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OBJECTIVE To compare the efficacy， safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia （CAP）. METHODS A retrospective cohort study was conducted to screen and include CAP outpatients during the period of January to December 2021 in Lianyungang First People’s Hospital. They were divided into generic drug group （1 058 cases） and bid-winning drug group （1 121 cases） according to the drug source. Two groups were respectively given original and bid-winning Moxifloxacin hydrochloride tablets， 0.4 g each time， once a day. The efficacy indexes （clinical effective rate， remission time， treatment course， revisiting rate） and safety indexes （allergy， nervous system symptoms， etc.） were compared between the two groups； and the influence factors of clinical treatment failure were analyzed with multi-factor modified Poisson regression model. The economic indicators of the two drugs [quantity， consumption sum， defined daily doses （DDDs）， defined daily dose cost （DDDc）， price ratio， replacement rate] were compared. RESULTS There were no significant differences in the clinical effective rate， treatment course， revisiting rate， the incidence of nervous system symptoms and Q-T interval prolongation between the two groups （P＞0.05）. The remission time of original drug group was significantly shorter than that of bid-winning drug group， and the incidence of total adverse drug reaction， allergy reaction， gastrointestinal symptom reaction and hyperglycemia were significantly lower than those in bid-winning drug group（P＜0.05）. Multivariate Poisson regression analysis showed that bid-winning drug did not increase the risk of clinical treatment failure in CAP outpatients [RR＝1.132， 95%CI （0.883， 1.542）， P＝0.327]. However， antibiotic exposure history， more than 2 items of abnormal clinical manifestations and auxiliary examination all increased the risk of clinical treatment failure （P＜0.05）. Compared with before the implementation of centralized volume-based procurement policy， the quantity and DDDs of Moxifloxacin hydrochloride tablets increased significantly， while the consumption sum decreased significantly， DDDc of bid-winning drug decreased significantly， the price ratio of it to original drug decreased to 0.117， and the replacement rate increased to 69.44% after the implementation of centralized volume- based procurement policy. CONCLUSIONS Compared with original drug， bid-winning Moxifloxacin hydrochloride tablet shows reliable efficacy and obvious price advantage in the treatment of outpatient CAP， but the incidence of adverse drug reactions is higher.
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OBJECTIVE To evaluate the clinical effectiveness and safety of domestic generic and imported original clopidogrel for antiplatelet therapy in patients with acute coronary syndrome （ACS）. METHODS The clinical data of ACS patients in Nanjing Drum Tower Hospital of China Pharmaceutical University from January 2020 to June 2021 were retrospectively collected by using electronic medical record system， and the patients were divided into original drug group （321 cases） and generic drug group （328 cases） according to the drug use. Both groups were given dual antiplatelet therapy with clopidogrel and aspirin. The effectiveness and safety outcomes of the two groups were followed up for 12 months and compared， the related influential factors were analyzed. RESULTS Major adverse cardiovascular events （MACE） occurred in 16 and 22 patients in original drug group and generic drug group respectively， including nonfatal myocardial infarction （4 and 5 cases）， stroke （2 and 4 cases）， revascularization （8 and 3 cases）， cardiovascular related death （2 and 4 cases）， and all-cause death （4 and 6 cases）. There were 12 and 7 patients with major bleeding events， 38 and 29 patients with minor bleeding events， and 33 and 21 patients with non-bleeding adverse events. There was no statistically significant difference in the cumulative incidence of related events （P values of Log-Rank tests were all greater than 0.05）. Cox regression analysis showed that the use of generic clopidogrel did not increase the risk of MACE and major bleeding events in ACS patients [hazard ratio of 1.305 and 0.416， 95% confidence interval of （0.678， 2.512） and （0.155， 1.117）， respectively， P＞0.05]， and the combination of proton pump inhibitors （PPI） could reduce the risk of major bleeding events [hazard ratio of 0.196， 95% confidence interval of （0.063， 0.611）， P＜0.05]. CONCLUSIONS Compared with imported original drug， domestic generic clopidogrel has similar clinical effectiveness and good safety. Combined use of PPI may be a beneficial factor to reduce the occurrence of major bleeding events in patients.
