The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has sparked much fear and anxiety during the coronavirus disease 2019 (COVID-19) pandemic. As a result, many individuals have decided to cancel scheduled physician visits, including visits to get vaccinated, over concerns of SARS-CoV-2 infection.

 In addition, many physician offices had reduced hours or temporary closings due to stay-at-home orders, limiting access.

 This decline in vaccinations has put many patients, especially pediatric patients, and communities at risk from otherwise vaccine-preventable diseases.

 However, as stay-at-home orders lift and communities start returning to a new sense of normal, pharmacists and pharmacies are well positioned to help individuals catch up on missed and overdue vaccines.

 The need for pharmacist immunization services is even more apparent. At the directive of the US Department of Health & Human Services (HHS), pharmacists can now play a larger role in increasing vaccination rates.

 Therefore, this article includes highlights of how pharmacies can continue to be safe and convenient settings in which patients can receive vaccines, and it explores the pharmacy’s role in COVID-19 vaccine administration, when such a vaccine becomes available.

IMMUNIZATION AUTHORIZATION FOR PHARMACISTS EXTENDED ACROSS THE UNITED STATES 

Prior to the pandemic, the physician’s office was the most common place to receive an influenza vaccine. Data from the early 2017 flu season indicate that 64.6% of children and 34.7% of adults were vaccinated in their physicians’ offices.

 However, since the pandemic began, a notable decrease in the administration of noninfluenza pediatric vaccines (for individuals aged between 24 months and 18 years) occurred, likely as a result of parental concerns regarding visits to the pediatrician’s office and possibly exposing their children to SARS-CoV-2.

 In response, HHS issued an amendment to the Public Readiness and Emergency Preparedness (PREP) Act in August 2020, which allows pharmacists to order those vaccines routinely recommended by the Advisory Committee on Immunization Practices and administer them to individuals aged 3 to 18 years.

 Although many states had already permitted pharmacists to order and administer vaccines to this age group, the amendment expands this authorization to pharmacists across all states to allow for more comprehensive and convenient care.

New HHS Regulations Expand Pharmacists’ Role in Childhood Immunizations

PHARMACIES AS ACCESSIBLE, COST-EFFECTIVE, AND SAFE PLACES TO RECEIVE VACCINES 

Community pharmacy—based immunization campaigns will be especially important during the 2020-2021 influenza season due to the risk of coinfection with SARS-CoV-2.

 Patients must be made aware that their local community pharmacy is an accessible, cost-effective, and safe place to receive vaccines.

 During the 2009 H1N1 influenza pandemic, the pharmacy was found to be the second-most preferred site for vaccination, after the physician’s office; this was associated with the patient’s comfort with their pharmacist as an immunizer and source of knowledge.

 Pharmacists can systematically assess vaccination histories, identify immunization gaps, and provide dedicated time to discuss the vaccine before its administration.

An appeal to many patients is that often, no appointment is required, and the convenience of walking into the pharmacy at any time to be immunized is appreciated.

 However, pharmacies may also decide to implement an appointment-based system to help with social distancing and patient wait times.

 Appointmentbased immunization programs have permitted pharmacists to methodically assess patient vaccination histories and facilitate better vaccine discussions.

 Regardless of whether the pharmacy adopts a walk-in model or an appointment-based one, all pharmacy team members must be active in promoting vaccinations in the pharmacy. Emails, text messages, and automated calls to remind patients during influenza season or about other vaccines can also be used to market immunization services.

As more health care offices open up to wellness visits, patients may still be hesitant to receive vaccines; however, pharmacists can help address and resolve vaccine hesitancy. Historically, hesitancy to become vaccinated has been a recurring threat that negatively affects immunization campaigns.

 In 2019, the World Health Organization identified vaccine hesitancy as being among the top 10 threats to global health.

 To address vaccine hesitancy, pharmacists can develop a communication plan to educate patients and aid in informed decision-making.

