综合医院医疗不良事件报告的障碍因素以及改进策略分析

????? 医疗不良事件的分析总结对保证医疗质量起着促进作用,而医疗不良事件的报告存在着许多障碍因素。通过调查湖北省、江苏省、浙江省12家医院的医疗不良事件的报告情况,分析阻碍医疗不良事件报告的原因,并提出相应建议。

     

医疗安全不良事件报告的现状调查及影响因素分析

?????? 目的 调查医务人员参与不良事件报告的现状及主要影响因素。方法 采用分层随机整群抽样方法,调查全院24个科室321名医务人员对不良事件报告制度实施的态度、知晓及执行情况。结果 85.9%的医务人员对不良事件报告制度的实施持积极态度,但10.3%的人员不知道医院实施不良事件报告制度,近一半的人员不知道报告程序,不良事件发现率仅为31.5%,报告率为13.4%。医务人员的个人认知、医院安全文化氛围、报告系统设计是影响医务人员参与报告的重要因素。结论 提高医务人员认知程度,强化不良事件报告责任,发挥管理者的重要作用,构建医院公正的安全文化,进而提高医务人员参与不良事件报告的积极性和主动性。     

医疗不良事件和病人安全隐患报告系统的构建

通过介绍北京协和医院进行医疗不良事件和病人安全隐患事件报告系统工作实务,论述了在大型综合医院如何结合具体实际情况,探索有效的病人安全实践措施,旨在对医疗机构进行医疗不良事件报告系统和制度的建立、正常运行和完善有所借鉴。     

医疗不良事件报告系统利用现状调查

目的 了解我国医疗不良事件报告系统的利用现状。方法 采用分层随机抽样的方法,调查山东省6个样本市30家二、三级医院对原卫生部和中国医院协会报告系统的利用上报情况。结果 有41.38%的医院表示利用过卫生部的报告系统,13.79%的医院表示原卫生部的2个报告系统都利用过,只有10.34%的表示原卫生部的2个报告系统和中国医院协会的报告系统都用过;报告的数量也十分有限,基本都是在个位数。结论 现有的不良事件报告系统利用率不足,可以通过完善报告系统和反馈机制、加强政策执行力等方式,提高不良事件报告系统利用率和不良事件报告率。     

医院不良事件报告制度的实施效果探析

目的 探讨和分析不良事件报告制度在医院内部的实施效果及存在问题。方法 对医院不良事件报告制度的实施进行资料回顾和报告数据分析。结果 不良事件报告例数呈逐年递增趋势,报告事件以未造成后果事件为主,急诊、重症医学科的报告比例明显高于其他科室,护理人员的报告比例相对较高。结论 不良事件报告对医院风险防范和医疗系统改进具有重要作用。     

手术室非惩罚性护理不良事件报告制度的建立

手术室护理不良事件发生率影响因素较多,建立非惩罚性护理不良事件报告制度是非常有效的控制不良事件的方法。通过在本院手术室建立非惩罚性护理不良事件报告制度,对上报的护理不良事件分析发生的根本原因并提出修正方案及预防措施,提升护理质量,完善护理流程及管理制度。     

国内外患者安全的行动举措与实践启示

通过回顾近年国内外应对患者安全问题所采取的行动与举措,总结其行动过程中的有效方法和经验,从优化医院管理理念、健全医疗不良事件报告系统及差错反馈机制、建立标准化数据库,持续评价改进效果、鼓励患者参与等方面为我国医院未来的患者安全行动提供借鉴与参考。

     

植入类医疗器械医疗机构的法律责任探讨

植入类医疗器械的法律责任属于医疗产品损害责任,既有医疗损害责任的特点,又有产品责任的特点。就产品责任而言,医疗机构一般承担无过错责任,即无论医疗机构是否有过错,患方均可向医疗机构追责。且如医疗机构不能指明缺陷产品的生产者,也不能指明缺陷产品的供货者,还应当承担最终责任。在植入类医疗器械的管理使用过程中,医疗机构应从严把采购关,完善购销记录,加强告知及培训,以及医疗器械不良事件报告和监测等几个方面来规避法律责任。     

