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Ex) Article Title, Author, Keywords

  • review | 2024-03-31

    Hee-Jin Kim1, Dong Wook Kim2, Myeong Gyu Kim3,4, Mi-Sook Kim5, Ye-Jee Kim6, Jeong Ah Kim1, Suvin Park1, SeungJin Bae3,4, Aesun Shin7, Ju-Young Shin8, Song Vogue Ahn1, Jeonghoon Ahn1, Bo Ram Yang9, Heehyun Won1, Seung-Mi Lee10, Joongyub Lee7, Hui-Eon Lee4, Sun-Young Jung11, Haerin Cho1, Nam-Kyong Choi1,4

    Pharmacoepidemiology and Risk Management 2024; 16(1): 1-10

    https://doi.org/10.56142/perm.24.0003
    Abstract

    While health insurance claims data in Korea have the potential as evidence for drug regulatory decision-making, its effective utilization remains limited. This study aims to identify the challenges encountered by researchers in utilizing claims data and discuss improvement strategies. We summarized practical difficulties encountered by researchers who have experience using claims data from the National Health Insurance Service and the Health Insurance Review and Assessment Service. Challenges encountered by researchers included difficulties in acquiring drug data, delays in data provision, limited provision of information on specific conditions, drugs, and treatments, small data capacity, short data usage periods, and spatiotemporal considerations when accessing data. To maximize the utility of claims data in drug regulatory decision-making, continuous communication between researchers and data providers is necessary for addressing these challenges.

  • review | 2024-03-31

    JuEun Park1, DaHyun Park1, SeoHyun Kim1, Sun-Young Jung2, Ju-Young Shin1,3,4

    Pharmacoepidemiology and Risk Management 2024; 16(1): 11-17

    https://doi.org/10.56142/perm.24.0007
    Abstract

    Globally, advanced therapy medicinal products (ATMP) such as stem cell therapies and gene therapies have become the focal point of the pharmaceutical market. In response to this trend, Korea, like the United States and Europe, has established various regulations and systems pertaining to ATMP. The Ministry of Food and Drug Safety enacted the ‘Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Therapy Medicinal Products,’ restructuring the existing approval system from one centered around synthetic drugs and conventional biopharmaceuticals to one tailored to the characteristics of ATMP. While this regulatory framework allows for consideration of the unique attributes of ATMP, standardized safety measures specific to each product category are currently lacking. To address this gap, we provided foundational data for the safety and effective management of ATMP. This was accomplished by comparing and analyzing the mechanisms of gene therapy products, which are central to ATMP. Additionally, we conducted an analysis of indications and potential adverse events. Based on our research, we anticipate that our study will serve as foundational data for the safety and effective management of gene therapy.

  • review | 2024-03-31

    Su Jeong Song1,2, Hye-Ryun Kang1,2,3, Ji-Hyang Lee1,2

    Pharmacoepidemiology and Risk Management 2024; 16(1): 18-28

    https://doi.org/10.56142/perm.24.0004
    Abstract

    Penicillin allergy labels are associated with significant challenges, including antimicrobial resistance, restricted prescribing options, and negative outcomes for both patients and health care systems. However, only 10% of individuals labeled as penicillin allergic are found to be truly allergic after formal assessment. The evaluation process for a penicillin allergy encompasses a detailed allergy history, often followed by skin testing, and drug challenge. Researchers have suggested assessment tools and clinical decision rules for risk stratification for efficient and precise removal of incorrect penicillin allergy labels. In particular, patients categorized as low risk based on the assessment may undergo direct challenge test with penicillin, a practice supported by accumulating evidence. This comprehensive approach, emphasizing history taking and risk stratification, highlights the important role of healthcare providers in reducing the burden related to penicillin allergy labels. This review aims to understand the process of penicillin allergy evaluation and potential benefits of delabeling.

