Download Policies and Procedures for Using Protocol

Pharmacist Administration of Vaccines to Prevent Diphtheria, Tetanus and
Pertussis
Policies
Tdap Vaccine Formulations
1. BOOSTRIX® vaccination is licensed for patients ages 10 and older.
2. ADACELTM vaccination is licensed for patients 11 through 64 years of age.
Note: The ACIP recommends that either preparation may be used for patients 65 years
and older.
Recommended Schedule
1. If a patient 18 years or older has not received a dose of Tdap, or if vaccine status is
unknown, the patient should receive a one-time dose of Tdap as soon as feasible.
2. Tdap can be administered regardless of the interval since the last tetanus or diphtheria
toxid-containing vaccine.
Indications for Use
1. Adults
a. Upon request, administer a single dose of Tdap to any adult 18 years and older
to replace a single dose of Td
b. Upon request, those adults with close contact to children, who are healthcare
personnel, or are parents who are at a high risk of pertussis
2. Pregnancy
a. Any patient who might become pregnant
b. Pregnant women who have not received a Tdap vaccine, should receive a dose
after 20 weeks gestation
3. Notes
a. If the patient has completed the recommended childhood DTap/DTP/DT
vaccination series and has not yet received a Td booster, then either Tdap
vaccine can be administered.
b. Tdap may be administered to other high-risk individuals at the recommendation
of the Immunization Section Medical Director
Administration
o Age- 18 years of age or older
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
o Dosage- 0.5 mL
o Route- Intramuscular (IM)
o Site- Preferably into the deltoid muscle
Side Effects
1. Local reactions (pain, redness, swelling)
Precautions/Contraindications
Note: Patients with possible precautions/contraindications who have NOT received a
Tdap vaccine in previous years or who have developed precautions/contraindications
since their last Tdap vaccine will be referred to PCP/specialist
1. History of Guillian-Barre syndrome within 6 weeks after a previous dose of toxoidcontaining vaccine
2. Progressive or unstable neurologic disorders, e.g., uncontrolled epilepsy,
encephalopathy cerebrovascular events and acute encephalopathic condition
3. History of a severe local reaction (Arthus reaction) following a prior dose of a tetanus
and/or diphtheria toxoid-containing vaccine
4. Syncope can occur in association with administration of injectable vaccines. Procedures
should be in place to avoid falling injury and to restore cerebral perfusion following
syncope
5. Moderate or severe acute illness
6. Refer to the package insert to determine if latex is contained in the product
7. Severe allergic reaction to vaccine component or following a prior dose
8. Encephalopathy not due to another identifiable cause occurring within 7 days after
vaccination with a pertussis-containing vaccine
Storage and Handling
1. Tdap vaccines should be stored between 35o-46o F (2o-8o C) at all times
2. Tdap vaccines should never be frozen
3. Vaccines exposed to temperature outside of the specified range must not be
administered
4. Contact the vaccine manufacturer for guidance if temperatures exceed recommended
range
Documentation
1. Provide VIS
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
2. Counsel patient regarding vaccines needed
3. Report doses to registry per store protocol
4. Provide patient with an immunization record
Exposure to Disease/Recovery from Disease
1. Patients 18 years of age and older with a history of pertussis generally should receive
Tdap according to routine recommendations.
2. History of tetanus or diphtheria may not confer immunity. Active immunization should
be initiated at the time of recovery and the remaining doses administered as early as
possible.
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
Pharmacist Administration of Vaccines to Prevent Influenza
Policies
Influenza Vaccine Formulations
1. The trivalent influenza vaccine in the United States for the 2012-2013 influenza season
contains an A/California/7/2009 (H1N1)pdm09-like virus, an A/Victoria/361/2011
(H3N2)-like virus, and a B/Wisconsin/1/2010-like virus (from the B/Yamagata lineage of
viruses).
2. An inactivated trivalent influenza vaccine may also be administered. It contains killed
viruses and thus cannot cause influenza.
3. A live, attenuated influenza vaccine (LAIV), Flu Mist ©, may be administered. It is a nasal
spray and indicated for healthy, non-pregnant patients. Pharmacists may administer Flu
Mist© to ages 7 to 49.
