Objective We aimed to investigate the attitude and suggestion from doctors, pharmacists and civil servants concerning brain death and organ transplantation and the legislation. Methods A questionnaire with 10 sections and 44 questions was designed and distributed. The effective questionnaire data was then recorded and checked for descriptive analysis. Results In 1 400 questionnaires distributed, 1 063 were responded and 969 of them were valid and analyzed. The respondents showed an incomplete understanding of brain death and organ transplantation laws. Seventy-four percent of the respondents recognized and accepted the standard of brain death. They agreed that legislation should be involved in the removal of organs for transplantation, the future use of the organs, and insurance and compensation for the donor for possible health risks induced by organ removal. Of the 969 respondents, 92% considered it necessary to have legislation in brain death and organ transplantation, and 61% thought that it is time to legislate. Conclusion Legislation for brain death and organ transplantation is urgent and timely in China. The laws must include the respective rights and obligations of patients, close relatives, and medical institutions. Educating the public about brain death and organ transplantation should also be encouraged in a variety of ways.
Objective To analyze the clinical application, ADR/AE involved systems and manifestations of the six injections containing Houttuynia cordata which are much complicated in their ingredients and pharmacological actions compared with the Houttuynia cordata Injection, and to assess their safety and efficacy, so as to provide references for further deep research. Methods Such databases as MEDLINE (1998 to December 31, 2010), EMBASE (1998 to December 31, 2010), The Cochrane Library (1998 to December 31, 2010), CNKI (1979 to December 31, 2010), CBM (1978 to December 31, 2010), and VIP (1989 to December 31, 2010) were searched to retrieve the case report, series of cases observation, cross-sectional study, and clinical control study. The studies were included according to the inclusive and exclusive criteria, and the data was abstracted to analyze the reason and regularity of ADR/AE. Meta-analyses for efficacy were conducted when the data was feasible. Results a) About ADR/AE: Among the included 132 studies, 118 cases were reported with the ADR/AE. There were 59 studies about the New Houttuyfonate sodium injection, 93 cases with ADR/AE mainly manifested as pain in injection site (41 cases), rash (19 cases), anaphylactic shock (11 cases) and other infusion or allergic reactions (21 cases). There were 69 studies about the Yu Jin injection, 25 cases with ADR/AE manifested as rash (12 cases), anaphylactic shock (four cases), pain in injection site (three cases), and other infusion or allergic reactions (six cases); and b) The good efficacy of the New Houttuyfonate sodium injection and the Yu Jin injection was reported in one cross-sectional study and one RCT respectively, but the limited data was not enough to properly judge the efficacy. Conclusion There are few of clinical studies about these six injections containing Houttuynia cordata, and the irrational use in clinic is serious. Most of the ADR/AE cases are related to irrational use, such as, non-indication use, and arbitrarily change of administration method. The proof for analyzing and evaluating the safety and efficacy of injections containing Houtturnia cordata is insufficient, so strict clinical trials with large sample size are required to support further research.
Objective To systematically evaluate the efficacy of Houttuynia cordata Injection (HI) in treating respiratory system diseases, such as infection of the upper respiratory tract, pneumonia and respiratory tract infection, so as to provide references for revaluation after having access to market and its rational use. Methods The literatures concerning both randomized controlled trials (RCTs) and clinical control study of HI were searched in PUBMED, EMBASE, Chinese Biomedical Disc (CBMdisc), Chinese National Knowledge Infrastructure (CNKI), Chinese Science and Technology Journal Full-text Database (VIP) from 1979 to December of 2010. The quality assessment and data extraction for RCTs were conducted by two reviewers independently. Meta-analyses were conducted with the Cochrane Collaboration’s RevMan 5.0 software. Results a) Fifty-three trials including 46 RCTs and 7 non-RCTs were included, the quality grade was generally lower from 2 to 6 scores: 24 trials scored 5, 11 trials scored 3, 7 trials scored 4, 2 trials scored 6, and the rest 9 trials scored 2; b) There were 7481 patients (2520 adult and 4961 children) with infection of the upper respiratory tract, pneumonia, or respiratory tract infection. The interventions in the treatment group were Houttuynia cordata Injection or the joint of Houttuynia cordata Injection