It is not a secret that the supply chain breaks down once vaccines (which are generally cold chain products that need to be refrigerated) are delivered to doctors’ offices and clinics. Household refrigerators are used to store them (and hopefully not in the refrigerator freezer, which destroys most vaccines); inventory is not tracked; and which patients received which product lots are not recorded. A 2010 study by the HHS Office of Inspector General (“Vaccines for Children Program: Vulnerabilities in Vaccine Management”) found that within a select group of high-volume dispensers, none met all VFC program oversight requirements; specifically, 76% of providers exposed vaccines to inappropriate temperatures for at least a cumulative five hours—possibly damaging the efficacy of the vaccines—and 13 providers had expired and unexpired vaccines intermingled. A physician survey* conducted by TempTime Corp., maker of cold chain sensors, in that same year found that 83% of pediatricians (who dispense most childhood vaccines) had experienced a “cold chain break” at first hand.
Since then, two groups have grappled with the problem, which is a combination of technology, training and medical standards and practices. One, the Immunization Action Coalition (St. Paul, MN; www.immunize.org), conducts healthcare provider training and performs public advocacy on behalf of medical professionals. The other, the SHAPE (Storage, Handling, Administration and Preparation Experts) Vaccine Delivery Working Group, is a self-selected team of immunization experts that has been meeting regularly to develop better provider practices. Dr. L.J. Tan, chief strategy officer of the Coalition and member of the SHAPE Group, tells Pharmaceutical Commerce that it is a struggle to raise the bar on vaccine delivery performance. “For many, this is a low-priority activity, constrained by limited public-health dollars, and a lack of training and standards,” he says. (Tan also stresses that his involvement in the Working Group is not necessarily an endorsement by the Coalition.) Jurisdictional issues also affect the situation: FDA does not regulate pharmacies or doctors’ offices, and multiple state and other regulatory bodies have a say in healthcare delivery practices.
There are vendors of refrigeration and related equipment for healthcare facilities, but the cost of the equipment is an impediment. Manufacturers are supportive of, for example, the educational activities of the Coalition through unrestricted grants, but there are regulatory entanglements to more-direct support of how facilities are managed and funded. In the meantime, the Working Group has published a paper proposing next steps (“From Refrigerator to Arm: Issues in Vaccine Delivery,” Vaccine 32  2389–2393) and will be holding an invitation-only meeting of healthcare providers in Raleigh, NC, next month as part of a national educational and fact-gathering program.