ObjectivesTo construct a follow-up evaluation indicator system on the implementation of the WHO resolution of " Access to essential medicines” by systematic review, and to provide a methodological support for tracking the implementation of the resolution, with a view to providing evidence of decision-making to promote the accessibility of essential medicines and further promote and improve the national essential medicine policy. It also provides a methodological reference for investigating the implementation of other public health sector resolutions.MethodsPubMed, EMbase, The Cochrane Library, Web of Science, CBM, WanFang Data and CNKI databases and relevant international or national official websites of pharmaceutical administration department or academic organization were searched to collect studies on accessibility of WHO essential drugs from inception to February, 2016. Two researchers independently screened literature, extracted data, and qualitative analysis was used to sort out and screen the evaluation indicators for the implementation of the WHO resolution of "Access to essential medicines".ResultsA total of 60 relevant literatures, three guides and 19 progress reports of the World Health Assembly from official websites were included. Through the screening of indicators, we could get two parts: the indicators of measures to implement the resolution and the indicators of the results of the implementation of the resolution.ConclusionsThis study analyzes the implementation of the resolution of the health system in the progress report of the World Health Assembly 2013–2015, divides the implementation of the resolution into two parts: the implementation of the resolution and the results of the implementation of the resolution. An indicator system for establishing measures and evaluation the resolution has been found. Expert consultations will be further developed to establish the final indicators for the implementation of the "Access to essential medicines".
Objective To evaluate and select essential medicine for acute exacerbation of chronic bronchitis (AECB) using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Five guidelines were included (four foreign guidelines, one domestic guideline; three based on evidence, two based on expert consensus). (2) Medicines recommended at least twice by the National Essential Medicine List (NEML, 2009 version) and Chinese National Formulary (CNF) contained: ipratropium bromide (four times), amoxicillin amp; clavulanate potassium (three times), and corticosteroid (three times), cefuroxime (twice), ciprofloxacin (twice), levofloxacin (twice), salbutamol (twice) and dextromethorphan (twice). (3) As for domestic study evidence, a result of one RCT indicated that amoxicillin amp; clavulanate potassium had efficiencies of 92.3% to 94.7% (n=77, low quality). A result of three RCTs (n=275, low quality) indicated that cefuroxime had efficiencies of 67.6% to 90% and an incidence of 5% as to adverse reaction that mainly included skin rashes, diarrhea, etc. A result of two RCTs (n=120, low quality) indicated that ciprofloxacin had efficiencies of 78.3% to 86.6%, bacterial clearance rates of 72.7% to 86.5% and the incidences of 8.7% to 16.2% as to adverse reaction that mainly included gastrointestinal reaction, skin rashes, etc. A result of seven RCTs (n=523, low quality) indicated that levofloxacin had efficiencies of 72.5% to 94.5%, bacterial clearance rates of 82.1% to 95.8% and the incidences of 5% to 7.5% as to adverse reaction. A result of two RCTs (n=239, low quality) indicated that salbutamol had efficiencies of 85.4% to 96.7%. A result of one RCT (n=95, low quality) indicated that ipratropium bromide had efficiencies of 98%. A result of five RCTs (n=466, low quality) indicated that the combined use of budesonide and bronchodilators had efficiencies of 93.4% to 97.8%. Conclusion (1) We offer a b recommendation for cefuroxime, amoxicillin amp; clavulanate potassium, ciprofloxacin and levofloxacin used in the treatment of AECB. (2) We offer a b recommendation for glucocorticoid (budesonide, aerosol) and anticholinergic bronchodilator (ipratropium bromide) and a weak recommendation for short-acting β2-agonist bronchodilator (salbutamol) and antitussive agent (dextromethorphan) for alleviating symptoms due to AECB. (3) We make a recommendation against mucolytic agents and theophylline as routine use. (4) More large-scale, multi-center, double-blinded RCTs are needed in clinical and pharmacoeconomic studies on AECB and outcome indicator should be improved in order to produce high-quality local evidence.
