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Immunization Update 2011 and the Pharmacist’s Role in Vaccination Advocacy

Justin D. Scholl, PharmD
Assistant Professor of Pharmacy Practice
Lake Erie College of Osteopathic Medicine School of Pharmacy
Erie, Pennsylvania

Maryann Scholl, PharmD
Assistant Professor of Pharmacy Practice
Lake Erie College of Osteopathic Medicine School of Pharmacy
Erie, Pennsylvania



8/19/2011

US Pharm. 2011;36(8):57-60.

The Healthy People 2020 objectives developed by the U.S. Department of Health and Human Services greatly stress the role of preventive services in the maintenance and improvement of the health of the American population over the course of the next decade.1 One major area of emphasis incorporates the reduction of vaccine-preventable diseases and an increase in immunization rates across all segments of the population. To facilitate the accomplishment of these goals, the CDC and the Advisory Committee on Immunization Practices (ACIP) create and frequently update recommendations for vaccine administration in children, adolescents, and adults. The immunization schedules, updated yearly, are available at www.cdc.gov/vaccines. ACIP recommendations, updated every 3 to 5 years, are found at www.cdc.gov/vaccines/pubs/ACIP-list.htm. This article discusses the 2011 changes to ACIP recommendations, as well as practical methods that pharmacists may employ in order to play an active role in improving vaccination rates in the patient population.

Influenza Vaccination

Based on evidence that yearly influenza vaccinations are safe and effective for all ages, yearly vaccination is now recommended for all individuals aged 6 months and older.2 While routine vaccination was not previously recommended for healthy, nonpregnant adults aged 18 to 49 years, it was observed that this group is at risk for influenza-related complications and should therefore receive the vaccine. This update also serves to simplify the recommendation for influenza vaccination and reduces the likelihood that an adult with unknown risk factors for complications of influenza will go unvaccinated.

A high-dose inactivated influenza vaccine containing 60 mcg of hemagglutinin antigen per strain of virus (180 mcg total) has been approved by the FDA as an alternative to standard dosing (15 mcg per strain, or 45 mcg total) in adults aged 65 years and older.2 This vaccine was developed because of the decreased immune response to standard dosing in elderly patients in some clinical trials. Three trials showed that the high-dose vaccine induces higher hemagglutinin-inhibition titers in this population; however, no trials have been conducted to determine whether this confers any clinically meaningful benefits.

In summary, the standard trivalent inactivated vaccine may be administered to all individuals in whom the influenza vaccine is recommended.2 The intranasally administered live, attenuated influenza vaccine may be given only to healthy children aged 2 years and older and to healthy, nonpregnant adults younger than 50 years. The high-dose influenza vaccine may be administered only to adults older than 65 years.

Pneumococcal Vaccination

The recommendations for vaccinating children and adolescents against pneumococcal disease have been updated based on FDA approval of a new 13-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV13).3 The original 7-valent vaccine (PCV7), which was recommended for use in all children aged 2 months to 59 months, proved to be highly effective for preventing invasive pneumococcal disease (IPD), moderately effective for preventing pneumonia, and only somewhat effective for reducing episodes of and office visits for otitis media. PCV13 was approved to prevent IPD caused by the 13 serotypes in the vaccine and to prevent otitis media caused by seven of the serotypes (the same ones as in PCV7). Clinical trials examining PCV13’s efficacy for the prevention of otitis media caused by the remaining six serotypes are not yet available.

The recommendations for PCV13 administration in children who have not received any PCV7 doses are identical to those for PCV7. In children who have already received PCV7 doses or who have underlying medical conditions, the immunization schedule should be used to determine how many doses of PCV13 should be administered and when they should be given.

The 23-valent pneumococcal polysaccharide vaccine (PPSV23) covers a wider range of serotypes.3 It has been recommended for children aged 2 years and older with underlying medical conditions that predispose them to IPD from a broader array of pneumococcal strains than typically affect healthy children. These conditions include diabetes mellitus, cochlear implants, sickle cell disease, leukemias, and solid organ transplantation. It previously was recommended to administer PPSV23 at least 8 weeks after completion of the PCV7 series, and recommendations remain the same as for the PCV13 series.

The recommendations for revaccination with PPSV23 have not changed, but they have been clarified because of confusion concerning the number of times to revaccinate and when to do so.3 PPSV23 vaccination is recommended for all adults who are at increased risk for IPD, including immunocompromised patients, patients with chronic lung or cardiovascular disease or diabetes mellitus, and residents of nursing homes. For patients who were vaccinated between the ages of 19 and 64 years, one-time revaccination is recommended after 5 years. Adults older than 65 years do not need to be revaccinated unless their original dose was before age 65 and it has been at least 5 years since the first vaccine was administered.

