Mean kinetic temperature evaluations through simulated temperature excursions and risk assessment with oral dosage usage for health programs.

Background: Temperature excursions occur during the transport and storage of pharmaceuticals, and often result in considerable losses for public health programs operating in countries with limited resources. After a temperature excursion has been identified, often products are discarded without any additional risk assessments. Consulting the manufacturer is the preferred approach but can be challenging depending on the responsiveness of the manufacturer. However, decisions are often required quickly depending on program needs and available stock in country.

Methods: To provide further guidance, simulations have been conducted based on mean kinetic temperature evaluations using accepted default kinetic parameters to assess loss of shelf-life for scenarios involving various levels of temperature excursions on a model pharmaceutical at different recommended storage conditions, shelf-life, and long-term storage conditions.

Results: Although an immediate loss to shelf-life occurred with excursions when the product was stored at the maximum allowed temperature, more extended excursion could be withstood before loss of shelf-life was detected when long-term storage was maintained at temperatures below the maximum storage condition for the product. With the assumption that a shelf-life loss of 2 weeks was negligible when managing program stock, a risk assessment was conducted to outline the various times that excursions at different temperatures could be considered low risk to the program.

Conclusions: Depending on the level of the temperature excursion and the guidance provided by the manufacturer, public health programs will have further information with this assessment to guide decisions that impact safety to the end user and resource management due to temperature excursions that can occur.