Immunization administration requires many elements, including vaccine vials, needles, syringes, and adhesive bandages.3 The COVID-19 pandemic has led to increased vigilance over the proper disposal of these materials as well as the necessity of using protective personal equipment (PPE).4 It is important to know the regulations for the proper disposal of items used during immunizations. For example, there must be a safe method to dispose of used needles and syringes, so sharps disposal containers should be present at all times during the immunization process.4,5 Different requirements for the disposal of empty or partially empty vaccine vials, as well as of PPE, which can be disposed of either as medical waste or in the regular trash depending on certain guidelines, are explained further in this article.4 Safe and compliant disposal is required and regulated by state and federal agencies.4 The regulatory requirements section of this article provides an overview of the relevant training and conditions.
Disposal requirements for empty vaccine vials are dependent upon the state in which the waste is generated. Some states allow disposal via trash, and others require sharps containers. If allowed, unused vials may be returned to the manufacturer, otherwise disposal options depend on the vaccine formulation. Full or partially used vials containing preservatives such as thimerosal (usually found in multidose vials) must be managed as a federally hazardous waste when the concentration of mercury is equal to or greater than 0.2 mg/L.7,8 Vials containing residual, preservative-free (ie, non-Resource Conservation and Recovery Act regulated [nonhazardous]), live attenuated formulations should be disposed of as biohazardous waste. Disposal of preservative-free non-live attenuated vaccines depends on state requirements.8
The safe use and disposal of sharps under the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens (BBP) Standard,9 as well as individual state rules on medical waste management, applies to immunizers working within the pharmacy and at off-site clinics. These rules require the immediate disposal of sharps waste into sharps disposal containers (see table) that are placed in visible locations and within easy horizontal reach.5,10 Once sharps disposal containers are filled to the premarked three-quarters line, the lids must be securely fastened prior to removing the container from the workplace.6 Some states require the maintenance of a medical waste management plan, which may require specified storage or labeling or sharps disposal container locations throughout a facility.11
Pharmacists who administer vaccinations at off-site immunization clinics where sharps disposal containers may travel between locations must comply with the Materials of Trade regulations of the Department of Transportation (DOT).12 These allow the transport of sharps in disposal containers as a part of doing business without having to register with the state as a medical waste transporter as long as the disposal container is closed, secured against movement during transport, and protected from damage.12 If using a mail-back system for sharps collection, the shipping box can serve as the outer packaging.12 Following proper protocol for sharps waste greatly reduces the risk of accidental needlesticks and facilitates the quick, safe replenishment of containers throughout the vaccination season.
PERSONAL PROTECTIVE EQUIPMENT
Many pharmacies and pharmacy clinics have incorporated PPE as a standard precautions tool to reduce the risk of disease transmission. The CDC recommends that pharmacy staff who interact with the public, while either immunizing or performing diagnostic tests, should use respirators or medical face masks as opposed to cloth face coverings.13 Such single-use PPE should be carefully removed and properly discarded after use.14 OSHA’s BBP Standard requires that items contaminated with blood or other potentially infectious materials be disposed of via a red biohazard bag or container,10 whereas some disposable PPE items, such as gowns, that are not deemed to be contaminated may be disposed of in the regular trash.14
OSHA’s BBP Standard (29 CFR 1910.1030) was first issued in 1991 to protect employees from occupational hazards posed by exposure to microorganisms present in human blood that can cause disease in humans.15 Employers must assess employee exposure to such contaminants using an exposure determination based on which job classifications entail specific duties and procedures with a reasonable expectation for exposure. They also must identify which waste streams in their workplace pose exposure risks. Depending upon the tasks their staff perform, pharmacies should have documentation of training on BBP and sharps safety, as well as medical waste management plan training if required by their respective state and/or organization.15,16
Compliant management of medical waste is not limited only to OSHA oversight but to other federal entities, including the DOT and Environmental Protection Agency. Health care facilities that have direct pickup of regulated medical waste (ie, sharps disposal containers and used health care materials) must ensure that employees involved in the packaging of that waste also have DOT hazmat training.17
As pharmacists continue to administer immunizations and educate their communities, disposal of medical waste continues to be regulated to ensure the safety of these communities. The results of a study published in 2018 found that people see their pharmacist up to 10 times as often as their primary care doctor.18 With the number of pharmacists growing every year and vaccinations remaining among the Health People 2030 goals, communities will keep benefiting from pharmacist-administered immunizations.19
Kathryn Kane-Neilson, BS, CT (ASCP), is a clinical specialist of regulatory compliance at Sharps Compliance, Inc, in Houston, Texas.
