Vaccine Vial Disposal Guidelines

NOVEMBER 19, 2017
Jan Harris, MPH, BSDH. and Robin Watson, MPH, MS
Vaccine Vial Disposal Guidelines
The Immunization and Infectious Disease initiative for Healthy People 2020 goal is to “increase immunization rates and reduce preventable infectious diseases."1 While this sounds very concise and achievable, it is a daunting task. However, pharmacists’ ability to administer immunizations in all 50 states brings us closer to achieving the Healthy People 2020 goal. According to Carmen Catizone, DPh, executive director of the National Association of Boards of Pharmacy, “In fact, today, more patients are receiving their vaccinations from pharmacists than other healthcare providers."2

Access and affordability of immunizations greatly influence immunization rates. Under the Affordable Care Act, private plans are required to fully cover the cost of recommended vaccinations for adults and children as preventive medical care.3 Medicare, however, only fully covers influenza, pneumonia, and hepatitis B vaccines under Medicare Part B, while other vaccinations are covered under Medicare Part D or Advantage plans.4
In their attempt to be proactive about their health and the health of their family members, patients often come to their pharmacist with many questions, including: Which vaccine is best? How much will it cost? Does it cause any reactions? The pharmacist is trying to be as helpful as possible, and the proper procedure to dispose of the waste generated from administering an immunization may get lost in the process. This waste, if disposed of improperly, may pose a risk to the patient, pharmacist, or other employees or shoppers.

Pharmacists have been administering immunizations for years; however, questions still arise regarding certain aspects of proper medical waste management. In this article, we will address the following:
  • Compliant disposal of vaccine vials
  • Proper management of expired or recalled vaccines
  • Necessary labeling and storage of sharps, containers, and transport boxes

Disposal of Vaccine Vials and Expired/Recalled Vaccines
Most pharmacists have been made aware of the requirements for proper disposal of sharps, such as syringes, since they started administering immunizations. The Occupational Safety and Health Administration (OSHA) regulates the handling of sharps, and states regulate their final disposal. OSHA mandates that immunizers use safety syringes, and that these syringes be placed in a compliant sharps container immediately after use. Empty prefilled syringes, even if using safety syringes, must be placed into the sharps container as well.5,6

But what about medication vials or prefilled syringes that are unused? As noted by Leslie Yasinac from the infectious waste program for the State of South Carolina, and by Gina Vallone-Hood, CEHP, environmental administrator, Bureau of Environmental Health, State of Florida, both in written correspondence on December 1, 2015, disposal is determined not only by the contents of contents of the vaccine vial or syringe, but by the state (Table).5,7,8-18



Empty medication vials.
In some states, empty medication vials can be placed into the trash. Several states (noted in Table) require that they be placed into sharps containers.6

Unused medication vials. Always check with your supplier to see which, if any, of the unused vaccine can be returned. If the vials cannot be returned, disposal options must be determined based on the following vaccine delivery method:
  • Preservative-containing vaccines. If unused vaccine vials or syringes are expired or subject to recall, it must be determined whether the vaccine exceeds the maximum concentration (0.2 mg/L) for the toxicity characteristic for mercury per federal law. Look for 0.01% thimerosal. These vaccines must be disposed of as hazardous waste if the concentration is >0.2mg/L, or as medical waste destined for incineration if it is <0.2mg/L.7
  • Preservative-free live attenuated vaccines. Used vials should go into the sharps container. If they are expired or recalled, and remain in their original packaging, they may be sent for incineration with your medical waste disposal company.6
  • Preservative-free non-live attenuated vaccines. Your medical waste disposal company may be able to take the expired drugs for incineration. Check with your state as some states may allow these vaccines to be placed into the trash, even though this is not considered a best-management practice.6
Having unused vials of vaccine is not the optimal situation, but when disposal of them is necessary, follow the guidance of the manufacturer, the FDA and state regulations, and your organization’s policies. Alternatively, reach out to your medical waste disposal provider regarding the best option.6,17

Storing and Labeling Sharps and Waste Containers
Space for storing sharps and other medical waste containers is limited in the pharmacy. Both OSHA and state health and environmental agencies regulate the storage of containers holding sharps or other medical waste. The pharmacy medical waste management plan, required by many states, must indicate where sharps containers are located within the pharmacy. When not in use, sharps containers should be kept with their lids secured on a shelf or inside a storage cabinet away from unauthorized individuals. States may require that if sharps containers are stored in a cabinet for interim storage, a biohazard label must be placed on the cabinet door.6

OSHA requires that when an immunization is being given, a sharps container must be located as close as possible to that point of use.18 Therefore, if you do not have a secured/locked area where immunizations are given and the container can be kept, the sharps container must be carried with the lid secured to the point where the injection is given. Immediately following the injection, the syringe safety component is activated, and the syringe is placed into the sharps container. The lid is then secured and the sharps container is taken back to its permanent storage location.

