Most pharmacists have probably heard numerous versions of these statements, always said emphatically and with conviction, and with a supporting story to boot. One’s inclination may be to reply immediately, “That’s not true!” Another option might seem to be to list the incontrovertible facts and evidence to counteract that argument. Alternately, a pharmacist may think resignedly, “I’m not going to be able to change their mind.”

Although the CDC clearly states that the influenza (flu) vaccine cannot cause the flu, it is often difficult for patients to reconcile their health beliefs with the actual facts, for a number of different reasons. However, a scenario like the one above provides an excellent opportunity for the pharmacist to address these flu myths and educate patients on flu vaccine facts.

A contributing factor to an individual’s decision making when it comes to the flu vaccine can be explained by the Health Belief Model.

 This theory, developed in the 1950s, states that 6 different constructs help predict whether someone will take action to prevent, screen, or control illness. Using the flu vaccine as an example, these constructs are susceptibility to contracting the flu; perceived potential seriousness of the flu; benefits to getting the vaccine; barriers to obtaining the vaccine; cues to action (ie, strategies to trigger a person to get the vaccine, such as marketing or a direct question asking the person if they want the vaccine); and self-efficacy.

 In addition, an individual’s decision to get the flu vaccine is influenced by knowledge, experience, beliefs, culture, social networks, perceptions of the vaccine’s efficacy and safety, access, and cost.

Dispelling the myths requires preemptively expecting the common misconceptions, empathizing with the complexity of factors that influence someone’s decision to obtain the flu vaccine, and attempting to reconcile their initial hesitation with the facts. Most of all, it requires optimal communication skills to present the evidence confidently and convincingly. Table 1

 describes some common myths surrounding the flu vaccine and methods you can use to respond to patients in an attempt to dispel them.

A systematic review, published in 2015, described potential strategies to respond to vaccine hesitancy.

 In general, the strategy of enhancing knowledge and awareness was not, on its own, effective. Rather, it’s more beneficial to tailor a discussion to the specific individual and their concern. The most effective strategies had multiple components and/or a dialogue-based approach, in which providers speak with patients directly about their actual concern, as opposed to providing general education or literature. It was noted that more data are needed to assess the best ways to approach vaccine hesitancy.

Dispelling myths surrounding the flu vaccine takes a holistic approach: A pharmacist needs to balance the evidence the patient brings with the evidence in the published literature and guidelines. Table 2 includes helpful resources to that end. Often, a delicate balance exists between respecting a patient’s beliefs and giving crucial facts. Although knowledge and awareness may allow for the dissemination of correct information about the flu vaccine, for patients to be truly willing to obtain the vaccine, an open dialogue may be key. 

Sneha Baxi Srivastava, PharmD, BCACP, CDE,

 is an associate professor at Rosalind Franklin University College of Pharmacy in North Chicago, Illinois.

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Articles

Feature

Most pharmacists have probably heard numerous versions of these statements, always said emphatically and with conviction, and with a supporting story to boot.

The Flu Vaccine Does Not Cause the Flu

Influenza (flu) vaccine efficacy (VE) varies each season based on the circulating flu strains and the patients receiving the vaccination.

 Findings on the effectiveness of the flu vaccine have fluctuated from 2004 through 2018, based on reports from the US Influenza VE Network. The network’s investigators have found that on average, vaccination reduces the incidence of flu-like illness by approximately 40% to 60%.

 The breakdown of the effectiveness of flu vaccines per season from 2004 to 2018 can be seen in the figure.

Effectiveness of the flu vaccine depends on 2 primary factors

The specific characteristics of the individual being vaccinated (eg, age, health)

Correspondence between the flu viruses the vaccine is designed to protect against and the flu viruses being disseminated throughout the environment

Although vaccine effectiveness can be difficult to determine based on these factors, the results of recent studies indicate that flu vaccination still aids overall public health.

The CDC uses a mathematical model to measure the disease burden of flu on affected patients. Analyses of flu illnesses, medical visits, hospitalizations, and deaths are typically used to create season-specific data on burden of disease, vaccine coverage, and VE. During the 2017-2018 flu season, for example, the vaccine was 38% effective.

