Pharmacy Times Immunization Guide for Pharmacists Instruction Manual

SPECIAL REPORT: IMMUNIZATION
Formulations, Recommendations, and Resources for the Pharmacist IMMUNIZATION GUIDE
FOR PHARMACISTS
SEPTEMBER 2023

Immunization Guide for Pharmacists

Predicting Vaccine Demand for the 2023-2024 Fall/Winter Season
Incorporating the Newly Approved RSV and Pneumococcal Vaccines Into Community Pharmacy Workflow
Impact of the Inflation Reduction Act on Vaccinations: What Pharmacists Need to Know
Developing and Implementing Immunization Standing Orders and Protocols
Focus on HPV Vaccination in Adults and Young Adults
Ensuring Health Equity in Vaccination Access: How Pharmacies Can Work With Community Organizations

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EDITOR’S NOTE

Predicting Vaccine Demand for the 2023-2024 Fall/Winter Season
COVID-19 and RSV Immunizations Are Wild Cards for Community Pharmacy By TROY TRYGSTAD, PHARMD, PHD, MBA, PHARMACY TIMES® EDITOR IN CHIEF

TROY TRYGSTAD, PHARMD, PHD, MBA, PHARMACY TIMES® EDITOR IN CHIEF

INFLUENZA IS THE “OLD RELIABLE” OF IMMUNIZATIONS
Pharmacy staff often refer to early fall as the beginning of “flu shot” season. I suppose this is so because every day is “pharmacy dispensing” season, but the fall brings increased workflows that used to be dominated by prescription cough and cold medicines. Workflow is now accelerated as patients request the added convenience of receiving immunizations while filling their medications. With a predicable rush of immunization opportunities that are increasingly important for the economic sustainability of the  pharmacy, 1,2 the demand for influenza vaccinations is a near guarantee for the pharmacy. The total percentage of eligible adults who get an influenza vaccination has not changed much over the past decade; it has grown slowly from approximately 45% to 50%.3
However, the percentage of influenza immunizations performed in adults in the pharmacy has increased substantially, from about 20% during the 2011-2012 season to approximately 60% in 2021. 1,4 Even more striking is the increase in pharmacy-based immunizations for other vaccine-preventable illnesses that have been administered over the past few years.
Pharmacies dominate the adult immunization marketplace, moving from approximately 50% of the market share through most of 2020 (the year before COVID-19 vaccination became available in the pharmacy) to roughly 90% of all claims submitted by health care providers, when considering the most common immunizations together (COVID-19, influenza, human papillomavirus, pneumococcal disease, and combined tetanus, diphtheria, and pertussis) in 2021 and 2022 are considered. 4
COVID-19 IMMUNIZATION: A DEMAND THAT’S HARD TO PREDICT
Last year, at this time, we didn’t know whether there would be an overall change in the demand for influenza immunizations for the upcoming 2022-2023 season.
Would the COVID-19 virus have a positive, negative, or negligible effect on the overall uptake of flu shots? Turns out, it was a third eventuality in 47 of the 50 states. However, some states with historically lower influenza immunization rates (Alabama,  Mississippi, Tennessee, and West Virginia) saw increased rates of influenza vaccination among adults. 5
These differences resulted in a significant increase (2%) in overall influenza coverage rates between the 2021-2022 and 2022-2023 seasons for adults (P < .05), with the greatest increase observed in individuals aged 65 years or older (3.7%; P < .05).
With the COVID-19 virus, we cannot know if and when future outbreaks will occur, although the prevailing wisdom is that each fall will bring an increased likelihood of a spike in infections, given the seasonality of other respiratory illnesses of this type. So, will demand for COVID-19 vaccines follow demand for flu shots? Factors that may impact COVID-19 vaccine uptake include patients’ perception of risk related to COVID-19 infection and sequalae, 6 emerging variants, booster availa bility, and cost. As the federal government moves away from the purchase of COVID-19 vaccines (and the relatively ubiquitous administration fee of $40), 7,8 re imbursement rates will depend upon health plan and pharmacy benefits. For the uninsured or underinsured, the CDC has launched the Bridge Access Program through Walgreens, CVS, and other pharmacies; staff may sign up for the program through a third party (eTrueNorth). 8
THE RSV VACCINE IS THE NEW KID ON THE BLOCK
Respiratory syncytial virus (RSV) also generally circulates in the fall and peaks in the winter.9
Most people who develop an RSV infection have a mild illness and recover within a week.10
However, RSV infection can produce severe disease in infants and young children, adults with chronic medical conditions, and the elderly, and can require hospitalization and supportive care for these vulnerable cohorts. Most pharmacists haven’t been conversant in RSV infection, as it hasn’t impacted their practice to any great extent. However, in May 2023, the FDA approved the 2 RSV vaccines, Arexvy (GlaxoSmithKline) and Abrysvo (Pfizer), for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients 60 years or older.11,12
In August 2023, the FDA approved Abrysvo for use in pregnant individuals at 32 to 36 weeks gestation to prevent LRTD from RSV infection in infants from birth to 6 months of age.12
RSV soon will become part of the regular community pharmacy lexicon because of the new availability of these RSV vaccines and the high percentage of adults who receive vaccinations in a pharmacy.4
RSV vaccine recommendations and patients willing to entertain that advice may follow guidance for influenza and COVID-19 immunizations; as with any new market entrant, how ever, uptake is hard to predict.
ALIGNING SEASONAL VACCINE PRACTICE, WORKFLOW, AND ECONOMICS
It appears that community pharmacies are now in the third era of immunizations. The first was groundbreaking, with pushes for scope of practice changes and reimbursement for administration that were driven almost entirely by influenza vaccines.
The second was the widespread adoption of multiple vaccinations administered at the pharmacy that was driven primarily by availability of the shingles vaccine and greatly accelerated by COVID-19 vaccination and the precipitating pandemic. We now have  entered an era in which the pharmacy has become the principal immunization site for adults and, increasingly, for children. The pharmacy is no longer considered to offer full service (or to be financially sustainable) without a robust vaccination practice. With additional seasonal entrants, the opportunity for critical mass is here. Patient encounters now showcase full immunization history reviews. At a minimum, pharmacists encourage patients to get all of their seasonal vaccinations assessed and administered in a short window of time as soon as it starts to get cold outside. Only time will tell whether demand will be strong for specific immunizations recommended for administration this fall. What is certain is that the planning, preparation, and eventual bustling of pharmacies serving members of their community with access to life-improving and life-saving vaccinations and convenience will be the welcomed by the patients they serve. ■
REFERENCES

1. Bach AT, Goad JA. The role of community pharmacy-based vaccination in the USA: current practice and future directions.
   Integr Pharm Res Pract. 2015;4:67-77. doi:10.2147/IPRP.S63822

2. Sederstrom J. Vaccination programs bring pharmacy profits. Drug Topics. https://www.drugtopics.com/view/vaccination-programs-bring-pharmacy-profits

3. Flu vaccination coverage, United States, 2021-22 influenza season.
   CDC. October 18, 2022. Accessed August 23, 2023. https://www.cdc.gov/flu/fluvaxview/coverage-2022estimates.html

4. Trends in vaccine administration in the United States. IQVIA Institute. January 13, 2023. Accessed August 23, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/trends-in-vaccineadministration-in-the-united-states

5. Influenza vaccination coverage, adults. CDC. April 28, 2023. Accessed August 23, 2023. https://www.cdc.gov/flu/fluvaxview/dashboard/vaccination-adult-coverage.html

6. Cohen LE, Spiro DJ, Viboud C. Projecting the SARS-CoV-2 transition from pandemicity to endemicity: epidemiological and immunological considerations. PLOS Pathogens. 2022;18(6):e1010591. doi:10.1371/journal.ppat.1010591

7. Medicare COVID-19 vaccine shot payment. CMS.gov. Updated July 27, 2023. Accessed August 23, 2023. https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment

8. CDC’s Bridge Access program. CDC. Accessed August 25, 2023. https://www.cdc.gov/vaccines/programs/bridge/index.html

9. Respiratory syncytial virus infection (RSV). For healthcare providers. CDC. August 4, 2023. Accessed August 23, 2023. https://www.cdc.gov/rsv/clinical/index.html

10. Respiratory syncytial virus infection (RSV). People at high risk for severe RSV infection. CDC. October 28, 2022. Accessed August 23, 2023. https://www.cdc.gov/rsv/high-risk/index.html

11. FDA approves first Respiratory Syncytial Virus (RSV) vaccine. News release. FDA. May 3, 2023. Accessed August 23, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-firstrespiratory-syncytial-virus-rsv-vaccine

12. FDA approves first vaccine for pregnant individuals to prevent RSV in infants. News release. FDA. August 21, 2023. Accessed August 23,  2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants

About the Author
TROY TRYGSTAD, PHARMD, PHD, MBA, is the Executive Director of CPESN USA, a clinically integrated network of more than 3500 participating pharmacies. He received his PharmD and MBA degrees from Drake University and a PhD in pharmaceutical outcomes and policy from the University of North Carolina.
He has recently served on the board of directors for the Pharmacy Quality Alliance and the American Pharmacists Association Foundation.

COVER STORY

Vax-Innovation: Incorporating the Newly Approved RSV and Pneumococcal Vaccines Into Community Pharmacy Workflow
By NICOLE C. PEZZINO, PHARMD, BCACP, CDCES; AND CHRISTOPHER SVETCOV, PHARMD

