Introduction: Robotic-assisted lobectomy (RL) is increasingly used nationally, but little comparative data exist on its safety compared to open lobectomy (OL) or video-assisted lobectomy (VL).

Aims: The study aimed to estimate the risk of perioperative complications for RL, VL, or OL.

Methods: Admissions were identified from the hospital administrative data collected between 2015 and 2019. Propensity score matching and inverse probabilistic weighting were used to account for selection bias. Logistic and quantile regression models were applied to determine perioperative outcome differences.

Results: We identified 26,140 cases of which 5,337 (20.4%), 12,680 (48.5%), and 8,123 (31.1%) underwent RL, VL, and OL, respectively. RL and VL were associated with lower complication rates, shorter lengths of stay, and fewer mortality risks. RL was associated with significantly elevated risks for perioperative respiratory complications (adjusted odds ratio [aOR] 1.10, p=0.010).

Discussion: Relatively low rates of perioperative complications for VL and RL, and higher respiratory complication rates in RL are concerning.

Introduction: The combination of TCM and Western medicine in sepsis treatment can significantly improve efficacy and alleviate adverse reactions in patients. Wherein, Xuebijing injection has been strongly recommended by multiple domestic clinical guidelines and expert consensus for sepsis treatment.
Aims: From the health care and societal perspectives, this study aimed to evaluate the clinical and economic effects of Xuebijing injection for patients with sepsis in comparison to conventional treatment in real-world practice.
Methods: Data was collected from the Hospital Information System of 8 hospitals across China from September 2016 to June 2019. Patients whose primary discharge diagnosis was sepsis according to ICD-10 diagnostic coding were included and divided into two samples: exposure group (Xuebijing injection group) and control group (non-Xuebijing injection group). Comparative analysis of the cost, hospitalization duration, effective rates, mortality rates, and biochemical indicators in these two groups was conducted. A subgroup analysis was conducted on ICU sample patients. Propensity Score Matching was used to control potential confounding factors.
Results: 1759 patients were included. The exposed group was significantly (P<0.05) better than the control group in effective rates (68.6% VS 56.3%), mortality rates (8.0% VS 13.2%), and inflammation indicators (-1.58 VS -.111). Compared with the control group, the exposed group resulted in a decline of 0.1 hospitalization day and an incremental cost of 4634.1 yuan, the ICER was 46,341.3 yuan/Day. From the view of efficacy, the exposed group resulted in an additional 12.3% and an incremental cost of 4634.1 yuan, the ICER was 376.8 yuan/efficacy. In the ICU subgroup, the ICER was 22,256.2 yuan/day and 2,503.8 yuan/efficacy, respectively.
Conclusions: Xuebijing injection showed advantages for inpatients with sepsis compared with conventional treatment. Future studies using prospective pragmatic controlled trials can test and explore more about the effects of Xuebijing injections on sepsis.

[Introduction]
Despite their frequent prescription, the safety of ADHD medications during pregnancy is not well-studied.

[Aims]
To assess the risk of adverse outcomes associated with exposure to ADHD medications during pregnancy.

[Methods]
We conducted a case-noncase disproportionality analysis using VigiBase, the World Health Organization’s pharmacovigilance database, which covers about 30 million safety report cases from 1967-2022. The study population consisted of women aged 12 to 44 years who were exposed to ADHD medications during pregnancy. The ADHD medications were identified by the ATC codes ‘N06BA’ or ‘N06BX’. Adverse outcomes included abortion, stillbirth, fetal death, congenital malformation, pregnancy complications, preterm birth, neonatal complications, and delivery complications. We analyzed reporting odds ratios (RORs) with 95% confidence intervals (CIs) using logistic regression while adjusting for maternal age group and region.

[Results]
A total of 200,670 reports were analyzed. Cases were 2,536 (1.3%) and noncases were 198,134 (98.7%). In the ADHD group, the most reported age group was 18-44 years (N=196,596, 98.0%). The ROR for exposure to ADHD medication was 1.4 (95% CI: 1.2 to 1.6), indicating a 37.3% higher risk of adverse outcomes among those exposed compared to those not exposed.

[Conclusions]
This study identified an association between the use of ADHD medications during pregnancy and an increased risk of adverse pregnancy outcomes. These findings underscore the need for continuous surveillance to monitor the safety of ADHD medications in pregnant women. Further study is essential to analyze these adverse outcomes in more detail.

Introduction Hepatitis B vaccines (HBV) are widely used duo to their high clinical use and mild effects. However, as post-marketing data accumulate, several serious adverse events following HBV have been reported. Currently, quantitative studies based on real-world data are lacking, and information on their adverse effects is limited.
Aims Adverse reaction signals of the hepatitis B vaccine were mined and analyzed using the U.S. Vaccine Adverse Event Reporting System (VAERS) to provide a reference for the safe clinical use of this vaccine.
Methods Multiple statistical methods, including the ROR method, the MHRA method, and the BCPNN method, were utilized to identify signals of HBV-associated adverse reactions, and positive signals consistent with designated medical events (DMEs) were singled out for focused comparison and discussion.
Results Analysis of 53,277 HBV-related adverse events identified 270 positive signals across 22 System Organ Classifications (SOCs), with systemic disease and various reactions at the site of administration being the most common. Four potential positive new signals consistent with Preferred Terms (PTs) were identified in DME: aplastic anaemia, dermatitis exfoliative, haemolytic anaemia, and hepatic failure, with dermatitis exfoliative showing a relatively strong signal.
Discussion/Conclusion This study suggests that HBV has a potential risk in terms of causing aplastic anaemia, dermatitis exfoliative, haemolytic anaemia and hepatic failure. Since some subtypes of aplastic anaemia and haemolytic anaemia are autoimmune diseases, and immunization may stimulate potential autoimmune genetic predisposition, people with autoimmune diseases or a family history of hereditary immune diseases should be monitored after receiving HBV. Health professionals should be contacted to take measures to help if anaemia, palpitations, and high fever occur.

Introduction:
There have been concerns about the potential impacts of the COVID-19 pandemic on mental health conditions since the pandemic, but global studies on this topic remain limited. The global monitoring of country-level psychotropic medication consumption trends can provide information on the availability and utilisation of psychotropic medications during the pandemic.

Aims:
To investigate trends in psychotropic medication consumption from 2017 to 2022 across 83 high- and middle-income countries according to country income level.

Methods:
We used quarterly pharmaceutical sales data of psychotropic medications from the IQVIA-Multinational Integrated Data Analysis System (IQVIA-MIDAS). Total psychotropic consumption included sales of antipsychotics, anxiolytics, hypnotics and sedatives, and antidepressants. Average annual sales trends of psychotropic medications were expressed as defined daily dose (DDD) per 1000 inhabitants per day. Compound annual growth rate (CAGR) was used to assess changes in consumption over time.

Results:
Psychotropic medication sales rose from 30.19 to 35.10 DDD per 1000 inhabitants per day from 2017 to 2022 (CAGR 3.06%). From 2017 to 2022, consumption of antipsychotics and antidepressants increased at a CAGR of 2.72% and 5.23%, respectively, while consumption of anxiolytics, hypnotics and sedatives decreased at a CAGR of -0.55% and -0.27%, respectively. From 2019 to 2020, anxiolytics (CAGR 3.04%), hypnotics and sedatives (CAGR 2.18%) observed a significant increase, but their consumption decreased from 2021 to 2022. High-income countries experienced the largest growth in consumption of psychotropic medications.

Discussion:
The overall consumption of psychotropic medications in 83 high- and middle-income countries has increased from 2017 to 2022, with the highest growth observed in antidepressants and high-income countries. The observed increase in consumption of anxiolytics, hypnotics and sedatives during the pandemic, followed by a decrease after the pandemic, indicates that there were increased anxiety and sleep difficulties during the pandemic and it's possible that these issues naturally improve after the pandemic.

Introduction:
The therapeutic landscape for chronic lymphocytic leukemia (CLL) has profoundly transformed recently. However, the demographic, clinical, and therapeutic differences in CLL between China and the US are not well known.

Objectives:
To enhance our understanding of the disparities in CLL between China and the US by providing a comprehensive comparative analysis of patient characteristics, therapeutic strategies, and survival outcomes.

Methods:
This cross-sectional study involves data from the Flatiron Database and a single-center hospital in China, focusing on patients diagnosed with CLL and receiving systemic therapy. The sample included patients newly diagnosed with CLL with continuous healthcare encounters.

Results:
A cohort of 18,782 CLL patients was identified from the Flatiron (n = 15,786) and Tianjin CAMS (n = 2,296) databases. Median ages at diagnosis were 66 (IQR: 59-74) and 61 years (IQR: 53-68) for the US and China, respectively. Advanced stages III-IV were diagnosed in 2,265 (25.7%) US and 915 (36.0%) Chinese patients (p<0.001). IGHV mutation rates were 39.0% and 67.8%, respectively (p<0.001). From 2017 to June 2023, the prevalence of targeted therapy in the US rose from 37.1% to 67.0%, and in China from 7.1% to 70.5%. Comparative analysis of treatment regimens revealed an initially lower uptake of first-line targeted therapy in China (23.2% vs. 41.4% in the US). Conversely, by the third line and beyond, China's targeted therapy usage (66.7%) surpassed that of the US (64.9%). Survival analysis showed no significant difference in overall survival between US and Chinese CLL patients (p=0.73), with median survival times of 9.7 (IQR: 8.8-10.8) and 9.4 years (IQR: 8.3-10.4), and 5-year survival rates of 70.5% and 69.2%, respectively.

Conclusions:
This cross-sectional analysis indicates that American and Chinese CLL patients have significant differences in baseline characteristics, but the gap in treatment regimens and survival outcomes is gradually narrowing.

Introduction. Bloodstream infection (BSI) is one of the leading causes of morbidity and mortality worldwide. Understanding prescribing patterns of antimicrobials for treating BSIs is imperative to improve clinical practices and particularly antibiotic stewardship programmes.
Aims. To characterize antimicrobial prescriptions of inpatients with bacterial BSIs in relation to characteristics of patients in Hong Kong in 2012-2021.
Methods. Individual electronic medical records for patients admitted into Hong Kong public hospitals from January 1, 2012 to December 31, 2021 provided by the Hospital Authority (HA) were utilized to identify BSI patients and events and to characterize related antibiotic prescribing patterns using information on patient demographics, antimicrobial prescriptions, microbiological testing result and antibiogram from antibiotic susceptibility test, etc.
Results. A total of 116,504 patients with BSI leading to 144,934 BSI events were identified over the study period, with 92.8% and 89.4% of the defined BSI events recorded of empirical and definitive antimicrobial treatment, respectively. Among empirical treated BSI events, 96.5% were prescribed with intravenous agents and amoxicillin/clavulanic acid, piperacillin/tazobactam and meropenem were mostly frequently used. There were 58,337 (43.4%) BSI events receiving monotherapy as empirical treatment. The median duration of definitive treatment was 7 (IQR, 4-13) days, with penicillins/β-lactamase inhibitors being most commonly used for BSIs with Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Citrobacter species. Antipseudomonal penicillins/β-lactamase inhibitors and carbapenems were also prescribed frequently for treating BSIs with various causative pathogens.
Discussion. The intensive use of broad-spectrum antibiotics in BSI inpatients warrants further investigations about the antimicrobial resistance profile of causative bacteria and the clinical impact of a plenty of antibiotic exposure on BSI patients. Appropriate recommendations could be provided after understanding antibiotic prescribing patterns to improve clinical practice guidelines for BSI treatment.

Introduction:

The impact of repeated influenza vaccination on vaccine effectiveness in the elderly has been debated, and comprehensive studies in China are limited.
Aims:

To evaluate the effect of repeated influenza vaccination on the prevention of laboratory-confirmed influenza in elderly individuals in Ningbo, China.
Methods:

We conducted a test-negative case-control study using data from the Regional Health Information Platform. The study included individuals aged 60 and above during four influenza seasons from 2018-19 to 2021-22. Influenza-positive cases and negative controls were matched in a 1:1 ratio based on the visiting hospital and the date of influenza testing. Propensity score adjustment and multivariable logistic regression were employed to estimate risk and control for confounding factors.
Results:

Out of 30,630 elderly patients tested, 1,976 influenza-positive cases and 1,976 influenza-negative controls were analyzed. Multivariable logistic regression showed no significant increase in influenza illness risk for those vaccinated in two consecutive seasons compared to those vaccinated only in the current season (adjusted OR: 1.22, 95% CI: 0.94-1.58). However, individuals vaccinated only in the previous season had an increased risk (adjusted OR: 1.56, 95% CI: 1.15-2.10), and the risk was highest in those not vaccinated in either of the two consecutive seasons (adjusted OR: 3.39, 95% CI: 2.80-4.09).
Discussion:

Our findings indicate that receiving the current season's influenza vaccine is the most effective strategy for protecting the elderly, regardless of their vaccination history from the previous season. This supports annual vaccination initiatives for elderly populations to maintain high levels of protection against influenza.

