Evaluation of vaccines cold chain monitoring during distribution from litha vaccines to the medical depots in Gauteng
Mosai, Princess Mmaphuti
An uninterrupted cold chain is very important in maintaining the quality and the potency of vaccines. The aim of this study was to assess if the cold chain is maintained at 2°C-8°C during vaccine distribution from Litha Vaccines® to the different depots in the Gauteng Province in RSA. To establish if Litha Vaccines® has a secure cold chain and was not exposing the vaccines to the risk of compromised quality and efficacy. The vaccines were dispatched from Litha with 2 CCM cards, 2 FW’s and 1 data logger per shipper. These were dispatched to the 4 different depots in Gauteng. Two sites declined to participate in the study. The receiving manager at the depot completed the questionnaire which was designed for the purposes of this study to collate important information on the shipment. The temperature data was downloaded from the data logger at Litha after the delivery of the vaccines to assess the temperature recordings for the particular shipment. Of the 186 CCM cards analysed, none had a colour change. All the 186 Freeze watches were intact. This confirmed that the vaccines were not exposed to undesirable storage conditions during transportation to the depots. The total number of data loggers evaluated was 86. The maximum temperatures of all the loggers were constant between 5°C-9°C whereas the minimum temperatures were between 2°C-8°C. Eighty seven percent of all the readings were within the recommended temperature range of 2°C-8°C. The integrity and the quality of the vaccines were not compromised. The study found that although the results were satisfactory there is still a lot of room for improvement. Cold chain monitoring studies such as this one need to be conducted frequently and in different points of the vaccine distribution channel including the storage facilities and the immunization points. Failure to monitor the cold chain all the way means that efforts to maintain the cold chain might be futile since the end user might still receive a vaccine that has lost its potency along the distribution channel. It is crucial to emphasize the importance of continuous staff training on proper vaccine handling and the need for evaluation of vaccine monitoring processes. The managers need to ensure that there are clear guidelines and vaccine handling standard operating procedures (SOP’s) on cold chain maintenance and staff training informed by the Good Distribution Practices. Due to the effects of climate change and global warming, the study might need to be validated for the hotter summer months.
A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfilment of the requirements for the degree of Master of Science in Medicine, Pharmaceutical Affairs Johannesburg, 2016