Pharmacy set-up, packaging selections, and patient management technologies are vital in the proper handling and administration of cold chain drug products.
INCREASINGLY, TEMPERATURE-CONTROLLED DRUG PRODUCTS (OTHERWISE KNOWN AS “COLD CHAIN”) are finding their way into patient therapeutic regimens.
These products are largely prevalent in the specialty pharmacy space, particularly due to distinct nuances with refrigerated or room temperature handling. It is estimated that the cost associated with transportation alone will total $12.6 billion in 2016, and will continue to rise based on the anticipated growth rates of these therapies across the industry.1
Pharmacies need to be equipped to manage the expectations of handling these products, from receipt through dispensing to the patient, as temperature excursions of therapies with such strict stability ranges could render products worthless. This would create excess waste and unanticipated spend due to the need for replacement.
Definition of Cold Chain
In order to understand the importance of appropriate handling, let’s use Figure 12 to establish several definitions surrounding commonly accepted temperature ranges from the US Pharmacopeia (USP), which not only impact the storage of medications, but also the components associated with appropriate shipping containers. Why so specific?
For starters, section 16 of every FDA-approved drug monograph refers to the nomenclature established by these USP guidelines. The section allows pharmacists to readily review and understand the approved storage and handling parameters established for the product and provides a framework for decision making related to necessary packaging for appropriate transportation.
Additionally, as we begin to look into the ice-and-gel pack components associated with different types of packaging, these temperature ranges will play a key factor in “conditioning” time. Receipt of Cold Chain Products Upon receipt of a cold chain product in the pharmacy, and in line with best practices associated with the Drug Supply Chain Security Act, inspection should occur to determine if any variance in temperature occurred in transit.
To serve as guidance for appropriate inspection, most wholesalers and manufacturers will provide, upon request, specifications surrounding their respective packaging containers. Additionally, measures can be taken to utilize methods, such as nonintrusive spectral projection, in the event that specifications cannot be provided. Through the utilization of a calibrated infrared temperature gun, the ambient temperature of the shipping container can be gauged.
If it is suspected that the product’s quality may have been compromised, it should be quarantined in a suitable location within the pharmacy until additional inquiries or validation can be completed. Should the product be deemed “out of range” upon receipt, it should be returned to the wholesaler or manufacturer in exchange for an appropriately handled product.
Designing a Pharmacy to Manage Cold Chain
Being able to appropriately document the receipt of cold chain products is one thing. Being able to store them appropriately is another. The design of physical pharmacy space to adopt true cold chain capabilities is crucial to maintaining acceptable temperature ranges while medication is under the care of the pharmacy prior to dispensing. Accounting for proper ice-and-gel pack preparation for shipping also plays a factor in space planning.
Product selection is key, and while many vendors of refrigerators and freezers may have options available that provide integrated sensors, thermometers, or alarms, the cost may be prohibitive depending on the size of your cold chain operations. Additionally, some integrated devices may only provide local notifications. What happens during off hours when no one is around to hear an audible alarm? Fortunately, with the utilization of technology, a wide range of solutions are available that can provide off-site, 24/7 monitoring which does not require the most state-of-the-art refrigeration devices.
At PANTHERx Specialty, we found that a multifaceted approach best protected our cold chain therapies, while affording the flexibility to manage after hours. Through utilization of refrigerators and freezers with integrated glycol chambers, in addition to a separate WiFi and cloud-enabled alerting system,3 our pharmacists are alerted around-the-clock, via e-mail and text message, if temperatures are nearing the point of excursion.
Within the pharmacy itself, ambient room temperature sensors are installed to ensure a constant controlled room temperature is maintained, as well. Alerts are also provided via our dedicated, 4G-enabled back-up generator system, to provide constant assurance that our portion of the cold chain is fully operational. By having 2 mechanisms to monitor the internal chamber temperature of each refrigerator and freezer, better allows for quality-assurance testing of the devices themselves to ensure appropriate temperature calibration.
The 2 records of continuous temperature monitoring are incorporated into our annual Installation Operational and Performance Qualification protocols, which help us abide by Good Distribution Practice standards.
Designing a Shipper to Manage Cold Chain
Just as the responsibility is on the pharmacy to maintain appropriate storage and handling temperatures while the drug resides on its shelves, it is also the duty of the pharmacy to ensure controlled temperature stability while the drug is in transit to its patient. Choosing the packing that is right for your product (and patient) makes all the difference.
