The FDA has determined the composition of the 2015-2016 influenza vaccine, and this year’s supplies were expected to arrive in pharmacies as scheduled in August, which means it is time to make room for new inventory by properly disposing of any vaccine remaining from the 2014-2015 season.
Ideally, unused vaccines are returned to the vaccine manufacturer for proper disposition at the conclusion of flu season. Pharmacies must contact each manufacturer directly to determine their policies for returning unused doses. For those vaccines that cannot be returned, it is important to identify the appropriate waste stream and ensure proper disposal. Given the number of flu vaccines that are not returnable, it is incumbent upon every pharmacy to have a formal vaccine disposal plan in place.
While requirements for medical waste disposal are regulated by state environmental agencies, any medications with a hazardous categorization fall under the purview of the EPA’s Resource Conservation and Recovery Act (RCRA).1 RCRA rules are intended to keep toxic waste, such as mercury, from polluting ground water. Pharmacies must dispose of full or partially used vaccines that are deemed hazardous under RCRA via RCRA-hazardous waste containers, or black bins.
Identifying RCRA-Hazardous Waste
According to the EPA, waste that is not specifically listed is still deemed hazardous if it exhibits characteristics of ignitability, corrosivity, reactivity, or toxicity.2 Given its toxicity, mercury is classified as a toxic hazardous waste under the code D009. Any product with a mercury concentration of 0.2 mg/liter or greater is considered hazardous solid waste. This applies to vaccines that use thimerosal, a mercury derivative, as a preservative.
Vaccines that exceed the EPA threshold for mercury, and therefore must be disposed according to hazardous waste guidelines, are listed in TABLE 1. Vaccines produced as 5-mL multidose vials for intramuscular injection contain approximately 25 mcg mercury per dose. Although Novartis’ single-dose prefilled 0.5 mL syringes of Fluvirin seasonal flu vaccine are preservative-free, these vaccines may contain trace amounts of mercury (≤1 mcg per 0.5 mL dose) leftover from the manufacturing process. When disposing of a full or partially used sharp syringe containing a vaccine with thimerosal, dispose of the sharp as dual hazardous and biohazardous waste.
The quadrivalent nasal spray vaccine FluMist does not contain mercury, and thus does not require disposal as hazardous waste, but it does contain live attenuated influenza virus (LAIV). Therefore, the proper disposal method for any unused vaccine and the sprayer is as biohazardous waste using a red sharps container.
Pharmacies should dispose of expired vaccine vials that do not contain mercury or LAIV according to state regulations. Included in this category are the many 0.5-mL single-dose formulations of seasonal flu vaccine that are preservative-free and manufactured without the use of thimerosal. Incineration is the best environmental practice for disposal.
For the coming influenza season, an FDA advisory panel endorsed the World Health Organization’s recommendations for an A/Switzerland/9715293/2013 (H3N2)-like virus, a B/Phuket/3073/2013-like virus (B/Yamagata lineage), and an A/California/7/2009 (H1N1) pdm09-like virus as the 2015-2016 trivalent vaccine.3 The change in H3N2 was expected because of low vaccine effectiveness in 2014-2015, which the CDC has estimated at 19%.4 The FDA panel also approved the WHO recommendation that the 2015-2016 quadrivalent vaccine should include these antigens and also a B/Brisbane/60/2008-like virus.3
The CDC Advisory Committee on Immunization Practices (ACIP) recommends either nasal spray delivery of LAIV or injected inactivated influenza vaccine (IIV) for children 6 months and older. This comes after an ACIP meeting in February at which the committee reversed its 2014 advice favoring LAIV for children ages 2 through 8 years.5 ACIP’s decision was based on findings that LAIV performed poorly against influenza A/H1N1 in children in 2013-2014. As with other age groups, neither LAIV nor IIV worked well in protecting children ages 2 to 8 years against H3N2 viruses in the 2014-2015 season, according to the CDC.5
MedImmune (maker of LAIV, sold as FluMist) informed ACIP that a mutation in the vaccine’s strain of hemagglutinin protein made it vulnerable to heat exposure.6 The 2015-2016 LAIV will contain an antigenically similar, more stable hemagglutinin.
When designing an effective vaccine management program, pharmacy often focuses on determining order quantities, expanding inoculation rates, and ensuring proper storage conditions. While these are all key factors, a program is not complete without a detailed disposal plan. Like all RCRA-hazardous products, vaccines containing thimerosal should include an indication of their D code to ensure unused doses are disposed in the proper waste stream at the end of the flu season.
For further guidance on compliant disposal procedures and documentation practices, contact your state environmental agency. The Healthcare Environmental Resource Center provides a convenient state-by-state regulated medical waste resource locator (www.hercenter.org/rmw/rmwlocator.cfm) that outlines each state’s statutes, regulations, and guidelines.
Lisa Hack is a senior editor for Pharmacy Purchasing & Products and MedicalLab Management magazines. She can be reached at firstname.lastname@example.org.