Jan Harris, MPH, BSDH.

The Immunization and Infectious Disease initiative for Healthy People 2020 goal is to “increase immunization rates and reduce preventable infectious diseases."

 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."

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.

 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.

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:

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.

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 (

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.

 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:

 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.

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.

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.

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.

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.

OSHA requires that when an immunization is being given, a sharps container must be located as close as possible to that point of use.

 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.

 For example, in California, the room entrance shall be marked with the international biohazard symbol, which must be readily legible from 5 feet.

 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.

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.

Carr T. Should you get vaccinated at the pharmacy? 

 website. consumerreports.org/vaccines/vaccinations-at-the-pharmacy. Published April 29, 2017. Accessed October 18, 2017.

Preventive health services. Healthcare.gov website. healthcare.gov/coverage/preventive-care-benefits/. Accessed October 27, 2017.

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.

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.

State regulatory map—medical waste. Sharps Compliance website. sharpsinc.com/regulatory-compliance. Accessed October 18, 2017.

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.

Regulations governing solid waste. State of Delaware website. regulations.delaware.gov/AdminCode/title7/1000/1300/1301.shtml#TopOfPage. Accessed October 18, 2017.

Environmental protection. Illinois Pollution Control Board website. ipcb.state.il.us/documents/dsweb/Get/Document-12277. Accessed October 18, 2017.

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.

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.

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.

Forum questions and answers. West Virginia Department of Health and Human Resources website. wvdhhr.org/wvimw/forum.htm. Accessed October 18, 2017.

Solid waste regulations. New Jersey Department of Environmental Protection website. nj.gov/dep/dshw/resource/26sch03a.pdf. Accessed October 18, 2017.

Recall procedures. FDA website. fda.gov/downloads/iceci/compliancemanuals/regulatoryproceduresmanual/ucm074312.pdf. Published October 2013. Accessed September 19, 2017.

Bloodborne pathogens. OSHA website. osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051. Accessed October 18, 2017.

California Health and Safety Code. §§117600-118360 (2017).

Articles

The Immunization and Infectious Disease initiative for Healthy People 2020 goal is to “increase immunization rates and reduce preventable infectious diseases.”

Vaccine Vial Disposal Guidelines

The CDC published the startling fact that “

 in the workplace costs US businesses approximately $10.4 billion each season.”

 Employers consistently look for programs to mitigate the impact influenza has on productivity in the workplace. Innovative pharmacists have taken 

, including the influenza vaccine, to off-site clinics located at employer sites, churches, malls, and various other community locations, with the intent to keep people healthy during the annual flu season, rather than having them experience extended illnesses and loss of productivity.

Not only is it important to follow state and federal regulations regarding vaccine administration, once a pharmacist has completed an off-site clinic, there are often questions regarding regulations surrounding the transport of full sharps containers. These regulations are as important as other considerations, such as insurance and billing, and include those from the Occupational Safety and Health Administration (OSHA), individual states, and the Department of Transportation (DOT).

COMPLYING WITH OSHA AND STATE REGULATIONS 

Immunizers must comply with OSHA’s Bloodborne Pathogens Standard, as well as individual state rules on medical waste management,

 whether inside the pharmacy or at an off-site clinic. Pharmacists should be clear on sharps safety, the use of safety syringes, and disposal of syringes immediately after injection. In addition, there are a few disposal considerations that are important for immunizing pharmacists to remember:

Always bring a sharps container and place it within arm’s reach and peripheral vision of the immunizer.

After the injection, activate the safety device and immediately place the syringe into the sharps container.

Secure the lid on the sharps container before transporting it within the facility, to the pharmacist’s vehicle, and during the drive back to the pharmacy.

Have a small trash bag to contain materials generated during the clinic, such as alcohol swabs, Band-Aids, syringe packaging and caps, and vaccine vials.

Most states allow trash disposal of vaccine vials, unless they contain residual live vaccine, in which case, they must be disposed of in a sharps container.

Empty multidose vials can be placed in the trash. An unused or partial vial would be considered a hazardous waste pharmaceutical and must be disposed of as such.

Some states require all glass vials to be disposed of in sharps containers.