 The communication plan should include preparing responses to antivaccine behaviors or comments, such as the expression of concerns about adverse events; tailoring messages to the target population; identifying underlying causes of the target population’s hesitancy, then brainstorming resolutions; and campaigning through a multitude of communication methods geared toward the target population.

In anticipation of increased vaccination rates, pharmacies must also minimize the risk of exposing both staff and patients to SARS-CoV-2 and implement standards to do so. Personnel should adhere to personal protective equipment recommendations and cleaning protocols to ensure the safety of all involved as outlined by the CDC. Engineering controls should be used to limit close contact with others. These controls include

using signage/barriers and floor markers to guide waiting patients to remain 6 ft apart;

installing clear barriers made of material such as plexiglass to shield against respiratory droplets;

regularly disinfecting patient service and contact areas, as well as phones, workstations, keyboards, and doorknobs; and

removing shared items such as magazines from the waiting area.

In addition to typical vaccine screenings, pharmacies should screen for signs and symptoms of SARS-CoV-2 infection. Pharmacies may also consider utilizing outdoor spaces including a drive-through model to vaccinate.

PHARMACISTS’ ROLE IN OPERATION WARP SPEED COVID-19 VACCINE ADMINISTRATION PLAN 

To accelerate the development and manufacture of the COVID- 19 vaccine, the HHS, in partnership with other federal agencies and private firms, created Operation Warp Speed.

 The goal of the operation is to produce and deliver 300 million doses of a COVID-19 vaccine beginning in January 2021.

 According to the results of a recent study by Reiter and colleagues, 69% of Americans were willing to get vaccinated with the COVID-19 vaccine when it becomes available.

 The HHS determined that increased accessibility of the vaccine was vital to the COVID- 19 response effort, and as a result, issued guidance under the PREP Act allowing pharmacists to order and administer the vaccine when it becomes available.

 Accessibility to pharmacists will be vital in administering the COVID-19 vaccine in order to achieve high vaccination rates.

 It will also be important to educate patients on the efficacy and safety of the vaccine in order for the maximum number of individuals to become vaccinated, as individuals are more likely to get vaccinated if they believe their health care provider recommends the vaccine.

Safety measures taken in response to the COVID-19 pandemic have contributed to a decrease in vaccination rates, particularly in the pediatric population. During these unusual times, the community pharmacy continues to be an ideal environment to administer vaccines. With the support of policy makers, pharmacists have been granted the ability to vaccinate individuals aged as young as 3 years, in addition to being able to provide the COVID-19 vaccine when it becomes available. Now that flu season is around the corner, there is an opportunity for pharmacists to educate their patients on the importance of receiving the influenza vaccine, as well as any other vaccines or vaccine series for which the patient may be overdue. Community pharmacists are widely accessible to the public, knowledgeable, and very capable vaccination providers, and therefore they will play a key role during this upcoming influenza season and when the COVID-19 vaccine becomes available.

, is the Community Pharmacy Enhanced Services Networks Executive Pharmacy Resident at Chapman University School of Pharmacy in Irvine, California.

KARL HESS, PHARMD, APH, CTH, FCPHA, FAPHA, AFTM RCPS (GLASG)

, is an associate professor of pharmacy practice, director of community pharmacy practice innovations, and Community Pharmacy Enhanced Services Networks Executive Pharmacy Residency program director at Chapman University School of Pharmacy in Irvine, California.

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Pharmacists can now play a larger role in increasing vaccination rates, while pharmacies can continue to be safe and convenient settings in which patients can receive vaccines.

Pharmacy as a Destination for Receiving Vaccines During the COVID-19 Pandemic

As we prepare for the 2020 influenza season, the additional effects of coronavirus disease 2019 (COVID-19) may lead to pharmacy technicians taking on nontraditional responsibilities to meet the heightened demand for health care. As a result, pharmacies, which are the second most common location for administering influenza vaccinations to adults, according to data on the 2018-2019 influenza season,

 may benefit from staff with advanced certifications. The 2017 administrative ruling in Idaho allowing adequately trained pharmacy technicians to administer immunizations has forged a path toward relieving the burden that pharmacists typically carry.

 By 2019, pharmacy technicians in Idaho had administered approximately 25,000 vaccinations with no reported adverse events or errors, according to Idaho’s board of pharmacy.

 In the 3 years since the groundbreaking law, 6 additional states allowed (or are in the process of allowing) technicians to administer immunizations, with more states considering similar legislation (see figure).

 This article provides information for pharmacy technicians on immunization administration certification and resources for further engagement with the pharmacy technician community. Despite being highly regulated, the pharmacy industry considers this a positive change, and technicians are garnering support from key industry leaders as they rally for more active roles and responsibility.

It is an exciting time to be a pharmacy technician, and in states where technicianadministered immunization is allowed, there are several points to consider. Some of these key points to keep in mind include the following:

 Talk with your pharmacy organization or pharmacy manager to understand the current policy and rules for technician-administered immunizations and what opportunities may exist. Understanding your organization’s viewpoint on advanced pharmacy technician duties and responsibilities may assist you in creating an applicable professional development plan that leads to future success.

 The requirements for training vary in each of the states that allow technicians to carry out immunizations, 4 ranging from 1 hour of education to the completion of training in current cardiopulmonary resuscitation techniques approved by the American Society of Health-System Pharmacists. In some states, holding a national pharmacy technician certification, CPhT, may also be required. It is important to research and learn what the specific training requirements are for your state, if applicable, so you can actively seek out the proper training to better prepare yourself to perform at a higher level.

 Look into opportunities to advocate for technicians, both inside and outside your organization. Get involved with local, state, or national associations to learn more about how you can affect the advancement of pharmacy technicians. Also, see if your state board of pharmacy includes a technician member. If they don’t, try advocating for one.

 Check with your organization to see if they have a technician advocacy group or a technician advisory committee and request to be considered or included, or actively participate. Reach out to organizations that share the same commitment to technicians and look for opportunities to write about, talk about, or engage in other activities (ie, committees, work groups, or advisory boards).

In March 2020, the American Pharmacists Association (APhA) House of Delegates, which represents over 60,000 pharmacists nationwide,introduced and adopted a policy statement regarding pharmacy technicians’ role in immunization administration at the annual meeting.

 In August 2020, the National Healthcareer Association spearheaded an initiative to form the Coalition for the Advancement of Pharmacy Technician Practice.

 The coalition’s purpose and mission is to bring pharmacy technician organizations and associations together to support the efforts of advancing pharmacy technicians (during the current health crisis and beyond), recognizing that regulation is often the largest barrier to moving forward.

 The coalition and its partners—such as 

, the National Community Pharmacists Association and the National Association of Chain Drug Stores—are actively engaged in advocating with state boards of pharmacy to recognize trained technicians and allow them to perform the technical function of administering immunizations.

 This new focus demonstrates growing industry support of technicians’ abilities and value within the pharmacy workforce.

 About 40% of pharmacy employers reported that pharmacy technicians have more responsibility in 2020 compared with 2019.

 Although growth may be slow, the level of support for the pharmacy technician workforce continues to increase, affording technicians the ability to work at the top of their credential or license.

 This continued support of technician advancement will only serve to improve the already high level of care being delivered by pharmacy professionals across our communities.  

, is the executive director of education and advocacy at the National Healthcareer Association in Leawood, Kansas.

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Pharmacy technicians are garnering support from key industry leaders as they rally for more active roles and responsibility.

How Pharmacy Technicians Can Be Certified to Administer Immunizations in 2020

In an effort to avoid further strain on a health care system already responding to the coronavirus disease 2019 (COVID-19) global pandemic, the CDC stressed the increased importance of receiving this year’s seasonal influenza vaccination, which is recommended for everyone 6 months or older.

