OREGON HEALTH AUTHORITY IMMUNIZATION PROTOCOL FOR PHARMACISTS. PNEUMOCOCCAL POLYSACCHARIDE, PPSV23 and CONJUGATE VACCINE, PCV13

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1 Revision September 2010 OREGON HEALTH AUTHORITY IMMUNIZATION PROTOCOL FOR PHARMACISTS PNEUMOCOCCAL POLYSACCHARIDE, PPSV23 and CONJUGATE VACCINE, PCV13 Addition of Prevnar 13 (PCV13) which replaces Prevnar 7 ACIP recommendations for high risk 1 children 6 18 years of age, regardless of whether they have previously received PCV 7 or PPSV23 PPV23 should be given 2 months after last dose of PCV7 or PCV13. PPV23 should be given 4 weeks before or after Zostavax. Pneumovax 23 should not be given concurrently with Zostavax due to reduced immunogenicity to Zostavax. 1 See section III, page 3 5 for specifics. I. Order: 1. Screen clients 11 years for contraindications. 2. Provide an Adolescent Well Visit Flyer to those years of age. 3. Provide a current Vaccine Information Sheet (VIS) answering any questions. 4. Obtain a signed Vaccination Administration Record (VAR) 5. a. Give (0.5 ml) PPSV23 vaccine (Pneumovax 23) intramuscularly (IM), or subcutaneously (SC) to eligible clients. See sect III, pg. 3 4: or b. Give (0.5ml) PCV13 vaccine (Prevnar 13) intramuscularly (IM) to eligible clients. See sect. III, pg Either Pneumovax 23 or Prevnar 13 may be given simultaneously with influenza and all routine immunizations. Pharmacist Signature Date Revised: Reviewed: Original:

2 Pneumonia Vaccine Page 2 of 10 II. A. LICENSED PNEUMONIA VACCINES PRODUCT NAME VACCINE COMPONENTS ACCEPTABLE AGE RANGE Thimerosol Prevnar 13 (Wyeth/Pfizer) PCV13 Polysaccharide conjugate of 13 serotypes of Streptococcus pneumoniae 6 weeks 59 months [ ,2 years of age] None Pneumovax 23 (Merck & Co.) PPSV23 Capsular polysaccharide of 23 serotypes of Streptococcus pneumoniae 65 years of age Or 2 2 years of age None 1 Although the Wyeth package insert states that PCV13 vaccine is approved for use only in children 6 weeks through 59 months of age, ACIP recommends that some children should receive this vaccine through 18 years of age (Table IIIB, p 4 5). 2. With certain chronic conditions, special environments or social settings.

3 Pneumonia Vaccine Page 3 of 10 III. A. RECOMMENDATIONS FOR USE of PPSV23 (Pneumovax 23) Indications for Single Initial Vaccination 1 Indications for Revaccination 2 Persons aged 65 years IMMUNOCOMPETENT PERSONS Persons aged 2 64 years with chronic Illness, including o Cardiovascular disease o Pulmonary disease (e.g. COPD, emphysema) o Cochlear implants o Diabetes mellitus o Alcoholism, chronic liver disease o CSF leaks Persons aged years with these issues o Asthma o Cigarette smokers (cessation counseling should be offered along with vaccine) Persons aged 2 64 years living in nursing homes and other long term care facilities Alaska Natives or American Indians years of age living in areas with high risk for invasive pneumococcal disease 3 PERSONS WITH IMMUNE COMPROMISE Persons 2 years of age with immune system compromise due to: o Congenital or acquired immunodeficiencies o HIV infection 4 o Hodgkins disease, multiple myeloma, generalized malignancy, leukemia o chronic renal failure or nephrotic syndrome o whole organ or bone marrow transplants 5 o immunosuppression 6 or o functional or anatomic asplenia (sickle cell disease or splenectomy) 7 2nd dose of vaccine if 1 st dose received 5 years previously and patient <65 years at time of 1 st dose A 2nd dose is recommended if 5 years have elapsed since receiving 1 st dose.

4 Pneumonia Vaccine Page 4 of 10 III. Footnotes to above PPSV23 vaccine recommendations for use 1. Pneumovax 23 should not be given concurrently with Zostavax due to reduced immunity to Zostavax. 2. Because data are insufficient concerning the safety of PPSV23 when administered three or more times, revaccination following a second dose is NOT recommended. 3. Routine use of PPV23 is no longer recommended for American Indian and Alaska natives <65years of age unless they have medical or other indications. However, public health authorities may recommend PPSV23 for Alaska Natives and American Indians who live in areas in which risk of invasive pneumococcal disease is increased. 4. Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed 5. Hematopoietic Stem Cell Transplant (HSCT) recipients should receive one dose of PPSV23 at 12 months post transplant and a second dose 24 months post transplant. Red Book, p Interval between vaccination and immunosuppressive therapy should be at least 2 weeks. Vaccination during chemotherapy or radiation should be avoided. 7. If an elective splenectomy is being planned, vaccine should be administered at least 2 weeks before surgery if possible or as soon as possible following surgery. III.B RECOMMENDATIONS FOR USE of PCV13 (Prevnar 13) Indications for Single Initial Vaccination 1,2 IMMUNOCOMPETENT PERSONS Persons aged , years of age with chronic Illness, including o Sickle cell disease o Congenital or acquired asplenia, or splenic dysfunction o HIV infection or other immunocompromising condition. o Cochlear implants o Diabetes mellitus o CSF leaks o Diseases associated with immunosuppressive therapy, radiation therapy, and solid organtransplantation. o Chronic cardiac disease Indications for Revaccination None