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OBJECTIVE：To evaluate the dissolution behavior consistency between the generic drugs and original drugs of Oxcarbazepine scored tablets ，and to compare the appearance ，the friability of the split portions ，loss of mass of the split portions as well as crystal form and morphology of raw material from different enterprises. METHODS ：HPLC method was adopted. The paddle method （rotation speed of 60 r/min，the temperature of 37.0℃）was adopted to determine accumulative dissolution rate of generic and original drugs in 4 mediums [ 0.6％ SDS hydrochloric acid solution （pH＝1.2），0.6％ SDS acetate buffer solution （pH＝4.5），0.6％ SDS phosphate buffer solution （pH＝6.8）and 0.6％ SDS water solution]. The similarity factor method was used to evaluate the similarity of dissolution curves as well as intra-batch uniformity of the split portions and whole tablets. The friability tester and electronic balance were used to determine the friability and the loss of mass of the split portions. X-ray diffractometer and scanning electron microscope were used to observe the crystal form and crystal morpho logy of the raw materials of different enterprises. RESULTS ：The linear range of oxcarbazepine was LOD was 0.04 μg/mL；RSDs of precision ，stability，reprodu- cibility and durability tests were lower than 2.0％；the reco- veries were 99.80％-101.63％（RSD＝0.37％-0.91％，n＝3）. The average cumulati ve dissolution rate of generic drug A ， generic drug B and original drug in 4 different dissolution media at 90 min were 92％，87％，90％ [0.6％ SDS hydrochloric acid solution（pH＝1.2）]；94％，94％，90％ [0.6％ SDS acetate buffer solution （pH＝4.5）]；95％，95％，91％ [0.6％ SDS phosphate buffer solution （pH 6.8）]；97％，98％，95％（0.6％ SDS water solution ）. The similarity factors of generic drug A ，generic drug B and original drug in 4 kinds of different dissolution media were 66 and 81，71 and 69，71 and 61，59 and 39. In the first 15 min，the difference of dissolution rate of split portions and whole tablets were －3％-13％，－2％-24％ and －3％-7％ for generic drug A ， generic drug B and original drug ，respectively. RSDs of accumulative dissolution rate of split portions and whole tablets were 6％-14％ and 2％-9％ for generic drug A （n＝12），4％-10％ and 1％-8％ for generic drug B （n＝12）and 2％-7％ and 2％-8％ for original drug. The appearance of the original drug was fusiform ，and the notch was deep ；the shape of the generic drug was different from each other ，and the notch of the generic drug was significantly shallower than that of original drug. The friability ， the loss of mass of the split portions for generic drug A and generic drug B ，original drug were 0.62％and 0.67％，0.12％ and 0.11％，0.08％ and 0.05％. The domestic raw materials possessed irregular lumps and debris ，while the raw materials produced by original drug enterprises possessed regular flat cuboids and regular strips with little debris ；but X-ray diffraction peaks of them were basically the same. CONCLUSIONS ：The dissolution behavior of generic drug A in 4 medium is consistent with that of the original drug；dissolution behavior of generic drug B in water containing 0.6％SDS is different from that of the original drug ；there is no significant change in the homogeneity of the original drug before and after splitting ，but the homogeneity of the generic drug A and B after splitting is lower than that of the whole tablet ；the fragility of generic drugs and loss of mass of split portions are higher than those of the original drugs ；two kinds of raw material have the same crystal form but different crystal morphology.
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OBJECTIVE：To study the skin irritation and se nsitization of domestic generic drug Clobetasone butyrate cream ， and to compare it with commercial drug （original drugs ）. METHODS ：The skin irritation test was conducted on rabbits. Totally 24 rabbits were randomly divided into test preparation intact skin group ，test preparation abraded skin group ，commercial drug intact skin group and commercial drug abraded skin group ，with 6 rabbits in each group. 0.5 mL test preparation or commercial drug was administered to the left side of intact or abraded skin and the same amount of excipient on the right side of each rabbit twice a day for consecutive 7 days. The irritation of the drug to the rabbit skin was observed ，and the erythema and edema of the skin were scored；the skin of administration site was taken at 72 h after last administration and the end of 7 d after drug withdrawal for histopathological examination. The skin sensitization test （Buehler test ）was carried out on guinea pigs. Totally 60 guinea pigs were randomly divided into test preparation group （n＝20），commercial drug group （n＝20），positive control group （n＝10）and excipient control group （n＝10）. 0.2 mL test preparation or commercial drug was administrated to the left side of the rib abdomen skin of each guinea pig at the 0，7th，14th day to induce model ，and an equal amount of corresponding preparation was administered to the right side in the same way at the 28th day for stimulation. Hypersensitive response such as erythema and edema were observed and scored at 24 h and 48 h after the stimulation. The incidence of hypersensitive response was then calculated. RESULTS：In skin irritation test of rabbits ，no erythema and edema was caused by the test preparation or commercial drug on intact skin of rabbits ；scores of skin irritation was 0；there was no dermal irritation. Both test preparation and commercial drug caused transient slight erythema on abraded skin of a few rabbits ；scores of intact and abraded skin irritation were 0-0.33；there was no dermal irritation. There was no statistical significance among groups. No dermal pathological changes were observed. In skin sensitization test of guinea pig ，no hypersensitive response such as erythema and edema was found on the skin of guinea pigs in both test preparation and commercial drug groups ；both score and the incidence of hypersensitive response were 0. Compared with excipient control group ，there was no statistical significance of average score and the incidence of hypersensitive response in test preparation group and commercial drug group. CONCLU- SIONS：In skin irritation test of rabbits and skin sensitization test of guinea pigs ， the evaluation results of generic Clobetasone butyrate cream are the same as those of the original drug. It has no irritation to the skin of rabbit ，and no sensitization to the skin of guinea pigs.