 The need to reduce this potential concurrent system strain has caused health care professionals, government officials, and research experts to use social media and news outlets to encourage patients to receive vaccines earlier in the season compared with last year. Additionally, in response to an expected increase in demand for the influenza vaccine, manufacturers plan to ramp up production and pharmacies are ready for an unprecedented busy season.

 A thorough understanding of immunization billing processes for Medicare, Medicaid, and other third-party payers will be critical to ensure pharmacy staff can efficiently serve their communities and facilitate a smooth reimbursement process. This review of third-party payer immunization guidelines includes considerations for seasonal immunizations and the COVID-19 vaccine(s) under development.

A large portion of patients receiving influenza and other eligible vaccines in community pharmacies have commercial health insurance with prescription coverage.

For example, approximately 52% of children 5 years or younger are covered by private insurance.

 To successfully bill for immunizations, the pharmacy must be contracted with the patient’s specific plan. If contracted, pharmacies can typically bill for influenza and other vaccines in real time using the patient’s prescription insurance information. In some cases, the medical plan must be billed rather than the drug benefit plan, in which case the pharmacy must be contracted to bill the medical plan instead. For medical billing, an immediate adjudication response is not common, although there are billing systems available that can check eligibility and provide a cost estimate. It is important to notify these patients that they may be responsible for a future co-pay—up to the full cost of the vaccine&mdash;after their medical plan finishes the adjudication process within a couple of weeks, especially if they have not met their plan’s deductible.

Often, a more complicated patient population to successfully bill for regarding influenza vaccines includes those with Medicare coverage, most of whom are 65 years or older. Most Medicare beneficiaries are eligible to receive 1 influenza vaccine each influenza season with direct pharmacy reimbursement by Medicare Part B or through a Medicare Advantage plan (Part C),

 assuming they choose a pharmacy that is contracted with Medicare.

 When billing Medicare Part B, pharmacies will need the patient’s identification number, which can be found on their red, white, and blue card.

 For most pharmacy software systems, Medicare Part B is not billed directly through online adjudication but rather through the mass immunization roster billing process in which a Medicare-enrolled provider, such as a pharmacy chain, works with a Medicare administrative contractor to compile a list of claims to submit through a centralized process on the pharmacy chain’s behalf.

 Medicare Part B covers medical and preventive services including influenza, pneumococcal, and hepatitis B vaccines.

 For these types of vaccines, there is typically zero copay for the patient. Of note, Medicare Part B will also pay for other vaccines as treatment after potential exposure has occurred, such as when a patient steps on a rusty nail and is at risk of contracting tetanus or has been bitten by an animal suspected of spreading rabies.9 For other types of regular preventive vaccines not covered by Part B, Medicare Part D may pay, assuming the patient has this coverage. However, Medicare Part D may require prior authorizations and/or additional copays for the provision of vaccinations.

MEDICAID COVERAGE AND OUT-OF-POCKET PAYMENTS 

Pharmacies should be prepared to offer immunization solutions or referrals for patients covered by local Medicaid plans. Medicaid plans do not have a standardized approach for vaccination administration and billing. Each state and county’s Medicaid plan decides which vaccines will be covered, who can provide those vaccines, and the vaccine and/or administration reimbursement rates.

 Pharmacists can familiarize themselves with the local Medicaid vaccine billing procedures, which are often available online or via a toll-free phone number.

There also will be uninsured patients and others who choose to pay for vaccinations out of pocket. As influenza symptoms may overlap with the symptoms of COVID-19, the cost of an unnecessary 2-week quarantine or the fear of needing care in overloaded health care facilities could correlate to an uptick in a patient’s willingness to pay out of pocket for the vaccine. Pharmacies can offer deals or incentives to help ease the financial burden of patients who need to pay out of pocket to receive an influenza shot. Such options include coupons or gift cards that can be used on store merchandise, as well as discount cards for the shot itself. At most big-box pharmacy chains, contracted discount cards also may give uninsured patients a price break.

