Safety Period Of Multidose Parenteral Medication:a Systematic Review

Objective:To evaluate the safety period of multidose parenteral medication and singledose parenteral medication after opening by a systematic review and provide basis for their safe, normative, rational use.Methods:PubMed, EMbase, CBM, CNKI, Wanfang and VIP Database were Retrieved since their foundation to the end of January,2014,to enroll literatures on study on sterility,stability of multidose parenteral medication and singledose parenteral medication after opening. Rev Man 5.2 was employed to conduct Meta analysis.Results:(1) Sixty one literatures of sterility and six literatures of stability were included for multidose parenteral medication and twelve literatures of sterility was included for singdose parenteral medication. (2) A total of 6863 vials were used for multidose parenteral medication,147 of them were contaminated(2.14%).The major sources of contamination were bactiria. (3)Meta analysis of sterility results suggested that multidose parenteral medication for 10d significantly reduced the contamination rate compared with those for 10-30d (RD=-0.07,95%CI=-0.12-0.01,P= 0.02),and more days for multidose parenteral medication,the risk of contamination was more higher.No significant difference was found in contamination rate between different puncture times (RD=-0.07, 95%CI=-0.19-0.06,P=0.30),which was not considerated as the influencing factor for sterility. (4) Aseptic techniques,opened days,temperature, nature of preservatives, properties of drugs, characteristics of storage containers,share drugs were the influencing factors of sterility after opening. (5)Meta analysis of stability results suggested that significant difference was found in content between 1-5d and 5-10d. It showed that the content of 1-5d was significant more higher than 5-10d.(6)A total of 716 vials were used for singledose parenteral medication,146 of them were contaminated(20.39%).(7)Meta analysis of sterility results suggested that no significant difference was found in contamination between≤1d and 1-3d, and singledose parenteral medication for 1-3d significantly reduced the contamination rate compared with those for 3-6d (RD=-0.21,95%CI=-0.34--0.07,P= 0.003),and for 3-6d significantly reduced the contamination rate compared with those for 6-9d (RR=0.46,95%CI=0.22-0.97,P=0.04).It showed that≤3d was more safer than 3-6d or 6-9d.Conclutions:Fllowing aseptic techniques strictly,It suggested that the maximum safety period is 10d for multidose parenteral medication and 3d for singledose parenteral medication.