PDA’s Tech Report 46 prescribes the use of qualified packaging for product delivery to the end-user.
As the supply chain for controlled-temperature medicinals addresses the hurdles of ‘last mile’ distribution, suppliers of thermal packaging have focused product development and services to this sector.
The Parenteral Drug Association has released Technical Report 46. Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User. The guidance covers proper handling and storage of temperature-susceptible product after it is handed-off by the manufacturer.
Tech Report 46 characterizes a complex system that involves multiple hand offs and multiple points in the supply chain where excursions outside the label long-term storage temperatures can occur.
“The manufacturer distributes in a well-controlled shipping lane that is routinely monitored for temperature excursions and is subject to uniform, stringent Good Distribution Practices. Conversely, shipping/distribution regulations vary widely from location to location, and uniform guidelines are lacking. This divergence has proven challenging for the pharmaceutical industry,” the guidance says.
In the wholesaler distribution leg, 21 CFR, in defining wholesalers, “does not address packaging and shipping requirements for temperature-controlled products.” And states’ guidance on refrigerated drugs is vague or lacking, the guidance says.
“Without specific requirements, wholesaler distributors have no way of knowing if they are providing adequate, appropriate, and proper packaging and shipping temperature ranges (for maintaining products’ integrity).
“In the absence of specific packaging requirements or stability data provided by the manufacturer, the distributor should use qualified packaging or transportation to maintain product storage labeling requirements . . . from removal (from) the distributor’s temperature-controlled environment until delivery at their customer’s location,” the report says.
In home delivery from mail service pharmacy, quality agreements should ensure suitable containers, temperature monitoring, and logistics. Sharing of information within the supply chain will support pharmacists and nurses in educating patients on proper product storage.
LOOKING TO EXCEL
“There is a tremendous upside potential to do a better job. There are many channels of distribution in the last mile out there, and we have to focus on and look at each,” says Larry Gordon, president, Cold Chain Technologies (CCT; Holliston, MA).
“Specialty distributors and wholesalers want to excel in demonstrating best practices. This gives them the ability to distinguish themselves among their peers, and establish for the manufacturers they are using qualified systems,” Gordon says.
The development of new drugs requiring temperature maintenance, and regulatory guidance covering cold chain practice are driving customer initiatives, says Bill Hingle, marketing director, TCP Reliable/Cryopak (Edison, NJ).
“The pharmaceutical manufacturers have to maintain responsibility for the efficacy of the drug all the way through to delivery to the patient, demonstrating complete traceability. The only way for manufacturers to address this is to start viewing themselves as partners with their service providers, and develop networks to manage the accountability,” Hingle says.
Gordon notes that manufacturers and distributors have differing needs operationally. “Manufacturers are generally working with more knowledge on the stability data, and will typically ship distributors in large packaging quantities. At the distributor level, the mix of products, quantity shipped per package, and order frequency differ.Their needs, while domestic, cover every corner of the country,” Gordon says.
CCT collaborates with distributors on maintenance of storage temperatures, definition of shipping lane profiles, and pack-out development.
“They look to us for data-driven qualified packaging with supporting documentation, that is easy to use, cost effective, environmentally smart, and that can be tailored to support their lane and season-specific requirements,” Gordon says.
“We are finding that distributors and 3pls are looking more and more for reusable temperature packaging solutions, as they look to meet the regulatory requirements for temperature sensitive products. Packaging has to be extremely cost-effective, while demonstrating maintenance of the product within label temperature range,” Hingle says.
Suppliers have developed packaging systems for farther down the chain, after product delivery from the community pharmacy or mail order provider to the patient.
A new series of introductions in CCT’s KoolTemp GreenSmart line will support community pharmacy distribution, mail order fulfillment, and home infusion products shipped directly from special distribution pharmacies to the patient’s home, Gordon says.
“The cold chain presents different types and levels of handoffs. Our business model provides an integrated network of solutions whether in the delivery by distributors to pharmacies or in single-use delivery to the patient, says Hingle
“Engineered phase change materials are well suited to these applications because they address indirect costs by reducing the size and weight of the packaging. Our challenge is to develop a variety of cost-effective packaging platforms,” Hingle adds.
TCP Reliable acquired a new business unit this year to market Alternative Technologie Pharma, Inc.’s cold chain compliance solutions in the US. ATP’s products include the ATP-Mirador web-hosted solution for continuous real time tracking of temperature controlled products and storage facilities. The system’s hardware and technology has been scaled down to provide a more cost effective solution for hospitals, Hingle says.
“Pharmacies have to be able to document and monitor their equipment to ensure it is functioning within specified ranges. (Using ATP-Mirador), hospitals can avoid the infrastructure expense of maintaining a data base. The system can be set up with alarms for immediate notification for corrective action,” Hingle says.