Affiliation:
1. Regional Centre of Excellence for Vaccines, Immunization and Health Supply Chain Management, College of Medicine and Health Sciences, University of Rwanda
2. Rwanda Food and Drug Authority
3. School of Medicine and Pharmacy, College of Medicine and Health Sciences, University of Rwanda
4. School of Health Sciences, College of Medicine and Health Sciences, University of Rwanda
Abstract
Abstract
Background
A strong health system cannot function without a well-designed, well-operated, and well-maintained supply chain management system. Temperature-sensitive products within the supply chain are products that encompass pharmaceutical goods or products, which, when not stored or transported within predefined environmental conditions and/or within predefined time limits, are degraded and rendered not fully effective. The objective of this study was to evaluate the compliance to the good distribution practices of temperature-sensitive products in Rwanda.
Methods
A cross-sectional study was conducted at a medical supply company in Rwanda and involved 30 staff members managing temperature-sensitive products. The staff came from the Quality Assurance and quality control unit, Warehouse and logistics unit, Sales and marketing unit, Distribution unit, as well as some branch directors. Interviews were conducted and historical data on recorded temperature and humidity levels in storerooms and refrigerators/freezers as well as transit temperature data from representative district branches were collected for a period of three years (2017–2019). All data were analyzed using SPSS version 25. For compliance, temperature and relative humidity were compared with international standards.
Results
It was found that the Standard Operating Procedures were available but not updated to ensure compliance. The scarcity of trained staff was found to be the main factor hindering adherence to standards, hence monitoring of temperature and relative humidity sometimes had loopholes that need to be addressed. This study also discovered that adherence to recommended temperature ranges for the products was compromised by inconsistency in recording and reporting temperature and humidity, and a lack of temperature monitoring tools and qualified equipment.
Conclusions
The study revealed the weaknesses that exist in the process of distribution of temperature-sensitive products at the medical supply company, which mainly, are attributed to paucity of trained staff. Strategic planning for short, medium, and long-term remedies will require that all parties involved in the management of these products work together towards upholding the standard.
Publisher
Research Square Platform LLC
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