low HL between immigrants and natives, adjusting for age, sex, family income, self-reported health status, cardiovascular diseases, respiratory diseases and mental diseases.

-Results: After weighting, there were 6,871,548 individuals in our study, comprising 54,674 immigrants and 6,816,874 natives. A chi-square test showed similar age distributions between immigrants and natives (p-value=0.25). Compare to natives, immigrants had lower family incomes and lower educational levels (p-value<0.01). The proportion of respondents with poor HL were 12% and 8% among immigrants and natives (p-value=0.48), respectively. Multivariable linear regression showed that immigrants had similar HL level as natives (OR: 1.57, 95% CI: 0.46-5.39).

-Discussion: Our study suggests that immigrants in Taiwan do not have a significantly poorer HL compared to the natives. However, the non-significant difference may be caused by the limited sample size of immigrants. Further studies are needed to better understand the HL of immigrants in Taiwan.

Introduction: Patient’s and customers regularly visit community pharmacies for buying medications and seeking information about medications, common illnesses and overall health issues. Health screening services if employed in the pharmacies will help to identify and prevent diseases, before symptoms appears. Health screening services for the screening of diabetes, hypertension can be made available at the community pharmacies. These services if implemented in the pharmacies helps to identify individuals who are at risk and referring them to their physicians. The services like hypertension and diabetes screening are relatively easy for community pharmacist to perform.
Aim: To understand the pharmacist knowledge, attitudes, practices, and barriers to offering health screening services in community pharmacies was the goal of the study.
Methods: This was a cross-sectional descriptive study, involving community pharmacists in Udupi district, using a structured questionnaire to assess their knowledge, attitude, practice and barriers to health-screening services. The questionnaire covered various domains including demographic traits, pharmacist knowledge, attitude, practice, and barriers to offering health screening services.
Results: A total of 71 community pharmacists from Udupi district participated in this study. The majority (76.1%) of pharmacists showed adequate knowledge and awareness of health-screening services, in addition to having a positive attitude towards health screening services. 64.8% of pharmacists, however, were against offering health screening services. Lack of training (32.4%), lack of time (26.8%), and non-payment (21.1%) for health screening services performed were cited as reasons for not providing health screening services.
Discussion/Conclusion: Due to the advantages of easily accessible health screening services in community pharmacies, which help in the early detection of illnesses in the community, pharmacists should receive training in health screening services.

Introduction: Chronic low back pain (CLBP) is a significant cause of disability worldwide, affecting millions and posing a substantial burden on healthcare systems. The condition's multifaceted nature, involving biological, psychological, and social factors, complicates its management.
Aims: This study investigates the biopsychosocial determinants of CLBP disability in this region to inform targeted interventions and public health strategies.
Methodology: A population-based cross-sectional design was employed, covering diverse urban and rural populations in Northern India from November 2017 to February 2020. The study included adults aged 18 and above diagnosed with CLBP, using face-to-face interviews to gather socio-demographic and medical data. The biopsychosocial model guided the analysis, utilizing tools like the Multidimensional Pain Inventory, Fear-Avoidance Beliefs Questionnaire (FABQ), and the WHO Disability Assessment Schedule (WHO-DAS). Statistical analyses, including ANOVA and multiple regression, were performed to identify significant determinants of CLBP disability.
Results: The study enrolled 457 participants, with a balanced gender distribution and a mean age of 46.4 years. Key findings revealed that biological factors (age, gender, comorbidities), psychological factors (anxiety, depression), and social factors (occupational status, educational level) significantly influenced CLBP disability. Higher levels of anxiety and depression were strongly associated with lower health-related quality of life (HRQOL) and greater disability. The FABQ scores highlighted the role of fear-avoidance beliefs in chronic pain management.
Conclusion: The research highlights the complex interplay of biopsychosocial factors in CLBP. Addressing these determinants through integrated, multidisciplinary approaches involving mental health services, physiotherapy, and community support can enhance CLBP management. The findings advocate for tailored public health policies and interventions to reduce the CLBP burden in Northern India, emphasizing the need for holistic care. To generalize the results future studies should explore longitudinal data and broader geographic areas
Keywords: Chronic Low Back Pain, Biopsychosocial Model, Disability, Quality of Life

Introduction: Smoking has various health consequences. The Japanese public medical insurance covers nicotine dependency treatment, including counseling, pharmacological treatment, and the use of an electronic device application.

