Human papillomavirus (HPV) consists of a group of more than 150 related viruses, some of which have been identified as causes of certain types of cancer. These types of cancer include cancer of the cervix, vulva, vagina, penis, anus, and throat (oropharyngeal cancer). Each virus in the HPV family is given a number, which is called its HPV type.

 Some types of HPV are linked to specific cancers. Other types are linked to genital warts. The most common high-risk, or cancer-causing types of HPV are types 16 and 18. The most common low-risk types, which are linked to genital warts, are types 6 and 11.

Human papillomavirus can be transmitted through skin-to-skin contact and is most commonly transmitted through vaginal, anal, or oral sex. HPV is so common that nearly all men and women will get it at some point in their lives.

 Most cases of HPV do not present with symptoms and eventually resolve on their own. However, some cases present as certain types of cancer. HPV cancer usually does not have symptoms until it is quite advanced, very serious, and hard to treat.

 Virtually all cases of cervical cancer, as well as about 70% of oropharyngeal cancers and 95% of anal cancers are caused by HPV.

The HPV vaccine (Gardasil, Merck & Company.), first introduced in 2006, is a quadrivalent, recombinant vaccine that protects against HPV types 6, 11, 16, and 18, which are the most common types that cause either cancer or genital warts. A newer version of the vaccine, a 9-valent recombinant vaccine (Gardasil 9, Merck & Company) was introduced in 2014 and has now replaced the original vaccine. The 9-valent HPV vaccine protects against the same 4 types of HPV as the original vaccine, as well as types 31, 33, 45, 52, and 58.

 These added types have also been identified as cancer-causing types and their inclusion can help give patients extra protection against HPV cancers. Table 1 outlines the benefits in adding the extra 5 types.

Vaccination with the 9-valent HPV vaccine is recommended for boys and girls as either a 2-dose series or 3-dose series, which can be started as early as age 9, but is usually started at age 11 or 12. The patient will receive 1 dose on day 0, followed by a second dose 6 to 12 months later. The 2-dose series can be used in all patients, provided it is started before their 15th birthday. Patients 15 to 26 years of age should follow a 3-dose series that includes doses at day 0, and then at 1 to 2 months and 6 months after the initial dose. There is no need to restart the schedule if the patient is late for a dose.

Starting the series at age 11 or 12 is recommended because those patients have likely not been exposed to HPV at that point in their lives. As children age, the likelihood of becoming sexually active increases.

 If vaccination can be initiated before exposure, it will have the greatest chance for success. Additionally, children tend to have fewer well visits to the pediatrician as they get older. It is imperative to protect these children while the opportunity is available.

According to the 2016 National Immunization Survey—Teen, 60% of teens 13 to 17 years of age have received one or more doses of the HPV vaccine. Approximately 65% of girls and 56% of boys have at least received their first dose.

The vaccine had originally been perceived by the public as a vaccine for cervical cancer. Because of this perception, mostly girls were seeking vaccinations in the early stages of its availability. Vaccination rates for boys are steadily increasing now that more facts are known about risks of cancers to boys, and the fact that boys can be carriers, putting their female partners at risk. The survey indicates a 6-percentage point increase for boys over the 2015 survey. Figure 1 shows a coverage map in the United States for teens according to this survey.

Although vaccination rates for HPV seem to be moving in the right direction for children and adolescents, is the same true for young adults 18 to 26 years of age? These patients may not have had access to as much information from their parents and physicians as children do today. Without the benefit of receiving HPV as a routine vaccine during childhood, college-aged adults now have to decide for themselves if they want to be vaccinated. Do they have enough information to understand the prevalence of HPV and how it can affect them? Are they even aware that a vaccine is available? If so, do they realize that this vaccine is recommended for everyone in their age range? A common perception may still be that only girls and women are at risk because HPV can cause cervical cancer. Young adults who are not sexually active may not see the need to be vaccinated, but they would be ideal candidates to receive the vaccine before they have had any exposure. Young men need to be aware that of the almost 12,000 cases of oropharyngeal cancer diagnosed in the United States each year, about 70% are caused by HPV. These cancers are four times more common in men than in women.

Living environments can make a huge difference in access to information about HPV, especially in young adults. Students on college campuses can be reached much more easily than young adults who are in the workforce or those who may be in low-economic environments. Colleges can use their health centers and pharmacies to target vaccine-eligible students by making sure to ask about vaccination history during routine or sick visits to the center, or when a patient picks up prescriptions at the pharmacy. Pamphlets or informational posters can be posted in classrooms, common gathering areas, or even dormitories. Speakers from the health center can ask to be invited to educate groups of students at organizational meetings throughout the campus.

Young adults in the workforce may be more difficult to reach. Many companies are now requiring annual visits to a primary care provider or other health care provider to obtain insurance, or to get a discount on premiums. Employers can—and should&mdash;include vaccination history as part of the screening process for all employees. It would then be up to health care providers to make suggestions or supply information about HPV and other vaccine-preventable diseases.

College-aged adults in low-economic environments may be the hardest to reach. Often these patients work difficult jobs with long hours. Costs of health care may be prohibitive in this type of environment, and opportunities to interact with health care providers might be limited. These patients need an advocate to help keep them informed about the importance of vaccinations. The advocate could be a nurse, doctor, or staff member at a community walk-in clinic.

A pharmacist can be a huge influence on these patients. Education about how to make vaccines affordable through federally funded programs and discount cards, or by working directly with the manufacturer to control costs can make a difference here.