and support measures. The control group included four categories: Antiviral, Antibiotics, the joint of Antiviral and Antibiotics, and Chinese medicine injection (CMI). Both the total effective rate and average defervescence days were regarded as the result indexes; c) In all adult trials, when HI was used alone to treat the infection of upper respiratory tract (compared with the control group of antiviral, antibiotics, and the joint of antiviral and antibiotics), the pneumonia (compared with the control group of antiviral, and antibiotics), and the respiratory tract infection (compared with the control group of antibiotics, and CMI), the differences between the treatment group and the control groups were significant different, and the total effective rate of the treatment groups was higher than that of the control groups. The average defervescence days of the treatment groups were one to one and a half days shorter than those of the control groups; and d) In children trials, compared with the three control groups of antiviral, antibiotics, and CMI for treating infection of upper respiratory tract, the pneumonia, and the respiratory tract infection, respectively, the total effective rate was similar in the treatment group without significant difference. The left groups corresponding to those in the adult trials also showed a certain effects. Conclusion Houttuynia cordata Injection for adult respiratory system diseases tends to have a good effect, and indicates the effect of rapid defeverscence, so it is still recommended in clinic with the cautions of rational use and ADR/AE supervision. There is no evidence to fully prove its safety and effectiveness although HI is widely used for children, so it is advisable to “stop using it for children”. It needs to carry out more new precise clinical trials to provide high-quality evidence.
Objectives To systematically evaluate the clinical characteristics of adverse drug reactions (ADRs) caused by Shuanghuanglian Injection (SHLI) and to provide reference for post-market evaluation and clinical application of SHLI. Methods We searched electronic databases such as the Chinese National Knowledge Infrastructure (CNKI, 1979.1-2009.9), the Chinese Science and Technology Journal Full-text Database (VIP, 1989.1-2009.9), and the Chinese Biomedical Disc (CBMdisc, 1978.1-2009.9). ADR cases were analyzed according to occurrences categorized. Available data was assessed using the Chi-square test including relative ratios (RR) with 95% confidence intervals (95%CI). Different medicine combinations and comparisons between SHL powder injection and SHL injection were calculated using the statistical software Stata 9.1. Results (1) A total of 452 articles were included with a total of 2 799 ADR cases reported. Case reports were the main design type of included literature, which accounted for 84.51%. According to 31165 cases of SHLI treatment and 1 013 corresponding ADRs, the incidence of SHLI ADR was calculated as 3.25%. (2) The ratio of male to female in the reported ADR cases was 1.13׃1. (3) Allergy to Penicillin, which accounted for 13.38% of the total cases, was at the top for past allergic history, followed by sulfonamides and asthma (2.68%). (4) In terms of disease treated respiratory disease accounted for 91.75% of all cases of SHLI ADRs, followed by digestive diseases (5.17%), and urinary diseases (1.11%). (5) Penicillins were the most common combination choice with SHLI, and such combination showed higher ADR risk than SHLI used alone [RR=3.14, 95%CI (2.58, 3.81)]. (6) Multiple systems/organs were involved in SHLI ADRs, and were ranked downwards according to proportion as: skin, digestive system, general reactions, respiratory system, nervous system, cardiovascular system, local reactions, urinary system, hematologic system and others. (7) According to the WHO ADR Classification Criteria, ADR cases were divided into four grades. There were 6.36%, 5.48%, 45.62%, and 2.12% cases of Grade Ⅰ, Ⅱ, Ⅲ and Ⅳ , respectively. And the prognoses of the rest 52.42% cases were reported unclearly. (8) All cases of death were caused by allergic shock, except for one, which was caused by myocardial infarction induced by pain at the injection site. The fastest ADR case occurred 1 minute after being injected. (9) There was a remarkable difference (Plt;0.05) in the rate of ADR caused by SHLI in power form (2.25%) and as a solution (4.14%). Conclusion The clinical manifestations of ADRs caused by SHLI mainly include skin allergic reactions and gastrointestinal reactions. There is an increased risk of ADR induced by combined uses of SHLI and other drugs, especially antibiotics. Compared to the solution, the powder has lower ADR occurrence and higher safety with statistical significance. We propose strengthening management and surveillance on SHLI from manufacturing to application, and improving the level of the risk management for post-market drugs.
