Background: This study aimed to analyze autologous and allogeneic cell therapies. A gap analysis of source-cell storage regulations and guidelines of allogeneic cell therapies was performed for regulatory authorities in target countries, including the USA, EU, Japan, and Korea.
Methods: Cell-storage regulations and guidelines regarding allogeneic cell therapy products framed by regulatory authorities were comparatively analyzed.
Results: Of 41 cell therapies, 10 allogeneic cell therapies were selected, and their source cells were categorized based on 3 types of cell storage, namely cell bank (n=6) in the USA, Japan, and Korea; cell stock (n=2) in the EU; and drug substance (n=2) in Korea. In the gap analysis of cell storage regulations and guidelines by the selected regulatory authorities, cell storage systems have regulations and guidelines similar to those stipulated by regulatory authorities, except for the regulation of source-cell changes. Most allogeneic cell therapies used cell banks for cell storage. Thus, to ensure the safety of allogeneic cell therapy, more detailed criteria must be established for source-cell changes in cell storage systems.
Conclusion: Regulatory authorities can ensure a safer and more effective supply of therapy products to the public by harmonizing the regulations associated with allogeneic cell therapies.

Background: Since the early 21^st Century, pharmacy practice has experienced critical changes diversely worldwide. This paper reviewed studies aimed at the development of pharmacy education and practice during the last 10 years in Vietnam.
Methods: Analyse data from official sources including Pubmed, Government website, University’s website and books.
Results: The results showed that Vietnam has taken great strides in the legal regulation of clinical pharmacy operations, which are considered a patient-centered pharmacy activity. However, the practice of clinical pharmacy in hospitals, especially direct patient care services, is very limited. Although patient-centered subjects have been added in teaching curricula, the clinical practice experiences of pharmacist students in hospitals have not been addressed.
Conclusion: Vietnam has built a favorable environment for clinical pharmacy practice and education; however, the pharmaceutical services provided by pharmacists remain very limited, especially in the hospital setting.

Here, we provide an overview of the international collaboration between Hai Phong University of Medicine and Pharmacy (HPMU) in Vietnam and Chungnam National University (CNU) in South Korea, followed by an outline of the plans for this collaborative relationship. These two pharmacy schools signed a Memorandum of Agreement in 2016, commencing a collaborative partnership that included student exchange programs and joint research initiatives in healthcare. Two exchange programs were held in 2018 and 2019, creating valuable opportunities for students and lecturers at each institution. The programs facilitated learning about the local healthcare system, pharmacy education practices, and hands-on experience in hospitals and drug stores. This collaboration has fostered a thriving environment for pharmacy research. Teams of researchers from both HPMU and CNU have collaborated effectively to address research innovations, scientific issues, and funding opportunities. To date, this partnership has generated 14 joint pharmacy research projects, leading to a significant increase in the number of annual publications by both institutions. To further enhance their commitment to collaboration, HPMU has developed a dual Master’s degree program specifically for HPMU students. The development of a joint educational program that integrates the curricula of both pharmacy schools is well underway. This step is expected to yield a multitude of benefits, including enhanced educational quality, scholarship opportunities for students, and significant improvements to the quality of materials and technical facilities in Vietnam through Korean funding.

Patients and survivors of cancer may develop cognitive impairment pre-, intra-, and post-treatment, which is a phenomenon known as cancer-related cognitive impairment (CRCI) or chemobrain. CRCI can adversely affect the quality of life in patients and survivors of cancer. Several factors are associated with CRCI, and the proposed CRCI mechanisms include oxidative stress, dysregulation of inflammatory cytokines, genetic susceptibility, hormone deficiencies and/or psychological distress. Over the past 15 years (2008–2023), our Singapore- and United States-based research team has conducted numerous human studies to evaluate the underlying mechanisms of CRCI through biomarker discovery and validation. Hence, this narrative review aims to elucidate the association between peripheral biomarkers evaluated in our past studies and cognitive function among non-CNS cancer survivors. In summary, plasma levels of brain-derived neurotrophic factor, inflammatory cytokines, and dynamin-1 in plasma extracellular vesicles have shown promising roles in CRCI pathophysiology. These findings indicate that further investigations are required to explore their potential to translate observational results into experimental therapeutics.