NICOLE C. PEZZINO, PHARMD, BCACP, CDCES| CHRISTOPHER SVETCOV, PHARMD
---|---

Recent advancements in the field of vaccines have led to the approval of an additional vaccine against pneumococcal infection and 2 new vaccines against respiratory syncytial virus (RSV). This article provides an overview of these vaccines and outlines  engagement strategies and counseling tips for pharmacy professionals to educate patients, involve them in their own care, and help them work toward acceptance and utilization of these novel vaccines. Best practices to train staff and team members to engage patients and to ease the new vaccine offerings into the workflow are also discussed.
PNEUMOCOCCAL 20-VALENT CONJUGATE VACCINE
Prevnar 20, marketed by Pfizer, is a pneumococcal conjugate vaccine that offers expanded coverage against 20 pneumococcal bacteria serotypes, providing enhanced protection against invasive pneumococcal disease.1
Since the approval of Prevnar 20 in June 2021, it is no longer recommended to use Prevnar 13 for older adults (≥ 65 years).2,3
Prevnar 20 is indicated and approved for the prevention of invasive disease caused by Streptococcus pneumoniae in individuals 6 weeks and older and for prevention of otitis media in individuals aged 6 weeks through 5 years.1
In patients 18 years and older, Prevnar 20 is indicated for active immunization for the prevention of pneumonia caused by S pneumoniae. (Please refer to the package labeling for strains included and further information.)
Available pneumococcal vaccines are highlighted in Table 1.1,4-6
In infants and children up to age 17 years, the most commonly reported adverse reactions associated with the use of Prevnar 20 include irritability; pain, redness, and swelling at the injection site; drowsiness; decreased appetite; fever; and headache.1
In adults, the most common adverse reactions were pain at the injection site, muscle pain and fatigue, headache, and arthralgia. The Advisory Committee on Immunization Practices recently updated recommendations to the pneumococcal vaccine series; the schedule can be found on the CDC website (https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumovaccine- timing.pdf).2
In the pneumococcal algorithm, if a pharmacy stocked Prevnar 20 for adults, they would meet all “Option A” criteria shown in the CDC table.
RSV VACCINES
RSV is a highly contagious virus that generally circulates seasonally, starting in the fall.7,8
Although it causes infections of the lungs in all age groups, older adults (≥ 60 years), infants, and young children are particularly vulnerable to RSV infection, which can result in lower respiratory tract disease (LRTD), that can lead to pneumonia and bronchiolitis.9
Two vaccines against RSV infection were approved in May 2023.
The RSV vaccine Abrysvo (Pfizer) and the adjuvanted RSV vaccine Arexvy (GlaxoSmithKline) are indicated for active immunization for the prevention of LRTD caused by RSV in individuals 60 years and older.10
The vaccines have been shown to be 85.7% (Arexvy) and 82.6% (Abrysvo) effective at reducing the first episode of RSV-LRTD in individuals with at least 3 symptoms and 66.7% (Arexvy) and 94.6% (Abrysvo) effective in reducing risk of first episode of RSV-LRTD with at least 2 symptoms. The most common adverse reactions are local injection site pain, fatigue, headache, and arthralgia.11,12 In August 2023, Abrysvo was approved for active immunization of pregnant individuals at 32 through 36 weeks gestational  age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.13
Table 2 describes the 2 RSV vaccines, which are expected to be available in fall 2023.11,12
Both vaccines require reconstitution. For health care providers, knowing which patients would benefit from RSV vaccines and educating them about the advantages of vaccination is critical.
For example, older adults with underlying lung disease or a weakened immune system are at greater risk for hospitalizations related to infection; therefore, health care providers should consider recommending the RSV vaccine at the same time they recommend the influenza vaccine.14
KEY TAKEAWAYS

• Recent advances in the field of vaccines have yielded an additional vaccine against pneumococcal infection that offers expanded coverage against a wider array of serotypes. Two novel respiratory syncytial virus (RSV) vaccines have also been developed.
• Applying the T.E.A.C.H. mnemonic for engagement strategies and counseling tips may aid pharmacy professionals in promoting patient acceptance and utilization of new vaccines.
• Best practices for training staff and engaging all team members include assessing the team’s needs and current level of training, and employing effective communication among team members, as well as engaging the patients in their care, to help promote vaccine uptake.

ENGAGEMENT STRATEGIES AND COUNSELING TIPS TO PROMOTE ACCEPTANCE OF NEW VACCINES AMONG PATIENTS
Vaccine hesitancy poses a considerable challenge to achieving optimal vaccination

rates; this challenge can be further exacerbated with the introduction of new vaccines as patients become aware of new information, policies, and reports of associated risks that can be difficult to understand or, in some cases, misleading or inaccurate.15,16
Pharmacists, as accessible health care providers, are uniquely positioned to engage with patients and address their concerns, ultimately promoting acceptance of these vaccines. The results of a study published in 2022 found that nearly 90% of Americans live within 5 miles of a community pharmacy.17
In addition, results of further studies have shown that patients visit their community pharmacy approximately twice as frequently as they visit primary care offices.18
Some studies have found that patients frequent their pharmacy approximately 35 times per year.19
Accordingly, pharmacists’ relationships with their patients strategically position them to assist

TABLE 1. Available Pneumococcal Vaccines in the United States1,4-6

| Pneumococcal conjugate vaccine–13 3| Pneumococcal conjugate vaccine–15 4| Pneumococcal conjugate vaccine–20 1| Pneumococcal polysaccharide vaccine–23 5
Brand or trade name| Prevnar 13| Vaxneuvance| Prevnar 20| Pneumovax 23
Year FDA approved| 2010| 2021| 2021| 1983
Approved age| 6 weeks to 17 years
(no longer recommended for ≥ 18 years)| ≥ 18 years| 6 weeks to 17 years and ≥ 18 years| ≥ 2 years
Volume| 0.5 mL| 0.5 mL| 0.5 mL| 0.5 mL
Available preparations| Single-dose prefilled syringe| Single-dose prefilled syringe| Single-dose prefilled syringe| Single-dose vial or prefilled syringe
Injection route| IM| IM| IM| SC or IM
Special handling instructions| Shake vigorously.| Shake vigorously.| Shake vigorously.| —

IM, intramuscular; SC, subcutaneous.

TABLE 2. Available RSV Vaccines in the United States11,12

| RSV vaccine, adjuvanted (GSK) 11| RSV vaccine (Pfizer) 12
Brand or trade name| Arexvy| Abrysvo
Indication(s) and FDA approval date(s)| May 2023: Active immunization for the prevention of LRTD caused by RSV in individuals ≥ 60 years| May 2023: Active immunization for the prevention of LRTD caused by RSV in individuals ≥ 60 years
August 2023: Active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.
Volume| 0.5 mL| 0.5 mL
Available preparations| Solution, reconstituted| Solution, kit
(vial of lyophilized antigen component [a sterile white powder], a prefilled syringe containing sterile water diluent component, and a vial adapter)
Injection route| IM| IM
Special handling instructions| Must use within 4 hours of mixing| Must use within 4 hours of mixing

IM, intramuscular; RSV, respiratory syncytial virus.
patients in accepting new vaccines and/or overcoming vaccine hesitancy. When informing patients about new vaccines, the mnemonic “T.E.A.C.H.” may be beneficial as an engagement tool:

• Trust: Establish a trusting relationship.
  Building a trusting relationship with patients is essential to promoting acceptance of new vaccines.
  Leverage your relationship with patients to engage in an empathetic and nonjudgmental conversation.
  As a health care professional, a pharmacist can help strengthen a patient’s trust in vaccines, thereby helping to prevent them from contracting infectious diseases.

• Educate: Tailor communication and provide clear information.
  Recognize that each patient has different information needs and communication preferences. When communicating with a patient, make sure you adapt your communication style and language to suit the individual patient’s needs. Ensure they fully comprehend the benefits and risks associated with the new vaccine by using open-ended questions. Make sure you offer evidence-based information about the new vaccine, emphasizing its role in preventing disease and safeguarding public health. When  discussing vaccines with the patients, including newly-approved vaccines, capitalize on your relationship with the patient to blend personalized experience with your recommendation.
  For example, if you know that an older adult patient (≥ 60 years) has frequent lower respiratory tract infections resulting in hospitalizations, tailor the conversation to recommend one of the RSV vaccines. Be certain that the information you’re providing  improves patients’ understanding and engagement.

• Address: Vaccine misinformation.
  Many patients may have misconceptions or may have encountered misinformation regarding new vaccines.
  Pharmacists serve as an accessible vaccine resource and should be prepared to address these concerns. Offering accurate information from reliable sources such as the CDC and the World Health Organization and debunking common vaccine myths can  help ensure patients are making well-informed decisions when encountering new vaccine offerings. When offering information that may be new to a person, consider the concepts of motivational interviewing.20
  For example, if a patient is doing research on vaccines, commend their research efforts, and then ask for permission to share new information. Some common motivational interviewing techniques can be found in Figure 1. 21,22

• Counsel: Discuss the vaccine risks vs benefits.
  Discuss the potential adverse reactions of new vaccines and emphasize the importance of reporting any adverse reactions to the pharmacy. Addressing adverse reactions proactively can help patients feel informed and prepared, reducing vaccine hesitancy. One counseling tip
  FIGURE. Motivational Interviewing Concepts and Strategies 21,22HCP, health care provider.
  that could be shared is that everything a person does has risks and benefits. For example, you could say, “When you decided to drive your car to the pharmacy today, there was a benefit (getting to a place to purchase your medicine) and a risk (potential car accident). To minimize the risk, you wore a seat belt. The benefits of this vaccine are , and the risks are . To minimize the risks, we encourage you to ___.” This can empower the patient to make an informed decision about their health.

• Highlight: Vaccine safety and development process.
  Emphasize the rigorous processes involved in vaccine development, including clinical trials and regulatory approvals. Reassure patients about the extensive monitoring systems in place to ensure vaccine safety post-licensing.

BEST PRACTICE TIPS FOR ENGAGING TEAM MEMBERS, EASING NEW VACCINE OFFERINGS INTO THE WORKFLOW, AND ENGAGING PATIENTS
With the introduction of new vaccines, it is imperative for pharmacy professionals to implement effective strategies for training and engaging their staff. Integration of new vaccine offerings into the pharmacy workflow effectively requires careful planning,  training, and collaboration.
Engaging the entire pharmacy team is a vital component to successful integration into the workflow and patient uptake. Following a few best practices can ensure a smooth transition and put your team in an optimal position to educate and engage the patient.
ASSESS THE TEAM’S NEEDS AND CURRENT LEVEL OF TRAINING
Successfully introducing a new vaccine requires conducting a needs assessment of your pharmacy team. The assessment should help to identify knowledge gaps and training requirements. Implementing the following best practices during the training process may be helpful.

• Tailor training programs: Develop training programs that are specific to the needs of your team. Consider factors such as experience level, familiarity with vaccine protocols and regulatory guidelines, and everyone’s role on the team.
• Provide up-to-date resources: Ensure the team has access to credible evidence-based resources such as guidelines from the vaccine manufacturer and the CDC. These resources should be available for your team to review before vaccine rollout and kept as a readily accessible resource.
• Provide practical training: Make sure to include hands-on practical training sessions to reinforce proper vaccination technique. Review storage and handling guidelines for all new vaccines and any specific documentation requirements.

