Module 4 PDF

2014 APhA Pharmacy-Based
IMMUNIZATION DELIVERY
APhA Pharmacy-Based
A National Certificate Training Program

Module 4. Patient Care Considerations for
Immunizing Pharmacists
13-561 © 2014, American Pharmacists Association. All rights reserved.

Introduction
Learning Objectives Module 3 focused on details about available vaccines and
target patient populations. In this patient-focused module,
At the completion of this activity, participants will be able to: the issues presented encompass identification of patients who
should receive immunizations, assessment of patients’ specific
1. Identify patients with immunization needs. vaccine needs, vaccine safety issues, screening for contra-
indications, patient education, and administration techniques.
2. Given a patient case, select appropriate vaccines Appropriate emergency responses and adverse event
using an immunization schedule from the Advisory reporting also are described.
Committee on Immunization Practices, and
identify appropriate timing, doses, and routes of
administration.
Screening Strategies for Immunization
3. Discuss the rationale for timing for vaccine admin
istration and intervals between doses, including
Needs
vaccine-vaccine spacing and vaccine-antibody Several strategies can be used to define which patients should
spacing. receive a vaccine (as well as which patients should not be
vaccinated).
4. Recall recommended patient screening questions for
vaccination and identify valid contraindications for
vaccinations. Determining Who Should Receive Vaccines
The two main vaccination strategies are universal
5. Educate patients about the benefits of vaccines and immunization and high-risk targeting.
address common concerns about vaccines.
Universal immunization is used to vaccinate entire populations
6. Provide accurate information that addresses common against vaccine-preventable diseases. For example, all
myths about vaccines. infants and children, with a few exceptions, should be
immunized with the following vaccines: diphtheria and
7. Describe the roles of the Vaccine Adverse Event
tetanus toxoids and acellular pertussis (DTaP); inactivated
Reporting System in managing vaccine safety.
poliovirus; Haemophilus influenzae type b (Hib); hepatitis A
8. Educate patients about potential adverse reactions (HepA); hepatitis B (HepB); pneumococcal conjugate (PCV13);
following the receipt of a vaccine and how to measles, mumps, and rubella (MMR); and varicella (VAR).1
manage them. Another example of universal immunization is the recommen-
dation by the Advisory Committee on Immunization Practices
9. Explain appropriate techniques for intramuscular, (ACIP) that all people aged 6 months and older should be
subcutaneous, intradermal, and intranasal vaccinated against influenza each year.2 These universal
administration of vaccines. recommendations make it easy to identify people in need of
these vaccines. However, even with a recommendation for
10. Describe the signs and symptoms of adverse universal influenza vaccination, individuals with conditions
reactions to vaccines and procedures that pharmacists that put them at risk of complications if they were to become
should follow to manage various infected with influenza may require specific outreach and
adverse reactions. education encouraging vaccination.
11. Describe appropriate documentation and follow-up High-risk targeting is used to identify certain patients whose
after vaccine administration. risk for infection, complications, or death from disease may
be higher than that for the general population. For example,
pneumococcal polysaccharide vaccine is recommended for
patients aged 2 years and older with chronic heart disease,
lung disease, and diabetes because these patients are at
high risk for complications and death from the disease.3
Module 4. Patient Care Considerations for Immunizing Pharmacists 2

Pneumococcal polysaccharide vaccine is also recommended Heart disease, chronic pulmonary disease, diabetes, chronic
for adults 19 to 64 years of age who smoke cigarettes liver disease, and renal disease are examples of diagnoses
because the risk for invasive pneumococcal disease increases that indicate a need for one or more vaccines.2-5,8-11 Informed
in people who smoke.4 Another example of high-risk targeting and mindful pharmacists can recognize a patient’s diagnoses
involves the rabies vaccine. Experts do not recommend when conducting a medication review and perform on-the-spot
routine rabies vaccination for the entire U.S. population, immunization assessments of the patient’s vaccine needs.
but they do recommend it for veterinarians, their staff, and
veterinary students.5 Vaccinations for international travelers Procedure-based screening involves assessing vaccine
are another example of targeting only those people likely to needs based on a patient’s receipt of a surgical, medical,
be exposed to certain pathogens (e.g., yellow fever). or pharmacy-based procedure. These events can include
splenectomy, dialysis, or bronchoscopy, or receipt of certain
pharmacy services such as diabetes management services.
Identifying People at Risk for Vaccine-Preventable Pharmacists are uniquely positioned to identify vaccine needs
Diseases each time a prescription is filled and the medication profile
Four main screening strategies can be used to identify people is reviewed. For example, medications associated with
at risk for vaccine-preventable diseases: mass screening, chronic liver disease or sexually transmitted diseases indicate
diagnosis-based screening, procedure-based screening, and a need for hepatitis B vaccine, while medications associated
occurrence-based screening. Mass screening is most useful with diabetes indicate a need for influenza, pneumococcal,
for vaccines that have universal immunization recommen- and hepatitis B vaccines.2-4,11 Table 4.1 lists some additional
dations for use. The other screening strategies are better- examples of medical conditions and the corresponding
matched for high-risk targeting. medications that suggest patients may need influenza and
pneumococcal polysaccharide vaccines.
Mass screening is used to identify candidates for vaccines
based on a common factor that will identify a large number Occurrence-based screening takes advantage of an event,
of people. Reviewing a child’s vaccination status prior to such as a hospital admission, clinic visit, or emergency
school entry (e.g., day care, primary, secondary, college) is department visit to identify people who need to be vaccinated.
one type of mass screening. (School vaccination requirements People who have these occurrences are likely to have health
vary by state and can be found at www.cdc.gov/vaccines/ conditions that warrant vaccination, and the occurrence
vac-gen/laws/default.htm.6) Additionally, federal law requires provides a convenient opportunity to screen the patient
that influenza and pneumococcal vaccine be offered to every and identify vaccine needs. Pharmacists in the institutional
nursing home resident.7 However, there are generally no setting can recognize patients on admission to the hospital
mass screening opportunities for adults. or the emergency department, identify vaccine needs, and
recommend vaccinations prior to discharge. Pharmacists in
Diagnosis-based screening identifies patients in need of the community setting have an opportunity to identify vaccine
vaccines based on the presence of a particular diagnosis. needs following an occurrence (e.g., a hospital discharge, a
Table 4.1. Conditions and Representative Medications Indicating the Need for Inactivated Intramuscular Influenza and
Pneumococcal Polysaccharide Vaccines
Condition Representative Medicationsa
Heart disease (e.g., congestive heart failure, Digoxin, warfarin, nitroglycerin, diuretics
myocardial infarction, heart anomalies)
Lung disease (e.g., emphysema, chronic Albuterol, ipratropium, zafirlukast, theophylline, chronic inhaler use, chronic corticosteroids
obstructive pulmonary disease, asthma)
Diabetes Insulin, oral hypoglycemics
Kidney disease (e.g., renal dysfunction, nephrotic Diuretics, angiotensin-converting enzyme inhibitors, erythropoietin
syndrome)
a The medications listed in this table are examples only and are not intended to represent a comprehensive listing of medications indicating the need for vaccination.
Source: References 2–4.

clinic appointment) when the patient presents to the pharmacy

to pick up medications. The newly adopted National Vaccine Find the Current Immunization Schedules
Advisory Committee (NVAC) Adult Immunization Standards Go online to www.cdc.gov/vaccines/schedules/index.html
identify an immunization role for health care providers to find the most recent versions of the child and adolescent
serving adult patients, regardless of whether these providers recommended schedule and catch-up immunization
administer vaccines. The NVAC standards recommend that schedule as well as the recommended adult schedule and
providers should assess vaccine status at every encounter.12 adult schedule for those with medical and other indications.
Print color copies of these four schedules because it will
Pharmacists have an opportunity to use each of these allow for easier interpretation of the information and will
screening options to identify vaccine needs for individual help you follow this section. (Note: learning reinforcement
patients and increase vaccination rates in their community. exercises should be completed using the 2013 schedules
Any time a pharmacist identifies a person’s need for a provided with the exercises, but pharmacists should ensure
particular vaccine, the pharmacist should consider all the they always use current schedules when determining
vaccines that person may need. To comprehensively evaluate vaccination needs in practice.)
a patient’s vaccine needs, the pharmacist must be able to read
an immunization schedule. Please bring the color printouts of current schedules to
the live training seminar. You will be asked to use these
schedules during the live seminar.
Identifying Individual Patients’ Vaccine
Needs
When determining the vaccine needs for an individual patient,
pharmacists should consult immunization schedules, review Reading the Child and Adolescent Immunization Schedule
the patient’s vaccination records, ensure appropriate spacing To determine the vaccine needs of children and adolescents,
between vaccines in a multidose series, and assess the patient consult the immunization schedule for persons aged 0 through
for any contraindications and precautions to the receipt of any 18 years of age and follow these steps1:
vaccines.
1. Locate the column at the top of the chart that
corresponds to the child’s age.
Using Immunization Schedules 2. Start at the top of the vaccine list and consider each
Immunization recommendations are updated frequently and vaccine separately.
the immunization schedules are revised annually to reflect
3. Count the number of doses in or to the left of the
new recommendations. It is critical for health care providers
child’s age on the table. This indicates the number of
to ensure that the most current version of the schedule is used
doses of each vaccine the child should have received
when making vaccination recommendations. The updated
by that age.
schedules are usually released in January or February of each
year. Current recommendations and up-to-date immunization 4. Compare the vaccines needed to the vaccines
schedules also can be obtained from the Centers for Disease recorded in the immunization record to determine
Control and Prevention (CDC) website (www.cdc.gov/ whether all recommended doses have been received.
vaccines), the Immunization Action Coalition (IAC) website 5. Read all the footnotes and follow them carefully. Be
(www.immunize.org), and local or state health departments. aware that the footnotes are just as important as the
Pharmacists are advised to keep current immunization schedule itself and provide vital information necessary
schedules in the pharmacy for easy reference. Note that a to appropriately interpret the schedule.
few vaccines, such as rabies vaccines, and those that may
be used exclusively for international travel or in the event of The child and adolescent immunization schedule is color-
bioterrorism are not included on these schedules. coded and it is necessary to understand these colors to
appropriately interpret the schedule. The yellow bars indicate
ranges of acceptable ages, meaning the vaccine may be
given at any time during this recommended range. Another
important point is that the “2 months” column applies to any

