Objective To evaluate and select essential medicine for chronic obstructive pulmonary diseases (COPD) 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) Nine guidelines were included (eight foreign guidelines, one domestic guideline; seven based on evidence, two based on expert consensus). (2) A result of one domestic RCT (n=72, high quality) indicated that tiotropium could significantly improve pulmonary function of severe COPD patient complicated with respiratory failure and increase their quality of life (SGRQ score: MD=–10.8%, 95%CI –12.2% to –9.4%). A result of one RCT (n=156, moderate quality) with 3-month follow-up indicated that tiotropium could significantly improve the proportion of measured value to expected value of FEV1 in patients with mild and moderate COPD in stationary phase (MD=10.3%, 95%CI 8.1% to 12.5%). A result of two RCTs (n=160, low quality) indicated that compound ipratropium bromide had efficiencies of 84.2% to 87.5% for moderate and severe COPD. A result of one RCT (n=60, moderate quality) indicated that salmeterol/fluticasone (inhalation) was superior to placebo for improving mild and moderate COPD in stationary phase. A result of one RCT (n=725, moderate quality) indicated that tiotropium combined with salmeterol/fluticasone for COPD in stationary phase was superior to tiotropium alone. A result of one RCT (n=110, low quality) indicated that nebulized budesonide inhalation had an efficiency of 86.8% for acute exacerbation of COPD (AECOPD) and an incidence of 7.9% as to adverse reaction that mainly included laryngo-pharyngeal irritation. (3) Imipenem, meropenem, cefoperazone/ sulbactam and ceftazidime were effective for COPD with low drug resistance rates in treating COPD caused by non-ICU pathogens (less than 8%). Conclusion (1) We offer a b recommendation for tiotropium, ipratropium, salbutamol, formoterol, salmeterol and theophylline used in the treatment of COPD in stationary and exacerbation phases, a b recommendation for streptococcus pneumoniae and influenza vaccines in preventing the deterioration of COPD, a b recommendation for inhaled corticosteroids (ICS) used in the treatment of COPD in stationary phase and a b recommendation for corticosteroids (for oral use) for AECOPD. (2) We offer a b recommendation for cefoperazone/sulbactam, imipenem and meropenem used in the treatment of moderate and severe AECOPD. (3) We offer a weak recommendation for ceftazidime, ciprofloxacin, lavofloxacin, moxifloxacin, amoxicillin amp; clavulanate potassium, amoxicillin, azithromycin, clarithromycin and doxycycline as first-line and second-line antibiotics for mild and moderate AECOPD, and a weak recommendation for compound sulfamethoxazole, cefatriaxone, cefotaxime and cefuroxime used in the treatment of severe and extremely severe COPD, mucolytic agents used in the treatment of stable COPD with difficult expectoration. (4) We make a recommendation against antibiotics, expectorants and corticosteroids (for oral use) as routine use in stationary phase of COPD.
Objective To investigate the situation of supplemental drugs to the national essential medicines list (EML) in primary health care facilities. Methods Supplemental essential medicine lists published by provincial governments around our country were identified. Characteristics of categories, names and quantities of the supplemental drugs were extracted and compared. Results Supplemental lists issued by 13 provinces were included. The number of the supplemental drugs of four provinces including Jiangsu, Guangdong, Inner Mongolia and Shandong surpassed 200. All the included lists contained chemicals and traditional Chinese medicine, as well as nine categories mentioned in the EML. The frequency of 17 drugs in the supplemental lists was over 10. Specific paediatrics drugs and antitumor drugs were considered by several provinces. Conclusion At present, EML cannot meet the requirements of the primary healthcare. Selection and amendment of EML may refer to the supplemental lists which reflect the demands of essential drugs in every area in our country.
ObjectiveComparing the worldwide Essential Medicines Lists for Children (EMLcs) and National Essential Medicine List (NEML) of China (2012 edition), to provide evidence for establishing EMLc of China. MethodWe searched the official websites of WHO and Ministry of Health of some countries to identify published EMLcs. We compared the situation of updating, the number and classification of medicines, and the dosage forms between these EMLcs and NEML of China (2012). ResultBy August 2013, the WHO, India and South Africa had established EMLc. The number of medicines of NEML of China (2012) ranked first in the four lists. The WHO, India and China classified the medicines by pharmacologic action, while South Africa classified it by anatomical therapeutic chemical (ATC) classification. Except the WHO, India, South Africa and China did not have specific medicines for neonatal care or medicines for diseases of joints. The main administration routes in these four lists were oral administration, injection, and topical application. There were medicine restrictions in EMLcs of WHO and India, while no medicine restrictions in lists of South Africa and China. ConclusionMedicines listed in NEML of China (2012) do not match children's disease burden of China. The applicable dosage forms for children are few and the medicine restrictions are absent for the list. So this list is not suitable for Children.