COMMUNICATION IS KEY
Effective communication among pharmacy team members, before and after rollout, is vital for successful integration of new vaccine offerings and patient engagement. Meet with the team to ensure everyone is aware of new vaccine offerings. Address team  member concerns through open dialogue and provide a platform for team members to ask questions. Team members who are educated on new vaccine offerings will be better equipped to provide accurate information and address patient concerns.
PATIENT ENGAGEMENT IS CRUCIAL TO PROMOTE VACCINE UPTAKE
Engage patients in person by displaying educational materials about new vaccines in prominent areas of the pharmacy including waiting areas, consultation areas, and vaccination rooms. Providing physical patient handouts and education resources can be a great way to get the patient thinking and talking about new vaccine offerings.
The handouts can serve as a visual reminder to the patient after they leave the pharmacy. Pharmacy teams also can use digital platforms, automated phone messages, and texting to disseminate new vaccine information and address common questions and concerns. Digital engagement can provide opportunities for patients to make vaccine appointments at a time that is convenient for them.
Patient engagement does not end when the patient receives the vaccine. Following up with the patient given vaccinations can help address any adverse effects or concerns the patient may have. Timely patient follow-up can help to strengthen patient trust in the pharmacy team and minimize vaccine hesitancy in the future.
CONCLUSIONS
Pharmacists are strategically positioned as being among the most accessible health care professionals and they have strong relationships with the communities they serve. In the community-based pharmacy setting, pharmacists can work together with colleagues (eg, technicians, interns) to engage patients in conversations about vaccines, especially in closing vaccine gaps and providing education on newly approved vaccines. ■

REFERENCES

1. Prevnar 20. Prescribing Information. Pfizer; 2023. Accessed July 28, 2023. https://www.fda.gov/media/149987/download
2. Pneumococcal vaccine timing for adults. CDC. Updated March 15, 2023. Accessed July 1, 2023. https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf
3. Prevnar 20 BLA Approval. FDA. June 10, 2021. Accessed August 1, 2023. https://www.fda.gov/media/150021/download?attachment
4. Prevnar 13. Prescribing Information. Pfizer; 2017. Accessed July 28, 2023. https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert——Prevnar-13.pdf
5. Vaxneuvance. Prescribing Information. Merck & Co; 2023. Accessed July 28, 2023. https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_pi.pdf
6. Pneumovax-23. Prescribing Information. Merck & Co; 2023. Accessed July 28, 2023. https://www.fda.gov/media/80547/download
7. Rose EB, Wheatley A, Langley G, Gerber S, Haynes A. Respiratory syncytial virus seasonality – United States, 2014-2017. MMWR Morb Mortal Wkly Rep. 2018;67(2):71-76. doi:10.15585/mmwr.mm6702a4
8. Hamid S, Winn A, Parikh R, et al. Seasonality of respiratory syncytial virus – United States, 2017-2023. MMWR Morb Mortal Wkly Rep. 2023;72(14):355361. doi:10.15585/mmwr.mm7214a1
9. Respiratory syncytial virus infection (RSV). CDC. Updated October 8, 2022. Accessed August 1, 2023. https://www.cdc.gov/rsv/index.html
10. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices – United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801. doi:10.15585/mmwr.mm7229a4
11. Abrexvy. Prescribing Information. GSK; 2023. Accessed July 28, 2023. https://www.fda.gov/media/167805/download
12. Abrysvo. Prescribing Information. Pfizer; 2023. Accessed August 31, 2023. https://labeling.pfizer.com/ShowLabeling.aspx?id=19589
13. BLA approval for respiratory syncytial virus vaccine (Abrysvo). Written communication. FDA. August 21, 2023. Accessed August 31, 2023. https://www.fda.gov/media/171492/download
14. RSV in older adults and adults with chronic medical conditions. CDC. Updated July 14, 2023. Accessed August 1, 2023. https://www.cdc.gov/rsv/high-risk/older-adults.html
15. Ten threats to global health in 2019. World Health Organization. January 10, 2019. Accessed July 3, 2023. https://www.who.int/news-room/spotlight/ten-threats-to-global-health-in-2019
16. Larson HJ, Gakidou E, Murray CJL. The vaccine-hesitant moment. N Engl J Med. 2022;387(1):58-65. doi:10.1056/NEJMra2106441
17. Berenbrok LA, Tang S, Gabriel N, et al. Access to community pharmacies: a nationwide geographic information systems cross-sectional analysis. J Am Pharm Assoc (2003). 2022;62(6):1816-1822.e2. doi:10.1016/j.japh.2022.07.003
18. Berenbrok LA, Gabriel N, Coley KC, et al. Evaluation of frequency of encounters with primary care physicians vs visits to community pharmacies among Medicare beneficiaries. JAMA Network Open. 2020; 3(7):e209132. doi:10.1001/jamanetworkopen.2020.9132
19. Valliant SN, Burbage SC, Pathak S, Urick BY. Pharmacists as accessible health care providers: quantifying the opportunity. J Manag Care Spec Pharm. 2022;28(1):85-90. doi:10.18553/jmcp.2022.28.1.85
20. Excellence in motivational interviewing. Understanding motivational interviewing. Motivational Interviewing Network of Trainers. Accessed July 1, 2023. https://motivationalinterviewing.org/understandingmotivational-interviewing
21. Zolezzi M, Paravattil B, El-Gaili T. Using motivational interviewing techniques to inform decision-making for COVID-19 vaccination. Int J Clin Pharm. 2021;43(6):1728-1734. doi:10.1007/s11096-021-01334-y
22. Talking with patients about COVID-19 vaccination. CDC. Updated November 3, 2021. Accessed July 10, 2023. https://www.cdc.gov/vaccines/covid-19/hcp/engaging-patients.html

About the Authors
NICOLE C. PEZZINO, PHARMD, BCACP, CDCES, is an associate professor of pharmacy practice in the Wilkes University, Nesbitt School of Pharmacy in Wilkes-Barre, Pennsylvania.
CHRISTOPHER SVETCOV, PHARMD, is a pharmacy manager at Wegmans Food Market in Allentown, Pennsylvania.

HEALTH SYSTEM AND HOSPITAL PHARMACY

Developing and Implementing Immunization Standing Orders and Protocols
ALFRED ADAM L’ALTRELLI, PHARMD, CFMC, MBA; TRISHA A. MILLER, PHARMD, MPH, BCACP; REBECCA MEDVA, MHMS, BS, CPHT; AND RACHEL V. MARINI, PHARMD, BCIDP

ALFRED ADAM L’ALTRELLI, PHARMD| TRISHA A. MILLER, PHARMD, MPH, BCACP
---|---
REBECCA MEDVA, MHMS, BS, CPHT| RACHEL V. MARINI, PHARMD, BCIDP

Throughout the COVID-19 pandemic, substantial misinformation was circulated about vaccinations and their safety and effectiveness.1 For many years, pharmacists have been identified as trusted health care providers who are readily accessible to support lifesaving vaccination efforts and provide education for the public. The results of 2 systematic reviews and meta- analyses, published in 2016 and in 2022, demonstrated substantial increases in vaccine uptake when a pharmacist was involved in immunization efforts.2,3
Pharmacists can administer vaccines in a variety of settings, such as community pharmacies, physician offices, inpatient hospital settings, and stand-alone vaccine clinics. The operational logistics of supporting a vaccination program are part of the pharmacist skill set, with patient safety and efficiency being key elements in the program development process. Critical tools developed to ensure the safety of vaccination programs are written protocols, policies, and procedures. These guidance documents support infrastructure for well- trained team members to establish best practices and to complete documentation and reporting requirements. This article describes types of immunization authority for pharmacists, outlines successful development and implementation of standing orders, and discusses the role of electronic health records (EHRs) in promoting patient adherence to and providing maintenance of vaccination schedules.

IMMUNIZATION AUTHORITY FOR PHARMACISTS
The ability of pharmacists to administer immunizations varies according to state regulations and professional boards. Immunization authority can be classified as a statewide protocol or standing order, a collaborative practice agreement (CPA), or an independent authority.4 Regulations for authority are granted on a statewide level or through individual collaboration between an authorized prescriber and pharmacist (Box).4-6

BOX. Pharmacist Immunization Authority Types4-6
Collaborative Practice Agreement— a written, defined document of agreement between prescriber(s) and pharmacist(s) that allows the pharmacist(s) to provide specific clinical services to referred patients5
Independent Authority— the ability to assess the need for, to order, and to administer vaccines independently based upon professional judgement4
Standing Order— a prescriptive order not limited to a particular patient for administration of a specific vaccine6

STANDING ORDERS, COLLABORATIVE PRACTICE AGREEMENTS, AND PROTOCOLS FOR IMMUNIZING
Standing orders provide pharmacists with the authority to administer vaccines without separate individual physician orders, whereas collaborative practice agreements provide pharmacists with the authority to administer vaccines in collaboration with physicians or physician groups; protocols for immunizing are comprehensive guidelines that govern the immunization process under a standing order or collaborative practice agreement. Multiple organizations, including the Advisory Committee on Immunization Practices (ACIP), recommend use of standing orders to improve vaccination rates.7 The benefits of standing orders include the ability to define a standard response in various settings, establish safe practices, and provide services to a greater number of patients. Standing orders allow determination of patient eligibility for vaccinations without a prescribing medical professional needing to be present at the time of assessment.8 Developing standing orders and protocols for immunizations requires multiple components for successful implementation (Table)9:

TABLE. Components for Successful Implementation of Standing Orders, Collaborative Practice Agreements, and Protocols for Immunizations9

1. Secure leadership—obtain organizational and physician leader buy-in, define a program leader, and establish a supporting/oversight committee.
2. Delineate scope—identify target patient population, age, risk factors, and types of vaccines and their availability.
3. Establish procedures—create standing orders or CPAs, protocols for managing vaccine reactions, and quality assessment criteria (eg, immunization rates).
4. Quality assessment—perform quality review of staff adherence to standing orders or CPAs and routine review of procedures required to renew programs and adopt relevant clinical updates.

When developing standing orders, securing the support of leadership—which may include the medical director or chief physician, clinicians, pharmacists, and nurse leaders—is essential.9 Leadership buy-in is imperative for writing standing orders and obtaining the necessary authorization to approve the drafted protocol. To keep the standing order or CPAs up to the latest clinical standards, a regular reassessment timeline should be outlined as part of the initial design. A program lead and committee should be identified to create any implementation protocols (ie, the written processes for the immunization program).
Whereas CPAs allow for customization of the specific aspects to be included based on the agreement between the physician and pharmacist and are customized within that relationship, standing orders have standard components that should be included when they are written. Within a standing order, the vaccinations to be provided should be targeted based upon assessment of the population’s needs.7,8 Additional considerations include the availability of a supply of vaccine from manufacturers, storage and stability capacity, and administration schedules for the vaccine series.8,9 Eligibility criteria (eg, age, individual risk factors, indications, contraindications) for each vaccine product should be defined. Individual state laws may restrict administration of particular vaccines and the age of eligible patients. Clinical screening questions should be established for each vaccine in the standing order and reviewed with patients prior to vaccine administration to ensure that they are eligible and that the vaccine is appropriate based on their clinical status.7,9
To minimize the potential for error, specific administration factors (eg, needle size, administration site, stability timeline, reconstitution directions) should be considered.8 A procedure should be established for reporting any adverse events (AEs), mitigating any administration errors, and preventing future errors. As health care providers, pharmacists are mandated to report any AEs to appropriate health authorities.
It is important to monitor for AEs and establish emergency procedures if anaphylaxis or any other medical emergencies occur.6,7 Management of AEs may include specific parameters, such as administering epinephrine, providing cardiopulmonary resuscitation (CPR), and contacting emergency services.
A standing order should also outline the planned procedures for documentation and reporting on the administration of each vaccine. There may be variable reporting requirements, including the distribution of patient education with the vaccine.
The legal authority to administer vaccines is granted at the state level through pharmacy practice acts. Completion of an accredited program, maintenance of CPR training, and registration with the state board are requirements; however, it is best to further ensure that pharmacists achieve comprehensive proficiency in vaccination standards before a standing order is implemented. This additional training should be a combination of written and hands-on application (ie, demonstration of vaccine administration). A process should be in place for team member remediation and ongoing quality assurance for staff members carrying out the standing order. Continued training should be considered to support frequent changes in vaccine schedules and procedure modifications.

