In direct-to-patient specialty pharmacy operations, investing in cold chain technology and processes can protect costly biologic medicines and minimize risk to patients. With few exceptions, biologics to treat chronic diseases require special storage, shipping and handling logistics to ensure they stay within the recommended temperature range. Exposure to excessive heat or cold can diminish or destroy drug potency, and patients unwittingly administered temperature-damaged medicine may experience a host of clinical failures, like interruptions in treatment protocol, lack of symptom relief, and adverse events.
In recent years, the increase in the number of new biologic treatments has contributed to the development of thermal packaging solutions to reduce risk and ensure better control of the cold chain process. Among these innovations are more advanced shipping materials, more effective packaging solutions, improvements in shipping methodology and management, and the introduction of portable thermal containers which allow patients to travel with their medicines --with confidence. All have helped improve outcomes and control the cost of caring for patients with chronic conditions.
However, these newer technologies are not universally suitable for all delivery channels. And, although they are all designed specifically to protect temperature-sensitive medicines from heat or freeze damage during transit, a recent study of the most commonly used technologies employed by specialty pharmacies for home delivery found they are not enough to protect these costly and important medicines.
UPS points to risk management planning, limiting supply chain handoffs, and quality agreements among five vital tips for temperature-sensitive product packaging and distribution.
"It’s a well-known fact that temperatures can fluctuate throughout the process of shipping products across the globe by air. Freight is left out on the tarmac in desert temperatures while temperatures can get close to freezing within the cargo hold of an aircraft. This might not be a concern for manufacturers of clothing or toys, but for pharmaceutical manufacturers shipping room temperature products it is a prime concern."
This article discusses how "Regulators and internal quality personnel are looking more closely at maintaining temperature sensitive drugs in the 15° C to 25o C range."
"Pharmaceutical manufacturers devote considerable time and resources to implement effective cold-chain practices that protect products, especially sensitive biopharmaceuticals, blood products, and vaccines, from damage. Although efforts have traditionally focused on refrigerated (2–8 °C) and frozen (-20 °C) products, there is growing attention to controlled room temperature (CRT) products, which require maintenance at 15–25 °C to ensure quality and efficacy.
The emphasis on CRT shipments, expanding volumes of biologics, and rising demand from emerging markets are spurring strong growth for goods and services related to temperature-controlled logistics, particularly in Asia and the southern hemisphere"
This article from Packaging World discusses "observations from Cool Chain Logistics Europe in Basel, Switzerland" relating to "the shift from Cold Chain to Cool Chain", by Healthcare Packaging Publisher Jim Chrzan.
This article from Packaging World, discusses the following topic: "Temperature-controlled distribution involves multiple variables, as discussed here with Geoffrey Glauser, vaccine and therapeutic supply chain contractor and subject-matter expert with Conceptual Mindworks, Inc."
This article from Packaging World discusses "ThermoPod's ThermoKeeper mail-order shippers provide temperature control and protective insulation for food, wine, pharmaceuticals, cosmetics, and more with environmentally-friendly insulating liners that fit snuggly into a protective corrugated outer box."
This article from Supply Chain Digital Edition compares VIP's to traditional insulation from an environmental perspective, focusing on the impact to landfills, recyclability and thermal performance.
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