Specialty pharmacy encompasses the management, handling, and distribution of high-cost, high-risk medications that are often used to treat rare and complex disease states. Implementing specialty pharmacy programs can allow health systems to provide more comprehensive, integrated care to patients and reduce fragmentation in the health care system.1,2 In order to provide best-practice services to specialty pharmacy patients, proper cold chain distribution of specialty pharmacy medications is a foremost consideration; maintaining appropriate temperatures is critical to ensuring the efficacy of these costly medications.
Cold chain distribution in specialty pharmacy refers to the process of shipping pharmaceutical products that require refrigerated storage. A well thought-out cold chain distribution system is crucial given that injectable and biologic medications make up a significant portion of the specialty products currently on the market. In 2017, 49% of medications approved by the FDA were cold chain products with specific temperature requirements from manufacturers, usually between 2˚C and 8˚C.3 These storage requirements are established to maximize effectiveness of the medications and deliver patient safety. Thus, every health system with a specialty pharmacy should develop and implement a strategy to maintain proper medication management throughout the cold chain distribution process.
The Critical Nature of Cold Chain Management
The importance of cold chain management is recognized by specialty pharmacy accreditation bodies, including URAC and the Accreditation Commission for Health Care (ACHC). In order to become accredited, specialty pharmacies must have a system in place to ensure consistency with manufacturer requirements. In 2015, the average cost for a single specialty drug was $52,486 per year.4 Based on this, the monthly cost for each shipment would exceed $4300 on average; thus, proper infrastructure must be in place to handle the distribution of these expensive products.
There is currently a lack of guidance detailing the necessary measures to implement a cold chain process specific to specialty pharmacy. Therefore, information to aid institutions in navigating the cold chain process, including a summary of the current pharmaceuticals requiring cold chain management, accreditation requirements, development of shipping and packing designs, and building a validation and audit process to monitor the distribution system, can prove extremely useful.
Storage and Stability Requirements
A robust cold chain process should incorporate a system to assess the integrity of products that may not have been stored in the correct temperature range throughout the supply chain. TABLE 1 includes a list of common specialty medications and their storage requirements, as well as their stability at room temperature. While the majority of these medications remain stable at room temperature for a period of time, manufacturer expiration dates are often drastically reduced when room temperature storage is utilized. This information can help pharmacies respond to patient concerns if a medication spends time outside of the appropriate temperature range.5-7
Specialty pharmacies seek to obtain accreditation to showcase the quality services they provide to patients. Accreditation demonstrates the processes, programs, and capabilities that are in place to provide quality, value-based care. Considering the intricacies surrounding specialty pharmacy practice, accreditation helps illustrate to payers and patients that the pharmacy has the necessary measures in place to successfully provide services, including accurate and safe dispensing, extensive patient management programs, and proper shipping and handling procedures for specialty products.8
Major accreditation bodies include URAC, ACHC, The Joint Commission, the Center for Pharmacy Practice Accreditation (CPPA), and the Community Health Accreditation Program (CHAP).9 In 2017, it was estimated that 42% of all specialty pharmacies were accredited by URAC, 32% by ACHC, and 26% by both URAC and ACHC.9,10
In URAC Specialty Pharmacy Version 3.0, shipping and cold chain distribution requirements are outlined under Standards 6 and 7 in the pharmacy operations module. Requirements to promote effective shipping practices include11:
For its cold chain distribution standards, URAC requires criteria for selecting modes of transit and packaging products, and requires a validated distribution process with controls that address11:
URAC also mandates annual monitoring of cold chain packaging under different temperature profiles and for various lengths of time in the shipping distribution system. In addition, monitoring must be conducted whenever packaging products are modified. The validated distribution process, monitoring system, and any patient or prescriber complaints and concerns related to shipments must be reviewed by a quality oversight body within the organization, at least on a yearly basis.
For ACHC accreditation, shipping and cold chain process requirements are markedly similar to those of URAC. ACHC requires that patients be informed of the expected time frame for delivery and that written policies and procedures (P&Ps) be established and implemented to address the timeliness of shipping, shipping errors, turnaround time, and lost shipments. Organizations must have P&Ps in place that address proper medication packing to ensure stability; appropriate sanitation, light, and temperature during the course of delivery; alternative methods for medication delivery in case of a disruption in the distribution process; and a periodic validation method to monitor whether containers maintain the specified temperature requirements.12
Internal Development vs External Vendors
Pharmacies must have the proper tools to comply with cold chain packaging requirements, including shipping supplies, shipping diagrams, and proper staff training. Perhaps most crucial is establishing packaging diagrams, which are validated instructions on how to package a cold chain item depending on external temperature. This provides staff with a visual aid to facilitate consistent packaging.
Various vendors provide packaging diagrams that have undergone rigorous testing to assure maintenance of 2˚C to 8˚C in specific external temperature ranges, and include validation documents. However, it is not required to utilize an outside vendor to provide these validated documents; pharmacies can develop and validate their own shipping process, if desired.
