Analysis of radioactive occupational hazard and protective measures in iodine-125 seed source manufacturer / 中国职业医学

Objective To analyze the occupational hazards and protective measures for personnel in an iodine-125(125I) seed source production company. Methods In 2022, a 125I seed source production enterprise in Guangdong Province was selected as the research subject. The occupational hazards in the workplace of the research subject was identified using the system engineering analysis method. The FLUAK program based on Monte Carlo method was used to simulate the blocking protection of the production of the 125I seed source, and to estimate the dose of internal and external irradiation of seed source that affected workers. Results The main occupational radiation hazards in the seed production were non-sealed radioactive materials, including external irradiation from X-ray and γ ray and internal irradiation from aerosols formed by iodine volatilization. Estimated maximum dose equivalent rate around the chest and eye lens for workers were 0.52 and 0.02 μSv/h, respectively. The expected annual effective dose for workers in each work site was 0.035 mSv, and the expected annual equivalent dose to the eye lens for all workers in various work sites was 0.001 mSv. The maximum annual equivalent dose of operator's hand was 80.620 mSv. The maximum dose of internal irradiation to the worker was 18.750 mSv, which was caused by the volatilization of nuclides. Conclusion With effective protection measures for internal and external irradiation in place, the annual exposure doses for seed production personnel and operator’s hand are below the national limits. Adequate measures should be taken on hand protection.

Investigation and suggestions on the smoothness of reporting channels for adverse drug reaction of pharmaceutical manufacturers in China based on the public perspective / 中国药房

OBJECTIVE To provide the suggestions for improving t he enthusiasm of the public to report adverse drug reactions （ADRs），promoting pharmaceutical manufacturers to improve the smoothness of ADR reporting channels by the public and the enthusiasm of assuming the main responsibility for drug safety ，and to provide reference for the performance of drug safety supervision by regulatory departments in China. METHODS Taking 180 pharmaceutical manufacturers that had entered the top 1 000 in the world as the objects ，the questionnaire was prepared to investigate the smoothness of ADR reporting channels through 4 channels：contact number ，e-mail，official website and new media （including Wechat and microblog ） of enterprise . The questionnaire involved the establishment of public reporting channels ，the records and the feedback of enterprises. The existing problems were analyzed and suggestions were put forward. RESULTS & CONCLUSIONS More than 70％ of pharmaceutical manufacturers in China had established the channels for reporting ADR by the public ，which were mainly regular channels such as contact numbers and e-mail ，and each channel had the phenomenon that ADR information couldn ’t be reported. More than 60％ of the public channels established by manufactures lacked inquiry and supplement for the miss ing part of th e reported information ； only 24 pharmaceutical manufacturers provided feedback on ADR information ，and the feedback contents were monotonous. gywf2021-11It is suggested that pharmaceutical manufacturers should pay more attention to ADR monitoring among the public ，consider increasing multiple reporting channels while ensuring the smoothness of channels ，strengthen the training of employee ’s information collection ability to improve the quality of information ，timely feed back the ADR information reported by the public ， and increase the feedback content concerned by the public.

Research and Application of Quality Inspection Information System in Medical Device Manufacturers / 中国医疗器械杂志

OBJECTIVE@#To improve the production and inspection efficiency of medical device manufacturers, improve the quality system management level of manufacturers, and ensure the safety and effectiveness of medical devices.@*METHODS@#Sort out the business process of the medical device manufacturer, connect the database of production and ERP system to inspection system, and build the operation software for the quality control department.@*RESULTS@#The system has covered all the products of the manufacturer, and has realized the informatization and visualization of the inspection process.@*CONCLUSIONS@#The research and application of the system can improve the quality management traceability system of medical device manufacturers, and improve the efficiency and accuracy of medical device quality inspection.