One last option for patients is to receive their influenza vaccine for free through a government agency or a nonprofit local health organization.

 For example, the CDC has taken the unusual step of purchasing 7 million doses to be distributed to states for adult vaccination.

 Furthermore, eligible children can receive vaccines at no cost through the Vaccines for Children (VFC) program.

 These free vaccines are subject to state-specific distribution and billing limitations, and many pharmacies choose not to participate because of no or very low administration reimbursement. In states paying the pharmacy an administration fee through the VFC program, these vaccines are most commonly billed through the state’s Medicaid plan.

An understanding of how influenza and other vaccines are billed is important, especially when one confronts the ongoing COVID-19 global pandemic for which the country is expected to have 1 or more vaccines available soon. The Coronavirus Aid, Relief, and Economic Security (CARES) Act requires all health plans to pay the entire cost of the vaccine as a preventive health service, although it may not be covered immediately. The approved vaccine for COVID-19 would have to be recommended by the US Preventive Services Task Force, the CDC, and the Advisory Committee on Immunization Practices. When a vaccine is recommended, the CARES Act will accelerate required coverage from the standard wait of up to 1 year down to 15 days from the date of approval.

 Once the vaccine is covered, pharmacies should be able to bill using the same procedure as for other vaccinations.

The pharmacist remains a critical member of the health care system, providing vaccinations that help promote health, prevent disease, and minimize strain on other segments of the system. All pharmacy staff must be knowledgeable about the billing of various vaccines, as well as the options available to patients when they are paying for vaccines. This influenza season, pharmacists will continue to provide essential services for America’s communities, including an expected record number of influenza vaccines followed by or concurrent with a potential COVID-19 vaccination effort. 

, is the corporate pharmacy trainer and residency program director for Albertsons Companies in Phoenix, Arizona.

, is a residency program director and student experiential coordinator at Albertsons Companies in Portland, Oregon. He is an alumnus of Oregon State University College of Pharmacy in Corvallis.

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A thorough understanding of immunization billing processes for Medicare, Medicaid, and other third-party payers will be critical to ensure pharmacy staff can efficiently serve their communities and facilitate a smooth reimbursement process.

Vaccine Billing Coverage Options: Seasonal Influenza and Future COVID-19 Vaccines

 Pharmacy-run, off-site (ie, outside the pharmacy) vaccination clinics, first introduced as a temporary means to increase vaccine coverage rates and reach underserved communities,

 have become increasingly important since the beginning of the coronavirus disease 2019 (COVID-19) pandemic. With the introduction of stay-at-home orders, social distancing, and the move to telemedicine, immunization rates among adults and children have declined,

 prompting pharmacists to think outside the box—or in this case, the pharmacy&mdash;to offer lifesaving immunizations for vaccine-preventable diseases in a safe environment.

These clinics increase the convenience of obtaining an immunization.

 Research has shown that off-site vaccination clinics reduce illness-related work absences and costs to employers due to time missed while employees are being vaccinated. They have also been shown to increase wellness and morale as a result of better overall health.

 Data from the CDC indicate that flu vaccines have been able to reduce the risk of influenza by 40% to 60%.

 If more patients are able to receive the vaccine through off-site vaccination clinics, the risk of influenza may be reduced even further. To learn more about implementing off-site vaccination clinics, 

 spoke with Jeff Goad, PharmD, MPH, professor and chair of the Department of Pharmacy Practice in the Chapman University School of Pharmacy in Irvine, California.

: Why are off-site vaccination clinics a desirable option for pharmacists, particularly during the COVID-19 pandemic? 