child over the age of 6 weeks. The purple bars indicate when 5. Read all the footnotes and follow them carefully.
vaccines are needed in certain high-risk groups (footnotes Be aware that the footnotes are just as important
provide specific information for these situations). The green as the schedule itself and provide vital information
bars represent the range of recommended ages for catch-up necessary to appropriately interpret the catch-up
immunization; follow the catch-up schedule in these situations. schedule.
Immunization Catch-Up Schedule for Children and Adolescents Decreasing the interval to less than the minimum recommen-
Every effort should be made to adhere to the recommended dation may interfere with antibody response and protection.
immunization schedule because appropriate timing of adminis- Any dose administered 5 or more days earlier than the
tration and intervals between vaccine doses are critical to recommended minimum interval in the catch-up schedule
ensure that patients mount an effective immune response to should be considered invalid and must be repeated.13,14
the vaccine and are protected against vaccine-preventable The repeat dose should be scheduled after the invalid dose,
diseases. However, when patients fall behind on their allowing for the minimum interval to pass before the dose is
vaccinations and need to get caught up, intervals between repeated.13
subsequent doses may be compressed to allow them to get
back on schedule. The childhood and adolescent catch-up Reading the Adult Immunization Schedules
schedule shows the minimum intervals that must be observed There are two different immunization schedules for adults: (1)
between doses.1 the recommended adult immunization schedule, by vaccine
and age group; and (2) the recommended vaccinations
If patients fall behind with vaccinations given in a multidose indicated for adults based on medical and other indications.15
series, it usually is not necessary to start the series over. (As
with many rules, there is an exception: failure to adhere to The steps used to read the adult schedule are similar to those
the administration schedule for oral typhoid vaccine would for the child and adolescent schedule:
necessitate restarting the series of this vaccine.) With all other
1. Determine whether patients have any of the medical
vaccines given in a multidose series, simply resume the series
conditions or other indications for vaccination when
at the point at which it was interrupted. Increasing the interval
selecting which adult schedule to read.
between doses of a multidose vaccine series does not diminish
the ultimate effectiveness of the vaccine, but it does delay 2. After selecting the schedule, locate the column
protection for the patient. corresponding to the patient’s age or medical
condition/indication.
When patients are behind on their immunizations, the
3. Start at the top of the vaccine list and consider
immunizing pharmacist should always consult the catch-up
each vaccine separately to determine whether all
schedule and consult updated references to determine
recommended doses have been received.
the appropriate schedule for the remaining doses in
the series.1,13,14 When using the catch-up schedule, the 4. Compare the vaccines needed to the vaccines
pharmacist should follow these steps: recorded in the immunization record.
1. Identify the vaccine(s) that are needed by the patient 5. Read all the footnotes and follow them carefully.
to catch up. Be aware that the footnotes are just as important
as the schedule itself and provide vital information
2. Look at the catch-up schedule and consider each
necessary to appropriately interpret the schedule.
vaccine separately.
The case studies in the learning reinforcement exercises will
3. Compare the number of doses the patient needs
provide an opportunity to practice reading these schedules
to the number of doses recorded in the patient’s
and applying them to individual patients.
immunization record and identify how many doses
are needed by the patient to catch up.
Reviewing Vaccination Records
4. Schedule the remaining doses, recognizing the As noted in the instructions for reading immunization
necessary minimum interval between the first dose schedules, reviewing a patient’s vaccination record is a key
and any more recent doses. activity when determining vaccination needs. Pharmacists
should ask the patient for his or her vaccination record and

compare the vaccines needed with the vaccines recorded in at any time before or after receiving exogenous antibodies
the patient’s record. such as those in a blood transfusion or immune globulin
products.
Patients may not be able to produce written documentation of
their vaccination history. In the absence of written documen- Live vaccines have different timing and spacing issues to
tation of vaccination, should the pharmacist vaccinate? The consider. Multiple live vaccines may be given at the same
answer is “yes” in most cases, but first do a bit of investi- time. However, if two live vaccines are not given simultane-
gating.13 If patients say they have had some shots, ask them ously, at least 4 weeks must elapse before giving additional
to look again for the records, checking the desk, the bottom live vaccines.13 Live vaccines also must be separated from
of the junk drawer, the safety deposit box, a baby book, or antibody exposures to avoid interference with the immune
other likely places where important papers may be stowed. response. Maternal antibodies that are passed to the baby
Next, ask patients to contact their parents, guardians, previous from the mother might reduce the immune response to live
health care providers, schools or day care centers, or the vaccines, therefore live vaccines are not administered before
public health department in the states where they resided an infant’s first birthday.13 If antibodies are given in the form
during childhood. For adult patients, previous employers, of immune globulin or other blood products, either vaccinate
schools or colleges, or health care providers should be 2 weeks before giving the antibodies, or wait 3 to 11 months
checked.16 If available, check the state immunization after administration of the antibodies.14 The recommended
information system or immunization registry to see if the time interval would be based on the product received and the
vaccinations were documented there. dose administered. In these situations, pharmacists should
consult updated references (e.g., Epidemiology and Prevention
If reasonable attempts fail to produce a vaccination record, of Vaccine-Preventable Diseases also known as “The Pink
the CDC recommends vaccination.13 A duplicate dose will Book”) to determine the specific recommended interval.13,14 If
do no harm other than a sore arm, but a missed dose could a shorter interval is used, perhaps due to a high-risk exposure,
result in a life-threatening infection. Do not waste too much revaccinate after an appropriate interval or check the vaccine
time searching for vaccination records, because waiting to response with an antibody titer.
vaccinate increases the interval during which the person is
vulnerable to a potentially dangerous infection. Work with the Theoretically, live vaccines can suppress reactivity to tuberculin
prescribing physician or the health department to establish a skin tests. When a patient needs a live vaccine and a
procedure for these situations. skin test with purified protein derivative (PPD) of tuberculin,
appropriate administration is important. At issue is the risk of a
false-negative skin test, which could delay or prevent treatment
Timing and Spacing of Vaccine Doses of a person infected with Mycobacterium tuberculosis. The PPD
When assessing vaccine needs for an individual patient, test and the live vaccine can be given at the same time and
the pharmacist must be sure the timing of administration and this is the preferred method.13 Simultaneous administration will
intervals between vaccine doses are appropriate to maximize not interfere with reading the PPD test result. Another option,
the immune response. Administration at recommended ages although not preferred because it delays protection, is to apply
and in accordance with recommended intervals between the PPD test first and then give the vaccine when the skin test
doses will provide optimal protection for the patient.13 is read 48 to 72 hours later. If a live vaccine has been given
According to ACIP, there are no contraindications to simulta- recently, ACIP recommends that the PPD test be delayed for
neous administration of any of the vaccines currently available 4 weeks after administration of the live vaccine to avoid the
in the United States and every effort should be made to potential for a false-negative skin test.13
provide all necessary vaccinations at one visit.13,14
Assessing for Valid Contraindications and Precautions
Inactivated vaccines do not interfere with the immune response Once a patient needing vaccinations has been identified,
to other vaccines, live or inactivated. There is no need to pharmacists must determine whether any contraindications or
observe any minimum interval between doses of two different precautions exist that may preclude the patient from receiving
inactivated vaccines, nor between combinations of inactivated the recommended vaccines. Vaccine-specific contraindi-
and live vaccines. Inactivated vaccines are generally cations and precautions were listed in Module 3 and are
not affected by antibodies circulating in the bloodstream; summarized in Table 4.2.
therefore, patients can be vaccinated with inactivated vaccines

