Hemorrhage induced by antithrombotic agents: new insights from a real-world pharmacovigilance study.

BACKGROUND: Hemorrhage represents the most common and serious side effect of antithrombotic agents. Many studies have compared the risk of bleeding between different antithrombotic agents, but analysis of time-to-onset for hemorrhage induced by these drugs is yet sparse. METHODS: We conducted a retrospective study based on the adverse drug reaction reports on antithrombotic agents collected by the Henan Adverse Drug Reaction Monitoring Center. We assessed the reporting odds ratio to determine the disproportionate reporting signals for bleeding and the Weibull shape parameter was used to evaluate the time-to-onset data. RESULTS: In the signal detection, crude low molecular weight heparin-hemorrhage was found as a positive signal. The hemorrhage for most antithrombotic agents was random failure profiles. In particular, the hazard of hemorrhage decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole. CONCLUSION: We found that the risk of bleeding in patients taking Crude low molecular weight heparins was significantly higher compared to other antithrombotic agents, but with a small magnificence, which may be attributed to the severely irrational use of this medication under improper management. Statistics in days, results showed that the risk of bleeding decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole.

Safety of Using Traditional Chinese Medicine Injections in Primary Medical Institutions: Based on the Spontaneous Reporting System 2016-2020 in Henan Province, China.

Objective: Traditional Chinese medicine (TCM) injection is widely used, but its adverse drug reaction (ADR) may be a serious public health concern in primary medical institutions. This research will explore the safety of TCM injections and provide clinical recommendations at the primary medical institutions. Method: ADR data were collected by the Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 were analized Descriptive statistics, chi-square analysis, binary logistic regression, and Mantel-haenszel hierarchical analysis were used to identify the risk factors associated with the rational use of TCM injections in primary medical institutions. Results: A total of 30,839 cases were collected in this study, 4905 cases (15.90%) were SADRs. Patients using TCM injections in primary medical institutions were more likely to cause SADRs (OR = 1.149, 95% CI: 1.061-1.245). Aged over 60 years (OR = 1.105, 95% CI: 1.007-1.212), non-essential drugs (OR = 1.292, 95% CI: 1.173-1.424), autumn (OR = 1.194, 95% CI: 1.075-1.326) and TCM injections with safflower (OR = 1.402, 95% CI: 1.152-1.706), danshen (OR = 1.456, 95% CI: 1.068-1.984) and medication reasons with chemotherapy (OR = 2.523, 95% CI: 1.182-5.386) and hypertension (OR = 1.495, 95% CI: 1.001-2.233) were more likely to suffer SADR in primary medical institutions. Conclusion: In general, the number of reported cases of TCM injection was declining over time, but the proportion of SADRs in primary medical institutions increased. In the future, it is necessary to continue to restrict TCM injections at the macro policy level, and vigorously promote the varieties in the essential drug list. At the micro level, it is necessary to intervene in specific populations, specific diseases and specific drugs, first start with them, step by step, and effectively prevent SADR occurrences in primary medical institutions.

Safety Profile of Antipsychotic Drugs: Analysis Based on a Provincial Spontaneous Reporting Systems Database.

Introduction: Antipsychotic drugs are the main therapy for schizophrenia and have been widely used in mental disorder fields. However, the research on the safety of antipsychotic drugs in the real-world is rare. The purpose of this research is to evaluate the safety of antipsychotic drugs based on real-world data. Methods: ADR reports collected by the Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 were analyzed. We described the safety of antipsychotic drugs by descriptive analysis and four signal mining methods. Meanwhile, the risk factors for serious adverse reactions of antipsychotics were identified. Results: A total of 3363 ADR reports related to antipsychotics were included. We found that the number of adverse drug reaction reports and the proportion of serious adverse reactions have increased year by year from 2016 to 2020. Most adverse drug reactions occurred within 3 months after taking the medicine. The symptoms caused by typical antipsychotics and atypical antipsychotics were different and dyskinesia was more common in typical antipsychotics. Most patients improved or recovered after treatment or intervention while only one patient had sequelae. Low-level hospitals, psychiatric hospitals, youth, and old age could increase the risk of serious adverse reactions. Four off-label signals were found through signal mining, including amisulpride-pollakiuria, ziprasidone-dyspnoea, quetiapine-urinary incontinence, olanzapine-hepatic function abnormal. Conclusion: We found that most ADRs occurred within 3 months after taking the medicine, so close observation was required for patients during the first 3 months of treatment. The ADRs of antipsychotics involved multiple organ-system damages but were not serious. It might be recommended to take alternative drugs after a serious ADR occurred. The symptoms caused by typical APDs and atypical APDs were different. For patients with typical APDs, dyskinesia was more common and should be given special attention. Statistics showed that low-level hospitals, psychiatric hospitals, youth, and old age were risk factors for serious ADRs. The four off-label signals obtained by signal mining should be paid special attention, including amisulpride-pollakiuria, ziprasidone-dyspnoea, quetiapine-urinary incontinence, and olanzapine-hepatic function abnormal.

Corrigendum: Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database.

[This corrects the article DOI: 10.3389/fonc.2021.807171.].

The severity of adverse drug reactions and their influencing factors based on the ADR monitoring center of Henan Province.

