The Pharmacy and Poisons Board (PPB) has sounded the alarm over widespread mishandling of medical products in Kenya, citing concerns that improper storage and handling are endangering patient safety and compromising the efficacy of health supplies. The board, which serves as the national regulator for pharmaceutical products, has reported a surge in complaints related to the degradation of Health Products and Technologies (HPTs), attributing many of these issues to non-compliance with recommended storage guidelines.
According to PPB Chief Executive Officer Fred Siyoi, the integrity of medicines and other critical health supplies is at risk due to the failure of manufacturers, distributors, healthcare providers, and retailers to maintain appropriate temperature and humidity conditions throughout the supply chain. Siyoi stressed that the entire health sector must prioritize adherence to the manufacturer-specified conditions in order to safeguard public health. The PPB has urged all players involved in the distribution and storage of medical products to strictly follow Good Distribution Practices (GDP) to avoid compromising the quality of these products before they reach patients.
The board has also directed manufacturers to ensure that any medical products intended for the Kenyan market are specifically designed to withstand the country’s climatic conditions, characterized by high temperatures and humidity levels. According to Siyoi, products must undergo rigorous testing during development, including stability studies under conditions classified as ICH Zone IVb, which account for tropical climates like Kenya’s. The results of such studies are critical to confirming that medical products retain their safety, efficacy, and overall quality throughout their shelf life.
Moreover, the PPB has called on marketing authorization holders to adopt more robust packaging solutions that provide adequate protection against environmental factors. These measures are aimed at minimizing the risk of degradation caused by exposure to heat and moisture. Clear labeling of storage instructions on all packaging is also mandated, ensuring that supply chain actors at all levels are well-informed about the specific conditions required for safe storage.
In addition to these technical measures, the board highlighted the need for comprehensive training programs for all stakeholders involved in the handling of medical products. This includes personnel working in warehouses, transportation, pharmacies, and health facilities, with a focus on educating them about the risks associated with temperature-sensitive products and the best practices to mitigate them.
To enforce compliance, the PPB announced that it would conduct regular inspections and audits across the supply chain. Siyoi warned that any entity found to be non-compliant with the new guidelines would face stringent regulatory action. Possible penalties include product recalls, suspension of licenses, and other enforcement measures deemed necessary to protect public health.
The board is urging all players in the healthcare supply chain to act swiftly in aligning their operations with the new requirements. By ensuring that medicines and medical supplies are handled correctly, the country can avoid serious health risks and maintain the effectiveness of its healthcare system. The PPB remains committed to safeguarding the quality of medical products in Kenya and has reiterated its resolve to take decisive action against any violations that threaten patient safety.