USE OF THE EHR
Support of the EHR is important for the successful implementation of a standing order, as it can offer decision support for ordering the correct product based upon vaccination guidelines. Proper screening and documentation are cornerstones for a successful immunization protocol, and EHRs can help facilitate completion. Immunization schedules can be integrated into the EHR, which can trigger alert notifications to the health care provider when patients may be eligible to receive specific immunizations. Screening tools and questionnaires can identify possible contraindications or precautions for vaccine administration. The introduction of automation and barcode scanning adds an additional level of safety to the vaccination procedure.
The benefits of using EHRs include both support of health care provider efforts and improvement of the patient experience. Rapid documentation methods (eg, defining the lot number, expiration date, or documentation templates) help to streamline the functioning of immunization clinics. Interoperability is promoted through automatic reporting to state registries using standard vaccine codes (CVX) and manufacturer codes. In addition to transmitting information to state registries, EHRs may also gather outside immunization records from other health care facilities or health information exchanges. EHR portals can also provide vaccine history to patients for their access and review at any time. The billing process is also streamlined based on the CVX code and the proper associated diagnosis code.
Despite their many benefits in facilitating and tracking immunizations, maintenance of EHRs still present  challenges. Duplicate patient profiles may be included in state registries, and these may require manual review and reconciliation of information to complete a vaccination history. If duplicate profiles exist, information may not readily flow from the state registry into the EHR. Creation of new patient profiles can result in extensive and sometimes time-intensive data entry requirements prior to vaccine administration. Vaccine schedule integration is beneficial for identifying eligible patients, yet frequent changes in vaccine schedules require modifications of EHR system modifications. Any adjustments to the EHR procedures or general workflow should be supported with training to provide a smooth transition.

CONCLUSIONS
Vaccine administration provides benefits at the patient and public health levels, and pharmacists are critical members of health care teams that provide these vital biologic medications. As readily accessible health care providers, pharmacists can meaningfully impact vaccination rates. Development of immunization standing orders and protocols helps to define the scope and streamline the effort. Taking the steps necessary for successful implementation of standing orders, continually evaluating the standing order and protocols, and providing pharmacist competency training ensures high quality immunization care by pharmacists to patients. ■

REFERENCES

1. Garett R, Young SD. Online misinformation and vaccine hesitancy. Transl Behav Med. 2021;11(12):2194-2199. doi:10.1093/tbm/ibab128
2. Le LM, Veettil SK, Donaldson D, et al. The impact of pharmacist involvement on immunization uptake and other outcomes: an updated systematic review and meta-analysis. J Am Pharm Assoc (2003). 2022;62(5):1499-1513.e16. doi:10.1016/j.japh.2022.06.008
3. Isenor JE, Edwards NT, Alia TA, et al. Impact of pharmacists as immunizers on vaccination rates: a systematic review and meta-analysis. Vaccine. 2016;34(47):5708-5723. doi:10.1016/j.vaccine.2016.08.085
4. Are A, Hauser R, Spencer R, Satterfield J, Nguyen E. States’ pharmacist immunization authority and the impact on adult influenza vaccination rates. J Am Pharm Assoc (2003). 2022;62(5):1666-1670. doi:10.1016/j. japh.2022.04.017
5. Collaborative practice agreements and pharmacists’ patient care services: a resource for pharmacists: a resource for pharmacists. CDC. October 2013. Accessed July 17, 2023. https://www.cdc.gov/dhdsp/pubs/docs/Translational_Tools_Pharmacists.pdf
6. Chapter 6: creating standing orders and protocols. In: Angelo LB. Immunization Handbook for Pharmacists. 5th ed. American Pharmacists Association; 2021. APhA Pharmacy Library. Published online June 22, 2021. Accessed August 2, 2023. https://pharmacylibrary.com/doi/10.21019/9781582123653.ch6
7. McKibben LJ, Stange PV, Sneller VP, Strikas RA, Rodewald LE; Advisory Committee on Immunization Practices. Use of standing orders programs to increase adult vaccination rates. MMWR Recomm Rep. 2000;49(RR-1):15-16.
8. Using standing orders for administering vaccines: what you should know. Immunize.org. May 29, 2023. Accessed June 9, 2023. https://www.immunize.org/catg.d/p3066.pdf
9. Steps to implementing standing orders for immunization in your practice. Immunize.org. June 12, 2023. Accessed August 2, 2023. https://www.immunize.org/catg.d/p3067.pdf

About the Authors
ALFRED ADAM L’ALTRELLI, PHARMD, CFMC, MBA, is the senior director of pharmacy at UPMC Presbyterian-Shadyside, an adjunct professor at the University of Pittsburgh School of Pharmacy, and program director for Health System Pharmacy and Leadership Residencies and Fellowships at UPMC and the University of Pittsburgh School of Pharmacy, all in Pennsylvania.
TRISHA A. MILLER, PHARMD, MPH, BCACP, is a supervisor of pharmacy ambulatory services in the Department of Pharmacy at UPMC Presbyterian- Shadyside and adjunct faculty at the University of Pittsburgh School of Pharmacy in Pennsylvania.
REBECCA MEDVA, MHMS, BS, CPHT, is a senior manager in information technology at UPMC Corporate Services in Jeannette, Pennsylvania.
RACHEL V. MARINI, PHARMD, BCIDP, is a clinical infectious diseases pharmacist at UPMC Presbyterian-Shadyside and a clinical assistant professor of medicine and program director for Pharmacy Infectious Diseases Fellowship Program at the University of Pittsburgh School of Pharmacy, all in Pennsylvania.

LEGAL & REGULATORY UPDATES

Impact of the Inflation Reduction Act on Vaccinations: What Pharmacists Need to Know
By LIBBI GREEN, PHARMD

LIBBI GREEN, PHARMD

The Inflation Reduction Act (IRA)— signed into law by President Joseph R. Biden on August 16, 2022—is a landmark piece of legislation that aims to curb inflation by reducing the federal government’s budget deficit.1,2 Included in the bill are provisions that will take sig­nificant action on some of the most crucial challenges facing the American public: climate change and the rising costs of health care and prescription drugs.1 The IRA will address these concerns by lowering prescription drug prices, extending subsidies to help people pay for health insurance, and investing in domestic energy produc- tion while promoting clean energy.2 The long-awaited bill is financed largely by tax code reforms intended to raise the minimum tax on large corporations and improve taxpayer compliance by funding the IRS.1,3
The bipartisan effort falls short of the goals of the Build Back Better (BBB) Act, which included more substantial changes to the tax code; the creation of a federal paid family and medical leave program; and measures to bring down the costs of childcare, housing, and home health care.4,5 The BBB Act was passed by the House of Representatives in November 2021, but it was stalled in the Senate due to lack of bipartisan support and some Democratic intraparty opposition.5 Although the BBB Act failed to pass both houses, many parts of its framework were successfully incorporated into the IRA, and it will have wide-ranging effects on the health care landscape starting as early as this year (2023).2,5

HEALTH CARE PROVISIONS OF THE IRA
The IRA legislation carries forward the vaccine provisions from the BBB Act and delivers increased access and elimination of cost-sharing for vaccines to patients enrolled in Medicare Part D, Medicaid, and the Children’s Health Insurance Program (CHIP).2 These policy changes will enable more than 64 million seniors and people with disabilities to have coverage for adult vaccines without cost-sharing, finally achieving parity with nongrandfathered commercial, employer-sponsored, or health marketplace plans under the Affordable Care Act (ACA) (See Table).2,6-8
Under the IRA, effective as of January 2023, Medicare Part D plans may no longer impose cost-sharing for vaccines recommended by the Advisory Committee on Immunization Practices (ACIP).2 Part D plans may not apply a deductible, coinsurance, or any other cost-sharing requirement for these vaccines. ACIP- recommended vaccines covered under Medicare Part D include9:

• shingles;
• tetanus/diphtheria (Td);
• tetanus/diphtheria/pertussis (Tdap);
• hepatitis A; and
• hepatitis B.

Influenza, pneumococcal, COVID-19, and certain other vaccines were already covered without cost-sharing under Medicare Part B.9
Starting in October 2023, the IRA will address gaps in adult immunization coverage under Medicaid and CHIP.2,10 Medicaid enrollees include families under a certain income threshold, qualified pregnant women, and individuals receiving supplemental security income.11 Without a federal mandate, vaccine coverage is determined by individual states, and cost- sharing can vary greatly.12 The ACA and subsequent regulations have improved access by mandating vaccine coverage without cost-sharing for the Medicaid expansion population: nonelderly adults with an income up to 138% of the federal poverty level for states that have chosen to adopt the ACA Medicaid expansion.8 As of March 2023, 41 states, and the capital city of the District of Columbia, have expanded Medicaid.8 The IRA creates parity between Medicaid and Medicaid expansion programs by mandating coverage of ACIP- recommended vaccines, much like the existing coverage standards for the commercial insurance market. These new requirements will secure access to recommended vaccines for all Medicaid-enrolled adults and CHIP enrollees 19 years or older by requiring states to provide coverage without cost-sharing, thereby closing long-standing gaps in adult vaccine coverage in the United States.2
In addition to improving access to adult immunizations, the IRA will deliver lower prescription drug costs for people with Medicare, reduce drug spending by the federal government, and expand Americans’ eligibility and access to health insurance coverage.2 For the first time, starting in 2026, it will allow Medicare to negotiate with manufacturers for prescription drug prices by establishing a Drug Price Negotiation Program for certain single- source chemical drugs and biological products covered under Medicare Part B and Part D.2 The drugs selected for negotiation will have the highest total Medicare spending, and new medications will be selected for negotiations each year, starting with 10 drugs in 2026 and increasing to 20 drugs for 2029 and beyond.2 Effective January 2023, for certain medications covered under Part D, the IRA requires drug companies to pay annual rebates to Medicare if they increase the prices faster than the rate of inflation.2 Also effective January 2023, the IRA set a $35 cap on monthly Medicare enrollee cost-sharing for insulin.
Starting in 2025, the Part D benefit will be reconfigured to cap annual out- of-pocket spending to $2000, compared with current coverage, which has no limit on the total amount that beneficiaries pay out-of-pocket each year.2,13 For those who meet income eligibility criteria, the IRA extends premium subsidies for health plans sold on exchanges through 2025.2 Starting in 2024, the Act expands eligibility for the Part D Low-Income Subsidy Program. These key health care provisions of the IRA will have the potential to make a meaningful difference in the lives of millions of Americans, ensuring certain drugs and vaccines are more accessible, and therapies like insulin are more affordable.