Aims: This study assesses the geographic variations in nicotine dependency treatment utilization in Japan.

Methods: The nicotine dependency management (NDM) fee and two medications indicated for nicotine dependency were assessed in the pooled open data of the National Database in Japan from 2018 to 2022. The standardized ratios (StdR) of the number of patients who claimed the initial NDM (type 1) and the total dose of each medication (varenicline and nicotine) were estimated using the indirect adjusted by the population stratified by age and sex in 47 prefectures. The coefficient of variance (CV) was used for the geographic variations.

Results: In the five years, a total of 458,382 patients had a claim for the initial NDM fee and 41,714,782 mg of varenicline (equivalent to 379,225 patients’ dosage for a standard treatment course) and 136,229,729 mg of nicotine (equivalent to 61,782 patients’ dosage for a standard treatment course) were prescribed. The StdR of the NDM, varenicline, and nicotine varied from 0.71 to 1.78, 0.73 to 1.68, and 0.49 to 1.96 among prefectures, respectively. The CV of the StdR of the NDM, varenicline, and nicotine were 0.20, 0.31, and 0.17, respectively. The correlation coefficients between NDM and varenicline, NDM and nicotine, and varenicline and nicotine were 0.96, 0.62, and 0.45, respectively. The StdRs of all three treatments assessed (NDM, varenicline, and nicotine) tended to be higher in Western than Eastern regions in Japan.

Discussion: The practice of nicotine dependency treatment varies geographically in Japan. The variation may be associated with the relevant healthcare resources available locally.

Introduction. Potential dug-drug interactions (pDDIs) are associated with decrease of effectiveness, and increased risks of drug side effects. Identifying pDDIs is significant for detecting and managing the risks. However, bare research has examined pDDIs in elderly people with depression who are likely to have comorbidities and co-medications, and be more susceptible to the side effects due to drug reactions.
Aims. Aims of this study are to investigate the epidemiology of pDDIs in geriatric patients with depression, examine factors associated with pDDIs, and identify severity and preventability of pDDIs.
Methods. The presence of pDDIs were assessed via Medscape Interaction Checker on the prescriptions extracted from medical records. Clinical outcomes and management strategies for pDDIs were displayed. Logistic regressions were used to analyse the potential associations between participant characteristics and pDDIs.
Results. Medication data for 3 years were collected from 845 geriatric patients. 75.6% of the patients ever had pDDIs. Severe levels of depression and polypharmacy were positively associated with the occurrence of pDDIs (Adjusted odds ratio = 2.1, 95% confidence interval = 1.2-3.8; aOR = 47.6, 95% CI = 7.8-289.1, respectively). Frequent drug pairs with pDDIs were combining selective serotonin reuptake inhibitors (SSRIs) and trazodone (or mirtazapine), and augmenting SSRIs with olanzapine.
Discussion. Prevalence of pDDIs were high in geriatric patients with depression. Drug combinations in highest frequency and serious severity are a priority for pDDI detection and management. Special attentions are also needed for drugs with pharmacodynamic synergism, and CYP enzyme substrates and inhibitors. Patients with severe levels of depression, polypharmacy, cardiovascular diseases, and liver or renal function impairments are of special interests as they are potentially more susceptible to the risks of pDDIs.