ObjectivesTo systematically review the implementation effects of the full coverage policy for medicines, and to provide evidence for the improvement of National Essential Medicine Policy in China.MethodsWe searched databases including ProQuest, PubMed, CNKI and WanFang Data databases from inception to June 30th 2018 to collect the studies on full coverage policy for medicines. Two reviewers screened literature and extracted related information independently. Then, qualitative analyses were applied to evaluate the impact of the full coverage policy for medicines.ResultsA total of 35 studies on the full coverage policy for medicines were included. Ten studies evaluated the effects of disease control, 12 studies evaluated the impact of the compliance of the patients, 9 studies evaluated the impact on medical expenses and drug costs, 2 studies evaluated the effects of equality, 7 studies evaluated economics, and 11 studies described the improper use and waste of medicines.ConclusionsIn the content of perfecting the selection mechanism and management system, the implementation of the full coverage policy for essential medicines is conducive to promoting equality and accessibility, enhancing drug compliance, improving the diagnosis and treatment of patient diseases ultimately, and making the policy more economical.
Objective To evaluate and select essential medicine for acute cholecystitis using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Three guidelines were included (two foreign guidelines, one domestic guideline; two based on evidence, one based on expert consensus). (2) Results of two RCTs (n=200, low quality) and two CCTs (n=230, low quality) indicated efficiencies of ampicillin/sulbactam, piperacillin/tazobactam, ciprofloxacin combined with metronidazole, and ceftazidime combined with metronidazole were 92.5%, 92.6%, 92.5% and 91.3%. A result of three RCTs (n=661, low quality) indicated that lavofloxacin had efficiencies of 82.2% to 95.8% which were 84.4% to 94.7% when combined with metronidazole. A result of three RCTs (n=553, low quality) indicated that for acute cholecystitis, ceftriaxone had an efficiency of 90.0%, cefuroxime 73.7% and cefoperazone/sulbactam 95.6% (Efficiency: ceftriaxone 93.3%, cefuroxime 82.5% and cefoperazone/sulbactam 92.3%, when combined with metronidazole). A result of one RCT (n=72, low quality) indicated that cephazoline had an efficiency of 70.9% with bacteria resistance rates of 70% for G+ and 87% for G. Conclusion (1) We offer a b recommendation for piperacillin/tazobactam and cefoperazone/sulbactam used in the treatment of acute cholecystitis (mild, moderate and severe). We offer a b recommendation for meropenem, imipenem/cilastatin and metronidazole as alternatives for severe acute cholecystitis. (2) We offer a weak recommendation for ceftazidime and cefepime used in the treatment of severe acute cholecystitis and a weak recommendation for cefotiam, ampicillin/sulbactam and cefuroxime used in the treatment of acute cholecystitis (mild and moderate). We offer a weak recommendation for lavofloxacin and ciprofloxacin used in the treatment of acute cholecystitis (mild and severe) and a weak recommendation for ceftriaxone used in the treatment of acute cholecystitis (mild, moderate and severe). (3) We make a recommendation against cephazoline as routine use. (4) More large-scale, multi-center, double-blinded RCTs are needed in clinical and pharmacoeconomic studies of acute cholecystitis and outcome indicator should be improved in order to produce high-quality local evidence.