Pharmacists in a community setting should make an effort to reach out to all recommended age groups, especially those who may be in their early twenties and about to age out of the recommendation window. Pamphlets and brochures can be requested from the manufacturer to help target specific groups. Young women who pick up birth control medication could be educated about the benefits of being vaccinated for HPV, along with a reminder to share that information with their partner. Young adults who come in from an urgent care facility or those who have prescriptions for attention deficit hyperactivity disorder also provide a great opportunity for pharmacists to discuss vaccination history and recommend an HPV vaccine when the time is appropriate. Healthy individuals should receive a strong recommendation to initiate their first dose while they are at the pharmacy. Pharmacists can offer to run an insurance claim to check the price for them. If they leave without being vaccinated, it is likely that the initial dose will be delayed or never initiated again. Pharmacists must make the most of opportunities when they have the chance.

The 9-valent HPV vaccine can prevent cancer. Some of the cancers that can be avoided cannot be detected by screening and are usually not discovered until they are in the late stages. Vaccination rates are on the rise, suggesting that parents of young kids and adolescents are on the right track.

Discussing HPV, especially with a parent, can be difficult because of what may be a perceived implication that their kids are sexually active at a young age. Pharmacists should not let a potentially uncomfortable conversation deter them from doing what is best for their young patients. Young adults should be targeted because they may be the least informed patients regarding HPV. We must all remember that the result of this type of outreach may be saving a young person from developing cancer.

Brady Cole, RPH, is pharmacy manager at Tom Thumb Pharmacy in Plano, Texas, and an active preceptor at Texas Tech University and the University of Houston. He is also founder of the website Helpful Pharmacist, helpfulpharmacist.com. 

The Centers for Disease Control and Prevention. What is HPV? CDC website. https://www.cdc.gov/hpv/parents/whatishpv.html. Updated December 20, 2016. Accessed February 6, 2018.

National Cancer Institute. Human Papillomavirus (HPV) Vaccines. NCI website. https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-vaccine-fact-sheet. Reviewed November 2, 2016. Accessed February 20, 2018.

The Centers for Disease Control and Prevention. The Link Between HPV and Cancer. CDC website. https://www.cdc.gov/hpv/parents/cancer.html. Updated December 16, 2016. Accessed February 6, 2018.

The Centers for Disease Control and Prevention. HPV Vaccination Information for Clinicians. CDC website. https://www.cdc.gov/hpv/hcp/need-to-know.pdf. Updated December 20, 2016. Accessed February 6, 2018.

de Sanjose S, Quint WGV, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. 

Alemany L, Saunier M, Tinoco L, et al. Large contribution of human papillomavirus in vaginal neoplastic lesions: a worldwide study in 597 samples. 

de Sanjose S, Alemany L, Ordi J, et al. Worldwide human papillomavirus genotype attribution in over 2000 cases of intraepithelial and invasive lesions of the vulva. 

Alemany L, Saunier M, Alvarado-Cabrero I, et al. Human papillomavirus DNA prevalence and type distribution in anal carcinomas worldwide. 

Vaccinating preteens. Merck vaccines website. https://www.merckvaccines.com/Products/Gardasil9/preteens. Accessed February 12, 2018.

Centers for Disease Control and Prevention; National Center for Immunization and Respiratory Diseases. National Immunization Survey—Teen. A User’s Guide for the 2016 Public-Use Data File. https://www.cdc.gov/vaccines/imz-managers/nis/downloads/NIS-TEEN-PUF16-DUG.pdf. October 2017. Accessed February 21, 2018.

HPV Coverage Maps — Infographic. CDC Website. https://www.cdc.gov/hpv/infographics/vacc-coverage.html. Updated August 24, 2017. Accessed February 12, 2018.

The Centers for Disease Control and Prevention. HPV and Oropharyngeal Cancer. CDC website. https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm. Updated July 17, 2017. Accessed February 14, 2018.

Articles

Special Section: Immunizations & Vaccinations

Human papillomavirus (HPV) consists of a group of more than 150 related viruses, some of which have been identified as causes of certain types of cancer.

HPV Vaccination in Young Adults: Are We Doing Enough?

The question of whether a state has the right to institute a mandatory vaccination policy against human papillomavirus (HPV) for school children remains hotly disputed. In June 2006, the national Advisory Committee on Immunization Practices (ACIP) strongly advised routine vaccination for girls 11 to 12 years of age, and it now strongly advises the same vaccination policy for boys in the same age bracket. The ACIP consists of medical as well as public health professionals who establish guidelines for vaccination policies in the United States and make recommendations targeting the application of vaccines.

The ACIP was created under the Public Health Service Act (1944).

 The Committee consists of 15 voting members who are responsible for making recommendations with respect to the use of public vaccination. The Secretary of the US Department of Health and Human Services (DHHS) is entitled to elect the members of the committee.

 Fourteen members are drawn from professionals in the fields of vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine. The fifteenth membership is reserved for a consumer representative who is expected to deliver a community point of view on the impact of any putative vaccination policy. There are also 8 

 members who represent other federal agencies charged with the responsibility for executing immunization programs in the United States. In addition, 30 non-voting representatives from liaison organizations contribute their experience and know-how on immunization matters.

The ACIP meets three times each year at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia. At these meetings, ACIP members and CDC staff present new research and engage in dialogue on related subjects, such as relevant scientific data, vaccination effectiveness, clinical trial outcomes, manufacturer’s package insert, and safety. Additionally, they examine the current state of vaccine-preventable diseases as well as variances in vaccine supply and/or shortages.

