Optimization of on-site supervision strategy based on big data of quality risk in drug enterprises / 中国药房

On-site supervision is a risk-based regulatory system that requires the scientific development of supervision plans for quality risks and hidden dangers in pharmaceutical enterprises， the rational allocation of supervision resources based on their risk levels， and the implementation of classified supervision measures. In this study， the quality risk monitoring business support system is set up for pharmaceutical enterprises by establishing the quality risk expert database and quality risk monitoring index system for pharmaceutical enterprises based on the difficulty analysis of on-site drug supervision. Based on this support system， the quality risk classification method， the differentiated spot check strategy and business auxiliary visualization system are established. This support system is used to learn the risk level of pharmaceutical enterprises， so as to innovate supervision methods and optimize monitoring strategies. Taking Jiangxi Province as an example， it is verified that the support system can guide the risk assessment of sample enterprises， can improve the targeting of on-site drug supervision in the process of technical review， scheme editing， on-site implementation and comprehensive evaluation， and can effectively improve the quality and efficiency of supervision.

HPV vaccination in the vaccination clinic of Shaanxi Provincial Center for Disease Control and Prevention / 公共卫生与预防医学

Objective To understand the HPV vaccination situation in the vaccination clinic of Shaanxi Provincial Center for Disease Control and Prevention, and to guide the rational use of the vaccine. Methods The vaccination information and the information on HPV vaccine inoculated subjects in the clinic of Shaanxi Provincial Center for Disease Control and Prevention from 2018 to 2019 were analyzed. Results A total of 5 714 HPV vaccination subjects were analyzed, among which the largest proportion (48.97%) was in the 20-26.5 years old group, and the smallest proportion (1.12%) was in the 9-15 years old group. The 9-valent HPV vaccination accounted for 98.72% of the 20-26.5-year-old group. There were statistically significant differences in the distribution of vaccination populations between the bivalent and quadrivalent HPV vaccines (P＜0.01，χ2=252.85), and between the bivalent and 9-valent HPV vaccines (P＜0.01，χ2=258.15). The vaccination rate of the bivalent HPV vaccine was 88.25% (894/1 013), and the vaccination rate of the quadrivalent HPV vaccine was 94.43% (1 915/2 028). The difference was statistically significant (Z=-2.02, P=0.043). Conclusion Vaccination subjects tend to choose high-valent HPV vaccines, and the proportion of HPV vaccination in the younger age group is seriously insufficient. Both bivalent and quadrivalent HPV vaccines have relatively high overall vaccination rates. The next step should be to strengthen the vaccination publicity for younger age groups.