Table 4.2. Contraindications and Precautions by Vaccine

Vaccine Contraindicationsa Precautionsb
Diphtheria and tetanus Severe allergic reaction (e.g., anaphylaxis) Progressive or unstable neurological disorder; defer DTaP until
toxoids and acellular pertussis to a previous vaccine dose or to a vaccine condition stabilizes.
adsorbed (DTaP) component.
Temperature ≥40.5°C (≥105°F) within 48 hours following a
Encephalopathy not attributable to another previous dose.
identifiable cause within 7 days following
administration of previous dose of DTwP or Collapse or shock-like state within 48 hours following a previous
DTaP. dose.
Persistent, inconsolable crying lasting ≥3 hours within 48 hours

following a previous dose.
Seizure within 3 days following previous dose.
Guillain-Barré syndrome <6 weeks following previous dose of

tetanus-containing vaccine.
History of Arthus-type hypersensitivity reactions after a previous dose

of tetanus-containing vaccine; defer vaccine until at least 10 years
have elapsed since the last tetanus toxoid–containing vaccine.
Moderate or severe acute illness with or without fever.
Diphtheria and tetanus toxoids Severe allergic reaction (e.g., anaphylaxis) Guillain-Barré syndrome <6 weeks following previous dose of tetanus-
adsorbed (DT) to a previous vaccine dose or to a vaccine containing vaccine.
component.
History of Arthus-type hypersensitivity reactions after a previous dose
of tetanus-containing vaccine; defer vaccine until at least 10 years
have elapsed since the last tetanus toxoid–containing vaccine.
Haemophilus influenzae type Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
b (Hib) to a previous vaccine dose or to a vaccine
component.
Hepatitis A (HepA) Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
to a previous vaccine dose or to a vaccine
component.
Hepatitis B (HepB) Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
component. Infants weighing <2,000 g.
Herpes zoster (HZV) Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
component (e.g., neomycin, gelatin).
Immunosuppression due to leukemia,

lymphoma, generalized malignancy, immune
deficiency disease, or immunosuppressive
therapy.
Pregnancy.
Untreated active tuberculosis.
(continued on next page)

Table 4.2. Contraindications and Precautions by Vaccine (continued)

Human papillomavirus (HPV) Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
component. Pregnant women should not be vaccinated because it is not known
whether the vaccine can cause fetal harm. If pregnancy is identified
after the vaccine series has begun, the remaining doses should be
delayed until pregnancy is completed.
Inactivated influenza vaccine Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
(IIV) to a previous vaccine dose or to a vaccine
component. Guillain-Barré syndrome ≤6 weeks following previous dose of
influenza vaccine.
Inactivated poliovirus (IPV) Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
component (e.g., streptomycin, polymyxin B, Pregnancy.
neomycin).
Live attenuated influenza Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
vaccine (LAIV) to a previous vaccine dose or to a vaccine
component. Previous history of Guillain-Barré syndrome <6 weeks after a
previous dose of influenza vaccine.
Patients <2 years of age.
Patients ≥50 years of age.
Patients with asthma.
Patients with chronic medical conditions.
Pregnancy.
Known immunodeficiency
Children or adolescents receiving long-term

aspirin therapy.
Measles, mumps, and rubella Severe allergic reaction (e.g., anaphylaxis) Recent receipt (within the last 11 months) of antibody-containing
(MMR) to a previous vaccine dose or to a vaccine blood product.
component (e.g., gelatin, neomycin).
History of thrombocytopenia or thrombocytopenic purpura.
Pregnancy.
Known immunodeficiency.
Meningococcal Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
(MCV4 or MPSV4) to a previous vaccine dose or to a vaccine
component.
Pneumococcal conjugate Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
vaccine (PCV) after a previous dose (of PCV7, PCV13, or
any diphtheria toxoid–containing vaccine) or
to a vaccine component.
Pneumococcal polysaccharide Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
vaccine (PPSV23) to a previous vaccine dose or to a vaccine
component.

Table 4.2. Contraindications and Precautions by Vaccine (continued)

Rotavirus vaccine (RV) Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
component. Pre-existing gastrointestinal disease.
Severe combined immunodeficiency. Previous history of intussusception.
Rotarix only: severe allergic reaction (e.g., Altered immunocompetence other than severe combined
anaphylaxis) to latex. immunodeficiency.
Spina bifida or bladder exstrophy.
Tetanus and diphtheria toxoids Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
adsorbed, adult (Td) to a previous vaccine dose or to a vaccine
component. Guillain-Barré syndrome ≤6 weeks following previous dose of
tetanus-containing vaccine.
History of Arthus-type hypersensitivity reaction following previous

dose of tetanus toxoid–containing vaccine.
Tetanus toxoid, reduced Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
diphtheria toxoid, and acellular to a previous vaccine dose or to a vaccine
pertussis adsorbed (Tdap) component. Guillain-Barré syndrome ≤6 weeks following previous dose of
tetanus toxoid–containing vaccine.
Encephalopathy not attributable to another
identifiable cause within 7 days following Progressive or unstable neurological disorder; defer Tdap until
administration of previous dose of DTwP, condition stabilizes.
DTaP, or Tdap.
History of Arthus-type hypersensitivity reaction following previous
dose of tetanus toxoid–containing vaccine.
Varicella (VAR) Severe allergic reaction (e.g., anaphylaxis) Moderate or severe acute illness with or without fever.
component (e.g., neomycin, gelatin). Recent receipt (within the last 11 months) of antibody-containing
blood product.
Immunosuppression due to leukemia,
lymphoma, generalized malignancy, immune
deficiency disease, or immunosuppressive
therapy.
Pregnancy.
a In general, vaccines should not be administered if a contraindication is present.

b In general, vaccines should be deferred if a precaution is present.
Source: Reference 1.
Contraindications are conditions likely to result in a Precautions are any conditions present that might compromise
life-threatening problem if the vaccine is given. If a valid the patient’s immune response to the vaccine or increase
contraindication is present, the risks of vaccinating the the patient’s risk of developing an adverse reaction to the
patient outweigh the benefits the patient would receive from vaccine. For example, immunosuppression is a precaution
the vaccine. The concern is serious enough to warrant not for the receipt of live vaccines; (this topic will be discussed in
vaccinating the patient and allowing him or her to remain more detail below in Screening for Live Vaccines). Precautions
vulnerable to a serious infectious threat. The one universal may be temporary. If a precaution to the needed vaccine is
contraindication that applies to all vaccines is history of a identified, vaccinations should be deferred and the patient
severe allergic reaction (i.e., anaphylaxis) following a previous should be fully evaluated to determine the risks of vaccination
dose of a vaccine.13 versus the potential benefits of protection from receiving the
vaccine.13 Each case should be evaluated individually to
determine an appropriate course of action.

Pharmacists should screen for contraindications and precautions explored through additional questions such as “What happens
by asking patients a series of key questions before administering when you eat eggs?” and “Do you eat baked goods?”
any vaccine.17 The 10 questions listed here are used to screen (because many have eggs in them).
patients for any valid contraindications or precautions prior to
receiving the vaccines. The specific questions that need to be Question 3. Have you ever had a serious reaction
asked will vary depending on whether the patient is receiving after receiving a vaccination?
inactivated or live vaccines. A sample screening question- If the answer to this question is “yes,” have the patient
naire for adults requesting immunization is available at www. describe what happened. The one contraindication that
immunize.org/catg.d/p4065.pdf. applies to all vaccines is an allergic reaction to an earlier
dose of the vaccine in question. Immediate, anaphylactic,
Screening for All Vaccines life-threatening reactions to vaccine components generally
Question 1. Are you sick today? contraindicate further vaccinations with a product containing
The immunizing pharmacist is specifically looking to determine that component.13,14
if the patient’s clinical illness is significant enough to refer
the patient for additional care (e.g., referral to a physician While this training program is not focused on infants and
or the emergency department). If the patient is ill enough children, pharmacists should be aware that if a patient has
to require referral to a physician or requires an emergency a history of encephalopathy within 7 days following DTP/
department visit, vaccination should be deferred until the acute DTaP, this would be considered a contraindication to receiving
event stabilizes or improves. However, symptoms such as a further doses of pertussis-containing vaccine. In addition, if a
low-grade fever, mild respiratory tract infection, mild diarrhea, child has had a fever of 40.5°C (105°F) or greater; seizures
or otitis media are not contraindications to vaccination and or convulsions; continuous crying for 3 hours or more; unusual
patients with these symptoms or diseases should receive sleepiness; unusual high-pitched screaming; or collapse or
recommended vaccines on schedule. Pharmacists should keep unresponsiveness within 7 days after receiving a dose of
track of all patients whose immunizations have been deferred pertussis-containing vaccine, this would be a precaution to
so those patients can be vaccinated promptly when the acute receiving further doses of pertussis-containing vaccines (see
illness has been resolved. For hospitalized patients, there is discussion in Module 3).
little need to ask this question. In general, if patients are well
enough to be discharged to home, they should be considered Question 4. Do you have a long-term health problem
well enough to receive vaccinations unless they have a direct with heart disease, lung disease, asthma, kidney
contraindication to a recommended vaccine. disease, metabolic disease (e.g., diabetes), anemia, or
other blood disorder?
Question 2. Do you have allergies to medications, Screening patients for chronic conditions (i.e., diagnosis-based
food, any vaccine, or latex? screening) allows for global assessment of immunization
Pharmacists should completely assess the patient’s allergies. needs. For example, patients with diabetes need influenza,
Only those allergic reactions to previous doses of vaccines or pneumococcal polysaccharide vaccine, and hepatitis B
to vaccine components are relevant to immunizing the patient.13 vaccine if they have never received the vaccines.2-4 This
Specific allergies to vaccine components are discussed in question also allows the pharmacist to determine whether
detail in Module 3. If a person in need of a vaccination has there are any chronic health conditions that would indicate a
a documented history of significant allergies to any vaccine contraindication or precaution to receiving the vaccine.
component, refer the patient for further evaluation by a
physician who is an expert in vaccines and/or allergies.13,14 Screening for Live Vaccines
Question 5. Do you have cancer, leukemia, AIDS, or
No vaccine currently available in the United States contains any other immune system problem?
penicillin, therefore patients with penicillin allergies can This question should be asked to determine if the patient
receive vaccines. Reactions that are not true allergies are has immunosuppression due to chemotherapy, radiation
largely irrelevant. For example, if the patient’s “allergy” turns therapy, human immunodeficiency virus infection, immuno-
out to be an episode of fainting or gastric upset, use this as suppression therapy following transplantation, or any immune
an opportunity to explain the difference between allergies system disorder. Immunosuppression caused by any of these
and intolerances. Local injection site reactions also do not treatments or conditions may preclude patients from receiving
constitute an allergy. Reported egg allergies should be further live vaccines, but may indicate the need for certain inactivated