 That season was severe among all age groups in the United States and led to an estimated 48.8 million cases of flu, 959,000 hospitalizations, and 79,400 deaths.

Conversely, an estimated 7.1 million illnesses, 109,000 hospitalizations, and 8000 deaths were prevented as a result of flu vaccinations.

In the next flu season—from October 1, 2018, to May 4, 2019&mdash;the CDC estimated that between 37.4 million and 42.9 million individuals in the United States contracted flu-related illnesses, which led to between 531,000 and 647,000 flu-related hospitalizations and 36,400 to 61,200 flu-related deaths.

 Interim estimates from the US Influenza VE Network for the 2018-2019 flu season indicate that the overall estimated effectiveness of the flu vaccine at preventing flu associated with attended acute respiratory illness was 47%.

Patients who are at high risk of flu complications, including young children and adults 65 years and older, are at higher risk of hospitalization and morbidity, while most patients with the flu do not require medical attention and will recover within 2 weeks. Indeed, a 2017 study analyzed data from healthy children and those with an underlying high-risk medical illness for the 2010 through 2014 flu seasons, and the results indicated that the flu vaccine decreased the risk of flu-related deaths in 65% of healthy children and in 51% of children with underlying medical conditions. Just 26% of the reported pediatric deaths reported during that time were in patients known to have been vaccinated during the study period.

 Furthermore, patients 65 years and older account for approximately 70% to 90% of flu-related deaths and for 50% to 70% of flu-related hospitalizations, supporting the importance of ensuring that patients in this population are vaccinated each year.

Flu vaccine effectiveness for the 2018-2019 flu season was estimated to be 61% against all flu types in children aged between 6 months and 17 years, and 24% for all flu types in adult patients 50 years and older.

It is important to discuss with patients that even when VE is not optimal, benefits of vaccination outweigh the risks associated with the vaccine. Identifying patient misconceptions surrounding vaccines can help pharmacists tailor programs to improve vaccination rates and help meet national health objectives. Pinpointing such barriers can lead to overall growth in vaccination rates and a decrease in vaccine-preventable deaths.

 is a clinical associate professor at Ernest Mario School of Pharmacy, Rutgers University, New Brunswick, New Jersey.

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Influenza vaccine efficacy varies each season based on the circulating flu strains and the patients receiving the vaccination.

Influenza Vaccine Efficacy Through the Years

The Advisory Committee on Immunization Practices (ACIP) is composed of medical and public health experts within the CDC who develop recommendations for the safe and appropriate use of vaccines to control disease in the US civilian population.

 The ACIP meets 3 times each year, in February, June, and October, to discuss pertinent immunization topics. ACIP recommendations are reviewed by the CDC director and, if adopted, are published as official recommendations in the Morbidity and Mortality Weekly Report. Additionally, professional organizations, such as the American Academy of Pediatrics, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American College of Physicians, collaborate with the ACIP to develop the annual childhood and adult immunization schedules.

 A review of influenza (flu) vaccine effectiveness during the 2018-2019 flu season and recommendations of vaccines for the 2019-2020 flu season are discussed below.

At the ACIP meeting in February 2019, a surveillance update was provided with statistics regarding the 2018-2019 flu season. According to the CDC, between October 1, 2018, and February 16, 2019, there were between 17.7 million and 20.4 million flu illnesses, between 8.2 million and 9.6 million flu-related medical visits, between 214,000 and 256,000 flu-related hospitalizations, and between 13,600 and 22,300 flu-related deaths.

 Additional data presented at that meeting revealed that during the 2017-2018 flu season, influenza vaccination prevented 7.1 million cases of the flu, 109,000 hospitalizations, and 8000 deaths.

 The interim results of the 2018-2019 flu season (through February 2, 2019) are summarized in table 1

Many pharmacy patients are skeptical about the efficacy of seasonal flu vaccine. However, these statistics support the ongoing need for pharmacists to emphasize the importance of an annual influenza vaccine to their patients.

AN UPDATE ON THE ACIP RECOMMENDATIONS RELATED TO INFLUENZA VACCINES

Recommendations provided by the ACIP about the use of each vaccine are developed after the committee critically reviews a great deal of vaccine-related information, including disease epidemiology and burden, vaccine efficacy and effectiveness, vaccine safety, quality of evidence, feasibility of program implementation, and economic analyses of immunization policy.