Introduction. Palliative care, including end-of-life care, aims to enhance the quality of life for those with life-limiting illnesses. Older adults at this stage often face challenges due to evolving health needs, leading to polypharmacy. Polypharmacy raises concerns about potentially inappropriate prescribing. Existing tools commonly used to identify prescribing issues such as the STOPP/START criteria are tailored for aged care and may be limited in palliative settings. Previous studies have developed tools for identifying inappropriate prescribing in palliative settings. However, the Western Pacific region has not received commensurate attention. A tailored checklist for this region is needed to address these gaps and improve the quality of palliative care.
Aims. To develop a medication checklist to guide prescribing decisions for older adults in the last 6 months of life.
Methods. A Delphi expert panel, consisting of palliative care clinicians from 12 Western Pacific countries and regions, will be convened. These include Malaysia, Singapore, India, Bangladesh, Sri Lanka, Taiwan, Hong Kong, Japan, South Korea, China, Australia, and New Zealand. Panellists will be tasked with indicating their level of agreement with statements on whether medication classes should be deprescribed, continued, or initiated in older adults during the last 6 months of life via an online survey. Consensus on a medication class will be deemed achieved if the level of agreement is ≥ 75%.
Results. Descriptive statistics will be employed to summarise and analyse the collected data. An overview of participant demographics will be presented. Data from the expert panel's consensus on medication classes will be analysed to identify areas for deprescribing, continuation, and initiation during the last 6 months of life.
Discussion. This study holds significant implications for rationalising prescribing decisions and mitigating potentially inappropriate prescribing issues in palliative care, particularly for older adults at the end-of-life in the Western Pacific region.

Objective:
To develop Claim-Based Frailty Index (CFI) by using Survey-based Frailty Index (SFI) as reference standard in the National Health Insurance Database (NHID) in Taiwan.

Methods:
The Taiwan Longitudinal Study on Aging (TLSA) survey was used to develop the SFI. And, ICD-9 codes were organized by subheadings and categorized based on prevalence into three groups: > 0.001, > 0.01, and > 0.05. The CFI was then estimated using a lasso regression model with SFI as a function of health deficit variables. Expand the ICD code subheadings to three digits and recalculating prevalence and categorization. Lasso regression was performed for each prevalence group, leading to the estimation of CFI using selected three-digit ICD-9 codes. The best approach was chosen based on C statistics from logistic regression for mortality and correlation with SFI. Finally, validation of the CFI derived from NHID 2015 was conducted by comparing it with the Charlson Comorbidity Index (CCI) in predicting mortality, 30-day readmission rates, the number of ER visits, and hospital days in 2016.

Results:
A total of 8,300 participants were interviewed in 2015 TLSA, of which 4,040 (48.7%) were male and 4,260 (51.3%) were female. The mean age was 67.6 ± 10.9 years. We choose prevalence threshold > 0.001 as our best CFI. The mean CFI was 0.039 ± 0.080. Validation results showed that after adjusted for age and sex, CFI was similar to CCI in predicting mortality (C statistic: 0.85 vs. 0.84), 30 days readmission (C statistic: 0.71 vs. 0.72) and number of ER visits (Pseudo R2: 0.17 vs 0.18) and was superior in predicting hospital days (Pseudo R2: 0.11 vs 0.08 ).

Conclusion:
Our CFI can be used to measure frailty in Taiwan NHID.

Keywords: Claim-Based Frailty Index (CFI), Survey-based Frailty Index (SFI), Taiwan Longitudinal Study on Aging (TLSA), National Health Insurance Database (NHID)

Introduction: Treatment for cancer remains a significant and escalating healthcare expense worldwide. Although annual reports on the total costs of cancer care are available in Australia, the potential impact of evolving treatment guidelines and the introduction of new drugs on future budgeting remains largely uncertain.

Aims: To examine the trends in the use of Pharmaceutical Benefits Scheme (PBS) cancer drugs subsidised by the Australian government over the past decade.

Methods: PBS codes for all PBS cancer drugs that were listed in government-endorsed treatment protocols were obtained and used to retrieve usage data. Their patterns of use, represented by the number of prescriptions (services) processed by Services Australia, were analysed for the period between 2012 to 2022.

Results: The overall prescribing of cancer drugs is outpacing Australia's population growth, primarily due to an ageing population and the accelerated rise in cancer diagnoses observed over the past decade. From 846 government-endorsed treatment protocols,142 cancer drugs were available on the PBS, of which kinase inhibitor (39 drugs) and monoclonal antibody drugs (24 drugs) had the highest increase in use during the study period: 16% and 23% respectively. Of the drug types analysed, hormonal agents (20 drugs) were the most prescribed, while the use of the drug aflibercept continued to rise despite the discontinuation of related treatment guidelines.