  • original article | 2024-03-31

    Jeong-Yeon Kim, Sewon Park, Min-Taek Lee, Seung-Hun You, Ju Won Lee, Dal Ri Nam, Sun-Young Jung

    Pharmacoepidemiology and Risk Management 2024; 16(1): 29-39

    https://doi.org/10.56142/perm.24.0001
    Abstract

    Objective: We aimed to identify factors associated with adverse event (AE) reports in statin-associated muscle symptoms (SAMS) using hierarchical clustering of patients in the Korea Institute of Drug Safety and Risk Management - Korea Adverse Event Reporting System database (KIDS-KAERS DB) (2105A0027). Methods: To explore the characteristics and risk factors of SAMS reports, we analysed the KIDSKAERS DB from 2016 to 2020. We included reports with a causality category level of “possible” or higher. Hierarchical clustering analysis was used to identify distinctive patterns within the dataset, with a particular focus on variables such as sex, age, statin type, contraindicated drugs and concomitant drugs. The reporting characteristics were described according to the cluster. Results: Four clusters of AE reports were distinguished by hierarchical clustering: atorvastatin- and rosuvastatinassociated AE (cluster 1), pitavastatin- and simvastatin-associated AE (cluster 2), rosuvastatin-associated AE (cluster 3), and atorvastatin-associated AE (cluster 4). Cluster 1 had a relatively higher proportion of men (57 cases, 50.9%) and a higher mean age (64.8 years) than the other clusters. Concomitant drug use was more common in cluster 1 (56 cases, 50.0%) than in other clusters (33.5%–46.2%), and all serious AEs were observed in cluster 1. Conclusion: Using hierarchical clustering, we found four distinct clusters based on SAMS report characteristics. Our findings further emphasize that patients prescribed statins, especially elderly male patients taking rosuvastatin and atorvastatin concomitantly with other medications, should be closely monitored for the development of rhabdomyolysis

  • original article | 2024-03-31

    Ju-Hee Han1,2, Ae-Hee Jung1, Minjung Kim1, Sun-Hoi Jung1, Ju-Yeun Lee2

    Pharmacoepidemiology and Risk Management 2024; 16(1): 40-48

    https://doi.org/10.56142/perm.24.0002
    Abstract

    Objective: This study aimed to assess diabetes medication intensification at discharge in older adults hospitalized for non-glycemic reasons, examining its shortterm benefits and risks. Methods: A retrospective review of electronic medical records from Boramae Medical Center (September 1, 2020, to August 31, 2022) was conducted. Medication intensification was defined as either increasing the dosage of existing diabetes medications, adding insulin or initiating new medications. We compared glycated hemoglobin (HbA1c) levels 90 days post-discharge and the incidence of blood glucose-related emergency department visits or diabetesrelated unplanned readmission within 90 days post-discharge between patients with and without medication intensification. Results: Out of 1,278 patients, 480 (37.6%) underwent medication intensification at discharge. Factors associated with intensification included longer hospital stays, consultations with endocrinologist, higher HbA1c at admission, frequent hyperglycemic events, and changes in steroid or immunosuppressant use. The intensification group showed a significant reduction (8.6% to 7.0%) in HbA1c 90 days post-discharge compared to the non-intensification group (6.9% to 6.9%, p < 0.001). However, there was no significant impact on postdischarge emergency visits or unplanned readmissions related to blood glucose (aOR 0.34; 95% CI 0.07–1.53). Conclusion: A third of older adults admitted for nonglycemic issues was discharged with intensified diabetes medications, leading to improved short-term glycemic control but did not significantly affect diabetesrelated unplanned readmissions or emergency visits.