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OBJECTIVE： To provide evidence support for the economic benefits of generic drugs as substitutes for original drugs， and to provide suggestions for promoting the use of generic drugs. METHODS： Twelve kinds of drugs with both original and generic versions for treating hypertension and diabetes were selected from a tertiary public hospital in Jiangsu province. The proportion of usage quantity， the ratio of amount， price ratio were analyzed quarterly during 2017-2018. RESULTS： From the first quarter of 2017 to the fourth quarter of 2018， the ratio of quantity of original drugs increased from 24.53％ to 39.12％， while that of generic drugs decreased from 75.47％ to 60.88％； the ratio of amount of original drugs increased from 39.45％ to 61.47％， while that of generic drugs decreased from 60.55％ to 38.53％； the price ratio of generic drug to original drug decreased from 0.50 to 0.40. With the same efficacy， the cost of generic drugs replacing original drugs in 2018 could save 622，100 yuan， and the cost savings rate could be 47.65％. CONCLUSIONS： Drug expenditure could be reduced by substituting original drug with generics， but the useage quantity and amount ratio of generic drug in this hospital is gradually declining. So， in order to save drug experditure， it is necessary to speed up the process of conformity evaluation and clinical equivalence study of generic drugs， increase the education and publicity of generic prescriptions and rational use， so as to improve doctors’ and patients’ recognition of the quality and efficacy of generic drugs， cooperate with the centralized procurement policy to encourage the purchase and use of generic drugs.
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OBJECTIVE:To provide suggestions for improving the quality of the instructions of domestic generic Levofloxacin injections. METHODS:A set of instructions of original Levofloxacin injection and 20 sets of instructions of domestic generic Levo-floxacin injections(with three kinds of acid radicals)were compared and analyzed in warning,indications,dosage and administra-tion,medication for children,drug interactions,toxicology,pharmacokinetics,etc. RESULTS & CONCLUSIONS:The rate of re-cording indications,dosage and administration and pharmacokinetics among the 21 sets of instructions is high,up to 100%. Among the instructions of domestic generic Levofloxacin hydrochloride injection,Levofloxacin lactate injection and Levofloxacin mesylate injection,the rates of mentioning a tendon injury in the warning section are 30.00%,0 and 33.33% respectively;those of recording antibacterial spectrum in the indications section are 10.00%,0 and 33.33% respectively;those of recording the specif-ic results of drug interactions are 10.00%,0 and 66.67% respectively;and those of recording toxicological information are 70.00%,85.71% and 33.33% respectively,all of which are lower than the recording rates of 100% for the instructions of original one. In the instructions of domestic generic Levofloxacin injection,there is a lack of clinical trial data in the sections of dosage and administration,medication for children and toxicology and of pharmacokinetic parameters for patients with impaired liver/kidney function and special population in the pharmacokinetics section. It is suggested that the manufacturers of domestic generic Levoflox-acin injections should improve the specific contents of the instructions;the instructions regulatory authorities should improve the ad-ministration of instructions examination and approval;and doctors and pharmacists should strictly follow the instructions.
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<b>Objective: </b>There are some cases in which the original drug and generic, or various generic drugs have different flavors. In prescription substitution, there is concern that difference in the flavor of the drug will influence on medication adherence. Therefore pharmacists should sufficiently understand information regarding the flavors of drugs. We investigated the source of information on flavor and an actual flavor.<br><b>Methods: </b>The study was limited to antibiotic powders for pediatric patients, 43 original drugs and 68 generic drugs were examined. We collected information on the flavor by the paper document, such as pharmaceutical reference issued by the pharmaceutical companies, and by telephone. We investigated the inclusion of the paper document, presence of descriptive information on the flavor listed in the paper document and the concordance between the flavor of the original drug and that of the generic drug.<br><b>Results: </b>For both the original drugs and generics, a flavor was added to many drugs (86.0 and 91.2%, respectively). There were many cases in which the original drug and generic drug had different flavors. However, information on the flavor was only described on the paper document of 28.6% of original drugs and 45.3% of the generic drugs. Inquiry to the pharmaceutical companies by telephone was needed to know the flavor of drugs not described. The inclusion of the paper document varied greatly with each pharmaceutical company.<br><b>Conclusion: </b>In the promotion of prescription substitution, it is necessary to promote proper administration of generic drugs by maintaining and collecting information on the flavor, and providing sufficient information to patients.
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OBJECTIVE:To provide references for drug pricing and drug administration for Chinese government.METHODS:The drug pricing and administration policies in UK were expounded and the effects of which were analyzed and evaluated,based on which some suggestions were put forward with the consideration of the specific condition of our country.RESULTS&CONCLUSIONS:The rules of market economy should be obeyed and market monitoring should be carried out in China.The non-governmental organizations should play a key role in the support and service for national drug supervision and administration.The drug prices should be controlled according to category so as to make the formula process of drug price policy scientific.The government-set price and the market price monitoring mechanism should be established and the legal system of drug price management should be established as soon as possible.