Recommended Schedule
1. All patients ≥ 7 years of age
2. Patients 7 years and older who have never received a flu shot will be referred to their
PCP
3. Patients between 7 and 8 years old who have not received 2 doses in one season should
refer to their PCP
4. Patients at higher risk for influenza-related complications
5. When vaccine supplies are limited, vaccination efforts should focus on delivering
vaccination to the following patients
a. Women who are or will be pregnant during the influenza season
b. Patients ≥ 50 years of age
c. Adults and children who have chronic pulmonary (including asthma),
cardiovascular (except hypertension), renal, hepatic, neurologic, hematologic, or
metabolic disorders (including diabetes mellitus)
d. Patients who are immunosuppressed (including immunosuppression caused by
medications or by human immunodeficiency virus)
e. Children and adolescents (aged 7 years through 18 years) who are receiving longterm aspirin therapy and who might be at risk for experiencing Reye Syndrome
after influenza virus infection
f. Residents of nursing homes and other chronic-care facilities
g. American Indians/Alaskan Natives
h. Patients who are morbidly obese (BMI ≥ 40)
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
i.
j.
Health-care personnel
Household contacts and caregivers of children aged < 5 years and adults aged ≥
50 years, with particular emphasis on vaccinating contacts of children aged < 6
months
k. Household contacts and caregivers of persons with medical conditions that put
them at higher risk for severe complications from influenza
Indications for Use
1. Influenza vaccine is recommended for all persons aged ≥ 6 months who do not have
contraindications to vaccination.
2. TIV can be used for any person aged ≥ 6 months, including those with high-risk
conditions
3. LAIV may be used for healthy non-pregnant persons aged 2 through 49 years.
a. The safety and effectiveness of LAIV has not been established in patients with
underlying medical conditions that confer a higher risk for influenza
complications; these patients should be vaccinated only with TIV
b. One dose is adequate for patients 9 through 49 years of age
c. Children 7 through 8 years of age may need two doses of LAIV administered at
least 4 weeks apart
Administration
1. TIV
a. For adults and older children, administer 0.5 mL intramuscularly in the deltoid
muscle.
b. Vaccine from a previous influenza season must not be used.
2. LAIV
a. LAIV is intended for intranasal administration only and should not be
administered by the intramuscular, intradermal or intravenous route. LAIV is not
licensed for vaccination of children < 2 year or adults > 49 years.
b. Vaccine from a previous influenza season must not be used.
c. LAIV is supplied in prefilled, single use sprayer containing 0.2 mL of vaccine.
Administer the vaccine according to the following directions:
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts

Insert the tip of the sprayer just inside the nose and rapidly depress the plunger until
the dose-divider stops the plunger which administers approximately 0.1 mL (half of the
total sprayer contents) into the first nostril while the recipient is in the upright position.
Side Effects
1. TIV
a. Soreness around vaccination site for up to 1-2 days
b. Fever, malaise or myalgia beginning 6-12 hours past injection and lasting 1-2
days
c. Severe local allergic response and anaphylaxis
2. LAIV
a. Runny nose or nasal congestion
b. Fever > 100o F
c. Sore throat
d. Headache
e. Vomiting
f. Abdominal pain
g. Myalgias
Precautions/Contraindications
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
Note: Patients with possible precautions/contraindications who have NOT received a flu
vaccine in previous years or who have developed precautions/contraindications since
their last flu vaccine will be referred to PCP/specialist
1. TIV
a. Moderate or severe acute illness with or without fever
b. Guillian-Barre Syndrome within 6 weeks following a previous dose of influenza
vaccine
c. If administering to an immunocompromised patient, their immune response may
be diminished
d. Vaccination may not protect all recipients
e. Serious allergic reaction to latex (the tip cap of the pre-filled syringes may
contain natural rubber latex)
f. Anaphylactic reactions to components of the vaccine
g. A serious reaction to a previous dose of influenza vaccine
h. Severe allergic reaction (anaphylaxis) to eggs
2. LAIV
a. Patients with a history of hypersensitivity, including anaphylaxis, to eggs, egg
proteins, gentamicin, gelatin or arginine or life-threatening reaction to previous
influenza vaccination
b. Patients > 49 years of age
c. Patients with any of the underlying medical conditions that serve as an indication
for routine influenza vaccination, including asthma, reactive airways disease, or
other chronic disorders of the pulmonary or cardiovascular systems; other
underlying medical conditions, including such metabolic diseases as diabetes,
renal dysfunction, and hemoglobinopathies; or known or suspected
immunodeficiency diseases or immunosuppressed states
d. Children or adolescents receiving aspirin or other salicylates (because of the
association of Reye Syndrome with wild-type influenza virus infection)
e. Patients with a history of Guillain-Barre̕ Syndrome after a prior influenza
vaccination
f. Pregnant women
Storage and Handling
1. TIV
a. Vaccines should be stored between 35o F to 46o F (2o C to 8o C) and should not be
frozen
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
i. Vaccine placed in coolers for use during influenza clinics should be
packaged with enough frozen packs to maintain the cold chain. Be sure
to place an insulating barrier (e.g., bubble wrap, crumpled brown packing
paper, styrofoam peanuts) between the frozen packs and the vaccines to
prevent accidental freezing. A layer of toweling is not sufficient as a
barrier.