Objective Interpretation of the growing body of global literature on health care risk is compromised by a lack of common understanding and language. This series of articles aims to comprehensively compare laws and regulations, institutional management, and administration of incidence reporting systems on medical risk management in the United Kingdom, the United States, Canada, Australia, and Taiwan, so as to provide evidence and recommendations for health care risk management policy in China. Methods?We searched the official websites of the healthcare risk management agencies of the four countries and one district for laws, regulatory documents, research reports, reviews and evaluation forms concerned with healthcare risk management and assessment. Descriptive comparative analysis was performed on relevant documents. Results?A total of 146 documents were included in this study, including 2 laws (1.4%), 17 policy documents (11.6%), 41 guidance documents (28.1%), 37 reviews (25.3%), and 49 documents giving general information (33.6%). The United States government implemented one law and one rule of patient safety management, while the United Kingdom and Australia each issued professional guidances on patient safety improvement. The four countries implemented patient safety management policy on four different levels: national, state/province/district, hospital, and non-governmental organization. Conclusion?The four countries and one district adopted four levels of patient safety management, and the administration modes can be divided into an “NGO-led mode” represented by the United States and Canada and a “government-led mode” represented by the United Kingdom, Australia, and Taiwan.
Objective To comprehensively compare the methods and tools for medical risk management and assessment in the United Kingdom, the United States, Canada, Australia and Taiwan region (hereafter shortened as “four countries and one region”), so as to provide evidence and recommendations for medical risk management policy in China. Methods The official websites of the healthcare risk management agencies in these four countries and one region were searched to collect materials concerning healthcare risk management and monitoring, such as laws, regulatory documents, research reports, reviews and evaluation forms, then the descriptive comparative analysis was performed on the methods and tools for risk management. Results a) A total of 146 documents were included in this study, including 2 laws, 17 regulatory documents, 41 guidelines, 37 reviews and 49 documents about general information; b) The United Kingdom applied the integrated risk management; Australia and Taiwan adopted the classical risk management process, including risk identification, risk analysis, risk evaluation and risk control, while the United States and Canada mainly chose the prospective failure mode and effects analysis (FMEA) for clinical risk management; c) The severity of clinical risk was divided into five grades in the United Kingdom and Australia, and six in Taiwan, respectively. The frequency of medical risk was divided into five grades with four grade responses in above two countries and one region; and d) There were almost the same processes and tools about Root Cause Analysis (RCA), but a little difference in the objects of analysis in these four countries and one region. Conclusion?There are three models of risk management with the same assessment tools in these four countries and one region: the prospective risk assessment, the retrospective assessment based on occurred incidents and the integrated risk management. Although the grading of risk is similar, the definition of grading is different in the United Kingdom, Australia and Taiwan. The methods and processes of analyses on the adverse events are almost the same in these four countries and one region.
Objective To analyze the policy and guideline, the institutional management and the operation mechanism of ICU medical risk management in the United Kingdom, the United States, Australia, Canada and Taiwan, so as to provide evidence and recommendations for health care risk management policy in China. Methods Such databases as PubMed, EMBASE, The Cochrane Library were searched to include the literatures such as the guideline documents and the research reports on ICU medical risk management in the United Kingdom, the United States, Australia, Canada and Taiwan; the institutional management and the operation mechanism of the risk management in the above four countries and one area were comprehensively analyzed, and especially the UK model was highly emphasized. Results A total of 31 literatures were included, including 1 guideline, 5 reviews, 2 investigative reports and 23 research documents. The United Kingdom guided the ICU risk management in forms of the standard and the guideline, formulated a clear tool of event classification and corresponding response mechanism. The United States learned from Australia’s experience and established the ICU safety reporting system; both of them regarded ICU as one part of the medical risk management and set up a special management column. Conclusion The ICU risk management with the independent report system in the United Kingdom is brought into the scope of national patient safety management, and is regarded as the relative complete system at present. In Australia and the USA, the national institutions are in charge of setting up the research projects of ICU risk management; the industry associations and the non-governmental organizations lead the risk research; and the experimental units popularize gradually after self-application.