vaccines (e.g., influenza, pneumococcal).2-4 Live vaccines with live vaccines depends on the type of antibody and the
are usually contraindicated in patients who are immunocom- dose given. If a patient answers “yes” to this question, refer
promised because immunosuppression may reduce vaccine to updated references to determine the appropriate interval
efficacy as well as pose a risk for disseminated infection between the live vaccine and blood product.14
with the normally attenuated pathogen in the live vaccine.
Pharmacists should refer immunocompromised patients to Question 8. Have you received any vaccinations in
physicians for most immunization decisions and work with the the past 4 weeks?
physician to coordinate the patient’s care. If any of the vaccines received were live vaccines and the
patient is receiving a live vaccine, a minimum interval of
Question 6. Do you take cortisone, prednisone, 4 weeks must be observed.13
other steroids, or anticancer drugs, or have you had
radiation treatments? Question 9. For women: Are you pregnant or is there
This is another way to ask patients about possible immunosup- a chance you could become pregnant during the next
pression. Patients on complex immunosuppressive regimens month?
should be evaluated by their physician to develop an optimal Live vaccines are contraindicated 1 month before and during
immunization strategy. pregnancy because of a theoretical risk to the fetus. Live
vaccines should be deferred until after delivery.
If patients state that they use an oral corticosteroid, take
note of the dose and duration of therapy. Prednisone doses Although pregnant women should not be vaccinated with
of 20 mg per day or an equivalent taken for more than 14 live attenuated influenza vaccine, the inactivated influenza
days are likely to be immunosuppressive.13 While patients vaccine is currently recommended for all patients who are
receiving prolonged high-dose corticosteroids may have pregnant or will be pregnant during the influenza season.2
a diminished response to inactivated vaccines, influenza In addition, tetanus and diphtheria toxoids and acellular
and pneumococcal vaccine may still be indicated. When pertussis vaccine (Tdap) is recommended during each
weighing benefits and risks, consider that such patients have pregnancy after 20 weeks and ideally at 27 to 36 weeks
little risk from inactivated vaccines and they could benefit gestation. Vaccination of pregnant patients should be
if their immune system responds adequately. Conversely, coordinated with the primary care physician or obstetrician
consider how infection with influenza or pneumococcal if any other vaccinations are deemed necessary during
disease could affect the condition of an immunosuppressed pregnancy. Inactivated vaccines are generally safe in
patient. Steroids given topically, by metered-dose inhalers, pregnancy and may be vital to protect the health of both the
intra-articular injections, or alternate-day or short-course woman and the fetus if there is imminent danger from the
(less than 2 weeks) therapies are generally not considered disease and immediate protection is needed.
immunosuppressive.
ACIP recommends against routine performance of pregnancy
It is important to determine whether a patient has received tests prior to administration of vaccines (including live
chemotherapy or radiation treatments (which are referred to vaccines).13
as x-ray treatments on some forms, but do not mean having
a bone x-rayed). Pharmacists should identify these patients Some states have enacted legislation that restricts the use of
and work with the patient’s physician to develop an optimal thimerosal-containing vaccines during pregnancy. Pharmacists
immunization strategy to maximize protection for the patient. should check with their state immunization manager to
In general, live vaccines should not be given for at least see if their state has such legislation (www.immunize.org/
3 months after radiation treatments or chemotherapy.13 coordinators).
Question 7. During the past year, have you received a Question 10. For patients who are candidates for
transfusion of blood or blood products, or been given vaccination with DTaP, Tdap, or other tetanus-
a medicine called immune (gamma) globulin? containing vaccines or influenza vaccines: Have
Live vaccines may need to be delayed for patients who have you had a seizure, brain, or other nervous system
received these products. Antibodies and blood products may problem?
interfere with the replication needed by live vaccines to elicit an Vaccines containing diphtheria and tetanus toxoids and
immune response. Timing between antibodies and vaccination acellular pertussis antigens (i.e., DTaP and Tdap) are contrain-

dicated if a child has a history of encephalopathy without an Educating Patients About Vaccines
identifiable cause within 7 days of administration of a previous Pharmacists may recommend vaccines to a patient, but
dose.18,19 If a patient has an unstable progressive neurologic ultimately the patient must decide whether or not to receive
problem, this would be a precaution to receiving DTaP or the vaccine. It is critical for pharmacists to understand the
Tdap. If a patient has a history of Guillain-Barré syndrome, factors that can influence vaccine decisions. Sociologists
this would be a precaution for influenza vaccines or tetanus- have identified five key factors in a person’s decision to be
containing vaccines.2,18,19 vaccinated20-23:
1. Perceived susceptibility to a disease.
Invalid Contraindications
Several myths about contraindications to vaccines persist. A 2. Perceived seriousness of a disease.
list of incorrect contraindications appears in Table 4.3.13,14
3. Perceived vaccine benefits.
Pharmacists must be able to distinguish between valid and
invalid contraindications. Patients with misinformation about 4. Perceived vaccine barriers (e.g., adverse effects,
contraindications should be educated and vaccinated as access).
appropriate. 5. Social influence (e.g., recommendation from a
pharmacist).
In addition to recommending vaccines, pharmacists can

Table 4.3. Invalid Contraindications for Vaccination
provide information about these issues and work with the
patient’s health care team to ensure access. Patients may not
Certain conditions are often inappropriately regarded as contraindica-
be aware of the risks associated with vaccine-preventable
tions to immunization. Do not routinely withhold immunization in the
diseases and may require education about the benefits of
following instances:
vaccines. Many people in the United States today have never
• Mild acute illness with low-grade fever or mild diarrhea in an
seen the devastation caused by diseases such as poliomyelitis,
otherwise healthy patient.
measles, mumps, rubella, diphtheria, or tetanus. As a result,
• Mild-to-moderate local reaction (e.g., swelling, redness,
soreness) after a previous dose.
many people do not appreciate the benefits of vaccines and
• Low-grade or moderate fever after a previous dose.
may be more likely to focus on their potential risks. To help
• Current antimicrobial therapy. There are two exceptions: educate the public about vaccine-preventable diseases,
(1) antibiotics can interfere with the oral typhoid vaccine; pharmacists should share information about the morbidity
(2) certain antiviral medications might interfere with LAIV or and mortality of the diseases before the vaccines were
varicella-containing vaccines. introduced. One useful resource to support these efforts
• Convalescent phase of illness. is the “Unprotected People” page on the IAC website
• Premature birth. Vaccines should be scheduled based on the (www.immunize.org/reports/), which provides reports of
infant’s chronological age. serious complications and deaths in recent years from
• Pregnancy in the household. vaccine-preventable diseases.24
• Recent exposure to an infectious disease.
• Allergies to penicillin. Furthermore, a number of myths and misperceptions exist
• Allergies to bird (duck or chicken) feathers. regarding vaccines and their risks. Antivaccine accusations
• A family history of sudden infant death syndrome. often appear in the media and a vast amount of information
• Need for tuberculin skin testing (see Timing and Spacing of blaming vaccines for causing diseases is available on the
Vaccine Doses section). Internet. Substantial education may be required to counter
• Reaction to a previous dose of DTwP that involved only these myths.
soreness, redness, or swelling at the vaccination site or
temperature <40.5°C (<105°F). These patients can receive
Pharmacists should familiarize themselves with the claims of
DTaP, Td, or Tdap as indicated.
antivaccine advocates as well as the evidence to refute these
claims so they can have informed discussions with patients.
DTaP = diphtheria and tetanus toxoids and acellular pertussis vaccine; DTwP =
diphtheria and tetanus toxoids and whole-cell pertussis vaccine; LAIV = live attenuated
The American Academy of Pediatrics regularly updates its fact
influenza vaccine; Td = tetanus and diphtheria toxoids vaccine; Tdap = tetanus and sheet “Vaccine Studies: Examine the Evidence” (www.aap.
diphtheria toxoids and acellular pertussis vaccine (booster). org/immunization/families/faq/VaccineStudies.pdf).25 This
Source: References 13 and 14. report provides a compilation of more than 40 peer-reviewed