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 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 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 the treatment of coronary heart disease by means of 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) 11 clinical guidelines on coronary heart disease were included, three of which are evidence-based guidelines. (2) Totally, those guidelines contained 61 medicines (of 13 classes). (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines and the quantity and quality of evidence, we made a b recommendation for nitroglycerin, isosorbide dinitrate, metoprolol, nifedipine, verapamil, enalapril and aspirin as essential medicine for coronary heart disease. We made a weak recommendation for amlodipine, clopidogrel, heparin, propranolol, simvastatin and streptokinase. (4) 13 recommended medicines have been marketed in China and their prices were affordable. (5) Results of domestic low-quality studies indicated that nitroglycerin, isosorbide dinitrate, metoprolol, aspirin and heparin were effective for coronary heart disease. We didn’t find systematic reviews or pharmacoeconomic studies on the recommended medicines in Chinese literature databases. Conclusion For coronary heart disease: (1) We offer a b recommendation for nitroglycerin, isosorbide dinitrate, metoprolol, nifedipine, verapamil, enalapril and aspirin and a weak recommendation for propranolol, amlodipine, clopidogrel, heparin, simvastatin and streptokinase. (2) There is lack of high-quality evidence from relevant domestic studies, especially on pharmacoeconomic evaluation. (3) We propose that more studies should be carried out on clinical guideline of coronary heart disease and pharmacoeconomic comparison should be also made between recommended medicine and medicine of the same class.
Objective To evaluate and select essential medicine for uterine neoplasms 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) Six guidelines were included, three of which were evidence-based. (2) Retrieved guidelines related to nine medicines (of three classes) for uterine neoplasms and five adjuvant drugs (of three classes) used after relevant surgery. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guideline and the quantity and quality of evidence, we offered a b recommendation for medroxyprogesterone acetate, oxytocin, ergometrine and a weak recommendation for testosterone propionate, methyltestosterone, tamoxifen, mifepristone, tranexamic acid, leonurus heterophyllus used in the treatment of uterine neoplasms. We offered a recommendation against danazol and aromatase inhibitors. (4) We found relevant domestic literature on mifepristone, methyltestosterone, tamoxifen, oxytocin and leonurus heterophyllus. Mifepriston combined with methyltestosterone or tamoxifen was recommended to use as a conservative therapy for uterine neoplasms. Oxytocin,and leonurus heterophyllus were used to reduce bleeding after the surgery of uterine neoplasms. As to daily expense, mifepriston (25 mg/d) cost 13.0 to 27.5 yuan, methyltestosterone (5 mg/d) 0.074 yuan, tamoxifen (20 mg/d) 0.6 to 1.4 yuan, leonurus heterophyllus (injection, 1 mL) 15 yuan and oxytocin (injection, 20 U) 1.5 yuan. (5) Results of domestic studies indicated that mifepristone, mifepristone plus methyltestosterone, and mifepristone plus tamoxifen were proved to be safe and applicable for the treatment of uterine neoplasms. Oxytocin and leonurus heterophyllus are effective in preventing postoperative bleeding and the combination of two effectively and safely promoted uterine contraction. Conclusion (1) We offer a recommendation for three medication plans used in the treatment uterine neoplasms during perimenopause, including: a) Mifepristone (25 mg/ tablet, once daily); b) Mifepristone (25 mg/ tablet, once daily) plus methyltestosterone (5 mg/tablet, once daily); c) Mifepristone (25 mg/ tablet, once daily) plus tamoxifen (10 mg/tablet, twice daily). The three plans mentioned above should be used from first day of menstrual cycle, continuously for three months. (2) Adjuvant drugs such as oxytocin (injection, 1 to 2 mL) and leonurus heterophyllus (injection, 10 U) can be applied to reduce vaginal bleeding flow after the surgery of uterine neoplasms. (3) Personnel in elementary healthcare institution should stick to drug indication, carefully make follow-up, and dynamically monitor the change of uterine neoplasms and menstruation so as to adjust medication plan according to patients’ situation.