Background: Sodium–Glucose cotransporter 2 (SGLT-2) inhibitors, such as dapagliflozin and empagliflozin, are commonly used to treat type 2 diabetes mellitus, chronic kidney disease, and heart failure with reduced ejection fraction. Recent landmark trials, EMPEROR-Preserved and DELIVER, have demonstrated that both drugs can improve cardiovascular outcomes in heart failure patients with preserved ejection fraction (HFpEF). However, differences in the primary outcomes between these trials were observed when stratified by Asian subgroups.
Methods: This study analyzed data from 59 adults using empagliflozin and 26 using dapagliflozin at Princess Margaret Hospital between August 2016 and March 2022. The primary composite outcome was combined cardiovascular death and hospitalization due to heart failure. Results were stratified using a Cox proportional-hazards model. Furthermore, the occurrence of side effects was evaluated and reported as safety outcomes.
Results: The study found that the cardiovascular and mortality outcomes were higher than previously reported in the literature. The use of empagliflozin resulted in 24.9 composite outcome events per 100 patient years, whereas the use of dapagliflozin resulted in 29.9 events per 100 patient years. Patients taking empagliflozin without heart failure hospitalization in the past 12 months had significantly better composite outcomes than those taking dapagliflozin (hazard ratio, 0.30; 95% confidence interval, 0.12–0.76). However, no significant differences were observed in the composite outcome and all-cause mortality between the two drugs.
Conclusion: A substantial initial decrease in overall survival toward the primary composite outcome within the first year after the start of SGLT-2 inhibitor administration indicates the need for early intervention for this specific patient subgroup. Although constrained by a modest sample size obtained from a single center, the findings of this study highlight the importance of conducting additional research to explore the comparative efficacy of SGLT-2 inhibitors for HFpEF in a larger local population.

Background: This study aimed to evaluate the cost-effectiveness and patient acceptance of a fast-track medication refill (FTMR) service whereby pharmacists and nurses recommend cardiovascular medication refills for stable patients requiring no medication change. It also aimed to create a model that would able to predict which patients are suitable for the FTMR service.
Methods: 472 patients were reviewed between April 2016 and March 2017. For each patient, data were collected on demographics, medical history, symptoms, vital signs, and laboratory results. These data were used to build logistic regression models able to predict whether a patient required medication change. Interviews were conducted with 92 patients to evaluate the time costs, financial costs, patient acceptance, and clinical need for an FTMR service. A cost-effectiveness analysis was performed to estimate the potential cost saving from the introduction of an FTMR service.
Results: The mean age of the study population was 58.7±12.4 years. Among the sample of cardiology patients, 89.4% were on anti-hypertensives; 25.6% were on hypoglycemics, and 59.8% were on cholesterol-lowering drugs. The majority (79%) of patients had no prescription changes recorded during the study period. Our predictive model demonstrated an accuracy level of >96% in the identification of the 50.6% of the cohort judged by physician consultation to be in stable condition, requiring no medication change or dose adjustment. Of the patients requiring no medication change, 53.6% agreed to use the FTMR service. Our analysis found that the FTMR service could lead to savings of 289 USD per 10 person-years, assuming each patient attended a follow-up visit every 6 months.
Conclusion: Within our cardiology clinic, a significant number of outpatients were eligible and willing to utilize an FTMR service, which was found to be a cost-effective improvement. Step-down care of stable patients may help to alleviate the increasing demands and pressure on healthcare providers.

Background: Sodium restriction is an accepted nonpharmacological strategy for fluid management in heart failure. In an intensive care unit (ICU) setting, high sodium loads have been associated with avoidable derailment of fluid balance. The international guidelines recommend restricting the total sodium intake to <2,000 mg/day or <87 mmol/day for patients with heart failure. Previous studies in the ICU have shown a high median daily sodium administration (approximately 225 mmol/day); however, there is a paucity of data on patients with heart failure with reduced ejection fraction (HFrEF).
Methods: A retrospective observational cohort study was performed in an tertiary teaching hospital network over a 3-month period. Data on intravenous (IV) fluids, IV medicines, medicine diluents, line flushes, and oral/rectal medicines with known high sodium were obtained. The amount of sodium administered each day from these sources was calculated and compared with the current guidelines.
Results: A total of 116 patients were reviewed, with an even distribution of patients from cardiac (57 patients) and noncardiac units (59 patients). The median sodium administration was 5.2 mmol/day (IQR, 0.00–15.55). For cardiac versus noncardiac units, the medians were 3.74 mmol/day (IQR 0.00–11.45) and 7.0 mmol/day (IQR 0.00–18.99), respectively. The primary sources of sodium were IV fluids, line flushes, and oral or rectal medicines.
Conclusion: This study suggests that patients with HFrEF admitted to a tertiary hospital network are not receiving sodium greater than the current recommendations mentioned in the guidelines. A pharmacist’s review on the amount of sodium administered might be a clinical pharmacy safety initiative to ensure that patients with HFrEF do not receive excessive sodium from inadvertent sources.