 Every year, the child and adult immunization schedules are published with updated vaccination recommendations.

 These documents are meant to help health care providers select the best vaccine and appropriate timing for each patient.

In the 2019 updates to the immunization schedules, a notable change was the addition of the live attenuated influenza vaccine (LAIV).

 The immunization schedule for all individuals between the ages of 2 and 49 years includes the LAIV unless 1 of the contraindications or precautions listed in table 2 is present.

 The ACIP also added a recommendation that any licensed influenza vaccine that is appropriate for the age and health status of a patient may be used.

 Although the LAIV was added to the list of approved vaccines, no specific preference was given to the use of either the LAIV or the inactivated influenza vaccine.

 The ACIP recommendations also include a Special Situations section that provides guidance on vaccinating patients who report an allergy to eggs.

 These recommendations are summarized in table 3.

The February 2019 ACIP meeting led to important changes in recommendations for influenza vaccine administration. Since these recommendations change frequently, it is a best practice for pharmacists to stay up-to-date on the most recent vaccination schedules and ACIP recommendations.

 is a clinical assistant professor in the department of pharmacotherapy at the Washington State University College of Pharmacy and Pharmaceutical Sciences in Spokane, Washington.

Advisory Committee on Immunization Practices (ACIP): general committee-related information. CDC website. cdc.gov/vaccines/acip/committee/index.html. Reviewed October 23, 2018. Accessed May 14, 2019.

Advisory Committee on Immunization Practices (ACIP). ACIP recommendations. CDC website. cdc.gov/vaccines/acip/recommendations.html. Reviewed March 21, 2019. Accessed May 14, 2019.

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Rolfes M, Flannery B, Chung J, et al; U.S. Flu VE Network; the Influenza Hospitalization Surveillance Network (FluSurv-NET); Assessment Branch, Immunization Services Division, Centers for Disease Control and Prevention. Effects of influenza vaccination in the United States during the 2017-2018 influenza season [published online February 2, 2019]. 

Flannery B, Chung J, Doyle J. National Center for Immunization & Respiratory Diseases: interim estimates of 2018-19 seasonal influenza vaccine effectiveness against medically attended influenza from the US Flu VE Network. CDC website. cdc.gov/vaccines/acip/meetings/downloads/slides-2019-02/flu-3-Flannery-508. pdf. Published February 27, 2019. Accessed May 14, 2019.

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Recommended adult immunization schedule for ages 19 years or older, United States, 2019. CDC website. cdc.gov/vaccines/schedules/hcp/imz/adult.html. Reviewed February 5, 2019. Accessed May 14, 2019.

Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2019. CDC website. cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html. Reviewed February 5, 2019. Accessed May 14, 2019.

Kim DK, Hunter P. Advisory Committee on Immunization Practices recommended immunization schedule for adults aged 19 years or older — United States, 2019. 

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Immunization schedule changes. CDC website. cdc.gov/vaccines/schedules/hcp/schedule-changes.html#child. Reviewed February 5, 2019. Accessed May 14, 2019.

A review of influenza (flu) vaccine effectiveness during the 2018-2019 flu season and recommendations of vaccines for the 2019-2020 flu season are discussed below.

An Update on the ACIP 2019-2020 Influenza Vaccine Recommendations

Pharmacists in a community setting have a wide variety of conversations with patients on any given day. Exchanges can occur about home life, medical questions, where to locate a certain product in the store, or the best product for the common cold. Relatively few detailed conversations, however, center around the influenza (flu) vaccine. Most patients approach the pharmacy counter knowing whether or not they want to receive a flu vaccine that day, and most do not engage in a lengthy discussion. Flu vaccine conversations typically consist of patients asking, “Do you have the flu shot in stock?” followed by the operational workflow of the immunization.

Pharmacists, being easily accessible to the community, can offer a unique perspective when discussing the flu vaccine. They can generate conversations around annual flu vaccines that may not otherwise occur between a patient and a health care provider, because a patient might not require medical care or have any other reason to see a provider during peak flu vaccination times.