VACCINE PROVISIONS IN THE IRA: PATIENT IMPACT
Challenges to improving adult immunization rates and reducing vaccine- preventable diseases (VPDs) persist in the United States.14,15 Annual expenditures for the treatment of VPDs in adults are estimated at nearly $27 billion, with substantial downstream effects on health care utilization.14 Immunization as a public health initiative is one of the most cost-effective health care interventions, resulting in decreased incidence of VPDs and associated morbidity and mortality, shorter hospital stays, and reduced courses of treatment.14-16 Despite the abundance of evidence demonstrating the benefits of vaccination for VPDs, adult vaccination rates remain low for most routinely recommended vaccines, such as influenza and pneumococcal disease.17 Furthermore, the United States has failed to meet many of its Healthy People 2020 targets for vaccinating adults; vaccination rates will continue to be an objective for Healthy People 2030.18,19
Disparities in vaccination status among adults exist across race, ethnicity, and socioeconomic status; immunization rates for most vaccines are low among minority groups and people who are at lower income levels.20-22 For most vaccines, coverage remains higher among adults with private health insurance compared with groups who receive public health insurance.17 Affordability factors into vaccine nonadherence as well, with research demonstrating that reduced out-of-pocket costs improve vaccination rates.23
Provisions set forth in the IRA address coverage and cost- sharing obstacles to immunizations. In 2021, 3.4 million people received vaccines under Medicare Part D, with out- of-pocket costs totaling $234 million, or about $70 per enrollee.9,24 The most commonly administered Medicare Part D−covered vaccine is for the prevention of shingles; it accounted for 90% of all out-of-pocket Part D vaccine spending in 2021. In addition to being the most utilized, it is the most expensive, with some seniors paying almost $200 per immunization (2-dose series).9 Under the IRA, Medicare Part D enrollees will pay $0 out-of- pocket for these vaccines, which should make them more accessible.2 For traditional Medicaid enrollees, the IRA ensures that vaccine coverage is a mandatory benefit and further reduces barriers to access by eliminating cost- sharing. Ensuring equal coverage for all recommended vaccines across government- sponsored health plans will promote public health, reduce disease burden from VPDs, and prioritize reducing racial and socioeconomic disparities compared with other sources of health insurance.

VACCINE PROVISIONS IN THE IRA: PHARMACIST’S ROLE
Pharmacists play a vital role in implementing public health efforts and educating the public on important legislative changes so that patients may take advantage of these new programs in real time.25 As frontline educators, and what many people consider to be the most patient-accessible member of the health care profession, pharmacists have an enormous opportunity to communicate changes from the IRA to their patients to aid in the improvement of their overall health. Pharmacists can, and should, incorporate efforts to disseminate this information into their practice through a stepwise approach. Patients who may be impacted can be identified based on insurance type and whether they are a Medicare Part D or Medicaid enrollee. Once identified, patients may be screened for all age-appropriate vaccines and educated on the IRA policy changes that may be applicable, such as new vaccine coverage or the elimination of cost-sharing for ACIP- recommended vaccines.2 Pharmacists can then recommend a patient-specific immunization schedule or, in some settings, directly immunize.

SPECIAL REPORT: IMMUNIZATION
TABLE. Impact of Inflation Reduction Act on Vaccinations2,6-8

Program| Pre- IRA| IRA provisions| Estimated impact
---|---|---|---
Medicare Part D| Cost-sharing permitted for covered vaccines (eg, shingles, tetanus)| Eliminates cost-sharing for ACIP-recommended covered vaccines| 51.6 million Part D enrollees6
Medicaid| Non-ACA Expansion Adults: Vaccine coverage not required Coverage and cost-sharing varies by state.| Expands coverage to all ACIP-recommended vaccines without cost-sharing| 12.8 million non-ACA expan- sion, nondisabled adults aged 21-64 years7

ACA, Affordable Care Act; ACIP, Advisory Committee on Immunization Practices; IRA, Inflation Reduction Act.

Research has consistently demonstrated increased uptake of immunizations when a pharmacist is involved.26-28 Pharmacists can serve as champions for vaccination campaigns by advocating for vaccines, immunizing patients, or both. All 50 states, Puerto Rico, and the District of Columbia allow pharmacists to administer vaccines under state-by-state regulations, with some even expanding the practice by authorizing vaccine administration by pharmacy technicians.29 In turn, patients appreciate the improved access by receiving immunizations in a pharmacy environment compared with a physician’s office, typically resulting in shorter wait times and none of the additional costs associated with an office visit.30 By educating their patients on the provisions of the IRA, pharmacists can have an even greater impact by increasing vaccine uptake in historically underserved groups. Increased uptake of recommended vaccines may directly translate into better patient outcomes with reduced patient morbidity and fewer overall long-term health care costs. ■

REFERENCES

1. FACT SHEET: The Inflation Reduction Act supports workers and families. The White House. Published August 19, 2022. Accessed June 15, 2023. https://www.whitehouse.gov/briefing-room/statements-releases/2022/08/19/fact-sheet-the-inflation-reduction-act-supports-workers-and-families/

2. Kirchhoff S. Selected health provisions of the Inflation Reduction Act. Congress.gov. Published September 1, 2022. Accessed June 15, 2023. https://crsreports.congress.gov/product/pdf/IF/IF12203

3. Summary: The Inflation Reduction Act of 2022. Senate.gov. Accessed June 15, 2023. https://www.democrats.senate.gov/imo/media/doc/inflation_reduction_act_one_page_summary.pdf

4. The build back better framework. The White House. Published March 31, 2021. Accessed June 15, 2023. https://www.whitehouse.gov/build-back-better/

5. McPherson L. How “Build Back Better” started, and how it’s going: a timeline. Roll Call. Published July 21, 2022. Accessed June 22, 2023. https://rollcall.com/2022/07/21/how-build-back-better-started-and-how-its-going-a-timeline/

6. Medicare monthly enrollment. HHS.gov. March 2023. Updated June 28, 2023. Accessed July 14, 2023. https://catalog.data.gov/dataset/medicare-monthly-enrollment

7. 2023 Medicaid & CHIP beneficiaries at a glance. Data.gov. April 2023. Accessed June 17, 2023. https://www.medicaid.gov/medicaid/quality-of-care/downloads/beneficiary-ataglance-2023.pdf

8. Rudowitz R, Drake P, Tolbert J, Damico A. How many uninsured are in the coverage gap and how many could be eligible if all states adopted the Medicaid expansion? KFF. Published March 31, 2023. Accessed June 17, 2023. https://www.kff.org/medicaid/issue-brief/how-many-uninsured-are-in-the-coverage-gap-and-how-many-could-be-eligible-if-all-states-adopted-the-medicaid-expansion/

9. Sayed B, Finegold K, Ashok K, et al. Medicare Part D enrollee savings from elimination of vaccine cost-sharing. Accessed June 17, 2023. https://aspe.hhs.gov/sites/default/files/documents/329fd579ada6515d3be404f06821c361/aspe-ira-vaccine-part-d.pdf

10. Quality of care vaccines. Medicaid.gov. Accessed June 17, 2023. https://www.medicaid.gov/medicaid/quality-of-care/quality-improvement-initiatives/quality-of-care-vaccines/index.html

11. Medicaid eligibility. Medicaid.gov. Accessed June 17, 2023. https://www.medicaid.gov/medicaid/eligibility/index.html

12. How to pay for vaccines. CDC. Updated March 31, 2017. Accessed July 17, 2023. https://www.cdc.gov/vaccines/adults/pay-for-vaccines.html

13. Big changes coming to Medicare Part D plans. AARP. August 15, 2022. Accessed July 17, 2023. https://www.aarp.org/politics-society/advocacy/info-2022/medicare-part-d-changes.html

14. Kolobova I, Nyaku MK, Karakusevic A, Bridge D, Fotheringham I, O’Brien M. Burden of vaccine-preventable diseases among at-risk adult populations in the US. Hum Vaccin Immunother. 2022;18(5):2054602. doi:10.1080/21645515.2022.2054602

15. Philip RK, Attwell K, Breuer T, Di Pasquale A, Lopalco PL. Life-course immunization as a gateway to health. Expert Rev Vaccines. 2018;17(10):851- 864. doi:10.1080/14760584.2018.1527690

16. Rémy V, Zöllner Y, Heckmann U. Vaccination: the cornerstone of an efficient healthcare system. J Mark Access Health Policy. 2015;3. doi:10.3402/ jmahp.v3.27041

17. Lu PJ, Hung MC, Srivastav A, et al. Surveillance of vaccination coverage among adult populations – United States, 2018. MMWR Surveill Summ. 2021;70(3):1-26. doi:10.15585/mmwr.ss7003a1

18. Immunization and infectious diseases. HealthyPeople.gov. 2020. Accessed June 18, 2023. https://wayback.archive-it.org/5774/20220414135306/
    https://www.healthypeople.gov/2020/topics-objectives/topic/immunization- and-infectious-diseases/national-snapshot

19. Healthy People 2030. HHS.gov. Accessed June 22, 2023. https://health.gov/healthypeople/objectives-and-data/browse-objectives/vaccination

20. Vaccination coverage among adults in the United States, National Health Interview Survey, 2017. CDC. Accessed June 18, 2023. https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubs-resources/NHIS-2017.html

21. Terlizzi EP, Black LI. Shingles vaccination among adults aged 60 and over: United States, 2018. CDC.gov. Published August 26, 2022. Accessed June 22, 2023. https://www.cdc.gov/nchs/products/databriefs/db370.htm

22. Vogelsang EM, Polonijo AN. Scarier than the flu shot?: the social determinants of shingles and influenza vaccinations among U.S. older adults. Vaccine. 2022;40(47):6747-6755. doi:10.1016/j.vaccine.2022.09.061.

23. Vaccination programs: reducing client out-of-pocket costs. The Community Guide. Updated December 23, 2015. Accessed June 17, 2023. https://www.thecommunityguide.org/findings/vaccination-programs-reducing-client-out-pocket-costs.html

24. Out-of-pocket costs for Medicare Part D enrollees on Part D covered vaccines. HHS.gov. Accessed June 23, 2023. https://www.hhs.gov/sites/default/files/ira-part-d-vaccines.pdf

25. ASHP statement on the pharmacist’s role in public health. ASHP. Accessed June 23, 2023. https://www.ashp.org/-/media/assets/policy-guidelines/docs/statements/pharmacists-role-public-health.pdf

26. Isenor JE, Edwards NT, Alia TA, et al. Impact of pharmacists as immunizers on vaccination rates: a systematic review and meta-analysis. Vaccine. 2016;34(47):5708-5723. doi:10.1016/j.vaccine.2016.08.085

27. Le LM, Veettil SK, Donaldson D, et al. The impact of pharmacist involvement on immunization uptake and other outcomes: an updated systematic review and meta-analysis. J Am Pharm Assoc (2003). 2022;62(5):1499-1513.e16. doi:10.1016/j.japh.2022.06.008

28. Higginbotham S, Stewart A, Pfalzgraf A. Impact of a pharmacist immunizer on adult immunization rates. J Am Pharm Assoc (2003). 2012;52(3):367-371. doi:10.1331/JAPhA.2012.10083

29. Pharmacist immunization authority. NASPA. Published April 25, 2023. Accessed June 23, 2023. https://naspa.us/resource/pharmacist-authority-to-immunize/

30. The essential role of community pharmacies in expanding access to vaccines. AJMC. Published July 26, 2018. Accessed June 23, 2023. https://www.ajmc.com/view/essential-role-community-pharmacies-expanding-access-vaccines

About the Author
LIBBI GREEN, PHARMD, is a formulary operations manager at Capital Rx in Philadelphia, Pennsylvania.