2. LAIV
a. Store between 35o F to 46o F (2o C to 8o C) upon receipt and maintain at that
temperature until the expiration date is reached.
b. Discard sprayer according to standard procedures for disposal of medical waste
(e.g., sharps container or biohazard container)
Drug Interactions with LAIV
1. If not simultaneously administered, FluMist can be administered 4 weeks after another
live vaccine such as MMR or varicella.
2. Do not administer FluMist until 48 hours after antiviral cessation.
3. Antiviral agents should not be administered until 2 weeks after FluMist administration
unless medically necessary.
Documentation
1.
2.
3.
4.
Provide VIS
Counsel patient regarding vaccines needed
Report doses to registry per store protocol
Provide patient with an immunization record
Factor
Route of Administration
Type of vaccine
Number of included virus strains
LAIV
Intranasal spray
Live virus
3 (2 influenza A, 1 influenza B)
Approved age for Pharmacist
administration
Can be given to persons with medical
risk factors for influenza-related
complications
Can be administered to family members
or close contacts of immunosuppressed
persons not requiring a protected
environment
Can be administered to family members
Patients aged 7 through 49
years
TIV
Intramuscular injection
Killed virus
3 (2 influenza A, 1
influenza B)
Patients aged ≥ 7 years
No
Yes
Yes
Yes
No
Yes
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
or close contacts of immunosuppressed
persons requiring a protected
environment (e.g., hematopoietic stem
cell transplant recipient)
Can be administered to family members
or close contacts of persons at higher
risk including pregnant women
Can be administered simultaneously
with other vaccines
Yes
Yes
Yes
Yes
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
Pharmacist Administration of Vaccines to Prevent Pneumonia
Policies
Pneumococcal Vaccine Formulations
1. Pneumococcal polysaccharide vaccine is composed of purified preparations of
pneumococcal capsular polysaccharide. PPSV23 contains polysaccharide antigen from
23 types of pneumococcal bacteria. The polysaccharide vaccine currently available in
the United States (Pneumovax 23, Merck) contains 25 mcg of each antigen per dose and
contains 0.25% phenol as a preservative.
Recommended Schedule
1. Most recipients need only a single lifetime dose of PPSV23. Patients with
uncertain or unknown vaccination status should be vaccinated.
2. Routine revaccination of immunocompetent patients previously vaccinated with
23-valent polysaccharide vaccine is not recommended. Only one PPSV23
revaccination dose is recommended for high-risk patients.
3. The following patients are eligible for revaccination with PPSV23
a. Patients ≥ 18 years of age with:
i. Functional or anatomic asplenia (from sickle cell disease or
splenectomy)
ii. Immunosuppression (from disease, chemotherapy or long term
corticosteroids)
iii. Transplant
iv. Chronic renal failure
v. Nephrotic syndrome
b. Patients vaccinated at < 65 years of age
i. The second dose should be administered 5 or more years after the
first dose.