Background: The common cold is a prevalent reason for visiting a doctor. This study aimed to determine the national prevalence of use of potentially inappropriate gastrointestinal (GI) drugs in treating common colds in ambulatory settings in Korea, and to identify its influencing factors.
Methods: This cross-sectional study analyzed National Patient Sample data from December 1 to December 31, 2018. We included patients aged ≥20 years who were diagnosed with a cold and visited a primary care clinic, and excluded those with GI disorders within the 3 months preceding their cold diagnosis. We investigated whether outpatient prescriptions for these patients included any GI medications and estimated the percentage of prescriptions for GI drugs. Multiple logistic regression analysis investigated the factors influencing GI drug prescription.
Results: The study revealed that 43.8% of patients with cold were prescribed potentially inappropriate GI medications. Women were more likely to receive these prescriptions (odds ratio [OR]=1.314, 95% confidence interval [CI]=1.144–1.508). Region and specialized areas of clinics played a role in the prescription of potentially inappropriate GI medications. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) was directly associated with potentially inappropriate GI drug prescription (OR=1.903, 95% CI=1.648–2.199), and patients prescribed fewer cold medicines were more likely to receive GI drugs.
Conclusion: This study highlights the high rate of potentially inappropriate GI medication in treating common colds in Korea. Factors identified as influencing this practice include female sex, surgical specialties of clinicians, nonmetropolitan areas, NSAID use, and fewer medications prescribed in common cold drug prescriptions.

Background: Chemotherapy-induced nausea and vomiting (CINV) is considered as the most distressing side effect of chemotherapy (CT). Overuse of prophylaxis leads to waste of resources, whereas underuse results in poor CINV prevention. Therefore, it is important to explore the pattern of CINV prophylaxis and CINV occurrence to improve the quality of medication use.
Methods: This prospective, observational study was conducted in two oncology-specialized hospitals in North Vietnam in 2019 to investigate the CINV prophylaxis regimens and CINV events among cancer patients receiving intravenous high-, moderate-, or lowemetic-risk CT (HEC, MEC, or LEC, respectively) after the administration of the first cycle of CT. The Multinational Association of Supportive Care in Cancer Antiemesis Tool was used to assess nausea and vomiting.
Results: The study included 294 patients (HEC: 224, MEC: 61, and LEC: 9). They were prescribed a similar pattern of prophylaxis for both acute and delayed emesis regardless of their emetic risks. Patient-specific factors, including sex, age, balance disorder, and comorbidity, but not the emetic risk of CT, were associated with the choice of prophylactic regimens. The incidence rate of CINV was 47.3% in all patients. Multivariate analysis revealed that HEC was associated with an increased risk of acute CINV compared with MEC (odds ratio, 2.34; 95% confidence interval, 1.03–5.32), whereas female sex and younger age were associated with a higher risk of delayed CINV.
Conclusion: CINV management is challenging and may involve over- and underuse of prophylaxis. A more effective approach to prophylaxis in the context of limited resources needs to be developed to improve patient outcomes.

Background: There is no objective and standardized tool for stratification of high-alert medications (HAMs) that reflect each institution’s practice of medication management, drug utilization in the institution, and patient safety protocols in the Korean hospital settings. We aimed to develop the Korean version of the high-alert medication stratification tool (K-HAMST) and assess its content validity and reliability.
Methods: Ten clinical pharmacists from multi-site hospitals completed a two-round Delphi survey to assess the content validity of the translated High-Alert Medication Stratification Tool-Revised. Content validity was demonstrated using the item content validity index and scale content validity index (S-CVI). An expert meeting was conducted to revise the tool to accommodate the clinical practice and workflow in Korea based on the results of the content validity index. Reliability was assessed by calculating the risk scores for 37 HAMs and 37 control medications. The interrater reliability of each medication was assessed using the Kendall’s coefficient of concordance (W).
Results: The initial S-CVI was 0.71. After revision, the final S-CVI of the K-HAMST was 0.92, indicating that the tool has content validity. The HAM scores ranged from 3 to 8 (n=37; median [interquartile {IQR}, 4 [3–5]), whereas the control medication scores ranged from 1 to 2 (n=37; median [IQR], 1 [1–1]). The Kendall’s coefficient of concordance (W) was 0.57, indicating moderate agreement between raters (p<0.001).
Conclusion: The K-HAMST is a valid and reliable tool for assessing and evaluating HAMs in hospital settings.