The role of mediation in solving medical disputes in China.

BACKGROUND: Medical litigation represents a growing cost to healthcare systems. Mediation, arbitration, and other alternative dispute resolution (ADR) methods are increasingly used to help solve the disputes and improve healthcare satisfaction. In China, the increasing number of medical disputes has contributed to concern for the safety of physicians and mistrust between physician and patients resulting in ADR processes being established in several provinces in recent years. Our aim was to describe and explain the impact of this new mediation process in the Chinese healthcare system. METHODS: Our study investigated mediation practices in China using case-level data from 5614 mediation records in Guangdong Province between 2013 and 2015. We investigated how the resolution success as well as the compensations are associated with the case characteristics using regression analysis. RESULTS: Among the cases analyzed, 1995 (41%) were solved with agreement through mediation, 1030 were closed by reconciliation, 559 were closed by referring to court and 1017 cases were withdrawn after mediation. Five hundred five Yinao cases were solved with the help of mediators on the spot. We find that mediation solved about 90% of medical disputes under present mechanisms, while more police support is needed to cope with Yinao. The average compensation of mediation is CNY60,200 and average length of mediation is 87 days. Longer time taken to reach resolution and more money claimed by patients are associated with lower resolution success rate (p < 0.01) and higher compensation levels (p < 0.01). CONCLUSION: Our results show the performance of mediation mechanisms in China to help solve medical disputes. ADR plays a role in reducing the need for initiating litigation and may ultimately increase satisfaction with the healthcare system.

[Mechanism of "unification of drugs and excipients" for Chinese medicine semi-extract based on powder compression behavior analysis].

In this paper, five representative Chinese herbal decoction pieces of Scutellariae Radix, Paeoniae Radix Alba, vinegar-processed Corydalis Rhizoma, Polygoni Multiflori Radix Praeparata and Lonicerae Japonicae Flos were selected to prepare the corresponding fine powder of pieces, extract powder, semi-extract powder and physical mixed powder. The physical properties of 20 kinds of powders, such as related parameters of particle size, density, stability and flowability, were evaluated comprehensively. The compression curves of powder porosity and tensile strength changing with pressure were plotted, and the Heckel equation and the Kawakita equation were used to describe the powder compression behavior. The results showed that compared with the fine powder of pieces, the compressibility of the semi-extract powder and the extract powder was significantly improved. Compared with the extract powder, the particle size and relative uniformity of the semi-extract powder were increased, indicating that the uniformity of the powder was improved. Besides, the semi-extract powder could reduce the hygroscopicity of the powder. Particularly, the semi-extract powder of Scutellariae Radix, Paeoniae Radix Alba and vinegar-processed Corydalis Rhizoma could maintain the porous structure of the tablet even under a high tableting pressure, which was beneficial to tablet disintegration. For some traditional Chinese medicines(such as Lonicerae Japonicae Flos), the semi-extract powder could reduce the viscosity, which avoided the sticking in the die compression. The semi-extract powder and the physical mixture powder prepared by the same Chinese herbal decoction pieces had similar physical properties and compression behaviors. Principal component analysis(PCA) was carried out on the 17 physical attributes and 5 compression parameters of the powder. It was found that the first principal component mainly reflected the differences among the material sources, while the second principal component could reflect the differences among fine powder of pieces, extract powder, semi-extract powder and physical mixed powder originating from the same Chinese herbal decoction pieces. In this paper, the mechanism of "unification of drugs and excipients" of Chinese medicine semi-extract powder was explained in terms of physical properties and compression behavior of powders, which provided reference for the formulation design and process development of Chinese medicine tablets.

Effect of Spray Drying Conditions on Physical Properties of Panax notoginseng Saponin (PNS) Powder and the Intra-Batch Dissolution Variability of PNS Hydrophilic Matrix Tablet.

PURPOSE: Understanding raw material variability and its impact on product quality are crucial for developing robust pharmaceutical processes. This work aimed to study the effects of spray drying conditions on properties of the spray dried Panax notoginseng saponin (PNS) powders as well as the subsequent intra-batch dissolution variability of PNS hydrophilic matrix tablets. METHODS: The Plackett-Burman design was applied to screen the critical process parameters (CPPs). Then, the Box-Behnken design was used to investigate the relationship between the CPPs and the physiochemical properties of spray dried PNS powders. The PNS hydrophilic matrix tablets containing 57% spray dried PNS powders were directly compressed. The partial least squares (PLS) regression was used to uncover the hidden multivariate relationships among the CPPs, intermediate powder properties, and tablet quality attributes. RESULTS: The identified CPPs were the feed concentration, the inlet air temperature, and the atomization pressure. It was found that the CPPs exerted little impact on chemical properties of spray dried PNS powders, but had significant impact on physical properties, such as particle size, specific surface area, bulk density, hygroscopicity, and inter-particle porosity, etc. Latent variable modeling results revealed that the high inlet air temperature of spray drying process could produce PNS powders with low moisture content and high hygroscopicity, which were beneficial to reduce the intra-batch dissolution variability of PNS hydrophilic matrix tablets. Finally, a design space of the spray drying process was built in order to ensure the dissolution consistency. CONCLUSION: Our research provided a reference for improving the spray drying conditions in order to ensure the dissolution consistency of the PNS hydrophilic matrix tablet.