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Adherence to Cold-Chain Management Guidelines and Influence on Stability of Live Attenuated Vaccines: Results from an Observational Study in Kisumu County, Kenya.

Moses Olunga Okomo John, Dickens S. Omondi Aduda, Bernard Guyah


Purpose: Guidelines provide ethical frameworks to streamline processes for best outcomes. Live-attenuated vaccines in routine immunization programs in Kenya have challenges of instability despite the availability of guidelines. Diseases preventable by these vaccines are reported in Kisumu County more than others in the region. This observation is suspected to be associated with lapses in adherence to cold-chain management procedures. This study, hence purposed to assess whether there was any association between instability of vaccines and staff adherence level to the guidelines.

Method: Using analytical cross-sectional design with repeated observations, data was collected from 120 out of 170 public and non-governmental health facilities in the Kisumu County at three intervals, between October 2018 and March 2019. In each health facility, immunization manager on duty was interviewed and observations made on compliance with cold-chain protocols using a checklist. Data was summarized descriptively and regression used to identify key points of adherence levels. Qualitative information was analyzed thematically to identify evolving themes.

Result: In 40% of the facilities, staff did not transfer vaccines when the need arose; 8.3% did not defrost fridges; while 45.8% did not dispense vaccines at VVM stage 2. Transferred vaccines accounted for improved stability of both OPV (95%C.I; 3.1 – 16.8, OR 7.2, p value< 0.001) and measles-rubella vaccines (95% C.I, 2.1 – 10.4, OR, 4.7, p=value <0.001). Dispensing vaccines at VVM stage 2 ahead of FEFO had better stability of OPV (95%C.I, 6.0 - 49, OR17.2, p=value <0.001) and measles-rubella vaccines (95%C.I 3.3-17.4; OR7.6, p=value <0.001) respectively. Defrosted fridge enhanced stability of OPV (95% C.I, 1.1 – 15.5; OR 4.17, p=value 0.033), measles-rubella (95% C.I, 1.3 – 12.3, OR 4, p-value 0.0017) and ROTA vaccine (95% C.I 1.9 – 21.5; OR 6.3, p= value 0.003).

Unique contribution to practice and policy: Lapses in transferring vaccines, defrosting of fridges and use of VVM to dispense vaccines significantly destabilized live attenuated vaccines worth linking to the outbreaks of Rota diarrhea and measles outbreaks in Kisumu. Due to inadequate staff adherence level to guidelines, new innovations meant to help improve stability of vaccines, inadequately improved the situation, so calls for strengthened capacity building to staff.

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Cold-chain system; adherence; guidelines; vaccine stability; routine immunization

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