临床实验室检验差错的测量研究

实验室对患者安全有重大的影响,因为所有诊断的80~90%是基于实验室检验作出的。据报道,实验室差错发生率为所有试验结果的0.012-0.6%。患者安全是一个管理问题,其可通过实施积极的系统来识别及监控质量故障得到提高。这可通过包括事件报告随后的根本原因分析的反应方法得到促进。这可导致识别及纠正该系统中方针及程序的不足之处。另一种方法是前瞻性方法,如失效模式和效应分析(或故障模式和影响分析)。本文的重点是整个检验过程,预测主要不良事件以及先发制人防止它们的发生。它可用于高风险过程的前瞻性的风险分析以减少实验室及其他患者医疗领域内出差错的可能性。     

哈尔滨市十家医院医疗风险管理现状分析姜乃浒毛静馥△齐英△吴国松赵璐郭思佳刘行宇

目的：通过对哈尔滨市10家医院医疗风险管理现状调查,掌握医院医疗风险管理情况,找出存在的问题,提出改进对策,为医院制定科学、完善的医疗风险管理体系提供参考。方法：运用文献法、访谈法、特尔菲法、头脑风暴法等方法;应用SPSS、EXCEL统计软件对数据进行统计学处理。结果：三级医院在风险管理体系相比于二级医院更为完善;两级医院在医护人员独立工作能力,医疗药品和设备的准入,医疗风险信息系统使用,医护人员培训满意度等方面均具有较大差异;大多数医护人员愿意主动报告医疗纠纷;医患沟通效果较好,科室之间沟通协作也比较好。结论：目标医院基本上建立了医疗风险管理体系,但是在功能上、风险管理措施的制定及落实上尚不完善,医疗风险管理人员的专业素质有待提高,医院医疗风险管理意识尚需加强。     

Adverse Effects of Cholinesterase Inhibitors in Dementia,According to the Pharmacovigilance Databases of the United-States and Canada

This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction Database (CVARD) concerning the side effects of cholinesterase inhibitors. The statistics calculated for each adverse event were the frequency and the reporting odds ratios (ROR). A total of 9877 and 2247 reports were extracted from the FAERS and CVARD databases, respectively. A disproportionately higher frequency of reports of death as an adverse event for rivastigmine, compared to the other acetylcholinesterase inhibiting drugs, was observed in both the FAERS (ROR = 3.42; CI_95% = 2.94–3.98; P<0.0001) and CVARD (ROR = 3.67; CI_95% = 1.92–7.00; P = 0.001) databases. While cholinesterase inhibitors remain to be an important therapeutic tool against Alzheimer’s disease, the disproportionate prevalence of fatal outcomes with rivastigmine compared with alternatives should be taken into consideration.     

Monitoring vaccine safety during an influenza pandemic

In the event that a vaccine is available during an influenza pandemic, vaccine safety monitoring will occur as part of comprehensive public health surveillance of the vaccination campaign. Though inactivated influenza vaccines have been widely used in the United States and much is known about their safety profile, attention will need to be paid to both common self-limited adverse reactions and rarer, more serious events that may or may not be causally related to vaccination. The primary surveillance systems used to generate and test hypotheses about vaccine safety concerns are the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), respectively. Examples of recent use of these systems to investigate influenza vaccine safety and enhancements planned for use during a pandemic are presented. Ethical issues that will need to be addressed as part of an overall vaccine safety response include risk communication and injury compensation. Advance planning and the use of available technologic solutions are needed to respond to the scientific and logistic challenges involved in safely implementing mass vaccination during a pandemic.     

T cell lymphoproliferative disorders associated with anti-tumor necrosis factor alpha antibody therapy for ulcerative colitis: literature summary

The enhanced risk of development of lymphoproliferative disorders in patients with inflammatory bowel disease has been attributed to immunosuppressive/immunomodulatory therapies. Infliximab is a chimeric monoclonal immunoglobulin G1 antibody directed against tumor necrosis factor alpha (TNF-α) that was approved by the Food and Drug Administration (FDA) in 1998 as an effective therapeutic agent against inflammatory bowel disease. Malignant lymphomas of both B and T cell lineage have been described in patients undergoing therapy involving TNF-α blockade. To date, eight cases of Epstein–Barr virus (EBV)-negative hepatosplenic T cell lymphoma associated with infliximab have been reported to the FDA’s Adverse Event Reporting System, as well as several other T cell lymphoproliferative disorders with aggressive clinical outcomes. We present the histologic, immunophenotypic, and molecular features of a T cell lymphoproliferative disorder involving the axillary lymph node of a 33-year-old male following infliximab treatment for ulcerative colitis. These EBV-negative lymphomas suggest that lymphoproliferative disorders following infliximab treatment for inflammatory bowel disease may involve EBV-independent immune dysregulation. The spectrum of lymphoproliferative disorders associated with infliximab and the potential mechanisms by which they occur are discussed.     