Table 4.4. Selected Sources for Reliable Vaccine Information

Organization Website
American Pharmacists Association www.pharmacist.com/immunization-resources
Centers for Disease Control and Prevention www.cdc.gov/vaccinesafety/
Immunization Action Coalition www.immunize.org
Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health www.vaccinesafety.edu
Institute of Medicine www.iom.edu
Vaccine Education Center at the Children’s Hospital of Philadelphia www.chop.edu/service/vaccine-education-center/
World Health Organization www.who.int/vaccine_safety/en/
studies on vaccine safety issues (e.g., thimerosal, autism) and rates were reduced. Furthermore, some of these vaccine-
includes links to original publications. Additional selected preventable diseases are still prevalent in other parts of the
sources for reliable, balanced vaccine information are listed world and travelers can contract these diseases resulting in
in Table 4.4. Be cautious of the vaccine information contained outbreaks in unvaccinated individuals. Outbreaks of measles
on the Internet and ensure the information you use is from a and mumps in the United States are frequently traced to
reputable source. international travelers.
Vaccinations also provide protection to those around the

Countering Myths and Misperceptions About vaccinated person. There are some people who cannot be
Vaccines vaccinated for medical reasons or who have incomplete
Pharmacists should become informed of misconceptions about responses to vaccines. Maintaining high immunization rates
vaccines and prepare themselves by knowing the facts. Some (i.e., herd immunity) helps to protect these individuals.
of the most common myths are discussed below.26-33
Myth: Most people who get vaccine-preventable diseases
Myth: Diseases began to disappear long before vaccines have been vaccinated. Fact: Antivaccine advocates often use
were available due to improved hygiene and sanitation. this argument to imply that vaccines are ineffective. It is true
Fact: Statements like this are very common in antivaccine that during an outbreak, sometimes there are more vaccinated
literature, apparently suggesting that vaccines are not needed. individuals who become sick than unvaccinated individuals.
Improved hygiene and sanitation, as well as improved nutrition However, it is incorrect to conclude from this situation that
and the development of antibiotics, have certainly reduced vaccines do not work.
disease incidence and mortality. However, a review of the
actual incidence of disease over the years leaves no legitimate No vaccine is 100% effective, so a small percentage of fully
doubt of the significant direct impact vaccines have had in vaccinated individuals will not have complete protection.
modern times. While some vaccines are not 100% effective, Some vaccinated individuals may not be fully vaccinated
a review of historical data on disease incidence demonstrates and therefore will have suboptimal protection. Additionally,
clear and dramatic drops in disease incidence when vaccines immunization rates are very high in the United States. If only
are introduced.26 Furthermore, some vaccines were not 1% of vaccinated individuals contract a disease, but 50% of
introduced until recent decades, long after the advent of unvaccinated individuals get the disease, there could still be
modern hygiene standards and medical treatment. These more ill vaccinated people, because their overall numbers are
vaccines also have produced dramatic declines in disease so high. Finally, it is important to note that illness that does
incidence. occur is often less severe in vaccinated people.
Myth: Vaccine-preventable diseases have been eliminated Myth: Some vaccine-preventable diseases aren’t that bad.
from the United States so there is no need to vaccinate Fact: Some people may believe that certain vaccine-
children. Fact: It is true that vaccination has reduced most preventable diseases, such as influenza, are not really
vaccine-preventable diseases to very low levels in the United serious (e.g., “It’s just the flu...”). Educating patients about the
States. However, many of the diseases are highly contagious morbidity and mortality associated with the disease can help
and could produce widespread outbreaks if vaccination dispel this myth. For example, influenza and pneumonia are
the eighth leading cause of death in the United States.34
Myth: The flu shot causes the flu. Fact: Injectable influenza There is no scientific evidence showing any short- or long-term
vaccine is inactivated (i.e., killed), thus it is impossible for this harm from exposure to thimerosal in vaccines.29 There is also no
vaccine to cause influenza. The intranasal influenza vaccine is scientific evidence showing adverse events among children born
a live vaccine, but the virus has been modified so that it cannot to women who received thimerosal-containing vaccine during
cause disease.35 Fact: Being vaccinated against influenza pregnancy.2 The IOM conducted a review that specifically
does not mean that patients are protected immediately upon evaluated the safety of thimerosal in vaccines.29 This review
receipt of the influenza vaccine. It takes up to 2 weeks for the examined five large epidemiological studies (three of which
vaccine to stimulate an immune response. Therefore, patients involved more than 100,000 children each) and concluded
who are exposed to the influenza virus shortly before or after that the evidence did not support a link between thimerosal-
the time of vaccination may still develop influenza before the containing vaccines and autism.
vaccine takes full effect.
Even though there has not been any scientific evidence to
Myth: Vaccines cause autism. Fact: The prevalence of autism show that exposure to thimerosal-containing vaccines causes
has risen in recent decades and no established cause harm, federal agencies recommended that manufacturers
has been identified. By coincidence, autism is often first strive to reduce or remove the preservative from all products
diagnosed when children are 15 to 18 months old—approxi- as a precautionary measure. Currently, thimerosal has been
mately the same age that many vaccines are administered.30 removed from all childhood vaccines except some brands of
Because of this temporal relationship, some individuals believe influenza vaccine. The Food and Drug Administration (FDA)
that vaccines and autism may be linked. These beliefs erupted provides a review of thimerosal safety data and a listing of
in a worldwide public health scare when a paper published thimerosal content in available vaccines at www.fda.gov/
in The Lancet in 1998 suggested that the MMR vaccine BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/
caused autism.36 This article has since been retracted after UCM096228.
it was determined that the author falsified data and did not
disclose the funding source for his research.37 Nevertheless, If thimerosal-free influenza vaccine is unavailable, the benefits
many individuals continued to believe that vaccines, the MMR of influenza vaccination outweigh the theoretical risk from
vaccine specifically, and/or thimerosal cause autism. thimerosal exposure through vaccination and it is acceptable
to immunize with thimerosal-containing vaccine if this is the
A substantial and authoritative body of research has investi- only vaccine available.2 The challenge in this situation is that
gated potential links between vaccines and autism and found some states have enacted legislation banning the adminis-
no association. The Institute of Medicine (IOM) has completed tration of vaccines containing mercury. Pharmacists must be
multiple safety reviews, conducted by impartial experts, aware of their state law and determine how they will address
to evaluate whether a causal relationship exists between this issue in their own practice. As noted above, information
vaccines and autism.28-30 The IOM has concluded that there about which states require preservative-free vaccines can be
is no identifiable link between vaccines and autism.28-30 obtained from state immunization managers (www.immunize.
Additionally, 14 large epidemiological studies showed no org/coordinators).
association between the MMR vaccine and autism, and other
research supports this conclusion.38 Myth: The courts have compensated people who developed
autism after being vaccinated. Fact: One child, Hannah
In 2009, the federal court that administers the National Poling, has received a monetary settlement related to autistic
Vaccine Injury Compensation Program (VICP) reviewed the symptoms that developed after vaccinations she received at
issue of a potential link between vaccines and autism. After 19 months of age. After receipt of vaccination and develop-
extensive proceedings, the court found the scientific evidence ment of symptoms, Hannah was diagnosed with encephalopathy
to be “overwhelmingly contrary” to the theory that vaccines caused by a mitochondrial enzyme deficiency; the symptoms
cause autism. Information about federal case decisions of this disorder included problems with language, communi-
regarding autism claims through the VICP can be found at cation, and behavior, which are also typical symptoms of autism
www.uscfc.uscourts.gov/omnibus-autism-proceeding. spectrum disorder. Because of Hannah’s genetic mitochondrial
deficit, any stress could have caused deterioration. The family
Myth: Thimerosal in vaccines causes autism. Fact: Thimerosal is a successfully sued the Department of Health and Human Services
mercury-containing compound that has been used for decades for compensation under the VICP. The court did not concede
as a preservative in vaccines to prevent bacterial contamination. that vaccines caused autism in this case.32,39

Myth: Vaccines cause Crohn’s disease, diabetes, multiple about vaccines is that some manufacturer lots are associated
sclerosis, rare cancers, and other problems. Fact: There is no with higher incidences of adverse events reported to VAERS. If
objective evidence that any of these diseases are caused by the number and type of VAERS reports for a particular vaccine
vaccinations. They occur at the same rates among vaccinated lot suggested that it was associated with more serious adverse
and unvaccinated people. Vaccine Adverse Event Reporting events or deaths than are expected by chance, the FDA has
System (VAERS) reports are reviewed weekly to provide the legal authority to immediately recall that lot. To date, no
ongoing postmarketing surveillance of vaccine safety and are vaccine lot in the modern era has been found to be unsafe on
used to monitor for emerging evidence of safety concerns that the basis of VAERS reports.
require further evaluation.
For example, in the autumn of 2005, meningococcal polysac-

