Nationwide Study of the Epidemiology, Diagnosis, and Treatment of Hypersensitivity Pneumonitis in Korea.

BACKGROUND: Hypersensitivity pneumonitis (HP) is a condition with an uncertain global incidence, and information on its diagnosis and management is limited. This study aimed to address these knowledge gaps. METHODS: This study utilized customized claims data from the Health Insurance Review and Assessment Service (HIRA) in South Korea from January 2010, to December 2021. Patients with HP were identified based on the diagnosis code (International Classification of Diseases, 10th Revision, J67) between 2011 and 2020. Incident HP cases were defined as new HP claims, excluding those with claims in the previous year. The study examined various factors such as age, sex, comorbidities, diagnostic methods, and treatment patterns. Additionally, multivariate logistic regression analysis was performed to identify risk factors associated with treatment initiation. RESULTS: A total of 8,678 HP incident cases were confirmed, with age- and sex-adjusted annual incidence rates ranging from 1.14/100,000 in 2020 to 2.16/100,000 in 2012. The mean age of patients with incident HP was 52 years, with a higher incidence observed among males. Additionally, the most common comorbidity was asthma. Bronchoscopy was performed on 16.9% of patients, and 25.4% of patients did not receive treatment within 1 year of diagnosis. Among those who received treatment, prednisone was the most used systemic steroid, and azathioprine was the most commonly used second-line immunosuppressant. Factors associated with treatment initiation included the female sex, having asthma or gastroesophageal reflux disease (GERD), and undergoing bronchoscopy. CONCLUSION: This study provides valuable insights into the incidence, diagnosis, and treatment patterns of HP in South Korea using nationwide medical claims data.

Exploring signals of myopathy associated with statin and contraindicated comedications in the realworld.

BACKGROUND: Using statins in combination with other drugs was reported to increase the risk of myopathy. However, there was a sparse number of studies on the incidence of adverse events (AEs) associated with the concomitant use of statin and contraindicated drugs in the real world. OBJECTIVES: This study aimed to identify the risk of concomitant use of statins with contraindicated drugs by exploring signals related to statin-drug interactions. METHODS: We performed a disproportionality analysis for drugs and AEs by applying the case/non-case study using the KIDS-KAERS database (KIDS-KD), 2016-2020. A case was defined as an individual case safety reports (ICSRs) including "rhabdomyolysis/myopathy." A non-case was defined as an ICSR, including all other AEs. We applied Ω shrinkage measure model, chi-square statics model, additive model, multiplicative model, and combination risk ratio model to detect signals of myopathy due to statin with concomitant drugs including antiviral agents, immunosuppressants, and antifungals. RESULTS: Among 1 011 234 ICSRs, 2708 were cases, with 861 cases of statin monotherapy and 1248 of concomitant uses of statin. The adjusted reporting odds ratios were 3.27 (95% confidence interval [CI]: 3.11-3.43), 8.70 (95% CI: 8.04-9.40), and 1.83 (95% CI: 1.73-1.94), respectively. Several combinations of signals were detected through an additive model or multiplicative model. CONCLUSION: Signals of an increased risk of myopathy associated with the use of statins with concomitant drugs, including contraindicated drugs, were confirmed in a real-world setting.

Status of Patient Safety Culture in Community Pharmacy Settings: A Systematic Review.