Introduction:
Evidence on the effectiveness of influenza vaccination in the elderly is limited and controversial, with few reports from China.
Aims:
To estimate the effectiveness of the inactivated influenza vaccine (VE) against laboratory-confirmed influenza-associated visits among elderly individuals in Ningbo, China, across four influenza seasons.
Methods:
A test-negative case-control study was conducted among elderly individuals (aged ≥60 years) from 2018-19 to 2021-22. Influenza-positive cases and negative controls were matched 1:1 by age, sex, hospital, and date of influenza testing. Logistic regression models were used to compare vaccination odds ratios (ORs) between cases and controls. VE was calculated as [100% × (1-adjusted OR)] with 95% confidence intervals (CI).
Results:
Out of 30,630 elderly patients tested, 1,825 influenza-positive cases and 1,825 influenza-negative controls were included. The overall adjusted VE for influenza-related visits was 63.5% (95% CI, 56.3–69.5%), varying by season. VE was 59.8% (95% CI, 51.5–66.7%) for influenza A and 89.6% (95% CI, 77.1–95.3%) for influenza B. VE for ages 60-69 was 65.2% (95% CI, 55.4–72.9%), for ages 70-79 was 69.8% (95% CI, 58.7–77.9%), but only 45.4% (95% CI, 6.2–68.2%) for ages 80 and over.
Discussion:
The standard-dose inactivated influenza vaccine provides substantial protection in elderly individuals in China, though its effectiveness decreases in those aged 80 years and older. These findings support continued vaccination efforts, with consideration for additional measures to protect the oldest age groups.

Introduction
Patients with aortic stenosis (AS) often require aortic valve replacement (AVR). The Ross procedure, first described by Donald Ross in 1967, replaces the damaged aortic valve with the patient's pulmonary valve. Compared to mechanical (M-AVR) and biological aortic valve replacements (B-AVR), the Ross procedure is associated with significant long-term reductions in stroke and major bleeding incidences and improved survival from cardiac and valve-related mortality. However, research on in-hospital outcomes among AS patients underwent Ross, M-AVR, and B-AVR remains limited.
Aims
To investigate in-hospital outcomes of AS patients underwent the Ross procedure compared to those underwent M-AVR and B-AVR.
Methods
Admissions of children and adults were identified from the Kids' Inpatient Database (KID) and National Inpatient Sample (NIS) collected from 2000 through 2020. Exact matching was employed to mitigate selection bias, and generalized estimating equations were applied to determine differences in in-hospital outcomes.
Results
We identified 875 pediatric AS patient cases, among which 480 (54.9%), 242 (27.6%), and 153 (17.5%) underwent the Ross procedure, M-AVR, and B-AVR, respectively. Among 1546 adult AS patients identified after exact matching, 168 (10.9%), 719 (46.5%), and 659 (42.6%) underwent the Ross procedure, M-AVR, and B-AVR, respectively. No statistically significant difference in mortality was observed among the three surgical types for both adults and children. However, the Ross procedure was associated with lower complication rates but higher acute kidney injury rates in children, especially compared to M-AVR. Adult AS patients underwent the Ross procedure exhibited worse outcomes than children regarding blood transfusions, procedural support, and acute kidney injury rates.
Discussion
Compared to M-AVR and B-AVR, the Ross procedure may be associated with increased complications but show no statistically significant difference in mortality, particularly in adult AS patients.

Introduction:
Type A aortic dissection (TAAD) surgery carries a significant risk of acute kidney injury (AKI), exacerbated by intraoperative hypotension and venous congestion. Effective hemodynamic management is crucial to mitigate these risks.

Aims:
To assess whether intraoperative hypotension and venous congestion are significant predictors of postoperative kidney injury and other major adverse events following TAAD surgery.

Methods:
We collected demographic, laboratory, and outcome data for adults who underwent TAAD surgery from January 2016 to July 2023. Primary exposures were venous congestion, defined by central venous pressure (CVP) thresholds of ≥12, 16, or 20 mmHg, and mean arterial pressure (MAP) thresholds of ≤55, 65, or 75 mmHg. Primary outcomes were AKI and acute kidney disease (AKD). Secondary outcomes included death and stroke. We used restricted cubic spline regression and multivariate logistic regression to adjust for confounding factors.

Results:
Among 543 subjects, AKI or AKD was significantly associated with each 10-minute epoch of CVP ≥10, 12, 16, or 20 mmHg (all p < 0.001), and each 60-minute epoch of CVP ≥10, 12, 16, or 20 mmHg area under the curve (AUC) (all p < 0.001). Mortality increased by 6% to 13% for each 10-minute epoch of CVP ≥10, 12, 16, or 20 mmHg (all p ≤ 0.003) and by 5% to 21% for each 60-minute epoch of CVP ≥10, 12, 16, or 20 mmHg AUC (all p < 0.001). Stroke risk increased by 5% for every 10-minute CVP AUC above 16 mmHg and by 11% for CVP AUC above 20 mmHg (p = 0.039 and p = 0.031, respectively).

Discussion:
Both CVP and MAP are associated with the risk of postoperative AKI and AKD in TAAD patients. CVP showed a direct correlation with postoperative mortality and stroke.

Introduction
Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic condition that often necessitate long-term care and social support. Pharmacotherapy is recognized as an important intervention to improve not only the core symptoms of ADHD but also social outcomes. Previous studies indicated low persistence and adherence to ADHD medications in those patients.

Aims
To clarify the persistence and adherence of ADHD medications in Japanese patients.

Methods
The study population were identified in the claims database provided by JMDC Inc. Patients who received an incident prescription of target medications from May 2017 to December 2021 were included. The target medications were methylphenidate slow-release preparation, atomoxetine, guanfacine, and lisdexamfetamine, approved for ADHD in Japan. An incident prescription was defined as one with no prior prescription record of the target medications during a lookback period of 180 days or more before the prescription date. A patient was considered to be continuously using a medication from the initial to last fill date plus the days supply dispensed on the last fill date and when a subsequent prescription was issued within a 60-day gap after the days supply dispensed on the last fill date. Switching among the target medications was also considered as continuation. Median medication persistence was estimated using Kaplan-Meier method and persistence rates were estimated at 1 and 2 years after the index date.

Results
Among the 31,457 subjects, 21,081 (67%) were male, with a median age of 19 years. The median medication persistence was 221 days, with persistence rates of 40.3% at 1 year and 27.3% at 2 years after the index date.

Discussion
Low persistence of ADHD medication was observed, and early discontinuation was common, as reported in the other countries. The reasons may include ineffectiveness of medications, side effects of medications, and poor self-management skills due to ADHD symptoms.

Introduction

Use of medications to treat attention-deficit/hyperactivity disorder (ADHD) is becoming increasingly prevalent among women of reproductive age, but little is understood about their cardiometabolic effects in pregnancy.

Aims

We aimed to examine potential associations between ADHD medication use and cardiometabolic conditions during pregnancy (gestational hypertension, preeclampsia and gestational diabetes) and the pharmacological treatment thereof.

Methods

We conducted a population-based matched cohort study based on linkage of the New South Wales (NSW) Admitted Patient Data Collection with Pharmaceutical Benefits Scheme (PBS) dispensing data. We included women aged 18-55 from NSW, Australia, who gave birth between January 2014 and June 2021. We compared the prevalence of cardiometabolic conditions and new cardiometabolic medication use during pregnancy among women who used ADHD medications during pregnancy (n=366) with a 1:10 matched cohort of unexposed women, and also with women who had used ADHD medications in the 12 months before pregnancy (n=252). We used Poisson regression models adjusted for various sociodemographic and pregnancy-related factors.

Results

Compared with unexposed women, women who used ADHD medications during pregnancy had an increased risk of gestational hypertension (10.1% vs. 4.8%; aRR: 1.76, 95% CI: 1.20-2.57) and gestational diabetes (17.9% vs. 13.5%; aRR: 1.41, 95% CI: 1.09-1.82), with slightly elevated risk estimates for preeclampsia (6.3% vs. 4.0%; aRR: 1.30, 95% CI: 0.82-2.05) and new cardiometabolic medication use (10.7% vs. 6.6%; aRR: 1.40, 95% CI: 0.97-2.01). Compared with women who used ADHD medications before pregnancy, women who used ADHD medications during pregnancy had a greater risk of gestational diabetes (17.9% vs. 8.3%; aRR: 1.76, 95% CI: 1.06-2.93), but not of hypertensive disorders of pregnancy nor initiation of cardiometabolic medications.

Discussion/Conclusion

Women using ADHD medications have an increased incidence of cardiometabolic conditions during pregnancy, but it remains unclear to what extent this is attributable to the medication rather than the underlying ADHD.

Introduction
Reliable coding algorithms are pivotal for real-world data studies to provide high-quality evidence to assist clinical medical decision-making.

Aims
To analyze the validity of the International Classification of Diseases, Ninth and Tenth Revision, Clinical Modification (ICD-9-CM and ICD-10-CM) diagnosis codes in a multi-institutional electronic medical records (EMR) database to identify patients diagnosed with relapsed metastatic breast cancer.

Methods
This validation study included patients diagnosed with early stage breast cancer who received curative operation from January 1, 2011 to December 31, 2023. A simple random sample of 5% was selected from the original cohort of 9221 early stage breast cancer patients. Relapsed metastatic breast cancer was defined by ICD code (ICD-9-CM: 195.x to 196.x, excluded 196.3; ICD-10-CM: C76.x to C80.x, excluded C77.3) after curative therapies. Medical chart review according to AJCC 8th staging criteria and pathology-confirmed was defined as the gold standard to determine the presence of metastases. We estimated the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ICD-CM codes in our database.

Results
A total of 391 early breast cancer patients with mean age of 54.8 (SD: 12.1) were included in our study. Among the total of 41 cases coded as metastases, 17 had met the AJCC criteria. As a result, the ICD-CM coding algorithm to define relapsed metastatic breast cancer reached a sensitivity of 73.9% (95% CI: 55.9–91.8), a specificity of 93.4% (95% CI: 90.9–96.0), and PPV and NPV of 41.4% (95% CI: 26.3–56.5), 98.2% (95% CI: 96.9–99.6), respectively.

Conclusion
Our analysis demonstrated utilization of ICD-CM codes had low PPV in identifying patients diagnosed with relapsed metastatic breast cancer in EMR database. Further additional operational definitions or algorithm needed to develop to identify relapsed metastatic breast cancer.

Background:
The assessment of chronic obstructive pulmonary disease (COPD) severity are guided by the GOLD guideline, which categorizes patients based on exacerbation history and symptoms using the modified Medical Research Council (mMRC) dyspnea scale or the COPD Assessment Test (CAT). However, these measures are unavailable in Taiwan claims database.
Objective:
We aimed to develop and validate a method to assess COPD severity using claims database.
Methods:
The study enrolled patients from the COPD pay-for-performance (P4P) program file between 2017 and 2022, using the enrollment date as the index date. The P4P file included information on lung function, forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), exacerbation frequency, CAT, mMRC, and the GOLD classification (Groups A to D), which served as the gold standard.
Further, COPD P4P file was linked to Taiwan National Health Insurance (NHI) claims database, containing medical diagnoses, procedures, and prescriptions. In claims database, three models using medical records of emergency room (ER) visit or hospitalization due to acute exacerbation (AE) with/without related medications were developed to identify COPD severity. The accuracy rate, sensitivity, specificity and positive predictive value (PPV) were reported.
Results:
Among the study subjects, 78% (35,603/45,632) were classified as having mild COPD (GOLD group A+B) according to the COPD P4P file. The model using AE hospitalization combined with related medications from the claims database demonstrated the highest accuracy rate of 78.8% for identifying mild COPD severity. This model exhibited a sensitivity of 88.3%, specificity of 45.2%, and PPV of 85.1%. However, its performance in identifying patients with severe COPD (GOLD group C+D) was lower, with a sensitivity of 45.2% and a PPV of 52.1%.
Discussion:
The model used AE hospitalization records with related medications is more effective to identify patients with mild COPD rather than those with severe COPD in claims database.

Aim/Objective: There is a lack of published evidence on factors associated with adherence (maintenance of cumulative vaccination) to seasonal influenza vaccination (SIV) in Manitoba, Canada. We sought to assess the associations.

Methods: A cohort study utilizing Manitoba administrative health databases. Participants received SIV in 2010/11 influenza season, remained registered Manitoba residents and received at least one SIV during the 2011/12-2019/20 seasons. We dichotomized adherence into “more adherent” (6-9 SIVs) and “less adherent” (1-5 SIVs) and used multivariable adjusted generalized estimating equation logistic regression models to assess association between adherence and socioeconomic, health-related, and primary care physician (PCP) characteristics, stratified by age group (<5-, 5-17-, 18-44-, 45-64-, ≥65-year-olds) and sex. Results are adjusted odds ratios with 95% confidence intervals.

Results: We included 152,493 individuals. Males had lower odds of being more adherent except among ≥65-year-olds (1.03 [1.01-1.05]). Compared with the lowest income quintile, those in higher income quintiles had higher odds of being more adherent. The odds mostly increased with increase in income quintile. Those with more contact with the PCP/hospitalization one year prior had higher odds of being more adherent. The odds increased with increased contact among 18-44-, 45-64- and ≥65-year-olds. Those who had PCP with more years of practice had higher odds of being more adherent. The odds increased as years of practice increased. These observations were mostly consistent irrespective of sex.

Conclusion: Female gender, and having higher income, more contact with the health system and experienced PCP may determine increased adherence to SIV in Manitoba. These findings require attention.

Introduction: Antipsychotic use for non-psychotic illnesses including anxiety, aggression, eating disorders, and behavioural and mood disorders is on the rise among children and adolescents. Paediatric antipsychotic treatment may be prescribed at low doses for many years along with psychotropic comedication, which is a cause for concern since safety issues have not been adequately examined in this situation.
Aims: This systematic review was conducted to investigate the cardiometabolic safety of prolonged antipsychotic use in this population with non-psychotic disorders.
Methods: A systematic search of six electronic databases was carried out. Both randomised clinical trials and observational studies with a duration of at least a year among patients aged 18 years or younger were included. Outcomes studied were hyperglycemia, dyslipidemia, hypertension, weight gain, metabolic syndrome, ischemic heart disease, and thrombosis, and any comparator was allowed. Both continuous and dichotomous measures were captured. Clinical heterogeneity necessitated data synthesis through a vote counting method and creation of an effect direction plot.
Results: There were 15 observational studies with 114,141 participants (mean age 10.93 years, 83.5% males); no clinical trials fulfilled the eligibility criteria. Autism and Tourette syndrome were studied in two-thirds of the studies. Prolonged antipsychotic treatment was associated with hyperglycemia (100%, n=6), metabolic syndrome (100%, n=2), weight gain (91.6% studies, n=12) and dyslipidemia (66.6%, n=6) as shown by the effect direction plot. Results were inconclusive for hypertension while no studies investigated ischemic heart disease or thrombosis. All studies were of moderate to high methodological quality.
Conclusions: Prolonged antipsychotic exposure in children, who are still undergoing physiological development, has the potential to disrupt metabolic processes that can have lasting repercussions. It is crucial that healthcare providers give careful consideration to safety issues in their approach to antipsychotic prescription in children and initiate metabolic monitoring in a proactive manner.