  • original article | 2024-03-31

    Yu Been Park1*, Sukmin Hong1*, Hye Jin Jang1, Sung Hwan Kim1, Eun Jung Cho1, Yoon Sook Cho1, Hyoung Jin Kang2,3,4, Ju-Yeun Lee5

    Pharmacoepidemiology and Risk Management 2024; 16(1): 49-56

    https://doi.org/10.56142/perm.24.0005
    Abstract

    Objective: This study aimed to examine the causality of hepatotoxicity related to sulfamethoxazole/trimethoprim (SMX/TMP) in pediatric patients with acute lymphoblastic leukemia (ALL). Methods: We retrospectively analyzed medical records of pediatric ALL patients, who were transitioned from SMX/TMP to aerosolized pentamidine (AP) for Pneumocystis jirovecii pneumonia prevention due to suspected hepatotoxicity between 2010 and 2023. The Roussel Uclaf causality assessment method (RUCAM) was used to assess hepatotoxicity due to SMX/ TMP, emphasizing cases considered “high probability” (RUCAM ≥ 6). Results: Of the 176 pediatric ALL patients who switched from SMX/TMP to AP, 112 did so due to elevated liver enzyme levels, and 38 of these (33.9%) were classified as “high probability” for hepatotoxicity according to RUCAM. Hepatotoxicity induced by SMX/TMP is characterised by an average ALT level of 430.6 IU/L, a total bilirubin level of 1.2 mg/dL at onset, typically manifesting after 223.1 days and resolving within 110.7 days. Multivariable analysis identified significant factors such as age (1–5 years), obesity, onset time (≤ 20 days), recovery time (≤ 20 days), and treatments with L-asparaginase and 6-mercaptopurine as associated with an increased risk of hepatotoxicity. Conclusion: This study found that 21.6% of pediatric ALL patients who discontinued SMX/TMP for prophylaxis had hepatotoxicity with a ‘probable or higher’ causality due to SMX/TMP. Identifying factors associated with ‘probable or higher’ causality for SMX/TMP-induced hepatotoxicity in these patients may be valuable for future research in this domain.

  • original article | 2024-03-31

    Dong-Yeop Lee1,2*, Boyoon Choi3*, Seung Hei Moon4, Eun Young Choi5, Dong Yoon Kang1,2

    Pharmacoepidemiology and Risk Management 2024; 16(1): 57-64

    https://doi.org/10.56142/perm.24.0008
    Abstract

    Objective: The importance of effective adverse drug reaction (ADR) management in local clinics is increasing. This study investigates the current status of ADR management and reporting system use in local clinics, and opinions on development directions for effective ADR prevention. Methods: From January 11th to January 17th, 2022, an online survey was conducted targeting physicians working at local clinics regarding ADR management, use of reporting systems, and development of ADR prevention systems. Results: The awareness of the ADR reporting system was 54.50%, and 22.07% of respondents actually reported ADR incidents. The primary reasons for not reporting were ‘lack of time and unfamiliarity with the process,’ accounting for the highest percentage at 36.62%. Regarding sharing ADR information with other healthcare institutions, 88.56% responded that it would be helpful, and 66.49% indicated they could trust such information. The most crucial areas for improvement identified from the survey were the sharing of ADR records and national-level management. Conclusion: Creating an environment where local clinics can diligently report ADRs and establishing a system to share verified ADR information with other clinics will be a great help to national drug safety.

  • original article | 2024-03-31

    Yunju Choe1, Se Jung Park1, Ju Hwan Kim2, Dongwon Yoon1,2, Dong Yoon Kang3, Jae Hoon Jung4, Ju-Young Shin1,2,5