Comparative Study on the Current Situation of Pharmacovigilance in Pharmaceutical Manufacturers of Different Scales in Jiangsu Province / 中国药房

OBJECTIVE：To study the current situation of pharmacovigilance work in large ，medium and small-scale pharmaceutical manufacturers in Jiangsu Province ，and to provide reference for the pharmacovigilance development of drug manufacturers with different scales. METHODS ：The situation of pharmacovigilance work in 108 manufacturers in Jiangsu province was investigated through a questionnaire survey and related websites. The pharmacovigilance work （organization，personnel and training，document，computer system ），drug safety monitoring （case report ，regular safety update report ，post-marketing safety research） and drug risk management （signal management ， risk management plan ， risk control measures ， drug safety communication）of different manufacturers were investigated to put forward the suggestions. RESULTS & CONCLUSIONS ：There was no significant difference in the organizational structure （independently established specialized agencies ）among manufacturers of different scales （P＝0.60）. Most of the manufacturers had less than 50％ of the proportion in the independent establishment of specialized institutions for pharmacovigilance. There was significant difference in personnel and training （situation and number of full-time staff in charge ，medical and clinical pharmacy personnel number ），document（formulating training management system ， entrusted management and key monitoring procedures ），computer system （P＜0.05）. There was no difference in the main collection ways of case reports among manufacturers of different scales ；however，the number of independent reports in 2019（P＜ 0.01），the proportion of quality control process for regular safety update reports （P＝0.01），and the proportion of carrying out post-marketing safety research in recent five years （P＜0.01）in large-scale manufacturers were all significantly higher than small- and medium-scale manufacturers. The proportions of large-scale manufacturers （70.00％） and medium-scale manufacturers （84.38％），which considered “lack of technical guidelines ”as an important factor affecting signal management ，were higher than that of small-scale manufacturers （53.57％）（P＝0.01）；the proportions of large-scale manufacturers （60.00％）and medium-scale manufacturers（50.00％），which had carried out risk management plans in the past five years ，were higher than that of small-scale manufacturers（30.36％）（P＝0.04）；the proportion of large-scale manufacturers （50.00％），which adopted the measures in recent 5 year，was higher than medium-scale manufacturers （37.50％）and small-scale manufacturers （25.00％）；the proportions of large-scale manufacturers （70.00％ ） and medium-scale manufacturers （59.38％ ）， which carried out communication for pharmacists，were higher than small-scale manufacturers （32.14％）（P＜0.01）. Large-scale manufacturers outperformed small- and medium-scale manufacturers in terms of pharmacovigilance system ，drug safety monitoring and drug risk management. Large-scale manufacturers had a certain degree of lack of initiative on performing risk management plans ，medium-scale manufacturers on full-time staffs in charge ，and small-scale manufacturers on pharmacovigilance system. So ，it is recommended that large-scale manufacturers take effective control of variety risk as the goal and actively risk management ；medium-scale manufacturers should continuously enhance the awareness of responsibility and improve the investment of resources on pharmacovigilance work ； small-scale manufacturers should pay more attention to improving the pharmacovigilance system and the compliance of specific work.

Analysis of Influential Factors for the Construction of ADR Damage Relief System under MAH System ：Based on the Perspec- tive of Pharmaceutical Manufacturers in Shaanxi Province / 中国药房

OBJECTIVE： To provide reference for constructing ADR damage relief system in China. METHODS： Questionnaire survey was conducted among 217 pharmaceutical manufacturers in Shaanxi province by census method. Fisher’s exact test， Pearson χ2 test and multivariate Logistic regression analysis were used to analyze the factors effecting construction of ADR damage relief systerm unter marketing authorization holder （MAH） system， and the interaction among various factors. RESULTS： A total of 217 drug manufacturers were investigated in this study （217 questionnaires were sent out）. 209 questionnaires were collected and 204 valid questionnaires were screened out with recovery rate of 94.01％. Totally 9 independent influential factors screened by Fisher’s exact test and Pearson χ2 test had a significant impact on the attitude of building ADR damage relief system under MAH system， i.e. the last year’s earnings of enterprises， the proportion of pharmaceutical technicians， whether to set up R&D departments， whether to obtain new drugs/generic drugs in recent 3 years， whether to actively carry out post-marketing safety evaluation of drugs， whether ADR commissioners are familiar with ADR-related policies in MAH system， cognition about whether MAH system promotes the development of pharmaceutical industry， the development direction of enterprises after the full implementation of MAH， cognition about the lack of legal basis for ADR damage relief （P＜0.05）. Multivariate Logistic regression analysis showed that whether the ADR specialist was familiar with the ADR-related policies in MAH system was the main influential factor for constructing ADR damage relief system under the MAH system （P＝0.044）. It was positively correlated with the attitude of approving the construction of ADR damage relief system under MAH system （B＝1.697）. CONCLUSIONS： The pharmaceutical manufacturers， in which ADR specialists who are familiar with the ADR-related policies in the MAH system， are more inclined to agree to constructing ADR damage relief system under  MAH system.

