Thực trạng triển khai pha chế tập trung thuốc kháng sinh cho trẻ sơ sinh tại Bệnh viện Phụ sản Trung ương

The safe and precise preparation of sterile medications is paramount in hospital pharmacy, especially when tailored dosages or formulations are required for specific patient populations. Any compounding error, particularly for intravenous preparations, carries a significant risk of adverse events, including life-threatening infections. This risk is profoundly elevated in vulnerable groups such as neonates, who often require specialized intravenous antibiotics. The National Hospital of Obstetrics and Gynecology, a prominent center for neonatal care, established a centralized compounding room to meet these critical needs. However, a detailed evaluation of its operational model, environmental conditions, and personnel adherence to standard procedures remained unassessed. This study addresses this gap by examining the facility's infrastructure, human resources, environmental quality control, and pharmacists' compliance with aseptic technique guidelines, ultimately aiming to enhance the safety and quality of preparations for neonates.

Dược sĩ lâm sàng, quản lý bệnh viện, chuyên gia kiểm soát nhiễm khuẩn, và nhà nghiên cứu trong lĩnh vực pha chế thuốc vô trùng cho trẻ sơ sinh.

This study aimed to evaluate the implementation of a sterile antibiotic compounding model specifically for neonates at the National Hospital of Obstetrics and Gynecology. Employing a mixed-method approach, the research involved retrospective data review combined with prospective observation. The assessment of the compounding room's physical infrastructure and environmental quality control was conducted against the stringent standards outlined in Chapter <797> of the United States Pharmacopeia (USP 797, 2024), "Pharmaceutical Compounding - Sterile Preparations." Furthermore, the adherence of pharmacists and compounding personnel to established Standard Operating Procedures (SOPs) was meticulously evaluated through 16 randomly conducted observations. Results indicated that the compounding facility generally complied with most USP <797> standards for infrastructure and air quality. However, significant challenges were identified, particularly concerning environmental control, where humidity levels frequently exceeded the recommended 60%, creating an environment conducive to microbial growth. Opportunistic pathogens such as Staphylococcus aureus and Staphylococcus epidermidis were occasionally detected on surfaces, posing a potential risk of contamination to sterile preparations intended for vulnerable neonates. While most procedures followed SOPs, compliance was incomplete in several critical steps, including mask-wearing (87%), head covering (81%), and disinfection protocols before handling medications (89%). These findings underscore the importance of consistent aseptic technique. In conclusion, while the facility meets many international standards for infrastructure and sterile conditions, there is a clear need for continuous improvement. This includes enhancing environmental control, implementing regular and robust staff training programs on aseptic technique, and ensuring strict supervision to bolster adherence to SOPs. Revisiting and updating SOPs to align with the latest international guidelines is also crucial. These measures are essential to further enhance the safety and quality of compounded sterile preparations and mitigate infection risks for neonates. The study’s implications highlight the ongoing need for rigorous quality assurance in pharmaceutical compounding.