Robin Watson, MPH, MS, is a senior director of sales at Sharps Compliance.
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2. Petrelli F, Tiffi F, Scuri S, Nguyen CTT, Grappasonni I. The pharmacist’s role in health information, vaccination and health promotion. Ann Ig. 2019;31(4):309-315. doi:10.7416/ai.2019.2264
3. Supplies you may need at an immunization clinic. Immunization Action Coalition. March 2019. Accessed May 27, 2021. https://www.immunize.org/catg.d/p3046.pdf
4. Shaw G. Navigating PPE waste disposal during a pandemic. Pharmacy Practice News. April 20, 2021. Accessed May 18, 2021. https://www.pharmacypracticenews.com/Policy/Article/04-21/Navigating-PPE-Waste-Disposal-During-a-Pandemic/63065
5. Stop Sticks Campaign: sharps injuries: sharps disposal. CDC. Updated February 26, 2019. Accessed May 3, 2021. https://www.cdc.gov/nora/councils/hcsa/stopsticks/sharpsdisposal.html
6. Sharps disposal containers. FDA. Updated April 28, 2021. Accessed May 25, 2021. https://www.fda.gov/medical-devices/safely-using-sharps-needlesand-syringes-home-work-and-travel/sharps-disposal-containers
7. Vaccine Storage and Handling Toolkit. CDC. March 4, 2021. Accessed May 7, 2021. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf
8. PharmEcology provides disposal guidelines for the 2016-2017 flu season. PharmEcology. October 11, 2016. Accessed May 7, 2021. https://www.pharmecology.com/News/Details/20
9. Bloodborne pathogens and needlestick prevention. OSHA. Accessed May 27, 2021. www.osha.gov/SLTC/bloodbornepathogens/index.html
10. OSHA fact sheet: OSHA’s bloodborne pathogens standard. OSHA. January 2011. Accessed January 12, 2021. https://www.osha.gov/OshDoc/data_BloodborneFacts/bbfact01.pdf
11. Harris J. How state medical waste regulations differ. Sharps Compliance. April 5, 2017. Accessed May 18, 2021. https://blog.sharpsinc.com/statemedical-waste-regulations-differ
12. Materials of Trade Exceptions. CFR 173.6 (2011). Accessed May 10, 2021. https://www.govinfo.gov/content/pkg/CFR-2011-title49-vol2/xml/CFR-2011-title49-vol2-sec173-6.xml
13. Using personal protective equipment (PPE). CDC. Updated August 19, 2020. Accessed January 12, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html
14. Interim infection prevention and control recommendations for healthcare personnel during the coronavirus disease 2019 (COVID-19) pandemic. CDC. Updated February 23, 2021. Accessed May 5, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html
15. Bloodborne pathogens. OSHA. Accessed May 3, 2021. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030
16. Training requirements in OSHA standards. OSHA. 2015. Accessed May 10, 2021. https://www.osha.gov/sites/default/files/publications/osha2254.pdf
17. Pipeline and Hazardous Materials Safety Administration. Hazmat transportation training requirements. Department of Transportation. October 1, 2016. Accessed April 7, 2021. https://www.phmsa.dot.gov/training/hazmat/hazmat-transportation-training-requirements
18. Tsuyuki RT, Beahm NP, Okada H, Al Hamarneh YN. Pharmacists as accessible primary health care providers: review of the evidence. Can Pharm J (Ott). 2018;151(1):4-5. doi:10.1177/1715163517745517
19. Healthy People 2030. Infectious disease. Department of Health and Human Services. Accessed May 3, 2021. https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease