On The Cover
Loren Bonner
Health experts are calling this year’s flu season one of the most important. For pharmacists, the call to action has never been more apparent.
Pharmacists—who are actively engaged in flu vaccinations this season—are setting up innovative, socially distanced practice models, such as drive-up clinics and appointments, as the COVID-19 pandemic surges on and patients avoid health care facilities and traditional mass vaccination events.
Federal officials have recognized how necessary pharmacists are during this time. On August 19, the U.S. Department of Health and Human Services (HHS) authorized pharmacists to provide all Advisory Committee on Immunization Practices (ACIP)-recommended vaccines to children aged 3 to 18 years during the COVID-19 public health emergency, regardless of state laws and regulations. CDC reported earlier this year that rates of childhood immunizations had sharply declined nationwide as a result of the pandemic. Through this newly granted authority, HHS understands that pharmacists can help increase access and administration of these vaccines at a time when individuals and communities need protection from vaccine-preventable diseases.
In addition, on September 9, HHS issued federal guidance authorizing pharmacists to order and administer FDA-authorized or licensed COVID-19 vaccines to patients aged 3 years and older. The guidance applies to pharmacy intern administration of COVID-19 vaccines as well.
The procedures for pediatric vaccination and COVID-19 vaccination authority for pharmacists and pharmacy interns are similar but different (see chart).
Ilisa Bernstein, PharmD, JD, FAPhA, senior vice president for pharmacy practice and government affairs at APhA, said it’s key for pharmacists to understand that these new authorities preempt state laws that are a barrier to national implementation—it does not change broader authority allowed by states.
“Regardless of what limitations your state scope of practice places, this is what pharmacists are able to do in states across the United States [for these populations]—that’s huge,” said Bernstein during a September 17 APhA webinar.
However, pharmacists in some states are experiencing issues trying to remove barriers.
“I think what we need to keep in mind is the intent of the executive order in the amendment and guidance,” said Rebecca Snead, RPh, executive vice president and CEO of the National Alliance of State Pharmacy Associations (NASPA), during the APhA webinar. “The intent is to increase access. For the first time I’ve ever known, [they want] to reduce barriers,” said Snead. “The federal government says you can do things that are restricted in your state unless your state is more liberal—if your state is more liberal, we don’t want to restrict you.”
When conflicts arise, Snead said pharmacists will have to work with state attorneys general and state boards of pharmacy to get everyone on the same page about the “intent” of the new authority.
Record keeping
Bernstein said that the record keeping requirements will be critical as pharmacists vaccinate under these new authorities. For example, patients may need two separate COVID-19 vaccinations, depending on the vaccine they receive. These two doses will need to be from the same manufacturer, requiring appropriate record keeping for documentation and patient recall.
“There is going to have to be some system in order to ensure that the type and the number of doses are being carefully monitored,” Bernstein said.
APhA worked with a coalition to develop three tools pharmacists can use to be compliant with the pediatric immunization patient/caregiver education requirements in the new authority. The tools, in the form of documents, can satisfy the requirement to notify the patient and their adult caregiver about the importance of the well-child visit with a pediatrician or other licensed primary-care provider and to refer patients when appropriate. There are three different forms that pharmacists can give patients—a referral form, a well-child visit brochure, and a template letter to be given to the patient. All can be found on www.pharmacist.com/coronavirus/immunizations.
Beyond that, what if a state is silent on record-keeping documentation when it comes to childhood vaccinations?
During the APhA webinar, Mitchel Rothholz, RPh, MBA, chief of governance and state affiliates for APhA and executive director of the APhA Foundation, said that if the authority is coming from the amendment, then a pharmacist should make a good faith effort to check with the registry to see if there is any applicable patient immunization history. Some states have bi-directional authority to check immunizations. If a patient’s records are not able to be accessed in a registry, pharmacists can also contact the patient’s physician or even ask the patient to obtain their record.
Considerations for COVID-19 vaccine
The COVID-19 vaccine product will be provided to health care providers for administration to patients at no cost. As far as a fee for administering the vaccine, pharmacists can expect to be compensated, as was done under H1N1.
As of press time, ACIP’s recommendations for the COVID-19 vaccine had not been released and much hinges on those recommendations, including coverage from payers. Reimbursement for vaccinations provided to those in public health programs is expected, but payment for those under- or noninsured is still to be determined.
The COVID-19 vaccines that will be produced from various manufacturers will have different storage and handling requirements, according to Snead. In accordance with the ACIP guidance, these vaccines will likely have indications for different age groups or populations as well.
“Pharmacists need to look at this like [pneumococcal vaccine]—there are different requirements based on different types of pneumococcal vaccine—and I think we need to start thinking about the COVID vaccine in that same regard,” said Snead. “There will be different recommendations for different vaccines.”
On September 16, CDC and the Department of Defense released their “Interim Playbook for Jurisdiction Operations,” detailing the federal government’s COVID-19 vaccination and distribution plan. The playbook states “pharmacies’ role is even more critical to vaccinations today and will be fully integrated into the distribution plan.”
Pharmacies would likely be utilized in an expanded administration network under Phase 2, where there will be an increased vaccine supply, according to the distribution plan. However, state and local public health departments may tap pharmacists based on local needs and logistics during Phase 1.
On October 2, the National Academies of Sciences, Engineering, and Medicine released its final report on an allocation framework for the vaccines and moved vaccinating pharmacists to Phase 1a priority status because they are “front line health care workers” and “willing providers” operating in areas of higher community transmission. The report will be provided to ACIP for consideration in its deliberations.
While the new HHS authorities only give pharmacists the ability to provide the COVID-19 vaccine and pediatric vaccines during the public health emergency, Bernstein said APhA will be fighting to try to continue some of the authorities beyond the public health emergency.
The information in this article is current as of press time. As information is updated, please check APhA’s Immunization Authority resources page for the latest: www.pharmacist.com/coronavirus/immunizations.
What to know about the flu vaccine this season
Back in September—just a couple of weeks into the flu season—Olivia Kinney, PharmD, manager for clinical program development at Kroger Health, said Kroger pharmacies were already experiencing an increased demand from patients for the flu shot.
“Compared to last year, we are seeing a huge influx of patients getting their vaccine right now,” said Kinney during a September 10 APhA webinar about the upcoming influenza season.
CDC has been reiterating how important the influenza vaccine is this season as a means to reduce the overall burden of acute respiratory illness in communities and health care systems, especially where there is close circulation of COVID-19.
No one knows what effect the ongoing COVID-19 pandemic will have on the influenza season in the United States, but pharmacists have been bracing for a surge in the number of patients who want a flu shot amid the ongoing COVID-19 pandemic.
Nearly 200 million doses of the flu vaccine are available—a record high amount, according to CDC. The agency is asking for effective outreach, aimed especially at those who are high-risk.
CDC’s ACIP released its 2020–2021 influenza statement in late August with a strong recommendation to give the annual influenza vaccine to all individuals aged 6 months and older who do not have any contraindications.
Frequently asked influenza questions for the 2020–2021 season are provided on the following page. Information is current as of press time.
Pharmacists lead innovative influenza clinic models
Pharmacists have been involved in efforts to safely vaccinate patients against the flu this season. Drive-up flu clinics have been the way to go in several cases. The belief is that patients are more likely to get vaccinated without having to enter a facility due to fear of exposure during the COVID-19 pandemic.
Hanna Sung, PharmD, BCACP, has been co-leading the flu vaccine planning efforts at the local Los Angeles, CA, public health agency where she works. They are partnering with local community pharmacies to operate drive-up flu clinics throughout the area.
“The main part is establishing the flow of the clinics,” said Sung. This includes registration, COVID-19 screening, as well as questions for patients about the flu vaccine. She said it’s also important to have a safe, designated area for patients to wait for 15 minutes to make sure they do not have a reaction to the vaccine.
Her team is working with an event company to plan the logistics.
Sung likens the model to a health fair, where pharmacists are blocking out time on a Saturday, for example, to work in the clinic. Pharmacists who are participating have been involved in vaccination efforts previously and can process claims and get reimbursed, said Sung. While the drive-up model is new for her group, it’s an existing model that has been used in public health emergencies before, especially by health systems.
Scott M. Vouri, PharmD, PhD, BCGP, assistant director of pharmacy service with the University of Florida (UF) Health Physicians, is contributing to efforts at UF to transform their two-story parking garage into a drive-up flu vaccination clinic for UF patients. He expects the process to be quick and seamless for all involved: appointments will be made online and connected to the patient’s electronic health record, and upon entering the vaccination area, patients will be instructed where to go when they check in. There will also be a designated area where patients will wait after vaccination to make sure they don’t have a reaction. The clinician will verbally confirm the patient before administering the vaccine and perform one last check against what the patient filled out online.
“Once we get a rhythm with the vaccinations, we’ll be able to do more per hour because we will gain efficiencies by not needing to move patients within the clinic, obtain necessary supplies, and properly clean the room between visits,” said Vouri, who is also a clinical assistant professor at UF College of Pharmacy.