Perhaps the most difficult conversations are with patients who are reluctant to get the flu vaccine. Patients may feel a need to get an annual flu vaccine because of concerns over their own health, concerns over a family member’s health, or societal pressure. Some patients have not ever received one before. Others have the strong belief—a widely held misconception&mdash;that they became infected with the flu from a previous flu vaccine.

Techniques such as motivational interviewing can make these conversations easier and lead to changes in patients’ behavior, ambivalent feelings, and insecurities.

 A variant of the motivational interviewing technique is the elicit—provide–elicit model, which can be used during a brief patient interaction.

Elicit: find out what the patient knows, or bet- ter ascertain the patient’s level of understand- ing, by asking questions of the patient directly;

Provide: fill in knowledge gaps and/or remove misconceptions, and;

Elicit: determine how this information pertains to the patient’s life.

By using the elicit—provide–elicit model, the pharmacist can assuage a patient’s fears and even change their mind regarding the receipt of a flu vaccine, during a brief interaction.

Asking a patient about their concerns and or fears can also have a positive impact. Active listening and empathy can provide a patient with a feeling of comfort.

 The pharmacist should look for nonverbal clues while clearly listening to a patient’s verbal response during conversations. When responding, motivational interviewing techniques suggest that the pharmacist asks permission to provide advice when attempting to change a health-related behavior. For example, a patient may state that their friend got the flu after receiving their flu vaccine. The pharmacist may then ask, “Would it be OK if I shared some information with you?” prior to discussing how the flu vaccine does not cause the flu. By using this method, the patient and the pharmacist can have a discussion, rather than the patient perceiving the pharmacist’s comments as a lecture.

Not every conversation with a patient will result in successful acceptance of a flu vaccine. No matter how well-respected and trusted the pharmacist may be to their patient, it can be difficult to move past some longstanding patient beliefs. By leaving the patient with the ability to continue the conversation in the future, the patient may perform further research on their own or think of more questions to ask at a later date. Changing behaviors and beliefs can take time, but the proper balance among listening, educating, and active discussion can be enough to engage a patient to accept an annual flu vaccine.

Urging patients to get vaccinated can be an effective follow-up method as well.

 If a patient has a prescription waiting to be picked up, a reminder note or customized sticker reminding them that flu vaccine is in stock and available can open discussions. Knowing what prescriptions the patient is having filled can help guide the conversation. For example, it is highly recommended for diabetic patients to receive an annual flu vaccine, so the pharmacist can share this information with the patient and encourage them to receive the vaccine at that visit, if they have not done so already. Patients in high-risk groups, such as individuals with diabetes, should be taken into account for follow-up discussions to increase rates of vaccinations in any given year.

When considering the trivalent versus quadrivalent vaccination, it is important to note that patients should not be denied a flu vaccine or have vaccination delayed if the pharmacy only stocks 1 type of vaccine. The CDC’s Advisory Committee on Immunization Practices does not recommend 1 vaccination type over another.

 The trivalent vaccine contains 1 type of flu B virus and the quadrivalent vaccine contains both types of B virus; however, if a patient received the trivalent vaccination, there is no reason to revaccinate with the quadrivalent. An exception to this is in certain children (aged 6 months to 8 years) who are recommended to receive 2 doses. Please visit the Immunization Action Coalition at immunize.org for more information.

Pregnant women are candidates for the flu vaccination and should receive the vaccination due to their high risk of complications from the flu.

 Only inactivated (not live) vaccines should be administered, and the woman can be immunized in any trimester (including her first trimester). All children aged 6 months or older should receive the flu vaccine, unless a contraindication is present.

The live, attenuated flu vaccine (LAIV) is approved to be given to healthy patients (nonpregnant) aged 2 to 49 years who are not immunocompromised.

 In this scenario, the patient receives the live vaccine through the dose, receiving half a dose in each nostril. Anyone receiving vaccination with LAIV should not come into contact with immunocompromised patients for at least 7 days.

Pharmacists play a key role in dispensing flu vaccines to the community. Prime accessibility, education, and strong patient relationships allow the pharmacist to build even stronger patient bonds through motivational and positive conversations sur- rounding the flu vaccination. These conversations can lead to healthier communities and positive patient outcomes.

 is a performance specialist at Pharmacy Development Services.