 Off-site vaccination clinics have always been desirable when it comes to flu season for communities that may not have convenient access to a pharmacy. Sometimes just seeing an outreach event gets people interested in what is going on, and if flu shots are available, they might [get one] if they are there anyway. We have always thought that outreach events can get the community involved and engaged in flu vaccination, so although having it at the pharmacy is a very convenient everyday option, hosting large events allows people to plan for it and for the community to rally behind it. Outreach events are still necessary in communities to get people thinking about vaccination and health together.

: How can community pharmacists start to set up an off-site vaccination clinic? 

 The CDC has provided several really good guidance documents on the operational level of cold chain management and storage, as well as administration.

 More recently, they provided [guidance for activity before, during, and after] in the form of checklists for hosting outreach clinics during the COVID-19 pandemic.

COVID-19 has led to new operational challenges, such as keeping appropriate personal protective equipment [PPE] in stock based on local recommendations. Additionally, there are structural changes for temperature stations with the need to maintain 6 ft between stations, as well as recommendations for setting up hard plastic barriers and separate areas for each step of the immunization process—versus 1 place for vaccine preparation, screening form check, and administration. The CDC recommends spacing these out to keep individuals, including staff and patients, from being too close together [to lower the risk of transmission].

 Some operational changes may also require a larger footprint when hosting a community outreach event. For example, many pharmacies are looking at [using] parking lots and drive-up or drive-through clinics to eliminate some of the social distancing problems [by having] people stay in their cars. The COVID-19 crisis has challenged pharmacy professionals to think about unique and innovative ways to host outreach events.

: How can clinics ensure that patients have the required paperwork needed upon their arrival, and how should they organize prescreening? 

 [Pharmacies are finding innovative ways to move] away from the old paper-and-pen system. For example, some places are utilizing their own websites (or creating new ones) to enable downloads of screening forms or online form completion. Some pharmacies have moved to a modified appointment-based system, in which patients come to the clinical during a specific range of time rather than for individual appointments. This gives patients a sense that if they show up, there won’t be a million other patients there, because the pharmacy is asking them to come during different time brackets. Email confirmations to patients about their time bracket should include the screening form, which patients can print, fill out, and bring with them to hand to the staff. Alternatively, they can fill the form out online, and the staff will then have it available at the event when someone checks in. The COVID-19 crisis has [made us rethink our normal] screening techniques, but I think these are things that will last well beyond the pandemic.

: Do you have any personal experience with setting up an off-site clinic? 

 Off-site clinics have been an evolving entity for community pharmacy. Traditionally, when we started, they were based primarily in the store, and then they began to expand. For example, if a pharmacy is part of a larger [business] like a grocery store, there are more places within that larger [business] footprint that they can utilize. We’ve also seen expansion into parking lots. Still, the pharmacist is fairly tied to their main place of employment in the pharmacy itself. As you venture outside [the pharmacy], you have to be able to staff it appropriately. For example, if you are an independent pharmacy owner, you still have to run your pharmacy and cannot shut it down to go run an event. You have to be able to rely on staffing and bring in enough people to help you do that. That might mean partnering with local public health offices, which may assist you in operating your vaccination clinic, and it could certainly mean partnering with a school of pharmacy with a workforce of student pharmacists ready to go. For example, the California Department of Public Health is very interested in what students can do to help enable these outreach events. Our outreach events at Chapman University are all run by students. Although our student health department is coordinating and organizing it, the actual workforce is student pharmacists, along with enough faculty to provide supervision.

: For patients who are hesitant to venture outside, what are your recommendations to let them know they can still safely go to either the pharmacy or an off-site clinic? 

[To help combat these fears,] in our clinic, we went with a time-bracket, scheduling-based system. We set up an online system that lets patients check that they want to come [to the clinic] in between 12:30 and 1:00, for example, and we create time slots within that based on the number of vaccinators and the amount of time it takes to vaccinate a patient. This [method allows pharmacies to] calculate their throughput for their clinics. In the COVID-19 era, we are trying to refine the number of patients coming through at a specific time, so you really have to think about your capacity for vaccinating. Using the system, we had 400 slots open, and within an hour, all 400 slots were filled; therefore, we knew the interest was there. Additionally, I think some of the things that help to make patients feel more comfortable can be in your advertisements: talking about what patients need to do, such as filling out the screening form before they come [to the pharmacy] and the need to wear a face covering. We also have extra face coverings for patients who show up without one. For our safety and to make patients feel safe, our own staff will be in full PPE, including surgical face masks, face shields, and gloves. You have to squeeze all of that into the advertising. Patients also realize that we are still holding flu shot clinics, just as we did last year and the year before; we just made some modifications so [patients] will be safe during this pandemic.

: Can student pharmacists administer vaccines? 

Student pharmacists absolutely can administer vaccines. They can do anything a pharmacist can do, depending on the state.

 In California, for example, the student pharmacists can do anything a pharmacist can do while under their supervision.

 we loosened the restrictions on ratios just for vaccination, to allow pharmacists to supervise more students.

 In California, we have 13 schools of pharmacy, and [the students] are all adequately trained in immunization within the first year.

There is also an opportunity to incorporate pharmacy technicians into the immunization process. Technicians have an evolving role in immunizations. We know, for example, that at least 2 states, Idaho and Rhode Island have changed the rules on the use of technicians in the immunization process.

 In the next 5 years, more states will allow technicians to administer vaccines under the supervision of a pharmacist. But until then, depending on state laws,

 technicians can still aid in the immunization process, from prepping the patient to drawing up doses… as well as many of the functions before and after vaccination [specifically], such as helping the patient to a waiting area and alerting the pharmacist if the patient has any symptoms post vaccination. There are many opportunities for the technician to get involved (see 

 on page 15), but changes to state law will be required to get them into the actual vaccination process.

: Do pharmacy staff members need to complete any additional training before setting up an off-site clinic, particularly in light of current guidelines specific to COVID-19? 

 When we have done outreach clinics, we have found it very useful to have the staff understand the environment where they are working. Every venue is different. For example, if you are setting up the vaccine venue within a church or a park, for example, you always have to do a site visit beforehand to look at your logistics and operation. The cold chain—getting the vaccine from the manufacturer or the wholesaler to your pharmacy’s refrigerator/freezer and then to the off-site clinic&mdash;is the most important part of an outreach clinic, and the CDC spends a lot of time explaining best practices.

 That is really important for pharmacies to understand: This has to continue outside the pharmacy, meaning you must have a portable refrigeration kit and understand that you should only draw up doses in anticipation of patients who are there or, even better, use prefilled influenza doses. Another modification you may have to make for an offsite clinic is [to consider colder temperatures] around the country as you move into fall, so your offsite venues may become limited. The important part is doing the legwork up front, which includes the preclinic preparation, knowing your site, knowing your ability to ensure cold chain, and making sure that you can mimic the same safeguards that you have in your own pharmacy in that outreach clinic.

: Speaking of safeguards, how should off-site clinics handle the observation period post immunization, especially for patients who are vaccine naïve? 

 That is a challenge, not only for pharmacy but also certainly for medicine. Many providers in medicine, especially in clinics, do not even think about the waiting period that is built in, although the CDC has recommended it for decades.

 Nevertheless, it is something that pharmacy has traditionally done. Pharmacy has a more standardized approach than medicine across the nation, both in training and in following recommendations from the CDC. Even for pharmacies and clinics, the CDC recommendation is that patients sit for 15 minutes in the waiting room, lobby area, or wherever else there is space, so they can be observed and/or have easy access to walk back up for help. If a patient decides to not take the recommendation to wait 15 minutes post vaccination and instead leaves the pharmacy, that does not necessarily have to be documented, although the pharmacy needs to make sure that a recommendation to wait is part of their standard operating procedure.

[A waiting area] also presents some new challenges in an outreach clinic. If we are running a drive-up clinic in a parking lot, for example, patients come in, and we scan them for their temperature while they are in their car. We then send them to a parking stall where we have vaccinators waiting to vaccinate them in their car. [Patients can then go to] another parking area to wait for 15 minutes before they leave. They cannot sit in the original stall for the 15 minutes because no one else would be able to come in for a vaccine. Again, it is a simple recommendation to say, “To make sure we can help you if you have a reaction, immediately following this vaccination, we ask that you wait for 15 minutes.” [The decision to] not stay is up to the individual. If you are doing drive-up clinics, and the driver, specifically, is getting the vaccine, we might more strongly recommend they wait 15 minutes before leaving. Although this does create some new challenges for the drive-through clinic, the basic recommendation to wait and to [designate a waiting place] really has not changed.

: How do you think this upcoming flu season will affect off-site clinics in light of COVID-19? 

 That is an interesting question. We are in the middle of conducting a survey of pharmacies in California related to their offerings of off-site clinics and the way they are offering the flu vaccine this fall. Along the way, we have learned that when we say outreach or off-site, sometimes that means just in their own parking lot. Being able to extend vaccination opportunities to an outdoor area makes some patients more comfortable, whereas some are still comfortable coming into the pharmacy. This might be something that lasts well beyond the pandemic. If we can make it as easy as possible, by having patients drive up and get a vaccine, that is probably something we should have been doing all along. But sometimes it takes a major event—like a pandemic&mdash; to spur innovation.

: What about off-site clinics where pharmacists set up at a place of business? 

 Off-site clinics at a place of business have always been a very popular option for companies so their employees do not have to take time off from work. However, for off-site clinics where the employees are no longer at the place of employment, some obstacles exist in getting them vaccinated. For organizations that have people on site, I think it is still a viable option, but it does create some challenges compared with how we may normally do it. Whereas we might have previously set up in a break room and had employees come by to get vaccinated, [during this time] many break rooms are closed, as employers do not want people congregating and eating in the same place at the same time. Instead, maybe you have to take a cart, which we used to do a long time ago, and go from cubicle to cubicle or office to office and vaccinate people as you go by. There are still opportunities to do employer-site vaccination, but you have to be a little more innovative with the approach to make sure you can get to [onsite] employees, as well as those working from home. [For those coming from home,] you can still offer an on-site event, but perhaps it is in the parking lot—almost like a health fair just for a company’s employees&mdash;so they only have to come to the lot to receive a vaccination. That is similar to what we are doing at our university because most of our employees are working remotely, as are faculty, staff, and even students who aren’t on campus; however, they are going to come back to a parking lot event and get their vaccination. It has to be modified, but I think work-based vaccination is still a viable option.

: Do you have any final advice for pharmacists who may be considering setting up an off-site clinic? 

After running off-site clinics for decades, [I find it] very fulfilling to see members of the community [we] may not normally see come into a pharmacy or even into a clinic. We find that many, many people use the health fair or an outreach event as their annual flu vaccination location. You have to understand that some people just do not get flu shots, but if you offer another venue for them, they may come. You just have to find the right place and the right time for them to come in. Offering an off-site option gives the pharmacy a way to better connect with their community, and whether you are an independent or chain pharmacist, connecting with your community is essential. Outreach events are one way to highlight your connection to your community.

If more patients are able to receive the vaccine through off-site vaccination clinics, the risk of influenza may be reduced even further.

Immunization Guide for Pharmacists November 2020

Pharmacy as a Destination for Receiving Vaccines During the COVID-19 Pandemic

How Pharmacy Technicians Can Be Certified to Administer Immunizations in 2020

Vaccine Billing Coverage Options: Seasonal Influenza and Future COVID-19 Vaccines

Understanding Off-Site Vaccination Clinics: An Expert Interview With Jeff Goad, PharmD, MPH

2020 Vaccination Recommendations for Patients With Chronic Medical Conditions

New HHS Regulations Expand Pharmacists’ Role in Childhood Immunizations