Aim/Objective: In 2010, the government of the province of Manitoba, Canada introduced universal seasonal influenza vaccination policy (USIVP), providing free-of-charge vaccination to all registered residents of the province at least six months of age. Impact of the policy on seasonal influenza vaccine (SIV) uptake (receipt of vaccine) in Manitoba remains unclear, as there is a lack of published evaluations.

Methods: We conducted an ecological study, utilizing population-wide data from several linked de-identified Manitoba Health and Seniors Care administrative health databases. The study period was from 2000/01–2019/20 influenza seasons. The primary exposure was USIVP (five influenza seasons pre-policy [2005/06–2009/10] compared with post-policy [2010/11–2014/15]). The outcome was SIV uptake. We conducted pre/post logistic regression analysis stratified by age group (<5-, 5-17-, 18-44-, 45-64-, ≥65-year-olds) and certain population socioeconomic and health-related characteristics. Results are adjusted odds ratios with associated 95% confidence intervals.

Results: We observed significantly increased adjusted odds of SIV uptake post-policy relative to pre-policy in all age groups except ≥65-year-olds already covered from inception of the vaccination program. The adjusted odds ratios ranged from 0.76 (0.75-0.76) among ≥65-year-olds to 2.15 (2.13-2.18) among 5-17-year-olds, and were largely homogeneous within age groups across sex, income quintiles, regions of residence, and categories of number of visits to primary care physician/hospitalization one year prior to an influenza season except among <5- and 5-17-year-olds. These findings were mostly consistent irrespective of sex and region of residence although there was variability across income quintiles in Northern Manitoba region.

Conclusion: Introduction of the USIVP in Manitoba was followed by a significant increase in SIV uptake in the five years post policy among <65-year-olds, with similar increased relative odds of vaccination observed within age groups across subpopulations. The observed variations in the relative odds of vaccination across income quintiles in Northern Manitoba region requires administrative attention.

Aim/Objective: Human papillomavirus (HPV) vaccination rates among females are lower than the World Health Organization target and vaccination rates specifically among adult females are even much lower.

Methods: We systematically evaluated individual socioeconomic/health-related characteristics associated with HPV vaccination initiation and completion among adult females. We performed a literature search on December 14, 2022, and supplemented the search on August 1, 2023. We pooled appropriate multivariable-adjusted results using an inverse variance random-effects model and expressed the results as odds ratios with associated 95% confidence intervals. A point pooled significantly increased/decreased odds of 30–69% was regarded to be strongly associated, and ≥70% was very strongly associated.

Results: We included 63 cross-sectional studies. There were strongly increased odds of vaccination initiation among White women compared with Blacks or Asian women, and those with higher education, health insurance, a history of sexually transmitted infection (STI), receipt of influenza vaccination in the preceding year, not married/cohabiting, not smoking, using contraception, and having visited a healthcare provider in the preceding year. We observed very strongly increased odds of vaccination initiation among those younger and having been born in the country of study. Similarly, there were strongly increased odds of completing the vaccination series for the same variables as initiating vaccination, except for higher education, prior STI, smoking and contraception use. Additional variables associated with strongly increased odds of vaccination completion not seen in initiation were higher annual household income, being lesbian/bisexual, and having a primary care physician. We observed very strongly increased odds of vaccination completion similar to vaccination initiation, but including for White compared with Black women, higher education, and prior cervical cancer screening.

Conclusion: These individual characteristics may be the key to identifying women at increased risk of not being vaccinated against HPV and could inform targeted messaging to drive HPV vaccination.

- Introduction
In advancing the use of observational routinely collected healthcare databases in Japan's vaccine pharmacovigilance, it is essential to establish epidemiological evaluation methods for each step of signal management (signal detection, signal verification, and risk minimization for identified risks). Systematic discussions on methodologies for signal confirmation are insufficient, and no guidelines have been issued from Japan.

- Aims
This study presents our findings of designs and analytical methods for verification of safety signals in vaccine pharmacovigilance.

- Methods
We reviewed optimal designs and analytical methods for assessing causality in vaccine adverse events using routinely collected healthcare databases. Specifically, we first conducted a literature search on vaccine adverse events mainly using vaccine safety datalink to identify representative designs and analytical methods. Next, we summarized the characteristics of each design and analytical method, along with the statistical considerations for their application.

- Results
Cohort studies and Self-Controlled Case Series (SCCS) were identified as representative designs. Additionally, the study design and analysis methods used tended to differ depending on the "target vaccination population," "vaccination method (frequency)," and "adverse events of interest. The importance of conducting Quantitative Bias Analysis and applying appropriate sensitivity analyses was highlighted due to the many assumptions used in any design or method.

- Discussion/Conclusion
We conducted a literature search on designs and analytical methods for verification of vaccine safety signals using healthcare databases and organized the statistical considerations. It is crucial to use methods tailored to disease characteristics and to quantitatively present the reliability of the results through sensitivity analyses.

Introduction: Endoscopic retrograde cholangiopancreatography (ERCP) is a commonly used procedure for diagnosing and treating conditions of the biliary tract and pancreas. However, this procedure can also result in post-ERCP pancreatitis, a severe and potentially life-threatening complication.
Aim: To evaluate the impact of the timing and procedures of cholecystectomy relative to ERCP on the risk of developing post-ERCP pancreatitis.
Methodology: A thorough literature search was performed in PubMed, Cochrane CENTRAL, and Google Scholar from the inception of 20th November 2023. A combination of keywords, MeSH terms, and entry terms on Cholecystectomy, Laparoscopic Cholecystectomy, Pancreatitis, and Gallbladder disease was combined with Boolean operators. All randomized controlled trials (RCTs) examined mainly the influence of timing and procedures of cholecystectomy on the incidence of post-ERCP pancreatitis were included. The Random-effects model was used based on the heterogeneity identified using the I² statistic and Cochran's Q test.
Results: The results showed that the incidence of post-ERCP pancreatitis varied widely depending on the type of ERCP procedure performed. Out of 16 non-duplicate research articles identified through database searching, 4 studies, with 3621 patients, were included in this study. The risk of pancreatitis (OR 0.43, 95% CI: 0.26-0.72, p=0.001) was significantly lesser in the pre-ERCP procedure group than in the post-ERCP procedure group.
Conclusion: This systematic review & meta-analysis provides evidence that post-ERCP cholecystectomy is associated with a higher risk of post-ERCP pancreatitis than pre-ERCP cholecystectomy. These findings have important implications for clinical practice and may guide decisions regarding the timing and procedure of cholecystectomy in patients undergoing ERCP. Further studies are needed to confirm these results and identify the underlying mechanisms contributing to this relationship.
Keywords: Pancreatitis, Endoscopic retrograde cholangiopancreatography (ERCP), Cholecystectomy, Systematic review.

Introduction:
Anemia and transfusion are closely linked to critical outcomes affecting postoperative recovery and renal function in cardiac surgery. The relationship between early postoperative hemoglobin levels and adverse kidney outcomes, including acute kidney injury (AKI) and acute kidney disease (AKD), remains underexplored, particularly with respect to sex-specific differences.

Aims:
This study aims to assess the sex-specific mediating effect of postoperative hemoglobin on the relationship between preoperative anemia and postoperative outcomes.

Methods:
We conducted a multicenter retrospective cohort study including patients who underwent cardiac surgery at three medical centers in China. Hemoglobin levels were measured preoperatively and postoperatively, with anemia defined by WHO criteria. A mediation analysis framework was applied; the main exposure was early postoperative hemoglobin, analyzed using spline regression, and further stratified by sex and preoperative anemia severity. Sensitivity analyses were performed using different reference levels for postoperative hemoglobin.

Results:
Among 9,135 patients, the incidence of preoperative anemia was slightly higher in females (35.0%) compared to males (32.9%). Among non-anemic patients, males exhibited a significant increase in AKI risk with postoperative hemoglobin levels below 9 g/dL, while females did not show significant risk changes. For anemic patients, risk curves were nearly linear for both sexes, but females with moderate to severe anemia had a higher increase in AKI risk when postoperative anemia was severe. Mediation analysis revealed that the indirect effect of postoperative hemoglobin on AKI was higher in males (mediation proportion 41.1% vs. 22.3%), with mediation proportions increasing with anemia severity (39.0%-50.8% vs. 19.0%-31.4%). For AKD and LOS outcomes, similar sex-specific patterns were observed, with males showing greater mediation effects.

Discussion:
Our findings show that early postoperative hemoglobin levels mediate the relationship between preoperative anemia and adverse kidney outcomes, with stronger effects in males. This highlights the need for sex-specific anemia management strategies to improve postoperative outcomes.

Introduction: Cardiac surgery is a crucial medical specialty that addresses a wide range of cardiovascular conditions. While technological advancements and surgical expertise have significantly improved outcomes, it is important to recognize that complications can still arise after these procedures. These complications can vary in severity and may affect different aspects of a patient's health, from the cardiovascular system to respiratory and neurological functions. Understanding and managing these potential issues is a fundamental aspect of ensuring successful clinical outcomes after surgical interventions.
Aim: This study aims to identify the risk factors for postoperative complications in patients following cardiac surgery and interventional procedures.
Methodology:
A total of 103 patients who had undergone any of the below cardiac surgeries such as Coronary-Artery-Angiography, Percutaneous transluminal coronary angioplasty, Coronary Artery Bypass Graft, Temporary pacemaker Implantation or Atrial Septa Defect, Closure/ Valve Replacement were included in the study. Suitable data collection forms were prepared to capture the patient details such as patient demographics, current medications, past medical and medication history, nursing notes, and laboratory data from patient case files.
Results: Postoperative complications occurred in 91 (88.3%) of patients. The most common complications were hyponatremia in 38 (36.8%), anemia in 33 (32%), hypertension in 33 (32%), tachycardia in 15 (14.5%), hypokalemia in 15 (14.5%), and hypophosphatemia in 10 (10.6%) patients.
Commonly reported risk-factors include patient demographics (such as advanced age and gender), preoperative comorbidities (hypertension, diabetes, and renal dysfunction), anatomical complexity of surgical procedure, duration of cardiopulmonary bypass and cross-clamp time, intraoperative blood loss and transfusion requirements, and perioperative management strategies.
Discussion:
Study findings reveal a high prevalence of postoperative complications after interventional-cardiac surgery, affecting nearly 9 out of 10 patients. Common complications include hyponatremia, anemia, hypertension, tachycardia, hypokalemia, and hypophosphatemia, stemming from surgical factors, pre-existing conditions, and postoperative protocols.
Key-Letter: - Cardiac-surgery, post-operative, Complications, Risk-factors

Introduction:
Intraoperative acquired pressure injuries pose significant risks to patients undergoing surgery, impacting their physical health and postoperative recovery. These injuries not only cause discomfort but also lead to complications, prolonged hospital stays, increased costs, and diminished quality of life. The incidence of intraoperative pressure injuries in cardiovascular surgery patients is alarmingly high, emphasizing the importance of prevention in this population.

Aims:
To identify factors influencing intraoperative acquired pressure injuries and develop a reliable risk prediction model to facilitate the implementation of preventive measures.

Methods:
Logistic regression, naive Bayes, random forest, support vector machine, Extreme Gradient Boosting, and Gradient Boosting Decision Tree models were individually established for risk prediction. These models were weighted and integrated, with evaluation based on accuracy, recall, precision, AUC, and F1 Score metrics.

Results:
The integrated model demonstrated superior predictive performance and robustness (Test set: Accuracy=0.955, Precision=0.962, Recall=0.945, F1 Score=0.953, AUC=0.994; Validation set: Accuracy=0.833, Precision=0.907, Recall=0.907, F1 Score=0.907, AUC=0.725), effectively forecasting the risk of intraoperative acquired pressure injuries. Interpretive analysis using the SHAP framework highlighted gender and age as significant risk factors visually. Anesthesia duration, estimated glomerular filtration rate, and white blood cell count emerged as critical decision-making factors in the model.

Discussion:
This analysis employed an integrated approach to optimize the predictive model for intraoperative acquired pressure injuries, contributing to the advancement of research in this domain.