Communication Skills for Discussing Myths and
charide vaccine was associated with a handful of cases of Misperceptions
Guillain-Barré syndrome, a rare neurological illness typically Robust evidence clearly supports the safety and efficacy of
associated with bacterial and viral infections. Further investi- vaccines. However, pharmacists must take care to present this
gation did not identify a cause-and-effect relationship between information in a manner that patients accept. In some cases,
the vaccine and the neurologic problem, although scientists patients will ask a straightforward question for which there is
continue to monitor the situation. a simple direct response. For example, “If I had a flu shot last
year, do I need another one this year?” can be given a direct
Myth: Vaccines are not safe and cause diseases/illnesses that response, such as “Yes, because the flu viruses that circulate
no one knows about. Fact: The United States has a strong change every year, and because the protection provided by
adverse event reporting system and surveillance network to the vaccine decreases over time, it is important to get a new
monitor vaccines once they come to market. The vast majority shot every year to be protected.”
of vaccines on the market today have been used safely and
effectively in millions of patients without significant adverse However, if patients refuse a vaccine due to a myth or
events. misperception, simply telling them that they are wrong and that
there is no credible data to support their belief is unlikely to
Myth: Giving several vaccines on the same day overloads the change their minds and will likely damage the patient-provider
patient’s immune system. Fact: Data show this simply is not the relationship. Approach these patients with respect and have
case. In immunocompetent people of any age, the immune compassion when addressing their concerns.41 Ask them to
system is fully capable of eliciting an appropriate immune share more about their concerns using open-ended questions.
response to multiple antigens administered on the same day Examples of such questions include:
through vaccination.31 Interestingly, a person’s immune system
• “What concerns do you have about being vaccinated?”
is exposed to more antigens every day from food or bacteria
in the mouth and nose than from some vaccines.31 • “Tell me about your understanding of [the issue].”
• “What information led you to believe that?”
Nevertheless, this myth has resulted in the development of
alternative vaccination schedules for children, such as “Dr. Be sure to use a caring and inquisitive tone, rather than a
Bob’s Alternative Schedule,” published in The Vaccine Book by dismissive tone, when asking these questions.
Robert Sears, MD, in 2007.40 This schedule advises parents
to delay, withhold, separate, or space out vaccines. At the After the patient shares his or her concerns, it is important to
very least, a problem with such schedules is that they increase acknowledge the concern to demonstrate that you respect the
the time during which children are susceptible to diseases. patient and have empathy. For example:
With more unprotected children, the chance of an outbreak
• “I can understand that you would be concerned after
spreading increases. This schedule also increases the burden
reading that.”
on the health care system, because many more visits to
vaccine providers are required, and increases the likelihood • “There have been stories about that on the Internet and I
that children will not complete immunization schedules.40 agree they can be concerning.”
• “I can see why that experience made you think that
Myth: There are “hot lots” of vaccines that may cause a greater
about vaccines.”
number of adverse events. Fact: One myth that has circulated

Reflective statements also can help to develop the relationship Education at the Point of Vaccination
and reframe the conversation. For example: Beyond educating patients about the importance of vaccina-
tions and countering common myths, pharmacists must provide
• “It sounds as though you felt quite miserable the last
patients with information at the time of vaccination. This
time you had the flu.”
information includes provision of Vaccination Information
• “I can tell that you are very concerned about making the Statements (VISs) prior to vaccination as well as counseling the
best decisions for your child’s health.” patient after administering the vaccine.
Next, ask the patient’s permission to share information. This Providing Vaccine Information Statements
step is important for making the patient more receptive to the Even though serious complications from vaccines are rare, it is
information you have to share. Examples of permission-asking crucial that all patients be provided with accurate information
include: about the risks and benefits of the vaccine. Patients must
have reliable information to make informed decisions about
• “Would it be all right if I tell you why that concerns
vaccines. The vaccine provider has a responsibility to provide
me?”
this information before immunizing a patient.
• “Would you mind if I share some information about this
issue with you?” VISs are standardized forms that provide an overview of the
risks and benefits of vaccines. Health care providers who
• “Can I share some articles with you about this issue?”
administer vaccines are required by law to provide patients with
The patient is likely to accept this invitation to share the most up-to-date version of the VIS for any vaccine covered
information and then the pharmacist can begin to present under the National Childhood Vaccine Injury Act (NCVIA).42
the facts about vaccine-preventable disease, vaccines, and (The NCVIA is discussed further in Module 5.) The appropriate
their risks. After explaining the data about the issue, ask the VIS must be provided for any vaccine containing diphtheria,
patient for his or her reaction and probe for understanding. tetanus, pertussis, measles, mumps, rubella, poliovirus, hepatitis
“I just shared a lot of information with you and you seem to A, hepatitis B, H. influenzae type b, influenza, pneumococcal
be giving this a lot of thought. What do you think about this conjugate, meningococcal, rotavirus, human papillomavirus, or
information?” and “What further questions do you have for varicella (chickenpox) vaccine. VISs also are available for the
me?” pneumococcal polysaccharide and herpes zoster vaccine; use
of these two VISs is recommended but not currently required by
If a patient does refuse your request for permission to share federal law.42 However, some state laws may require the use of
information, do not press the issue. Rather, leave the door these VISs, and pharmacists need to identify and abide by the
open for further discussion. “Okay, we don’t have to talk about laws applicable in their own state.
this issue now. But I do want you to know that I care about
your health and if you ever want to come back and discuss The CDC creates the VISs and updates them as needed.
this further, my door is always open.”41 Current versions of VISs are available at www.cdc.gov/
vaccines/hcp/vis/index.html and should be obtained and
Vaccine recommendations from pharmacists and other health provided to each patient prior to vaccination. VISs in a
care providers are important determinants of patient behavior. variety of languages are available from the CDC at
However, while some individuals will be open to considering www.cdc.gov/vaccines/Pubs/vis/default.htm and from IAC
new information and can be swayed by a thoughtful review at www.immunize.org/vis. Be sure to provide the most
of the evidence, others have deeply entrenched antivaccine current VIS to patients.
beliefs and are unlikely to change their minds after a brief
conversation. Some antivaccine advocates are mistrustful of Immunization providers should not only provide the VIS to
health care providers, the CDC, and public health officials, patients prior to vaccine administration but they also should
and they are unlikely to approach new information with an actively invite patients to ask questions about the vaccine or
open mind.40 Continue to offer these individuals information, any information contained in the VIS. Open-ended questions,
and point them to reputable resources where they can review such as “What questions do you have?” are more likely to
the data themselves. elicit meaningful conversations than questions such as “Do you
have any questions?” Once a patient has made an informed

decision to be vaccinated, the provider may then administer Figure 4.1. Adolescent and Adult Intramuscular Injection
the vaccine. Technique
1. Organize supplies, wash hands, and wear gloves.
Counseling Patients After Vaccine Administration 2. Verify the correct vaccine and check expiration dates.
Following administration of a vaccine, the pharmacist should 3. Load dose into the syringe using aseptic technique.
provide postvaccination counseling to the patient. This should 4. Select a 5/8 –1½ inch, 22–25 gauge needle as appropriate for
include what the patient can expect following the vaccination the individual patient.
(e.g., symptoms of an injection site reaction). The pharmacist 5. Locate the thickest and central portion of the deltoid. Expose the
entire injection target area to permit unobstructed access to the
should provide a personal vaccination record of the vaccine
injection site.
administered and educate the patient about any additional
6. Wipe site with alcohol swab to clean oils and dirt from the
recommended doses of vaccines. At this time, the patient can
injection site and allow the alcohol to dry.
be scheduled for a follow-up visit to administer any additional 7. Insert the needle at a 90° angle in one smooth, controlled
doses required to complete a vaccine series and receive other motion.
vaccines they might need. Patients also should be educated 8. Depress the plunger at a slow to moderate rate.
to report any adverse events that may occur following 9. Remove the needle at the same angle (90°) that entered the skin.
vaccination. 10. Activate the safety device. Discard used needle and syringe into
a biohazard sharps container. Do not take your eyes off the
used needle until it is safely inside the sharps container. Never
recap the needle after it has been exposed to the patient.
Vaccine Administration 11. Apply slight pressure to the injection site with a cotton ball to
discourage bleeding. Apply adhesive bandage if needed or
This section will review intranasal, intramuscular (IM), subcuta-
desired.
neous (SC), and intradermal vaccine administration strategies.
12. Wash hands.
All vaccines must be administered in compliance with require- 13. Give patient appropriate education, document the vaccination
ments from the Occupational Safety and Health Administration (i.e., immunization record card), and provide information about
(OSHA). Note that OSHA requires specific training that is not future doses.
provided by this course. More information about OSHA will
IM site for older children
be presented in Module 5. and adults in the
deltoid muscle
Administration technique will be discussed in detail during the
live training seminar portion of the Pharmacy-Based Immunization Acromion
Delivery certificate training program, and pharmacists will be Level of armpit
Deltoid muscle
(shaded area)
required to demonstrate appropriate administration technique.
IM injection site
By reading this section and becoming familiar with the illustra-
tions shown in Figures 4.1 and 4.2, pharmacists will gain Elbow
an understanding of important general principles of vaccine IM = intramuscular.
administration in preparation for the seminar. Additionally, the IM Injection Site
Source: Reference 14.
IM Needle Position
American Pharmacists Association has videos available online
(www.pharmacist.com/vaccine-administration-techniques) that
demonstrate techniques for all routes of vaccine administration.
Sprayer Device Administration
Keep in mind that proper vaccine preparation is a crucial step
in maintaining the integrity of the vaccine during transfer from Intranasal Vaccine
the manufacturer’s vial or single-use syringe to the patient. Live attenuated influenza vaccine (FluMist) is the only vaccine
Some vaccines are suspensions, while some are solutions. currently marketed that requires intranasal administration.
Some need to be shaken vigorously, others need to be shaken This vaccine should be administered only by a health care
gently—and some don’t need any shaking, whether they are in professional and not self-administered by patients. The
a vial or a syringe. Table 4.5 summarizes preparation instruc- vaccine comes packaged with two sprays of vaccine in a
tions for selected vaccines.43 Always refer to product labeling single device with a dose-separating clip on the unit plunger.
for updates to the instructions. With the patient’s head tilted slightly backward, the pharmacist
should remove the rubber tip and insert the nasal apparatus

