Adequacy of the cold chain used for the storage of heat-sensitive pharmaceuticals in a department of anaesthesiology

Abstract

Background Anaesthesia frequently involves administration of refrigerated intravenous drugs to patients. Often overlooked, maintenance of the cold chain forms a key component of pharmacovigilance for anaesthetists. However the South African national Department of Health guidelines on: “Cold Chain and Immunisation Operations Manual”, does not detail specific requirements for medically validated cold boxes. Consequently the risk of iatrogenic harm to patients from heat-sensitive pharmaceuticals in inappropriately temperature regulated cold boxes exists. Methods The research design was that of a descriptive, prospective and contextual study. Part I study population comprised the ambient air temperatures of the refrigerator and cold boxes used for storage of heat-sensitive pharmaceuticals in theatre at CHBAH taken at one minute intervals over eight hours. Part II study population was newly purchased cold boxes and cold packs for the purpose of assessing individual cold box thermal performance over eight hours. Results In Part I, only a single cold box (polystyrene box number 19) was able to maintain the recommended temperature range of 2 − 8°C for the eight hour period (4.35%). The refrigerator temperature time plot showed a significant deviation of temperature at approximately 30 minutes. In Part II, only fabric and polystyrene cold boxes with three cold packs in situ were able to maintain the recommended temperature of 2 − 8°C. Conclusion This study highlighted the failure of non-medically validated cold boxes to reliably maintain the temperature of heat-sensitive pharmaceuticals.