Introduction:
Postoperative complications in patients following cardiac surgery remain a significant concern, with drug-related problems (DRPs) being potential contributors. Identifying and addressing these DRPs are essential for optimizing patient outcomes and reducing morbidity and mortality.
Aim:
To analyze Drug-Related Problems (DRPs) as contributors to postoperative complications in patients following cardiac surgery and interventional procedures.
Methodology:
Between December 2023 and June 2024, a prospective observational study investigated the incidence and preventability of DRPs in a single cardiac care center. DRPs were classified by Hepler-Strand Classification and scales utilized to analyze these DRP’s are Naranjo causality assessment scale, Schumock and Thornston preventability scale, WHO causality assessment scales, Hartwig’s severity scale, predictability scale.
Results:
A total of 103 patients were included in the analysis. DRP’s occurred in 49 (47.5%) of patients. The most common DRP’s were drug-drug interaction were 34 (33%), ADR in 8(7.7%), and unindicated indication in 7 (6.79%) patients. The most frequently observed adverse drug reactions (ADRs) included heparin-induced thrombocytopenia and drug-induced hypoglycemia. Additionally, untreated indications comprised two cases of respiratory acidosis, one case of lactic acidosis, and one case of anemia.
Discussion:
This study highlights the significant impact of drug-related problems (DRPs) on postoperative complications in patients following interventional cardiac surgery. Among the identified DRPs, drug-drug interactions, and adverse drug reactions (ADRs) were notable contributors.
High DRP prevalence, affecting nearly half of patients, highlights medication management complexity postoperatively. Unindicated indications emerged as significant DRPs, stressing rational prescribing and evidence-based perioperative care.
By addressing DRPs effectively, healthcare providers can optimize patient outcomes, reduce morbidity and mortality, and enhance the overall quality of care delivered to patients undergoing cardiac surgery.
Key Words: - Postoperative complication, Drug-related problems (DRPs), Cardiac surgery, Drug-drug interaction, Adverse drug reactions (ADRs)

Introduction:
Postoperative acute kidney injury (AKI) and acute kidney disease (AKD) are significant risks, affecting up to 30% of cardiac surgery patients. Various factors contribute to these outcomes, including patient and surgical factors. Despite its potential as a predictor, biological aging remains underexplored in the analysis of postoperative AKI.

Aims:
This study aimed to describe biological aging in cardiac and noncardiac surgery patients and evaluate its association with postoperative renal dysfunction (AKI and AKD). We hypothesized that accelerated biological aging would correlate with increased risks of AKI and AKD, and assessed healthcare resource utilization linked to postoperative renal outcomes.

Methods:
Baseline demographics, stratified by phenotypic age acceleration (PhenoAgeAccel), were reported using mean (SD), median (IQR) for continuous variables, and number (percentage) for categorical variables. Outcome frequencies with 95% confidence intervals were depicted. Cox models assessed PhenoAgeAccel’s association with postoperative AKI, while generalized linear models explored links with AKI stages and AKD.

Results:
A total of 23,247 patients were included. Analysis showed that patients with AKI and AKD tended to have higher phenotypic age. Patients with PhenoAgeAccel, particularly those with SD >2, were more susceptible to AKI, stage 2+ AKI, and AKD compared to those with phenotypic age deceleration. Subgroup analysis showed males (aOR 2.60) and non-cardiac surgeries (aOR 2.79) were more prone to AKI, whereas females (aOR 4.04) and non-cardiac surgeries (aOR 2.79) were more associated with stage 2 or above AKI and AKD. Non-linear regression demonstrated a rising trend, indicating an increased likelihood of AKI and AKD with higher SD. Cumulative incidence curves showed notably higher AKI likelihood in patients with SD >2, especially within 2 days postoperation.

Discussion:
As biological age increases, the risk of postoperative AKI and AKD escalates. This highlights the importance of considering biological age as a predictor in managing postoperative outcomes.

Introduction: Medical devices play a crucial role in healthcare delivery system but can also cause adverse events compromising patient safety and effecting overall outcomes.
Aims: To assess the pattern of Medical Device Associated Adverse events (MDAEs) among patients in critical care settings.
Methods: An active surveillance study was conducted over nine months in critical care units. Patients were monitored daily for MDAEs through case sheet reviews, interviews with patients and healthcare professionals. Reported MDAEs were assessed for causality, severity, and device disposition according to Materiovigilance Program of India (MvPI) guidelines version 1.2. Patterns of MDAEs were analyzed categorically, risk stratification, and nature of adverse events. Predictors associated with MDAEs were calculated using odds ratios at a 95% confidence interval
Results: A total of 242 MDAEs were reported among 180 patients, with the majority of MDAEs occurring in elderly patients (25.5%). Ventilator-associated pneumonia was higher among mechanical ventilator users [80(33.05%)], and most were non-implantable devices [203(83.88%)]. Regarding device risk classification, category C was the most frequently reported [130(53.71%)]. The causality assessment for [136(56.19%)] of the MDAEs was probable, with [195(80.57%)] being non-serious events. Almost all MDAEs [114(47.10%)] were device-associated and were disposed of within healthcare facilities [96(63.2%)]. Concerning patient outcomes, [222(91.7%)] of the study population recovered. Comorbidities and length of hospital stay were significant predictors [OR= 2.6 CI: 1.05-6.76, p= 0.039].
Conclusion: MDAEs in ICUs and in-patient wards contribute to patient distress and extended hospital stays. Continuous monitoring and reporting of MDAEs are essential to mitigate their incidence and improve patient safety.
Keywords: Materiovigilance, Medical devices, Medical Device Associated Adverse events

Introduction/Aims: Real-world evidence (RWE) has been used widely in many countries during Health Technology Assessment (HTA) submissions and appraisals. Japan formally implemented cost effectiveness analyses (CEA) for price adjustment (HTA system) from April 2019. This presentation assessed the use of RWE in Japan CEA.
Methods: We reviewed HTA dossiers submitted by pharmaceutical companies and appraisal reports created by the Center for Outcomes Research and Economic Evaluation for Health (C2H) published on their website until December 2023. We categorized RWE use cases based on the area supported and summarized by the type of RWE data source in those reports.
Results: Company dossiers on 13 products and C2H appraisal reports on 25 products were available on the C2H website until December 2023. From these reports, 70 RWE use cases were identified for 22 products, with multiple use cases in some products. Resource utilization estimation (health state cost, adverse event cost, complication cost) is the most common RWE use (24), followed by analytical population proportion estimation (17). Other RWE uses include epidemiology data of patient background characteristics for economic models (8), treatment costs of designated drugs and comparators (7), external comparator for single arm studies (4), health-state transition probability in economic models (4), comparative drug determination (3), effectiveness or additional benefit (3). Regarding the type of RWE data source, the most common source is the national database of health insurance claims and specific health check-ups of Japan (NDB) (23), followed by Japan commercial claims databases which include MDV, JMDC and IQVIA claims (15). Other sources include physician survey (11), patient disease registry (6) and retrospective cohort study (3).
Conclusion: These results showed that RWE was used in most HTA products with various purposes and diverse data sources in Japan and this will promote RWE use in HTA submissions and appraisals in the future.

【Introduction】
Health insurance claims data and diagnosis procedure combination (DPC) data are commonly used sources of medical information, but they have limitations when it comes to evaluating clinical outcomes like treatment effectiveness and safety. A database called "Millennial Medical Record" combines health insurance claims data, DPC data, and electronic health records (EHRs) data, which may allow for the evaluation of clinical outcomes using unstructured data from EHRs, such as progress notes.

【Aims】
The aim of this study is to examine methods for extracting clinical outcomes from unstructured data in the "Millennial Medical Record" and to assess their feasibility.

【Methods】
In this study, we analyzed progress notes in EHRs data to investigate the actual treatment status, including reasons for discontinuation of mite sublingual immunotherapy (SLIT). We focused on patients who took Actair® or MITICURE® between March 2019 and October 2022. We set keywords to extract progress notes, specifically focusing on reasons for discontinuation and adverse events. Keywords related to "discontinuation" and "drug suspension" were used to extract reasons for discontinuation, and the entire text containing these keywords was reviewed. Extracted text related to adverse events were then classified using the MedDRA for analysis.

【Results】
Out of the total study population of 640 patients, the reason for discontinuing SLIT could be determined from the progress notes in EHRs data for 139 patients. Adverse events were assessed in 457 patients. The latest figures and details will be presented on the same day.

【Discussion】
While progress notes in EHRs data provide detailed information about a patient's treatment status, the variation in what physicians write could pose a challenge for accurately determining and analyzing clinical outcomes. Further research will be conducted to establish methods for effectively utilizing unstructured data.

Introduction
Converting data from multiple databases into the common data model (CDM) allows for the rapid, convenient application of different databases. However, there is a variety of biases present in the currently conducted related studies.
Aims
To systematically summarize the biases presented in the application of CDM in pharmacoepidemiologic research, and to provide insights for controlling these biases in future research.
Methods
Five English databases (PubMed, Web of Science, EMBASE, Scopus, Virtual Health Library) and four Chinese databases (CNKI, Wan-Fang Data, VIP, SinoMed) were electronically searched to collect relevant studies on applying CDM in pharmacoepidemiologic research from inception to January 2024. Two reviewers independently screened studies and extracted information on research details, CDM-related, pharmacoepidemiology-related information, and biases reported in the articles.
Results
This study included 309 studies, with 308 in English and 1 in Chinese. Among all the included articles, 76 reported selection bias (24.6%), 198 reported information bias (64.1%), and 114 reported confounding bias (36.9%). The most frequently reported selection bias was related to the vaccine safety datalink (VSD) data, which predominantly covers individuals with long-term commercial insurance, making the data potentially non-generalizable to other populations or representative of the U.S. population (31/76). The most frequently reported information bias was misclassification bias (98/198), which was due to not all exposures being recorded (e.g., vaccinations outside the VSD system or self-medication). Confounding bias mainly included unrecorded information and passively collected missing variables in the databases, such as certain laboratory test information (97/114).
Discussion
Our study extracted and summarized the spontaneously reported biases in the application of CDM in pharmacoepidemiologic research, outlining the proportion of each type of bias and describing their main content. Given the current state of inadequate data governance quality in this field, future research should pay greater attention to controlling these biases.

Introduction: Real-world evidence (RWE) is increasingly used for regulatory, reimbursement, and patient access decisions in Asia-Pacific. RWE has the capability to address similar evidence gaps across different countries in a single study through standardized research methodologies, which enables the results to be analyzed and presented holistically. However, the heterogeneity of real world data sources in Asia-Pacific poses a major challenge to conduct multi-country real-world research using a standardized approach.

Aims: To identify an innovative approach to utilize unharmonized data sources for multi-country research.
Methods: We evaluated data sources across Asia-Pacific countries for RWE generation and described a hybrid approach to utilize unharmonized data sources of varying levels of data maturity for multi-country research. Data sources were evaluated based on technical and operational elements: E.g. data availability; data format (charts, electronic records); completeness; access (individual, aggregate-level); consent requirements; and capacity and burden on research team and patients.

Results: We adopted a hybrid approach-Mosaic Model to harmonize data collected using different methods when a single collection method was not feasible for all data sources. In the Mosaic Model, data was directly extracted and enhanced from electronically structured data sources (e.g. electronic medical records, registries), and transformed using a common data model. For paper-based or electronically unstructured data sources, data was abstracted from medical records and subsequently transformed to the same common data model.

Discussion: The use of a common data model harmonizes the data for analysis and overcomes the challenges faced with unharmonized data sources and concerns about data privacy, while ensuring consistency and validity of the research under a single protocol, analysis, and timeline.
This hybrid approach was successfully implemented in oncology and metabolic disease studies in Asia-Pacific, enabling variables captured across different unharmonized data sources to be standardized for analysis.

Introduction: Recent guidelines and reviews on Infantile epileptic spasm syndrome (IESS) recommend the use of adrenocorticotropic hormone (ACTH), corticosteroids or vigabatrin, as the first-line treatment. However, a consensus on the most effective approach remains elusive. Aims: This umbrella review aims to synthesize evidence from systematic reviews and meta-analyses to evaluate the efficacy of first-line treatments for IESS.
Methods: Comprehensive searches of PubMed, Embase, Cochrane, and Scopus databases were conducted up to February 12, 2024. The methodological quality of the included reviews was evaluated using the “Assessing the Methodological Quality of Systematic Reviews (AMSTAR)” and the certainty of evidence was evaluated using the GRADE approach. Effect sizes and 95% confidence intervals (CI) of each related outcomes, was calculated using fixed effects models and risk ratio (RR). Reviews without meta-analyses were reported descriptively.
Results: Among 133 studies, nineteen were included for final assessment, published between 2010-2022. AMSTAR shows study quality ranges between “low “to “critically low”. For prednisolone versus ACTH, the OR for spasm cessation was 1.02 (CI: 0.42-2.44, I²=71%), and for hypsarrhythmia resolution, it was 1.07 (CI: 0.54-2.13, I²=71%). The certainty of evidence varied from moderate to very low. Electroclinical and clinical remission outcomes were graded as low, while reduction in spasms ranged from moderate to low, and adverse drug reactions (ADRs) were very low. Corticosteroids were superior in two studies, LD-ACTH was superior to HD-ACTH in four studies, and few studies showed no difference between HD-Prednisone and ACTH.
Conclusions: The findings indicate minimal differences in treatment efficacy for IESS, with evidence insufficient to make definitive clinical recommendations. The low to critically low quality of the studies underscores the need for higher-quality research to better inform clinical decisions.

Introduction: Antipsychotic use in people with dementia has been associated with adverse events including heart failure, myocardial infarction, stroke, fractures and pneumonia. Clinical practice guidelines recommend against routine use of antipsychotics for changed behaviours in dementia. Risperidone is the only antipsychotic indicated for changed behaviours in Australia. When prescribed, the total initial duration should not exceed 12 weeks.
Aim: To characterise 12-month trajectories of risperidone use for psychotic symptoms and aggression in people living with Alzheimer’s disease in Australia.
Methods: A cohort of people who initiated risperidone for changed behaviours from July 2013 to February 2023 were identified from a 10% random sample of Australia’s Pharmaceutical Benefits Scheme (PBS) dispensing data. All people who initiated risperidone and who were dispensed two or more prescriptions over 12 months were included. Group-based trajectory modelling was used to characterise medication trajectories.
Results: Of 9,156 people who initiated risperidone for changed behaviours, 6,881 were dispensed two or more prescriptions over the following 12 months. Four trajectories of risperidone use were identified: rapid discontinuation (16%), gradual discontinuation (25%), intermittent dispensing (46%) and persistent (13%).
Discussion: Despite the risk of harms outweighing the potential benefits, 44% of people who initiated risperidone for changed behaviours became intermittent or persistent users over a 12-month period. By extrapolation, over the past decade, more than 40,000 Australians with Alzheimer’s disease were dispensed risperidone on an intermittent or persistent basis in the 12-month period following initiation.