Objective To evaluate and select essential medicine for acute and chronic gastritis using evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Five guidelines for acute gastritis and seven guidelines for chronic gastritis were included. The recommended included omeprazole, ranitidine and domperidone. (2) A result of three CCTs (n=315, low quality) indicated that omeprazole was superior to famotidine and ranitidine in alleviating symptoms of chronic gastritis such as pain or discomfort in the upper abdomen, regurgitation, a burning sensation in the heart, distention and fullness in the upper abdomen (71.2% vs. 47.3%, 94.4% vs. 84.3%, Plt;0.05). A result of one RCT (n=100, low quality) and two CCTs (n=213, low quality) indicated that in HP eradication rates, omeprazole triple therapy and the control intervention had no significant difference (OR=1.09, 95%CI 0.44 to 2.70, Pgt;0.05). A result of one RCT (n=100, low quality) indicated that omeprazole caused no adverse reaction. A result of five CCTs (n=528, low quality) indicated that adverse reaction of omeprazole included poor appetite (two cases), nausea and vomiting (four cases), headache or vertigo (one case) and increased transaminase (one case). Omeprazole cost eight yuan (tablet) or four yuan (capsule) daily. (3) HP eradication rates of ranitidine bismuth citrate was higher than the control group (OR=2.05, 95%CI 1.29 to 3.25, P=0.002). A result of 15 RCTs (n=3 638, high quality) indicated adverse reaction of ranitidine bismuth citrate mainly included symptoms in the digestive system. A result of one RCT (n=100, low quality) indicated ranitidine bismuth citrate and omeprazole triple therapy had no significant difference (Pgt;0.05) and ranitidine bismuth citrate caused no adverse reaction. Ranitidine cost 0.36 yuan (tablet), 0.40 yuan (capsule) or 2.7 to 5.4 yuan (injection) daily. (4) A result of two CCTs (n=133, low quality) indicated that compared with the control intervention, domperidone was more efficient without adverse reaction in improving indigestion, promoting gastric emptying effect, and alleviating pain and distention in the upper abdomen, belching and regurgitation. Domperidone cost 1 to 1.3 yuan daily. (5) All kinds of recommended medicines are listed and legalized in China Pharmacopoeia (2010) and CNF (2010). (6) In clinical setting, above-recommended medicines should be applied strictly according to the CNF (2010) and the National Clinical Prescription Guidelines for Essential Medicine. Conclusion For acute and chronic gastritis, indigestion and HP eradication: (1) We offer a b recommendation for omeprazole (immediate release tablet/capsule for oral use, 10 mg/tablet) which should be cautiously used in children, elderly people, and women during pregnancy or lactation. (2) We offer a b recommendation for ranitidine (immediate release tablet/capsule for oral use, 150 mg/tablet) which should be cautiously used in patients with severe insufficiency in the liver or kidney, women in the pregnancy or lactation, and children under eight years of age.
Objective To provide baseline datum for further evidence-based selecting essential health technology or essential medicine by comparing the top 15 inpatient diseases in the three pilot township clinics in western China from 2008 to 2010. Methods With the key words as disease spectrum, constitution of disease, inpatient disease category, inpatient diseases and so on, such databases as CBM, CNKI, VIP, WanFang and official websites of Ministry of Health were searched on computer, and the manual search was also conducted in combination to extract the related datum of provinces where the pilot township health centers were situated. The Excel software was used for data classification and analyses. Results (1) Among the 16 included literatures including 15 journal papers and 1 master thesis, 4 scored from zero to 3.5, 9 scored from 3.5 to 6.75, and the left 3 scored 7 or more than 7; (2) The common inpatient diseases in the township health centers in eastern, central and western regions in China were different. The upper respiratory tract infection, acute/chronic bronchitis, acute/chronic gastritis and appendicitis were the common inpatient diseases in the township health centers throughout China. The pneumonia, emphysema, cholelithiasis, cholecystitis, and acute/chronic gastroenteritis were the common inpatient diseases in the township health centers in southwest and northwest regions. The top 15 inpatient diseases in the three pilot township clinics in this study covered all the common inpatient diseases in the township health centers in southwest and northwest regions in China; (3) The total number of the top 15 inpatient diseases of the three pilot township health centers in western China between 2008 and 2010 was 35, including 20 chronic and 15 acute diseases. The chronic diseases were chronic bronchitis, chronic gastritis, hypertension, lumbar/cervical disease, cholelithiasis or cholecystitis, coronary heart disease, chronic pulmonary