Objective To evaluate and select essential medicine for diabetes mellitus 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 and published from 2006 to 2011. (2) Five recommended medicines were included according to recommendations and evidence of WHOEML (2011), NEML (2009), CNF (2010) and other guidelines. They were metformin, glibenclamide, glipizide, rosiglitazone and pioglitazone. Domestic evidence of the first three drugs was evaluated. (3) The first three have been marketed with the specifications and dosage forms corresponding to guidelines in China. The FBG cost-effectiveness ratios of metformin with different dosage forms as immediate release compressed tablet, enteric-coated tablet and sustained release capsule were 3.37, 3.76 and 3.50 respectively. 2-hour BG cost-effectiveness ratios of metformin were 3.74, 4.00 and 3.71 respectively. The cost-effectiveness ratio of glibenclamide and glimepiride were 11.23 and 13.81 respectively. Conclusion We offer a recommendation for: (1) Metformin (immediate release tablet/capsule for oral use, 0.25 g), contraindicated in patients with renal insufficiency. (2) Glibenclamide (tablet, 2.5 mg; capsule, 1.75 mg) and glipizide (tablet, 2.5 or 5mg; dispersible tablet, 5 mg), contraindicated in children, women during pregnancy or lactation, patients in the perioperative period of major operation, patients after total pancreatectomy, and patients allergic or adversely reacted to sulfa drug. (3) Evidence-based and standardized primary healthcare guidelines as well as clinical and pharmacoeconomic studies on diabetes mellitus (large-scale, multi-centre, randomized and double-blinded) are needed to produce high-quality local evidence.
ObjectivesTo investigate the utilization of essential medicines and antibiotics in primary healthcare system of Xinjin county of Chengdu city from 2009 to 2011. MethodsThe data of utilization of all the medicines, essential medicines and antibiotics was collected from 17 hospitals of Xinjin primary healthcare system. Microsoft Excel 2003 was used to analyze the data. ResultsCompared with 2009, the total costs of medicines and essential medicines increased by 72.27% and 135.4% respectively in 2010. After the implementation of essential medicine policy in 2010, the proportion of essential medicines accounted for more than 90% in community healthcare centers (CHCs) and township hospitals (THs) and over 50% in county-level hospitals in 2011. In 2010, the average cost per prescription among outpatients increased by 3.51% in total, but deceased by 16.23% in CHCs/THs (RMB 15.09 yuan per prescription). In July of 2011, the policy to control the use of antibiotics was implemented in Xinjin county. The use of antibiotics decreased, but still accounted for over 30% in 9 out of 13 CHCs/THs. The use of bigeminy antibiotics and trigeminy antibiotics accounted for 0.42 to 5.56% and 0 to 0.44%, respectively. ConclusionsThe use of essential medicines increases in Xinjin county and met the national requirements. The average cost per prescription among outpatient decreases in THs and CHCs. After controlling the use of antibiotics, the proportion and cost of antibiotics is still very high, and irrational use of antibiotics probably still exists. The training and guide for evidence-based rational use of medicine should be enhanced in future.
