Pediatric medication error reports in Korea adverse event reporting system database, 1989-2012: comparing with adult reports.

Children have dynamic process of maturation and substantial changes in growth and development which eventually make the drug safety profiles different from adults. Medication errors (MEs) in pediatrics are reported to occur three times more likely than adults. The aims of this study were to identify the characteristics of pediatric MEs in Korea at national level and help raise awareness of risks from the MEs in pediatrics. We conducted a descriptive analysis with the pediatric ME reports in Korea Adverse Event Reporting System (KAERS) database from 1989 to 2012 and 208 ME reports in pediatrics were found. Based on KAERS database, the proportion of reported pediatric ME in adverse drug event (ADE) reports was 2.73 times (95% CI, 2.35-3.17) higher than that of adult ME. In 208 ME reports, we found a total of 236 ME-related terms within 19 types of MEs. The most common type of MEs was "accidental overdose" (n=58, 24.6%), followed by "drug maladministration" (n=50, 21.2%) and "medication error" (n=41, 17.4%). After the narratives of ME reports were reviewed, we noticed that most of them did no harm to patients, but some cases were needed for medical treatment. Our data suggest that MEs in pediatrics are not negligible in Korea. We expect that this study would increase the awareness of the problem in pediatric MEs and induce the need for further development of an effective national ME preventing system in Korea.

Neural mechanisms of acupuncture for peripheral facial nerve palsy: A protocol for systematic review and meta analysis.

BACKGROUND: Peripheral facial nerve palsy (PFNP) is a cranial neuropathy that occurs when the seventh facial nerve is damaged. PFNP seriously affects patients' quality of life, and approximately 30% of patients suffer from sequelae, such as unrecovered palsy, synkinesis, facial muscle contracture, and facial spasm. Many studies have confirmed the effectiveness of acupuncture for the treatment of PFNP. However, the specific mechanism remains unclear and needs to be further explored. Therefore, the purpose of this systematic review is to investigate the neural mechanisms underlying acupuncture treatment for PFNP using neuroimaging methods. METHODS: We will search all published studies from inception to March 2023 using the following databases: MEDLINE, Cochrane Library, EMBASE, CNKI, KMBASE, KISS, ScienceON, and OASIS. All clinical studies evaluating the effectiveness of acupuncture for treating PFNP using functional neuroimaging will be selected without language restrictions. Two reviewers will independently conduct the study selection, data extraction, and risk of bias assessment, according to a predetermined protocol. The outcomes, including the types of functional neuroimaging techniques, brain function alterations, and clinical outcomes, such as the House-Brackmann scale and Sunnybrook Facial Grading System, will also be analyzed. Coordinate-based meta-analysis and subgroup analyses will be performed if possible. RESULTS: This study will analyze the effect of acupuncture on brain activity alterations and clinical improvement in patients with PFNP using functional neuroimaging. CONCLUSION: This study will provide a comprehensive summary and help elucidate the neural mechanisms of acupuncture treatment for PFNP. PROSPERO REGISTRATION NUMBER: CRD42022321827.

Appraising the safety and reporting quality of thread-embedding acupuncture: a protocol for a systematic review and meta-analysis.

INTRODUCTION: Thread-embedding acupuncture (TEA) is a special type of acupuncture treatment in which medical threads are inserted into subcutaneous tissues or muscles at therapeutic points. TEA is a medical practice that combines acupuncture and medical threads. As such, it is necessary to evaluate the safety of TEA. This systematic review and meta-analysis aimed to assess the safety of TEA and reporting quality of studies regarding TEA. METHODS AND ANALYSIS: The systematic review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the Cochrane Handbook for Systematic Reviews of Interventions. Searching strategies will be systemically conducted using the following databases from their inception date to September 2022: MEDLINE, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), CiNii, J-STAGE, Korean Medical Database, Korean Studies Information Service System (KISS), ScienceON and Oriental Medicine Advanced Searching Integrated System (OASIS). The search strategies will be adjusted for each database as appropriate. The risk of bias will be assessed using the McMaster tool to identify the quality of harm assessment and reporting in study reports (McHarm). A meta-analysis will be used to synthesise the frequency and incidence of adverse events. ETHICS AND DISSEMINATION: No ethical approval and consent is required for this systematic review. The results of this systematic review will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42022297123.

The effectiveness and safety of Simiao Xiaobi decoction on rheumatoid arthritis: A study protocol for systematic review and meta-analysis.

BACKGROUND: Rheumatoid arthritis (RA) is a common chronic autoimmune disease that contributes to progressive disability, systemic complications, higher mortality, and societal burden. Typical symptoms of RA include symmetrical pain and swelling in multiple joints, morning stiffness, and elevated levels of erythrocyte sedimentation rate, C-reactive protein, and rheumatoid factor. The representative treatment for RA is medication, including disease-modifying antirheumatic drugs, glucocorticoids, and nonsteroidal anti-inflammatory drugs. However, these medications are not yet curative nor preventative and are associated with several adverse effects, leading to their discontinuation. Recent articles reported that Simiao Xiaobi decoction (SXD) could relieve the symptoms of RA by clinical trial and experimental study, but an evidence-based review on the effectiveness and safety of SXD on RA has not yet been provided. METHODS: Searching for randomized controlled trials on the use of SXD for RA will be performed by using multiple electronic databases, manual search, and contacting the authors by e-mail if needed. Studies will be selected according to the predefined criteria and the data collected on study participants, interventions, control groups, outcome measurements, their results, adverse events, and risk of bias will be summarized. The primary outcome will be the disease activity score (including effective rate, swollen joint count, tender joint count, and morning stiffness), and the secondary outcomes will be blood tests (including erythrocyte sedimentation rate, C-reactive protein, and rheumatoid factor) and adverse events. We will use Review Manager software to perform a meta-analysis, the Cochrane Collaboration "risk of bias" tool for assessing the risk of bias, and grades of recommendation, assessment, development and evaluation for the determination of the quality of evidence. TRIAL REGISTRATION NUMBER: https://inplasy.com; INPLASY202230026. RESULTS: We are going to investigate the effectiveness and safety of SXD for RA. CONCLUSION: This study will provide reliable evidence on whether SXD is effective on RA.