Hettema J, Steele J, Miller WR. Motivational interviewing. 

Butterworth S. Health-coaching strategies to improve patient-centered outcomes. 

Fogarty CT, Crues L. How to talk to reluctant patients about the flu shot. 

O’Reilly KB. 6 ways to get your patients immunized this flu season. American Medical Association website. ama-assn.org/delivering-care/public-health/6-ways-get-your-patients-immunized-flu-season. Published November 7, 2016. Accessed May 13, 2019.

Ask the experts. Immunization Action Coalition website; For Health Care Personnel section. immunize.org/askexperts/experts_inf.asp#workers. Updated February 28, 2019. Accessed May 15, 2019.

Pharmacists, being easily accessible to the community, can offer a unique perspective when discussing the flu vaccine.

Guide to Discussing Influenza Vaccine With Patients

A dvancing technology in vaccine development has allowed for the production of cell culture—based vaccines for illness such as chickenpox, rotavirus, polio, smallpox, hepatitis, rubella, and most recently influenza (flu). Cell-based vaccines have many potential advantages (see Table

), one of which includes longer stability and more rapid manufacturing, as cellbased vaccines can be frozen and used at a later date, with dependable cell lines to ensure consistent supply. Cell-grown, cell-based candidate vaccine viruses (CVVs) more similarly resemble circulating flu viruses; in contrast, egg-adapted alternatives may result in production of antibodies that less effectively prevent specific flu viruses.

 Additionally, cell-based vaccine formulations are preservative-free and present less concern for viral mutations caused by the egg-based vaccine production (which, in turn, can cause less effective immune responses to flu viruses). Avoidance of traditional manufacturing processes may also help reduce the risk of adverse reactions in patients with egg allergies.

Since the advent of increased legislation and funding in 2005, cell-based vaccine development has been a priority for US pandemic influenza preparedness.

 As a result, cell-based influenza vaccine development has rapidly advanced. Traditional egg-based vaccines face limitations such as a reliance on an adequate global egg supply, the inability to ramp up manufacturing quickly, a long production process, and the potential for mismatch with influenza strains based on antigenic variations. Cell-based vaccine development processes include a quicker production cycle, which, again, may reduce the time necessary to implement widespread vaccination efforts in the face of a potential epidemic.

Cell-based influenza vaccines are grown via cultured cells of mammalian origin rather than in hens’ eggs, as has been usual. Cell-based vaccines are produced via inoculation of CVVs with selection recommendations from the World Health Organization (WHO).

 These are grown in cultured animal cells and given time to replicate. Following replication, virus-containing fluid is isolated from cells and virus antigen is purified. The virus antigen then undergoes testing and approval processes through the FDA. Cell-based vaccines do not rely on the animal production and farming processes that are required for egg-based vaccines.

This cell-based vaccine process was approved by the FDA in 2012, and production of Flucelvax, the sole cell-based influenza vaccine available in the United States, began in August 2016. Flucelvax’s approval was based on a clinical trial conducted in Europe and United States which included more than 11,404 participants who were randomized to receive Flucelvax (n = 3828), Agriflu (n = 3676), or placebo (n = 3000). The results of the clinical trial indicated that Flucelvax was 83.8% effective in preventing influenza infection compared with placebo and was noninferior to the egg-based vaccine, Agriflu.

As additional support for the vaccine’s effectiveness, a retrospective study, which included data from more than 13 million Medicare beneficiaries aged 65 years and older during the 2017-2018 H3N2-dominated flu season, compared the effectiveness of Flucelvax with egg-based quadrivalent, egg-based high-dose, adjuvant, and standard-dose vaccines. Of the 13 million participants, 5% received a cell-based quadrivalent, 14% received an egg-based quadrivalent, 63% received a high-dose vaccine, 11% received an adjuvant, and 7% received the standard trivalent. The results indicated that the cell-based vaccines were approximately 11% more effective in preventing flu-related hospital admissions and clinic visits compared with the egg-based vaccines.

 Although this finding was not statistically significant, the reduction in hospital admissions and clinic visits was likely clinically significant.