5 Pneumonia Vaccine Page 5 of 10 o Chronic pulmonary disease Chronic renal insufficiency, including nephritic syndrome Note: The Red Book, p None III. B Footnotes to above PCV13 vaccine recommendations for single vaccine use 1. When indicated, give PPSV23 at least 8 weeks after PCV Children who have previously received PPSV23 should also receive the recommended PCV13 doses for age. 3. A single dose of PCV13 should be administered to children 6 18 years of age regardless of whether they have previously received PCV7 or PPSV23. IV. A. VACCINE SCHEDULE: PCV 13 (Prevnar 13) Schedule for administering PCV13 to children6 18 years of age by PCV vaccination history and age Age and health status Recommended PCV13 regimen years with certain high risk conditions 2 Regardless of any previously received PCV7 or PPV23 doses 1 supplemental dose 1 Minimum interval between doses is 8 weeks. 2 Sickle cell disease, HIV, immunocompromising conditions, cochlear implants, cerebrospinal fluid leaks.

6 Pneumonia Vaccine Page 6 of 10 IV. B. VACCINE SCHEDULE: PPSV 23 (Pneumovax 23) Schedule for administering PPSV (Pneumovax 23) Age and health status Recommended PPSV Years of age (Healthy) 1 dose 2nd dose of vaccine if 1 st dose received 5 years previously and patient <65 years at time of 1 st dose Persons aged years with chronic Illness, including o Cardiovascular disease o Pulmonary disease (e.g. COPD, emphysema) o Cochlear implants o Diabetes mellitus o Alcoholism, chronic liver disease o CSF leaks years of age Asthma, Cigarette smokers (cessation counseling should be offered along with vaccine) 1 dose 2nd dose of vaccine if 1 st dose received 5 years previously and patient <65 years at time of 1 st dose 1 dose 2nd dose of vaccine if 1 st dose received 5 years previously and patient <65 years at time of 1 st dose

7 Pneumonia Vaccine Page 7 of 10 V.CONTRAINDICATIONS VI.PRECAUTIONS A. Persons who experienced an anaphylactic reaction to a previous dose of pneumococcal vaccine or a vaccine component. B. Defer vaccine in persons with moderate or severe illness, with or without fever, until symptoms have resolved A. Pregnancy: The safety of pneumococcal vaccine for pregnant women has not been studied. Women who are at high risk of pneumococcal disease and who are candidates for PPV23 should be vaccinated before pregnancy, if possible. C. Pneumovax 23 should not be given concurrently with Zostavax due to reduced immunity to Zostavax. Reference: 12/09 package insert: ulars/z/zostavax/zostavax_pi2.pdf

8 Pneumonia Vaccine Page 8 of 10 VII.SIDE EFFECTS AND ADVERSE REACTIONS TYPE OF EVENT FREQUENCY OF OCCURRENCE erythema (usually lasts <48 hrs) 30% 50% pain at injection site (usually lasts <48 hrs) 30% 50% fever 1% myalgia 1% severe local reactions 1% anaphylaxis Rarely reported NOTE: Local reactions occur more frequently after the second dose of pneumococcal vaccine. VIII. OTHER CONSIDERATIONS A. For someone with a history of fainting with injections, a 15 minute observational period is recommended post immunization. B. Simultaneous administration of PPV23 and PCV7 is NOT recommended. There should be a minimum of 8 weeks between administration of PCV7 and PPV23. C. Pneumovax 23 should not be given concurrently with Zostavax due to reduced immune response to Zostavax. IX.ADVERSE EVENTS REPORTING Adverse events following immunization must be reported to the Vaccine Adverse Events Reporting System (VAERS) at Forms and procedures can be found at the VAERS website: In addition, a copy of the reporting form should be reported to the patient s primary provider, per Oregon Revised Statute (ORS) (4).

9 Pneumonia Vaccine Page 9 of 10 REFERENCES 1. CDC. 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). 2010;59(RR11);1 18. Available at e 2. CDC. Licensure of a 13 valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children Advisory Committee on Immunization Practices (ACIP) MMWR 2010;59: Available at 3. CDC. Updated recommendations or prevention of invasive pneumococcal disease among adults using the 23 valent pneumococcal polysaccharide vaccine (PPSV23) MMWR 59: Available at 4. Pneumococcal disease. In: Epidemiology and Prevention of Vaccine Preventable Diseases ( Pink Book ), Atkinson W, Hamborsky J, Wolfe S, eds. 10th ed. Washington, DC: Public Health Foundation, 2008: Available at: pdf 5. Immunizations in special clinical circumstances in: Pickering LK, ed. Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009: Pneumococcal infections in Pickering LK, ed. Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009: CDC. Pneumococcal vaccination for cochlear implant candidates and recipients: updated recommendations of the Advisory Committee on Immunization Practices. MMWR 2003; Vol. 52: Available at:

10 Pneumonia Vaccine Page 10 of CDC. Prevention of pneumococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997; 46(RR 8): 1 24, Available at: 9. Pneumovax package insert. Available at: Pneumovax 23 package insert Available at CM pdf 11. Prevnar 13 package insert Available at CM pdf 12. Merck & Co., Inc. Zostavax package insert ( ), available at To request this material in an alternative format (e.g., Braille) or to clarify any part of the above order, contact the Oregon Health Authority Immunization Program at For other questions, consult with the vaccine recipient s primary health care provider or a consulting physician. Electronic copy of this protocol available at: #24I:\IMM\Standing Orders\2011 Pharmacy Protocol\Pharm_Pneumo_01_2011.docx

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