HEALTH EQUITY FOCUS

Ensuring Health Equity in Vaccination Access: How Pharmacies Can Work With Community Organizations
By MIRANDA WILHELM, PHARMD

MIRANDA WILHELM, PHARMD

The COVID-19 pandemic did not weigh equally on all community groups. Rather, some populations were impacted more than others. This disproportionate burden of COVID-19 infection created new gaps in the health care system and highlighted existing ones. This was especially true regarding COVID-19–vaccination access and acceptance, resulting in racial and ethnic minority groups who were less likely to be vaccinated (Table).1
One of the greatest impacts that community pharmacists made during the COVID-19 pandemic was provision of immunizations. As of July 21, 2023, staff at pharmacies administered more than 305.5 million doses of COVID-19 vaccines; this includes 8 million doses administered onsite at long-term care facilities during the pandemic.2 Developing innovative models to address health care disparities and inequalities are key to optimizing population health. This article describes how community pharmacies can connect with community organizations to promote equity in vaccine access and increase vaccination rates. Lessons learned from the COVID-19 pandemic can be applied to the administration of current and new vaccines.

ESTABLISHING EFFECTIVE COMMUNITY PARTNERSHIPS
Pharmacy staff working with community partners can tailor strategies and interventions to address the challenges and specific needs of the community and to increase vaccine access and immunization rates (Figure).3 Specific considerations include:

• sharing information and materials (eg, vaccine efficacy and possible adverse events, clinic locations) with community members;
• determining the best methods and platforms (eg, interviews with trusted leaders, faith leaders, or celebrities; billboards; local media [TV or radio stations]; print media) to share information with community members;
• identifying appropriate venues and locations (eg, grocery stores, churches, schools, barbershops, local pharmacies) for outreach;
• deciding who are trusted messengers (eg, faith leaders or vaccine administrators of the same race/ ethnicity as those in the community) to share information and administer vaccines to community members; and
• maximizing site logistics, which may increase access to vaccine clinics for community members and allow vaccination to be bundled with other services.

Information and Materials
Vaccine information should be transparent, promote the benefits of and reasons for immunization, and address potential risks of the vaccine in a culturally relevant manner.3 Information should be provided in English and the predominant language spoken within the community. Undocumented or uninsured patients may avoid vaccination due to concern about language accessibility, insurance requirements, and immigration status. During the fall of 2022, which coincided with the peak of the harvest season in

SPECIAL REPORT: IMMUNIZATION
TABLE. Percentage of People Receiving COVID-19 Vaccines by Race/Ethnicity (December 2020-May 2023)1

Race/Ethnicity| People receiving ≥ 1 dose, %| People completing primary series, %| People receiving updated (bivalent) booster dose, %
---|---|---|---
American Indian/Alaska Native,
Non-Hispanic/Latino| 78.5| 65.2| 15.5
Asian,
Non-Hispanic/Latino| 73.6| 66.4| 22.1
Black,
Non-Hispanic/Latino| 51.3| 45.0| 9.5
Hispanic/Latino| 67.2| 57.3| 9.1
Multiracial,
Non-Hispanic/Latino| 62.1| 62.2| 24.4
Native Hawaiian or Other Pacific Islander,
Non-Hispanic/Latino| 71.8| 64.5| 12.7
White,
Non-Hispanic/Latino| 56.9| 51.9| 16.7

Adapted from: COVID data tracker: trends in demographic characteristics of people receiving COVID-19 vaccinations in the United States. CDC. Updated May 11, 2023. Accessed June 17, 2023. https://covid.cdc.gov/covid-data-tracker /#vaccination-demographics-trends. References made to specific commercial products, manufacturers, companies, or trademarks do not constitute their endorsement or recommendation by the United States Government, Department of Health and Human Services, or Centers for Disease Control and Prevention. Materials are available on the Centers for Disease Control and Prevention website at no charge.

Idaho, pharmacy professionals established an outreach program to vaccinate the migrant farm worker community against COVID-19.4 They developed a multicomponent media campaign in Spanish. The pharmacy staff advertised extended hours in Spanish on radio stations and billboards to accommodate workers’ schedules. They also established a partnership with the Idaho State University College of Pharmacy involving student pharmacists assisting with COVID-19 vaccination. In addition, all immunization paperwork was made available in Spanish, and a Spanish interpreter was available at the pharmacy to describe the immunization process and answer any questions. This successful program resulted in dozens of migrant workers receiving COVID-19 vaccines.

Methods and Platforms
Vaccine information should be disseminated through a variety of different media and sources.3 This can include written materials (eg, flyers, postcards, advertisements), social media graphics and information (eg, Facebook, Twitter), online platforms (eg, newsletters, listservs), text messages, and in-person opportunities for community dialogue (eg, town hall meetings, question and answer sessions, small group discussions).
A Nigerian-American pharmacist in Indiana used social media to provide culturally-relevant COVID-19–vaccine information during the pandemic.5 She used social media to address vaccine hesitancy and vaccine-related concerns of people in the community who are often underserved or underrepresented (eg, Black and African-American individuals, residents of urban areas, people who are socioeconomically disadvantaged). Using her personal and professional experience, she provided online educational resources to her followers, who likely did not have access to such information. She provided patient-friendly, evidence- based information from trusted scientific experts who also came from minority backgrounds to help her followers make their own educated decisions. As a result, she was able to reach thousands of people about the importance of COVID-19 vaccination through her social media efforts.

Venues and Locations
Vaccine information should be provided in places frequented by community members.3 These locations can include community-wide areas, such as grocery stores, recreation centers, libraries, schools, and faithbased communities. In addition, health-specific areas (eg, pharmacies, medical clinics, health systems) should be used for vaccine information and administration.
Faith-based institutions have a wide reach in the community, and they may serve as a venue for vaccine clinics. Churches can offer use of larger capacity facilities (eg, halls, gyms), parking lots, and volunteers. Pastors can be trusted messengers in racial or ethnic minority group communities. Local churches can be used to host influenza vaccine clinics each fall.
During the COVID-19 pandemic, a pharmacy in North Carolina partnered with local churches to host COVID-19– vaccine clinics at their houses of worship.6 As part of the immunization effort, local pastors emailed congregants or knocked on doors to inform them about upcoming vaccine clinics. To reach more people, the pharmacist worked with the local housing authority; social workers went door-to-door to inform residents about upcoming clinics and schedule appointments. In addition, the pharmacist worked with local physician groups to identify and vaccinate homebound residents. By April 2021, these efforts resulted in the vaccination of over 40,000 people in North Carolina and Virginia.
Local food pantries are another trusted community partner. During the pandemic, a pharmacy in Iowa collaborated with a local food pantry to host a COVID-19– vaccination clinic.7 Staff at the pharmacist-run clinic administered more than 600 COVID-19 vaccines in 1 day; as of May 2021, more than 35,000 people were immunized as a result of this collaboration. Many patients may not have received a COVID-19 vaccine otherwise, as they were members of socioeconomically disadvantaged groups, did not speak English, and/or were undocumented individuals.

FIGURE. Community Partner Examples for Racial and Ethnic Minority Groups (eg, Black and Hispanic/Latino Communities)3

NAACP, National Association for the Advancement of Colored People.
Repurposed from: A guide for community partners: increasing COVID-19 vaccine update among members of racial and ethnic minority communities. US Department of Health and Human Services/CDC National Center for Immunization and Respiratory Diseases. CDC. April 6, 2021. Accessed July 1, 2023. https://www.cdc.gov/vaccines/covid-19/downloads/guide-community- partners.pdf. References made to specific commercial products, manufacturers, companies, or trademarks do not constitute their endorsement or recommendation by the United States Government, Department of Health and Human Services, or Centers for Disease Control and Prevention. Materials are available on the Centers for Disease Control and Prevention website at no charge.

Trusted Messengers
Vaccine information should be provided by messengers who represent the community and provide a positive influence. Trusted messengers can include local radio and TV personalities, celebrities and leaders from community, faith-based, or civil rights organizations; government; and businesses who engage with the community and have their trust and support.3 In addition, health care messengers (eg, local providers; staff from health clinics, pharmacies, and health systems) should provide vaccine information and administration.
Black individuals are twice as likely to trust a messenger from their own racial or ethnic group in their community as are their White counterparts.3 The social hub of the barbershop in the Black community and the trusted relationship between barber and client has been used to successfully provide health screening and education. In 2018, a mobile booking app for barbershops evolved into Live Chair Health, an initiative designed to reduce health disparities among people of color and to address chronic health issues that disproportionally affect Black individuals.8 During the pandemic, the Live Chair Health program trained staff at more than 50 barbershops on the East Coast about the symptoms of COVID-19 infection and the advantages of receiving vaccines. The barbers used their connection with clients to share accurate information, dispel misinformation, and help clients make informed decisions about their health. Local community pharmacists could educate barbers; in turn, barbers could refer their clients to the pharmacist for their vaccination needs. In addition, barbershops could be used to host influenza vaccine clinics each fall.
As another example, in 2020, a tribal-owned health system in Arizona relied on trusted residents and health providers of the Navajo Nation to address specific COVID-19 vaccine–related concerns.9 Members of the Tuba City Regional Health Care Corporation health system surveyed unvaccinated members of the Navajo Nation each week to determine their reasons for not receiving the vaccine. The team then tailored written materials and social media video posts to address those specific concerns. Providers from the health system answered questions in real time on Facebook Live. Once again, having vaccine workers and messengers who share the same race/ethnicity of community members can promote vaccine acceptance.