OBJECTIVES: This systematic aimed to understand the global status using the results of survey studies based on the Community Pharmacy Survey on Patient Safety Culture and set the directions of development in terms of the patient safety culture of community pharmacies. METHODS: Electronic searches were performed in EMBASE, MEDLINE, PubMed, and CINAHL databases by using the words "patient safety," "culture," and "community pharmacy" with synonyms or associated words in the original English language research articles published between January 1, 2012, and March 2, 2023. This systematic review was conducted based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Eleven surveys from 10 countries were selected. Five studies were conducted on pharmacists, whereas 6 studies were carried out on all pharmacy staff members such as pharmacists, technicians, clerks, and pharmacy students on apprenticeship. There was a considerable variation in the positive response rates across the dimensions of all the surveys. The highest positive response score was demonstrated for "teamwork" and "patient counseling," whereas the "staffing, work pressure, and pace" dimension was essential for improving patient safety culture in community pharmacy settings. For overall rating of the pharmacy on patient safety, 84.8% of pharmacy staff members gave good, very good, or excellent as their responses. CONCLUSIONS: Despite the differences among studies, findings of this study are expected to be used as valuable evidence to develop patient safety improvement strategies after reflecting each country's health care setting or community pharmacy practice. Furthermore, the results would offer meaningful assistance to achieve the goals of global campaigns such as the World Health Organization Patient Safety Challenge.

Nationwide patterns of hydroxychloroquine dosing and monitoring of retinal toxicity in patients with systemic lupus erythematosus.

This study identified trends in hydroxychloroquine (HCQ) prescription and retinopathy screening in patients with systemic lupus erythematosus (SLE) according to clinical practice guidelines to minimise the risk of HCQ retinopathy. We used data from patients diagnosed with SLE between 2004 and 2019 from the National Health Insurance Service in Korea. To assess trends of daily dose per actual body weight (ABW), we performed an interrupted time-series analysis and identified effects after revision of guidelines. Among 38,973 patients with SLE, 28,415 (72.9%) were prescribed HCQ from 2004 to 2019. The proportion of patients using HCQ among SLE patients was 63% in 2004 and increased to 76% in 2019. The median daily dose per ABW for HCQ users decreased from 5.88 mg/kg in 2004 to 3.98 mg/kg in 2019, and from 5.45 mg/kg in 2005 to 4.17 mg/kg in 2019 for HCQ new users. The annual implementation rate of screening tests among HCQ new users increased from 3.5% in 2006 to 22.5% in 2019. Study results indicated that HCQ dosing management was adequate based on the revised guidelines. Although the implementation rate of retinal screening has increased, it is necessary to enhance awareness of retinal screening in clinical settings.

Safety Profiles of mRNA COVID-19 Vaccines Using World Health Organization Global Scale Database (VigiBase): A Latent Class Analysis.

INTRODUCTION: Although messenger RNA (mRNA) vaccines have been developed and widely utilized to mitigate the coronavirus disease (COVID-19) pandemic, it is essential to describe the adverse events (AEs) following immunization. This study aimed to identify the patterns associated with serious AE reports after mRNA COVID-19 vaccination in the World Health Organization (WHO)'s global scale database (VigiBase). METHODS: This study performed a latent class analysis (LCA) of reports of serious AEs following mRNA COVID-19 vaccination from VigiBase between December 28, 2020 , and February 28, 2022 (N = 312878). The Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) terms were selected for LCA. The reporting characteristics in accordance with the cluster were described. We used a multinomial logistic regression model to estimate the association between potential factors and each cluster. RESULTS: Five clusters of AE reports were distinguished through LCA: infection AEs (cluster 1), cardiac AEs (cluster 2), respiratory/thrombotic AEs (cluster 3), systemic AEs (cluster 4), and nervous system AEs (cluster 5). Compared to cluster 4, cluster 2 had a higher proportion of males (OR 2.98; 95% confidence interval (CI) 2.87-3.09), and cluster 1 had a longer time to onset than other AEs (≥ 14 days) (OR 16.2; 95% CI 15.5-16.9). CONCLUSION: Using LCA, we found five clusters of serious AEs following mRNA COVID-19 vaccination. Each cluster was distinguished by potential factors such as age, gender, region, and time to onset. We suggest that monitoring should carefully consider the patterns of young males with cardiac AEs and elderly individuals with thrombosis after respiratory AEs. Our findings could contribute to enhancing understanding of safety profiles and establishing management strategies for serious AEs of special interest following mRNA COVID-19 vaccination.