Although the ACIP presents its own recommendations, school vaccination requirements are determined on a state-by-state basis by respective legislatures. Some state legislatures have devolved the power to mandate vaccinations to state regulatory agencies, whereas others have voted to retain such authority.

In cases in which states have relegated the authority to mandate vaccination to regulatory bodies, the legislatures in question, as a matter of course, must still allocate funding. The general public may, in principal, favor the availability of such vaccines, but it may not favor mandatory inoculation in schools. Such objections may be related to questions of the vaccination’s cost and overall safety, as well as to an individual parent’s right to opt out a child from any proposed immunization program. Others potentially harbor ethical objections to a mandatory vaccine related to a sexually transmitted disease. 

In 2006, the Michigan State Senate proposed a bill requiring HPV school vaccination for sixth-grade girls.

 The bill, however, did not pass. In the same year, Ohio proposed legislation mandating vaccination, but this bill also failed to pass. Since then, legislators in some 42 states and territories have proposed legislation to: a) mandate the vaccine, or b) either to allocate funding or to raise public awareness about the HPV vaccine, particularly among school children. Currently, 25 states and territories have enacted legislation related to HPV vaccination, and 3 jurisdictions require HPV vaccinations for school attendance.

 Of note, 10 states initiated HPV-related legislation for the 2015-2016 sessions, and at least another eight states proposed HPV-related legislation for their 2017—2018 sessions.

If states mandate such vaccination programs, they must, of necessity, also allocate appropriate funding, which includes government payer programs covering the uninsured.  These states must also determine whether to make such coverage a requirement for insurance plans. These questions have kindled a debate on the question of whether such vaccines ought to be mandatory in the first place.

Beyond the state level, it is worth noting that the HPV vaccine is now available through a federal program called Vaccines for Children (VFC), which is operative in all 50 states. The program covers vaccines for children 9 to 18 years of age who are eligible through federal health care payer programs.

While state legislatures continue to make efforts to preserve public health by enforcing the administration of HPV vaccinations in one form or another, the debate ensues at community levels as to whether such a vaccine should be required or made voluntary. The balance of protecting the public against HPV virus harm and an individual’s right to object to submission to receiving such a vaccine is a continuing dialogue among public stakeholders. Importantly, the availability of such a vaccine worldwide as an option for those who believe it will improve public health is a testament to new strides in research and improved quality of life.

Ned Milenkovich, PharmD, JD, is chair of the healthcare law practice at Much Shelist PC and former vice chair of the Illinois State Board of Pharmacy.  

The Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP). CDC website. https://www.cdc.gov/vaccines/acip/about.html. Accessed February 20, 2018.

The National Conference of State Legislature. HPV Vaccine: State Legislation and Statutes. The NCSL website. http://www.ncsl.org/research/health/hpv-vaccine-state-legislation-and-statutes.aspx. Accessed February 20, 2018.

The question of whether a state has the right to institute a mandatory vaccination policy against human papillomavirus (HPV) for school children remains hotly disputed.

The Path Ahead for the HPV Vaccine

Human papillomavirus (HPV) is a known cause for virtually all cases of cervical and anal cancer and about 70% of oropharyngeal cancer cases.

 Vaccination represents an effective way to prevent these types of cancer. The 9-valent HPV recombinant vaccine (Gardasil 9, Merck & Company) protects against 9 different types of HPV, most of which have the potential to cause cancer. It is recommended for children, adolescents, and young adults 9 to 26 years of age.

 Vaccination rates within this age group have steadily improved over the last decade as education about the vaccine has become more prevalent. However, certain barriers prevent parents from vaccinating their children for HPV, one of which can be cost. Therefore, it is essential that patients and their parents are educated about strategies and programs to reduce the cost burden and increase vaccination rates.

The 9-valent HPV vaccine is one of the most expensive vaccines on the lists of recommended vaccines for children and for adults from the Advisory Committee on Immunization Practices (ACIP).

 At a cost of over $200 per dose, the price can be a real deterrent for parents. Some parents may have the perception that HPV is a 3-dose series, which is true in some cases. However, as of October 2016, the ACIP changed its recommendation to a 2-dose schedule, provided that the first dose is initiated before the patient’s fifteenth birthday.

 This fact alone can save parents one-third of their expected cost, and it may also discourage delaying vaccination for their children. The 2-dose schedule is more convenient and can be less costly for the patient.

Insurance coverage rates for vaccines have improved over the past decade, especially through pharmacies. Many Pharmacy Benefit Managers have included vaccines, including HPV, in their patients’ pharmacy benefit. Patients should be encouraged to visit the pharmacy first to check the price and to see if the 9-valent HPV vaccine is covered under their pharmacy plan. If the price is not acceptable for patients, pharmacists can encourage them to make a call to their medical insurance to see if the vaccine would be covered at a better rate at their provider’s office.

The passing of the Affordable Care Act (ACA) in 2010 provided the opportunity for many individuals living in the United States to obtain health insurance who did not have access previously. One of the notable provisions in the ACA is mandatory coverage of vaccines. All marketplace health plans and many other plans are required to cover HPV vaccines for children (in accordance with ACIP recommendations) without charging a copayment or coinsurance, even if the patient’s yearly deductible has not been met.

 According to a study published by the North American Society for Pediatric and Adolescent Gynecology in 2017, female respondents to a survey were 3.3 times more likely to receive the HPV vaccine after the implementation of ACA than previously.

 Obviously, other factors were involved in this increase, but these results definitely indicate a move in the right direction.