Introduction The associations between extreme temperature and heat-related outcomes in people with mental disorders and the role of antipsychotics in these associations are unclear.
Aim To investigate the associations between extreme temperature and heat-related illness in people with severe mental illness (SMI) and the role of antipsychotics in these associations.
Methods People with SMI between 1/1/2003 and 31/12/2019 were identified in Hong Kong population-based database (Clinical Data Analysis and Reporting System). We conducted self-controlled case series to estimate the incidence rate ratio (IRR) of heat-related illness, myocardial infarction (MI), ischemic stroke, delirium and all-cause Accident and Emergency (A&E) during 5-day pre-heatwave, heatwave, and 5-day post-heatwave periods versus all other periods (baseline) within an individual using conditional Poisson regression. We stratified the observation period into periods taking antipsychotics and periods not taking antipsychotics, respectively. We also excluded periods when they were hospitalised as sensitivity analysis as it may indicate no exposure to heatwave.
Results Among people with SMI, when we stratified by antipsychotic use, only those taking antipsychotics were observed to have a higher rate of heat-related illness (IRR:1.43 (95%CI:1.18-1.73) versus 0.79 (95%CI:0.53-1.16) for non-users but there was only weak statistical evidence for this difference (p-value interaction:0.06). After removing the period during hospitalisation, the difference widened (with antipsychotics: IRR:1.49, 95%CI:1.22-1.82; without antipsychotics: IRR: 0.73, 95%CI:0.48-1.12) and statistical evidence was stronger (p-value interaction:0.02). There was no higher risk of MI, ischemic stroke, delirium or all-cause A&E associated with heatwave versus baseline.
Conclusion We showed an increased risk of heat-related illness associated with heatwave in people with mental SMI prescribed antipsychotics. No increased risk of other outcomes was found during heatwave versus baseline.

Introduction:
Numerous studies have highlighted the bidirectional association between depression and chronic kidney disease (CKD). However, the nature of their causal relationship remains a subject of debate.

Aims:
This study aimed to explore the mutual associations between depression and chronic kidney disease.

Methods:
This retrospective cohort study utilized the Taiwan Biobank database, including a total of 189,132 Taiwanese individuals aged 20-70 from 2012-2023. After excluding 142,571 individuals without follow-up data, 46,561 participants remained for analysis. For Analysis 1, investigating CKD and incident depression, participants were excluded if they were missing baseline estimated glomerular filtration rate (eGFR) data or had depression at baseline (n=1,605), resulting in a total of 44,956 participants included for analysis. For Analysis 2, which explored the association between depression and incident CKD, subjects were excluded if they were missing follow-up eGFR data or had CKD at baseline (n=515), leaving 46,046 participants for analysis. Both Analysis 1 and Analysis 2 utilized Chi-square, Fisher's exact test, and independent t-test for baseline descriptive analysis. Cox proportional hazards regression analysis was conducted to examine the mutual relation between depression and CKD, with adjustment for several covariates.

Results:
For Analysis 1, the incident depression rate was 2.424 per 1000 person-years in the CKD group and the adjusted hazard ratios were 0.562 (95% CI: 0.230-1.371). Conversely, in Analysis 2, the incidence rate of CKD was 3.334 per 1000 person-years and the adjusted hazard ratios were 1.513 (95% CI: 0.988-2.316).

Conclusion:
The findings of the study have some important implications: depressive patients may have a higher prevalence of developing CKD, whereas CKD patients do not exhibit a significant tendency to develope depression. Longer follow-up studies are required for further validation of these findings.

Introduction:
Environmental and seasonal factors significantly influence mental health, with winter particularly affecting mood and behavior due to shorter daylight, colder temperatures, and increased isolation. This study investigates how these seasonal changes affect antidepressant usage, a subject currently underrepresented in empirical research.

Aims:
The study aims to assess the impact of winter on antidepressant use across different regions and provide empirical support for policy improvements in mental health resource allocation and intervention strategies.

Methods:
Data from the Chinese Pharmaceutical Bidding and Procurement Database (2018-2023) were used, quantifying antidepressant consumption using the WHO's Defined Daily Doses (DDDs). The study employed linear mixed-effects models to analyze the seasonal impact of winter on antidepressant usage, considering variables like temperature and year.

Results:
The analysis revealed a significant increase in antidepressant use during winter (p < 0.001). Temperature showed a strong negative correlation with usage (p < 0.001), with yearly data indicating a consistent rise in antidepressant use. Notably, the interaction between temperature and year also proved significant (p < 0.001), suggesting that colder years exacerbate the demand for antidepressants. Variability in usage across cities was also significant (p < 0.001).

Discussion:
The study confirms that winter contributes to increased antidepressant usage, with colder temperatures and reduced daylight linked negatively with mental health. This inverse relationship underscores the need for strategic policy interventions during winter months. To mitigate winter's impact, enhancing access to mental health services and increasing awareness about seasonal affective disorder (SAD) and other related mood disorders are crucial. These findings advocate for targeted mental health interventions tailored to the specific needs arising during colder months.

Introduction: Currently, students are increasingly using social media, which may lead to social media addiction.

Aim: This study aimed to investigate the prevalence of social media addiction, usage behaviors, and detoxification among undergraduate university students in northern Thailand.

Method: A cross-sectional study was conducted using an online questionnaire distributed to undergraduate university students in northern Thailand who were willing to complete the questionnaire. Data collection occurred from September to October 2023. Social media addiction was measured by the Social Media Addiction Test (SMAT), composing of 16 items with Likert scale responses from from 0 (definitely not true) to 3 (definitely true). Scores were categorized as follows: ≥ 30 = addicted, 20-29 = almost addicted, and 0-19 = not addicted. Additionally, the questionnaire included a section on social media detoxification practices.

Results: Of 312 students, 219 were female (70.2%). The majority were third-year undergraduate students (36.5%). The Social Media Addiction Test (SMAT) scores indicated that 39.1% of the students were addicted to social media, 38.8% were almost addicted, and 22.1% were not addicted. Instagram was the most frequently used platform in one day (32.1%). On average, participants spent 7.25±3.58 hours per day on social media from Monday to Friday and 9.63±5.77 hours during weekends and holidays. The objective of social media usage was for entertainment or relaxation. 39 students (12.5%) had experienced social media detoxification and the main method was substituting social media use with other activities.

Discussion: The study revealed that about 40% of university students were addicted to social media, primarily using it for entertainment and relaxation. Some students attempted social media detox by engaging in other activities. This study underscores the impact of social media on students' lives and indicates the necessity for balanced usage approaches.

Introduction The real-world drug utilizations of antipsychotics [AP] in schizophrenia treatment remain understudied in adolescent, especially in Asia.

Aim With paliperidone extended-release (PER) tablet as the first approved AP for adolescent indication for schizophrenia in China, this study aims to explore its real-world persistence and adherence.

Methods This 5-year retrospective cohort study utilized electronic medical records (2018-2022) from a psychiatry specialized hospital (PH) and a general hospital (GH) in China. Adolescent patients (12-17y) who prescribed PER during the study period were included. Index date was the date of first identified PER prescription. Patients initiated PER monotherapy at outpatient setting on the index date with a prior schizophrenia diagnosis (ICD-10: F20.x) were included. To ensure long enough follow-up for evaluation, patients were required to have had at least 1 visit during the second or third month following an initial month of care. Persistence was calculated from index date to discontinuation of PER (gap >60d between prescriptions). Adherence (proportion of days covered [PDC]) to PER was assessed during persistence use and stratified by patients with at least 1 to 6 months of persistence.

Results Overall, 44 (mean age: 15.4y, male 31.8%) and 43 (mean age: 15.6y, male 46.5%) patients were included in PH and GH, respectively. In PH, the persistence of PER was 172.4 (SD:180.80) days, and the overall adherence was 84.6% (SD: 15.53%). The adherence for patients with at least 1 to 6 months of persistence ranged from 75.3% to 82.1%. In GH, the persistence of PER was 165.3 (SD:159.39) days, and the overall adherence was 79.4% (SD:16.46%). The adherence for patients with at least 1 to 6 months of persistence ranged from 72.2% to 78.4%.

Conclusion This study provides evidence of PER’s real-world persistence of about half year and demonstrates its good adherence in clinical practice.

Introduction. Non-adherence to antipsychotic medication is a significant challenge, to long-term maintenance therapy and increasing the risk of recurrence. Pharmacist has a critical role in improving the adherence to medication in psychiatric patients. It is important to study the pharmacist’s perspective in this aspect.
Aims. Evaluate the pharmacists' knowledge, attitudes and perceived barriers on medication counseling for psychiatric patients in selected hospitals and pharmacies in Colombo district, Sri Lanka.
Methods. A cross sectional study conducted using a self-administered questionnaire to 253 pharmacists in selected government and private hospitals and community pharmacies. Pharmacists between 18-60 years who had not less than six months of working experience and were registered with the Sri Lanka Medical Council fulfilled inclusion criteria were selected for the study. Participants' demographics, knowledge, attitude, perceived barriers on providing medication counseling was summarized using descriptive statistics. Relationships between those variables analyzed by Chi-square at a significant threshold of p < 0.05.
Results Demographic data results stated predominant pharmacists were females, 29-39 years age gap, 1-5 years of experiences, working in government hospital, certificate holders in Pharmacy. Gaps existed in knowledge with unaware of antipsychotic drugs and side effects. Majority had positive attitudes favoring medication counseling, believing it enhances compliance and job satisfaction. Time constraints, communication challenges, lack of experts were identified as barriers. Concerns about confidentiality and space shortage were mentioned. No associated factors between knowledge and attitudes with demographic data were found. Only perceived barriers with demographic data had correlations. Limited counseling time was associated with education level (p=0.025).
Discussion. Although Colombo district pharmacists welcome medication counselling, need for improvement in knowledge and practical issues are required. Enhancing the provision of counselling services could involve implementing strategies that optimize availability of time, expand knowledge regarding antipsychotics manage space constraints within pharmacies.

Key words: Medication counseling, Knowledge, Attitudes, Barriers

Introduction:
The efficacy and safety of ADHD treatment affect medication adherence and persistence. The information remains insufficiency.
Aims:
To evaluate ADHD medication usage in clinical practice by retrospectively reviewing electronic medical records (EMRs) at a medical center.
Methods:
This retrospective study enrolled patients under 18 years old diagnosed with ADHD who visited our clinics and were prescribed methylphenidate (MPH) or atomoxetine (ATX) from January 1, 2020, to December 31, 2022. We conducted a chart review using EMR to observe the initial prescription patterns of ADHD treatment at a medical center and evaluate the rationality, effectiveness, and safety of these medications. The chi-squared test and t-test were conducted to compare categorical and continuous variables, respectively.
Results:
There were 544 patients enrolled in the final analysis, with 76% being male. The majority received immediate-release methylphenidate (IR-MPH) as a first-line treatment, and the mean age of this group (7.64 ± 2.36 years) was significantly lower than those using long-acting methylphenidate (LA-MPH) or ATX. Regarding rationality, 70% of the patients underwent symptom assessment before medication use. In terms of medication dosage, over 90% of the patients followed the guidelines' recommendations. During the 90-day follow-up period, 159 individuals discontinued medication. In regards to effectiveness, approximately 80% experienced symptom improvement, with longer treatment duration observed among patients who perceived the medication as effective. As for safety, about one-third of the patients experienced adverse effects within three months. The most common side effects in our study are decreased appetite and weight loss. However, most patients showed improvement with continued observation or medication adjustment. Less than 3% of the study participants discontinued treatment due to intolerable side effects.
Conclusions:
The efficacy of medication can affect patients' willingness and ability to continue treatment over time. With appropriate monitoring and adjustment, most patients can safely and effectively receive treatment.

Introduction: The shortened life expectancy observed in patients with schizophrenia is primarily attributed to cardiovascular-related mortality, highlighting the importance of preventive measures against obesity and diabetes. This study investigated the real-world monitoring of HbA1c levels in patients diagnosed with schizophrenia and bipolar disorder using actual data obtained from DATuM IDEA®, a comprehensive medical information database in Japan that includes electronic medical records.

Objective: The primary goal of this study is to assess the frequency of HbA1c testing and other relevant clinical data in patients diagnosed with schizophrenia or bipolar disorder using a medical information database.

The cases of schizophrenia and bipolar disorder were identified using ICD-10 codes F20 and F31. Parameters such as age, HbA1c levels, diabetes diagnosis, and prescribed medications were taken into consideration. The data was extracted from electronic medical records of approximately 980,000 individuals registered in the DATuM IDEA® medical information database managed by TOPPAN Holdings Inc. from January 2019 to December 2022.

Results: Within DATuM IDEA®, there were 22,332 cases of schizophrenia and 2,350 cases of bipolar disorder. Among these cases, 15,924 underwent HbA1c evaluation, resulting in a total of 74,607 recorded HbA1c data. Throughout the data collection period, 9,885 patients had a maximum HbA1c value below 6.0%, while 2,559 patients had values of 7.0% or higher.

Discussion: In the cohort of 24,682 registered patients diagnosed with schizophrenia or bipolar disorder, 27.7% did not undergo HbA1c testing. It is crucial to consider the possibility of HbA1c evaluations being conducted at medical facilities not integrated into the database. Notably, 14.3% of cases with recorded HbA1c measurements showed values exceeding 7%, emphasizing the need for enhanced focus on blood sugar management in patients diagnosed with these disorders. The study confirms the feasibility of investigating HbA1c levels in patients diagnosed with schizophrenia or bipolar disorder using DATuM IDEA®.

