Earticle

This review examines the pivotal clinical trials that evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, in the management of obesity. The reported findings underscore significant and sustained weight loss achieved with semaglutide in diverse patient groups, although gastrointestinal disorders occurred frequently, leading to therapy discontinuation. Overall, the studies demonstrated the potential of semaglutide as a therapeutic option not only for type 2 diabetes but also for obesity. The treatment landscape in obesity is evolving, as reflected in changing regulatory approvals and clinical guidelines, suggesting a paradigm shift toward personalized approaches in this chronic disease states to achieve optimal treatment outcomes for patients.

Background: Daytime sleepiness, a common phenomenon among adolescents focused on academics, has negative effects on aspects such as growth and overall learning. However, research on various drugs and diseases affecting daytime sleepiness is lacking in the reality. Therefore, this study aims to investigate the factors influencing daytime sleepiness in adolescents with daytime sleepiness. Methods: This study was conducted through a survey of 2,432 middle and high school students, aged 14 to 19. The questionnaire consisted of information on socio-demographic characteristics, overall health status, and sleep patterns. The Pediatric Daytime Sleepiness Scale (PDSS), translated into Korean, was used to assess daytime sleepiness. Daytime sleepiness was measured by calculating the total score for each item of the PDSS, and divided into two groups based on the cutoff value of 19, which was the upper quartile. Results: We analyzed a total of 1,770 students including 799 boys and 971 girls. Students with a PDSS score of 19 or higher made up 33.3% of boys and 66.7% of girls. In multivariate analyses, females, smoking, poor self-reported health level, sleep after 12 am, not feeling refreshed in the morning, headache, muscle pain, and scoliosis increased the risk of daytime sleepiness significantly. The AUROC of PDSS, including significant factors in multivariate analyses, was 0.751 (95% CI 0.725~0.776). Conclusions: Daytime sleepiness in adolescents affects growth, academic performance, and emotional stability. Therefore, it is important to manage medications, diseases, and other factors that affect daytime sleepiness on a social level.

Background: This study examined the public’s perceptions of repeat dispensing as one of the measures to reduce the harmful effects of long-term prescriptions in Korea. Methods: From January 11 to 25, 2021, an online survey was conducted for adults using convenience sampling. A self-developed questionnaire was used. Results: There were 310 respondents, of which 228 (73.5%) preferred repeat dispensing. When considering the additional fee payment, 188 (60.6%) preferred repeat dispensing, and 54 (67.5%) out of a total of 80 chronic disease patients preferred it. It was confirmed that there was a difference in the willingness to repeat dispensing considering the additional cost depending on whether the patient had a chronic disease and the distance from home to the nearest pharmacy. As a result of subgroup analysis for patients with chronic diseases, frequency of outpatient visit, number of prescription days, method of packaging pharmaceuticals, and distance from home to the nearest pharmacy were identified as variables that could well predict the willingness to repeat dispensing considering paying additional fees. The preference for repeat dispensing may vary depending on conditions such as additional cost range, frequency and period of prescription use, disease and patient characteristics, so a careful approach is necessary. Conclusion: It is necessary for the government to consider the introduction of repeat dispensing with interest in the public demand.

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

Background: Drug-related problems have the potential to threaten patient health, and pharmacists are in a position to prevent such problems through prescription reviews and patient counseling, actively engaging in pharmaceutical care activities. This study aims to categorize and analyze the intervention activities of pharmacists in community pharmacies concerning drug-related problems, following international criteria. Methods: Over a six-month period, prescription interventions completed in a community pharmacy in Seoul were selected as the research subjects. The causes of interventions were classified according to the Pharmaceutical Care Network Europe (PCNE) drug-related problems (DRPs) classification system and the types and frequencies of DRPs were identified. Results: Among a total of 49,334 prescriptions, 527 interventions were completed, constituting approximately 1.07% of the daily average filled prescriptions. Individuals over 60 years of age represented more than 50%. The primary cause of DRPs was prescribing and drug selection issues, comprising 256 cases (48.58%), with specific subcategories including 109 cases of drug selection, 79 cases of treatment duration errors, 47 cases of dose selection, and 21 cases of inappropriate dosage form selection. Patient-related issues accounted for 204 cases (38.71%). Conclusion: The study demonstrated that the pharmacists’ intervention in community pharmacies contributes to the safe use of medication by patients.

Background: Oral cancer drugs, particularly tyrosine kinase inhibitors (TKIs), are increasingly popular due to their convenience. However, they pose challenges like drug interactions, especially with medications like azole antifungals. While the FDA provides some guidance, more detailed information is needed to manage these interactions effectively. A meta-analysis was conducted to understand the impact of interactions between TKIs and azole antifungals on adverse events during clinical studies. Methods: A meta-analysis followed PRISMA guidelines. Data from PubMed, EMBASE, and references were searched until November 30, 2021. Inclusion criteria encompassed studies on TKI-antifungal interactions in English. Study selection and quality assessment were conducted by two independent investigators. Results: Out of 158 articles, 11 were selected for analysis. Combination therapy showed a slight increase in adverse events but was not statistically significant (OR 1.02, 95% CI 0.49-2.13, p=0.95). AUC and Cmax fold changes did not significantly impact adverse event development. Both itraconazole and ketoconazole showed no significant difference in adverse event development compared to TKI alone. Conclusions: Study finds TKI-DDI not significantly linked to AE increase; azole antifungal types not related to AE. Future DDI research crucial for drug development.