Vaccine efficacy measured by titers is another method to evaluate effectiveness of various vaccine formulations. Investigators have explored titerresponse between cell-based and egg-based vaccine preparations. In 2018, Rajaram et al conducted a retrospective evaluation of vaccine effectiveness comparing egg-based and cell-based isolations of influenza strains; this was based on data that was collected about antigenic similarity between mammalian cell— based versions and egg-based versions of the H3N2 viruses, and on measured titers using hemagglutination inhibition assays. After analyzing the data, the investigators found that a higher proportion of the H3N2 virus samples matched the mammalian reference compared with the egg-based reference. The low level of antigenic similarity between the H3N2 virus and egg-based reference may explain the relatively low effectiveness of eggbased vaccines against the H3N2 strain.

In April 2019, Seqirus announced its decision to manufacture Flucelvax Quadrivalent for the 2019-2020 season using the cell-based approach that is recommended by the WHO. The decision was based on the decreased vaccine effectiveness of egg-based vaccines against the H3N2 strain found by Rajaram et al. The 2019-2020 vaccine formulation includes the following 4 strains: (1) A/Singapore/GP1908/2015 IVR-180 (H1N1) (an A/Michigan/45/2015-like virus); (2) A/North Carolina/04/2016 (H3N2) (an A/Singapore/INFIMH-16-0019/2016-like virus); (3) B/Iowa/06/2017 (a B/Colorado/06/2017-like virus); and (4) B/Singapore/INFTT-16-0610/2016 (a B/Phuket/3073/2013- like virus).

 Cell-based vaccine technology is an encouraging advancement that should allow more people to receive more effective and more timely flu vaccines. The widespread use of cell-based vaccines may prove to offer additional benefits as well, such as decreased hospitalization and health care—associated costs for patients, among the other potential advantages discussed. Further research is warranted to help quantify the impact of cell-based vaccines on clinical outcomes.

 is currently completing his PGY-1 residency training at Northwestern Memorial Hospital where he will also complete his PGY-2 infectious diseases residency.

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Cell-based flu vaccines. CDC website. cdc.gov/flu/prevent/cell-based.htm. Updated April 18, 2019. Accessed June 5, 2019.

Perdue ML, Arnold F, Li S, et al. The future of cell culture-based influenza vaccine production. 

. 2011;10(8):1183-1194. doi: 10.1586/ erv.11.82.

Schnirring L. Study: Cell-based flu vaccine just a bit better than egg-based. Center for Infectious Disease Research and Policy website. cidrap.umn.edu/ news-perspective/2018/12/study-cell-based-flu-vaccine-just-bit-better-egg-based. Published December 18, 2018. Accessed June 5, 2019.

Flucelvax: first seasonal vaccine using cell-culture technology. American Pharmacists Association website. pharmacist.com/flucelvax-first-seasonal-vaccine- using-cell-culture-technology. Published January 1, 2013. Accessed June 5, 2019.

Rajaram S, Van Boxmeer J, Leav B, Suphaphiphat P, Iheanacho I, Kistler K. 2556. Retrospective evaluation of mismatch from egg-based isolation of influenza strains compared to cell-based isolation and the possible implications for vaccine effectiveness. 

. 2018;5(suppl 1):S69. doi: 10.1093/ofid/ ofy209.164.

Flucelvax Quadrivalent [prescribing information]. Summit, NJ: Seqirus USA Inc; 2018. labeling.seqirus.com/PI/US/Flucelvax/EN/Flucelvax-Prescribing- Information.pdf. Accessed June 5, 2019.

Seqirus announces further advances in cell-based influenza vaccine technology [news release]. Summit, NJ: Seqirus; April 15, 2019. prnewswire.com/news-releases/ seqirus-announces-further-advances-in-cell-based-influenza-vaccine-technology- 300831979.html. Accessed June 5, 2019.

Kokosky G. Manufacturer to produce cell-based flu vaccine for next season. Pharmacy Times website. pharmacytimes.com/resource-centers/flu/vaccine-manufacturer- to-produce-cellbased-flu-shots-for-next-season. Published April 16, 2019. Accessed June 5, 2019.

Cell-based vaccines have many potential advantages, one of which includes longer stability and more rapid manufacturing, as cellbased vaccines can be frozen and used at a later date, with dependable cell lines to ensure consistent supply.