Pharmacists transporting full, or partially full, sharps containers between the pharmacy and the site of the vaccination clinic must comply with the DOT Materials of Trade (MOT) Exception

, which applies to all states. The MOT Exception allows pharmacists to transport sharps in a sharps container, as a part of doing business, without having to register with the state as a medical waste transporter. There are requirements that must be followed:

The sharps container must be securely closed and placed within packaging that is strong, tight, securely closed, and secured against movement during transport.

Nonsharps regulated medical waste must be placed in a single or combination package.

If using a mailback system for sharps collection, the shipping box can serve as the outer packaging. Carrying the sharps container inside the shipping box when traveling will assure compliance.

If immunizing at an off-site clinic in California, a log must be maintained with the sharps container packaging per California Health and Safety Code, Section 11796, Chapter 4(a).

 According to an e-mail from Alison Dabney from the California Department of Public Health, if using a mailback disposal system, a completed tracking form will suffice for the log.

The pharmacist or sponsor of the off-site clinic must e-mail the local enforcement agency at least 72 hours before the event.

Prior to participating in an off-site clinic, the pharmacist should have documentation of his/her annual bloodborne pathogens and sharps safety training

; medical waste management plan training, if required by the state

; DOT hazmat training as prescribed in 49 CFR Part 172, Subpart H6; and training on any applicable organization policies and procedures. For more information on the federal and state trainings needed for specific waste disposal programs, pharmacies can contact their medical waste disposal companies.

In addition to pharmacists providing immunizations inside of pharmacies, their participation in off-site clinics provides a valuable and convenient service to communities and employers. Complying with state and federal regulations that govern the transportation of full sharps containers generated at these clinics is a public safety and risk management responsibility.

1. Make it your business to fight the flu. CDC website. cdc.gov/flu/pdf/business/ toolkit_seasonal_flu_for_businesses_and_employers.pdf. Accessed June 20, 2017.

2. Bloodborne pathogens and needlestick prevention. Federal Occupational Safety and Health Administration website. osha.gov/SLTC/bloodbornepathogens/index. html. Accessed June 20, 2017.

3. State regulatory map—medical waste. Sharps Compliance website. sharpsinc. com/regulatory-compliance. Accessed June 20, 2017.

4. Materials of trade exceptions, 49 CFR § 173.6 (2016). Government Printing Office website. gpo.gov/fdsys/pkg/CFR-2016-title49-vol2/xml/CFR-2016-title49- vol2-sec173-6.xml. Accessed June 20, 2017.

5. Medical Waste Management Act. California Department of Public Health website. archive.cdph.ca.gov/certlic/medicalwaste/Documents/MedicalWaste/2013/ MedicalWasteManagementAct.pdf. Accessed June 20, 2017.

6. Hazardous materials transportation training requirements. U.S. Department of Transportation website. phmsa.dot.gov/staticfiles/PHMSA/Hazmat/digipak/pdfs/ presentation/Training_Requirements(04_07).pdf. Accessed July 18, 2017.

Jan Harris, MPH, BSDH, is the director of environmental health and safety at Sharps Compliance, Inc.

Robin Watson, MPH, MS, is the director of client services at Sharps Compliance, Inc.

Wanda Lingner, RN, BSN, is a clinical specialist of strategic regulatory customer compliance at Sharps Compliance, Inc.

Innovative pharmacists have taken immunizations, including the influenza vaccine, to off-site clinics located at employer sites, churches, malls, and various other community locations, with the intent to keep people healthy during the annual flu season rather than having them experience extended illnesses and loss of productivity.

Sharps Disposal: Assuring Regulatory Compliance During Off-Site Vaccination Clinics

A day does not go by without pharmacists, like most Americans, hearing about the overwhelming prescription opioid epidemic. In the past, when patients or visitors asked hospital personnel how to dispose of their unused or expired drugs, the answer included flushing them or mixing them with coffee grounds and throwing them out. However, due to the passage of the Secure and Responsible Drug Disposal Act of 2010,

 implemented by the DEA’s Final Rule on Disposal of Controlled Substances released on September 9, 2014,

 there now are solutions that provide a safe way to prevent opioid diversion and are better for the environment.