heart disease, urinary calculi, pelvic inflammation, vertebrobasilar insufficiency, arthritis, acute exacerbation of chronic bronchitis, Meniere’s disease, chronic obstructive emphysema, myocardial ischemia, prostatitis, etc.. The acute diseases were upper respiratory tract infection, pulmonary infection, fracture, superficial injury, acute appendicitis, acute bronchitis, urinary tract infection, acute gastritis, acute gastroenteritis, delivery amp; cesarean section, soft tissue injury, acute urticaria, etc.; and (4) While the common inpatient disease categories were relatively centralized and stable, but some of them were different in regions, inpatients’ age and sex structure. Conclusion (1) There are some differences in the common inpatient diseases in the township health centers among eastern, central and western regions in China, thus it is necessary to select essential health technology and essential medicine according to local conditions; (2) As a good representation, the common inpatients diseases in the three pilot township health centers in western China can provide the baseline evidence for selecting essential health technology and essential medicine for the township health centers in western China; (3) There are lack of national/regional statistics, survey data and evidence-based research on disease spectrum of the township health centers currently. While the investigation methods or statistics measurements/quality of these included studies are variable without standard regulation; and (4) It suggests that the state and every provinces should implement and improve the statistic analysis of disease spectrum of the township health centers, train staffs and fulfill the construction of information system.
Objective To evaluate and select essential medicine for community-acquired pneumonia (CAP) using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Eleven guidelines were included (nine foreign guidelines, two domestic guidelines; nine based on evidence, two based on expert consensus). For CAP, amoxicillin amp; clavulanate potassium had efficiencies of 77.1% and an incidence of 18.8% as to adverse reaction that mainly included gastrointestinal reaction, skin rashes, etc. Piperacillin/tazobactam had an efficiency of 92.1% and a bacterial clearance rate of 88.9%. Cefuroxime had an efficiency of 89% and a bacterial clearance rate of 85.5%. There was no statistical significance between azithromycin and cefuroxime for CAP (RR=0.98, 95%CI 0.9 to 1.06); however, azithromycin was superior to cefuroxime in shortening fever-relief time (MD=–0.98, 95%CI –1.24 to –0.55) and cough-relief time (MD=–1.36, 95%CI –1.94 to –0.78). Efficiencies of ceftriaxone, cefotaxime, moxifloxacin and lavofloxacin were all more than 80% and among the three, moxifloxacin was the most efficient (RR=1.08, 95%CI 1.02 to 1.13, P=0.004). Meropenem had an efficiency of 90%, a bacterial clearance rate of 83.3% and an incidence of 3.33% as to adverse reaction that mainly included diarrhea. Conclusion (1) We offer a b recommendation for antibiotics such as amoxicillin, amoxicillin amp; clavulanate potassium, ampicillin/sulbactam, piperacillin/tazobactam, doxycycline, azithromycin, clarithromycin, cefuroxim, ceftriaxone, cefotaxime, lavofloxacin, moxifloxacin, ertapenem, meropenem, imipenem and vancocin. (2) We offer a weak recommendation for penicillin G, ciprofloxacin and erythromycin. (3) We propose that doctor should choose optimal antibiotics based on commonly-seen pathogenic bacteria that cause CAP, local criteria of antibiotic susceptibility, severity of CAP, and risk factors of patients.
ObjectivesTo provide methodology support for the tracking assessment of specific resolution execution through evidence-based construction of tracking assessment index system for resolution execution of WHO essential medicine accessibility resolution, so as to further promote and improve the establishment of national essential medicine policies, and offer a methodology reference to survey and assess the resolution executions in other public health fields.MethodsA multi-disciplinary team was set up to preliminarily construct the index system by means of earlier system assessment index through index screening based on Delphi method. The weight of each index was determined by analytic hierarchy process.ResultsAfter two rounds of expert consultation, the index system available for resolution execution measures and results of WHO essential medicine accessibility were established, including 9 indexes of resolution execution measures. Meanwhile, the execution results of index contained 4 first class indexes, 13 second class indexes and 36 third class indexes. Each of the indexes obtained its own weight according to degree of importance.ConclusionsIn this study, the assessment index for resolution execution of essential medicine accessibility is established, however, the empirical research is still required to further verify the scientificity as well as feasibility of this index system.