Cracking the Code of Optimized Influenza Prevention: Cell-Based Influenza Vaccine Advancement

The community pharmacist wears multiple hats in the daily delivery of health care to patients, one of which might be providing immunization services. Certainly, the patient who walks in for an immunization benefits from the convenience provided by the community pharmacy.

Over the past 20 years, growing numbers of pharmacists have completed training in vaccine administration, and for good reason. In 1997, the US Department of Health and Human Services requested the help of the American Pharmacists Association in drafting new guidelines to broaden the role of the pharmacist in service of the goal of increasing vaccination rates. Each of the 50 states now permits pharmacists to provide some vaccination services (specific laws vary by state because the practice is not regulated by federal law). Capitalizing on that opportunity by servicing patients who are seeking vaccination adds overall value to the pharmacy experience.

In 2014, the National Vaccine Advisory Committee released its recommendations for adult immunization standards, recognizing pharmacists as having a vital role in increasing adult vaccination rates.

 In response, community pharmacies now offer 2 routes to providing immunization services: outsourcing these services and providing immunizations in-house. Both efforts are intended to increase vaccination rates among adults for vaccine-preventable diseases, such as influenza, shingles, and pneumonia, as well as to increase foot traffic in the pharmacy.

Outsourcing immunization services requires that the pharmacy reaches out to employers or community-center supervisors for permission to administer vaccinations to the general public off-site periodically throughout the year, most often during flu season and the period when students return to school. This approach requires some planning from the pharmacy, such as sending an immunizing pharmacist, supplies, and vaccines to the site. A major advantage of this method, however, is that it enables the pharmacy to plan its patient encounters without such encounters impeding the daily workflow.

Alternatively, a pharmacy can provide vaccination services in-house. This practice is the most cost-effective and can help generate the highest rates of vaccination.

 In contrast to outsourcing, providing vaccines in-house means that the pharmacy’s immunization-trained staff members do not have to leave the pharmacy. In-house vaccine services, versus off-site services, also have a higher rate of direct patient interaction.

Pharmacists who are trained to administer vaccinations usually need to set up a protocol with a physician. The protocol permits a single physician to sign standing orders and prescriptions for multiple pharmacists as well as for the patients whom they treat. Each state differs in the requirements that need to be met by an immunizing pharmacist; in some states, pharmacists have the right to administer certain immunizations by way of statute and without the need for a protocol.

APPOINTMENT-DRIVEN VERSUS WALK-IN TRAFFIC

Vaccination services can be offered by appointment, by accepting walk-ins, or both. Offering appointments minimizes interruptions in the transaction of daily business in the pharmacy; however, it lowers the possible number of patients who can be immunized. For this reason, a growing number of pharmacies have opted to serve walk-in patients. For a patient, simply walking into the pharmacy and getting a vaccination may be the most convenient option; however, walk-in patients interrupt the pharmacy’s prescription-fulfillment workflow. Offering walk-in vaccination services also requires that the pharmacy has a wide variety of vaccines on hand because walk-in patients cannot be screened in advance.

COMMUNITY PHARMACY—BASED VACCINATIONS LOWER COSTS

Despite modest improvements in the past 5 years, the adult vaccination rate in the United States remains below recommended standards.

 In contrast to a landscape where vaccinations may only be administered in a physician’s office, community pharmacy—based administration of vaccines can improve immunization rates among undervaccinated population sectors by offering expanded business hours, convenient locations, and lower costs. A recent study indicated that “the average direct costs paid per adult vaccination were lower in pharmacies compared with physician offices and other medical settings by 16%-26% and 11%-20%, respectively.”

The average cost of vaccination was determined by analyzing the health plan— and enrollee–paid amounts for the vaccine itself, administration of the vaccine, the dispensing fee, and the visit, if applicable. For pneumococcal vaccinations, for example, the average costs were $65.69 at a physician’s office, $72.11 in other medical settings, and $54.98 at the pharmacy. Pharmacy-based administration of vaccinations drives value to both the patient and the pharmacy through convenience and access efficiencies.

Just like pharmacies, doctors’ offices must also have enough of the most common vaccines on hand to meet their patients’ needs. However, according to a recent survey, almost 70% of family physicians and 80% of general internists reported that they did not stock all recommended adult vaccines because the costs of stocking and administering these vaccines were prohibitive.