Introduction:Recent disproportionality analyses and nationwide case-control studies have identified safety signals suggesting a potential association between the use of clozapine and haematological malignancy (HM) with little information on the associated incidence rate difference.
Aims: Our aim was to test for the association of clozapine use with HM in comparison with olanzapine users and examine the absolute rate difference, adjusting for prior other antipsychotic use within both groups.
Methods: A territory-wide public healthcare database in Hong Kong covering the entire population provided data for this study. We included a retrospective cohort of anonymized patients aged 18 or older with a diagnosis of schizophrenia who had used clozapine or olanzapine (drug comparator with highly similar chemical structure) for 90 days or more, with at least two prior other antipsychotic use records within both groups. Weighted by inverse probability of treatment based on propensity scores, Poisson regression was used to estimate the incidence rate ratio (IRR) of HM between clozapine and olanzapine users.
Results: In total, 9,965 patients were included, with 834 clozapine users. Clozapine users had a significant IRR of 2.15 (95% CI 1.50, 3.29) for HM compared to olanzapine users. The absolute rate difference between the two groups was estimated to be 49.35 (95% CI 39.22, 67.49) per 100,000 person-years. Findings were consistent across various sub-groups by age and sex in terms of effect size, although the IRR was non-significant for those aged 65 or older. Sensitivity analyses all supported the robustness of the results.
Discussion: A twofold elevated rate of HM associated with clozapine is identified. However, the absolute incidence rate difference is small with limited impact on the risk-benefit ratio of clozapine use for treatment- resistant schizophrenia.

Introduction:
Managing diabetes in children is challenging and can lead to psychiatric disorders, making it a global health issue. However, investigations on the association between mental health care and diabetes among children is limited.
Aims:
This study aimed to 1) report the prevalence of mood disorders and mental health care utilization among children with and without diabetes in the U.S. from 2019-2022 and 2) examine the association between diabetes and mood disorders as well as mental health care utilization among children.
Methods:
The U.S. National Health Interview Survey (NHIS) were used. Children aged 0-17 with and without diabetes were identified through survey questionnaires. Mood disorders were defined as self-reported anxiety or depression at least weekly in the past year. Mental health care utilization was defined as receiving mental health counseling, therapy, or medication in the past survey year. Chi-square tests were used to estimate trend changes and multivariable logistic regression models were used to evaluate the association between diabetes and mental health conditions. All analyses were weighted and adjusted by the NHIS survey design with the clustering and stratification.
Results:
There were 293,825 children with diabetes and 72,368,355 children without diabetes. The prevalence of mental health care utilization among children with diabetes decreased from 2019 to 2022 (counseling or therapy: 37.2% to 16.3%, p=0.07; medications: 27.4% to 7.9%, p=0.09). Children with diabetes were more likely to report experiencing anxious or depressed at least weekly when compared to children without diabetes (anxious: ORs: 1.87, 95% CI 1.08-3.25; depressed: ORs: 1.20, 95% CI 0.58-2.52).
Discussion:
A decreasing prevalence of mental health care utilization from 2019 to 2022 was observed among children with diabetes. Nonetheless, children with diabetes were more likely to have mood disorders than children without diabetes. Pediatric diabetes management should include psychological cares to improve overall health outcomes for children.

Introduction. Parkinson's disease is a neurodegenerative disorder caused by dopamine neuron loss, leading to tremors, stiffness, etc. Levodopa, a treatment for Parkinson's motor symptoms, becomes less effective over time and can cause a complication- levodopa-induced dyskinesias (LID). Individual susceptibility to LID can vary considerably. A pharmacovigilance study on PD patients receiving levodopa therapy is crucial to address this knowledge gap.
Aims. This study aims to evaluate the prevalence and severity of levodopa-induced dyskinesia (LID) in Parkinson's disease (PD) patients on levodopa therapy and to identify disease-related, and treatment-related factors associated with LID development.
Methods. We conducted a retrospective observational study at a tertiary-care teaching hospital in Southern India over one year. Adult patients (>50 years) diagnosed with Parkinson's disease (PD) receiving levodopa therapy were included. Data on demographics (age, sex), PD characteristics (age at onset, severity), and levodopa treatment history (dosage, duration) were collected from medical records.
Results. A total of 160 Parkinson's patients [101(63%) males, 59(37%), females] with a mean age of 75.20 ± 4.28 years were recruited for the study after obtaining informed consent and by interacting with them and their caregivers. Levodopa + Carbidopa accounted for 60.0% of all prescriptions. The observation was carried out for LID developments and its treatment. Among 160 PD patients, 122(76%) patients showed LID symptoms [76 (62%) males, 46 (38%) females]. Following drugs like Rasagiline [40%], Amantadine [50%], and Levetiracetam [10%] were used for treating LID.
Discussion. This study highlights the high prevalence of LID in Parkinson's patients on levodopa therapy. The employed treatment options suggest a co-delivery approach to manage LID. Further research with larger, prospective designs can provide more definitive insights into LID development and optimal treatment strategies.
Keywords: Parkinson's disease, Levodopa, Levodopa-induced dyskinesia, Prevalence

Introduction: A notification issued in August 2018 in South Korea recommended caution while prescribing typical antipsychotics to elderly over 65 years.

Aims: This study aimed to determine changes in outpatient prescription volumes for elderly before and after Drug Utilization Review(DUR) provision for five of the eight typical antipsychotics.

Methods: From April 2017 to December 2019, prescription volumes of the five typical antipsychotics(schlorpromazine, levomepromazine, haloperidol, perphenazine, and pimozide) to outpatients aged 65 years or older, under the National Health Insurance Service-Senior(2002~2019)[1](NHIS-2024-2-082) were analyzed. Change in monthly averages pre and post DUR provision per 100,000 elderly people was calculated.

Results: A total of 657,959 seniors aged 65 years or older were seen in the study period, of which 639,504 (97.2%) were prescribed drugs at least once, and 2,646 (0.4%) were prescribed one of the five typical antipsychotics at least once. These were mainly women (57.6%), of which 58.0% received their prescriptions at primary hospitals and 33.7% at secondary hospitals. The most frequently prescribed drugs were perphenazine (56.0%), haloperidol (32.0%), and chlorpromazine (11.7%). The monthly averages of prescriptions per 100,000 elderly people within 16 month periods before and after DUR provision, excluding the month in which it was provided, dropped for haloperidol by 2.5% from 19.6 to 19.1. Additionally, while it increased for levomepromazine from 0.2 to 0.5, and remained static for pimozide at 0.3, the average monthly prescriptions for both was less than 1 post DUR provision. The proportion of chlorpromazine and perphenazine prescriptions increased by 7.7% from 6.8 to 7.3, and by 17.1% from 31.3 to 36.6, respectively.

Discussion: Despite no restrictions on prescribing cautionary drugs in South Korea, DUR provision on typical antipsychotics effectively reduced outpatient haloperidol prescription to elderly patients. Additional studies are essential to analyze the effect on in-hospital administration of typical antipsychotics.

Aims: To identify the clinical characteristics, treatment patterns, and outcomes of reflex epilepsy.
Methods: A prospective case series study was conducted at a multispecialty tertiary care hospital in Northeast India from October 2022 to May 2024. We collected demographic and clinical data, epilepsy characteristics, and treatment patterns data of reflex epilepsy patients. Therapeutic outcomes were categorized based on International League Against Epilepsy (2009) guidelines. Categorical data were expressed in frequency and percentage.
Results: A total of 32 cases, with a majority of males (62.5%) predominantly of young adults (65.6%). The majority of seizures (71.9%) were triggered by eating (rice consumption), followed by watching TV/mobile devices (6.3%). The majority of the patient's seizures were triggered by eating (71.9%), followed by TV/mobile watching (6.3%). Focal epilepsy was diagnosed in 62.5% of cases, and neuroimaging revealed structural abnormalities in 34.4%. Most of the patients had a history of febrile seizures and family epilepsy (18.8%), head injury, and delayed developmental milestones (9.4%). Comorbidities such as cognitive impairments, psychosocial difficulties, and psychiatric disorders were present in 15.6% of patients. Most patients (68.8%) were on polytherapy, commonly a combination of clobazam and levetiracetam (31.2%). Poor compliance was noted in 37.5%, with refractory epilepsy in 31.3%. Undefined drug responsiveness was seen in 18.8%, and 31.3% had undetermined outcomes.
Discussion/Conclusion: The study shows that young adult males with epilepsy often have seizures starting in adolescence, frequently triggered by eating, with common focal epilepsy and structural abnormalities. Polytherapy is common, but poor compliance and refractory epilepsy are significant challenges. These findings underscore the need for better treatment strategies, patient education, and support systems.
Keywords: Reflex Epilepsy; Eating Epilepsy; Refractory Epilepsy; Structural Etiology

Introduction: Depressive disorders are among the leading causes of disability globally. However, information on the burden of depressive disorders in Vietnam is limited.
Aims: We aimed to analyse the burden of depressive disorders in Vietnam from 1990 to 2019.
Methods: Using data from the GBD 2019, prevalence and disability-adjusted life years (DALYs) were used as indicators to analyse the burden of depressive disorders by age and sex. The average annual percent change (AAPC) in prevalence and DALY rates due to depressive disorders from 1990 to 2019 were calculated using the joinpoint regression analysis.
Results: In 2019 in Vietnam, depressive disorders comprised 2629.1 thousand (95% uncertainty interval (UI): 2233.3–3155.9) estimated cases and 380.6 thousand (95% UI: 258.9–533.8) estimated DALYs. The crude prevalence rate of depressive disorders was higher among females than among males. The DALYs of depressive disorder accounted for a higher percentage of the total all-cause DALYs in the 10–64-year age group than in other age groups. Major depressive disorder was the largest contributor to the burden of depressive disorders. From 1990 to 2019, the crude prevalence and DALY rates per 100 000 population due to depressive disorders were significantly increased, whereas age-standardised rates of prevalence and DALYs significantly decreased; the respective average annual percent changes were 0.88% (95% confidence interval: 0.87 to 0.89), 0.68% (0.66 to 0.70), -0.20% (-0.21 to -0.19), and -0.27% (-0.28 to -0.25).
Conclusion: Although the age-standardised prevalence rate was lower than that seen globally, depressive disorders were considerable mental health issues in Vietnam. This study will help governments and policymakers to establish appropriate strategies to reduce the burden of these disorders by identifying the priority areas and individuals.

Introduction: The rise in e-cigarette use among Thai youth is attributed to curiosity, peer influence, and perceptions of reduced harm compared to conventional cigarettes.
Aim: To identify barriers and influential factors affecting the cessation or reduction of e-cigarette use among university students in Thailand.
Methods: An online survey was administered from December 2020 to February 2021 to active e-cigarette users enrolled in two northern Thai universities. The questionnaire assessed five barriers and seven influential factors for quitting or reducing e-cigarette use using a 4-point Likert scale (1=strongly disbelieve, 2=disbelieve, 3=believe, 4=strongly believe). Responses were dichotomized into disbelief (1 and 2) and belief (3 and 4) categories.
Results: Of the 306 respondents (61% male, mean age 21.8 ± 3.0 years), 53% were dual users of e-cigarettes and conventional cigarettes, while 47% exclusively used e-cigarettes. Curiosity was the primary motivator for initiation (68%), with approximately 10% starting in junior high school. The top three barriers they believe in quitting e-cigarette use were: 1) required effort and determination (62%), 2) peer e-cigarette use (50%), and 3) perceived cost-effectiveness of e-cigarettes compared to conventional cigarettes (49%). The top three influential factors they believe for quitting were: 1) family requests (78%), 2) requests from significant others, such as lovers (75%), and 3) internet media highlighting e-cigarette risks (60%).
Discussion/Conclusion: The perceived barriers to quitting, such as the effort and determination required, peer influence, and cost considerations, indicate the need for comprehensive cessation programs that address these factors. Additionally, the significant influence of family, significant others, and internet media on quitting decisions suggests that interventions involving these influencers could be particularly effective. Future research could explore the effectiveness of such interventions in promoting cessation among young e-cigarette users.

Introduction
Gabapentinoid use is linked with impairment to consciousness and cognitive function, raising concerns about their safety. With a surging consumption of gabapentinoids, it is critical to investigate whether patients taking them are at an increased risk of road traffic incidents.

Aims
To investigate the association between gabapentinoids use and the risk of road traffic incidents.

Methods
We utilised data from the UK Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES). We included individuals aged above 18 years old who had received at least one prescription of gabapentinoids and at least one hospitalisation record due to road traffic injuries between January 1, 2000, and December 31, 2022. Self-controlled case series design was employed to control for time-invariant factors. Patient-time was divided into pre-, on-, post-treatment and baseline periods. The incidence rate ratio (IRR) of road traffic injuries during different riskperiods were compared with baseline periods. Time-varying confounders such as age, season and concomitant medications were adjusted in the conditional Poisson regression model.

Results
The study identified 1,089,433 individuals who had at least one prescription of gabapentinoid within the study period. A total of 12,533 patients who had at least one road traffic incident were included in the analysis. The mean age at baseline was 44.92 years, and 6,333 (50.53%) of these individuals were female. No increased risk of road traffic injuries was identified during the treatment period (IRR, 1.05; 95% CI, 0.97-1.13). Only a slight increased risk was detected in the female subgroup (IRR, 1.13; 95% CI, 1.02-1.25). The trend remained consistent across different age groups, ethnicities, gabapentinoid types, other subgroups and sensitivity analyses.