Objective To investigate the disease constitution and hospitalization cost in Yong’an Central Township Health Center (YaC) in Shuangliu County of Sichuan Province from 2008 to 2010, so as to provide baseline data for further research. Methods Questionnaire and focus interview were carried out; case records and cost information of YaC inpatients in 2008, 2009 and 2010 were collected. The diseases were classified according to ICD-10 based on the first diagnose and the cost was analyzed. Data including general information of the inpatients, discharge diagnosis, hospitalization expenses, and drug cost etc. were rearranged and analyzed by Excel software. Results a) The total number of inpatients were 4 236, 4 335 and 4 844 in 2008, 2009 and 2010, respectively. Females were more than males (56.99% vs. 42.96%, 55.59% vs. 44.1%, 54.36% vs. 45.62%), and their disease spectrum included 20 categories, which accounted for 95% of disease classes of ICD-10; b) The inpatients suffering from top three systematic diseases accounted for 62.74% to 72.31%, which included the respiratory, digestive, urinary tract and urogenital systematic disease; c) The top 15 single diseases were upper respiratory infection, acute bronchitis, pulmonary infection, acute gastroenteritis, fracture, acute appendicitis, chronic bronchitis, calculi in urinary system, cerebral vascular insufficiency, lumbar vertebra disease, acute gastritis, superficial injury, chronic gastritis, hypertension, and cholecytolithiasis or cholecystitis; d) The number of inpatients in the group of over 15-24 ages with chronic diseases increased with age and females were more than males. The acute disease burden of inpatients in 0-4 age group was the heaviest, who only suffered from acute diseases and males were more than females. The inpatients in 25-54 age group suffered from more acute diseases than chronic diseases and females were more than males; and e) The inpatients’ average costs of chronic diseases were higher than those of acute diseases in 2010 (1 564.45 yuan vs. 1 104.11 yuan) and those of either Xintian Central Township Health Center (1 311.81 yuan) or Gaozha Central Township Health Center (1 002.99 yuan). Conclusion a) In recent three years, the main systematic diseases that inpatients suffer are digestive, respiratory, and urinary tract and urogenital system diseases; the acute diseases are more than the chronic; the acute diseases mainly include infection and injury; b) During the past three years, the top 15 diseases have been stable and the same diseases include upper respiratory infection, pulmonary infection, acute bronchitis, acute appendicitis, acute gastritis, acute gastroenteritis, fracture, chronic gastritis, chronic bronchitis, and calculi in urinary system; c) It should be paid attention to the inpatients with chronic diseases in over 15-24 age group and the inpatients with acute diseases in 0-4 age group; and d) The inpatients’ average costs of top 15 diseases in 2010 were higher than those of either XtC or GzC, and consideration on rationality of the hospitalization cost should be paid attention to.
Objective To provide the evidence on the selection and related policies of essential medicine for policy-makers through systematic review of the National Essential Medicine List(NEML) around the world. Method We systematically searched the official websites of the health authorities, like the departments of health and pharmaceutical administrations. We selected the published NEML. Two reviewers independently selected literature and extracted data. We analyzed the time of NEML published and updated, NEML committees, selection criteria, medicine category, number of medicines, and medicine information in NEML and standard treatment guidelines (STGs) as well. Results Thirty-six NEMLs from 25 countries were included with 34 in English and 2 in Chinese. From 1982 to 2009, Twenty-five countries developed their NEMLs respectively. They were updated from four months to eight years. The NEML committee members came from central government, ministry of health, pharmaceutical administrations, ministry of public health, ministry of education, essential medicine division, etc. The committees were composed of clinical specialists, health officials, pharmacists (pharmacologists), medicine educators, economist, statisticians, epidemiologist and experts from WHO/UNICEF, etc. Most of the countries took the WHO’s concept of essential medicine and selection criteria as standard. The applications of essential medicine were reviewed by considering the following aspects: safety, effectiveness, economic characteristics, the main disease burden, rational use of drug and supply. The medicines in NEMLs of 25 countries varied from 103 to 2 033, and the median is 447. The Anatomical Therapeutic Chemical (ATC) classification was used to classify the medicines in NEMLs of 12 countries. The drug information was provided, including generic name, dosage, form of medication and administration route as well. The STGs or formularies covered from 73 to 167 common diseases, including the diagnosis, treatments, rational use of drug, contraindications, adverse effects, etc. Conclusions The NEMLs in 25 countries have shown great differences because of the variation of the social and economic developments, disease burdens and the developments of health care systems in different countries. We can learn from the experience of other countries, like Australia and South Africa, in the selection and use of essential medicines, STGs and related policies. We should develop the national essential medicine system for policy making and administration, especially the national essential medicine list for common diseases base on the high quality evidence, the local disease burden as well as specific demands in different areas.