Hospitals with onsite pharmacies are one of several types of health care institutions authorized by the DEA to collect controlled and noncontrolled drugs from consumers through onsite kiosks. However, due to the need to comply with the regulations, plan the logistics, and market the program to the community, hospitals have asked questions such as, “How do we comply with the DEA?” “Where does a hospital get a kiosk?” “How does it get emptied?” “How are the collected drugs transported and destroyed?”

The information below can assist with answering these and other questions, as well as outline the steps to implementing a drug collection program:

The hospital must have an onsite pharmacy and modify its DEA registration to become an authorized collector, for which there is no fee.

The hospital must select a DEA-registered reverse distributor that can provide the kiosk, inner liners for the drugs, transportation, schedule II storage, destruction, and documentation. Like medical waste disposal companies, the vendor is strictly regulated.

 The kiosk and inside container (or inner liner) must meet criteria defined by the DEA.

The vendor must supply a Department of Transportation special permit to transport the material.

The kiosk must have a locking door through which the drugs are dropped. It is recommended that the door providing access to remove the inner liner has 2 separately keyed safety locks. The goal is to add as much security as possible to prevent diversion.

Signage on the receptacle will also help guide users as to which materials can and cannot be deposited into the kiosk, including “no sharps disposal.”

The hospital must provide the vendor with a copy of their “Registrant-Collector” certificate.

The hospital must secure the kiosk in a public area in view of hospital personnel, but not near the emergency department.

When full, 2 authorized hospital employees open the kiosk, close the inner liner, and either store the container in a locked area or send it through a common carrier (eg, UPS) or authorized reverse distributor, as indicated by the vendor.

Each step of placement, removal, storage, and transfer must be documented in a specific manner to comply with the DEA. The reverse distributor vendor can supply the proper forms.

The DEA’s Drug Disposal website is a comprehensive resource, providing easy access to register as a collector, FAQs, industry-specific factsheets, and a “wastage” letter clarifying the disposal of pharmaceutical wastage.

 The final rule does not change the way inventory controlled substances or drug wastage are accounted for and disposed; however, the DEA letter4 clarifies that practitioners shall continue to record the destruction of medication wastage in accordance with 21 CFR§1304.22(c). The letter emphasizes the following:

A controlled substance that has been ordered and dispensed to a patient, but not fully administered, is considered wastage, not inventory, and should be disposed of per 21 CFR §1304.22(c), as well as all applicable federal, state, tribal, and local laws and regulations. No DEA Form 41 is required.

In addition to inventory drugs, drug wastage may not be placed in a disposal kiosk.

Hospital pharmacists play a major role in educating hospital personnel, patients, and visitors on safe management of pharmaceuticals. Hospitals that provide a proper and compliant pharmaceutical collection and destruction program participate in the prevention of drug misuse, which has the potential to reduce hospital visits and deaths in the communities that they serve. 

Jan Harris, MPH, BSDH, is director, Environmental, Health and Safety at Sharps Compliance, Inc.

Robin Watson, MPH, MS, is director of Client Services at Sharps Compliance, Inc.

Wanda Lingner, RN, BSN, is clinical specialist — Strategic Regulatory Customer Compliance at Sharps Compliance, Inc.

One Hundred Eleventh Congress of the United States of America; S. 3397 [act]. DEA Diversion Control Division website. 

www.deadiversion.usdoj.gov/drug_disposal/non_registrant/s_3397.pdf

. Published September 9, 2014. Accessed June 23, 2017.

21 CFR Parts 1300, 1301, 1304, et al. Disposal of controlled substances; final rule. DEA Diversion Control Division website. 

www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf

Rannazzisi JT. Dear practitioner letter. 

www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf

. Published October 17, 2014. Accessed June 23, 2017.

A day does not go by without pharmacists, like most Americans, hearing about the overwhelming prescription opioid epidemic.

A Proactive Approach to Reducing the Prescription Opioid Epidemic in Your Community

Do patients ever come into your pharmacy holding a bag of unused and expired medications and asking you to take them?

