Recently, several of our clients have asked us to advise them on how to properly dispose of their H1N1 vaccines. In researching the H1N1 vaccines, we have noticed that there is a good deal of confusion and conflicting recommendations regarding the proper disposal of this vaccine. In response to these requests and the different recommendations we're seeing, we're providing this summary of the disposal considerations as a service to our clients and to the broader healthcare community.

The U.S. Food and Drug Administration provides a wealth of information about all approved vaccines including the H1N1 vaccine. The section of their web site covering the H1N1 vaccine, Influenza A (H1N1) 2009 Monovalent, 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 H1N1 vaccine.

Several manufacturers produce 5 mL or 10 mL multidose vials of the vaccine 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 multidose vials of the H1N1 vaccine should be disposed of as federally hazardous waste.

In addition to producing a 5 mL multidose vial of the H1N1 vaccine, Novartis also produces a prefilled single-dose 0.5 mL syringe. 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.

Both Sanofi Pasteur and CSL Limited also produce preservative-free single-dose formulations of the H1N1 vaccine, in 0.25 mL dosages for children under 3 and in 0.5 mL dosages for everyone else. However, both 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. (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 H1N1 vaccine containing a live attenuated version of the H1N1 virus. 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.

Note that in some instances, it may be necessary to dispose of a syringe containing one of the above formulations which we've indicated should be considered federally hazardous. In these few cases, the full or partially empty syringe should be disposed of as dual hazardous and biohazardous waste.

In most cases, manufacturers create their seasonal flu vaccines using the same techniques described here. As a result, PharmEcology recommends disposal as federally hazardous waste for any formulation of the seasonal flu vaccine containing thimerosal as a preservative or trace thimerosal left over from the manufacturing process.

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 H1N1 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.