Indications for Use
1. Adults ≥ 65 years of age
2. Patients ≥ 18 years of age with chronic illness to include cardiovascular disease,
pulmonary disease, diabetes, alcoholism, cirrhosis, cerebrospinal fluid leak,
cochlear implant, or immunocompromised patients
3. Adults ≥ 18 years with asthma or cigarette smoking
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
Administration
1. PPSV23 is 0.5 mL to be administered either by intramuscular injection or
subcutaneously. The preferred sites would be the deltoid muscle or anterior
lateral thigh if administered IM.
Side Effects
1. Pain, swelling or erythema at site of injection
2. Fever and myalgia (most frequently following a second dose of PPSV23)
Precautions/Contraindications
Note: Patients with possible precautions/contraindications who have NOT received a
pneumonia vaccine in previous years or who have developed
precautions/contraindications since their last pneumonia vaccine will be referred to
PCP/specialist
1. Severe allergic reaction to vaccine component or following a prior dose of
vaccine
2. Moderate or severe acute illness
3. Use caution and appropriate care for individuals with severely compromised
cardiovascular and/or pulmonary function in whom a systemic reaction would
pose a significant risk
Storage and Handling
1. Store between 35o F to 46o F (2o C to 8o C)
2. Vaccine should be shipped in an insulated container with cool packs
Documentation
1.
2.
3.
4.
Provide VIS
Counsel patient regarding vaccines needed
Report doses to registry per store protocol
Provide patient with an immunization record
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
Pharmacist Administration of Vaccines to Prevent Shingles
Policies
Herpes Zoster Vaccination Formulations
®
1. ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of live,
®
attenuated VZV, the same strain used in the varicella vaccines (VARIVAX ,
®
PROQUAD ).
Recommended Schedule
1. A single dose of zoster vaccine is recommended for adults age 60 years and older
regardless of whether they report a prior episode of herpes zoster. Although the
vaccine is licensed by the FDA for use among, and can be administered to,
patient’s age 50 years and older, ACIP recommends that vaccination begins at
age 60.
Indications for Use
1. Patients 60 years and older regardless of whether they report a prior episode of
herpes zoster
Administration
1. Administer a 0.65 mL dose subcutaneously in the deltoid muscle
2. Reconstitute only with the diluent supplied
3. Administration must be within 30 minutes of reconstitution. Ensure all screening
and paper work is complete before reconstituting.
Side Effects
1. Pain, erythema and swelling around the injection site
2. Headache
Precautions/Contraindications
Note: Patients with possible precautions/contraindications who have NOT received a
zoster vaccine in previous years or who have developed precautions/contraindications
to the vaccine will be referred to PCP/specialist
1. Moderate or severe acute illness with or without fever
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts
2. Receipt of specific antivirals (i.e., acyclovir, famciclovir or valacyclovir) 24 hours
before vaccination, if possible; avoid use of these antiviral drugs for 14 days after
vaccination
3. Hypersensitivity reactions including anaphylaxis have occurred with ZOSTAVAX
4. Transmission of vaccine virus may occur between vaccines and susceptible
contacts
5. Severe allergic reaction (anaphylaxis) to neomycin, gelatin or any other vaccine
component
6. Known severe immunodeficiency (e.g., from hematologic and solid tumors,
receipt of chemotherapy, or long-term immunosuppressive therapy or patients
with HIV infection who are severely immunocompromised)
7. Pregnancy
a. Avoid pregnancy for 3 months following vaccination
Storage and Handling
1. Vaccine must be frozen between -58°F and +5°F (-50°C and -15°C) until
reconstitution.
2. It may be stored and/or transported at refrigerator temperature between 36°F
and 46°F (2°C to 8°C) for up to 72 continuous hours prior to reconstitution. If the
vaccine is not used within the 72 hours, it must be discarded.
3. The vaccine should be reconstituted immediately upon removal from the freezer.
4. The diluent should be stored separately at room temperature (68°F to 77°F, 20°C
to 25°C), or in the refrigerator (36°F to 46°F, 2°C to 8°C).
Documentation
1.
2.
3.
4.
Provide VIS
Counsel patient regarding vaccines needed
Report doses to registry per store protocol
Provide patient with an immunization record
Adapted from Immunization Polices of the Arkansas Department of Health and respective drug package inserts