Patients and their caregivers want to do the right thing in that they don’t want to keep unused medications in their homes with the potential risk of an unauthorized individual—perhaps a child or grandchild&mdash;ingesting them. They also don’t want to just throw those unused medications into their trash, where they would end up contaminating landfill leachate and, ultimately, the water supply.

Many patients have also heard that flushing unused medications is bad for the environment in that it can contaminate our lakes and rivers, causing mutations of fish and perhaps even harming humans. To prevent the dangers that arise when disposing of unused medications improperly, these caring individuals ask their trusted pharmacists for guidance.

The need for a simple, reliable, and effective solution is growing more crucial, as the increasing “abuse of certain prescription drugs—opioids, central nervous system depressants, and stimulants&mdash;can lead to a variety of adverse health effects, including addiction,” according to the National Institute on Drug Abuse (NIDA).

“Among those who reported past-year nonmedical use of a prescription drug, nearly 14% met criteria for abuse of or dependence on it,” the NIDA reported. “The reasons for the high prevalence of prescription drug abuse vary by age, gender, and other factors, but likely include greater availability.”

Because of this “greater availability”, the Drug Enforcement Administration (DEA), under the Department of Justice (DOJ), took action.

On September 9, 2014, the DOJ published a final rule to implement the Secure and Responsible Drug Disposal Act of 2010, which expanded the options available to collect controlled substances from ultimate users (eg, patients) for the purpose of disposal. This rule allows registered collectors, such as 

, to update their DEA registration to become a collector and place receptacles at their pharmacies for the collection and disposal of ultimate users’ controlled substances (Schedules II-V).

As outlined in § 1317.60 of the Disposal of Controlled Substance Regulations, a collection receptacle is composed of a substantially constructed permanent outer container and a removable inner liner. Collection receptacles must be securely fastened to a permanent structure, and the outer container must include a small opening that allows contents to be added to the inner liner but does not allow removal of the inner liner’s contents.

In a retail pharmacy, this receptacle is placed in front of the pharmacy within eyesight of employees, so that they can monitor use of the receptacle and answer any questions that the patient may have during the process. 

The process of managing the installed receptacle is easy and streamlined. Once full, the liner is removed and replaced with a new one. The inner liners are returned via prepaid postage and shipped via common carrier to a DEA-registered reverse distributor facility for proper destruction. Since drug diversion is always a concern, all of these steps must be conducted by 2 pharmacy employees.

King Kullen, a grocery/pharmacy chain with stores located throughout Long Island, New York, recently installed receptacles in its stores that have pharmacies, and according to Albert W. Hesse Jr., RPH, King Kullen’s Director of Pharmacy, “Expanding the program to all drugs is critical to providing a one stop for safe disposal for all our customers.”

“This critical expansion will only continue to build upon the success of the program,” he said. “We are gratified that people have heard our message and come to our stores to dispose of their unused or outdated medications. It is a strong signal that these types of programs are needed. People understand their role in protecting our waters and getting unused medications out of the home.”

Intermountain Healthcare, a not-for-profit health system based in Salt Lake City, Utah, with 22 hospitals, clinics, and services, implemented a drug disposal receptacle program in 2015.

“Through a 3-pronged effort of public awareness, provider education, and treatment services, we aim to reduce misuse and abuse of prescription medications among our patients and within the communities in which we operate,” stated Mikelle Moore, vice president of community benefit for Intermountain, about why the receptacles are being used.

Placing a receptacle in the pharmacy offers additional benefits. For instance, it can be an excellent forum for discussions with patients regarding their medication use and compliance. It can also provide an opening for patients to ask that question about their medications they were always too afraid to ask. The placement of receptacles can even potentially generate additional foot traffic.

All of these benefits, plus an emphasis on reducing the possibility of inappropriate use by unauthorized individuals and contamination of the environment, are valuable reasons to offer current and prospective customers this convenient, safe, and compliant disposal option for unused medications.

Robin Watson, MPH, MS, is the Director of National Accounts for Sharps Compliance, Inc, a 

nationwide provider of solutions for improving safety, efficiency, and costs related to the proper disposal of medical waste by health care professionals.

Jan Harris, MPH, BSDH, is the Director of Environmental Health & Safety for Sharps Compliance, Inc.