Risk analysis and suggestions of 570 drug wholesale enterprises in Hunan province / 中国药房

OBJECTIVE To provi de reference for standardizing the distribution behavior of drug wholesale enterprises and improving the supervision level of drug supervision departments. METHODS The defective items found in the on-site inspection of 570 drug wholesale enterprises in Hunan province in 2020 were summarized ，the main risks were analyzed to put forward countermeasures and suggestions. RESULTS & CONCLUSIONS The provincial drug regulatory departments conducted daily supervision and inspection among 192 drug wholesale enterprises ，of which 168 enterprises（87.50％）were ordered to make corrections；a total of 1 804 defective items were found ，involving 11 serious defects ，806 major defects and 987 general defects. The provincial drug regulatory departments conducted special inspections among 20 wholesale enterprises of narcotic drugs and psychotropic drugs ，of which 18 enterprises（90.00％）were ordered to make corrections ；a total of 48 defective items were found ， involving 33 major defects and 15 general defects ，and no serious defective items were found. The drug regulatory departments of all cities （autonomous prefectures ）inspected 358 drug wholesale enterprises ，of which 290 enterprises（81.00％）were ordered to make corrections ；a total of 1 499 defective items were found ，including 665 main defects and 834 general defects ，and no serious defective items were found. According to the statistics of occurrence frequency ，defective items of drug wholesale enterprises in Hunan province were mainly concentrated in storage and maintenance （687 items，20.50％），facilities and equipments （608 items， 18.14％），personnel and training （579 items，17.28％），receipt and acceptance （272 items，8.12％）and quality management system documents （260 items，7.76％），which together accounted for 71.80％ of the total defects. The main risks of drug wholesale enterprises included weak enterprise risk awareness ，high frequency of quality risks in drug marketing ，imperfect enterprise quality management system documents ，and fraud in enterprise business behavior. It is recommended that drug wholesale enterprises should establish quality risk management institutions ，evaluation standards and management systems ，improve the operation quality management system ，strengthen the management of drug storage ，standardize the operation and management of enterprises，strengthen personnel training and standardize procurement behavior ，so as to j ointly maintain the safety and efficacy of drugs and controllable quality.

Determination of Residual Formaldehyde in EDTA-2Na by Headspace Gas Chromatography / 中国药师

Objective:To establish a headspace GC method for the determination of residual formaldehyde in EDTA-2Na. Meth-ods:A headspace GC was used to separate the residual solvents on an Agilent DB-WAX (30 m×0.32 mm,0.5 μm) capillary col-umn with an FID detector. The carrier gas was nitrogen at the flow rate of 1.0 ml·min-1. The temperature of the injector was 230 ℃and that of the FID was 260 ℃. The programmed column temperature was set as follows: maintained at 40 ℃ for 6 min, and then raised to 230 ℃ at the rate of 40 ℃·min-1and maintained for 10 min. The injection volume was 1μl with the split ratio of 2:1. The reference solvent and sample were filled into the containers of headspace injector and the containers were in equilibrium at 95℃ for 25 min. The amount of residual formaldehyde was calculated by an external standard method.Results:There was a good linear relationship of formaldehyde reference solvent within the concentration range of 5.10-102.00 μg·ml-1(r=0.999 7). The average recovery was 84.60%(RSD=3.82%,n=9). Conclusion: The method is simple,rapid and accurate for the determination of residual formalde-hyde in EDTA-2Na.

Identification of Enterovirus C105 for the first time in New Zealand

In this report we describe a new approach in HIV sentinel surveillance that was piloted in Viet Nam in 2009 and is currently being rolled out in all provinces. It comprises a brief behavioural questionnaire added to the HIV sentinel surveillance surveys conducted routinely among people who inject drugs, female sex workers and men who have sex with men. Timely reporting of data from this system has resulted in improvements to HIV prevention efforts for most at-risk populations.