Conclusions
Our study findings suggest that no increased risk of road traffic injuries during gabapentinod exposed period. Additional real-world studies of other outcomes are warranted to ensure safe use in the wider population.

Introduction:
Several studies indicated that incretin-based therapies, such as GLP-1 receptor agonists (GLP-1 RAs) and DPP-4 inhibitors (DPP-4is), reduce depression risk in type 2 diabetes mellitus (T2DM) patients. However, these studies often lacked an active comparator and did not capture depressive symptoms without a formal diagnosis.
Aims:
Examine the risk of depression and health-related quality of life (HRQoL) in GLP-1 RA and DPP-4i users compared to sodium-glucose cotransporter-2 inhibitor (SGLT2i) users.
Methods:
This was a cross-sectional study utilizing 2019-2021 data from the Medical Expenditure Panel Survey. We included patients aged 18 or older, had T2DM, and received SGLT2i, DPP4i, or GLP-1RA. Incretin-based therapies, DPP4is and GLP-1RAs, were the exposure, and SGLT2is were the reference. The primary outcome, depression, was assessed using the Patient Health Questionnaire-2 (PHQ-2) scale; a PHQ-2 score equal to or above three indicated depression. The secondary outcome, HRQoL, was evaluated using the Mental Component Summary (MCS) score from the Veterans RAND 12-Item Health Survey (VR-12), with a higher score reflecting better mental health. Logistic regression models and ordinary least-square models were estimated to assess depression risk and compare the mean MCS score, respectively.
Results:
For the primary outcome, the risk of depression was significantly lower in the DPP4i group (OR: 0.42, 95% CI: 0.23–0.80) and in the GLP-1RA group (OR: 0.56, 95% CI: 0.33–0.95) compared to the SGLT2i group. Regarding the secondary outcome, the mean of MCS scores was not significantly different between the DPP4i group (Mean difference = 0.65, p = 0.39) and the GLP-1RA group (Mean difference = 0.27, p = 0.70) relative to the SGLT2i group.
Discussion:
Our results suggest that DPP4is or GLP-1RAs were associated with a lower risk of self-reported depressive symptoms compared to SGLT2is. However, future longitudinal studies are required, as the cross-sectional design of this study cannot establish causality.

Introduction: The use of social media among university students is continually increasing; this can lead to social media addiction behavior. Social media addiction may cause low self-esteem, leading to impostor syndrome.
Objective: To investigate the association between social media addiction and impostor syndrome among undergraduated students.
Method: In this cross-sectional study design, undergraduate students participate with an online self-report questionnaire from August to December 2023. Social media addiction was measured by Social Media Addiction Test (SMAT), composing of 16 items with Likert-scale response from 0(not at all) to 3(yes). A score of above 30 indicated social media addiction, whereas a score of less than 30 indicates no addiction. Impostor syndrome was measured by Clance Impostor Phenomenon Scale (CIPs) which comprises 20 items, each scored on a 5-point Likert scale. The values of 60 or higher indicate the presence of imposter syndrome, whereas values below 60 indicated no impostor syndrome. The analysis was conducted with STATA version 14.0; logistic regression analysis adjusted with potential confounding factors was used.
Results: Of the 322 students who answered the questionnaire, 66.7% were female, 52.5% were under the age of 20, and 33.5% were second-year students. Among those who experienced impostor syndrome, 44.6 % addicted to social media, while 55.6% did not addict to social media. Social media addiction correlated with a higher of experiencing impostor syndrome compared to non-addicted students (Adjusted OR=2.33; 95%CI: 1.35-4.01; p=0.002).
Conclusion: The levels of social media addiction was found to be associated with an imposter syndrome.

Introduction
Emerging animal studies regarding the neurotrophic effect of lithium use have suggested the potential neuroprotective benefit on neurological disorders including stroke. However, the association between lithium therapy and stroke in human is not well-investigated.

Aims
To determine the effect of lithium on stroke prevention.

Methods
Patients aged≥20 years old, newly-diagnosed with stroke, using lithium during 2013-2019, without previous major mental disorders were identified from 2013-2018 Taiwan’s National Health Insurance Research Database. Self-controlled case-series (SCCS) analysis was conducted for the age-adjusted incidence ratios (IRs) of stroke within-person in treatment exposure versus non-exposure and pre-exposure (i.e., 14 days before lithium initiation) periods. Analyses were also stratified by the presence/absence of comorbid diabetes and age (i.e., ≥35/<35 years old). Patients using lithium≥30 and 90 days were further classified for the analysis of long-term lithium exposure on stroke risk. A cohort study using time-dependent cox proportional model analysis was finally conducted to assess the causal relationship to corroborate the SCCS analysis findings.

Results
There were 994 lithium users developing stroke events. We found insignificant effect of lithium exposure on hemorrhagic, ischemic and composite strokes compared to non-exposure (i.e., IRs [95% CIs]: 0.93 [0.61-1.40], 1.31 [0.98-1.75], and 1.20 [0.94-2.53]). Such an insignificant effect was also found for composite strokes across patient subgroups: i.e., IRs (95% CIs) in non-diabetes: 1.58 (0.89-2.77), having diabetes: 1.14 (0.87-1.48), age≥35: 1.18 (0.91-1.53), and age<35:1.36 (0.73-2.59), with lower risks following longer lithium exposures: i.e., ≥30 days: 0.97 (0.58-1.64) and ≥90 days: 0.84 (0.54-1.30). The time-dependent Cox model analyses suggest lower but insignificant hemorrhagic/ischemic/composite stroke risks (i.e., hazard ratios [95% CIs]: 0.84 [0.55-1.26]/0.85 [0.61-1.68])/0.87 [0.67-1.14]) following lithium use.

Discussion
The potential neutral protection of lithium use on stroke is revealed as prolonging treatment exposures, highlighting the importance of patient’s persistence/adherence to lithium therapy on neurological outcomes.

Aim:
To assess the caregiver burden amongst the caregivers of cognitively impaired elderly patients.
Methods:
A cross-sectional, hospital-based, prospective cohort study amongst cognitively impaired patients was carried out at the Department of Geriatrics, Neurology, and Psychiatry for six months. Patients diagnosed with Parkinson’s disease (PD) and Dementia; their caregivers were given consent to be included in the study. The Zarit burden questionnaire (ZBQ) was administered, and the responses were collected.
Results:
A total of 156 caregivers shared their experiences, and the results were like, ‘No to mild burden. 133 (85.2) ‘Mild to moderate burden’ 16 (10.2) ‘High burden’ 7 (4.4) [males; 105 (67.3) females; 51 (32.6) patients]. On analysis after using the ZBQ scale, mild burden was highly observed in male patients [94 (89.5%)] and in female patients [43 (84.3%)]. The age group analysis showed that 70–79-year-olds showcased a high, mild burden of 42.42% [56]. Moderate burden was observed within the age group of 80–89 years old, with [6 (35.29%)], followed by [2 (28.57%)] observed in the age groups of 60–69 years, 70–79 years, and above 90 years old. with respect to the area of domicile, and it was identified that high caregiver burden was observed in the study participants belonging to the sub-urban area, with mild burden [85 (63.90%)], moderasste burden [9 (52.94%), and severe burden [3 (5.0%)]. Rural and urban areas with less caregiver burden were observed to have mild burden [01 (16.66%)] and [2 (33.33%)], moderate burden [5 (29.41%)] and [3 (17.64%)], and severe burden [18 (13.53%)] and [30 (22.55%)], respectively.
Conclusion:
With respect to the study, we found that the cognitively ill patients in a suburban area are more focused. Assessment of caregiver burden will help in identifying the social and physiological burden that should be assessed and addressed by the clinicians, understanding their challenges, and resolving them.

Objective: to assess the psychotropic drug utilization pattern in various non-psychiatric wards of a tertiary care hospital
Methodology: A prospective interventional study was conducted in the study site for a period of six months. The patients treatment charts were analysed for psychotropic drug prescribing and the patient were closely monitored until discharge. DRPs observed were reported and pharmacists intervention was provided accordingly. The reported DRPs were documented and classified using Hepler and Strand classification. Additionally, both off-label and on-label prescribing were examined throughout the study period to determine whether the observed DRPs stemmed from on-label or off-label prescribing. The correlation between psychotropics and DRPs were analysed using Pearson Coefficient statistical analysis.
Results: 143 patients experienced DRPs during the course of study. It was found that 97.02% were drug interactions followed by ADRs comprising 6.99%. The identified drug interactions was classified as major(45.3%) moderate(51.07%) and minor(3.50%). The ADRs were classified according to Naranjos Algorithm and it was found that 50% of the ADRs were probable while the rest 50% belonged to possible category. Severity assessment of the ADRs revealed that 70% of the ADRs belonged to mild level 2 category.The preventability and predictability parameters revealed that majority of the ADRs were not preventable(60%) but predictable(60%). Pearson coefficient statistical method was employed to identify any correlation between off label prescribing and the DRPs. Pearson coefficient value was found to be 0.925 which indicated strong correlation between off label prescribing of psychotropic and DRPs.
Conclusion: this study demonstrates that by monitoring use of drugs, it allowed the clinical pharmacists to identify DRPs and propose interventions aimed at promoting rational drug prescribing, optimizing therapy and bolstering patient safety. This study highlights the need to develop guidelines and policies to ensure rational use of psychotropic drugs, especially in non-psychiatric wards hence promote patient safety.
​

Introduction. DUE in cognitively impaired geriatric patients focuses on the outcome of the patient’s medication therapy.
Aims. The study aimed to assess the drug utilization pattern of cognitively impaired patients in the geriatric population
Methods. A prospective observational study was conducted at the Departments of Geriatrics, Neurology, and Psychiatry in a tertiary-care teaching hospital in Southern India from Sept 2024 to Feb 2024. Patients’ demographics, treatment charts, health profiles, and medical orders were analyzed. Prescriptions containing medications for cognitive impairment used in the treatment of Parkinson’s disease and/or dementia were screened to assess drug usage patterns for Parkinson’s disease and dementia. The analysis included drug usage patterns for Parkinson's disease and dementia using WHO prescribing indicators and Defined Daily Dose (DDD).
Results. A total of 156 eligible patients [105(67%), males; 51(33%), females] with a mean age of 75.18 ± 8.28 years were recruited for the study after obtaining informed consent and by interacting with them and their caregivers. The majority (67%) were diagnosed with PD, followed by 25% of them diagnosed with dementia. 1087 medications were used, with an average of 7.91 per participant. Levodopa + Carbidopa accounted for 67.9% of all prescriptions, followed by Olanzapine at 23.1%. WHO's core prescribing indicators showed that, on average, 7.91 drugs were prescribed per encounter. Only 3.7% of drugs were prescribed by their generic name, while 8.75% of encounters involved antibiotics and 20.5% of injections. Levodopa+Carbidopa(8217.4 DDD) and Trihexyphenidyl(1212.7 DDD) were used for PD, and Donepezil (2473.6 DDD) and Memantine (407.25 DDD) were used for treating dementia.
Conclusion. The most commonly prescribed medications in our hospital setting are those used for PD and dementia. This study provides a framework of the prescribing pattern in the above-mentioned departments to assess drug utilization evaluation amongst cognitively impaired patients.

Introduction:
Atypical antipsychotics (AAPs) are the first-line treatment for schizophrenia but are found to be associated with an increased risk of cardiovascular diseases. Aripiprazole is considered to have a lower risk of metabolic side effects compared to other AAPs. However, there was a lack of studies directly assessing the cardiovascular risk of aripiprazole compared to other AAPs among patients with schizophrenia.

Aims:
To compare the risk of cardiovascular events (CVE) among patients with schizophrenia who were newly treated with oral aripiprazole versus other oral AAP medications.

Methods:
A retrospective cohort study with an active comparator design utilized the Taiwan National Health Insurance Database to enroll adults with schizophrenia who had initiated a single oral AAP medication from 2014 to 2019. The exposure group comprised aripiprazole users, and the control group included other AAP users. The cardiovascular outcomes included ischemic heart disease, ischemic stroke, arrhythmias, and heart failure. Propensity score matching (PSM) was used to balance covariates, including sociodemographic variables, comorbidities, comedication, and disease severity. Cox proportional hazard models were used to estimate the CVE risk between the two groups. Several sensitivity and subgroup analyses were conducted to assess the dosage effect of aripiprazole use.

Results:
The study included 5,505 new AAP users with schizophrenia, of which 943 (17.1%) were using aripiprazole. After 1:2 PSM, the findings indicated that aripiprazole did not significantly reduce the risk of CVE compared to other AAPs (aHR=1.44; 95% CI= 1.00-2.08). However, users of high-dose aripiprazole had a significantly higher risk of CVE than users of high-dose AAPs (p<0.05).

Discussion:
The use of aripiprazole did not decrease the risk of CVE compared to the use of AAP use among patients with schizophrenia. Patients taking high-dose aripiprazole should be closely monitored for their cardiovascular risks.

Introduction
The association between antidepressant use in patients with depression and the risk of type 2 diabetes (T2DM) has been extensively studied, but results remain inconsistent. Depression and diabetes comorbidity lead to poorer health outcomes and increased mortality risk compared to either condition alone. Therefore, preventing T2DM onset in patients with depression is crucial.
Aims
This study aimed to investigate the association between antidepressant use and the risk of type T2DM in patients with depression. Additionally, we studied the effects of switching or concomitant use of different types of antidepressants on T2DM risk.
Methods
This nested case-control study was conducted using a Japanese health insurance claims database. Patients with depression prescribed antidepressants at least once between January 2005 and June 2017 were identified. Odds ratios (ORs) and 95% confidence intervals (CIs) for T2DM risk associated with antidepressant use were estimated using conditional logistic regression.
Results
This study included a cohort of 32,988 patients treated with antidepressants between January 2005 and June 2017, with a mean follow-up of 2.5 years. During this period, 1,505 T2DM cases were identified, with an incidence rate of 1.81 per 100 person-years. The estimated ORs of T2DM risk for current antidepressant use compared to past use was 1.41 (1.24 to 1.62). Compared to past use without switching, the ORs of T2DM risk for past use with past switching, current use without switching, current use with past switching, and current use with current switching were 1.08 (0.87 to 1.34), 1.43 (1.20 to 1.71), 1.40 (1.14 to 1.71), and 1.69 (1.02 to 2.79), respectively.
Conclusions
Antidepressant use is associated with an increased risk of T2DM. However, no significant association was found between switching antidepressants and increased T2DM risk.

