Effective vaccine storage and handling is an important component of proper vaccine management. Several recent scientific studies on equipment used for vaccine storage, as well as an improved understanding of best practices, have prompted the Centers for Disease Control and Prevention (CDC) to provide updated guidance on proper vaccine storage and handling practices (see the CDC’s November 2012 Vaccine Storage & Handling Toolkit at: http://www.cdc.gov/vaccines/recs/storage/toolkit/default.htm).
Develop and adhere to a detailed, written vaccine storage and handling policy and procedure (P&P), including an emergency plan. Each hospital should develop a vaccine storage and handling plan that is updated annually. The plan should include all aspects of routine vaccine management, and cover ordering, managing inventory, storing, and monitoring. The plan should be kept in a prominent and easily accessible location near the vaccine storage unit for staff reference. A written P&P promotes organization, serves as a reference and training tool, and provides quality assurance for management of vaccines. In addition, a contingency plan should be developed to ensure vaccine integrity in the event of a natural disaster or extended power outage (see Table 1). Given the recent difficulties in the Northeast following the power outages caused by Hurricane Sandy, hospitals without robust and easily disseminated emergency plans were left scrambling for connectivity. Implementing an emergency preparedness plan could make the difference between ensuring the integrity of expensive vaccines and being forced to dispose of out-of-range inventory.
Ensure vaccine cold chain integrity. Vaccines are only effective when they have been stored properly from the time of manufacture through the point of patient administration. Variations in heat or cold alter vaccine potency, increasing the risk that patients will not receive the full disease-preventative effects of these medications. A single exposure to freezing temperatures can render some refrigerated vaccines useless; HepB and DTaP/DT/Tdap/Td vaccines are especially vulnerable to freezing. Cold chain integrity depends on utilizing effectively trained personnel, proper transportation and storage equipment, and robust management P&Ps.
Appropriate vaccine cold chain custody starts when the vaccine is manufactured and stored at the plant, and extends through the transport to the distributor, delivery to the provider, and finally administration to the patient. Pharmacists are responsible for vetting appropriate vaccine storage temperatures and conditions with manufacturing and distribution partners. Vaccines must be transported in a refrigerated or frozen state specified by manufacturer PI for each vaccine.
After exposure to inappropriate temperatures, some vaccines will exhibit visually apparent clumping that does not disappear upon shaking, yet other vaccines will maintain their typical appearance. For example, inactivated vaccines exposed to freezing temperatures may not appear frozen and give no indication of decreased potency. Therefore, visual inspection of vaccines is an unreliable tool to evaluate vaccine integrity.
Jennifer Karpinski is a senior editor at Pharmacy Purchasing & Products magazine. PP&P would like to thank the CDC for their assistance with this article.
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