1.Updates on Vaccine Safety and Post-Licensure Surveillance for Adverse Events Following Immunization in South Korea, 2005–2017
Dongwon YOON ; Ju Hwan KIM ; Hyesung LEE ; Ju-Young SHIN
Yonsei Medical Journal 2020;61(7):623-630
Purpose:
Vaccine hesitancy is among the top ten threats to global health, and access to precise data on adverse events following immunization (AEFIs) is imperative to alleviate public concerns surrounding vaccines. This study aimed to present the overall trends of AEFIs reported in South Korea.
Materials and Methods:
We evaluated the trends of AEFIs using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System database between January 2005 and December 2017. AEFIs were classified into five categories to evaluate associations between vaccines and AEFIs through a case-non-case study: neurologic reactions, general systemic reactions, local reactions, allergic reactions, and others.
Results:
Among 54378 reported adverse events (AEs) associated with all vaccines approved in South Korea, more than half (56.7%) occurred following influenza vaccination, followed by the pneumococcal (11.6%) and Bacillus Calmette-Guérin (BCG) vaccines (5.0%). After immunization with most vaccines, general systemic reactions were most common, followed by local and neurologic reactions. Adjusted reporting odds ratios were calculated for all neurologic, general, local, and allergic reactions: of all vaccines, rotavirus [neurologic 2.43, 95% confidence interval (CI), 2.25–2.62], BCG (general; 2.20, 95% CI, 1.91–2.53), BCG (local; 3.15, 95% CI, 2.69–3.68), and Japanese encephalitis (allergic 2.38, 95% CI, 1.98–2.87) vaccines showed the highest values.
Conclusion
The majority of reported AEFIs were non-serious and mostly general systemic reactions. Sufficient knowledge on the AEFIs would secure public confidence on the safety of vaccines, thereby reducing public health burden from vaccine-preventable diseases.
2.Exploring the Perception on Drug Utilization Review System and DUR Modernization Pilot Project: A Qualitative Study Using Focus Group Interviews
Sungho BEA ; Ha-Lim JEON ; Dongwon YOON ; Ahhyung CHOI ; Hyesung LEE ; Ju-Young SHIN
Korean Journal of Clinical Pharmacy 2021;31(2):104-114
Objective:
To explore the perception of drug utilization review (DUR) system and DUR modernization pilot project among healthcare professionals and patients.
Methods:
We conducted 8 times of focus group interviews (FGI) between August 1, 2019 to December 31, 2019. The healthcare professionals and patients who participated in the DUR modernization pilot project were included in the present study. Based on the type of project participation or medical institution, the participants were divided into the following four groups: group 1, hospital; group 2, clinic; group 3, pharmacy; and group 4, patient. Within each group, interviews were conducted under a pre-defined agenda to identify the implicit perceptions of the participants; the contents of the interviews were, then, categorized.
Results:
Healthcare professionals established a consensus on the positive aspects of the DUR system and DUR modernization pilot project. However, substantial concerns remain, such as additional workload associated with monitoring adverse events or acquiring consents from patients. Furthermore, a difference of opinion over the DUR convenience system was observed. Among 3 DUR convenience system, the personal medication history review service was highly utilized, but pop-up hold function and communication system was rarely used.
Conclusion
We observed that systematic intervention using the DUR system is effective for both healthcare providers and consumers. Adverse events caused by inappropriate drug use can be prevented by continuous patient monitoring. Therefore, the role of DUR system needs to be expanded to establish a safe drug management system.
3.Sex Differences in Attitudes Toward Marriage and Childbearing Based on the Assumption of Being BRCA1/2 Mutation Carriers Among Young People
Jiwon JEONG ; Boyoung PARK ; Dongwon KIM ; Jiyoung KIM ; Bom-Yi LEE ; Junghyun YOON ; Sung-Won KIM
Journal of Breast Cancer 2022;25(3):233-243
Purpose:
This study investigated changes in attitudes toward marriage and childbearing assuming a BRCA1/2 mutation carrier status among healthy, unmarried individuals in Korea.
Methods:
A nationally representative sample of healthy, unmarried individuals aged 20–39 years was surveyed. A questionnaire on marriage and childbearing intentions was administered to the participants before and after providing them with information on BRCA1/2 mutation carriers’ breast and ovarian cancer risks and their autosomal dominant inheritance pattern. The participants were asked about their attitudes toward childbearing through preimplantation genetic diagnosis (PGD).
