A Case for Expanding Thermochromic Vial Monitor Technology to Insulin and Other Biologics

Abstract

Insulin quality and efficacy determine glycemic control, which determines quality of life for people with diabetes. Insulin efficacy is reduced by heat exposure, especially in tropical climates, remote areas, and with improper handling. Insulin doses can be adjusted based on blood glucose monitoring, which may compensate for lack of viability. However, a measured response may be difficult with other biopharmaceuticals. Thermochromic vial monitor technology developed for oral polio vaccines (vaccine vial monitors) is an inexpensive, easily available, visible modality which can be used for insulin and other biopharmaceuticals to detect excessive heat exposure and thus reduced potency at any point in the cold-chain, till the end-users, thus improving patient care. Regulatory authorities must urgently consider the need to impose mandatory use of this technology for all biopharmaceuticals, including insulin, to ensure efficacy till end usage.