Figure 4.2. Adolescent and Adult Subcutaneous Injection nasal passageway where it will replicate and produce systemic
Technique immunologic protection. The pharmacist should give the patient
1. Organize supplies, wash hands, and consider wearing gloves a tissue in the event any nasal discharge or sneezing follows
(recommended). vaccination. Revaccination is not necessary if nasal discharge
2. Verify the correct vaccine and check expiration dates. or sneezing occur.
3. Load dose into the syringe using aseptic technique.
4. Select a 5/8 inch, 23–25 gauge needle.
5. Select the posterolateral aspect of the upper arm. Expose the General Injection Principles
entire injection target area to permit unobstructed access to the
Pharmacists should become familiar with the components of a
injection site.
needle (e.g., bevel, shaft, hub, gauge), the parts of a syringe
6. Wipe site with alcohol swab to clean oils and dirt from the
(e.g., tip, barrel, plunger), and safety needle activation before
injection site and allow the alcohol to dry.
7. Pinch skin and insert the needle at a 45° angle in one smooth,
administering injections. Several general principles of vaccine
controlled motion. injection are discussed here, and a step-by-step process for
8. Depress the plunger at a slow to moderate rate. administering injections is listed in Figure 4.1 for IM injections
9. Remove the needle at the same angle (45°) that entered the and Figure 4.2 for SC injections.14
skin.
10. Activate the safety device. Discard used needle and syringe Vaccine storage and dose preparation are important steps
into a biohazard sharps container. Do not take your eyes off in vaccine administration. Pharmacists must ensure that the
the used needle until it is safely inside the sharps container. vaccine was stored appropriately prior to dose preparation.
Never recap the needle after it has been exposed to the Vaccine-specific instructions for dose preparation must be
patient.
heeded. For example, some vaccines must be reconstituted
11. Apply slight pressure to the injection site with a cotton ball to
prior to administration whereas other vaccines are suspensions
discourage bleeding. Apply adhesive bandage if needed or
desired.
that must be shaken well prior to drawing up the dose. All
12. Wash hands. doses of vaccine should be prepared using aseptic technique to
13. Give patient appropriate education, document the vaccination ensure the dose of vaccine is not contaminated while drawing
(i.e., immunization record card), and provide information about up the dose. The appropriate technique for preparing vaccine
future doses. doses will be reviewed during the live seminar.
SC site for young children
and adults in the outer Universal precautions to prevent the spread of infectious
aspect of the upper arm diseases are the minimum infection prevention practices that
apply to all patient care, regardless of suspected or confirmed
Acromion infection status of the patient, in any setting where health
SC injection site area
care is delivered. These precautions include hand hygiene
and use of gloves in situations involving possible contact with
blood or body fluids. When using gloves, pharmacists should
Elbow
not wear the same pair of gloves for the care of more than
one patient, and should not wash gloves for the purpose of
SC Injection Site SC Needle Position reuse. Additionally, pharmacists should perform hand hygiene
SC = subcutaneous.
Source: Reference 14. immediately after removing gloves. Some patients may have
a latex allergy, therefore a supply of non-latex medical gloves
should always be available.44
just inside one nostril and push the plunger until it stops. The Key recommendations for safe injection practices in
dose-separating clip should be removed and the second spray ambulatory care settings include:
should then be administered in the opposite nostril in the same
1. Use aseptic technique when preparing and adminis-
manner. Both sprays must be administered to the patient to
tering medications.
ensure complete protection. The patient should be instructed
not to inhale or strongly “sniff” the vaccine back into the nasal 2. Cleanse the access diaphragms of medication vials
passage, which is the natural tendency for many patients using with 70% alcohol before inserting a device into the
nasal inhalers. The vaccine needs to remain in the cooler vial.

Table 4.5. Preparation Instructions for Selected Vaccines

Type of Vaccine Trade Name Preparation of Vaccine Prior to Administration
(Manufacturer)
Hepatitis A Havrix (GlaxoSmithKline) (1) Shake well before use. With thorough agitation, Havrix is a homogeneous, turbid,
white suspension. Do not administer if it appears otherwise. (2) Parenteral drug products
should be inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. If either of these conditions exists, the vaccine
should not be administered. (3) For the prefilled syringes, attach a sterile needle and
administer intramuscularly. (4) For the vials, use a sterile needle and sterile syringe to
withdraw the vaccine dose and administer intramuscularly. Changing needles between
drawing vaccine from a vial and injecting it into a recipient is not necessary unless the
needle has been damaged or contaminated. Use a separate sterile needle and syringe for
each individual.
Vaqta (Merck) (1) Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly
opaque, white suspension before withdrawal and use. Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to administration, whenever
solution and container permit. (2) Discard if the suspension does not appear homogenous
or if extraneous particulate matter remains or discoloration is observed. (3) For single-dose
vials, withdraw and administer entire dose of Vaqta intramuscularly using a sterile needle
and syringe.
Hepatitis A and Twinrix (GlaxoSmithKline) (1) Shake well before use. With thorough agitation, Twinrix is a slightly turbid white
hepatitis B suspension. Do not administer if it appears otherwise. Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to administration, whenever
solution and container permit. If either of these conditions exists, the vaccine should not
be administered. (2) For the prefilled syringes, attach a sterile needle and administer
intramuscularly. (3) For the vials, use a sterile needle and sterile syringe to withdraw the
1-mL dose and administer intramuscularly. Changing needles between drawing vaccine
from a vial and injecting it into a recipient is not necessary unless the needle has been
damaged or contaminated. Use a separate sterile needle and syringe for each individual.
Hepatitis B Recombivax HB (Merck) Shake well before use. Thorough agitation at the time of administration is necessary to
maintain suspension of the vaccine.
Engerix-B (GlaxoSmithKline) (1) Shake well before use. With thorough agitation, Engerix-B is a homogeneous, turbid
white suspension. Do not administer if it appears otherwise. Parenteral drug products
should be inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. If either of these conditions exists, the vaccine should
not be administered. (2) For the prefilled syringes, attach a sterile needle and administer
intramuscularly. (3) For the vials, use a sterile needle and sterile syringe to withdraw the
vaccine dose and administer intramuscularly. Changing needles between drawing vaccine
from a vial and injecting it into a recipient is not necessary unless the needle has been
damaged or contaminated. Use a separate sterile needle and syringe for each individual.
Human Gardasil (Merck) Shake well before use. Thorough agitation immediately before administration is necessary
papillomavirus, to maintain suspension of the vaccine. Gardasil should not be diluted or mixed with other
quadrivalent (types 6, vaccines. After thorough agitation, Gardasil is a white, cloudy liquid. Parenteral drug
11, 16, and 18) products should be inspected visually for particulate matter and discoloration prior to
administration. Do not use the product if particulates are present or if it appears discolored.

Table 4.5. Preparation Instructions for Selected Vaccines (continued)

(Manufacturer)
Human Cervarix (GlaxoSmithKline) Shake syringe well before withdrawal and use. Parenteral drug products should be
papillomavirus, inspected visually for particulate matter and discoloration prior to administration, whenever
bivalent (types 16 solution and container permit. If either of these conditions exists, the vaccine should not
and 18) be administered. With thorough agitation, Cervarix is a homogeneous, turbid, white
suspension. Do not administer if it appears otherwise.
Influenza inactivated, Afluria (CSL Limited) (1) Shake thoroughly and inspect visually before use. (2) When using a single-dose syringe,
trivalent shake the syringe thoroughly and administer the dose immediately. (3) When using the
multidose vial, shake the vial thoroughly before withdrawing each dose, and administer
the dose immediately. Draw up the exact dose using a separate sterile needle and syringe
for each individual patient. It is recommended that small syringes (0.5 or 1 mL) be used to
minimize any product loss.
FluLaval (GlaxoSmithKline) (1) Shake the multidose vial vigorously each time before withdrawing a dose of vaccine.
(2) Use a sterile needle and sterile syringe to withdraw the 0.5-mL dose from the multidose
vial and administer intramuscularly. A sterile syringe with a needle bore no larger than 23
gauge is recommended for administration. It is recommended that small syringes (0.5 or
1 mL) be used to minimize any product loss. Use a separate sterile needle and syringe for
each dose withdrawn from the multidose vial.
Fluarix (GlaxoSmithKline) Shake well before administration.
Fluvirin (Novartis) Shake the syringe vigorously before administering the vaccine and shake the multidose vial
preparation each time before withdrawing a dose of vaccine.
Agriflu (Novartis) Shake the contents of each syringe to aid inspection. Inspect Agriflu visually for the
presence of particulate matter or discoloration prior to administration, whenever suspension
and container permit. If either of these conditions exists, do not use the contents.
Fluzone, Fluzone High-Dose, (1) Fluzone: Before administering a dose of vaccine, shake the prefilled syringe or single-
and Fluzone Intradermal dose vial. Withdraw the vaccine using a sterile needle and syringe. (2) Fluzone High-Dose:
(Sanofi Pasteur) Before administering a dose of vaccine, shake the prefilled syringe. (3) Fluzone Intradermal:
Gently shake the microinjection system before administering the vaccine.
Flucelvax (Novartis) Shake the syringe vigorously before administering. Flucelvax should be inspected visually
for particulate matter and discoloration prior to administration, whenever solution and
container permit.
Influenza, trivalent, Flublok (Protein Sciences Shake the single-dose vial gently before withdrawing the vaccine dose.
recombinant Corporation)
Influenza live, FluMist Quadrivalent No indication.

