PharmEcology
 
 
 
 
 
PharmEcology® News Alert

September 8, 2010 –
PharmEcology® Presents Disposal Guidelines for the 2010-2011 Flu Vaccines

As part of our ongoing tracking of flu vaccines, PharmEcology presents updated disposal guidelines for this year's seasonal flu vaccines, which provides immunization for the H1N1 flu in addition to the current strains of the seasonal flu. These vaccines are now widely available and vaccination programs are well underway.

The U.S. Food and Drug Administration provides a wealth of information about all approved vaccines including the seasonal flu vaccines at Influenza Virus Vaccine, Trivalent, Types A and B. This web site includes links to the actual manufacturer package inserts and other key resources addressing frequently asked questions about the vaccines. These package inserts include specific information about each formulation of the vaccine and we have relied upon that information to develop our recommendations for disposing of the flu vaccines.

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 or a healthcare facility has the test performed and the waste does not fail, 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.

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.

Novartis also produces a 0.5 ml syringe of the Agriflu seasonal flu vaccine. Because Novartis does not use thimerosal in this manufacturing process, Agriflu can be displosed 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).

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.

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, 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.

For a printable summary of this information, including the NDC codes for the specific products, go to 2010 - 2011 Seasonal Flu Vaccines. For information about disposing of last year's flu vaccines, please refer to our May 19th news alert PharmEcology® Presents Disposal Guidelines for the H1N1 and 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 vacinnes or if you have any questions about managing your pharmaceutical waste, please contact us at info@pharmecology.com., call us at 414-292-3959, or visit our web site at www.pharmecology.com.


  ABOUT PharmEcology Services, WM Healthcare Solutions, Inc.

PharmEcology Services, WM Healthcare Solutions, helps healthcare facilities identify and manage pharmaceutical waste. PharmEcology works closely with the healthcare and regulatory communities to insure cost-effective and compliant pharmaceutical waste management programs. PharmEcology was founded in 2000 as PharmEcology Associates, LLC and was acquired by Waste Management in 2009.

  Copyright (C)2010 WM Healthcare Solutions, Inc.

Legal Disclaimer: This presentation is solely for educational purposes and provides only a general description of various regulatory requirements. For a complete description, please consult the relevant federal and state regulatory statutes. Nothing in this presentation constitutes legal advice and you should not legally rely on any information provided in this presentation. We make no warranty, express or implied, with respect to such information and disclaim all liability resulting from any use or reliance of this information.

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