Package size, composition, and thickness of cooler material, as well as the composition and quantity of cooling materials, directly affects the length of time that internal contents can remain in a controlled cold temperature or a controlled room temperature. Certain solutions, like Cold Chain Technologies,4 can also provide prequalified data surrounding testing associated with validation of their multiple solutions, as well as illustrated diagrams to specify the quantity of ice or refrigerated gel coolants required to ensure correct packout.
With cost again serving as a potential decision maker, there is always the option to purchase a nonqualified packing container and utilize a single-use temperature indicator that will change color to notify the recipient that a temperature excursion has occurred. Ultimately, no matter the composition of the packing solution to manage drug product from time of fulfillment at the pharmacy level, it is crucial to establish processes with your shipping carrier to track packages and ensure they arrive in the correct timeframe or route back to the pharmacy in the event of a delay.
Patient Counseling Surrounding Cold Chain
Whether a patient is receiving his or her first shipment of drug, or his or her 50th shipment, there are certain points of counseling that can be provided to reiterate the importance of the patient’s role in the final mile of cold chain continuity. During introductory patient counseling, any specific storage and handling requirements from the package insert should be discussed with the patient, along with instructions on what to expect when it comes to product transit.
Descriptions of the packing solution can help to provide clarity to a patient’s experience of opening the box and when to identify potential issues with the integrity of the shipment. Descriptions of the packaging can help to provide clarity for the patient as to what to expect when opening the shipment, as well as how to identify potential issues.
For instance, counseling surrounding differences between ice and refrigerant packs, and their expected condition upon arrival, can afford additional confidence when the package arrives. If a patient expects a frozen ice brick, only to receive a cool refrigerant gel, they may question why the pack is melted. Reiteration, upon refill, of the need to refrigerate a product can serve as a friendly reminder each month to quickly move the drug from a shipping container into home refrigeration. Furthermore, discussion surrounding the implications of “breaking” the chain, including maximum excursions or product viability and usefulness after excursion, can greatly impact the patient experience.
Lastly, the patient can benefit from a discussion surrounding appropriate disposal or recycling of packaging material. Receiving a cooler each month could create a burden on the patient as to the appropriate way to discard of this waste. Some municipalities will not allow the discarding of larger sized boxes, so providing common locations for disposal or recycling in advance can alleviate this potential frustration.
We have found that by creating a recycling program that provides patients a pre-paid return label helps manage the burden of recycling the coolers to ensure they are appropriately recycled, thereby minimizing the impact on the environment.
Innovations in Cold Chain
There have been many advancements in respect to most areas of cold chain integrity, but what really happens once the drug product enters the custody of the patient? Historically, pharmacists relied on a patient’s home refrigerator, where the specialty product sits next to grocery-store produce. The coordination of efforts to bring medications to the patient’s home, and ensure product integrity, was lost.
At PANTHERx Specialty, we work with ASD Healthcare, a company of AmerisourceBergen, and their myCubixx in-home patient solution,5 to handle an exclusive orphan product with a narrow stability window. The myCubixx solution consists of a small in-home refrigerator unit, fully equipped with radio frequency identification (RFID) and 4G technologies, which allows our team to ensure appropriate handling of the drug once it resides at the patient’s home.
Each carton of medication is commissioned with an RFID tag, which is recognized by the patient’s myCubixx. We can remotely monitor when the door of the refrigerator is opened and the drug is removed, and receive alerts when medications may have accidentally been left on a counter. Through constant internal temperature monitoring, we also receive alerts if the internal temperature of the refrigerator experiences an excursion outside of the 2°-to-8°C range, and intervene as necessary.
This unique solution helps us provide true connected care, bring cold chain management full circle, and ensure correct handling for highly sensitive products once they leave our pharmacy.
From start to finish, handling cold chain drug products in the intended manner will add additional steps to all parties involved: manufacturer, wholesaler, pharmacy, and patient. With so many options available for pharmacy set-up, packaging selections, and even patient management technologies, the possibilities are endless for what makes the most sense for managing your workflow and, more importantly, your patients.
About the Author
JONATHAN OGURCHAK is Vice President for Business Operations at PANTHERx Specialty Pharmacy. PANTHERx Specialty is a dually-accredited, national specialty pharmacy focused on transforming lives by delivering medical breakthroughs, clinical excellence and access solutions to patients afflicted with rare and devastating conditions. Uinnovations in technology and patient services, we Reinvent Specialty, Revolutionize Pharmacy, and Redefine Care® on a daily basis.