Pneumococcal Vaccine

US Pharm. 2007;32(7):22-29.

In the United States, the most common infectious cause of death is pneumonia. ¹ While pneumonia occurs in individuals of all ages, the most severe clinical manifestations are seen in the elderly, the very young, and those with special health conditions such as alcoholism, diabetes, heart or lung disease, kidney failure, HIV infection, or certain types of cancer. In otherwise healthy adults, Streptococcus pneumoniae(pneumococcus) and Mycoplasma pneumoniae are the most prominent pathogens causing community-acquired pneumonia (CAP).¹ In the U.S., pneumococcus is considered the most common cause of bacterial pneumonia in all age categories, accounting for approximately 70% of all acute bacterial pneumonias.¹

Pneumococcal disease is a serious condition that may result in considerable morbidity causing pneumonia, bacteremia, or meningitis. It is known to kill more people in the U.S. each year than all other vaccine-preventable diseases combined.^2,3 Pneumococcal morbidity statistics identify death in approximately one out of every 20 people with pneumococcal pneumonia, two out of 10 with bacteremia, and three out of 10 with meningitis; death from these conditions is even more likely in patients with the special health conditions identified above.^2,3 Pneumococcal infection accounts for approximately 66% of all fatal cases of CAP of unknown etiology.⁴ Prevention of pneumococcal pneumonia is particularly important because this infection, once commonly treated with penicillin, has become more difficult to treat due to antibiotic resistance. ^2,3

According to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), pneumonia is a core performance measure; additionally, one related quality indicator measure for JCAHO and the Centers for Medicare and Medicaid Services (CMS) is the screening for and administration of the pneumococcal polysaccharide vaccine (PPV) in individuals 65 and older.⁵

Pneumococcal Polysaccharide Vaccine
The term immunization, considered more specific than the term vaccination, refers to the process of inducing or providing immunity artificially by administering an immunobiologic agent.⁶ The PPV provides protection against 23 types of pneumococcal bacteria. TABLE 1 outlines those individuals who should receive the PPV. Most healthy adults develop protection to all or the majority of these various types within two to three weeks following injection of the vaccine. Those who may not respond as well or at all include the very old, individuals with long-term illnesses, and children younger than 2. The PPV is administered intramuscularly or subcutaneously as a single 0.5-mL dose.

In general, one dose of the PPV is usually all that is needed. Under some circumstances, however, a second dose may be necessary and is recommended for individuals 65 and older if they were vaccinated 5 or more years earlier and were younger than 65 at the time of the primary vaccine injection. A second dose is also recommended for individuals with special conditions (e.g., damaged spleen or no spleen, sickle-cell disease, HIV or AIDS, etc.) or those who are taking immunosuppressant medication (e.g., chemotherapy or long-term corticosteroids). Additionally, the PPV may be less effective in some people, particularly those with lower resistance to infection (see TABLE 1). These patients should still be immunized, however, since they are more susceptible to increased morbidity secondary to pneumococcal disease.

While a suppressed response to vaccines may occur in patients receiving glucocorticoids, there is no contraindication to immunization in patients receiving the following glucocorticoid therapy: up to two weeks of low- to moderate-dose, long-term, alternate-day therapy with short-acting agents; topical; aerosol; maintenance physiologic doses; intra-articular, bursal, or tendon injections.⁶ Caution is advised, however, in all patients receiving immunosuppressant therapy.

Risks and Allergic Reactions Associated with the PPV
While the PPV is a very safe vaccine, approximately half of individuals who receive it experience very mild side effects, including pain or redness at the injection site; less than 1% develop muscle aches, fever, or more severe local reactions.^2,3 Although very rare, severe allergic reactions have been reported following vaccine administration, and there is a very small risk that serious complications, including death, may ensue. Taking all of this into account, coming down with pneumococcal disease is significantly more likely to cause serious problems than receiving the vaccine.^2,3

Patients receiving vaccines may respond with allergic reactions, not only to the immunobiologic agent itself, but also to other components of the vaccine preparation. These would include suspending agents (e.g., complex fluids containing proteins such as albumin) and additives to help maintain sterility such as preservatives, stabilizers, and antibiotics.⁶ Formulations may vary from manufacturer to manufacturer. A severe allergic reaction requires immediate medical attention. Patients should report to the physician exactly what occurred, including the date and time it transpired, and when the vaccine was administered. A physician, nurse, pharmacist, or health department should file a Vaccine Adverse Event Reporting System form, or if necessary, the patient can self-report the event (see RESOURCES SIDEBAR).^2,3,7

Vaccine Information Statements
Vaccine Information Statements (VISs) are information sheets produced by the CDC that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal law requires that a VIS be handed out whenever (before each dose) certain vaccines are administered. VISs are available in a variety of languages (see RESOURCES SIDEBAR).^2,3 It is recommended that health care providers consult their state requirements pertaining to immunization, since the federal requirement to provide the vaccine information materials supplements any applicable state laws.^2,3