Hypothyroidism Side Effect in Patients Treated with Sunitinib or Sorafenib: Clinical and Structural Analyses

Tyrosine kinase inhibitors (TKIs) provide more effective targeted treatments for cancer, but are subject to a variety of adverse effects, such as hypothyroidism. TKI-induced hypothyroidism is a highly complicated issue, because of not only the unrealized toxicological mechanisms, but also different incidences of individual TKI drugs. While sunitinib is suspected for causing thyroid dysfunction more often than other TKIs, sorafenib is believed to be less risky. Here we integrated clinical data and in silico drug-protein interactions to examine the pharmacological distinction between sunitinib and sorafenib. Statistical analysis on the FDA Adverse Event Reporting System (FAERS) confirmed that sunitinib is more concurrent with hypothyroidism than sorafenib, which was observed in both female and male patients. Then, we used docking method and identified 3 proteins specifically binding to sunitinib but not sorafenib, i.e., retinoid X receptor alpha, retinoic acid receptors beta and gamma. As potential off-targets of sunitinib, these proteins are well known to assemble with thyroid hormone receptors, which can explain the profound impact of sunitinib on thyroid function. Taken together, we established a strategy of integrated analysis on clinical records and drug off-targets, which can be applied to explore the molecular basis of various adverse drug reactions.     

Adverse Drug Reaction Reporting Program of the Ontario Medical Association: the first 3 years.

This paper describes the Adverse Drug Reaction Reporting Program developed and operated by the Committee on Drugs and Pharmaco-therapy of the Ontario Medical Association. Analyses were done to demonstrate some of the trends derived from the reports. Some of the clinical observations based on the reports, which are published quarterly and circulated to physicians and to pharmacy, nursing and hospital organizations, are also reviewed.     

Pro-Arrhythmic Potential of Oral Antihistamines (H1): Combining Adverse Event Reports with Drug Utilization Data across Europe

Background

There is appreciable utilisation of antihistamines (H₁) in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in ’90 because of their cardiac toxicity, but only scarce clinical data are available on other antihistamines.

Aim

To investigate the pro-arrhythmic potential of antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS) with drug utilization data from 13 European Countries.

Methods

We identified signals of antihistamine arrhythmogenic potential by analyzing FAERS database for all cases of Torsades de Pointes (TdP), QT abnormalities (QTabn), ventricular arrhythmia (VA) and sudden cardiac death/cardiac arrest (SCD/CA). Number of cases ≥3 and disproportionality were used to define alert signals: TdP and QTabn identified stronger signals, whereas SCD/CA identified weaker signals. Drug utilization data from 2005 to 2010 were collected from administrative databases through health authorities and insurance.

Results

Antihistamines were reported in 109 cases of TdP/QT prolongation, 278 VA and 610 SCD/CA. Five agents resulted in stronger signals (cetirizine, desloratadine, diphenhydramine, fexofenadine, loratadine) and 6 in weaker signals (alimemazine, carbinoxamine, cyclizine, cyproeptadine, dexchlorpheniramine and doxylamine). Exposure to antihistamines with stronger signal was markedly different across European countries and was at least 40% in each Country. Cetirizine was >29 Defined Daily Doses per 1000 inhabitants per day (DID) in Norway, desloratadine >11 DID in France and loratadine >9 DID in Sweden and Croatia. Drugs with weaker signals accounted for no more than 10% (in Sweden) and in most European countries their use was negligible.

Conclusions

Some second-generation antihistamines are associated with signal of torsadogenicity and largely used in most European countries. Although confirmation by analytical studies is required, regulators and clinicians should consider risk-minimisation activities. Also antihistamines without signal but with peculiar use in a few Countries (e.g., levocetirizine) or with increasing consumption (e.g., rupatadine) deserve careful surveillance.     