Current status of the spontaneous reporting and classification/coding system for herbal and traditional medicine in pharmacovigilance.

BACKGROUND: While the use of herbal and traditional medicine (H&TM) has been extensive worldwide, the current status of H&TM management in pharmacovigilance remains to be investigated. To date, there is little information regarding the use of the classification/coding system (CCS) to detect signals for certain drugs within databases built on the basis of the spontaneous reporting system (SRS). The purpose of this study is to investigate the status of the SRS and CCS for H&TM in the pharmacovigilance systems of various countries around the world. METHODS: An e-mail survey was performed from late December 2018 to early January 2019 with 54 experts in pharmacovigilance. The results based on the information provided by the respondents were summarized. RESULTS: Fourteen experts from 13 countries responded to the survey. Eleven countries/regions were found to already include H&TM in their SRSs, managing only limited range of H&TM. Of the 9 countries/regions that provided the information on the status of CCS for H&TM in their domestic pharmacovigilance systems, only China had a separate CCS for H&TM. CONCLUSION: Revising the current pharmacovigilance systems to include or expand the range of H&TM, and developing an internationally harmonized system to classify and code H&TM suitable to the unique characteristics of H&TM are critical and overall beneficial.

Effectiveness of Integrative Therapy for Parkinson's Disease Management.

Objectives: To investigate the effectiveness of integrative therapy on prevalence and length of hospitalization and management of major complications of Parkinson's disease (PD) in the South Korea. Methods: This study was a retrospective cohort analysis conducted using the National Health Insurance Service-National Sample Cohort in the South Korea. Patients over 65 years old who were newly diagnosed with PD during 2007-2011 were identified. The integrative therapy group was defined as patients treated with both Korean medicine (KM) and biomedicine, and the monotherapy group consisted of patients treated with biomedicine alone. From PD diagnosis to 2013, the prevalence and annual length of hospitalization because of PD and major complications (dementia, depression and pneumonia/sepsis) were analyzed using logistic regression, ANOVA and t-tests after propensity score (PS) matching with a 1:1 ratio. Results: After PS estimation and matching, the cohort used in the analysis included 228 subjects (114 integrative therapy group, 114 monotherapy group). Sex, age, index year, comorbidity, severity of disability, neurologic care, and anti-parkinsonism medication (levodopa, ropinirole, pramipexole, selegiline) were adjusted in both groups. The prevalence of hospitalization due to pneumonia/sepsis was 0.50 times (95% C.I.: 0.26-0.96) lower in the integrative therapy group than the monotherapy group, which was statistically significant (p = 0.038). The prevalence and annual length of total hospitalization and hospitalization because of PD, dementia, and depression in the integrative therapy group showed positive results compared to the monotherapy group, but these differences were not statistically significant. Conclusion: It has not been clearly identified that integrative therapy with KM and biomedicine for PD management is better treatment for patients compared to biomedicine monotherapy; however, we found a clue of better result in integrated therapy. Therefore, further investigation by increasing the number of subjects is needed to confirm the findings presented herein.

Evaluation of cardiovascular risk associated with SKI306X use in patients with osteoarthritis and rheumatoid arthritis.

ETHNOPHARMACOLOGICAL RELEVANCE: SKI306X (Joins®) is an anti-inflammatory analgesic herbal medicine extract that was clinically approved for treatment of osteoarthritis in the previous trials and shown to be effective on follow-up studies. However, its potential cardiovascular risk has yet to be investigated. AIM OF THE STUDY: This retrospective cohort study investigated the cardiovascular safety of SKI306X, celecoxib and naproxen. MATERIALS AND METHODS: We used the National Health Insurance Service-National Sample Cohort (NHIS-NSC) to investigate patients over 20 years old with osteoarthritis and rheumatoid arthritis who received a single prescription of SKI306X, celecoxib or naproxen at least once from January 1, 2011 through December 31, 2012. Patients who received SKI306X, celecoxib or naproxen from January 1, 2009 to December 31, 2010 were excluded. Data pertaining to the included patients were investigated to determine the risk of major cardiovascular events associated with the aforementioned prescription using the Cox proportional hazards model after being adjusted for sex, age and comorbidity. RESULTS: A total of 27,253 patients were selected, among which 10,983 were prescribed SKI306X, 12,311 celecoxib and 3959 naproxen. The incidence of major cardiovascular events was highest for celecoxib (15.4%), followed by SKI306X (8.6%) and naproxen (8.0%). Celecoxib had a higher cardiovascular risk than naproxen, while SKI306X did not have a higher risk of cardiovascular events than naproxen. Upon sensitivity analysis, SKI306X was associated with 1.36 times (95%CI: 1.08-1.72) more cardiovascular events than naproxen during 15-60 days of prescription, but not at less than 14 days or more than 61 days. CONCLUSIONS: Evaluation of the cardiovascular safety of the anti-inflammatory analgesic herbal medicine SKI306X revealed that it did not differ from that of naproxen, which is known to have low cardiovascular risk.