PharmE^® News Alert

PharmEcology® Provides Disposal Guidelines for the 2014 - 2015 Flu Vaccines

As a public service to the healthcare community, every year Waste Management publishes an analysis of the proper disposal guidelines for the current year's seasonal flu vaccines. For 2014-15, U.S.-licensed influenza vaccines will contain the same vaccine virus strains as those in the 2013-14 vaccine. Trivalent influenza vaccines will contain hemagglutinin (HA) derived from an A/California/7/2009 (H1N1)-like virus, an A/Texas/50/2012 (H3N2)-like virus, and a B/Massachusetts/2/2012-like (Yamagata lineage) virus. Quadrivalent influenza vaccines will contain these antigens, and also a B/Brisbane/60/2008-like (Victoria lineage) virus (9).

For a summary of this information, including recommended waste categorizations and the NDC codes for the specific products, see the table below. For information about disposing of last year's flu vaccines, please refer to our News Alert PharmEcology^® Provides Disposal Guidelines for the 2013 - 2014 Flu Vaccines, located under the NEWS section at www.pharmecology.com.

An expanded discussion of the vaccines including the rationale for waste categorization follows the table. Additional details about the criteria outlined below are available to subscribers to the PharmE^®Waste Wizard^® and the PharmE^® Inventory Analysis.

If you have any additional questions about disposal of the 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 (2014-2015)

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The Center for Disease Control (CDC) provides a wealth of information about the seasonal flu vaccines at What You Should Know for the 2014-2015 Influenza Season http://www.cdc.gov/flu/about/season/flu-season-2014-2015.htm and provides a chart of current flu vaccines at Influenza Vaccines United States 2014-2015 Influenza Season http://www.cdc.gov/flu/protect/vaccine/vaccines.htm. Several manufacturers produce 5 mL multidose vials of the vaccines for intramuscular injection. In each case, these formulations contain thimerosal, a mercury derivative, added as a preservative. Each recommended 0.5 mL dose contains approximately 25 mcg mercury. The U.S. EPA defines a waste as hazardous under the toxicity characteristic if the concentration of mercury is equal to or greater than 0.2 mg/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 quadravalent nasal spray version of the seasonal flu vaccine containing 4 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.

Generally, prefilled vaccines are supplied in needleless syringes. However, in the rare instances 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 intranasal spray for FluMist^® should be discarded in a red sharps container as a biohazardous waste.

[1] Information regarding the composition of the vaccines is excerpted from the FDA's website at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm.

• Posted: November 11, 2014