URAC’s Heather Bonome, Director of Pharmacy and Jennifer Richards, Product Development Principal discuss URAC’s approach to cold chain, as well as overall temperature management, standards, which were developed with industry leaders, URAC-accredited pharmacies and other advisors with specific expertise in temperature management.
The new year sparks hope that breakthrough COVID-19 vaccines will slow the worldwide pandemic. However, the logistics of distribution will present some daunting challenges. Some of the first vaccines require cold storage; Pfizer’s solution must be kept in a deep freeze of -70° Celsius. And any misstep along the ‘cold chain’ can be disastrous – improper packaging, storage or shipping can render the drugs ineffective or potentially harmful.
With the FDA fast-tracking COVID-19 vaccination approval, pharmaceutical manufacturers and their distribution partners must keep pace to ensure safe and proper medication administration. URAC’s expertise in setting temperature-management standards provides great insight into the in-depth requirements surrounding vaccine distribution and storage.
URAC has addressed temperature management within its standards since we first launched our specialty and mail service accreditation standards. As pharmacies continue to play a critical role in health care delivery, URAC continues to ensure that any organization receiving the URAC accreditation seal has met the highest standards of temperature management in the United States.
As Jennifer explains in the video, URAC’s first set of standards addressed prescription drug stability and integrity at the pharmacy level and during shipping. In 2015, URAC implemented specific validation requirements for transporting cold chain medications. In 2019, URAC expanded those requirements to address medication delivery and internal storage procedures at all temperature levels. To obtain accreditation, URAC now requires organizations to qualify their product storage and delivery programs through continuous monitoring and testing.
From storage to shipping, URAC helps pharmacies build trust with their patients, ensuring medication distribution practices are safe and effective. These concepts are clearly important in the distribution and storage of the COVID-19 vaccine.
Learn more about URAC’s Pharmacy accreditation programs