Many of the high-cost, complex therapies dispensed by specialty pharmacies have specific temperature range requirements. There is a lot a stake when it comes to proper cold chain management of medications. (Cold chain refers to the management of temperature-sensitive products as they move through the supply chain from the manufacturer to the end user, the patient.) 

If the drug is not maintained within the appropriate temperature range during all phases of the manufacturing, distribution, dispensing, and shipping processes, the medication could become ineffective. The potential consequences of such a temperature excursion range from a subtherapeutic benefit for the patient and unnecessary changes in therapy if the prescriber is not aware why the medication did not work to the potential for very serious adverse events.

Last year, URAC had the opportunity to invite a distinguished expert in medication temperature management to join our standing Pharmacy Advisory Council. Rafik Bishara, PhD has become one of the most respected figures in the pharmaceutical supply chain distribution sector, following a distinguished 35 year career with Eli Lilly & Co. as Director, Quality Knowledge Management and Technical Support where he was responsible for Quality Knowledge Management, Global Compendial Affairs, Stability and Distribution Excellence, Global Product Protection, Special Security Substances and Controlled Substances Administration. Now retired from Eli Lilly, Dr. Bishara remains a sought after expert often traveling internationally for speaking engagements and currently serving on expert panels for the World Health Organization (WHO) and United States Pharmacopeia (USP).

In May, Rafik spent an hour with the URAC Pharmacy Review team to provide a foundational training on pharmaceutical temperature management. He presented some key definitions and covered the different references, guidelines, and regulations that impact the drug supply chain. He provided an overview on the selection of packaging products for shipping, chamber testing, and the different kinds of indicators that are used to track temperature during shipping. 

The URAC Specialty Pharmacy and Mail Service Pharmacy programs have standards that require pharmacies to maintain proper temperature management for medications, including a standard that was new with the most recent revision of these programs requiring validation of the pharmacy’s cold chain shipping processes. The URAC Pharmacy Reviewers often find themselves educating pharmacies and answering questions about validation of cold chain processes. At the end of the training, one Reviewer remarked that there was a lot of good information presented in the training. The team will be more confident when educating Applicants about URAC’s standards pertaining to temperature management.