Vouri said the lessons they learn at this stage of the operation can be applied later on—for instance, when the COVID-19 vaccine becomes available. The project will also go beyond the flu vaccine and include pneumococcal vaccine as a next step.
What flu vaccines are recommended this season?
For the 2020–2021 flu season, CDC says health care personnel may choose to administer any licensed, age-appropriate flu vaccine (IIV, RIV4, or LAIV4) with no preference for any one vaccine over another. During APhA’s September 10 webinar, Stephan Foster, PharmD, FAPhA, APhA Liason to ACIP, said it’s important that pharmacists follow ACIP’s recommendations. He discourages pharmacists from trying to memorize the age indications—it’s always best to verify it, said Foster. See schedules for all vaccinations and ages at https://www.cdc.gov/vaccines/schedules/index.html.
Vaccine options this season include
Additionally, two new vaccines have been approved for those aged 65 and older: FLUAD Quadrivalent and Fluzone High-Dose Quadrivalent. Fluzone is expected to replace the previous trivalent formulation of Fluzone High-Dose, and FLUAD Quadrivalent will be available in addition to the previous trivalent formulation of FLUAD.
The new seasonal vaccine includes updates to the influenza A(H1N1)pdm09, A(H3N2), and B/Victoria components.
When should flu vaccination occur?
Ideally, CDC recommended flu vaccine administration by the end of October. But the vaccine should be offered as long as influenza viruses are circulating locally and unexpired vaccine is available.
Should a flu vaccine be given to a patient with suspected or confirmed COVID-19?
Routine vaccination should be deferred for patients with suspected or confirmed COVID-19, regardless of symptoms and until criteria have been met for that individual to discontinue isolation.
Additionally, CDC said a prior infection with suspected or confirmed COVID-19 or flu does not protect someone from future flu infections. Patients need to get a flu vaccine every year.
What steps should health professionals, including pharmacists, take to safely give the flu vaccine during the COVID-19 pandemic?
CDC has outlined specific recommendations on its site. They say health care personnel should
1. Minimize chances for exposures, including steps such as these:
- Limit and monitor points of entry to the facility and install barriers, such as clear plastic sneeze guards, to limit physical contact with patients at triage.
- Implement policies for adults and children over the age of 2 years to wear cloth face coverings (if tolerated).
2. Ensure all staff adhere to the following infection prevention and control procedures:
—Moderate-to-substantial transmission: Health care personnel should wear eye protection given the increased likelihood of encountering asymptomatic COVID-19 patients.
—Minimal-to-no transmission: Universal eye protection is considered optional, unless otherwise indicated as a part of standard precautions.
3. Consider these additional steps during vaccine administration:
—Health care personnel should wear gloves when giving I.N. or oral vaccines because of the increased likelihood of coming into contact with a patient’s mucous membranes and body fluids. They should change their gloves and wash their hands between patients.
—Giving these vaccines is not considered an aerosol-generating procedure and thus, the use of an N95 or higher-level respirator is not recommended.
—If health care personnel wear gloves when administering vaccine, they should change their gloves and wash their hands between patients.
4. Ensure physical distancing by implementing strategies, such as:
- Ensuring that physical distancing measures, with separation of at least 6 feet between patients, are maintained during all aspects of the visit, including check-in, checkout, screening procedures, and postvaccination monitoring. Strategies such as physical barriers, signs, ropes, and floor markings are encouraged.
- Using electronic communications as much as possible. For example, filling out needed paperwork online in advance to minimize patients’ time in the office as well as their sharing of materials, like clipboards or pens.
What does CDC say specific to pharmacies, temporary, off-site, or satellite clinics, and mass influenza vaccination clinics?
CDC released guidance specific to pharmacies earlier this year to help minimize the risk of exposure to the coronavirus for pharmacy staff and reduce the risk for patients during the pandemic.
According to CDC, the general principles outlined for health care facilities should also be applied to alternative vaccination sites, with additional precautions for physical distancing that are particularly relevant for mass vaccination clinics, such as:
- Providing specific appointment times or other strategies to manage patient flow and avoid crowding.
- Ensuring sufficient staff and resources to help move patients through the clinic flow as quickly as possible.
- Limiting the overall number of attendees at any given time, particularly for populations at increased risk for severe illness from COVID-19.
- Setting up a unidirectional site flow with signs, ropes, or other measures to direct site traffic and ensure physical distancing between patients.