Problem Analysis and Regu latory Countermeasures of Unannounced Inspection and Tracking Inspection of 28 Pharmaceutical Manufacturers / 中国药房

OBJECTIVE： To provide reference for pharmaceutical manufacturers improving the quality system of GMP and drug regulatory departments improving their supervision level. METHODS： Through analyzing and summarizing the problems existing in the 28 pharmaceutical enterprises which had been published on the website in the National Medical Products Administration from February 6th， 2018 to January 25th， 2019， the common problems were found and their causes were analyzed， then the regulatory countermeasures were put forward. RESULTS & CONCLUSIONS： Pharmaceutical enterprises have some problems of inadequate implementation of GMP， such as the inadequate performance of personnel in key positions and the unsatisfactory training effect of relevant personnel， the inconsistency between actual production technology and approved legal technology， the non-standard management of enterprise materials， the incomplete batch production records and the inability to effectively monitor the production cycle. However， there are also some problems in the supervision department， such as the large difference in the scale of inspectors’ on-site inspection， the need to strengthen the inspectors’ inspection ability and level， and the lack of innovation in the means of supervision. It is suggested that pharmaceutical manufacturers should improve the construction of GMP quality management system and strengthen the training of relevant personnel； the regulatory authorities should continue to promote the reform of “release， control and service”， strictly enforce the access conditions of inspectors， strengthen the training of inspectors and ideological construction of the inspector team，further strengthen the construction of supervision system and enhance the innovation of supervision means， so as to jointly maintain the safety， effectiveness and quality controllability of medicines.

Investigation on the influencing factors of low back pain in automobile factory workers / 中国职业医学

OBJECTIVE: To investigate the prevalence and influencing factors of low back pain in workers in automobile manufacturing plants. METHODS: A judgment sampling method was used to select 394 workers with working length ≥1 year in an automobile manufacturing plant as study subjects. A questionnaire survey was conducted to investigate the prevalence of low back pain in these workers using the Nordic Musculoskeletal Disorders Questionnaire. RESULTS: The prevalence of low back pain in these study subjects was 28. 9%( 114/394). The multivariate logistic regression analysis results showed that the relative risk ranked from high to low is as follow: uncomfortable working posture [Odds ratio( OR) =7. 31,95% confidence interval( 95% CI) = 2. 92-18. 28],feeling tired after work( OR = 5. 34,95% CI = 1. 22-23. 32],the commu time more than 30 minutes( OR = 2. 76,95% CI = 1. 38-5. 52),insufficient operating space( OR = 2. 22,95% CI = 1. 28-3. 83),hand or arm frequently used at work( OR = 2. 08,95% CI = 1. 14-3. 78) and age( OR = 2. 00,95% CI = 1. 19-3. 35),that were all risk factors of low back pain( P < 0. 05). CONCLUSION: The frequent use of hand or arm at work,insufficient operating space,uncomfortable working posture,feeling tired after work,and long commute time are the main influencing factors affecting the low back pain of automobile manufacturing workers.