Site Logistics
Community pharmacies are a convenient location for patients to obtain a variety of patient care services. Approximately 90% of the United States population lives within 5 miles of a community pharmacy.10 When other health care settings are typically closed, a number of community pharmacies are open on nights and weekends to provide improved public access to vaccines and other patient care services.
When transportation to the pharmacy is a barrier for patients, community organizations and faith-based communities can help. During the pandemic, county officials in Fairfax, Virginia, created the Vaccine Transportation Program.11,12 The county provided free taxi rides to residents who had an appointment to receive the COVID-19 vaccine but no access to transportation. In addition, the county provided information and links on their website about other transportation services offered via community partners and  aith-based communities.
Other transportation efforts were conducted on a much larger scale during the COVID-19 pandemic. At the height of COVID-19–vaccination initiatives, Uber provided 10 million free and discounted rides to and from COVID-19–vaccine centers.13

CONCLUSIONS
The crucial role that community pharmacists play in the health care system to address patient care gaps was emphasized during the COVID-19 pandemic. Community pharmacists are highly visible health care providers who are readily accessible to the public. These pharmacists have the opportunity to address health disparities and inequalities to optimize population health. To increase vaccine access and immunization rates, community pharmacies and organizations can collaborate to tailor strategies and interventions and address the challenges and specific needs of the community. ■

REFERENCES

1. COVID data tracker: trends in demographic characteristics of people receiving COVID-19 vaccinations in the United States. CDC. Updated May 11, 2023. Accessed June 17, 2023. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends
2. Vaccines & immunizations: the federal retail pharmacy program for COVID-19 vaccination. CDC. Reviewed July 25, 2023. Accessed July 27, 2023. https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/index.html
3. A guide for community partners: increasing COVID-19 vaccine update among members of racial and ethnic minority communities. US Department of Health and Human Services/CDC National Center for Immunization and Respiratory Diseases. CDC. April 6, 2021. Accessed July 1, 2023. https://www.cdc.gov/vaccines/covid-19/downloads/guide-community-partners.pdf
4. Collins S. VaccineConfident: Community pharmacist connects with hard-to-reach population. American Pharmacists Association. April 2023. Accessed July 1, 2023. https://vaccineconfident.pharmacist.com/Success-Stories/Articles/Community-Pharmacist-Connects-With-Hard-to-Reach-Population
5. Chan C. VaccineConfident: Pharmacist leads by example and uses social media to educate her community. American Pharmacists Association. April 2021. Accessed July 1, 2023. https://vaccineconfident.pharmacist.com/Success-Stories/Articles/Pharmacist-Leads-by-Example-and-Uses-Social-Media
6. Collins S. VaccineConfident: Pharmacist partners with faith-based communities to provide COVID-19 vaccinations. American Pharmacists Association. April 2021. Accessed July 1, 2023. https://vaccineconfident.pharmacist.com/Success-Stories/Articles/Vaccine-Confident-Pharmacist-North-Carolina
7. Chan C. VaccineConfident: Putting people at ease by providing vaccines at familiar community locations. American Pharmacists Association. May 2021. Accessed July 1, 2023. https://vaccineconfident.pharmacist.com/Success-Stories/Articles/Putting-People-at-Ease-by-Providing-Vaccines-at-Familiar-Community-Locations
8. Perlow B, Moton K. Barbershops in Black communities provide information on COVID-19, vaccine. Live Chair Health trains barbers to address health disparities. ABC News. January 12, 2021. Accessed July 1, 2023. https://abcnews.go.com/Politics/barbershops-black-communities-provide-information-covid-19-vaccine/story?id=75198074
9. Collins S. VaccineConfident: Tribal pharmacist addresses individual concerns and appeals to cultural values, American Pharmacists Association. July 2021. Accessed July 1, 2023. https://vaccineconfident.pharmacist.com/Success-Stories/Articles/Tribal-Pharmacist-Addresses-Individual-Concerns-and-Appeals-to-Cultural-Values
10. Berenbrok LA, Tang S, Gabriel N, et al. Access to community pharmacies: a nationwide geographic information systems cross-sectional analysis. J Am Pharm Assoc. 2022;62:1816-1822.e2. doi:10.1016/j.japh.2022.07.003
11. Fairfax County Health and Human Services COVID-19 response updates. FairfaxCounty.gov. December 2022. Accessed July 1, 2023. https://www.fairfaxcounty.gov/neighborhood-community-services/sites/neighborhood-community-services/files/assets/documents/coronavirus/hhs-update.pdf
12. Need help getting to your COVID-19 vaccine appointment? View several transportation options. Fairfax County Emergency Information. March 1, 2021. Accessed July 1, 2023. https://fairfaxcountyemergency.wpcomstaging.com/2021/03/01/need-help-getting-to-your-covid-19-vaccine-appointment-view-several-transportation-options/
13. Uber Impact. Rides for vaccinations. Uber. Accessed July 1, 2023. https://www.uber.com/us/en/impact/rides-for-vaccines/

About the Author
MIRANDA WILHELM, PHARMD , is a clinical professor in the department of pharmacy practice at the Southern Illinois University Edwardsville (SIUE) School of Pharmacy and a clinical pharmacist with SIUE Health Service in Edwardsville, Illinois.

VACCINE SPOTLIGHT

Focus on Human Papillomavirus Virus Vaccination in Adults and Young Adults
By JESSICA HUSTON, PHARMD; AND ERIC F. EGELUND, PHARMD, PHD

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JESSICA HUSTON, PHARMD| ERIC F. EGELUND, PHARMD, PHD

The human papillomavirus (HPV), a double-stranded DNA virus, is consid- ered to be the most common pathogen related to sexually transmitted infection in the United States.1,2 Approximately 13 million persons are newly infected each year, add- ing to the estimated 42 million people cur- rently infected.3 Infection with HPV, which can involve human epithelial cells, usually produces no symptoms and resolves spon- taneously within a year or 2 of infection.2 In certain cases, however, HPV infection leads to cell differentiation, which can further develop into warts or various cancers. Over 100 HPV types have been molecularly char- acterized, and they are generally divided into 2 clinical classifications: low risk and high risk. Low-risk HPVs are not carcinogenic, but they can generate anogenital warts. High-risk HPVs can lead to life- threatening malignan- cies including, but not limited to, cancers of the anus, cervix, penis, vagina, and mouth and throat (oropharynx).1 Associated risk factors for HPV infection include increased age difference between a woman and her first sexual partner, number of sexual partners, and nonmonogamous partners.2
Vaccines are available to prevent certain types of HPV infection. To date, 3 vaccines have been approved by the FDA: a bivalent HPV vaccine (2vHPV), a quadrivalent HPV vaccine (4vHPV), and a 9-valent HPV vaccine (9vHPV) (Figure).4 Although the 2vHPV and 4vHPV are licensed in the United States, they are no longer distributed. The 9vHPV vac- cine (Gardasil 9; Merck Sharp & Dohme) was granted initial FDA approval in 2014, and it is currently the only HPV vaccine distributed in the United States.5

SAFETY AND EFFICACY OF HPV VACCINES HPV
vaccine safety and efficacy was de­mon- strated in the results of several long-term studies in men and women.6-9 The most common adverse events (AEs) associated with the HPV vaccine are pain, swelling, or redness at the injection site; redness and swelling can increase with subsequent HPV vaccine doses.10 Other AEs include fever, headache, nausea, and muscle and joint pain.10,11 Syncope and dizziness have also been reported.10-12 In regard to serious AEs, few have been reported via the Vaccine Safety Datalink, which examined 2 years of 9vHPV data, or through the Vaccine Adverse Event Reporting System (VAERS).11,12
According to the results of studies exam- ining infection, cervical epithelial neoplasia, and adenocarcinoma in situ, HPV vaccines are over 99% effective when administered prior to exposure to specific strains of HPV covered by vaccination.13 An in-depth review of efficacy studies is located in the CDC’s Epidemiology and Prevention of Vaccine- Preventable Disease (“The Pink Book”).4

CURRENT RECOMMENDATIONS FOR HPV VACCINATION
The Advisory Committee on Immunization Practices (ACIP) currently recommends rou- tine HPV vaccination for adolescents aged 11 or 12 years, although the series can be given in patients as young as 9 years.14 For those who were not routinely vaccinated, catch-up vaccination is recommended for people 13 to 26 years old.14,15 Shared clinical decision-making is recommended for non­ vaccinated individuals who are aged 27 to 45 years and who may benefit if they are at risk of a new HPV infection or exposure.15 Patients should complete the vaccine series with the 9vHPV vaccine regardless if they received the 2vHPV or 4vHPV vaccine. Restarting the HPV vaccine series is not necessary in this situation.14

SPECIAL REPORT: IMMUNIZATION
FIGURE. HPV Types Targeted by FDA-Licensed Vaccines4,a

aColors delineate differences in vaccine coverage.

The ACIP recommendations for HPV vaccination do not vary based on a patient’s behavioral or medical risk factors for HPV infection or disease.14 HPV vaccination should be delayed in pregnant persons until after pregnancy. However, pregnancy testing is not required for HPV vaccination. HPV vaccine can be administered in patients who are breastfeed- ing or lactating.
The American Academy of Pediatrics (AAP), however, recommends that the HPV vaccination series first be admin- istered to patients aged 9 to 12 years.16 The AAP has listed several reasons for this minor differentiation, noting that an earlier offering of the vaccine would increase flexibility for providers in addition to detaching discussions about vacci- nation from those of sexuality. This earlier recommendation may also relieve some of the vaccine hesitancy fatigue sur- rounding HPV vaccination recommendations and increase vaccine uptake. The American Cancer Society also recom- mends routine vaccination for males and females aged 9 to 12 years.17
A 2-dose HPV vaccination schedule is recommended for patients aged 9 to 14 years.14 The second dose should be administered 6 to 12 months following the first (minimum dosing interval, 5 months). A 3-dose HPV vaccination schedule is recommended for patients who receive their first dose on or after their 15th birthday or for those who are immunocompromised (eg, due to HIV infection, cancer, transplantation, autoimmune disease, or use of immunosuppressant medications). The second dose should be administered 1 to 2 months after the first dose, and the third dose should be given 6 months after the initial dose. The first and second dose should be given at least 4 weeks apart, with at least 12 weeks between the second and third doses and at least 5 months between the first and third doses. If an HPV vaccine dose is received within a shorter time frame, the dose should be given again after another minimum interval has passed since the most recent dose.
For both the 2- and 3-dose series, doses do not need to be restarted if the elapsed time is more than the recommended minimum interval.
The World Health Organization’s (WHO) guidelines, however, differ from those of the CDC. The difference lies mainly in the recommended dosages. The WHO updated their recommendations in December 2022 to a 1- or 2-dose schedule compared with the 2- or 3-dose series recom- mended by the CDC.14,18 In the CVT trial (NCT00128661), women who only received 1 dose showed lower antibody titers than those noted in studies of women given a 2- or 3-dose series.19 However, results of another clinical study (NCT00923702) revealed that at a 10-year follow-up, pro- tective antibody levels were found in patients given a single dose of vaccine.20 Additionally, the 1-dose schedule may increase access to the vaccine and provide similar efficacy; therefore, it is considered to be an alternative, off-label single-dose schedule.18,20

COUNSELING TIPS FOR ADULTS
HPV vaccination is recommended for persons 26 years or younger, and a shared clinical decision-making recommendation exists for persons aged 27 to 45 years who have not yet received the immunization.14,15 Clinical decision-making should be shared by the provider and the patient to determine the best outcomes that align with the patient’s needs and wants. Discussion of the benefits and risks for patients who fall into the shared clinical decision- making category can help ensure the availability and administration of appropriate vaccinations. Counseling should cover the safety and efficacy of the vaccine. Patient concerns regarding safety can be delineated broadly into the physical act of receiving a vaccine and the potential concerns related to its contents (eg, acute or chronic effects on the body). Physicians can cite data from the CDC’s VAERS, which indicate that the HPV vaccination series does not produce AEs at a rate higher than expected.21 Syncope following vaccination is not unusual; to avoid harmful falls, patients should be seated during vaccination and then observed for at least 15 minutes after the vaccine is given.22

COUNSELING TIPS FOR ADOLESCENTS
The previously mentioned safety concerns also apply to adolescents; however, syncope occurs more frequently in adolescents following vaccinations.21 Additional counseling may be necessary as parental concerns regarding HPV vacci- nations can differ from those of adults making health care decisions for themselves. Results from a cross-sectional study by Sonawane et al identified a nearly 2-fold increase (13.0% to 23.4%) in US parents declining HPV vaccination for their child from 2015 to 2018, respectively, because of safety concerns.23 Aside from safety, parents have cited a child’s lack of sexual activity as a reason for declining vac- cination; however, the rate of HPV vaccine refusal for this reason decreased over time in 2 studies.23,24 Counseling should focus on the prevention of future disease; it should not be perceived as a reflection of the person receiving the immunization.
Researchers and health care professionals believe that the decline in parental acceptance of the HPV vaccine is partial- ly attributable to misinformation on social media (eg, HPV vaccines leading to infertility or autoimmune disorders).25 Negative media coverage, frequent changes in treatment recommendations, and the stigma surrounding HPV vacci- nation are also believed to contribute to lower-than-antici- pated acceptance by the public.26,27
Despite these concerns, a strong recommendation from a health care provider is associated with greater vaccine acceptance.26 Therefore, counseling provided to patients by health care practitioners regarding the vaccine’s efficacy and safety is important to ensure protection against HPV infection.

