Vulnerabilities and risk management in the multimodal importation of pharmaceutical products under cold chain conditions in Honduras

Resumen

The pharmaceutical cold chain is a critical component for preserving the quality, safety, and efficacy of thermosensitive medicines throughout importation and distribution processes. In Honduras, strong dependence on the international market, together with limitations in specialized infrastructure, thermal monitoring, and standardized logistical procedures, has created significant vulnerabilities that increase both health and economic risks. This study aimed to analyze the operational practices, risks, and vulnerabilities associated with the multimodal importation, air, maritime, and land, of pharmaceutical products under cold chain conditions in Honduras, in order to identify gaps in relation to international standards such as Good Distribution Practices and applicable ISO standards. A qualitative, exploratory, and descriptive research approach was adopted. Data were collected through semi-structured interviews with key stakeholders involved in pharmaceutical logistics, including personnel responsible for importation, logistics, storage, and quality assurance. The study population consisted of 36 importing companies identified from official records, from which a non-probabilistic convenience sample of 16 importers was selected. Qualitative content analysis was used to examine the data. The findings indicate that logistical decisions are largely based on empirical criteria, such as cost and prior experience, with limited use of advanced thermal control systems and low levels of procedural standardization. Customs delays, international transshipment points, and transfer facilities were identified as critical stages, where more than 70% of importers reported recent temperature deviations, resulting in significant economic losses. The study concludes that strengthening thermal controls, traceability, and alignment with international standards is essential to mitigate risks in pharmaceutical importation in Honduras.