Pharmacist's Role as Educator, Facilitator, and Immunizer
According to the American Pharmacists Association, pharmacists have an important role in immunizations--one of educator (motivating people to be immunized), facilitator (hosting others who immunize), and immunizer (protecting vulnerable people, consistent with state law).⁷ It has been reported nationally that the availability of vaccines that are administered by pharmacists increases immunization rates and can lead to a larger number of physician-administered vaccinations.^8,9 Furthermore, physician associations (e.g., the American College of Physicians and the American Society of Internal Medicine) have supported the pharmacist acting as an immunization information source, host of immunization sites, and immunizer, as allowed by state law. Research has shown that in states that allow pharmacist immunizations versus those states that do not, a statistically significantly greater percentage of patients 65 and older were vaccinated and pharmacist-managed programs can substantially increase compliance.^10,11

Vaccine Standing Orders Programs and Collaborative Agreements
Standing orders for vaccines reduce and eliminate missed opportunities to immunize and have proven to be effective in improving immunization rates.¹² In many states, through the establishment of a collaborative practice arrangement with a physician, a pharmacist is able to obtain a standing order for vaccines that remains in place for administration by the pharmacist as a service offered by a pharmacy immunization practice. Vaccine standing order programs were developed to avoid the labor-intensive process of requiring pharmacists to contact a physician for a verbal order to vaccinate each time a patient is identified as a candidate for immunization (see TABLE 2).

Once a patient is screened and identified as a candidate, a vaccine may be offered and administered by the pharmacist. Documentation of the screening process (e.g., indication appropriateness and contraindications) and the reporting process (e.g., informing primary care provider of vaccine administration), for example, would be formally addressed in the collaborative practice agreement to ensure completeness of the medical record. In order to sustain the vaccination program and allow pharmacists to focus on patient risk assessment and evaluation of vaccine contraindications, pharmacy students and technicians are employed, providing a formalized structure of workflow (see TABLE 2). ⁵ This general strategy may be utilized, and modified appropriately, for a variety of practice settings, such as a community pharmacy, hospital pharmacy, or consultant pharmacy practice.

The 2002 CMS regulation does allow for the use of standing orders with regard to billing of pneumococcal immunization.⁵ It is recommended that pharmacists familiarize themselves with the specific requirements for the periodic review of collaborative agreements and/or standing orders by the board of pharmacy or medicine in their state.⁵ The CMS reimbursement fees for the PPV vary by state or locality, with coverage provided as a Medicare Part B benefit. ¹³

Summary

Pneumococcal disease is considered a serious condition that may result in considerable morbidity and mortality. Pharmacists, as advocates, hosts, and immunizers for the PPV, can assist with the overall prevention of morbidity and mortality associated with this vaccine-preventable disease.

References
1. Glover ML, Reed MD. Lower respiratory tract infections. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A Pathophysiologic Approach. 5th ed. New York, NY: McGraw-Hill; 2002:1849-1867.

2. Pneumococcal polysaccharide vaccine: what you need to know. Centers for Disease Control and Prevention. Available at: www.cdc.gov/nip/publications/VIS/vis-ppv.pdf. Accessed June 8, 2007.

3. At a glance: Vaccine Information Statements (VISs), Centers for Disease Control and Prevention. Available at: www.cdc.gov/nip/publications/vis. Accessed May 18, 2007.

4. Beers MH, Porter RS, Jones TV, et al. The Merck Manual of Diagnosis and Therapy. 18th ed. Whitehouse Station, NJ: Merck Research Laboratories; 2006:424-430.

5. Sokos DR, Skledar SJ, Ervin KA, et al. Designing and implementing a hospital-based vaccine standing orders program. Am J Health-Syst Pharm. 2007;64:1096-1102. 

6. Bertino JS Jr , Hayney MS. Vaccines, toxoids, and other immunobiologics. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A Pathophysiologic Approach. 5th ed. New York, NY: McGraw-Hill; 2002:2123-2145.

7. Guidelines for pharmacy-based immunization advocacy. American Pharmacists Association. Available at: www.aphanet.org/AM/Template.cfm?Section=Search&template=/CM/HTMLDisplay.cfm&ContentID=6253. Accessed June 8, 2007.

8. Field RI. Pharmacists set to become more active clinicians in Pennsylvania. P & T. 2006;31:100,105.

9. Jelesiewicz E. Pennsylvania pharmacists could soon be "calling the shots." Temple Times (online edition). March 17, 2005. Available at: www.

temple.edu/temple_times/3-17-05/pharmacy.html. Accessed April 10, 2006.

10. Steyer TE, Ragucci KR, Pearson WS, Mainous AG III. The role of pharmacists in the delivery of influenza vaccinations. Vaccine. 2004;22:1001-1006.

11. Van Amburgh JA, Waite NM, Hobson EH, Migden H. Improved influenza vaccination rates in a rural population as a result of a pharmacist-managed immunization campaign. Pharmacotherapy. 2001;21:1115-1122.

12. Hogue MD, Grabenstein JD, Foster SL, Rothholz MC. Pharmacist involvement with immunizations: a decade of professional advancement. J Amer Pharm Assoc. 2006;46:168-182.

13. Medicare Preventive Services: adult immunizations. Centers for Medicare and Medicaid Services. Available at: www.cms.hhs.gov/MLNProducts/downloads/Adult_Immunization_06-08-05.pdf. Accessed June 8, 2007.

14. Semla TP, Beizer JL, Higbee MD. Geriatric Dosage Handbook. 12th ed. Ohio: Lexi-Comp, Inc; 2007:1749-1751,1759.

15. Recommended adult immunization Schedule–United States, October 2005-September 2006. Morb Mortal Wkly Rep. 2005;54:Q1-Q4.

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