Discussion/Conclusion: The utilisation of government-subsidised cancer drugs is increasing faster than Australia's population growth, especially for newer, high-cost monoclonal antibody and kinase inhibitor drugs, indicating continued pressure on government spending.

Introduction: Drug-related problems (DRPs) are common among elderly patients in critical care units and can lead to adverse outcomes, increased healthcare costs, and prolonged hospital stays.

Aim: To determine the rate, pattern, and severity of DRPs among elderly patients admitted to critical care units.

Methods: A prospective interventional study was conducted over a period of 9 months in all intensive care units at a tertiary care hospital. Elderly patients (≥ 60 years) were enrolled in the study, and data on DRPs was collected. DRPs were identified and classified according to Hepler and Strand's classification. The severity of DRPs was assessed, and pharmacist interventions were recorded.

Results: A total of 137 elderly patients (mean age: 68.5 ± 7.3 years) were included, with 78.1% experiencing at least one DRP (with a total of 210 DRPs identified). The average number of DRPs per patient was 1.53 ± 0.76. The most common types of DRPs were subtherapeutic doses (37.1%) and adverse drug reactions (20.5%). Pharmacist interventions were made for all identified DRPs, with an acceptance rate of 92.4%. The severity assessment revealed that 52.4% of DRPs were major, 40.5% moderate, and 7.1% minor. Among the 43 adverse drug reactions (ADRs) identified, the most common were hypokalemia (23.3%) and hypoglycemia (11.6%). Causality assessment classified 62.8% of ADRs as possible and 37.2% as probable, while severity assessment showed that 72.1% were moderate and 4.7% severe. Preventability assessment revealed that 86.0% of ADRs were not preventable.

Conclusion: The high prevalence of DRPs among elderly patients in critical care units emphasizes the importance of pharmacist interventions in identifying and resolving DRPs to optimize patient care and improve treatment outcomes in this vulnerable population.

Keywords: drug-related problems, elderly, critical care, pharmacist interventions.

Introduction: The Drug Utilization Review (DUR) system has provided information on drugs to be used with caution of geriatric precaution for Korean since 2015.

Aim: We aim to expand the DUR provisions for centrally acting muscle relaxants, with strong anticholinergic effects, for the elderly population by analyzing prescription patterns of these to geriatric patients.

Methods: From 2018 to 2020, prescription patterns of centrally acting muscle relaxants in patients aged 65 years and older were analyzed using data from the Health Insurance Review and Assessment Service-Aged Patient Sample (HIRA-APS). The centrally acting muscle relaxants approved in Korea, including, afloqualone, baclofen, chlorphenesin, chlorzoxazone, cyclobenzaprine, dantrolene, eperisone, methocarbamol, orphenadrine, pridinol, tizanidine, tolperisone, were selected.

Results: From 2018 to 2020, 2,245,833 elderly patients aged 65 and over were seen, of which 880,813 patients (39.2%) were prescribed centrally acting muscle relaxants. These were more often female (61.2%) than male (38.8%), and most received prescriptions at primary care clinics (76.5%). Additionally, almost all patients received prescriptions via outpatient treatment (95.6%). Of the 12 selected drugs, eperisone was the most prescribed at 67.3%, followed by afloqualone at 9.6%, orphenadrine at 7.8%, and chlorphenesin at 6.2%. Elderly patients were most frequently prescribed these drugs in orthopedic clinics (53.9%), apart from internal medicine (13.1%) and neurosurgery clinics (10.0%). Patients received the drugs for dorsalgia (15.8%), spondylopathy (11.8%), gonarthrosis (7.5%), intervertebral disc disorders (6.0%), and shoulder lesions (5.7%), with most prescriptions being made for musculoskeletal disorders.