Objective To evaluate and select essential medicine for children with fever and adult gastrointestinal flu caused by common cold 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) 12 guidelines were included, 11 of which were evidence-based or based on expert consensus. We offered a recommendation for medicines used in the treatment including analgesics and antipyretics, decongestants, antihistamines, cough-relieving drug, phlegm-removing drug and drug for gastrointestinal symptoms. (2) A result of four RCTs (very low quality) indicated that in the treatment of children with cold, ibuprofen suspension had an antipyretic effect similar to paracetamol solution (for oral use) with a pooled result of 6-hour efficiency in relieving fever (RR 1.48, 95%CI 0.66 to 3.30, P=0.34). The major adverse effects of ibuprofen suspension included gastrointestinal reaction and profuse sweats (RR=1.23, 95%CI 0.72 to 2.11, P=0.45). With good applicability, ibuprofen suspension (for oral use with no need to be supervised) cost 1.93 yuan daily. (3) A result of three RCTs (low quality) indicated that after given for 30 minutes and one hour, paracetamol solution (suppository) was fairly superior to ibuprofen suspension in lowering the high temperature caused by fever (given for 30 min: MD= –0.16°C, 95%CI –0.21 to –0.11, Plt;0.01; given for one hour: MD= –0.19°C, 95%CI –0.28 to 0.10, Plt;0.01). As to adverse reaction, paracetamol solution (suppository) mainly included anal irritation, skin rashes and profuse sweats, which had a comparative result of incidence with ibuprofen suspension (RR=1.84, 95%CI 0.62 to 5.44, P=0.27). For children with fever, paracetamol solution (suppository) cost 0.90 yuan daily. With good applicability, paracetamol solution (suppository) was administered via the anus. Conclusion (1) We offer a b recommendation for ibuprofen suspension (2 g/100 mL) or acetaminophen (0.1 g/suppository) as symptomatic treatment used in children with fever, pain and discomfort caused by common cold, and for Huo Xiang Zheng Qi Jiao Nang (0.3 g/ capsule) used in adults with gastrointestinal flu. We also offer a weak recommendation for acetylcysteine (injection, 300 mg/mL, 10 mL/ampoule) used in patients with paracetamol poisoning. (2) In order to produce high-quality local evidence, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on ibuprofen suspension and acetaminophen suppository in the treatment of children with fever, pain and discomfort caused by common cold should be further carried out. Besides, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on Chinese patent drugs of Huo Xiang Zheng Qi used in chidren and Huo Xiang Zheng Qi Jiao Nang used in adults should further carried out. Moreover, we suggest that epidemiological investigation as well as clinical and pharmacoeconomic studies of acetylcysteine injection for paracetamol poisoning should be carried out and the instructions of acetylcysteine injection should be added in the guidelines of essential medicine in China. Finally, further studies on evidence of oxymetazoline, dextromethorphan and other Chinese patent drugs with the effect of relieving cough and treating cold should be carried out.
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 antihypertensive medicine 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 clinical guidelines on hypertension were included, two of which were evidence-based. (2) Totally there were nine classes and 70 antihypertensive medicines listed in the guidelines. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines, and the quantity and quality of evidence, we offered a b recommendation for nifedipine, verapamil and enalapril and a weak recommendation for hydrochlorothiazide, indapamide, spironolactone, propranolol, metoprolol and amlodipine. We made a recommendation against furosemide and timolol due to the lack of evidence from guidelines. (4) Nine recommended medicines have been marketed with the dosage forms and specifications corresponding to guidelines in China. The prices of metoprolol, amlodipine and enalapril were higher than those of other six (daily cost: metoprolol 3.80 to 7.60 yuan, amlodipine 2.16 to 4.32 yuan, and enalapril 0.86 to 6.88 yuan). As a whole, the prices of recommended antihypertensive medicine were affordable. (5) Results of domestic studies indicated that three bly-recommended medicines (including nifedipine, verapamil and enalapril) were safe, effective, economical and applicable. Conclusion (1) We offer a b recommendation for nifedipine, verapamil and enalapril as antihypertensive medicine and a weak recommendation for hydrochlorothiazide, indapamide, spironolactone, propranolol, metoprolol and amlodipine. (2) There is lack of high-quality evidence from relevant domestic studies, especially on long-term safety and pharmacoeconomic evidence. (3) We propose that more studies should be carried out on the safety, efficacy and pharmacoeconomics of six medicines for which we make a weak recommendation to produce high-quality local evidence.
