1.Study on the present situation of narcotic drugs equipment and management in 251 primary healthcare institutions from Qiandongnan prefecture
Jinxingyi WANG ; Hanshuai HU ; Yang LIU ; Jie XIA ; Zhenzhu ZHANG ; Minzhen HAN
China Pharmacy 2023;34(13):1642-1645
OBJECTIVE To investigate the present equipment and management situation of narcotic drugs in primary healthcare institutions from Qiandongnan prefecture of Guizhou province. METHODS The questionnaire survey was conducted among pharmacy department heads and medical staff from primary healthcare institutions in Qiandongnan prefecture of Guizhou province. Descriptive statistical analysis was conducted on the survey results. RESULTS Of 251 healthcare institutions in this survey, 29 healthcare institutions were equipped with narcotic drugs, accounting for 11.55%. The reasons for the narcotic drugs unequipped were mainly as follows: insufficient attention, no storage conditions for narcotic drugs, complex program of narcotic drug management, small amount usage and so on. Among the 29 primary healthcare institutions equipped with narcotic drugs, all of them did not monitor patient usage, accounting for 100%; 29 healthcare institutions did not implement a return visit or follow-up every 3 months, accounting for 100%. CONCLUSIONS The health administration departments should strengthen the administration of narcotic drugs in primary healthcare institutions. At the same time, training on standardized management and clinical rational application of narcotic drugs for medical staff in primary healthcare institutions should be enhanced by the health administrative department.
2.Signal mining and analysis of adverse drug events for gilteritinib
Yang LIU ; Minzhen HAN ; Jie XIA ; Hanshuai HU ; Lei YAO ; Xue LAN ; Qian LIU ; Jinxingyi WANG
China Pharmacy 2024;35(15):1888-1892
OBJECTIVE To mine the adverse drug events (ADE) signals for gilteritinib, and provide a reference for safe drug use in clinic. METHODS ADE reports with gilteritinib as the primary suspected drug were extracted from the FDA Adverse Event Reporting System (FAERS) database from February 1st, 2018 to December 31st, 2023. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) were applied to detect the risk signals from the data in the FAERS database. The classification and statistics of collected signal data were conducted by using the preferred term (PT) and systemic organ class (SOC) in ADE terminology set of the Medical Dictionary for Regulatory Activities (24.1 edition). RESULTS Totally, 2 755 gilteritinib-related ADE reports were collected from the database, involving 676 ADE signals (95 positive signals), 313 PTs and 25 SOCs. Among them, nine signals were not recorded in the package insert. The top 5 PTs consisted of abnormal liver function, decreased platelet count, febrile neutropenia, pneumonia and myelosuppression. The top 6 SOCs for positive signal counts were examinations, general disorders and administration site conditions, respiratory, thoracic and mediastinal disorders, infections and infestations, heart organ disorders, and nervous system disorders. ADEs not recorded in the drug package insert included pneumonia, myelosuppression, decreased blood cell count, sepsis, hemorrhage, infection (not specifically referred to), septic shock, respiratory failure, and aspergillosis. CONCLUSIONS In addition to paying attention to common ADEs such as liver dysfunction and thrombocytopenia, it is necessary to monitor ADEs with strong signals that are not mentioned in the drug instructions when using gefitinib, such as pneumonia, bone marrow suppression, cytopenia, sepsis, bleeding, infection (not specifically referred to), septic shock, respiratory failure, Aspergillus infection, elevated serum creatinine and interstitial lung disease.