Discussion: Prescription of centrally acting muscle relaxants requires caution in geriatric patients due to their anticholinergic effects. A significant proportion of elderly patients had been prescribed centrally acting muscle relaxants before. DUR information for these drugs tailored to geriatric patients should be developed.

Aims. To assess the impact of clinical pharmacists’ counselling and to identify the facilitators and barriers of medication adherence amongst elderly patients with cognitive impairment

Methods. A single-centre, prospective, pre-post, cross-sectional study was performed in the Departments of Geriatrics, Neurology, and Psychiatry at a tertiary-care teaching hospital in Southern India from Aug 2024 to Mar 2024 Treatment charts of the cognitive impaired patients aged ≥ 65 years, diagnosed with Parkinson's Disease and/or dementia of either gender were reviewed. Written informed consent obtained from the patients’ representatives. Patient demographic details, treatment charts, and medical orders were recorded to assess drug usage pattern. Standard Medication adherence rating scale (MARS) and pre-validated facilitators/barriers question tool consisting a few open-ended questions were administered with direct patient interview to assess patients’ adherence levels towards their prescribed medications at baseline and after 30 days of follow-up.

Results. The study enrolled 156 participants with an average age of [mean±SD: 75.18 ± 8.28 years]. Among the study participants, [141 (90.38%)] of the participants completed the questionnaires at baseline and after 30 days, remaining [15(9.61%)] were lost of follow-up after 30 days. Of 156 participants, [122 (78.2%)] showed good adherence, followed by 34 (22.4%) showed poor adherence at baseline. After the counselling by Clinical Pharmacist ,medication adherence improved significantly (mean= 9.17 ±1.134) after 30 days compared to baseline (Mean = 7.75±2.281), with mean difference = -1.418,±1.856; [t (140) = - 9.074, p < 0.001]. A validated facilitators and barriers questionnaire revealed that 67.3% of patients often forgot to take medications, while 51.7% were careless. Accessing healthcare was a challenge for 77.5% patients, and 52.5% faced issues due to polypharmacy and therapy-related factors.

Conclusion. The study reported that medication adherence significantly improved from baseline to 30-day of follow-up. But, optimizing medication adherence is quite challenging amongst the cognitively impaired geriatrics.

Aim: The primary objective of veterinary medicine is to ensure the health and welfare of animals through appropriate therapeutic interventions, which include disease prevention, diagnosis, growth promotion, and improved feed efficiency. This study explores medication utilization and extra-labeled use among pet owners in Saudi Arabia, emphasizing the patterns and knowledge of crossover medication use.
Methods: A population-based cross-sectional online survey was conducted from December 2022 to April 2023. The survey targeted Saudi Arabian citizens and residents with at least one pet or involved in animal husbandry.
Results: The final sample included 347 participants after refining the data for completeness. The demographic analysis revealed that most participants were adults (90.2%), with a significant portion holding university-level education (63.68%). Cats (63%) and birds (30.54%) were the most common pets, with 59.65% of participants providing regular vaccinations to their animals. Veterinary doctors were the primary source of medication information (43.33%) and providers of medications (60.58%). While 40% of participants never used human medications on their pets, those who did commonly used antibiotics and topical preparations. About half (50%)of these participants adjusted the dosage when administering human medications to animals. The study also found that 52% of pet owners believed only veterinary doctors should prescribe medications for animals, whereas 42% thought both veterinarians and pet owners could use human medications in animals. Despite recognizing the dangers of human medications for animals, participants did not perceive significant risks to human health from this practice.
Discussion/conclusion : The reliance on human medications for animals, particularly antibiotics and topical preparations, raises substantial concerns about the potential for adverse reactions and the development of antibiotic resistance. The findings underscore the need for enhanced education on the risks of extra-labeled medication use and the development of clear guidelines to promote responsible medication practices among pet owners.