Tetanus, Diphtheria, and Pertussis Vaccination

Despite high immunization rates for infants, pertussis has reemerged as a clinically significant cause of illness and was reported as the cause of death in 12 U.S. infants in 2009.4 Because of these reports and the risk of transmission from older adults, the recommendations for pertussis vaccination have been updated. The ACIP now recommends the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in more patient populations and has removed one of the barriers to immunization.

A single dose of Tdap is now recommended for all adolescents aged 11 through 18 years (preferably at the wellness visit at 11-12 years) who have completed the primary series, as well as for all adults aged 19 to 64 years who have not had the vaccine previously or whose vaccine status is unknown.4 In these cases, a one-time dose of Tdap should serve as the tetanus booster. Remaining boosters should be given with traditional tetanus and diphtheria toxoids (Td). In children aged 7 and 10 years—for whom no recommendations previously existed—Tdap should be administered as a one-time dose and the series should be completed with the Td vaccine. In adults aged 65 years and older who have not received Tdap, a single dose should be administered to all individuals anticipating close contact with infants less than 1 year old.

With previous recommendations, Tdap commonly was not administered if the time since the last Td booster was not known.4 There is no longer a specific amount of time that must elapse between doses of Td and Tdap, as the benefits of preventing pertussis outweigh the potential for increased local reactions with a shorter dosing interval. This recommendation applies to people of all ages who are eligible to receive Tdap.

Meningococcal Vaccination

Quadrivalent meningococcal conjugate vaccine (MCV4) is used to protect children, adolescents, and high-risk individuals against disease caused by four serogroups (A, C, Y, and W-135) of Neisseria meningitidis.5 Although rates of meningococcal disease have continued to decline since 2000, recommendations regarding dosing have been redefined for adolescents and adults. Based on studies of immune response and duration of protective antibody persistence, a booster dose of MCV4 is now recommended 5 years following the initial dose. Therefore, adolescents should initially be vaccinated at 11 years and given a booster dose at 16 years. This strategy is believed to provide greater protection from meningococcal disease through the likely time of peak exposure (18-21 years).

In patients at high risk for meningococcal disease, including those with HIV, asplenia, or complement deficiencies, a two-dose primary series of MCV4 is now recommended to improve overall vaccine response.5 Patients aged 2 through 54 years should receive a two-dose primary series with MCV4 and a booster dose every 5 years. All other at-risk individuals, such as travelers or laboratory workers who are likely to be exposed, should still receive a single dose as previously recommended.

Human Papillomavirus (HPV) Vaccination

Since its approval in 2006, a quadrivalent vaccine containing HPV (HPV4) types 6, 11, 16, and 18 has been recommended for routine vaccination in females to prevent cervical cancer and genital warts.6 HPV4 is recommended for children aged 11 to 12 years, with catch-up vaccination recommended through age 26 years. A bivalent vaccine containing HPV types 16 and 18 has since been approved; it is indicated only to prevent cervical cancer. The immunization schedules now state that either vaccine may be given to females aged 11 through 26 years to prevent cervical cancer. The recommendations for vaccinating males to prevent the spread of HPV and to protect against genital warts remain unchanged.

Zoster Vaccination

Zoster vaccine, a live vaccine, is indicated to prevent shingles in adults; it may not be used in children to prevent primary varicella infection.7 Prior to March 2011, the indicated age of administration was 60 years and older. However, the FDA recently approved the zoster vaccine for use in adults age 50 years and older. This change will not be reflected in the immunization schedule until at least 2012. For this reason, not all pharmacists may be permitted to vaccinate the expanded age range, and state-specific regulations should be followed.

The Pharmacist’s Role

It has long been established in clinical practice that the pharmacist is one of the most trusted and accessible health care providers. Because of this, the pharmacist is in a unique position to improve vaccination rates and reduce the burden of vaccine-preventable diseases on the population.

The American Pharmacists Association proposes three roles that pharmacists can play in improving immunization rates.8 The fundamental role, that of immunization advocate, can have a profound effect on public health. Pharmacists who are up-to-date on current recommendations can advise patients during the normal course of care and encourage them to talk to their primary care provider or other health care professional about immunization. Second, pharmacists may act as facilitators hosting other health care professionals in a given setting to provide immunizations directly to the public. An example of this is a pharmacist hosting a nurse at his or her pharmacy to vaccinate patients during flu season.

The third, and most active, role is that of immunizer. Immunizing pharmacists not only can educate and counsel patients and address their concerns and immunization needs, but can then administer the indicated vaccine directly, thereby ensuring compliance. Pharmacists in all states are allowed to administer vaccinations, but regulations vary from state to state, and a pharmacist who wishes to immunize patients must first be familiar with his or her state’s rules and regulations.