Results:
Of the participants who initially wanted to marry, the assumption that they or their partners had BRCA1/2 mutation caused 25.3% to no longer want to get married and 36.2% to change their attitude from wanting to bear children to no longer wanting them. Females were more likely than males to change their attitudes toward marriage and childbearing. The participants who had negative attitudes toward genetic testing were more likely to change their attitudes regarding marriage and childbearing than those who were favorable toward both disclosure and testing. More than 50% of the participants who did not want children were willing to bear children through PGD when it was assumed that they were BRCA mutation carriers.
Conclusion
On the assumption of being carriers, general, young, and healthy females were more likely than males to negatively change their attitudes toward marriage and childbearing. Public education on the implications of living with mutation carriers and reproductive options may be required.
4.Attitudes toward Risk-Reducing Mastectomy and Risk-Reducing Salpingo-oophorectomy among Young, Unmarried, Healthy Women in Korea
Boyoung PARK ; Dongwon KIM ; Jiyoung KIM ; Bom Yi LEE ; Junghyun YOON ; Sung-Won KIM
Cancer Research and Treatment 2022;54(2):375-382
Purpose:
This study investigated the attitudes toward risk-reducing mastectomy (RRM) and risk-reducing salpingo-oophorectomy (RRSO) as cancer prevention options for BRCA1/2 carriers in healthy, young, unmarried Korean women.
Materials and Methods:
A nationally representative sample of 600 women, aged 20-39 years, completed a questionnaire on sociodemographic variables, preference for genetic testing, and intention to undergo risk-reducing surgeries after receiving information on the cancer risk of BRCA1/2 mutations and benefits of risk-reducing surgeries.
Results:
A total of 54.7% and 57.7% had the intention to undergo RRM and RRSO, respectively, on the assumption that they were BRCA1/2 carriers. Older age and no intention to undergo genetic testing were associated with a reduced likelihood of undergoing RRM (odds ratio [OR], 0.30; 95% confidence interval [CI], 0.14 to 0.61 for age 35-39 years and OR, 0.35; 95% CI, 0.20 to 0.62 for no intention for genetic testing) and RRSO (OR, 0.39; 95% CI, 0.19 to 0.79 for age 35-39 years and OR, 0.30; 95% CI, 0.17 to 0.53 for no intention for genetic testing). Women who chose to be single were likely to undergo risk-reducing surgeries (OR, 1.67; 95% CI, 1.07 to 2.60 for RRM and OR, 1.56; 95% CI, 1.00 to 2.44 for RRSO).
Conclusion
More than 50% of healthy, unmarried, young Korean women were inclined to undergo prophylactic surgeries if they were BRCA1/2 mutation carriers. Further studies on decision-making process for cancer prevention in individuals at high risk for cancer need to be conducted.
5.Exploring the Perception on Drug Utilization Review System and DUR Modernization Pilot Project: A Qualitative Study Using Focus Group Interviews
Sungho BEA ; Ha-Lim JEON ; Dongwon YOON ; Ahhyung CHOI ; Hyesung LEE ; Ju-Young SHIN
Korean Journal of Clinical Pharmacy 2021;31(2):104-114
Objective:
To explore the perception of drug utilization review (DUR) system and DUR modernization pilot project among healthcare professionals and patients.
Methods:
We conducted 8 times of focus group interviews (FGI) between August 1, 2019 to December 31, 2019. The healthcare professionals and patients who participated in the DUR modernization pilot project were included in the present study. Based on the type of project participation or medical institution, the participants were divided into the following four groups: group 1, hospital; group 2, clinic; group 3, pharmacy; and group 4, patient. Within each group, interviews were conducted under a pre-defined agenda to identify the implicit perceptions of the participants; the contents of the interviews were, then, categorized.
Results:
Healthcare professionals established a consensus on the positive aspects of the DUR system and DUR modernization pilot project. However, substantial concerns remain, such as additional workload associated with monitoring adverse events or acquiring consents from patients. Furthermore, a difference of opinion over the DUR convenience system was observed. Among 3 DUR convenience system, the personal medication history review service was highly utilized, but pop-up hold function and communication system was rarely used.
Conclusion
We observed that systematic intervention using the DUR system is effective for both healthcare providers and consumers. Adverse events caused by inappropriate drug use can be prevented by continuous patient monitoring. Therefore, the role of DUR system needs to be expanded to establish a safe drug management system.