Introduction Adverse drug events (ADEs) significantly impede the development of Africa’s healthcare system as it is one of the predominant burdens it faces.
Aims This study aimed to systematically review published studies on ADEs and summarize the burden of ADEs across different settings in Africa.
Methods Studies with ADE rates reported in African settings were identified by searching PubMed, EBSCO, Science Direct, and Web of Science. Settings of ADEs included those leading to hospital admissions, developed during hospitalizations, and captured in the outpatient departments or communities. Grouped ADE prevalence rates were described using median and interquartile range (IQR). PROSPERO registration (CRD42022374095).
Results Seventy-eight studies carried out in 15 African countries were included. The median ADE-related fatality rate was 0.3%. The overall median prevalence of ADEs leading to hospital admissions was 6.3% (IQR: 1.5%–10.3%) in any patient population and the median prevalence of ADEs developed during hospitalizations was 12.8% (IQR: 6.4%–49.4%), while the median prevalence of ADEs in the outpatient and community settings were 22.9% (IQR: 14.6%–56.1%) and 32.6% (IQR: 26.0%–41.3%), respectively, with a median of 43.5% (IQR: 16.3%–59.0%) of ADEs being preventable.
Conclusion The healthcare burden of ADEs was significant in both hospital and community settings in Africa, with many being preventable. Due to limited studies conducted in the community setting, future research in this setting is encouraged.

Introduction Adverse drug reaction (ADR) monitoring is crucial in ensuring patient and pharmaceutical safety, given the significant global issues associated with patient well-being. However, there is lack of evidence regarding the trend pattern of ADR reports in Ghana.
Aims We therefore, aimed to analyse and characterize trends in ADRs reported in Ghana over 16 years.
Methods We analysed ADR reports received by the Ghana National Pharmacovigilance Centre and entered into VigiBase from 2005 to 2021. Jointpoint regression was used to estimate age-adjusted ADR rates, stratified by sex and patient characteristics, suspected medication groups, clinical indications and the manifestation of ADRs. To evaluate trends over time, the percentage annualised estimator was used. Suspected medication groups for ADRs were coded using the Anatomical Therapeutic Chemical classification system and the Medical Dictionary for Regulatory Activities was employed to classify ADRs and indications.
Results We identified a total of 6,189 ADR reports from 2005 to 2021. The age-adjusted ADR report rates increased significantly from 2005–2019, with an annual increase of 18.6%, however, there was a downward trend from 2019–2021, although not statistically significant. Males accounted for the majority (64.3%) of ADR reports compared to females (35.7%). The medication group most frequently associated with ADRs were antiprotozoals accounting for 35.6% of all ADR reports while vascular disorders (21.0%) were the most commonly observed clinical indication in relation to ADRs. An increase in ADR report rates was noted for infections and infestation with an annual increase of 22.4% (95% CI: 9.7–36.7%; p < 0.001). General disorders and administration site conditions (20.1%) were the most frequently reported ADRs.
Conclusion ADRs remain a huge burden on the healthcare systems of Africa, especially Ghana, with an increasing trend of ADR-related medication use. The findings of this study call for multifaceted strategies aimed at reducing the ris

Introduction: Pregabalin, a gabapentinoid, has been used worldwide for neuropathic pain. Mirogabalin, a new gabapentinoid, was recently launched in several Asian countries, and may be as effective as pregabalin but with less dizziness and somnolence. Although cohort and case-crossover studies have shown an association between pregabalin use and fall-related injuries, these studies might suffer from residual confounding due to the lack of an appropriate comparison group in cohort studies, as well as bias from exposure-time trends or treatment persistence in conventional case-crossover studies. Additionally, findings on mirogabalin and its association with fall-related fractures are lacking.
Aims: We evaluated the risk of fracture associated with the use of pregabalin or mirogabalin while adequately addressing the aforementioned biases using a case-case-time-control design.
Methods: A case-case-time-control study was conducted using future cases as controls for current cases. Patients with incident fractures were identified in a Japanese claims database between September 27, 2014, and October 31, 2022. The fracture event date was defined as day 0. For each current case, a hazard period (day −1 to −30) and a control period (day −61 to −90) were set. Each current case was matched by age and sex to one future case with a fracture occurring 120−365 days later. Conditional logistic regression models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for fractures in both current and future cases, adjusting for time-varying covariates. The ORs of case-case-time-control study were obtained by dividing the ORs in current cases by the ORs in future cases.
Results: A total of 814,216 current cases were eligible, with an average age of 75.0 years. The ORs were 1.31 (95% CI, 1.21−1.41) for pregabalin and 1.57 (95% CI, 1.33−1.85) for mirogabalin.
Discussion: Given the fracture risk observed, caution is advised when prescribing pregabalin or mirogabalin in clinical practice.