-Introduction: When a new vaccine launched to the market, active surveillance on the impact of which to pregnancy outcomes is one of common requirements from regulatory authorities as an important part of post-marketing safety evaluation, especially indication population including reproductive-age women, such as HPV vaccines. Knowledge of APOs’ epidemiology is critical for designing a post-marketing study.
-Aims: To describe the epidemiology and risk factors of major APOs among Chinese women and newborns.
-Methods: We conducted a systemic literature review by reviewed APOs-related literatures published from 1st Jan 2018 to 30th Jun 2023, in PubMed, CNKI and Wanfang databases. APOs of interest including, for maternal, premature birth (PTB), spontaneous abortion (SA), ectopic gestation, therapeutic labor induction, gestational hypertension, and gestational diabetes mellitus, and low birth weight (LBW), stillbirth, birth defects (BD), small for gestational age (SGA) and macrosomia for neonatal. Literatures’ quality was assessed via the Newcastle - Ottawa Scale score and Joanna Briggs Institute critical appraisal checklist.
-Results: A total of 98 studies was included, 43 on APOs’ epidemiology and 61 on risk factors. The incidence rate of over-all APOs was 5.0%-25.45% across different Chinese regions. Incidence rate of maternal-APOs studied was 14.9%-17.42% for GDM, 5.2% for gestational hypertension, 0.18% - 11.79% for PTB, 2.13% - 6.89% for SA, 0.05%-0.1% for ectopic gestation, 0.11% for therapeutic labor inductio; and for neonatal, 0.13% - 5.96% for LBW, 0.06% - 2.3% for stillbirth, 0.11% - 1.88% for BD, 2.19% - 13.90% for macrosomia, and 1.8%-5.6% for SGA. Advanced maternal age (≥35 years), infection, stress, anxiety, depression, overweight/obesity, and high-risk Down's syndrome was studied main risk factors that should be considered.
-Discussion: Only a few literatures described APOs’ epidemiology nationwide. It is necessary to conduct large-scale, prospective studies to fully understand the regional distribution differences and risk factors of APOs.

Introduction:
Asthma is prevalent during pregnancy and can adversely affect neonatal health. Omalizumab is an anti-immunoglobulin E (anti-IgE) monoclonal antibody for the treatment of poorly controlled asthma. However, evidence regarding the safety of omalizumab use during pregnancy is limited.

Aims:
To investigate the safety of omalizumab use on neonatal outcomes among pregnant women with severe asthma.

Methods:
This was a population-based retrospective cohort study with the active comparator design. The databases included the Health and Welfare Database, Birth Certificate Application, and Maternal and Child Health Database in Taiwan. Pregnant women with severe asthma who delivered babies between 2010 and 2021 were identified as the study population. The Global Initiative for Asthma (GINA) criteria were used to classify asthma severity. The use of omalizumab and inhaled corticosteroids (ICS) was the exposure and control, respectively. Neonatal outcomes included gestational age, preterm birth, low birth weight (LBW), small for gestational age (SGA), and the delivery way. Student's t-test and chi-square test were used to compare outcome differences between omalizumab users and ICS users. Multivariable logistic regression models were used to calculate the adjusted odds ratio (aOR).

Results:
Our study identified 13 (0.3%) omalizumab users among 4,995 pregnant women with severe asthma. There was no difference in gestational age (37.2 weeks vs.37.8 weeks, p=0.48) and delivery way (cesarean section: 61.5% vs. 46.4%, p=0.40) between omalizumab users and ICS users. After adjustment, omalizumab use was not associated with increased risk of preterm birth (aOR: 1.09, 95% CI: 0.29-4.15), LBW (aOR: 0.89, 95% CI: 0.19-4.22), and SGA (aOR:0.93,95% CI: 0.11-7.64) when compared to ICS users.

Discussion/Conclusion:
Our study showed no increased risk of neonatal outcomes among pregnant women using omalizumab. Further studies with a larger sample size and event number or with randomized, double-blind, placebo-controlled is needed to verify our findings.

Key words
Omalizumab, Pregnancy, Asthma

Aim/Objective:
There is few evidence of rheumatoid arthritis (RA) medications in pregnant although it is broadly known that uncontrolled disease activity during pregnancy poses the risk to pregnancy outcomes and the health of mother and child after delivery. Specifying safety RA medications in pregnant is these women’s considerable needs since methotrexate, the anchor drug of RA, is teratogenic in human. Our objective of this study is to evaluate prescription for RA before pregnancy, during pregnancy, and after delivery in Japan.

Methods:
We used JMDC Claims database and estimated pregnant with rheumatoid arthritis. We identified infants born and linked them to their mothers by family identifiers. Next, we defined pregnancy period based on infants born year and month. We used data from pregnancy period and 6 months before and after it according to the previous studies in Japan.

Results:
Totally, 229 pregnancy cases were eligible for study. Percentage of pregnant prescribed RA drugs decreased during pregnancy regardless of drug category. Only 5 cases used Methotrexate until 1st trimester, but all stopped it after. Oral corticosteroids were the most commonly used throughout all periods. Salazosulfapyridine was the second highest percentage in before pregnancy and 1st trimester. However, in 2nd and 3rd trimester, Tacrolimus, Etanercept, and Certolizumab Pegol were more prescribed than Salazosulfapyridine.

Conclusion:
It is written Etanercept and Certolizumab Pegol are less into the fetus in guidelines for pregnant with RA in Japan. In our results, these drugs were more commonly prescribed than other Tumor Necrosis Factor inhibitors during pregnancy. This suggests the guidelines affected to the treatment strategy. In a few years, biologic agents will be more used because the latest guideline for RA (2024) says Tocilizumab and Abatacept are also acceptable for pregnant. We revealed how pregnants treat RA in Japan and provided real-world evidence about RA medications in pregnancy.

Introduction: The use of oral antihypertensives (OAHs) over parenteral drugs in the treatment of preeclampsia is highly controversial. The current meta-analysis would provide conclusive evidence on the safety and effectiveness of OAHs when compared to parenteral drugs.
Aim: To assess the safety and effectiveness of OAHs when compared to parenteral drugs in the treatment of preeclampsia and adverse perinatal outcomes.
METHODOLOGY: A systematic search was conducted in PubMed, Cochrane Central Register of Controlled Trials, and Google Scholar to identify RCTs comparing OAHs with parenteral drugs. The primary outcome was a mean change in systolic and diastolic blood pressure (SBP and DBP, respectively) after one hour of administration. The quality of studies was assessed using the JADAD scale. Pooled odds ratios and standardized mean differences with 95% confidence intervals were calculated using the fixed or random-effects model, which was based on heterogeneity between studies.
Results: 19 RCTs with 2672 participants were included in the meta-analysis. The average reduction in SBP one hour after administration was significantly greater (SMD: -4.95; 95%CI: -7.21, -2.70; P < 0.0001) in patients receiving OAHs. Similarly, the mean reduction in DBP one hour post-administration was also significantly higher (SMD: -4.57; 95%CI: -6.25, -2.89; P < 0.0001) in the OAHs group. The safety of OAHs was assessed, and it was found that there was a reduction in flushing in the OAHs group (OR:0.30; 95%CI: 0.18,0.50; P<0.0001) along with other outcomes such as headache, hypotension, and postpartum haemorrhage even though the statistical significance is not observed. Moreover, fetal outcomes such as fetal distress, APGAR score <7, and perinatal death were found favouring OAH therapy, though not statistically significant.
Conclusion: Our current meta-analysis highlights the efficacy of oral antihypertensive drugs in preeclampsia. OAHs significantly reduce blood pressure with favorable safety profiles and potential benefits for maternal and fetal outcomes.

Introduction: Severe maternal morbidity (SMM) is critical threat to pregnant women, yet knowledge concerning its impact on perinatal outcomes is sparse.
Aims: To assess the prevalence of SMM in the US and its impact on perinatal outcomes.
Methods: A cross-sectional analysis was conducted on hospitalizations related to pregnancies (HRP) in the US using Healthcare Cost and Utilization Project Nationwide Inpatient Sample (HCUP-NIS) data from 2016-2020. We identified HRP, SMM, maternal physical and mental comorbidities, preterm birth (PTB), spontaneous abortion (SA), and still birth (SB) with ICD-10 codes. Prevalence of having at least one SMM (HALOS) and each of the twenty-one SMM conditions were assessed in total HRPs and across different demographic subgroups. Logistic regression model adjusted for maternal demographics and comorbidities was used to investigate the associations between SMM and each of the four outcomes (PTB, SA, SB, LOS > 2 days).
Results: We identified 19,533,050 HRPs during 2016-2020, among which an increasing trend in prevalence of HALOS was observed (2.3% in 2016 and 2.8% in 2020). During the study period, the general prevalence of HALOS was 2.5% and the most common SMM conditions included blood transfusion (1.3%), sepsis (0.4%), and acute renal failure (0.2%). Higher prevalence of HALOS was found in subgroups of age over 35 (3.1%), Black (4.2%), low-income (3.1%), publicly insured (3.1%) HRPs. Adjusted odds of PTB, SA, SB and LOS > 2 days among HRPs with SMM were 1.13 (95% CI: 1.10-1.16), 7.23 (95% CI: 6.95-7.51), 2.66 (95% CI: 2.55-2.78) and 3.16 (95% CI: 3.12-3.21) times those in HRPs without SMM, respectively.
Discussion: The older, Black, low-income and publicly insured HRPs are more likely affected by SMM. The association between SMM and adverse perinatal outcomes emphasizes the need for interventions in these populations to improve maternal health.
Keywords: Real-world evidence, Maternal health, SMM, Perinatal outcomes

Background
Safety of antineoplastic agents is a crucial issue faced the cancer patients during their treatment, especially for pregnant women and women of childbearing age since they usually excluded from clinical trials during the drug development process. In addition, some antineoplastic drugs remain in the blood at least 6 months after the completion of the therapy.
Objectives
To review the information on the use of antineoplastic agents during pregnancy and lactation in the current Summary of Product Characteristics (SPCs) of antineoplastic agents registered by the Saudi Food and Drug Authority (SFDA).
Methods
First, we identified a list of registered antineoplastic agents. Second, we assessed the current information regarding 'Fertility, Pregnancy, and Lactation ' of product information (PI) by crosschecking the local SPCs with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) PI. The information was assessed and classified as complete or incomplete depending on whether (or not) they provided complete description of medicine use in pregnancy and lactation. Third we conducted a comprehensive safety assessment of the antineoplastic drugs with “incomplete” information and needs further in-depth assessment.
Results
A total of 53 SFDA-registered antineoplastic agents were retrieved based on drug classes (alkylating agents, antimetabolites, and hormone antagonists) which were subjected to an initial review of Fertility, Pregnancy, and Lactation information in their SPCs. We assessed 29 SPCs as incomplete information. Of these, a total of 26 (49%) SPCs of antineoplastic agents have been updated and 3 antineoplastic agents (5.6%) were referred to comprehensive safety evaluation. The comprehensive safety evaluation was closed with no further regulatory action due to limited evidence to draw a conclusion.
Conclusion
Important information on the use of antineoplastic agents during pregnancy and lactation was lacking in the local SPCs. This project shows the importance of monitoring safety information in local PI.

Introduction: Retail pharmacies play an important role in promoting access to contraceptive and abortion products in the community. Yet, there is limited information on the availability of contraceptives and abortion products at the country-level, including by product type in retail pharmacies

Aims: We examine the availability of contraceptive and abortion products in retail pharmacies for HICs and LMICs at the regional and country-level between 2015 and 2020.

Methods: We used quarterly pharmacy retail sales data collected from IQVIA™ MIDAS® for 71 countries from January 2015 - September 2020. We report utilization as defined-daily-doses (DDD) per 1,000 women/girls of reproductive age (15-49), per day.

Results: Global contraceptive use declined from 2015 to 2020 (76.3 DDD to 71.9 DDD; p<0.01). Oral contraceptives and long-acting reversable contraceptives (LARCs) were substantially higher in HICs compared to LMICs (130.9 DDD vs. 16.8 DDD; 47.1 DDD vs. 0.7 DDD). Utilization of LARCs increased significantly in LMICs (0.2 DDD to 0.7 DDD; p<0.01), and emergency contraceptive use remained higher in LMICs compared to HICs (0.40 DDD to 0.18 DDD vs. 0.13 DDD to 0.16 DDD, respectively). Abortion product utilization was more common in LMICs compared to HICs (6.5 DDD vs. 1.2 DDD); use declined substantially over time in HICs (2.3 DDD to 1.2 DDD; p<0.001) but increased significantly in LMICs (3.6 DDD to 6.5 DDD; p<0.001). There were substantial variation within LMICs at the regional and country-level.

Discussion/Conclusion: There were persistent disparities between HICs and LMICs in contraceptive utilization which may contribute to worsening disparities in reproductive health. Our findings also suggest that LMICs are more likely to rely on abortion medications from retail pharmacies than HICs which may be related to limited access to contraceptives from the public sector.