When determining whether to use an external vendor versus developing an internal program, weigh the following considerations:
Building a Validation and Audit Process
Regardless of whether a specialty pharmacy partners with an external vendor, a validation and audit process must be in place to ensure compliance with the cold chain process, and to continually evaluate that packaging guidelines still meet the needs of the pharmacy and the patients. Accreditation standards vary with regard to auditing and validating requirements for pharmacies’ cold chain shipping processes. Generally, an annual validation utilizing a temperature tracker and test package is the minimum requirement; however, it is best practice to test each packaging diagram at least once annually.
The current regulatory environment requires that pharmacies develop a customized process that follows best practices to assure patient safety and maintains the stability and sterility of shipped medications. It is important to note that validation and audit programs must incorporate parameters beyond simple temperature tracking. For example, visual evaluation of employees who complete the packaging and shipping is necessary to verify that the correct packaging diagrams are being utilized.
Some pharmacies utilize a new technology to validate their process: Temperature strips that are placed on the outside of each drug product, which allow pharmacies to monitor individual products and identify excursions on a case-by-case basis. While this option provides comprehensive monitoring and can aid in situations where a package is lost or in extreme temperatures, it is costly and may be unnecessary for those cold chain medications that are stable during excursions at higher temperatures for a short duration of time.
In order for specialty pharmacies to maintain patient services that reflect best practices, a robust cold chain distribution process is vital. Specialty pharmacy accrediting bodies have placed continuous emphasis on pharmacy’s cold chain process to preserve product quality. Building a strong program to guarantee appropriate shipping of cold chain items, while also troubleshooting any errors and deviations, is key to ensuring patients receive the maximum benefit from their specialty medications.
See the CASE STUDY, which discusses Cone Health’s specialty pharmacy cold chain distribution process.
Michael Li is a PharmD candidate at the University of North Carolina Eshelman School of Pharmacy. He graduated in 2015 from UNC Chapel Hill with a Bachelor’s degree in Chemistry. Michael is currently a fourth-year pharmacy student. His professional interests include pharmacy informatics and the pharmaceutical industry.
Nick Gazda, PharmD, MS, BCPS, is the assistant director of specialty pharmacy at Cone Health in Greensboro, North Carolina. He received his PharmD from the UNC Eshelman School of Pharmacy and MS with a concentration in health-system pharmacy administration from the UNC Eshelman School of Pharmacy.
Molly Schneider, PharmD, MHA, CSP, is the assistant director of specialty pharmacy with oversight of specialty pharmacy, ambulatory clinical services, and accreditation at Cone Health. She received her PharmD from the UNC Eshelman School of Pharmacy and an MHA from the UNC Gillings School of Public Health.
Cone Health’s Cold Chain Distribution Process
Cone Health, a six-hospital, regional community teaching health system with 1273 beds in Greensboro, North Carolina has a URAC-accredited specialty pharmacy with a sizable mail order business. Licensed in North Carolina and Virginia, the specialty pharmacy primarily serves patients with cancer, Hepatitis C, HIV, and rheumatological disorders. The majority of shipping activity occurs within the surrounding counties in central North Carolina and southern Virginia.
The initial step in implementing a URAC compliant cold chain distribution process was to develop a specialty pharmacy shipping policy with broad objectives to outline the conditions for a successful cold chain process:
➊ Select an external vendor for both packaging materials and packaging diagrams
➋ Choose a shipping vendor (eg, UPS, FedEx, USPS, etc)
➌ Identify storage requirements for both medications and cooler packs
➍ Develop a process for tracking packages and troubleshooting issues that arise
➎ Identify the responsibilities of the specialty oversight and quality committees in providing ongoing monitoring of the cold chain process
After the development and approval of this policy, an external vendor was selected to provide validated packaging diagrams. A modified version of these three-season diagrams was adopted to best meet the geographic shipping conditions at Cone Health. A shipping carrier was selected based on their rates and customer support feedback as well as alignment with services the shipping carrier could provide across the health system.
Finally, a cold chain distribution guideline was developed, detailing the specific daily requirements of the cold chain distribution process.
Cold Chain Distribution Guideline
Purpose: To ensure all packages maintain a temperature of 2°C to 8°C (36°F to 46°F) throughout the cold chain process, until the product is received by the patient.
Packaging Selection: Summarizes the requirements for the cold chain distribution process, as outlined in the shipping policy.
Shipping Conditions: Outlines the average temperatures by month within the shipping area, as well as the temperature ranges for the different packaging. Cone Health utilizes a three-season system, wherein different packaging diagrams are used for each of the three seasons. The packaging selected is based on the forecasted high temperature within the next 48 hours:
Validation and Monitoring: Outlines the frequency of validation and monitoring by the specialty oversight and quality committees:
Reception and Next Steps: This process has delivered significant gains in efficacy and quality control. Staff initially had many questions for the clinical pharmacist to verify that they were using the correct packaging due to discrepancies between the forecasted high and low temperatures. By focusing on high temperatures, we minimize questions from shipping personnel. A clinical pharmacist reviews the daily forecasted temperature to determine if expected low temperatures may affect the packaging selected. Streamlining this process has increased staff satisfaction as less time is needed to prepare cold chain packages.
Since the implementation of this program, no temperature deviations have been identified in the validation process. Future directions include evaluating options to provide for more frequent testing of cold chain shipping conditions via temperature strips or more frequent test packages.
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