The Study Of Drug Sample Testing Status In Ningxia

Objective Statistical analysis of five years from2008to2012in Ningxiadrugs to sample plans and sample result, the overall status and level ofdrug quality in Ningxia to make objective and accurate evaluation, the keyof proper analysis of the unqualified drugs, founding the regularity of theiremergence, distribution characteristics, to grasp the agency drugregulatory focus and the difficulty to provide the reference.Method We collected from2008to2012in Ningxia drugs to sampledata and sample plan, and used of statistical methods to analyze the drugsituation, found that the change of sample fraction defective drugs.Results①Ningxia plans to sample11600batches in2008-2012, a total of777drugs, basic drugs directory varieties of proper596accounted for the76.71%of the total varieties. The actual crud drug12648batches tocomplete the sample plan for109.3%, unqualified batch1060, fractiondefective is8.38%； Between2008and2011to sample total batchbasically stable and increased, in turn, is2080,2054,2350,3202, fractiondefective decrease, respectively is11.15%,5.21%,4.04%,5.21%; In2012to sample2962batches, fraction defective is as high as17.22%；Differentyears of proper fraction defective by chi-square test, x2=704.16, p=0.000<0.05, suggesting that sample is not qualified rate was statisticallydifference between each year, and pair wise comparisons between multiplesets, found in2008and2012, the sample is not qualified rate and otheryears have differences, no statistical difference between other years.②According to the sampling unit properties are divided into productionunits, business units, the use of units, units unknown, fraction defective is in turn2.17%,10.07%,8.74%,10.07%, fraction defective by chi-squaretest, x2=94.58, p=0.000<0.05, fraction defective is statisticallysignificant between different units；Production units is not qualified rate islow, but not qualified rate is as high as30.0%in2008； Business unitsgenerally high fraction defective, five years is in turn12.68%,8.89%,6.69%,4.82%,6.69%；Unit using the fraction defective is relatively high,five years, in turn, were8.81%,4.81%,2.97%,4.81%,18.39%, and ineach of the different unit fraction defective are statistically significant.③According to the nature of drug-handling units, will be divided into thewholesale business, retail stores, retail chain, monomer to fractiondefective is4.52%,10.93%,4.52%, fraction defective by chi-square test,x2=146.93, p=0.000<0.05, fraction defective is statistically differencebetween different business units. And two comparisons between groups,between different business units are statistically significant.④Accordingto the different units used, divided into individual clinics, townshiphospitals and village clinics and other medical institutions, fractiondefective is24.11%,7.77%,24.11%, fraction defective by chi-square test,x2=195.96, p=0.000<0.05, fraction defective is statistically significantbetween different unit using two different two comparison unit usingfraction defective were statistically significant between the two.⑤According to the drug kinds different, divided into chemicals,antibiotics, proprietary Chinese medicine, Chinese Traditional Medicine,other drugs, fraction defective is in turn0.69%,0.34%,0.87%,51.07%,9.09%,0.00%, fraction defective by chi-square test, x2=781.23, p=0.000<0.05, fraction defective is statistically significant between different typesof drugs, and comparing between two more groups of two, Chinese traditional medicine (slices) and active pharmaceutical ingredients andother kinds of drugs were statistically significant between； Chinesetraditional medicine material unqualified batch,783is73.87%of thesample is unqualified drugs,2008-2012, fraction defective is in turn50.48%,32.75%,36.09%,42.20%,36.09%.⑥According to the sample isdivided into daily supervision to sample, in the form of three essentialmedicines, unified the basic of proper drugs, real estate, traditionalChinese medicine (slices), the state evaluation sample, to fractiondefective is6.53%,0.28%,1.24%,6.53%,64.39%and2.04%,respectively, by the chi-square test, x2=5654.62, p=0.000<0.05,different sample category, fraction defective is statistically significant andpair wise comparisons between groups, daily supervision to sample threeunified basic drugs, traditional Chinese medicine (slices) material sampleof proper fraction defective and other categories, are statisticallysignificant real estate drugs to sample and the national evaluation sampleis also statistically significant. Three of the unified medicine to sample6036batches, the percent of pass is0.50%.⑦According to the dosageform, divided into tablet, capsule, granule, pill, injection, oral liquid andother dosage forms, its fraction defective is0.27%,1.26%,0.94%,0.27%,0.15%,46.13%,0.44%, fraction defective by chi-square test, x2=4225.89,p=0.000<0.05, the difference between different dosage forms, betweentwo comparison groups, an oral liquid, and other dosage forms arestatistically significant between capsules, pills, granules and tablets werestatistically significant.⑧Involved in the drug inspection standards withthe ministry of health of drug standards, from2008to2012, such as thenational drug standard "Chinese pharmacopoeia"31,"Chinese pharmacopoeia"2005edition and an expanded executed5530times,accounting for43.72%of the total inspection standards, which involved2011drug standards, most of22classes.⑨Inspection items have acharacter, identification and content determination, examination, ashcontent, moisture, etc. including2779full inspection batch, all inspectionrate is21.97%, unqualified batch343, fraction defective is12.25%,unqualified drugs, character, identification, content determination andcheck-the total ash content, extract project unqualified batch is more,unqualified projects accounted for54.88%,16.67%,11.06%,6.75%,11.06%.⑩In2012, Chinese Traditional Medicine special sample of584batches of unqualified423batches, the percent of pass is72.43%.Involving122drugs, unqualified54kinds, fraction defective is44.26%,the whole143batches, full inspection rate of24.49%; There are tenpharmaceutical production enterprise is listed in the drug safetysupervision blacklist, different by sampling unit does not pass rate above50.0%; Aloes and100%Chinese Eaglewood、Spine of Chinese Honeylocust、Ricepaperplant Pith and so on drugs to sample is unqualified, theearthworm, orange and ricepaperplant pith with crud drugs, such as batchnumber, show that the consignment has been in existence before enteringthe circulation field quality problems.Conclusion The quality of drug is in good condition, overall Ningxia, anddrug to sample a very fruitful work. But there are also such as drugmanagement, use the unit, especially in remote areas of monomer retailpharmacies, individual clinic, fraction defective is obviously on the highside; Drug standards too much and not unified, the inspection result can’tform a conclusion; Essential medicines quality condition, traditional Chinese medicine (slices) high fraction defective, its quality is worrying,and a series of problems. To this end, the author combined the actualNingxia, through a series of research, and drug targeted Suggestions toconsummate the Ningxia to sample capacity, enhance the level ofsupervision the basic train of thought.