Because of the low vaccination rates in the general population and the emphasis on preventive health care outlined in reports such as Healthy People 2020, the logical question becomes: What can pharmacists do on a daily basis to identify at-risk patients and improve overall vaccination rates? For one thing, the pharmacist can act as a vaccine advocate whenever the opportunity arises. This requires no specialized training or additional licensure, and it can be done effectively in the normal course of caring for patients, as all pharmacists do each day.

Strategies

Organizations such as the World Health Organization, the CDC, and the Immunization Action Coalition (IAC) provide a wealth of information regarding strategies for improving overall rates of vaccination in the general population. Because many strategies exist and some are not applicable to all practice settings, this article focuses on those strategies that can most directly be employed by pharmacists during daily patient interactions.

The first strategy is education. Education can be as simple as distributing bag-stuffers or informational pamphlets during flu season or as complex as formal group educational sessions at a pharmacy or other location where patients gather.9 Patient education may be done by technicians or other pharmacy staff, or directly by the pharmacist. The pharmacist may choose to provide educational materials about specific vaccines or those that discuss the importance of vaccinations in general. Web sites such as www.cdc.gov (CDC) and www.immunize.org (IAC) contain a host of patient-friendly materials that can be used to prompt or guide a conversation about vaccination. These sites also contain reliable information that can be used to dispel any myths or misunderstandings that patients may have about vaccines. It is important to remember that pharmacists should treat vaccines as they do as any other medicine and feel comfortable discussing them with patients and health care providers.

In addition to providing patients with information in person, mail or telephone reminders can be a useful tool to help improve vaccination rates in a given population.9 As with education, these reminders can focus on a particular vaccine or simply be related to the importance of vaccination in general. This strategy can work extremely well in the case of a pharmacy with an immunizing pharmacist on staff. A patient can be notified that he or she is overdue for a vaccination—for example, a flu shot—and be prompted to schedule an appointment with the pharmacist for immunization. In a pharmacy without an immunizing pharmacist on staff, the pharmacist could partner with health care providers who administer vaccines and direct at-risk patients to the appropriate provider to receive the vaccination.

Perhaps the simplest method of improving vaccination rates among patients is to add patient screening to the normal pharmacy workflow. With access to patients’ medication records, a pharmacist can make a fairly accurate assessment of the conditions a patient is likely being treated for and make appropriate recommendations for vaccines that are indicated in patients with those conditions. For example, a patient using a bronchodilator may have asthma and would therefore qualify for a pneumococcal vaccine, while a patient filling a prescription for antimalarial medications may need vaccines such as hepatitis A and B prior to foreign travel. Likewise, age alone is an indication for almost all vaccines; children, adolescents, and the elderly could be screened simply based on age at regular pharmacy visits. Additionally, a pharmacist may look for indicators, such as expectant fathers, and vaccinate them against pertussis with Tdap if they have not already been vaccinated. In addition to protecting the newborn from pertussis, the vaccination would give the father a bolstered immune response to tetanus.

Conclusion

Whether it consists of asking a simple question or providing general information on vaccinations at each patient encounter, the pharmacist’s role as a front-line health care provider positions him or her perfectly to advocate for and educate patients about vaccines and may have the net effect of dramatically improving vaccination rates in the public at large. For this reason, it is necessary for the pharmacist to maintain a current level of knowledge about vaccines, just as he or she would for any other medication. The CDC’s immunization schedules and the ACIP recommendations provide a strong foundation that will equip each pharmacist to deliver the highest-quality patient care and make the goals of Healthy People 2020 attainable.

REFERENCES

1. U.S. Department of Health and Human Services. Healthy People 2020: Immunization and Infectious Diseases. Washington, DC: U.S. Department of Health and Human Services; 2010.
2. Fiore AE, Uyeki TM, Broder K, et al. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Recomm Rep. 2010;59(RR-8):1-62.
3. Nuorti JP, Whitney CG. Prevention of pneumococcal disease among infants and children—use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2010;59 (RR-11):1-18.
4. Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine from the Advisory Committee on Immunization Practices, 2010. MMWR Morb Mortal Wkly Rep. 2011;60:13-15.
5. Updated recommendations for use of meningococcal conjugate vaccines—Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2011;60:72-76.
6. FDA licensure of bivalent human papillomavirus vaccine (HPV2, Cervarix) for use in females and updated HPV vaccination recommendations from the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59:626-629.
7. Zostavax (zoster vaccine live) package insert. Whitehouse Station, NJ: Merck & Co; June 2011.
8. Angelo LB. APhA’s Immunization Handbook. Washington, DC: American Pharmacists Association; 2010.
9. CDC. Strategies list. www2a.cdc.gov/vaccines/ed/
whatworks/strategies_list.asp. Accessed April 3, 2011.

To comment on this article, contact rdavidson@uspharmacist.com.

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