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Quality of In-Use Insulin Under Real-World Storage Conditions in Mwanza, Tanzania
Emmanuel Kimaro1, Eveline T Konje2, Benson R Kidenya3
1Department of Pharmaceutics and Pharmacy Practice, School of Pharmacy, Catholic University of Health and Allied Sciences (CUHAS), Mwanza, Tanzania.
Journal of Diabetes Science and Technology
|July 1, 2026
Summary
Substandard insulin is a significant problem in Tanzania, with nearly half of patients using compromised medication. Even when stored correctly, insulin potency can be reduced, impacting diabetes management.
Area of Science:
- Endocrinology
- Pharmaceutical Science
- Public Health
Background:
- Insulin stability is critical for diabetes management, but storage conditions, especially in regions with unreliable refrigeration like Tanzania, can compromise its potency.
- Previous research indicates mixed findings on factors contributing to insulin degradation, including temperature fluctuations and formulation issues.
- This study specifically investigated the impact of storage conditions on insulin content during patient use at Bugando Medical Centre (BMC).
Purpose of the Study:
- To assess the quality and active insulin content of insulin batches used by diabetic patients at BMC.
- To evaluate the impact of real-world storage conditions on insulin potency in a developing country context.
- To identify the prevalence of substandard insulin among diabetic patients in Mwanza, Tanzania.
Main Methods:
- A cross-sectional study was conducted from April to July 2024 in Mwanza, Tanzania.
- 16 insulin batches from 48 diabetic patients were analyzed for physical appearance, identity, and concentration using high-performance liquid chromatography (HPLC).
- Storage conditions were monitored using Bluetooth temperature data loggers.
Main Results:
- 43.8% of insulin batches had low active insulin content, and 25% contained no active insulin.
- 50% of the 48 sampled patients were using substandard insulin.
- Among patients using multiple vials, a significant proportion had at least one vial failing to meet specifications.
Conclusions:
- Despite patients storing insulin within recommended temperature ranges, a substantial number of samples were substandard, failing to meet specifications.
- Over 40% of analyzed insulin batches did not meet required standards, indicating a critical issue with insulin quality in the region.
- The findings highlight the need for improved quality control and distribution systems to ensure effective diabetes management in developing countries.
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