Analysis of Drug Use in 34 Hospitals from Chongqing Area during 2012-2014 / 中国药房

OBJECTIVE:To provide reference for drug production,parchase and use in local governments,health care depart-ment,hospitals,manufacturers and sales enterprises,etc. METHODS:By consumption sum sorting method,the information of 14 categories and key types in 34 hospitals from Chongqing area during 2012-2014 were analyzed statistically such as sales,produc-tion manufacturers. RESULTS:The consumption sum of 34 hospitals from Chongqing area increased by 15%-17% during 2012-2014. The consumption sum and proportion of anti-infective drugs showed a downward trend,decreasing by 3.28%. Those of respi-ratory system drugs and anti-tumor drugs had the largest increase,with increasing rate of 79.01% and 69.39%,respectively. Do-mestic drugs accounted for about 73% market share,and sales of imported drugs increased more than domestic and joint-stock drugs,increasing by 40.17%. Among 6 Chongqing pharmaceutical manufacturers on the top 100 consumption sum shortlist,total consumption sum of 3 manufacturers had increased;the consumption sum of top 10 foreign pharmaceutical manufactures increased year by year. CONCLUSIONS:The consumption sum of drugs is increasing in Chongqing area. Anti-infective drugs accounted for less than 16%,which is the achievements of clinical application of antibiotics special rectification activities for 3 years. Both respi-ratory system disease and malignant tumor have high incidence in Chongqing area. Domestic drugs still are main types in hospital. Foreign manufacturers develop well in China,but Chongqing pharmaceutical manufacturers show unsatisfactory development pros-pect.

Investigation of Drug Manufacturers’Attitude to the National Assessment Programs of Sampling and Testing Policy / 中国药房

OBJECTIVE:To provide reference for improving the national assessment programs of sampling and testing policy. METHODS:Questionnaire was designed to investigate the drug manufacturers’attitude and suggestions to the national assessment programs of sampling and testing policy;SPSS 18.0 software was adopted to analyze the data;a reliability analysis was conducted for the 17 variables in the table;and a principal component analysis was conducted for the topics with strong correlation. RE-SULTS:A total of 340 questionnaires were sent out,314 were effectively received with the effective rate of 92%. the total internal consistency reliability coefficient Alpha was 0.92;the awareness coefficient of enterprise on the evaluation of sampling and testing was 9.78;4.24 enterprises were relatively agree the evaluation of sampling and testing;the attitude coefficient of enterprise on the improvement of evaluation of sampling and testing was 13.39;and the average score of enterprise on the overall satisfaction scoring was 8.73. CONCLUSIONS:The drug enterprises show high overall recognition for the national assessment programs of sampling and testing policy,and willing to cooperate with the development,and hoping the policy can be improved.

Results of the assessment study of GMP implementation level among local pharmaceutical manufacturers / Монголын Анагаах Ухаан

IntroductionCurrently there are 31 pharmaceutical manufacturers in Mongolia. The first standard on Goodmanufacturing practice was adopted in 2005 and during these 9 years the Good manufacturing practicestandard was upgraded twice in 2011 and 2014, and the latest version reached to WHO GMP guidelinelevel.Purpose of the studyAccording to the Law of Medicine and medical devices of Mongolia, all pharmaceutical manufacturersshould comply with the Good manufacturing practice standard MNS 5524:2014. The study was aimedto asses GMP implementation level among local pharmaceutical manufacturers and to define mostlyobserved deficiencies in three categories as “critical”, “major” and “minor”.Materials and MethodAll stable operating pharmaceutical manufacturers were asked to be involved in this study accordingto the Helsinki declaration and 11 of them were involved. Direct observation method was used for thisstudy. WHO guideline on Good manufacturing practice: Main principles and on Sterile products wasused as the criteria of the assessment.ResultsAll deficiencies observed during the study were classified into three groups as critical, major and minorand the frequency was defined.Conclusions:The critical deficiencies are related mainly with the design and general layout of the premises and heatingventilation and air conditioning system. It requires investment and proper planning from the manufacturers.The major deficiencies are mainly related to documentation, qualification and validation.The minor deficiencies are with regard of documentation system, technical requirements of equipmentand storage area condition and its management.For taking corrective actions of major and minor deficiencies do not require investment, but it requirestime, training, implementation, monitoring and continuous improvement from the manufacturer.

