Almost three-quarters of physicians have experienced a 'cold chain break' in drugs they've prescribed; less than a third are 'very confident' that the cold chain is being properly managed
Ensuring that shipments of temperature-controlled biopharma products are safely delivered is often regarded as a detail attended to by supply chain and logistics managers, but a Harris Interactive survey sponsored by Temptime Corp. (Morris Plains, NJ) might make it a worry of marketing and brand-integrity managers. The survey found that a majority of physicians, ranging from primary-care physicians to such specialists as hematologists/oncologists, endocrinologists and rheumatologists are “very concerned” about potential adverse events due to heat-damaged products.
Equally troubling, more than 70% of physicians surveyed—and as many as 83% of pediatricians, who are likely to be focused on childhood vaccines—have experienced a “cold chain break” at first hand. Specialists reported more delivery-related breaks, which are thought to occur when products are in transit to physicians’ offices; PCPs/pediatricians reported more breaks in storage, occurring after delivery.Heat-damaged pharmaceuticals “may be a complete loss of product efficacy, or loss of product potency—which can lead to interruptions in treatment protocol, serious adverse events or failure to relieve patient symptoms,” say Donald Allegra, MD, FACP, quoted by Temptime but not affiliated with the study. “The impact can go beyond individual patients to the public health level, particularly when vaccines are involved.”
Temptime, a manufacturer of cumulative temperature indicators, notes that its devices, mounted on individual product packages, provide an on-the-spot reading of the heat exposure of the product, and are in use in many countries outside the US. However, most US temperature-controlled shipments are monitored by temperature recorders, which provide a temperature profile to the shipper or distributor, but not necessarily to the end user. Regardless of the technology deployed, however, it looks like the increasingly complex regulatory regime for cold chain transportation is raising awareness of cold chain quality among prescribers.