- When feasible, arranging a separate vaccination area or separate hours for persons at increased risk for severe illness from COVID-19, such as older adults and persons with underlying medical conditions.
- Selecting a space large enough to ensure a minimum distance of 6 feet between patients in line or in waiting areas for vaccination, between vaccination stations, and in postvaccination monitoring areas (ACIP recommends that health care personnel consider observing patients for 15 minutes after vaccination to decrease the risk for injury should they faint).
Vaccine messaging for communities of color
Lakesha M. Butler, PharmD, immediate past president of the National Pharmaceutical Association, sat down with Pharmacy Today to share advice on tailoring flu shot communication to communities of color that efforts have traditionally not been effective in reaching.
Why is it more important than ever that minority groups and people of color receive a flu shot this season?
We’ve already seen a disproportionate effect of COVID-19 [on these communities] this year and we are expecting there to be a clash with both COVID-19 and the flu. Also, we don’t know what it will look like if a patient develops both. There are unknowns with co-infection.
Why have flu shot efforts not been traditionally effective in reaching communities of color?
We have to understand the historical context, which plays a tremendous part in the mistrust of anything pertaining to clinical trials and medications. Unfortunately, people of color have been mistreated—we have been socialized and traumatized. My parents grew up in Jim Crow and saw the Tuskegee trials [The Tuskegee Syphilis Study] and numerous other examples of legal discrimination. There were instances when African Americans in hospitals were used against their wills for clinical trials. The fear and mistrust has been passed down from generation to generation due to trauma. In fact, my mother has significant reservations about the flu and COVID-19 vaccine.
With all of this in mind, how should pharmacists—who are vaccinating patients against influenza this season and COVID-19 eventually—be approaching communities of color?
I think it’s important to start the conversation, listen with understanding, check biases, and build the relationship with individuals in the population. We know it’s proven that patients trust individuals who look like them—so utilizing minority pharmacists to reach out to underrepresented members of the community. But at same time, we don’t want to perpetuate cultural taxation—we don’t want to leave the minority pharmacists to be the only ones to shoulder the task of reaching the minority communities. All pharmacists must be adequately prepared to approach patients of color with cultural humility. However, the longer-term goal is intentionally improving diversity in the pharmacy workplace.
Overall, it’s about getting to know individuals, understanding the barriers, and wanting to learn from them. Pharmacists need to listen to patients to understand what challenges they have with the vaccine. Once you understand that, then you can provide the education about the vaccine.
There’s definitely a misunderstanding of how vaccines work—for example, they don’t make you sick—so helping the individual truly understand how vaccines work, using layman’s terms when explaining it, and creating space for patients to share their thoughts and concerns. I also think it’s a good idea to provide some data and metrics to share vaccine efficacy.
It’s also important that we don’t look down on a patient if they refuse the vaccine.
Pharmacy technicians gear up to immunize
As pharmacists prepare for a surge in demand during this year’s flu season and the anticipated release of a COVID-19 vaccine, many state boards of pharmacy are engaged in discussions around allowing pharmacy technicians to participate in immunization administration, according to Ryan Burke, PharmD, director of professional affairs at the Pharmacy Technician Certification Board (PTCB).
“Several chain pharmacies are the driving force behind advocacy efforts in some states, arguing that pharmacy technicians will be critical to meeting the demand,” Burke said.
States that currently permit pharmacy technicians to immunize include Michigan, Idaho, Washington, Rhode Island, Utah, and Nevada (see map). However, there are states where the language does not prohibit it. Information is changing quickly, but as of press time, Alabama, Arizona, Colorado, Illinois, Indiana, Massachusetts, Nebraska, New Mexico, and North Dakota were actively discussing allowing technicians to immunize.
“We have heard from pharmacists working in states that allow technicians to immunize that they now have more time to focus on the core pharmacy workflow, counsel patients, provide clinical services, and handle other issues that demand their time and attention,” said Burke. Patients spend less time waiting to receive immunizations, and the public benefits from having additional health care workers provide access to vaccinations.
“With pharmacists feeling overwhelmed by the increased workflow and demand, they can feel confident in technicians who have earned a credential in immunization to take on this role,” said Burke. He added that this will be one of the credentials PTCB will be releasing in the near future, and like its Assessment-Based Certificate Programs, employers will know the CPhT is qualified since it includes education and training.
“Expanding pharmacy technician roles to add immunizations not only provides an advancement opportunity, but also gives technicians a chance to build upon the great relationships that many of them have with patients,” Burke said.