Ontology-Based Combinatorial Comparative Analysis of Adverse Events Associated with Killed and Live Influenza Vaccines

Vaccine adverse events (VAEs) are adverse bodily changes occurring after vaccination. Understanding the adverse event (AE) profiles is a crucial step to identify serious AEs. Two different types of seasonal influenza vaccines have been used on the market: trivalent (killed) inactivated influenza vaccine (TIV) and trivalent live attenuated influenza vaccine (LAIV). Different adverse event profiles induced by these two groups of seasonal influenza vaccines were studied based on the data drawn from the CDC Vaccine Adverse Event Report System (VAERS). Extracted from VAERS were 37,621 AE reports for four TIVs (Afluria, Fluarix, Fluvirin, and Fluzone) and 3,707 AE reports for the only LAIV (FluMist). The AE report data were analyzed by a novel combinatorial, ontology-based detection of AE method (CODAE). CODAE detects AEs using Proportional Reporting Ratio (PRR), Chi-square significance test, and base level filtration, and groups identified AEs by ontology-based hierarchical classification. In total, 48 TIV-enriched and 68 LAIV-enriched AEs were identified (PRR>2, Chi-square score >4, and the number of cases >0.2% of total reports). These AE terms were classified using the Ontology of Adverse Events (OAE), MedDRA, and SNOMED-CT. The OAE method provided better classification results than the two other methods. Thirteen out of 48 TIV-enriched AEs were related to neurological and muscular processing such as paralysis, movement disorders, and muscular weakness. In contrast, 15 out of 68 LAIV-enriched AEs were associated with inflammatory response and respiratory system disorders. There were evidences of two severe adverse events (Guillain-Barre Syndrome and paralysis) present in TIV. Although these severe adverse events were at low incidence rate, they were found to be more significantly enriched in TIV-vaccinated patients than LAIV-vaccinated patients. Therefore, our novel combinatorial bioinformatics analysis discovered that LAIV had lower chance of inducing these two severe adverse events than TIV. In addition, our meta-analysis found that all previously reported positive correlation between GBS and influenza vaccine immunization were based on trivalent influenza vaccines instead of monovalent influenza vaccines.     

Enhancing adverse drug event detection in electronic health records using molecular structure similarity: application to pancreatitis

Background

Adverse drug events (ADEs) detection and assessment is at the center of pharmacovigilance. Data mining of systems, such as FDA’s Adverse Event Reporting System (AERS) and more recently, Electronic Health Records (EHRs), can aid in the automatic detection and analysis of ADEs. Although different data mining approaches have been shown to be valuable, it is still crucial to improve the quality of the generated signals.

Objective

To leverage structural similarity by developing molecular fingerprint-based models (MFBMs) to strengthen ADE signals generated from EHR data.

Methods

A reference standard of drugs known to be causally associated with the adverse event pancreatitis was used to create a MFBM. Electronic Health Records (EHRs) from the New York Presbyterian Hospital were mined to generate structured data. Disproportionality Analysis (DPA) was applied to the data, and 278 possible signals related to the ADE pancreatitis were detected. Candidate drugs associated with these signals were then assessed using the MFBM to find the most promising candidates based on structural similarity.

Results

The use of MFBM as a means to strengthen or prioritize signals generated from the EHR significantly improved the detection accuracy of ADEs related to pancreatitis. MFBM also highlights the etiology of the ADE by identifying structurally similar drugs, which could follow a similar mechanism of action.

Conclusion

The method proposed in this paper provides evidence of being a promising adjunct to existing automated ADE detection and analysis approaches.     

Tracking Official Development Assistance for Reproductive Health in Conflict-Affected Countries

Background

Reproductive health needs are particularly acute in countries affected by armed conflict. Reliable information on aid investment for reproductive health in these countries is essential for improving the efficiency and effectiveness of aid. The purpose of this study was to analyse official development assistance (ODA) for reproductive health activities in conflict-affected countries from 2003 to 2006.

Methods and Findings

The Creditor Reporting System and the Financial Tracking System databases were the chosen data sources for the study. ODA disbursement for reproductive health activities to 18 conflict-affected countries was analysed for 2003, 2004, 2005, and 2006. An average of US$20.8 billion in total ODA was disbursed annually to the 18 conflict-affected countries between 2003 and 2006, of which US$509.3 million (2.4%) was allocated to reproductive health. This represents an annual average of US$1.30 disbursed per capita in the 18 sampled countries for reproductive health activities. Non-conflict-affected least-developed countries received 53.3% more ODA for reproductive health activities than conflict-affected least-developed countries, despite the latter generally having greater reproductive health needs. ODA disbursed for HIV/AIDS prevention and treatment increased by 119.4% from 2003 to 2006. The ODA disbursed for other direct reproductive health activities declined by 35.9% over the same period.

Conclusions

This study provides evidence of inequity in disbursement of reproductive health ODA between conflict-affected countries and non-conflict-affected countries, and between different reproductive health activities. These findings and the study''s recommendations seek to support initiatives to make aid financing more responsive to need in the context of armed conflict.