Objective To evaluate and select essential medicine for urolithiasis 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 evidence-based guidelines were included. Based on WHOEML (2011), NEML (2009), CNF (2010) and the quantity and quality of evidence, we made a recommendation for diclofenac sodium, nifedipine, allopurinol and ibuprofen used in symptomatic treatment of urolithiasis. (3) Results of domestic studies (including four RCTs, n=566; two observational studies, n=96) indicated that calculus-removed rates of diclofenac sodium, nifedipine and allopurinol were 91.5%, 86.4%~93.3% and 86.4% respectively with significant differences. Diclofenac sodium daily cost 7.00 to 8.57 yuan, nifedipine 1.48 to 4.44 yuan, and allopurinol 0.24 to 0.82 yuan. Ibuprofen had a total efficiency of 94.5% with a significant difference for alleviating renal colic, which cost 0.11 yuan daily. Four recommended medicines with safety, clinical efficacy, high economical efficiency and applicability had been marketed with specifications and dosage forms corresponding to guidelines in China. Conclusion For urolithiasis: (1) We offer a b recommendation for diclofenac sodium (capsule/tablet, 50 mg×24, or 25 mg×24) which is contradicted in patients with gastrointestinal bleeding and in pregnant women or women with planned pregnancy. (2) We offer a weak recommendation for nifedipine (tablet/capsule, 10 mg×100 or 10 mg×60) which is contraindicated in dialysis-receiving patients with malignant hypertension and should be cautiously used in patients with irreversible renal failure. (3) We offer a weak recommend allopurinol (tablet, 100 mg×100) which is contraindicated in patients with allergic reaction, severe insufficiency of the liver or kidney, or significant lack of blood cells. (4) We offer a b recommendation for ibuprofen (tablet, 20 mg×20) which is contraindicated in patients with allergic reaction to aspirin.
Objective To investigate the disease constitution and cost of inpatients in Gaozha Central Township Health Center (GzC) in Wuzhong City of Ningxia Hui Autonomous Region from 2008 to 2010, so as to provide baseline data for further research. Methods A questionnaire combined with a special interview was carried out, and case records and cost information of GzC inpatients in 2008, 2009 and 2010 (from January to November) were collected. The diseases in discharge record were classified according to International Classification of Diseases (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 the inpatients was 1124, 642 and 747 in 2008, 2009 and 2010, respectively. The female was more than the male in both 2008 (59.34% vs. 40.66%) and 2009 (60.75% vs. 39.25%), and their disease spectrum included 17 categories, which accounted for 81% of ICD-10; b) The top six most commonly seen systematic diseases with a constituent ratio from 86.63% to 92.06% in recent three years were as follows: the respiratory system, digestive system, circulatory system, genitourinary system, injury and toxicosis, skeletal musculature and connective tissue disease. Except the injury and toxicosis, the other five systematic diseases were commonly seen in females rather than in males; c) The top 15 monopathies in recent three years were pulmonary infection, tracheitis or bronchitis, coronary heart disease, soft tissue injury, gastritis or chronic gastritis, upper respiratory infection, hypertension, urinary tract infection, prolapse of lumbar intervertebral disc, pelvic inflammation, fracture, pneumocardial diseases, superficial injury, chronic cholecystitis and arthritis; d) The main burdens of disease for inpatients focused on 35-54 age groups, then followed by the age groups above 55 in 2008 and 2009. Except the injury and toxicosis, the other diseases were commonly seen in females rather than in males. Pulmonary infection focused on the age groups above 35; the onset of hypertension increased obviously and a sharp rise of hypertension existed in the 45-54 age groups in 2008, but the hypertention focused on 35-44 age groups in 2009; e) The total inpatients with top 15 monopathies accounted for 64.06% to 71.21%, including 8-9 chronic diseases ranking higher in 2010, and 6-7 acute diseases focusing on infection and injury; and f) The average costs of chronic diseases were higher than those of acute diseases. Conclusion a) There is a big gap between GzC and Yong’an Central Township Health Center (YaC) regarding the level of the regional economic development, the situation of disease burden and cost of inpatients. The former is demonstrated as general Central Township Health Center, while the latter as affluent Central Township Health Center in western China; b) In recent three years, the main systematic diseases are in respiratory, circulatory and digestive system; the inpatients suffer from more chronic diseases rather than acute diseases in their young age; the acute diseases mainly include infection and injury, and the pulmonary infection has ranked as the first during the past three years; c) The inpatients in 2008 and 2009 are mainly in ages of 35 to 54, and then are over 55 years old. Except the injury and toxicosis, the other diseases were commonly seen in females rather than in males; d) The patients’ average costs of chronic diseases for hospitalization and drug in 2010 were lower than those of YaC. Consideration on reasonable constitution of the cost for hospitalization should be paid attention to; and e) It is urgent to strengthen the construction of infrastructure and informatization in GzC.