Introduction. The risk of drug-drug interactions might increase due to polypharmacy. A chronic disease such as gout arthritis especially in the geriatric patients that is frequently accompanied by multicomorbidities is often prescribed polypharmacy, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) to treat a symptom of pain.
Aims. This study aimed to determine the association of potential adverse drug pair interactions from NSAIDs use in gout patients with polypharmacy compared to those whithout polypharmacy.
Methods. This analytical observational study with a cross-sectional approach was conducted at a Public Regional Hospital Banjarmasin in December 2023 using the electronic medical record. Potential drug-pair interactions of NSAIDs and the association were analysed by using Lexicomp® and the Fisher Exact test, respectively.
Results. In 13 gout patients 32 drug pair interactions were found. Among all NSAIDs, glucosamin was the most prescribed by 62 times (79.49%) followed by meloxicam by 18 times (23.08%) and diclofenac by 4 times (5.12%). According to the potency of drug-drug interaction, most of drug pairs were under category C (the benefit outweight the risks, but proper monitoring should be done) by 26 drug pairs (81.25%). Most of drug pairs were categorized to have moderate severity by 26 drug pairs (81.25%). Major interaction between meloxicam and diclofenac was found in 1 drug pair (3.13%) increasing the risk of adverse event in gastrointestinal system. Among the patients with polypharmacy, 29 (96.7%) drug-pair interactions found were not potentially harmful and only 1 (3.33%) drug-pair interaction was potentially harmful. While among patients without polypharmacy, only 2 (100%) drug-pair interactions were not potentially harmful and no potentially harmful drug-pair interactions were found (0%). The statistical test showed the p-value of 0.938.
Conclusion. This study concluded that there was no difference in adverse drug pair interactions using NSAIDs between polypharmacy compared to non-polypharmacy in patients with gout.

Introduction
Proteasome inhibitors, such as bortezomib, carfilzomib, and ixazomib, have revolutionized multiple myeloma therapy by disrupting protein degradation, halting cancer cell growth. Despite their established efficacy, concerns endure about long-term safety in broader patient populations, attributed to limited data on infrequent and delayed adverse events (AEs).
Aims
The study aimed to deepen the comprehension of proteasome inhibitors' safety profile in multiple myeloma patients through disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) data.
Methods
The FAERS database, accessed via Open Vigil 2.1 MedDRAv24, was utilized, covering data up to September 2023. Signal refinement involved limiting drug roles to 'primary suspect' status. Disproportionality analysis employed the proportional reporting ratio with chi-square value and reporting odds ratio. Evans 2001 criteria, n > 2, chi2 > 4, PRR > 2, ROR_LB > 1, defined a probable association between the drug and AE.
Results
In the FAERS database, reports indicated AEs linked to Carfilzomib in 12,513 patients, Ixazomib in 18,123 patients, and Bortezomib in 43,195 patients. Notably, significant signal scores were detected in the System Organ Classes (SOCs) of 'Respiratory, thoracic, and mediastinal disorders' and 'Infections and infestations'. Even after signal refinement, the majority of these associations remained significantly associated. Significantly associated Preferred Terms (PTs) included pneumonia, respiratory tract infections, bronchitis, pulmonary sepsis, acute pulmonary oedema, etc…
Discussion
Bortezomib, carfilzomib, and ixazomib each have their own unique safety profiles, which reflects their distinct structural and mechanistic properties. The study detected significant disproportionality signals linking pulmonary events to proteasome inhibitors, underscoring the necessity for clinicians to account for patient comorbidities and concurrent medications when prescribing these agents. These findings contribute to refining the safety profile of proteasome inhibitors during post-marketing, facilitating better risk assessment and patient care.

