Analysis of marked items for special population in drug package inserts of antimicrobial agents

Key words: 
• antimicrobial agents /
• package inserts /
• special population /
• investigation and analysis

Abstract: Objective To investigate and analyze the current package inserts of antimicrobial agents and provide references for the further standardization of drug package inserts. Methods A total of 185 package inserts of antimicrobial agents were collected and the marked items of drug use for pregnant and lactating women, paediatric patients, and geriatric patients were analyzed respectively. Results Among the package inserts, most marked items for drug use were found in pregnant and lactating women items, the proportion of which the marked items were still unknown was lower; it had higher proportion that marked items not yet established for drug use for all or part of age (month old, day old) paediatric patients in paediatric use items, and in some drug package inserts which were marked items lackage for drug use for paediatric patients in dosage and administration items, or marked not detailed and standard; moreover there was higher proportion of labeling as to dosage and administration in geriatric use items. Conclusion It was necessary to improve the drug package inserts continually so as to ensure the drug use safety.