Patients without insurance often have the most difficult time keeping their vaccinations up to date. With the expensive price tag on the 9-valent HPV vaccine, some parents may decide to forego it. However, there are options for some children to receive the vaccine for free, or at a reduced price, and pharmacists can be influential in directing patients toward these programs. It may mean that the patient goes elsewhere for service, but ensuring that they get protected in an affordable way is most important.

Vaccines for Children (VFC) is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay.

 Vaccines for Children makes all vaccines recommended by the ACIP, including HPV, available to children who qualify. The vaccines are purchased by the Centers for Disease Control and Prevention (CDC) and distributed to grantees, who then provide them at no charge to clinics, physicians, or pharmacies that are registered VFC providers. Children younger than 19 years of age who are Medicaid eligible, uninsured, underinsured, or are American Indian or Alaska Native, are eligible for VFC. Underinsured is defined as someone who has insurance that doesn’t cover vaccines, or only covers certain agents.

Some VFC providers may ask for an administration fee. This fee must be waived if the family cannot afford to pay it.

 Pharmacists who are interested may be able to establish their store up as a VFC provider location. Providers can be located by contacting the state’s VFC Coordinator. Pharmacy staff should be ready to assist qualified patients in locating a provider.

For older patients who do not qualify for the VFC program, such as those 19 to 26 years of age, Merck & Company offers the Merck Helps program that provides the 9-valent HPV vaccine free of charge to eligible individuals who cannot afford it on their own.

 Patients must be 19 to 26 years of age and live in the United States to be eligible. They must also be uninsured and fall below a minimum income level, either for themselves or their household. To apply, patients must fill out an application form and fax it to Merck & Company, which often provides an answer via a phone call to the provider in as little as 10 minutes. This allows patients who qualify to receive their first dose while they are still at the provider location.

 Providers must be licensed with Merck & Company to participate in this program.

Many patients will be able to receive the 9-valent HPV vaccine at an affordable cost, or at no cost, through their insurance plan. For patients who are uninsured, or who cannot afford a copay, pharmacists should be prepared to present other available options to assist with cost. If you are knowledgeable about the Vaccines for Children program or the Merck Helps program, you may be able to help someone receive an HPV vaccine for whom it would not otherwise be affordable. It may take an extra few minutes or a couple of phone calls, but possibly helping prevent someone from developing cancer is worth the time. Please take a moment to review these programs if you believe you have patients who could benefit from them.

Brady Cole, RPH, is pharmacy manager at Tom Thumb Pharmacy in Plano, Texas, and an active preceptor at Texas Tech University and the University of Houston. He is also founder of the website Helpful Pharmacist, helpfulpharmacist.com.

The National Cancer Institute. Human papillomavirus (HPV) Vaccines. NCI website. www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-vaccine-fact-sheet. Accessed February 15, 2018.

The Centers for Disease Control and Prevention. Pediatric/VFC Price List. The CDC website. https://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html#modalIdString_CDCTable_0. Accessed February 26, 2018.

The Centers for Disease Control and Prevention. Adult Vaccine Price list. The CDC website. https://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html#modalIdString_CDCTable_1. Accessed February 26, 2018.

Preventive care benefits for children. Healthcare.gov website. https://www.healthcare.gov/preventive-care-children/. Accessed February 15, 2018.

Corriero R, Gay JL, Robb SW, Stowe EW. Human papillomavirus vaccination uptake before and after the Affordable Care Act: Variation According to Insurance Status, Race, and Education (NHANES 2006-2014). 

 2018 Feb;31(1):23-27. doi: 10.1016/j.jpag.2017.07.002. Epub 2017 Jul 26.

The Centers for Disease Control and Prevention. Vaccine for Children Program (VFC). CDC website. https://www.cdc.gov/vaccines/programs/vfc/index.html. Updated April 24, 2014. Accessed February 15, 2018.

Merck Helps. Merck Vaccines website. http://www.merckhelps.com/GARDASIL%209. Accessed February 15, 2018.

Human papillomavirus infection (HPV) is a known cause for virtually all cases of cervical and anal cancers and about 70% of oropharyngeal cancer cases.

Making HPV Vaccination Affordable for Patients

As the margin between acquisition cost and sales price continues to narrow for traditional community pharmacy medication dispensing, many pharmacies are increasingly turning to service-based opportunities to improve their profitability. The cornerstone of many pharmacy service programs offered beyond medication dispensing has traditionally been found in pharmacy vaccination programs. 

The business case for vaccines within daily pharmacy practice has been compelling for many community pharmacies.

 The margins are good, the service itself is both relatively quick and directly connected to a billable product, it fits well into conventional pharmacy workflows, and pharmacists are excellently positioned and well-trained to deliver the service. Nevertheless, most pharmacies are only capturing a fraction of vaccination opportunities within their panel of patients. Even for patients who are presenting specifically to receive a vaccine, pharmacists often miss the chance to close additional vaccine gaps when the patient presents.

As an example of how to increase overall non-influenza vaccinations year-round, this article examines some best practices associated with the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil 9, Merck & Company). 

Pharmacists should have a strong familiarity with the basic epidemiology and background of any vaccine they administer. The ability to provide a clear and concise explanation for the importance of a vaccine in an important component for making a cogent case that the vaccine a pharmacist is recommending is indeed necessary for the patient, especially for non-influenza vaccinations.

The HPV vaccine is used to prevent HPV, the single most common sexually transmitted infection in the United States. An estimated 80 million persons are infected, and an estimated 14 million new HPV infections occur every year among individuals 15 to 59 years of age. Roughly half of new infections occur among individuals 15 to 24 years of age, due to the fact that HPV infection is associated with the first few months to years of becoming sexually active. HPV infections have been strongly associated with a variety of cancers in both men and women, including cervical, vulvar, vaginal, penile, anal, and oropharyngeal cancers, hence the importance of its prevention.