Objective To compare administration of incidence reporting systems for healthcare risk management in the United Kingdom, the United States, Canada, Australia, and Taiwan, and to provide evidence and recommendations for healthcare risk management policy in China. Methods We searched the official websites of the healthcare risk management agencies of the four countries and one district for laws, regulatory documents, research reports, reviews, and evaluation forms concerned with healthcare risk management and assessment. Descriptive comparative analysis was performed on relevant documents. Results (1) A total of 142 documents were included in this study. The United States had the most relevant documents (68). (2) The type of incidents from reporting systems has expanded from medication errors and hospital-acquired infections to near-misses, and now includes all patient safety incidents. (3) The incidence-reporting systems can be grouped into two models: government-led and legal/regulatory/NGO-collaborative. (4) In two cases, reporting systems were established for specific incident types: One for death or serious injury events (the sentinel events database in Britain, SIRL), and one for healthcare-associated infections (NHSN in America). (5) Compared to the four countries, Taiwan’s system put more emphasis on public welfare, confidentiality, and information sharing. The contents of reporting there covered every aspect of risk management to create a more secure environment. Conclusion (1) Britain’s national reporting and learning system was representative of a government-led model; (2) The United States was the earliest country to have a reporting system, which included a limited range of incident types. Management of incidents became more reliable with increased application of laws, regulations, and guidances; (3) Both the Canadian and the Australian systems drew from the American experience and are still developing; (4) The Taiwanese system was comprehensive and is an instructional case.
Objectives We conducted a literature review of 33 kinds of Traditional Chinese medicine injections (CMIs) on the national essential medicine list (2004 edition) of China in ADR articles to retrieve basic ADR information and research trends related to CMIs and to provide evidence for the research and development as well as the rational use of CMIs, particularly pharmacovigilance and risk management of CMIs. Methods We electronically searched Chinese Biomedical Literature Database (CBM, Jan. 1978-April 2009), the China National Knowledge Infrastructure Database (CNKI, Jan. 1979-April 2009), Chinese Science and Technology Periodical Database (VIP, Jan. 1989-April 2009) and the Traditional Chinese Medicine Database (Jan. 1984 April 2009). We also retrieved the websites of Ministry of Health and State Food and Drug Administration, to collect data about CMIs ADRs reports and regulations from “Newsletter of Adverse Drug Reactions” (Issue 1 to 22). Then we descriptively analyzed all the results on the year published, periodicals and types of study design of included ADR literatures, the major CMIs as well as the regulations about their ADRs. Results (1) There were 5 405 citations found in total and 2160 were removed because of duplication. After screening the title, abstract and full text of the selected papers, 1 010 studies finally met the eligible criteria. (2) The total and cumulative amount of research articles published about CMIs ADRs significantly increases over time. (3) The included 1,010 articles were scattered among 297 periodicals. A total of 55 journals on pharmaceutical medicine, containing 399 articles, accounted for 39.50% of total; 64 journals on traditional Chinese medicine and pharmaceutical medicine, containing only 197 articles, amounted for 19.50% of total. Only 22 periodicals were included on the core journals of the Beijing University List (2008 edition) (8.94% of the total journals in the list), which published 129 articles (12.77% of the total articles published). (4) We categorized the articles included into eight categories based on their content and study methodology. There were: 348 case reports and 254 case series which accounted for 34.46% and 25.15% of the total articles, 119 overviews (11.78%), 116 randomized controlled trials (11.49%), 78 cross-sectional studies (7.72%), 61 ADR literature analyses (6.04%), and 28 non-randomized controlled clinical studies (2.77%). (5) In the three of top ten journals, "Adverse Drug Reactions Journal", "China Medical Herald", and "Chinese Pharmaceuticals" published literature accounted for 5.84%, 3.76% and 2.67% of the total respectively. (6) The reports of ADRs to Shuanghuanglian, Qingkailing and Yuxingcao injections were the most in all reports for CMIs (All the three injections had more than 200 articles, accounting for 41.95% of the total). The Ministry of Health and the State Food and Drug Administration took measures to supervise them. (7) The four kinds of CMIs (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) among the top 5 reported ADR literatures were removed from the market or were suspended for sale. The varieties and numbers of reports for CMIs ADRs have relationship with the supervision to them. Conclusions (1) Articles published on CMIs ADRs increased year by year, but overall the research is of low quality and is scattered in a large number of sources. (2) It is very urgent to create a clear standard to grade ADRs of CMIs for the risk management. (3) It is necessary to enforce safety re-evaluation work for CMIs and to promote the clinical rational use.