Although community pharmacy—based immunization programs have amply demonstrated their success, they still face obstacles that prevent pharmacies from assuming full vaccination responsibilities. In addition to different reimbursement and compensation programs across pharmacies, state reporting requirements lack uniformity. Pharmacists in all 50 states are legally permitted to administer vaccines; however, more than 60% of states still restrict vaccine administration at pharmacies by requiring a prescription from a physician or demanding that a protocol be created with a physician. In addition, state laws vary considerably with regard to the minimum age of the patient and the types of permissible vaccines they can receive. And, of course, compliance with these state regulations imposes added expenses on pharmacies.

Nevertheless, the benefits of convenience, efficiency, and public health education that pharmacies provide bring value to the patient and increase opportunities for the pharmacy to engage in cross-selling its other services to that patient.

The continued success of community pharmacy—based immunization services may be secured by focusing on serving

patients, national legislative reform, and the standardization of both reimbursement programs and pharmacy information management systems.

One such agency that supports these efforts is the Pacific Research Institute (PRI) for Public Policy. In its mission state- ment, PRI champions “freedom, opportunity, and personal responsibility for all individuals by advancing free-market policy solutions” through policies that stress private initiative and limit- ed government. PRI recommends that pharmacists be granted the power “to independently screen, assess, and administer all CDC- recommended adult vaccines without a protocol or prescription from a physician on a national basis.”

Continuing these reforms would likely drastically reduce the needless regulatory costs that encumber pharmacists and would further give patients more choices in vaccination services. This would result in greater and more effective health care quality as well as an increased symbiotic value-based relationship between patients and pharmacists.

, PharmD, JD, is chairman of the health care law practice at Much Shelist PC, based in Chicago, Illinois, and is the former vice chairman of the Illinois State Board of Pharmacy.

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The Impact of Community Pharmacies on Immunization

Because between 70% and 85% of seasonal influenza (flu)-related deaths occur in people 65 years and older and between 54% and 70% of seasonal flu-related hospitalizations occur in this age group, the CDC recommends that adults 65 years and older receive a flu vaccination each year (see table).

 vaccination in these patients also has shown to decrease mortality and intensive care unit admissions, as well as hospital length of stay.

 Many patients in this population do not realize that more than 1 vaccine formulation is available or that they may benefit from a higher-dose vaccine, so pharmacists have a crucial role in educating these patients about the importance of receiving the most appropriate flu vaccine.

 to consider for people 65 years and older are Fluad and Fluzone High-Dose (HD). Fluad is a standard adjuvanted trivalent vaccine made with the MF59 additive, which creates a stronger immune response to vaccination than the standard trivalent vaccine alone. Fluzone HD contains 4 times the amount of antigen as the standard trivalent dose. Both Fluad and Fluzone HD are administered intramuscularly as a single dose of 0.5 mL. Adverse effects seen for both vaccines are mild and may include pain, redness, or swelling at the injection site; headache; muscle ache; and malaise.

Patients should be advised that immunity will start to develop about 2 weeks after receiving the vaccination. For patients with an egg allergy that results in symptoms more severe than hives (ie, angioedema or respiratory distress), the vaccine should be administered in a medical setting under supervision of a health care provider who is able to recognize and manage a severe allergic reaction. Patients with a history of Guillain-Barré syndrome within 6 weeks of a previous dose of flu vaccine are not advised to be vaccinated unless their health care provider has advised that the benefit of receiving the vaccine outweighs the risk. The intranasal flu vaccine, FluMist, is not recommended for this age group because of its potentially poor efficacy.

The results of a clinical trial indicated that adults 65 years and older who received Fluzone HD had 24% fewer influenza infections compared with those who received the standard trivalent-dose vaccine.

 Randomized clinical trials are underway comparing Fluad and Fluzone HD to determine more definitively if one vaccine is inferior to the other; however, the CDC and its advisory committee have not indicated a preference between Fluzone HD and Fluad for prevention of flu in people 65 years and older.

 Vaccination choice should therefore be based on insurance coverage and cost for patients.

Influenza vaccination decreases mortality and intensive care unit admissions and length of stay among patients who are 65 years and older.