PharmE^® News Alert

PharmEcology® Provides Disposal Guidelines for the 2015-2016 Flu Vaccines

Each year, PharmEcology Services, a division of WM Sustainability Services, publishes a summary of the proper disposal guidelines for the current year’s flu vaccines as a public service to the healthcare community. For this season, it is estimated that manufacturers will provide between 171 to 179 million doses of vaccine to the U.S. market.

All of the 2015-2016 influenza vaccine is made to protect against the following three viruses: (1) an A/California/7/2009 (H1N1) pdm09-like virus, (2) an A/Switzerland/9715293/2013 (H3N2)-like virus, and (3) a B/Phuket/2073/2013-like virus. (This is a B/Yamagata lineage virus). For the 2015-2016 quadrivalent vaccines, they also protect against an additional V virus (B/Brisbane/60-2008-like virus).

The Centers for Disease Control (CDC), publishes extensive information about the flu vaccine. That information may be found at http://www.cdc.gov/flu/protect/keyfacts.htmincluding a table listing all available forms of the vaccine for 2015-2016, available at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.

The table below summarizes the waste categorizations of the specific products available this season. Unused or partial vials of some of the flu vaccine products may meet the criteria of a hazardous waste and should therefore be disposed of appropriately. This information is reflected in the table below. The categorization is based on federal regulations that fall under the purview of the U.S. Environmental Protection Agency. Utilizing the federal regulation as it applies to some flu vaccines, the vaccines meet the toxicity characteristic when the concentration of mercury is equal to or greater than 0.2mg/liter as a result of performing a test known as the toxicity characteristic leaching procedure (TCLP).

While we do not have results for such tests for vaccines, a calculation of the concentration of mercury in vaccines in which thimerosal is present as a preservative would cause the waste vaccine to fail the TCLP. Unless a manufacturer provides actual TCLP data indicating the mercury level to be below 0.2mg/liter or a healthcare facility has the test performed and the waste does not fail the TCLP, any vaccine waste containing thimerosal as a preservative should be managed as a toxic hazardous waste. As a result, all full or partially used multidose vials of the seasonal flu vaccine should be disposed of as federally hazardous waste, waste code D009. .

In addition to producing 5 mL multidose vials of the Fluvirin® seasonal flu vaccine, Novartis also produces single-dose prefilled 0.5 mL syringes of the vaccine. Although this vaccine is preservative free, thimerosal is used during the manufacturing process. While most of the thimerosal is removed by subsequent purification steps, the final vaccine may contain a trace amount of mercury, less than or equal to 1 mcg per 0.5 mL dose. This amount exceeds the federal threshold noted above and, as a result, the Novartis single-dose formulation should be disposed of as federally hazardous waste. Novartis also produces Flucelvax®, a single-dose prefilled syringe that contains no thimerosal and can be disposed as non-hazardous pharmaceutical waste.

Sanofi Pasteur, Glaxo Smith Kline, and CSL Limited also produce preservative-free single-dose formulations of the seasonal flu vaccine. However, all three manufacturers indicate they do not use thimerosal in manufacturing these vaccines and, as a result, these formulations can be disposed of as non-hazardous pharmaceutical waste. This year Sanofi Pasteur is again producing an intradermal formulation of the seasonal flu vaccine in a 0.1mL dosage. The vaccine is supplied as a prefilled single-dose syringe which Sanofi Pasteur indicates is preservative-free, and thus it can be disposed of as non-hazardous pharmaceutical waste. Sanofi-Pasteur has also introduced Fluzone® High-Dose , a 0.5mL single-dose prefilled syringe with no thimerosal preservative which can also be disposed as non-hazardous pharmaceutical waste. (Note that PharmEcology recommends that all non-hazardous pharmaceutical waste be incinerated rather than disposed of down the drain or in a landfill.)

Finally, MedImmune produces FluMist®, a quadrivalent nasal spray version of the seasonal flu vaccine containing four live attenuated versions of viruses. Vaccines containing live attenuated viruses do not contain mercury-based preservatives, so they do not need to be disposed of as federally hazardous pharmaceutical waste. However, as with any vaccine containing an attenuated live virus, any unused vaccine and the sprayer should be disposed of as biohazardous waste.

In the rare instance that it is necessary to dispose of a full or partially used sharp syringe containing a vaccine with thimerosal, the sharp should be disposed of as dual hazardous and biohazardous waste.

Also note that in all cases other than live attenuated viruses, empty syringes and vials are non-hazardous and can be disposed of in either a red sharps container, for sharps, or in the landfill, for vials. The used intranasal spray for FluMist® should be discarded in a red sharps container as a biohazardous waste.

If you have any additional questions about disposal of any vaccines or if you have any questions about managing your pharmaceutical waste, please contact us at info@pharmecology.com, call us at 877-247-7430, or visit our web site at www.pharmecology.com.

Disposal Guidance Seasonal Flu Vaccines (2015-2016)

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• Posted: November 02, 2015