If a transport or shipping box is used to contain filled sharps containers and is kept in a storage room, states may require that a biohazard label and other state-specific warning signage be placed on the room entrance to let employees know of the presence of a biohazard.6 For example, in California, the room entrance shall be marked with the international biohazard symbol, which must be readily legible from 5 feet.19 Regardless of your state medical waste regulations, it is important to remember that the generator/pharmacy is responsible for employee and customer safety.

As pharmacy-based immunization programs grow and expand to meet the Healthy People 2020 goal, it is imperative that the appropriate handling of sharps, vaccine vials, and sharps containers be researched, documented, and implemented for the safety of all.
 
JAN HARRIS, MPH, BSDH, is the director of environmental health and safety at Sharps Compliance, Inc, Houston, Texas.

ROBIN WATSON, MPH, MS, is the senior director of sales at Sharps Compliance, Inc, Houston, Texas.


References
  1. Immunization and infectious diseases. Office of Disease Prevention and Health Promotion website. healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases. Updated October 25, 2017. Accessed October 27, 2017.
  2. Carr T. Should you get vaccinated at the pharmacy? Consumer Reports website. consumerreports.org/vaccines/vaccinations-at-the-pharmacy. Published April 29, 2017. Accessed October 18, 2017.
  3. Preventive health services. Healthcare.gov website. healthcare.gov/coverage/preventive-care-benefits/. Accessed October 27, 2017.
  4. Medicare coverage of vaccines and immunizations. Medicare Interactive website. medicareinteractive.org/get-answers/medicare-covered-services/preventive-care-services/medicare-coverage-of-vaccines-and-immunizations. Accessed October 15, 2017.
  5. Enforcement procedures for the occupational exposure to bloodborne pathogens. Occupational Safety and Health Administration (OSHA) website. osha.gov/pls/oshaweb/owadisp.show_document?p_table=directives&p_id=2570. Published November 27, 2001. Accessed October 18, 2017.
  6. State regulatory map–medical waste. Sharps Compliance website. sharpsinc.com/regulatory-compliance. Accessed October 18, 2017.
  7. Hazardous waste characteristics. United States Environmental Protection Agency website. epa.gov/sites/production/files/2016-01/documents/hw-char.pdf. Published October 2009. Accessed October 18, 2017.
  8. Regulations governing solid waste. State of Delaware website. regulations.delaware.gov/AdminCode/title7/1000/1300/1301.shtml#TopOfPage. Accessed October 18, 2017.
  9. Iowa Code §455B.501.
  10. Environmental protection. Illinois Pollution Control Board website. ipcb.state.il.us/documents/dsweb/Get/Document-12277. Accessed October 18, 2017.
  11. Minimum requirements for the management of medical or biological waste. Massachusetts government website. mass.gov/courts/docs/lawlib/104-105cmr/105cmr480.pdf. Accessed October 18, 2017.
  12. Managing vaccine: how to keep vaccines viable and patients protected. Minnesota Department of Health website. health.state.mn.us/divs/idepc/immunize/hcp/provguide/mangvax.pdf. Published July 2011. Accessed October 18, 2017.
  13. NJ AC §7:26-3A.1 (2009).
  14. Infectious waste management. State of Oregon website. arcweb.sos.state.or.us/pages/rules/oars_300/oar_333/333_056.html. Updated August 15, 2017. Accessed October 18, 2017.
  15. Forum questions and answers. West Virginia Department of Health and Human Resources website. wvdhhr.org/wvimw/forum.htm. Accessed October 18, 2017.
  16. Solid waste regulations. New Jersey Department of Environmental Protection website. nj.gov/dep/dshw/resource/26sch03a.pdf. Accessed October 18, 2017.
  17. Recall procedures. FDA website. fda.gov/downloads/iceci/compliancemanuals/regulatoryproceduresmanual/ucm074312.pdf. Published October 2013. Accessed September 19, 2017.
  18. Bloodborne pathogens. OSHA website. osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051. Accessed October 18, 2017.
  19. California Health and Safety Code. §§117600-118360 (2017).


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