 A majority of HPV-associated cancers are connected with infections of HPV 16 and 18, two of the strains covered in the 9-valent HPV vaccine.

 In the US, there are approximately 30,000 HPV-associated cases of cancer every year, of which 28,000 could have been prevented by the vaccine.

One of the most important aspects of making a strong recommendation is identifying appropriate patients to whom to make a recommendation. The need to directly incorporate a knowledge of the Centers for Disease Control and Prevention (CDC) guidelines and schedules issued by the Advisory Council for Immunization Practices (ACIP) into recommendations included in everyday workflows cannot be overemphasized. Simply printing the most current schedules and posting them in the pharmacy is not sufficient to allow for a pharmacist to make a recommendation to a patient; the information within the schedules needs to be constantly front of mind. 

For pharmacists who struggle with maintaining an up-to-date knowledge of the somewhat complex ACIP schedules for children, adolescents, and adults, some technology vendors have incorporated tools that generate an ACIP schedule-based forecast for a given patient directly into pharmacy management systems and clinical platforms. Although these tools can be especially helpful for age-based vaccination recommendations, they are not designed to identify disease-based conditional recommendations. Thus, the pharmacist is fundamentally responsible for knowing who should receive the vaccine. 

The 9-valent HPV vaccine is no exemption. The current age-based recommendations from the CDC are that all children ages 11 to 12 years should receive two doses spaced 6 to 12 months apart. For children older than 14 years of age, 3 shots should be given over six months for women up to 26 years of age and men up to 21 years of age. But there is no substitute for talking to the patient when it comes to making recommendations for young men who have sex with men (especially those who identify as gay or bisexual), young adults who are transgender, and young adults with immunocompromising conditions, all of which extend the recommendation to receive the vaccine through age 26.

The state immunization registries can be helpful for identifying patients who could potentially be eligible for vaccination. Pharmacists in many community settings are now able to use either a given state’s web portal, or a vendor-provided platform to directly search the state or municipal registry for a patient’s vaccine history. State registry immunization data reliability varies by state but is generally very good for children and adolescents. Pharmacists should be aware of limitations of their jurisdiction’s registry when it comes to completeness for adults. Pharmacists should also keep in mind that while the registries are useful tools for identifying age-based opportunities, they will not be helpful in identifying disease-based recommendations because they do not house diagnostic information. Immunization registries can be especially helpful at identifying patients who have started but not completed a vaccine series or regimen, such as HPV.

Healthcare is increasingly moving from a paternalistic model toward one of shared decision-making. When making healthcare decisions, patients may not rely as extensively on information from healthcare providers as they do on information found on the Internet.

 As such, patients will often have challenges associated with the uptake of any given vaccine that pharmacists should be prepared to address. 

While a comprehensive overview of vaccination challenges and solutions is beyond the scope of this article, there are two important barriers worth noting:

The first barrier is related to preference for non-vaccination. Vaccine hesitancy is a real phenomenon that affects approximately 25% of the population, with a continuum between those that accept all vaccines with doubts, ranging to individuals with complete refusal, and a heterogeneous group that lies between those two extremes.

 Pharmacists should keep in mind that directly challenging vaccination beliefs is not the most effective way of addressing vaccine hesitancy; do not fight fire with fire. Patients will often become more entrenched in their beliefs when directly confronted with epidemiological facts.

 Research has shown that vaccine-hesitant individuals are more likely to respond to messaging that appeals to their sense of community and vaccine effectiveness.

 Invite patients to protect their loved ones, and stress that the benefits of the vaccine outweigh the risks.

The second barrier—and one of the most common reasons that patients decline an invitation to be vaccinated&mdash;is related to point of care expectations rather than vaccine concerns. Patients generally expect to leave a pharmacy quickly. Pharmacists should consider proactively mitigating those expectations by reaching out to patients in advance of their coming into the pharmacy. For example, if a pharmacist sees a prescription for a younger patient, that’s an opportunity to check the immunization registry for the 9-valent HPV vaccine series, then directly reach out to either the patient or the parent to invite them to reserve more time to receive the vaccine when they come in to pick up the prescription.

The last opportunity for pharmacists to capture are those associated with initiated vaccine series. Vaccine series and regimens that are not completed are truly a waste. Vaccine series reminders represent one method of ensuring that patients who start a series see it through to the end. The 9-valent HPV vaccine is a great example of this. Using electronic calendar items, postcards, mailers, phone calls, text messages, emails, and the like have all proven effective in helping patients remember to complete a series, including HPV.

 Whichever modality makes the most sense for the pharmacy and the patient is the one that should be chosen.

Samuel Stolpe, PharmD, MPH, is vice president, private sector, for the Scientific Technologies Corporation.

Stolpe SF. The race to improve adult vaccination rates in the information age. 

. September 7, 2017. pharmacytimes.com/publications/issue/2017/immunizationsupplementaugust2017/the-race-to-improve-adult-vaccinationrates-in-the-information-age.

Centers for Disease Control and Prevention. Genital HPV infection fact sheet.  http://www.cdc.gov/std/HPV/HPV-factsheet-March-2014.pdf.

Muñoz N, Bosch FX, de Sanjosé S, et al; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. 

IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. Biological agents. Volume 100 B: a review of human carcinogens. 

Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. 