    Pharmacoepidemiology and Risk Management 2024; 16(1): 65-78

    https://doi.org/10.56142/perm.24.0006
    Abstract

    Objective: This study aimed to evaluate the association between nirmatrelvir/ritonavir, molnupiravir and adverse events and identify safety signals not previously known. Methods: To identify major adverse events and safety signals associated with nirmatrelvir/ritonavir and molnupiravir, we conducted pharmacovigilance study using drug-related adverse events reported to KIDS KAERS DB (2305A0011). Disproportionality analysis were performed using reporting odds ratio (ROR) and information component (IC) method to detected new safety signals not listed in drug label. Results: Adverse events related to nirmatrelvir/ritonavir and molnupiravir were frequently reported in women and person aged ≥ 65, and mostly reported as not serious. Following nirmatrelvir/ritonavir administration, ‘sensory abnormalities’ (20.18%), ‘diarrhoea’ (13.76%), and ‘nausea and vomiting symptoms’ (9.87%) were most commonly reported, while for molnupiravir, ‘nausea and vomiting symptoms’ (15.92%), ‘neurological signs and symptoms’ (15.92%), ‘urticarias’ (10.45%) were predominantly reported. Disproportionality analysis revealed a significant association of nirmatrelvir/ritonavir with ‘sensory abnormalities’ (ROR [95% CI] = 223.74 [207.24–241.55]), ‘interactions’ (ROR [95% CI] = 37.35 [15.10–92.35]), ‘faecal abnormalities’ (ROR [95% CI] = 32.33 [18.68–56.36]). Adverse events not listed on drug label included ‘olfactory nerve disorders’, ‘appitite disorder’, ‘hallucinations’ and urinary adverse events. For molnupiravir, strong association were observed with cardiovascular adverse events such as ‘heart rate and pulse investigations’ (ROR [95% CI] = 58.60 [18.96–181.16]) and ‘vascular tests’ (ROR [95% CI] = 10.97 [4.09–29.47]), which were not included in drug label. Conclusion: Adverse events following the use of nirmatrelvir/ritonavir and molnupiravir were generally not serious, but some safety signals not listed on drug label were newly detected and warranted attention. We expected this study to provide basic data of safety for oral antivirals of COVID-19 and may contribute to the development of future drug safety guidelines.

  • original article | 2024-03-31

    Jin Yoon1,2*, Hyun Jee Kim1,2, Yeh-Hee Ko3, Siyeon Yi4, Kyung-Min Ahn1,2, Jiung Jeong5, Ji-Hyang Lee1,2, Kwangsoo Kim6,7*, Hye-Ryun Kang1,2,5*

    Pharmacoepidemiology and Risk Management 2024; 16(1): 79-89

    https://doi.org/10.56142/perm.24.0009
    Abstract

    Objective: Fimasartan, an angiotensin II receptor blocker (ARB) with superior potency and longer-lasting effects than losartan, demonstrates a good safety profile. However, recent case reports have emerged, linking fimasartan to hepatotoxicity. The aim of the study is to compare the occurrence of liver injury induced by fimasartan. Methods: Patients prescribed with fimasartan and losartan from 2011 to 2021 were identified from electronic health recordbased Common Data Model (CDM) of Seoul National University Hospital. Using clinical data warehouse, clinical information was collected and employed to cross-reference the results retrieved from the CDM. To assess causality and compare the incidence of drug-induced liver injury (DILI), 100 randomly selected patients with liver function abnormalities were evaluated. Results: The CDM analysis included 3,063 patients on fimasartan and 9,688 patients on losartan, among which 302 patients (2.37%) exhibited liver function abnormalities within the first year of ARB therapy. Specifically, 107 (3.49%) patients on fimasartan showed elevated serum alanine aminotransferase or aspartate aminotransferase, compared to 195 (2.01%) patients on losartan. However, when causality was assessed, patients with causality graded as probable or certain did not show any significant difference between the two medications. Conclusion: Although patients taking fimasartan exhibited a slightly higher incidence of mild liver enzyme elevations, this study did not find a significant difference in the occurrence of DILI. Consequently, fimasartan is less safe than losartan in terms of hepatotoxicity cannot be asserted. However, similar to other ARBs, fimasartan poses a risk of DILI, underscoring the importance of monitoring liver function tests to promote safer use of the medication.

