Meeting accreditation standards in the temperature-sensitive distribution process requires careful monitoring.
Gone are the days of simply placing a temperature-controlled product from the freezer into a box with a frozen gel pack and shipping it to some far-flung destination.
Such haphazard practices, which can put the efficacy of high-cost specialty drugs at risk, lack the careful controls needed to protect the drugs and that meet current specialty pharmacy accreditation standards for temperature management. In the session, “Improving Your Direct to Patient Temperature Sensitive Distribution Process to Meet Accreditation Standards” at the Asembia Specialty Pharmacy Summit 2017, an expert panel discussed the need for an evolution in the current paradigm that surrounds cold chain management, which seeks to ensure a constant temperature between 2°C and 8°C.
“I want you to depart from cold chain. I want you to think temperature control,” said panelist Rafik Bishara, PhD, a technical advisor in the pharmaceutical supply chain distribution sector. “The cold chain addresses frozen and refrigerated products. [United States Pharmacopeia] and the government are also asking you to know ambient temperature and control room temperature.”
Bishara noted that the farther a product travels, the less control a manufacturer has over it. As such, a collaborative partnership throughout the distribution chain is vital to prevent hot or cold excursions in the shipping process.
Additionally, it is also important to protect against damage from dropping a package, vibration, humidity, pressure, and light, he added.
Panelist Heather Bonome, PharmD, director of pharmacy at URAC, noted that obtaining accreditation from the organization requires adhering to the pharmacy operation standards set forth to ensure cold chain maintenance based on the appropriate temperature recommended by the manufacturer.
She noted that it is vital to follow standard operating procedures (SOP) when monitoring the temperatures of freezers and the ice packs used in shipping to ensure they are within the correct level and will not cause thermal shock. URAC utilized a group of cold chain engineers to guide their advisory committee in establishing these standards, according to Bonome. URAC requires a documented program for the distribution of cold chain products, with specific criteria for packaging and transportation.
This process includes controls that address the correct packaging, directives to maintain a steady recommended temperature, and methods to determine whether a package should be held in the case of a potential delay, such as extreme weather. Bonome said that URAC also requires an annual review of quality management in the distribution process along with complaints or concerns related to cold chain shipments.
“You have to monitor the temperature of all of your freezers, including your ice packs, because that is part of your validated distribution process,” Bonome said. “How do you know that you’re following the same SOP if your freezer packs are not being monitored to make sure they are the correct temperature?”
Panelist Marianne Hoonakker-Kelly, of Sonoco ThermoSafe, said that the placement of a coolant within a package, and its temperature, have to be considered. She recommended the use of buffer material to prevent a product from thermal shock. Panelist Mark Maurice, senior project manager at Sensitech, noted the numerous challenges that affect distribution requirements for accreditation. As such, he said that Sensitech conducts studies of summer and winter temperatures, creates ambient temperature profiles from exterior data, and analyzes 10,000 shipments annually to obtain a better understanding of failures in the cold chain.
“I do a lot of observations with customers, and it is a puzzle,” Maurice said. “There are 5 pieces to that puzzle, let’s say, and you can’t just throw the puzzles into the box. You actually have to know how the pieces are used.” He noted that pharmacists are generally not properly educated on how to use a pack or how internal package temperature is affected by frozen gel packs, which emphasizes the need to find a partner to serve as an expert advisor in proper cold chain management.
“I’m not trying to be an alarmist, but all of you, or at least a majority of you, are freezing your products,” he said. “You have to be extremely concerned because it is a thermal shock placing [medication] on a frozen gel pack and bringing the temperature of that product to -10°C.”