Introduction: Inflammation has been reported to be associated with the aging and multimorbidity.
Aims: The objective of this study was to elucidate the relationships between polypharmacy and markers of inflammation.
Methods: Participants who were 65 years of age or older and took at least one prescription medication from the National Health and Nutrition Examination (1999-2018) were included in the cross-sectional study. The concurrent use of 5 to 9 medications was defined as polypharmacy, while the use of more than 9 medications was defined as hyper-polypharmacy. Systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), neutrophil to lymphocyte ratio (NLR), monocyte to lymphocyte ratio (MLR), platelet to lymphocyte ratio (PLR), and product of platelet count and neutrophil count (PPN) were calculated from blood cell counts. Weighted linear regression analysis, subgroups analysis and sensitivity analysis were used to investigate the relationship between polypharmacy and markers of inflammation.
Results: Of 10,753 participants assessed, 4,115 (weighted percentage: 38.3%) were taking between 5 and 9 medications and 474 (weighted percentage: 4.4%) were taking more than 9 medications. After adjustment for covariates, multivariable linear regression revealed a significant correlation between both polypharmacy and hyper-polypharmacy and inflammatory indicators. Weighted β-coefficient and 95% confidence interval of polypharmacy were 0.077(0.045, 0.109), 0.102(0.070, 0.134), 0.07(0.044, 0.096), 0.064(0.042, 0.086), 0.038(0.014, 0.063), 0.045(0.016, 0.075), 0.021(0.004, 0.037), and 0.028(0.011, 0.044) for SII, SIRI, NLR, MLR, PLR, PPN, white blood cell (WBC) and C-reaction protein, respectively. The positive associations between hyper-polypharmacy and inflammatory markers were more pronounced, with the exception of WBC. The results of subgroup and sensitivity analyses demonstrated a robust, positive correlation between polypharmacy and inflammatory markers, particularly for SII, SIRI, NLR, and MLR.
Conclusion: In a population of older Americans, polypharmacy was found to significantly increase levels of inflammation, a relationship that was independent of the presence of comorbidities.

Omeprazole, a Proton Pump Inhibitor (PPI) approved in Saudi Arabia for the management of gastroesophageal disease, peptic ulcer disease, gastric ulcers, duodenal ulcers, reflux esophagitis, Zollinger-Ellison syndrome. Erectile dysfunction (ED) adverse event is already included in the product information of other PPIs (e.g. esomeprazole, pantoprazole, lansoprazole, rabeprazole and dexlansoprazole).

To evaluate the potential association between omeprazole and ED as a part of drug class effect project.

We conducted a systematic literature search on January 2024, using PubMed, Embase, and Google Scholar, for English articles on human investigating the association between omeprazole and the risk of ED. The search terms included ‘omeprazole’ OR ‘Losec’ AND ‘erectile dysfunction’ OR ‘organic erectile dysfunction’. Moreover, we conducted a search in the World Health Organization (WHO) database “VigiBase” and in the local database of National Pharmacovigilance Center to retrieve case reports up to March 2023. Then, cases were assessed using the WHO-Uppsala Monitoring Center causality system.

Six observational studies were identified. First study found a significant association between PPIs and ED (odds ratio: 1.81 [95% Confidence Interval (CI): 1.07-3.07]. A prospective observational study showed significant reduction in testosterone levels post omeprazole with one patient developing ED. Three pharmacovigilance database analysis studies identified several cases of ED. In 2 studies, ED reporting with omeprazole was higher compared to other medications within VigiBase [Reporting Odds Ratio (ROR): 2.13, 95% CI: 1.83-2.48] and Lareb (ROR: 2.54, 95% CI: 1.52-4.25). Forty cases were assessed; 1 probably related, 19 possibly related, 1 unlikely, and 19 un-assessable. In VigiBase, 288 global cases were reported and 13 cases with completeness score one were assessed; 2 probably related, 8 possibly related, and 3 were unlikely. No local cases were reported to the SFDA.

The available evidence suggests potential association between ED and omeprazole. Further epidemiological studies are needed to investigate this potential association.