  • review | 2023-09-30

    Da Jung Lim1*, Jonghyun Jeong1*, Jung Min Lee2, Mose Lee2, Ju-Yeun Lee1

    Pharmacoepidemiology and Risk Management 2023; 15(2): 101-106

    https://doi.org/10.56142/perm.23.0005
    Abstract

    Objective: This systematic review aimed to investigate the potential risk of neurodevelopmental disorders resulting from fetal exposure to topiramate. Methods: A comprehensive search was conducted in major foreign databases, including PubMed and EMBASE, up to November 6, 2022. Studies that reported the risk of neurodevelopmental disorders in children exposed to topiramate during prenatal life were included in this review. Two reviewers independently screened the titles, abstracts, and full-text articles, and data were extracted using a standardized form. Results: Three studies that met the inclusion criteria were selected for analysis. Even though a recent large cohort study based on Nordic data showed that prenatal topiramate exposure significantly increases the risk of neurogenerative disorders including intellectual disability or autism spectrum disorder, other two studies did not show the significant results. Conclusion: While a recent study suggested that topiramate increases the risk of neurodevelopment disorders, previous two studies did not show the consistent results. Further studies with larger sample sizes, longer follow-up periods are needed.

  • review | 2023-09-30

    Hyeon Ji Lee, Ju Won Lee, Shin Young Park, Soo Hyun Seong, Sun-Young Jung

    Pharmacoepidemiology and Risk Management 2023; 15(2): 107-116

    https://doi.org/10.56142/perm.23.0013
    Abstract

    World Health Organization (WHO) has declared the termination of a public health emergency of international concern (PHEIC) about COVID-19 and regulatory authorities diminished the level of crisis response and transitioned into a long-term management system. The COVID-19 pandemic has had a significant impact on public health and healthcare infrastructure. In the early stages of the COVID-19 outbreak, there were no therapeutics or vaccines available. In response, expeditious development and dissemination of COVID-19 therapeutics and vaccines have been facilitated through processes such as prioritized examination and emergency use authorization (EUA). Consequently, the heightened emphasis on drug safety has prompted the U.S. Food and Drug Administration (FDA) to respond to the COVID-19 pandemic by implementing an information visualization platform to enable swift dissemination of safety information. Additionally, the FDA has undertaken research and safety measures, including the improvement of signal detection analysis and collaboration with international initiatives. In this review, we assessed the safety monitoring and evaluation system employed by the FDA for COVID-19-related therapeutics and vaccines, with the aim of providing pertinent information for the domestic drug safety management system in preparation for potential future outbreaks of novel infectious diseases.

  • review | 2023-09-30

    Su Yeon Lee1,2, Hyun Jee Kim1,2, Jiung Jeong3*, Hye-Ryun Kang1,2,3*

    Pharmacoepidemiology and Risk Management 2023; 15(2): 117-127

    https://doi.org/10.56142/perm.23.0019
    Abstract

    All antineoplastic agents can potentially cause hypersensitivity reactions. Hypersensitivity reactions to antineoplastic agents may not provide patients with optimal treatment and may affect future survival. Hypersensitivity reactions to antineoplastic agents are classified by time of onset of symptoms. If it occurs within 1–6 hours, it is classified as an immediate hypersensitivity reaction, and after 1–6 hours as a delayed hypersensitivity reaction. Mechanisms that cause hypersensitivity reactions to antineoplastic agents differ from drug to drug, and management strategies that match those mechanisms must be used. Management of hypersensitivity reactions to antineoplastic agents includes culprit antineoplastic agent withdrawal, administration after premedication, and desensitization of culprit antineoplastic agent. A better understanding of these management strategies can provide the best antineoplastic agent therapy for patients. In addition to this, it can prevent events leading to death and developing severe reactions. Although there have been many reports on the hypersensitivity reactions of antineoplastic agents, there are very few literatures detailing the hypersensitivity characteristics of individual antineoplastic agents. The purpose of this review is to improve the understanding of the hypersensitivity reactions of individual antineoplastic agents and to reduce the incidence of hypersensitivity reactions by proposing a premedication method.

