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.
Background and Objective Organ transplantation has become an essential and irreplaceable treatment for patients with organ failure. Although organ transplantation was introduced to China in the 1960s, it has witnessed rapid development in recent years. However, problems have been identified in the course of its development. We aim to present both medical and legal points of view on organ transplantation, to compare the current status of organ transplantation in China with that in developed countries, and discuss the challenges China faces in developing its own legislation for organ transplantation. Methods We searched the websites of WHO, NIH, AST, UNOS, and governments, as well as relevant conference proceedings and expert consensus documents. Articles or documents involving organ transplantation legislation were identified. Results We included 10 legal documents, 1 regulation, 9 government documents, and 4 expert consensus documents. Organ transplantation legislation started in the 1960s in the United Kingdom, and was soon followed by New Zealand and the United States. The first law on brain death was enacted in the United States in 1978. Since 1991, the World Health Assembly (WHA) and other non-governmental organizations have issued 7 consensus documents in order to regulate behaviors related to organ transplantation. China including Hong Kong, Macau and Chinese Taipei has not yet formulated any law on organ transplantation. Conclusion At least six challenges about organ transplantation and brain death legislation in China are identified: ① death definition and source of organ donors; ② prevention of organ transplant tourism; ③ risk assessment and insurance for living donors; ④ defining who has the right to choose about potential organ donation for an individual: whether spouses, parents, or children; ⑤ whether an organ donor should receive compensation; ⑥ whether brain death and organ transplant laws should be formulated separately.
Objective To analyze and evaluate the present status of application of clinical pathway evaluation indexes in China, in order to provide references to establish an evaluation system on clinical pathway. Methods Such databases as CBM (2004-2009), VIP (2004-2009), CNKI (2004-2009) and WanFang Data (2004-2009), and some relevant websites were searched systematically for collecting Chinese literature about domestic clinical pathway evaluation indexes. Results Among the 1 175 articles included, 135 (11%) were published in the core periodicals, 19 (2%) were masterate theses, and 1 021 were other kinds of articles. As to 135 core periodical literature and 19 masterate theses, most of which were graded into the second level of evidence, accounting for 96%. The analysis on the appearance of indexes showed that 87% of inconsistency could be identified between the contents and terms of indexes. Common indexes were summarized as the following four aspects: cost index, clinical index, serving index and quality evaluation index. There were 78% of all the 1 175 articles focusing on the application of nursing and medical education, in which only one masterate thesis used social research methods such as Delphi, focus group, experts scoring (percentile), etc. Conclusion Currently, there are some issues existing in the evaluation indexes of clinical pathway in China, such as low methodological quality of literature, irregularly and randomly using statistical terms, and lack of studies on system construction of clinical pathway evaluation indexes.
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.
Objective To establish a risk evaluation indicator system for intrauterine device (IUD), to determine the weight of indicators, to comprehensively evaluate the risk of IUDs by using a variety of comprehensive evaluation methods according to the data of IUDs, so as to provide references for the government purchasing decision-making. Methods The literature review, long-term monitoring of IUD adverse events, large sample randomized controlled trials (RCTs) and Delphi methods were applied to establish the risk evaluation indicator system for IUD. The weight of each indicator was determined by jointly using the subjective scoring method and CRITIC method. Based on the established indicator system, primary research (RCT) data and secondary research data (literature data), the analytic hierarchy process (AHP), technique for order preference by similarity to ideal solution (TOPSIS) and synthetical scored method were used to assess the risk of IUDs respectively, and then the assessment results of three methods were integrated to obtain a comprehensive rank of various IUDs. Results A two-level risk evaluation indicator system for IUD was established and the seven 1st level indicators included unwanted pregnancy, expulsion, menstruation problems, pain, IUD ectopia, position and shape changes as well as total health problems, which were divided into 26 2nd level indicators. Through the subjective and objective weighting method, the weights of each 1st level indicator were 0.147 5, 0.144 3, 0.140 7, 0.174 8, 0.163 2, 0.132 8, and 0.096 6, respectively. The risk evaluation of the above three methods showed that among the three kinds of IUD in a multicenter RCT, yuangong365 was with the lowest risk, followed by TCu380A and MLCu375. The risk evaluation showed that among the 14 kinds of IUD from literatures, medicated γ IUD was with the lowest risk, followed by HCu280, yuangong365, and Gyne IUD, while the medicated stainless steel ring 165 was with the highest risk. Conclusion The established indicator system has a good representation and credibility, and the ways to identify the weight of indicators are scientific, comprehensive and accurate. Meanwhile, the findings which were demonstrated by various assessing methods are consistent to a large extent. Now that medicated γ IUD and HCu280 have been already included in the National Coverage Plan, it is suggested that if the prices of yuangong365 and Gyne IUD are reasonable, the two IUDs could be considered to be listed in the National Coverage Plan and freely chosen by women of child-bearing age.
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.
Objective We investigated the effectiveness of legislation in developed countries by analyzingtheir legislation, and produced ideas and strategies for organ transplantation and brain death legislation in China.Methods Official websites were searched as follows: UNOS, TCE, CLTR, ANZDATA, and SRTR through December6, 2008. We included statistical reports and data analysis of organ donations and transplants, and excluded literatureabout non-solid organs. The absolute transplantation numbers were standardized to per one million people. Results 1.The following data was retrieved: The number of eight kinds of organ transplants and organ donations in Britain, the United States, New Zealand, Spain, France, Italy, Germany, and Australia from 2003 to 2005; the number of deceased donors in the United States and Spain from 1988 to 2007; the total number of organ transplants in Australia from 2002 to 2006; the amount of organ transplants in the United States from 1993 to 2006; liver and kidney transplant totals in the United States from 1988 through March, 2008; liver transplants number of China from 1993 through March, 2008; and the number of kidney transplants in some provinces and cities in China. 2. Transplant totals were greatest in the United States; in Spain, after ONT was founded in 1990, the rate of donation from the deceased was the most in theworld. 3. Spain had the best rate of donation with 34.5 pmp, 10.9 pmp higher than in the United States with separate legislation from 2003 to 2005. There was a rate difference of 0.98 pmp between Germany and the United Kingdomwhich implemented separated legislation nine years earlier. 4. Southern Australia had a maximum rate of average kidneytransplant in the country from 2002 to 2006. 5. Live donor kidney transplants accounted for 31.2~44% compared to4.3% and 4.1% for liver transplants in 2006 and 2007 respectively in the United States. 6. The following have been appliedglobally to regulate organ transplantation and brain death: 1) International or multilateral treaties; 2) Regulation ofNGOs; 3) Self-discipline in the field of organ transplantation; 4) Expert consensus; 5) Establishment of patient’s alliance.Conclusion Countries that have implemented organ transplantation and brain death laws have developed successfulmeasures to improve and support insurance and follow-up information for donors and recipients, however, legislation isstill urgently needed in China. As long as brain death and organ transplant laws are reasonably developed and legislatorsresolve to deal with the difficult issues, then the legislation and its subsequent enforcement will reflect the interests of the people and improve health quality for all.