6.A Nationwide Survey of mRNA COVID-19 Vaccinee’s Experiences on Adverse Events and Its Associated Factors
Dongwon YOON ; Ha-Lim JEON ; Yunha NOH ; Young June CHOE ; Seung-Ah CHOE ; Jaehun JUNG ; Ju-Young SHIN
Journal of Korean Medical Science 2023;38(22):e170-
Background:
Although coronavirus disease 2019 (COVID-19) vaccines have been distributed worldwide under emergency use authorization, the real-world safety profiles of mRNA vaccines still need to be clearly defined. We aimed to identify the overall incidence and factors associated with adverse events (AEs) following mRNA COVID-19 vaccination.
Methods:
We conducted web-based survey from December 2 to 10 in 2021 with a 2,849 nationwide sampled panel. Study participants were individuals who had elapsed at least twoweeks after completing two dosing schedules of COVID-19 vaccination aged between 18–49 years. We weighted the participants to represent the Korean population. The outcome was the overall incidence of AEs following mRNA COVID-19 vaccination and associated factors.We estimated the weighted odds ratios (ORs) using multivariable logistic regression models to identify the factors associated with AEs.
Results:
Of the 2,849 participants (median [interquartile range] age, 35 [27–42] years; 51.6% male), 90.8% (n = 2,582) for the first dose and 88.7% (n = 2,849) for the second dose reported AEs, and 3.3% and 4.3% reported severe AEs, respectively. Occurrence of AEs was more prevalent in mRNA-1273 (OR, 2.06; 95% confidence interval [CI], 1.59–2.67 vs. BNT162b2), female sex (1.88; 1.52–2.32), and those with dermatologic diseases (2.51; 1.32–4.77). History of serious allergic reactions (1.96; 1.06–3.64) and anticoagulant medication use (4.72; 1.92–11.6) were associated with severe AEs.
Conclusion
Approximately 90% of participants reported AEs following mRNA COVID-19 vaccination. Substantial factors, including vaccine type (mRNA-1273), female sex, and dermatologic diseases were associated with AEs. Our findings could aid policymakers in establishing vaccination strategies tailored to those potentially susceptible to AEs.
7.Predictors of COVID-19 Vaccine Hesitancy Among Parents of Children Aged 5–11 Years in Korea
Ju Hwan KIM ; Dongwon YOON ; Yunha NOH ; Jaehun JUNG ; Young June CHOE ; Ju-Young SHIN
Journal of Korean Medical Science 2023;38(42):e315-
This was a cross-sectional study using the data collected from a nationwide survey between November and December 2022 to explore factors associated with hesitancy towards coronavirus disease 2019 (COVID-19) vaccination for children. Among 3,011 participants with child aged 5–11 years, 82.5% demonstrated hesitancy towards vaccinating their child. This was more common among mothers (odds ratio 1.84 [95% confidence interval 1.46–2.31]), those residing outside metropolitan area (urban: 2.46 [1.89–3.20]; rural: 2.87 [2.09–3.93]) or with history of COVID-19 diagnosis (2.22 [1.78–2.76]). Parents were also hesitant if their child recently had COVID-19 (3.41 [2.67–4.37]). Conversely, they were less likely to be hesitant if they had three or more children (0.66 [0.46–0.94]) or if their child has underlying medical condition(s) (0.54 [0.41–0.71]). Our findings highlight high prevalence of parental hesitancy towards COVID-19 vaccination for children, and call for targeted outreach efforts from the stakeholders to facilitate the vaccine uptake in this pediatric population.
8.The Revised Korean Practice Parameter for the Treatment of Attention-Deficit Hyperactivity Disorder (IV): Non-Pharmacologic Treatment.
Yun Mi SHIN ; Eui Jung KIM ; Yunsin KIM ; Soo Young BHANG ; Eunha LEE ; Cheol Soon LEE ; Hyoung Yoon CHANG ; Minha HONG ; Dongwon SHIN
Journal of the Korean Academy of Child and Adolescent Psychiatry 2017;28(2):84-95
Attention-deficit hyperactivity disorder (ADHD) is a neuropsychiatric disorder that begins in early childhood and can persist throughout adulthood. ADHD causes difficulties in various area of life, such as academic achievement, peer relationships, family functioning, employment and marriage. Although ADHD is known to respond well to medication, such treatment is more effective when combined with psychosocial (non-pharmacologic) therapy in terms of alleviating the core symptoms and improving appropriate functions. Psychosocial treatment interventions are divided into psychoeducation, behavioral parent training, school intervention, cognitive behavior therapy, social skill training, parent-child interaction therapy, play therapy, other treatments (coaching, complementary and alternative medicine), neurofeedback and Cogmed. Adult ADHD cognitive behavioral therapy is described separately. These practice parameters summarize the evidence for psychosocial treatment. Based on this evidence, specific recommendations are provided for psychosocial interventions.
