The introduction to and inspiration from FDA Guidance: alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical / 中国输血杂志

U.S. Food and Drug Administration recently issued a guidance on alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical. It was allowed to use platelets stored at 1 ℃ to 6 ℃, with a storage period of up to 14 days from the date of collection.The validation and quality monitoring of platelet manufacture retained pH items testing at the end of the storage, and platelet count and actual plasma volume testing items were not required. The guidance provided the recommendations and considerations for the manufacture, labeling, storage, transportation, bacterial contamination control, process validation, and quality monitoring sampling of cold-stored platelets, as well as the further research needs for its efficacy, particularly when conventional platelets are available and their use is practical. The scientific and regulatory considerations on cold-stored platelets in the guidance would be informative and instructive to the development of blood regulation and standards related with urgent transfusion in China.

Risk Management of Rabies Vaccine and Rational Medication / 中国药房

OBJECTIVE:To explore how to establish good procedure,system and mode of drug management,dispensing and application,in order to provide reference for risk management and rational use of rabies vaccine. METHODS:The use of rabies vaccine and storage temperature monitoring in our hospital during 2013-2014 were analyzed statistically,and risk management and use of rabies vaccine in our hospital were analyzed,and management measures and attentions were put forward. RESULTS:The amount of vaccinum rabiel (Vero cell) and human rabies immunoglobulin in our hospital were increased in 2014,compared to 2013. The position labeled with #1 in storehouse and that of labeled with #1 and #2 in dispensing store could meet the storage condi-tion of rabies vaccine. Risk management could be carried out in fields of drug requisition,cold chain management,drug manage-ment and drug dispensing. ADR should be paid attention. CONCLUSIONS:It is of significance to develop risk management and ra-tional medication guidance of rabies vaccine.