ABSTRACT
OBJECTIVE:To investigate off-label drug use of Ambroxol hydrochloride injection,and to provide reference for further evidence-based evaluation on rationality and standardized management of off-label drug use. METHODS:All medical orders for inpatients receiving Ambroxol hydrochloride injection were selected from 10 hospitals of Guangdong province during Apr. 2014 to Mar. 2015. Situation of drug use in different categories of departments was summarized,the incidence of off-label administation route and off-label dosage were analyzed;according to drug package inserts,prescription daily dose(PDD)and drug utilization in-dex(DUI)were calculated for each category of department,and the degree of off-label dosage was evaluated. RESULTS:A total of 761 821 person·day who used Ambroxol hydrochloride injection was included. Off-label drug use occurred in each category of departments,and the incidence of off-label drug use was 62.10%. The incidence of off-label administration route was 40.51%, mainly atomization inhalation;the incidence of it was the high-est in gynecology and obstetrics department(92.70%).The in-cidence of off-label dosage was 36.30%,and the incidence of it was the highest in cardiothoracic surgery department (85.36%). Departments whose PDDs were higher than the drug package inserts were cardiothoracic surgery department,ICU,surgical department,cardiovascular medicine department,emer-gency department,department of internal medicine and pediatrics department.CONCLUSIONS:Off-label drug use of Ambroxol hy-drochloride injection is common,and the effectiveness,safety and necessity remain controversial,which need to be proved by multi-center randomized controlled prospective trial.
ABSTRACT
OBJECTIVE:To investigate off-label drug use of Ambroxol hydrochloride injection,and to provide reference for further evidence-based evaluation on rationality and standardized management of off-label drug use. METHODS:All medical orders for inpatients receiving Ambroxol hydrochloride injection were selected from 10 hospitals of Guangdong province during Apr. 2014 to Mar. 2015. Situation of drug use in different categories of departments was summarized,the incidence of off-label administation route and off-label dosage were analyzed;according to drug package inserts,prescription daily dose(PDD)and drug utilization in-dex(DUI)were calculated for each category of department,and the degree of off-label dosage was evaluated. RESULTS:A total of 761 821 person·day who used Ambroxol hydrochloride injection was included. Off-label drug use occurred in each category of departments,and the incidence of off-label drug use was 62.10%. The incidence of off-label administration route was 40.51%, mainly atomization inhalation;the incidence of it was the high-est in gynecology and obstetrics department(92.70%).The in-cidence of off-label dosage was 36.30%,and the incidence of it was the highest in cardiothoracic surgery department (85.36%). Departments whose PDDs were higher than the drug package inserts were cardiothoracic surgery department,ICU,surgical department,cardiovascular medicine department,emer-gency department,department of internal medicine and pediatrics department.CONCLUSIONS:Off-label drug use of Ambroxol hy-drochloride injection is common,and the effectiveness,safety and necessity remain controversial,which need to be proved by multi-center randomized controlled prospective trial.
ABSTRACT
OBJECTIVE:To probe into the rational drug use condition in Shenzhen area and to promote the rational drug use level. METHODS: A multi-center randomized parallel test was conducted in 6 different levels of hospitals in Shenzhen area. In which the prescriptions in two months and the outpatients visiting the hospitals on that day were surveyed on the spot in respect of the international rational drug use (RDU) indicators then the data were analyzed statistically. RESULTS: Prescription indicators were as follows: the average number of drugs was 2.44; the percentage of antibiotics prescribed was 43.7%and that for injection was 22.3%. Patient care indicators were as follows: the average consultation time was 6.97 minutes; average dispensing time was 16.77 seconds; percentage of drugs actually dispensed was 100%; percentage of drugs actually labeled was 100%; percentage of patients’ knowledge of correct use of drugs was 96.5%. CONCLUSIONS: The rational drug use level in Shenzhen area is still low and problematic and the care given by doctors and pharmacists to the patients is insufficient, which remain to be improved and tackled.
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OBJECTIVE:To prepare diclofenac sodium controlled release pellets and investigate the mechanism of re?lease.METHODS:Single-factor method was used to investigate the influence of the composition of solvent system in coating solution,the concentration of coating material,porogenic agent and plastifier on the release rate of drug.RESULTS:When the concentration of coating material and the proportion of water increased,the release rate of pellets was increased;the release rate was further increased with PVP K30 added.CONCLUSION:The pellets belongs to the matrix-coating pellets,and the release mechanism varies with the change of coating thickness.
ABSTRACT
OBJECTIVE:To establish a RP-HPLC method for simultaneous determination of chlorapheniramine maleate,furacilin and ephedrine hydrochloride in Puma nose drops.METHODS:The analysis was carried on a XDB C 8 column;the mo?bile phase was composed of methanol(A),acetonitrile(B)and0.02mol/L potassium dihydrogen phosphate solutions(containing0.2%triethylamine and adjusted to pH3.0with phosphoric acid,C)with linear gradient elution(0min～3.5min,A∶B∶C=6∶13∶18,8.5min,A∶B∶C=6∶30∶64)and the flow rate was1.0ml/min;the detection wavelength was254nm and the column temperature was30℃.Chloramphenicol was used as the internal standard.RESULTS:The linear ranges were0.04～0.20mg/ml for chlorapheniramine maleate,0.02～0.10mg/ml for furacilin,0.50～2.50mg/ml for ephedrine hydrochlo?ride.The average recoveries were99.44%(RSD=0.48%,n=3)for chlorapheniramine maleate,101.36%(RSD=0.41%,n=3)for furacilin and99.43%(RSD=0.59%,n=3)for ephedrine hydrochloride.CONCLUSION:The method is reliable,accurate and suitable for quality control of Puma nose drops.