  • original article | 2023-09-30

    Sang-Bong Lee1*, Dong-Yeop Lee2*, Ji-Hyun Kim2, Seung Hei Moon3, Gwijin Lee4, Boyoon Choi5, Ye Seul Kim6, Jae Hyoung Im7, Dong Yoon Kang2,4

    Pharmacoepidemiology and Risk Management 2023; 15(2): 128-136

    https://doi.org/10.56142/perm.23.0010
    Abstract

    Objective: This study aimed to assess the status and characteristics of adverse events caused by treatments of coronavirus disease 2019 (COVID-19) in hospitalized patients in Korea. Methods: The medical records of patients hospitalized with COVID-19 at 30 medical institutions nationwide from January 1, 2020 to November 30, 2021 were retrospectively reviewed. Data of clinical characteristics; type of COVID-19 treatments; symptoms and severity of adverse events according to CTCAE classification; and prognosis of each patient were analyzed and presented descriptively. Results: Adverse events were observed in 853 of 5,740 (14.9%) hospitalized patients with COVID-19: 732 (85.8%), mild; 106 (12.4%), moderate; and 15 (1.8%), severe. Serious adverse events were observed in 70 (1.2%) patients, with 56 prolonged hospitalizations and four deaths. Adverse events were more frequently found in patients with a lower-than-normal body mass index or many concomitant medications. Moreover, 4,912 patients (85.6%) received multiple medications for treatment of COVID-19, wherein the drugs most mainly administered were steroids (66.4%), antibiotics (59.5%), and remdesivir (52.6%). Adverse events were relatively common in patients administered immunoglobulin, other antiviral drugs, and interleukin-6 inhibitors. Each patient with adverse events had an average of 3.8 symptoms. The most frequent symptoms were increased hyperbilirubinemia (n = 256), nausea (n = 216), and pruritis (n = 188). Conclusion: The incidence of adverse events in hospitalized patients with COVID-19 in Korea was approximately 14.9%. The type of treatment of COVID-19 might affect the incidence and prognosis of specific adverse events. Clinicians should consider the possible adverse effects of each medication before initiating treatment.

  • original article | 2023-09-30

    Seong-Hwan Hwang1, Min-Young Ha1, Chae-Young Lee1, Mo-Se Lee2, Young-Wook Kim2, Jung-Min Lee2, Ju-Young Shin1,3

    Pharmacoepidemiology and Risk Management 2023; 15(2): 137-144

    https://doi.org/10.56142/perm.23.0012
    Abstract

    Objective: Zolpidem is a non-benzodiazepine drug that is known for its relative safety benefit compared to traditional benzodiazepines. However, adverse events (AEs) on the central nervous system such as somnambulism, nightmares, and hallucinations have been consistently reported following its use. This study aimed to identify the AEs related to zolpidem in South Korea. To detect signals of AEs of zolpidem by data mining using the Korean Pharmaceutical Association adverse event reporting system (KPA) database. Methods: We evaluated KPA database from April 2013 to December 2021, a nationwide drug database reported from pharmacy, analyzing AEs reported for zolpidem. We compared the distribution of patient age and sex, frequent AEs, serious adverse events, and causality assessment were performed according to the KPA database system. To identify zolpidem-related AEs, we conducted disproportionality analysis. Estimating reporting odds ratio (ROR) with 95% confidence interval (CI) for each AE by using logistic regression. Results: A total of 155,771 AEs were reported in the KPA database, out of which 1,529 (0.01%) were related to zolpidem. The analysis revealed that dizziness (86 cases, 5.69%) and headache (72 cases, 4.76%) were the most frequently reported adverse events. Notably, somnambulism (ROR: 143.75, 95% CI, 109.17–189.28) was reported more frequently in association with zolpidem than with any other drugs. Additionally, 13 cases of serious AEs were reported. Conclusion: We identified 3 signals out of 5 most frequent AEs. It is necessary to monitor for these AEs related to zolpidem for appropriate and safe use.