CONCLUSIONS
The Healthy People 2030 initiative has a target goal of 80% of adolescents having received the recommended doses of the HPV vaccine.28 Data from this initiative indicate that as of 2021, approximately 58.5% of adolescents received the recommended doses of the HPV vaccine. The American College of Obstetricians and Gynecologists noted that the vaccination rates for HPV in the United States are unaccept- ably low compared with those of other countries, and the burden of disease could be drastically prevented with vac- cination.29 Further, for each year that HPV vaccination rates do not increase, an additional 4400 women may develop cervical cancer.
The importance of being nonjudgmental when offering vaccination and providing disease state prevention counsel- ing is paramount. Additionally, strong practitioner recom- mendations and increasing counseling opportunities are 2 strategies to increase HPV vaccination rates.30,31 Pharmacists are uniquely positioned to offer vaccine-related services and counseling among persons aged 18 to 26 years who can receive the catch-up regimen of 3 doses of 9vHPV. For example, HPV infection is believed to cause 70% of oropha- ryngeal cancers; even though men are at least 4 times more likely than women to develop oropharyngeal cancer due to HPV infection, a 20-year-old man may not be an obvious target for this recommendation by a pharmacist.4,32 Current guidelines reflect an effort to capture individuals who may have missed vaccination when first eligible.
Pharmacists are very accessible to patients and well- trained in discussing scientific subjects and sharing infor-mation with all adults, regardless of gender. Combining strong evidence-based recommendations with caring, compassionate, and frequent counseling opportunities hopefully will increase vaccine acceptance and ultimately reduce the incidence of HPV and associated cancers among our patients. ■

REFERENCES

1. Genital HPV infection – basic fact sheet. CDC. Reviewed April 12, 2022. Accessed July 1, 2023. https://www.cdc.gov/std/hpv/stdfact-hpv.htm
2. Chelimo C, Wouldes TA, Cameron LD, Elwood JM. Risk factors for and prevention of human papillomaviruses (HPV), genital warts and cervical cancer. J Infect. 2013;66(3):207-217. doi:10.1016/j.jinf.2012.10.024
3. Lewis RM, Laprise JF, Gargano JW, et al. Estimated prevalence and incidence of disease-associated human papillomavirus types among 15- to 59-year-olds in the United States. Sex Transm Dis. 2021;48(4):273-277. doi:10.1097/OLQ.0000000000001356
4. Meites E, Gee J, Unger E, Markowitz L. Human papillomavirus. In: Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 14th ed. Public Health Foundation, 2021.
5. Gardasil 9. Prescribing information. Merck Sharp & Dohme; 2023. Accessed July 20,2023. https://www.merck.com/product/usa/pi_circulars/g/garda-sil_9/gardasil_9_pi.pdf
6. Castellsagué X, Muñoz N, Pitisuttithum P, et al. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. Br J Cancer. 2011;105(1):28-37. doi:10.1038/bjc.2011.185
7. Goldstone SE, Giuliano AR, Palefsky JM, et al. Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2022;22(3):413-425. doi:10.1016/S1473-3099(21)00327-3
8. Luna J, Plata M, Gonzalez M, et al. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil in adult women. PLoS One. 2013;8(12):e83431. doi:10.1371/journal.pone.0083431
9. FUTURE I/II Study Group; Dillner J, Kjaer SK, Wheeler CM, et al. Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial. BMJ. 2010;341:c3493. doi:10.1136/bmj.c3493
10. Vaccine safety: human papilloma virus. CDC. Reviewed September 9, 2020. Accessed July 3, 2023. https://www.cdc.gov/vaccinesafety/vaccines/hpv-vaccine.html
11. Shimabukuro TT, Su JR, Marquez PL, Mba-Jonas A, Arana JE, Cano MV. Safety of the 9-valent human papillomavirus vaccine. Pediatrics. 2019;144(6):e20191791. doi:10.1542/peds.2019-1791
12. Donahue JG, Kieke BA, Lewis EM, et al. Near real-time surveillance to assess the safety of the 9-valent human papillomavirus vaccine. Pediatrics. 2019;144(6):e20191808. doi:10.1542/peds.2019-1808
13. Vaccines and preventable diseases: about HPV vaccines. CDC. Reviewed November 16, 2021. Accessed July 1, 2023. https://www.cdc.gov/vaccines/vpd/hpv/hcp/vaccines.html
14. Human papillomavirus (HPV): HPV vaccine schedule and dosing. CDC. Reviewed November 1, 2021. Accessed July 21, 2023. https://www.cdc.gov/hpv/hcp/schedules-recommendations.html
15. Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human papillomavirus vaccination for adults: Reviewed recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019;68:609-702. doi:10.15585/mmwr.mm6832a3
16. O’Leary ST. Why the American Academy of Pediatrics recommends initiating HPV vaccine at age 9. Hum Vaccin Immunother. 2022;18(6):2146434. doi:10.1080/21645515.2022.2146434
17. Guidelines for human papillomavirus (HPV) vaccine use. American Cancer Society. Accessed July 3, 2023. https://www.cancer.org/health-care-profes-sionals/american-cancer-society-prevention-early-detection-guidelines/hpv-guidelines.html
18. Human papillomavirus vaccines: WHO position paper, December 2022. Weekly Epidemiological Record. 2022;97(50):645-672. WHO. Accessed July 31, 2023. https://www.who.int/publications/i/item/who-wer9750-645-672
19. Kreimer AR, Sampson JN, Porras C, et al. Evaluation of durability of a single dose of the bivalent HPV vaccine: the CVT trial. J Natl Cancer Inst. 2020;112(10):1038-1046. doi:10.1093/jnci/djaa011
20. Joshi S, Anantharaman D, Muwonge R, et al. Evaluation of immune response to single dose of quadrivalent HPV vaccine at 10-year post-vaccination. Vaccine. 2023;41(1):236-245. doi:10.1016/j.vaccine.2022.11.044
21. Human papillomavirus (HPV): HPV vaccine safety and effectiveness data. CDC. Reviewed November 1, 2021. Accessed July 22, 2023. https://www.cdc.gov/hpv/hcp/vaccine-safety-data.html
22. Vaccine safety: fainting (syncope) after vaccination. CDC. August 25, 2020. Accessed July 31, 2023. https://www.cdc.gov/vaccinesafety/concerns/fainting.html
23. Sonawane K, Zhu Y, Lin YY, et al. HPV vaccine recommendations and parental intent. Pediatrics. 2021;147(3):e2020026286. doi:10.1542/peds.2020-026286
24. Beavis A, Krakow M, Levinson K, Rositch AF. Reasons for lack of HPV vaccine initiation in NIS-Teen over time: shifting the focus from gender and sexuality to necessity and safety. J Adolesc Health. 2018;63(5):652-656. doi:10.1016/j.jadohealth.2018.06.024
25. Jaber N. Despite proven safety of HPV vaccines, more parents have concerns. National Cancer Institute. October 22, 2021. Accessed July 4, 2023. https://www.cancer.gov/news-events/cancer-currents-blog/2021/hpv-vaccine-parents-safety-concerns
26. Morales-Campos DY, Zimet GD, Kahn JA. Human papillomavirus vaccine hesitancy in the United States. Pediatr Clin North Am. 2023;70(2):211-226. doi:10.1016/j.pcl.2022.11.002
27. Updyke EA, Welsh E. Episode 67 HPV: my wart be with you. This Podcast Will Kill You. February 23, 2021. Accessed June 27, 2023. https://thispodcast-willkillyou.com/2021/02/23/episode-67-hpv-my-wart-be-with-you/
28. Increase the proportion of adolescents who get recommended doses of the HPV vaccine — IID08. Healthy People 2030. Accessed July 4, 2023. https://health.gov/healthypeople/objectives-and-data/browse-objectives/vaccination/increase-proportion-adolescents-who-get-recommended-doses-hpv-vaccine-iid-08
29. Human papillomavirus vaccination. American College of Obstetricians and Gynecologists. July 23, 2020. Accessed July 3, 2023. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2020/08/human-papillomavirus-vaccination
30. Holloway GL. Effective HPV vaccination strategies: what does the evidence say? An integrated literature review. J Pediatr Nurs. 2019;44:31-41. doi:10.1016/j.pedn.2018.10.006
31. Evidence-Based Cancer Control Programs (EBCCP): HPV vaccination evidence-based programs listing. National Cancer Institute. Accessed July 4, 2023. https://ebccp.cancercontrol.cancer.gov/topicPrograms.do?topicId=22626661
32. Moriarty C. Throat cancers are on the rise: why this matters to you. Yale Medicine. March 5, 2020. Accessed July 24, 2023. https://www.yalemedicine.org/news/throat-cancers-on-the-rise

About the Authors
JESSICA HUSTON, PHARMD , is a clinical assistant professor in the Department of Pharmacotherapy and Translational Research in the College of Pharmacy at the University of Florida in Jacksonville.
ERIC F. EGELUND, PHARMD, PHD , is a clinical assistant professor in the Department of Pharmacotherapy and Translational Research in the College of Pharmacy at the University of Florida in Jacksonville. You can find him on X (formerly Twitter) @labskills

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APRIL 2023 Vol. 5 No. 3

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ANN TONG, PHARMD; YIJUN CAI, PHARMD CANDIDATE; SAMANTHA SHI, PHARMD, BCOP; HIEN TANG, PHARMD, BCOP; HARRY SHAMAMIAN, PHARMD, MBA, FACHE; AND AMIR ALI, PHARMD, BCOP
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• Flu Vaccination Coverage, United States, 2021–22 Influenza Season | FluVaxView | Seasonal Influenza (Flu) | CDC
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