Serrano B, Alemany L, Tous S, et al. Potential impact of a nine-valent vaccine in human papillomavirus related cervical disease. 

Centers for Disease Control and Prevention. HPV Vaccines: Vaccinating Your Preteen or Teen.  https://www.cdc.gov/hpv/parents/vaccine.html. Accessed Feb 16, 2018.

Weaver JB, Thompson NJ, Weaver SS, Hopkins GL. Healthcare non-adherence decisions and internet health information. 

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The SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope and determinants. 

Nyhan B, Reifler J, Richey S, Freed GL. Effective Messages in Vaccine Promotion: A Randomized Trial. 

. 2014;133(4):835-842. doi: 10.1542/peds.2013-2365.

Nyhan B, Reifler J, Richey S.  The Role of Social Networks in Influenza Vaccine Attitudes and Intentions Among College Students in the Southeastern United States. 

Rand CM, et al. Effects of Phone and Text Message Reminders on Completion of the Human Papillomavirus Vaccine Series. 

. 2017;60(1):113—119.doi.org/10.1016/j.jadohealth.2016.09.011.

As the margin between acquisition cost and sales price continues to narrow for traditional community pharmacy medication dispensing, many pharmacies are increasingly turning to service-based opportunities to improve their profitability.

Year-Round Solutions Beyond the Influenza Season

Vaccinations are often given to protect populations whose immune systems are most vulnerable, but pharmacists are aware that some vaccinations are also important during the adolescent and young adult years. These include tetanus/diphtheria/pertussis, meningococcal, and human papillomavirus (HPV). Unfortunately, due to misinformation, confusion, lack of consistent medical care, and other barriers, these vaccines may not be obtained. One particular vaccine that continues to need attention is the HPV vaccine.

HPV is the most common sexually transmitted disease in the United States, with 79 million active cases and an estimated 14 million new infections each year.

Sexually active individuals are at an estimated 50% lifetime risk of being infected.

 Transmission is through vaginal, anal, or oral sexual contact.

There are approximately 120 types of HPV.

 Low-risk strains are responsible for the presence of genital warts, and high-risk strains are found in cancers of the cervix, vulva, vagina, penis, anus and oropharyngeal areas.

 In many cases, HPV can clear from the body on its own without causing any health concerns.

Importantly, there is no cure and no screening test for HPV. Many people will not know they have been infected until signs and symptoms occur.

Since the introduction of an HPV vaccine in 2006, there has been confusion and misinformation regarding its utility and benefits. Coloring the public view were questions about the recommended age for vaccine administration (11 or 12 years) as well as the potential implications for wider use, specifically whether recommending the vaccine amounts to consent from providers for children to have sexual contact.

Although the impact of these factors on the use of the vaccine cannot be measured, overall rates of coverage remain low. In 2014, only 40.2% of women 19 to 26 years of age reported obtaining 1 or more doses of the vaccine, while 13.3% of men 19 to 21 years of age had received at least 1 dose of the series.

 Of the 14 million new cases of HPV every year, 50% occur in individuals 15 to 24 years of age.

 The HPV vaccine series is indicated in females 9 to 26 years of age and in males 9 to 21 years of age. There is an additional recommendation for males up to 26 years of age if they are at high risk. Current recommendations call for a 2-dose series for individuals 9 to 14 years of age and a 3-dose series for individuals 15 to 26 years of age.

A good way to open the dialogue with existing patients in the pharmacy is through an immunization update program. All patients who come into the pharmacy should be assessed for any immunization needs. Talk to patients about which vaccines they have received and then focus on the potential needs for vaccines based on age and risk factors. This process may be initially time consuming for the pharmacist, but creating a “vaccine of the month” program could help minimize the time demands. For example, if the HPV vaccine were “vaccine of the month,” any patient between the ages of 11 and 26 years would be assessed during that month. Over time, this program would become less demanding and help open the dialogue with potential patients.

The most difficult aspect of starting a conversation with a young adult is making that initial contact.  Young adults in their late teens and early twenties tend to be healthy individuals, so it often is not as simple as waiting for them to walk into the pharmacy to pick up a prescription. Working together with other healthcare professionals or community groups may represent a way to bridge the gap. Collaborating with college wellness centers is an effective way to work with other healthcare professionals. Since wellness centers see a number of these students, they could identify students who have not been vaccinated and start to educate these students regarding the importance of the vaccine. If they are able, they can also provide the first vaccine in the series. As the pharmacist, you could assist them with the education process and provide the vaccination if the wellness center cannot, or offer to follow up and complete the series with the student. Setting up an information table at a campus or community event is another way to start sharing information and open a dialogue that could result in this population coming to your pharmacy for further education or to obtain the vaccine.

Due to past confusion and misinformation about the HPV vaccine, it is essential to educate young adults and help answer any questions they may have regarding the disease and the vaccine. It often takes more than one interaction with a patient before they agree to the vaccine, therefore providing education is an important first step. Find out what the patient knows about HPV and then fill in the gaps. Then, provide educational materials and encourage the patient to learn more about HPV and the vaccine. 

Young adults often believe that if they are engaging in safe sexual practices, they do not need the vaccine. The best ways to prevent HPV are to get vaccinated, use latex condoms during sexual contact, and be in a monogamous relationship.

 An important consideration for patients is that although they may be engaging in safe sex practices, there may be a time in the future when they will not use condoms, such as when they or their partner are trying to get pregnant. If either partner is infected with HPV, the disease could be spread at that time. 