  • original article | 2023-09-30

    Abstract

    Objective: Dual antiplatelet therapy (DAPT) has been used following percutaneous coronary intervention (PCI) to prevent major adverse cardiovascular events (MACEs). This study aimed to analyze cardiovascular events and bleeding incidents in the elderly on antiplatelet therapy. Methods: The elderly patients on post-PCI DAPT, aspirin+clopidogrel (AC) and aspirin+ticargrelor (AT), were selected from the Korean Health Insurance Review and Assessment Service–Aged Population Sample (HIRA-APS) in 2017. Patients were excluded if they were on antiplatelets before PCI, had no DAPT, and the follow-up period was less than 30 days. For the study outcomes, negative adverse cardiovascular events (NACE) including bleeding were identified. Incidence rate and time to MACEs were analyzed. The odds ratio of MACEs was assessed by patient characteristics, comorbidities, or concomitant medications. Results: A total of 153 patients on DAPT of AC (n = 132) and AT (n = 21) were included. NACE was observed in 52 cases (34.0%), comprising 32 cases (20.9%) of MACE and 20 cases (13.1%) of bleeding. In the AC vs. AT groups, the incidence of MACE was 27 (20.5%) vs 5 (23.8%), and bleeding occurred in 17 (12.9%) vs. 3 (14.3%), with no statistical significance. The time to NACE was 69.5 ± 82.3 days and significantly shorter in patients with renal disease (2.8 ± 2.2, p < 0.001), cerebrovascular disease (19.0 ± 19.4, p = 0.002), and liver disease (4.5 ± 2.1, p < 0.001) compared to those without these specific conditions. Conclusion: Among elderly post-PCI patients with DAPT, NACE was similar between the AC and AT groups. Patients with renal and liver diseases experienced a shorter time to NACE. Post-PCI antiplatelet therapy should be used carefully in the elderly.

  • original article | 2023-09-30

    Jonghyun Jeong1*, Suhyun Lee1*, Ah Young Lee1, Kyu-Nam Heo1, Soyoung Park1, Hyunwoo Chae1, Ju-Yeun Lee1, Sang il Min2, Young-Mi Ah3, Ji Min Han4

    Pharmacoepidemiology and Risk Management 2023; 15(2): 157-164

    https://doi.org/10.56142/perm.23.0015
    Abstract

    Objective: This study aimed to estimate the rate of high-alert medication (HAM) use in nationwide representative claims data and compare the rates by types of healthcare settings. Methods: This cross-sectional study used data obtained from 2019 and 2020 Health Insurance Review and Assessment Service National Patient Sample (HIRA-NPS) and National Inpatient Sample (HIRA-NIS). The study focused on essential HAMs from the HAM list for acute, long-term, and primary care settings. The usage was quantified in terms of the number of patients receiving the medications at least once, the proportion within the entire patient population, and the ratio of prescription days for HAMs to total days. We also analyzed the rate of inpatients who received HAMs in HIRA-NIS. Results: Among 1,888,831 patients included in the database, 480,852 patients (25.5%) received HAMs at least once annually, with oral benzodiazepine derivatives being the most commonly prescribed. Substantial variations were observed in HAM usage across healthcare settings with the highest prevalence observed in long-term care hospitals (32.4%) followed by acute care hospitals (24.8%) and primary care clinics (15.3%). Among inpatient populations, injectable benzodiazepines, anesthetics, and neuromuscular blockers were frequently prescribed. Conclusion: This study offers insights into the utilization of HAMs across various healthcare settings. It highlights the need for targeted interventions and management strategies to ensure the safe use of these medications, particularly in long-term care settings.