Adverse drug reactions (ADRs) may be a serious public health problem and have received widespread attention in recent years. This study has analyzed the factors leading to the occurrence of serious ADRs (SADRs), determined the factors affecting the prognosis of patients with severe adverse reactions at different levels of medical institutions, and finally made corresponding recommendations for the monitoring, prevention, and treatment of SADRs. We used descriptive analysis and chi-square test to analyze the year, age, gender, proportion of SADRs, and the results of the ADRs in the report. Use the logistic regression to analyze the factors affecting the prognosis of SADRs in different levels of medical institutions. A total of 387 642 people's 394 037 ADRs were collected from the Henan Provincial Adverse Drug Reaction Monitoring Center from 2016 to 2020. Among them 35 742 cases of serious ADRs (9.1%), 96.1% were eventually relieved or cured, but 39 cases of SADRs caused death. The main causes of death included hemorrhages, organ failure, and allergies. Age, number of medication and illnesses, level of medical institution, history of adverse reactions, and type and method of medication were all factors that affected the severity of ADR. The prognosis of SADRs is worse than normal ADRs. The ADRs in autumn and winter and new adverse reactions are unique risk factors found in this study. The elderly and patients with multiple diseases or taking multiple drugs should pay attention to their adverse reactions. They should be closely observed within a week after taking the medicine. The supervision of patients with a history of allergies and new adverse reactions should be strengthened by primary medical institutions, and in nonprimary medical institutions should paid attention with past medical histories, and use imported drugs and biological agents with caution to ensure the safety and health of patients.

Safety Profile of Monoclonal Antibody Compared With Traditional Anticancer Drugs: An Analysis of Henan Province Spontaneous Reporting System Database.

Introduction: Monoclonal antibody (mAb) is an important treatment option for cancer patients and has received widespread attention in recent years. In this context, a comparative safety evaluation of mAbs and traditional anticancer drugs in real-world is warranted. Methods: ADR reports submitted to Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 for individuals taking antineoplastic drugs were included. Data were analyzed with respect to demographic characteristics, disease types, polypharmacy, past history of ADRs, system organ class, name of suspected drugs per ADR report, severity, result, impact on the primary disease, and biosimilars. Results: A total of 15,910 ADR reports related to antineoplastic drugs were collected, 575 (3.61%) cases were related to mAbs. Female had more reports of ADRs than male. The ADRs of non-mAbs mainly occurred in 1-3 days after injection (4,929, 32.15%), whereas those of mAbs mainly occurred on the same day (297, 51.65%). Serious ADRs accounted for 30.26% (n = 174) of mAb-related reports and 34.46% (n = 5,285; four death cases) of non-mAb-related reports, respectively. A total of 495 (86.08%) reports were related to the branded drugs of mAbs. In general, our findings indicate that the female, the population aged 60-79 years, people with a single disease, people who have no ADRs in the past and people who have received treatment regimens were less likely to be affected by the primary disease after receiving mAbs therapy. The signal mining method produced 14 signals, only Sintilimab-Hepatic failure was off-label ADR. Conclusion: This study partly confirmed the safety profile of mAbs. It is unlikely to affect groups such as the female, the population aged 60-79 years, people with a single disease, people who have no ADRs in the past and people who have received treatment regimens. Combined drugs have little effect on the primary disease. By conducting signal mining method, 14 signals were produced, and only one of them was off-label ADR.

Satisfaction with Public Hospital Reform and Associated Factors Among Medical Staff: A Cross-Sectional Survey in Wuhan, China.

PURPOSE: To assess whether medical staff are satisfied with public hospital reform and its influencing factors. METHODS: A sample of 2000 medical staff from 13 public hospitals in Wuhan were surveyed with a self-administered questionnaire. Descriptive analysis and binary logistic regression were conducted to identify the status of the medical staff's attitude to the reform and the influencing factors. RESULTS: A total of 61.4% of medical staff satisfied with the reform and the main reason was the promotion of their practice environment and social status brought by the reform. The logistic regression model indicated that the attitude to the reform of medical staff was positively associated with 9-11 hours of daily working time (OR = 2.373, as compared with less than 8 hours), higher income (OR = 1.966), the occupation of the nurse and medical technician (OR = 2.196-1.464 as compared with the doctor) as well as negative attitude towards the effectiveness of reform (OR = 3.676). CONCLUSION: More than half of medical staff are satisfied with the public hospital reform, while some still hold negative attitude to the reform because of the extra working hours, low salary and high expectations due to professional characteristics and high input costs (education and time). Thus, in the current epidemic of prevention and control, more attention should be paid to the work pressure and enthusiasm of medical personnel. Administrators should pay attention to increasing income and improving the practicing environment and social status to prevent medical staff from treating reforms negatively.

Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database.

INTRODUCTION: Adverse drug reactions (ADRs) in pediatric cancer patients have not yet received due attention in the world. Antineoplastic drugs are frequently related to ADRs. Few studies focus on the ADR and the intervention measures in pediatric cancer patients. METHODS: ADR reports submitted to Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 for individuals aged from birth to 17 years (including 17 years) were included. Data were analyzed with respect to gender, age, disease types, past history of ADR, occurrence time of ADR, polypharmacy, route of administration, off-label drug use, name of suspected drugs per ADR report, and severity of ADR reports. RESULTS: A total of 431 ADR reports related to antineoplastic drugs in pediatric patients were collected, 31.55% were serious ADRs (SADRs). The median age of patients was six years (inter quartile range, IQR: 3-11), the age groups with higher reporting rates were concentrated in 1-3-year-olds (130). Past history of ADR, occurrence time of ADR and polypharmacy were statistically associated with SADR. Myelosuppression was the most frequent ADR (15.55%), cytarabine was the most frequent drug (26.22%). The signal mining method produced 14 signals, three signals were off-label ADRs. CONCLUSIONS: This study described the characteristics of ADRs in pediatric cancer patients. By conducting signal mining method, three off-label ADRs need further study. We should pay more attention to these ADRs and develop relative management strategies. More researches are needed to achieve a better understanding of the characteristics of ADRs in pediatric cancer patients of China.