“Cold chain monitoring” has always been an issue in the specialty pharmacy world. The cold chain process in the pharmacy setting refers to maintaining consistent temperatures to ensure pharmaceutical ingredient stability. This starts from the transport of ingredients used in manufacturing a drug to shipping medication to a patient. This can save money for a pharmacy by ensuring that the patient’s medication has not degraded due to either extremely high or low temperatures. This is illustrated by the “Goldilocks principle,” which refers to the temperature of the medication always being in the right range. For example, it might be inadequate to lower temperatures of medications so that it will be the right temperature when it reaches a patient, because the medication may freeze and denature. Rather, the medication must include a way to modulate the temperature during transit.
There may be a trend toward increased PBM scrutiny because many PBMs have their own specialty pharmacies, which provide incentives for these PBMs to scrutinize the actions of independently owned specialty pharmacies. Additionally, there is an expected increase in dispensing biologics in the pharmaceutical industry, and since biologics generally have increased temperature sensitivity cold chain monitoring becomes that much more important. Currently, there are no industry-wide standards or certifications, so this is a prime area for regulation in the future. If you need Standard Operating Procedures to streamline this process, or have any questions related to the cold chain pharmacy, contact Frier Levitt today.