The most common questions regarding the vaccine are how well it protects patients and whether it is safe. The HPV vaccine has been shown highly effective in preventing cancers related to common strains of HPV, with 98% to 100% efficacy against cervical, vulvar, and vaginal cancer, 75% efficacy against anal cancer, and 89% and 99% efficacy against genital warts in males and females, respectively.

 Overall, the vaccine has been found to be safe.

 The most common adverse reactions include injection site reactions such as pain, redness, and swelling. Headaches may also occur after the vaccination.

It is important when educating teens and young adults for pharmacists to ensure that patients have received all doses in the series. The recommendation for a 2-dose series for those 9 to 14 years of age was only recently incorporated into the immunization recommendations (in 2015). Of note, a third dose is required if the second dose was obtained less than 5 months from the first dose.

 This adds to the complexity of dosing and highlights why it is vital to discuss with patients the number of doses as well as when those doses were received. The series does not need to be restarted if the previous doses were received at an earlier age, but completing the series is important to reach the efficacy levels previously discussed.

Young adults in their late teens to early twenties are at a point where they make their own decisions about their healthcare. This age is an important time for patients to make decisions about the HPV vaccine if they have not already received the series. Pharmacists have a significant opportunity to identify those young adults who either have not started the series, or who may have started and need to complete the series. Opening a dialogue and educating these individuals on the importance of protecting themselves is critical. 

Sheri Stensland, PharmD, AE-C, FAPhA, is an associate professor of pharmacy at Midwestern University-Chicago College of Pharmacy in Downers Grover, Illinois.

Satterwhite CL, Torrone E, Meites E, et al. Sexually transmitted infections among US women and men: Prevalence and incidence estimates, 2008. Sex Transm Dis 40(3):187—93. 2013.

Genital HPV Infection — CDC Fact Sheet. https://www.cdc.gov/std/hpv/stdfact-hpv.htm. Accessed February 9, 2018.

National Foundation for Infectious Diseases. HPV (human papillomavirus). NFID website. http://www.adultvaccination.org/vpd/hpv. Accessed February 9, 2018.

The Center for Disease Control and Prevention. HPV vaccine information for clinicians. CDC website. https://www.cdc.gov/hpv/hcp/need-to-know.pdf. Accessed February 12, 2018.

The National Foundation for Infectious Diseases. Facts about human papillomavirus (HPV) for adults. NFID website. http://www.adultvaccination.org/vpd/hpv/facts-about-hpv-adults.html. Accessed February 16, 2018.

The Center for Disease Control and Prevention. Morbidity and mortality weekly report: 

 / February 5, 2016 / 65(1);1—36. CDC website. https://www.cdc.gov/mmwr/volumes/65/ss/ss6501a1.htm

The Center for Disease Control and Prevention. Prevalence of HPV in adults aged 18-69: United States, 2011-2014. CDC website. https://www.cdc.gov/nchs/products/databriefs/db280.htm  Accessed February 2, 2018.

Efficacy of Gardasil 9. https://www.merckvaccines.com/Products/Gardasil9/efficacy.  Accessed February 2, 2018.

The Center for Disease Control and Prevention. HPV vaccination recommendations. CDC website. https://www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html. Accessed February 9, 2018.

Vaccinations are often given to protect populations whose immune systems are most vulnerable, but pharmacists are aware that some vaccinations are also important during the adolescent and young-adult years.

Dialogue and Education: Engaging Young Adults on the HPV Vaccine

Pharmacists have long been considered among the most accessible and trusted health care advisors. In fact, in a recent Gallup survey, pharmacists ranked as the second most trusted group among a variety of professions. The high level of trust patients hold for their pharmacist is most likely the result of the ongoing nature of the relationship, with many patients seeing their pharmacist monthly.

 Over the last decade, community pharmacists have leveraged this position and taken on a greater role in the health care spectrum.

One area in which pharmacists are well positioned to offer support is in the provision of immunizations. Most community pharmacies already offer influenza, pneumonia, shingles, and a variety of other immunizations according to demographics and need. Some even offer travel medicine clinics and have collaborative practice relationships, allowing pharmacists to collect, assess, and deliver vaccines as recommended based on the specific trip each patient may be taking.

A newer immunization offering that community pharmacists have begun to support is for prevention of the human papillomavirus (HPV). Unfortunately, HPV is fairly common and can infect both men and women. It has been shown to cause cervical cancer, which is the second leading cause of cancer deaths among women. HPV is also associated with less common cancers, such as vaginal and vulvar cancers in women, and anal and throat cancer in both men and women.

Expanding access to the vaccine is a huge win for health care, as we can potentially reduce the spread of HPV and its associated long-term complications, such as cervical cancer. By providing this vaccine at community pharmacies, we can simplify and reduce barriers to access, leading to increased utilization of the vaccine, and ultimately support cancer prevention in the community. The target population for the vaccine is individuals 19 to 26 years of age, many of whom only see their physician once a year and who may not grasp its importance. Community pharmacists are positioned to interact with these patients during everyday pharmacist/patient consultations. These patients also typically are more apt to come in for influenza vaccinations due to comfort with personal education about the flu shot. This represents a good opportunity to educate the patient about HPV vaccines.

As pharmacies continue to add services such as HPV immunizations, the pharmacist should establish deep relationships with other health care providers in our community. These relationships enable us to function as true partners in caring for patients and create a collaboration focused on increasing vaccination rates in the community.

Patient Engagement: Challenges and Strategies

One of the initial barriers to starting an HPV immunization program is deciding how best to engage with eligible patients. This initial conversation can be delicate, so having a good understanding of the advantages, risks, and potential concerns of the patient is important. Since we are usually starting from a point of strong relationship, we can leverage that credibility alongside our expertise in medications.

