Over the past few years, I have had the opportunity to connect with some key experts in the field of medication temperature management. We have created a “core foursome” of collaborators who want to bring forward quality practices for appropriate temperature management of medications. The group includes:

• Rafik Bishara, PhD, officially “retired,” he serves as the current Chair of the Pharmaceutical Cold Chain Interest Group (PCCIG), USA Branch within the Parenteral Drug Association (PDA); serves on expert panels for the World Health Organization (WHO) and United States Pharmacopeia (USP); and is a member of URAC’s Pharmacy Advisory Council.
• Desmond Hunt, PhD, Principal Scientific Liaison with the United States Pharmacopeia (USP) who works with the Expert Committees on Physical Analysis, Dosage Forms, Packaging, Storage, and Distribution. 
• Mark Maurice, Professional Services Senior Project Manager- Industrial Engineer with Sensitech Inc., a world leader in supply chain visibility that offers products and services that maintain the quality, integrity, and security of products throughout the supply chain. 
• Me 😊

On March 13, Desmond invited Rafik, Mark and I to present to the USP Packaging and Distribution Expert Committee at the United States Pharmacopeia (USP) headquarters in Rockville, MD. The USP is a non-profit, non-government standards setting organization established in 1820. They set public quality standards for prescription and over-the-counter medicines, dietary supplements and food ingredients. Their standards are recognized worldwide and used by state and international governments to promote the quality of medications. They have over 800 external experts in health and science from governments, non-profits, and academia that serve on their twenty-four (24) expert committees. Much like URAC, when the USP recognizes a public health need, they use their expert committees to draft standards that are then reviewed by public comment. The standards are then reviewed, approved and published.  URAC has long recognized USP standards within our pharmacy programs. For example, our pharmacy compounding standard requires compliance with current USP guidelines.

The USP Packaging and Distribution Expert Committee is responsible for developing new and revising existing general chapters related to packaging (container-closure systems), storage, and distribution of pharmaceutical ingredients or dosage forms. This includes chapters <659> and <1079> on Good Storage and Distribution Practices which are key to pharmacy practice. Our presentation, “How Trends in Specialty Pharmacy Impact Medication Handling, Storage, and Distribution” gave me the opportunity to educate the group on specialty pharmacy trends and the importance of accreditation in this space. Mark provided real life case studies of specialty pharmacy temperature management testing, and Rafik tied it all together emphasizing the opportunity for continued collaboration between URAC and the USP.   

There was robust conversation during and following the presentation about the importance of educating pharmacists on good temperature management practices for all medications – not just for specialty drugs or just “cold chain” medications (i.e., those requiring refrigeration), but for all medications. I shared that we are currently revising our Specialty Pharmacy and Mail Service Pharmacy standards and based on input from our “core foursome” have already drafted proposed updates to the temperature management requirements within our standards to bring them in line with current practices and USP guidelines. We discussed other tools that the USP could create to help pharmacists understand and implement USP standards into their practice. Desmond has asked that URAC continue to let him know when we see opportunities where the USP and URAC can work together to promote medication safety.