Vademecum / vademecum

En este artículo se presenta una revisión de la literatura disponible sobre la farmacología de las diferentes preparaciones farmacéuticas en la oferta de vacunas de Costa Rica. Se identifican las vacunas que están disponibles en la Caja Costarricense de Seguro Social. Se presentan cuadros de registro de las vacunas disponibles en las farmacias de Costa Rica, ordenadas por nombre, indicación y fabricante. En una secuencia de cuadros se presenta en detalle los antígenos y excipientes de las vacunas disponibles en Costa Rica

Market Structure,Manufacturer Behavior and Market Performance of the Pharmaceutical Industry in Hangzhou / 中国药房

OBJECTIVE:To provide references and suggestions for the further development of pharmaceutical industry in Hangzhou city.METHODS:Using the classic normal form of SCP in the industry economics,i.e.market structure-the manufacturer behavior-market performance,a transverse and longitudinal comparative study was carried out on the market structure,the manufacturer behavior and the market performance of the Hangzhou's pharmaceutical industry between 2003 and 2006.RESULTS:Hangzhou's pharmaceutical industry was characterized by oligarch model in concentration degree,low differentiation in products;high barrier of entry and exit;low strength in advertisement,and rational in the merge and recombination.The manufacturers in this area attached increasingly importance to technological progress and the market performance was remarkable.CONCLUSIONS:Considering the status quo of Hangzhou's pharmaceutical industry,it is advisable for the manufacturers enlarge and strengthen their business,enhance its R&D investment and product differentiation,and stick to the market-oriented marketing concept.

Market Analysis of Immunosuppressive Agents in China from 2004 to 2006 / 中国药房

OBJECTIVE: To provide references for clinical rational and safe use of immunosuppressant agents. METHODS: The data regarding the consumption quantity and consumption sum of the immunosuppressant agents were retrieved from "China medical economy information network" ( "menet" ), which were analyzed and compared with the pertinent literature both at home and abroad. RESULTS & CONCLUSIONS: From 2004 to 2006, dominating the first 3 places in respect of consumption quantity and consumption sum were mycophenolate mofetil, ciclosporin, and tarcolimus. And tacrolimus is expected to become the choice drug for organ transplantation.

Management situation and using industrial chemicals at some productive manufacturer in Vietnam

The investigation was performed on employees and workers who contact with chemicals at 9 institutions using various substances in the process of production of paint, rubber, shoe and wood articles in Ha Noi, Hai Phong and Da Nang. Results showed that the current regulations were not complied preserve and use of chemical substance, without emergency equipments available for working staff and environment. A high rate of workers had not been educate on chemical safety and a high rate of work place and facilities had not guideline for using chemical substances.

A Survey of the Consumption of Convenience Foods / 대한지역사회영양학회지

No abstract available.

A Comparison of Hertel Exophthalmometer Measurements Between Various Manufacturer`s Models

To detect differences among the measurements of the Hertel exophthalmometers at different bar sizes and with different anufacturer`s models, exophthalmometries were performed for 27 normal subjects and 24 patients with thyroid ophthalmopathy at the three different bar sizes and with the models of three different manufacturers. The measurements decreased with the decrease of the bar size and increased with the increase of the bar size in all situations. The measurements of three different manufacturer`s models at the same bar size were different from each other. Therefore, Hertel exophthalmometries should be performed at the same bar size and with the same manufacturer`s model to find the exact changes of exophthalmos between repetitious examinations.

Marketing Analysis of Hemostatic Drugs in China from 2006 to 2008 / 中国药房

OBJECTIVE:To evaluate the marketing of hemostatic drugs use in China from 2006 to 2008.METHODS:By reviewing literature both at home and abroad and combining the data of the sales volume and consumption sum of hemostatic drugs from 2006 to 2008 and in the first 3 quarters of 2008 available in the "State Medicine Economy Information Network",the drug variety and manufacturers were analyzed statistically.RESULTS & CONCLUSIONS:Hemopexin assumed a dominate place in the market of hemostatic drugs,accounting for 38% of total in sales value,followed by tranexamic acid and aprotinin.Switzerland Sugao pharmaceutical factory ranked at the first place in terms of sales value of hemostatic drugs.