Objective To investigate current situation of medical service and management in Gaozha Central Township Health Center (GzC), so as to provide baseline data for township health centers in both key techniques research and product development of drugs allocation and delivery. Methods A questionnaire combined with a special interview was carried out, which included the general information, human resources, medical service and management, and the practice of essential medicine list. Results a) The hardware condition of GzC was not good enough, and the economic status of the service recipients was lower than the average level of both Wuzhong City and China mainland; b) The constituent ratio of general practitioner (GP) and nurse, and GP and laboratorian were all lower than those of national level, while, the constituent ratio of GP and technician was a little bit higher. GzC was in short of medical technical personnel and, especially, the professional pharmacists. The logistics technical workers were as the same proportion as the nurses. The medical technical personnel without professional education background accounted for 3.4%, and about 38% of the staff members had no college degree, about 86.2% had at most primary profession titles. There was no personnel turnover of GzC in recently years; c) The bed utilization ratio was lower than national level (46.4% vs. 60.7%), while the average duration of stay and the in-patient and out-patient service workload of GP were longer or heavier than national level (8 vs. 4.8, 9 vs. 8.3, 4 vs. 1.3); d) The out-patient service in 2010 decreased 26.9% compared to 2009; and the in-patient service in 2010 decreased 42.4%; e) The average medical expense per outpatient and per inpatient increased 127.3% and 56.2%, respectively in 2010 compared to 2009; and f) Essential medicine list was put into practice in April 1st of 2010 and there was only 195 species available in GzC, which has not met the requirements of the national essential medicine list. Conclusion In order to meet the standards of general rural township health center in western China, GzC needs to cope with challenges of insufficient hardware conditions, short of staff, unreasonable personnel structure, low educational background and professional title of the staff, none human resources flow and low technical level of medical service. GzC dose well in drug expenses control, and the hospitalization costs are lower than those of the national level. However, it increases rapidly in 2010. The management of GzC may be influenced by zero-profit sale of the essential drugs, and appropriate subsidy and policy support are necessary to maintain its service quality. And it is required to complement the medicine based on the evidences, to carry out staff training and usage guidance of essential medicine, and to finally guarantee the safe and reasonable use of medicines.
Objective To evaluate and select essential medicine for the treatment of cerebral circulation insufficiency by means of evidence-based approaches based on the burden of disease for township health centers located in the 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 clinical guidelines on transient ischaemic attack/ischaemic stroke were included, all of which were evidence-based clinical guidelines. (2) In total, there were 13 medicines (of five classes) listed in these guidelines. (3) We offer a b recommendation for aspirin as essential medicine for cerebral circulation insufficiency and a weak recommendation for warfarin, clopidogrel, heparin, paracetamol, insulin, normal saline and glucose/dextrose. We made a recommendation against tPA, GPⅡb/Ⅲa and antibiotics according to WHOEML (2011), NEML (2009), CNF (2010), other guidelines and the quantity and quality of evidence. (4) Recommended medicines have been marketed in China and their prices were affordable except Clopidogrel’s. (5) Some results of domestic low-quality studies indicated that recommend medicines were safe and effective, which had significant differences compared to high-quality evidence from foreign studies. Further studies were needed to be confirmed. Conclusion (1) We offer a b recommendation for aspirin and a weak recommendation for warfarin, clopidogrel, heparin, paracetamol, insulin, normal saline and glucose/dextrose. We make a recommendation against tPA, GPⅡb/Ⅲa and antibiotics. (2) There is lack of high-quality evidence from relevant domestic studies, especially on long-term safety and pharmacoeconomic evidence. (3) We propose that more studies should be carried out on the safety, special efficacy and pharmacoeconomic of Chinese medicine, Chinese medicinals and medicine with special efficacy. Besides, we also compare recommended medicine with those of the same class and construct Level 1 to 2 systems of preventing and treating cerebral vascular diseases.
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.