Objective To establish standards, methods and processes for evidence-based evaluation and selection of essential medicine that meet the needs of the 8 pilot township health centers in China. Methods A descriptive analysis was conducted to compare the similarities/differences and the advantages/disadvantages of the standards, methods and processes between the World Health Organization (WHO) essential medicines evaluation and selection, and the GRADE evidence quality and recommend intensity. In combination with the former outcomes of this series of study, the standards, methods and processes of evidence-based evaluation and selection of essential medicines in the domestic pilot township health centers were optimized, restructured and improved. Softwares such as GRADEprofiler were used to assess the quality of evidence. Results a) Localized standards, methods and processes for evidence-based evaluation and selection of essential medicine were established, and the evaluation tool was ascertained; and b) Disease and drug names, guidelines and searching processes for evaluation and selection of essential medicine were developed with standardized, systematic and transparent approaches. Conclusion a) Standards, methods and processes for searching, evaluating and recommending the best evidence are preliminarily established, through comparative analysis on the effectiveness, safety, cost-effectiveness and applicability of the candidate medicines for diagnosing, treating and preventing diseases in township health centers in China; b) Following the principle of “utilizing the best existing evidences and developing the urgently-needed but lacking evidence”, a good exploration was done for the localization, standardization and transparency of the standards, methods and processes of evidence-based evaluation and selection of essential medicine for pilot township health centers.
Objective
To systematically review the diseases constitution of children in Chinese medical institutions from 2010 to 2016, and to provide evidence for establishing essential medicine list for children (EMLc) of China.
Methods
We searched PubMed, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Data from January 2010 to February 2016 to collect studies about diseases constitution of Chinese children. Two reviewers independently screened literature, extracted data, and assessed the risk bias of included studies, then data was descriptively analyzed.
Results
A total of 33 studies of diseases constitution were included, involving 1 797 696 children among 0 to 18 years from 17 provinces of China. Neonatal hyperbilirubinemia, neonatal pneumonia and premature were the main diseases of inpatient newborns. The main diseases of children hospitalized were pneumonia, upper respiratory tract infection and tumor. Upper respiratory tract infection, bronchopneumonia, bronchitis and diarrhea were the main diseases of outpatients. Hyperspasmia, upper respiratory tract infection and pneumonia were the main diseases of emergency patients. Diseases constitution of different medical institution: the main diseases were pathological jaundice, neonatal asphyxia and neonatal pneumonia in both tertiary and secondary medical institution in the newborn group. In the children group, the main diseases were pneumonia, upper respiratory tract infection and bronchitis in both tertiary and secondary medical institution. Besides these diseases, indigestion and fever of unknown origin were also the main diseases of primary medical institution. Disease constitution of different areas: in the newborn group, pathological jaundice, neonatal pneumonia and neonatal hyperbilirubinemia were the main diseases in coastal areas. Neonatal pneumonia, neonatal hyperbilirubinemia and premature were the main diseases in inland areas. Neonatal hyperbilirubinemia, neonatal pneumonia and neonatal hypoxic-ischemic encephalopathy were the main diseases in remote areas. In children group, pneumonia, bronchitis and premature were the main diseases in coastal areas. Pneumonia, bronchitis and hand-foot-and-mouth disease were the main diseases in inland areas. Upper respiratory tract infection, bronchopneumonia and bronchitis were the main diseases in remote areas.
Conclusion
Diseases constitutions of children vary in different medical institution, and because of extreme lack of date from primary medical institution, we suggest to carry out investigation in primary medical institution to provide evidence for EMLc. Diseases constitutions of children vary in different area, additions should be made according to local conditions when essential drugs of children selected. Newborn, as a special group of children, should be considered separately when EMLc of China established.