Most patients are not aware initially of the seriousness of HPV and its associated risks. Anchoring the conversation around cancer prevention is one of the best ways to increase patient interest in receiving the vaccine. Also, providing clear, simple information on the potential risks and benefits is crucial, because patients typically want more information before deciding on the vaccination. Leveraging pharmacist/patient interactions during the counseling process and consistently discussing HPV risks can lead to increased vaccinations. As part of this, we lay out the vaccine schedule and ensure the patient understands the full picture as well as their responsibilities through the series of injections.

Patients who decide to receive the HPV vaccination can have their first dose administered at that time. Often, the initial discussion does not lead to immunization; however, we can send our patients home with additional HPV information to review. By helping them understand the full picture, we gain commitment to complete the full series. Additionally, pharmacists should make a commitment to support patients and remind them about due dates. In today’s health care team approach, we have a unique opportunity to stay connected with patients using our medication synchronizations service to conduct mini comprehensive medication reviews on subsequent visits to help ensure positive immunization outcomes and series completions. Educating all patients about the services we provide is a continuous process and builds over time.

Patients who are asymptomatic represent a challenge in immunization. In target patients (19 to 26 years old), the HPV vaccine is administered in a 3-dose schedule at 0, 2, and 6 months. Insurance coverage varies, but many plans cover all vaccinations under preventive care. For patients who do not have insurance, the cost for all 3 administrations is affordable. When discussing the value of the vaccine, patients often account for the fact that an office visit is not needed for vaccinations, nor is a scheduled appointment. It is also important to have a professional, private area to administer immunizations to better reflect a clinic setting in which patients are comfortable. Patients take all of these factors into consideration when making a commitment to the series.

At the pharmacist level, time is always a challenge when providing additional services. Successful teams are well trained in all aspects of workflow and administrative requirements when immunizing. If possible, integrating immunizations into your workflow by maximizing the technician capabilities and talent around you may represent the best approach.

Increasing patient acceptance of vaccines presents unique opportunities for pharmacists. As trusted health care resources playing an important role in the evolving continuum of patient care, it is essential that we educate patients on the safety and efficacy of the HPV vaccine. Moreover, consistently discussing HPV immunizations may help to increase immunization rates. Ultimately, our approach to immunizations should not differ from assuring adherence to any medication therapy: we want to increase healthy outcomes and deliver the best care for our patients.

Ray Glaser, PharmD, is chief pharmacist at Thrifty White Pharmacy in Alexandria, Minnesota. 

Americans Rate Healthcare Providers High on Honesty, Ethics. Gallup poll. Dec 19, 2016. http://news.gallup.com/poll/200057/americans-rate-healthcare-providers-high-honesty-ethics.aspx. Accessed February 15, 2018.

The Centers for Disease Control and Prevention. HPV Vaccine Information Sheet (VIS). CDC website. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv.html. Accessed February 15, 2018.

Pharmacists have long been considered among the most accessible and trusted health care advisers.

Patient Communication Strategies for Boosting HPV Vaccination Coverage

The 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil 9, Merck & Company, Inc.) is indicated for women and men 9 to 26 years of age for the prevention of certain diseases, precancerous lesions, and genital warts caused by HPV (Table 1).

 The exact mechanism of action of the vaccine is unknown but is thought to prevent HPV through humoral immune responses stimulated by the vaccine.

The 9-valent HPV vaccine is supplied as a single-dose 0.5 ml vial and 0.5 ml prefilled syringe.

 It should be refrigerated at 36° to 46° F and protected from light.

The vaccine is administered as a 0.5 ml intramuscular injection, and the dosage schedule is based on age (Table 2).

 It should be shaken well before use and should not be diluted or mixed with other vaccines. Inspect the product for particulate matter and discoloration prior to administration, and do not use if these characteristics are present. If using the single-dose vial, withdraw the 0.5 ml dose using a sterile needle and syringe and administer immediately.

The prefilled syringe package does not contain a needle. A needle must be attached by twisting in a clockwise direction until it fits securely on the syringe. The entire dose should be administered. Also of note, because the 9-valent HPV vaccine is not live, it can be administered at a separate injection site at the same time as any inactivated or live vaccine.

Immunosuppressive medications such as chemotherapy and corticosteroids may reduce the efficacy of the vaccine.

 It is contraindicated in patients that have experienced hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose.

Warnings, Precautions, and Adverse Reactions

Patients should be monitored for signs of syncope.

 Epinephrine should be administered to patients that experience an anaphylactic reaction after receiving the vaccine.

The most common adverse effects reported with the 9-valent HPV vaccine are dizziness, injection site pain, swelling, redness, nausea, headache, and fever. Syncope has also been reported after administration. Adverse reactions should be reported to the Vaccine Adverse Event Reporting System.

There is a registry to monitor pregnancy outcomes.

 Merck can be contacted at 1-800-986-8999 to enroll.

 Limited available human data demonstrate that there is not an increased risk of major birth defects and miscarriages when the vaccine is administered during pregnancy.

 The Advisory Committee on Immunization Practices (ACIP) recommends that no intervention is needed for pregnant women who receive the vaccine inadvertently.

 The remaining doses should be delayed until after pregnancy.

 Women who are breastfeeding can receive the vaccine.

The 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil 9, Merck & Company, Inc.) is indicated for women and men aged 9 to 26 years for the prevention of certain diseases, precancerous lesions, and genital warts caused by HPV.