PharmE^® News Alert

PharmEcology® Presents Disposal Guidelines for the 2011-2012 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 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 2011 - 2012 vaccines are very similar to last year's vaccines. However, this year Sanofi Pasteur is producing a new intradermal vaccine, and Novartis is not shipping its Agriflu vaccine.

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. (Note that the Agriflu vaccine produced by Novartis is incorrectly listed on the FDA website. We spoke with Novartis who indicated they would not be shipping Agriflu this year and would inform the FDA of the incorrect listing.)

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.

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. This year Sanofi Pasteur is also 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 of 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.

• Posted: September 12, 2011