  • original article | 2023-09-30

    Ah Young Lee1*, Ji Min Han2*, Jonghyun Jeong1, Suhyun Lee1, Kyu-Nam Heo1, Soyoung Park1, Hyunwoo Chae1, Sang il Min3, Young-Mi Ah4, Ju-Yeun Lee1

    Pharmacoepidemiology and Risk Management 2023; 15(2): 165-171

    https://doi.org/10.56142/perm.23.0016
    Abstract

    Objective: In this study, we aimed to analyze national claims data to assess the usage of high-alert medications among hospitalized patients and to identify associated potential harm. Methods: This study was a cross-sectional analysis based on the Health Insurance Review & Assessment Service National Inpatient Sample (HIRA-NIS) data for the years 2019 and 2020. All patients with records of hospitalization were included from this data source. We categorized patients into two groups based on the usage of high-alert medications in the acute care setting. The primary outcome of interest was the prevalence of potential harms related to the use of each high-alert medication among hospitalized patients. Each potential harm was then identified based on diagnostic codes, procedure codes, and medication administration recorded in the claims data. Results: From the HIRA-NIS dataset for the years 2019 and 2020, the patient-hospitalization count was 1,291,922. Out of the total 1,291,922 patient-hospitalizations involving the use of high-alert medications, the prescription rates for the specific medications were as follows: injectable narcotic analgesics (434,328 cases, 33.6%), injectable benzodiazepines (295,775 cases, 22.9%), and injectable anticoagulants (140,989 cases, 10.9%). Regarding the prevalence of potential harm, the top three were bleeding related to thrombolytic therapy (9.5%), hypoglycemia related to insulin vials (4.5%), and bleeding associated with injectable anticoagulant use (3.7%). Conclusion: High-alert medication usage was identified in over one-third of patients who underwent hospitalization treatment. Bleeding associated with the use of anticoagulants and thrombolytics was the most prevalent potential harm.

  • original article | 2023-09-30

    Hayun Chung1*, Jeong Uk Baek1*, Kyung A Kim1, Hyein Kang1, Eun Jung Cho1, Yoon Sook Cho1, Ju-Yeun Lee1,2, A Jeong Kim1

    Pharmacoepidemiology and Risk Management 2023; 15(2): 172-180

    https://doi.org/10.56142/perm.23.0017
    Abstract

    Objective: Heparin, a high-risk medication with narrow therapeutic range, poses a significant risk to patient safety due to fatal accidents resulting from administration errors. This study aimed to analyze the cases of bleeding accompanied by prolonged activated partial thromboplastin time (aPTT) in patients undergoing continuous intravenous heparin infusion. Methods: We retrospectively reviewed the medical records of 200 adult patients who received continuous intravenous heparin infusion at Seoul National University Hospital from August 1, 2018 to July 31, 2021, and exhibited a prolonged aPTT exceeding 150 seconds. Bleeding was classified into major or minor bleeding. We classified the reasons for aPTT prolongation into four main categories: ‘protocol-related factors’, ‘human errors’, ‘administration of heparin bolus due to medical procedure’, and ‘individual variability’. This categorization was established through a thorough analysis of individual cases, including structural assessments. Results: Among the 200 patients, 62 (31.0%) patients experienced bleeding, with 20 (32.3%) exhibiting major bleeding. Notably, 37 (59.7%) of bleeding patients were concurrently administered other antithrombotic agents. The analysis revealed that 32 (16.0%) cases of aPTT prolongation were attributed to ‘protocol-related factors’, 73 (36.5%) to ‘human error’, and 83 (41.5%) to ‘individual variability’. Conclusion: This study showed that 'human error' and ‘protocol-related factors’ collectively contributed to more than 50% of prolonged aPTT among heparin users. To ensure safer heparin administration, it is strongly recommended to focus on optimizing heparin protocols and implementing strategies to reduce human errors.

Korean Society for Pharmacoepidemiology and Risk Management

Vol.16 No.1
March, 2024

eISSN 2982-5954

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Aims and Scope

Pharmacoepidemiology and Risk Management is an official publication of the Korean Society for Pharmacoepidemiology and Risk Management to provide broad and in-depth development of pharmacoepidemiology.
The journal publishes special articles on clinical and basic studies pertaining to pharmacoepidemiology, pharmacovigilance, risk management, post-marketing surveillance, drug utilization review, causality assessment of drug adverse reaction, which are to promote drug safety in Korea. The editorial board calls for the articles that originate from worldwide research or ... +More