PharmE^® News Alert

PharmEcology® Provides Disposal Guidelines for the 2012-2013 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. This year's seasonal flu vaccines provide immunization for the A/California/7/2009 (H1N1)-like virus, A/Victoria/361/2011 (H3N2)-like virus, and B/Wisconsin/1/2010-like virus. These vaccines are now widely available and vaccination programs are well underway. The 2012- 2013 vaccines are very similar to last year's vaccines. However, this year there are two new vaccines available which use new technologies in their production. They are Flucelvax by Novartis and Flublok, produced by Protein Sciences.

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In addition to producing 5 mL multidose vials of the Fluvirin seasonal flu vaccine, Novartis also produces prefilled single-dose 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.

Sanofi Pasteur, Glaxo Smith Kline, and CSL Limited also produce preservative-free single-dose formulations of the seasonal flu vaccine, in 0.25 mL dosages for children under 3 and in 0.5 mL dosages for everyone else. 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. Flucelvax is intended for patients over the age of 18 and is a preservative-free formulation and may be discarded as non-hazardous waste. Flublok is also preservative free according to their press release and may be discarded as a non-hazardous waste. This year Sanofi Pasteur is again producing an intradermal formulation of the seasonal flu vaccine in a 0.1mL dosage for adults 18 - 64 years of age. 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. (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 a nasal spray version of the seasonal flu vaccine containing 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.

For a printable summary of this information, including the NDC codes for the specific products, go to 2012 - 2013 Seasonal Flu Vaccines. For information about disposing of last year's flu vaccines, please refer to our news alert 2011 - 2012 Seasonal Flu Vaccines.

Additional details about the criteria outlined here 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.

• Posted: January 24, 2013