Adult
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Cognitive Therapy
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Employment
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Family Relations
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Humans
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Marriage
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Neurofeedback
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Parents
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Play Therapy
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Social Skills
9.Selecting the Priority Research Topics Addressing Unmet Post-immunization Safety Needs: A Model for Generating Research Proposal and Designing a Questionnaire for the Clinical Experts
Hyun Jeong KIM ; Hyesung LEE ; Ju Hwan KIM ; Dongwon YOON ; Yunha NOH ; Ju Young SHIN
Korean Journal of Clinical Pharmacy 2019;29(3):173-185
OBJECTIVE: To gather inputs from clinical experts on selecting and prioritizing research topics, to address unmet vaccine safety needs. METHODS: A questionnaire containing 15 vaccine safety assessment research proposals was sent to 28 vaccine experts chosen from various domestic medical association boards, and the rationale for each of the proposals was provided by presenting the following information: 1) a brief summary of the clinical safety studies on the vaccine, conducted by the Clinical Immunization Safety Assessment (CISA) project group, supervised by the United States Center for Disease Control (U.S. CDC), and 2) a summary of recently published studies that address vaccine safety issues. The experts were instructed to select and rank 5 topics in the order of preference, and the preference score for each proposed topic was calculated by assigning points on a scale of 1 to 5. RESULTS: All 28 experts responded to the questionnaire, and the following topics were selected according to their calculated preference scores: 1) Human papillomavirus vaccine safety profile in the Korean female adolescents; 2) A signal detection of adverse events following Influenza vaccination: comparison between the US and South Korea; 3) Incidence of anaphylaxis following National Immunization Program vaccines between 2008 and 2017; 4) Safety of quadrivalent influenza vaccines compared to trivalent influenza vaccines; and 5) Pneumococcal vaccine safety profile in the general population. CONCLUSION: Five research topics addressing vaccine safety were selected, for which well-constructed research protocols need to be promptly developed to address current unmet vaccine safety needs in South Korea.
Adolescent
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Anaphylaxis
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Centers for Disease Control and Prevention (U.S.)
;
Decision Making
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Humans
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Immunization
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Immunization Programs
;
Incidence
;
Influenza Vaccines
;
Influenza, Human
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Korea
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Research Design
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United States
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Vaccination
;
Vaccines
10.Arthralgia and Myalgia Associated with the Use of Bisphosphonate:An Active Monitoring Study
Jung-woo SONG ; So-Hee PARK ; Dongwon YOON ; Mo-Se LEE ; Jung-Min LEE ; Na-Young KIM ; Young-Wook KIM ; Ju-Yeun LEE ; Ju-Young SHIN
Korean Journal of Clinical Pharmacy 2021;31(3):180-187
Objective:
We investigated arthralgia and myalgia associated with the use of oral bisphosphonate (BP) by conducting a survey of patient.
Methods:
The pharmacists conducted a survey between 1 Oct 2019 and 30 Sep 2020 among patients who were dispensed BP in community pharmacies to assess their demographic and medical characteristics, and their experiences with, and process for pain. Logistic regression analyses were performed to find the risk factors associated with the pain, and the odds ratios (OR) and 95% confidence intervals (CI) were determined.
Results:
A total of 160 patients who used BP participated in the survey (74 [46.3%] used risedronate; 61 [38.1%] used alendronate; 23 [14.4%] used ibandronate), and 20 (12.5%) of them experienced pain. Significant statistical differences of the characteristics between patients who experienced pain or not were observed regarding menopause, and parity. Compared with women who had one or two parity, women who had more than three parity were associated with the decreased risk of pain (OR, 0.24; 95% CI, 0.04-0.98). Moreover, steady exercise was associated with the decreased risk of pain compared to less exercise (OR, 0.37; 95% CI, 0.14-0.98).
Conclusion
Our findings suggest that the risk of pain in BP-treated patients might be different regarding the different ingredients of BP, and dosing frequency. This survey highlights a need for a further safety research to understand the factors influencing the pain associated with the BP treatment.