intranasal, (MedImmune)
quadrivalent


(Manufacturer)
Influenza inactivated, Fluarix Quadrivalent Shake well before administration. Parenteral drug products should be inspected visually for
quadrivalent (GlaxoSmithKline) particulate matter and discoloration prior to administration, whenever solution and container
permit. If either of these conditions exists, the vaccine should not be administered.
Fluzone Quadrivalent (Sanofi Before administering a dose of vaccine, shake the prefilled syringe or single-dose vial.
Pasteur) Withdraw the vaccine using a sterile needle and syringe.
FluLaval Quadrivalent (1) Shake the multidose vial vigorously each time before withdrawing a dose of vaccine.
(GlaxoSmithKline) (2) Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit. If either of
these conditions exists, the vaccine should not be administered. (3) Use a sterile needle
and sterile syringe to withdraw the 0.5-mL dose from the multidose vial and administer
intramuscularly. A sterile syringe with a needle bore no larger than 23 gauge is
recommended for administration. It is recommended that small syringes (0.5 or 1 mL) be
used to minimize any product loss. Use a separate sterile needle and syringe for each dose
withdrawn from the multidose vial.
Meningococcal Menveo (Novartis) Menveo is supplied in two vials that must be combined prior to administration. Menveo
(groups A, C, Y, and must be prepared for administration by reconstituting the MenA lyophilized conjugate
W-135) conjugate vaccine component with the MenCYW-135 liquid conjugate vaccine component. Using
vaccine a graduated syringe, withdraw the entire contents of the vial of MenCYW-135 liquid
conjugate component and inject into the MenA lyophilized conjugate component vial.
Invert the vial and shake well until the vaccine is dissolved and then withdraw 0.5 mL of
reconstituted product.
Meningococcal MenHibrix (GlaxoSmithKline) MenHibrix is a solution for injection supplied as a single-dose vial of lyophilized vaccine
(groups C and Y) to be reconstituted with the accompanying vial of saline diluent. Shake well in the
and Haemophilus reconstitution process. A single dose after reconstitution is 0.5 mL.
influenza type b
conjugate vaccine
Meningococcal Menactra (Sanofi Pasteur) Menactra vaccine is a clear to slightly turbid solution. Parenteral drug products should be
(groups A, C, Y, and inspected visually for particulate matter and discoloration prior to administration, whenever
W-135) conjugate solution and container permit. If any of these conditions exist, the vaccine should not be
vaccine administered (no indication of shaking). Withdraw the 0.5 mL dose of vaccine from the
single-dose vial using a sterile needle and syringe.
Meningococcal Menomune-A/C/Y/W-135 After removing the “flip-off” caps, cleanse the vaccine and diluent vial stoppers with a
polysaccharide (Sanofi Pasteur) suitable germicide. Do not remove the vial stoppers or metal seals holding them in place.
vaccine (groups A, C, Using a suitable sterile needle and syringe and aseptic technique, withdraw the supplied
Y and W-135) diluent (0.6 mL for single-dose presentation and 6.0 mL for multidose presentation) and
inject into the vial containing the lyophilized vaccine. Swirl the vial until the vaccine is
thoroughly dissolved. When reconstituted, the vaccine should be a clear, colorless liquid.
Pneumococcal Pneumovax 23 (Merck) No indication.

polysaccharide
vaccine 23-valent
Pneumococcal Prevnar 13 (Pfizer) Since this product is a suspension containing an adjuvant, shake vigorously immediately
conjugate vaccine prior to use to obtain a homogenous, white suspension in the vaccine container. Do not
13-valent use the vaccine, if it cannot be resuspended. Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration. This product should
not be used if particulate matter or discoloration is found.


(Manufacturer)
Tetanus and diphtheria Adacel (Sanofi Pasteur) (1) Just before use, shake the vial or syringe well until a uniform, white, cloudy suspension
toxoids and acellular results. (2) Parenteral drug products should be inspected visually for particulate matter and
pertussis discoloration prior to administration, whenever solution and container permit. If either of
these conditions exists, the vaccine should not be administered. (3) When withdrawing a
dose from a stoppered vial, do not remove either the stopper or the metal seal holding it in
place. Use a separate sterile needle and syringe for each injection. Using a sterile needle
and syringe, withdraw the 0.5-mL dose of vaccine from the single-dose vial and administer
the vaccine to the individual. Changing needles between withdrawing the vaccine from the
vial and injecting it into a recipient is not necessary unless the needle has been damaged or
contaminated. (4) Adacel vaccine should not be combined through reconstitution or mixed
with any other vaccine.
Boostrix (GlaxoSmithKline) (1) Shake vigorously to obtain a homogeneous, turbid, white suspension before
administration. Do not use if resuspension does not occur with vigorous shaking.
(2) Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit. If either of
these conditions exists, the vaccine should not be administered. (3) For the prefilled syringes,
attach a sterile needle and administer intramuscularly. (4) For the vials, use a sterile needle
and sterile syringe to withdraw the 0.5-mL dose and administer intramuscularly. Changing
needles between drawing vaccine from a vial and injecting it into a recipient is not
necessary unless the needle has been damaged or contaminated. Use a separate sterile
needle and syringe for each individual. (5) Do not administer this product intravenously,
intradermally, or subcutaneously.
Zoster, live Zostavax (Merck) (1) Use only sterile syringes free of preservatives, antiseptics, and detergents for each
injection and/or reconstitution of Zostavax. Preservatives, antiseptics, and detergents
may inactivate the vaccine virus. (2) Zostavax is stored frozen and should be reconstituted
immediately upon removal from the freezer. (3) When reconstituted, Zostavax is a
semihazy to translucent, off-white to pale yellow liquid. (4) Reconstitution: (a) Use only
the diluent supplied. (b) Withdraw the entire contents of the diluent into a syringe. (c)
To avoid excessive foaming, slowly inject all of the diluent in the syringe into the vial of
lyophilized vaccine and gently agitate to mix thoroughly. (d) Withdraw the entire contents
of reconstituted vaccine into a syringe and inject the total volume subcutaneously. (e)
ADMINISTER IMMEDIATELY AFTER RECONSTITUTION to minimize loss of potency. Discard
reconstituted vaccine if not used within 30 minutes. Do not freeze reconstituted vaccine.
Source: Reference 43
3. Never administer medications from the same syringe to 6. Do not use fluid infusion or administration sets (e.g.,
multiple patients, even if the needle is changed or the intravenous tubing) for more than one patient.
injection is administered through an intervening length
7. Dedicate multidose vials to a single patient whenever
of intravenous tubing.
possible. If multidose vials will be used for more than
4. Do not reuse a syringe to enter a medication vial or one patient, they should be restricted to a centralized
solution. medication area and should not enter the immediate
5. Do not administer medications from single-dose patient treatment area (e.g., operating room, patient
or single-use vials, ampules, or bags or bottles of room/cubicle).
intravenous solution to more than one patient.

8. Dispose of used syringes and needles at the point of For children older than 3 years of age, adolescents,
use in a sharps container that is closable, puncture- and adults, the deltoid muscle of the upper arm is the
resistant, and leak-proof. recommended site for IM injections.13,14 Vaccines should be
administered while the patient is sitting or lying horizontally.
9. Adhere to federal and state requirements for protection The pharmacist should select the thickest part of the muscle
of health care personnel from exposure to bloodborne for an injection site. The deltoid muscle forms a fairly large
pathogens. triangle on the shoulder prominence, but the actual area
available for injection is limited to avoid major bones, blood
Before administering an injection of vaccine, it is not necessary vessels, and nerves. Immunizers must be certain to avoid
to aspirate (i.e., to pull back on the syringe plunger after the acromion, clavicle, and humerus as well as the brachial
needle insertion). veins and arteries and the radial nerve. Because the area
available for IM injections is relatively small, it cannot
When preparing to administer an injection, the pharmacist tolerate repeated injections or large volumes of medication.
must identify an appropriate site (e.g., the deltoid muscle for The gluteal muscles should never be used to administer
an IM injection) based on the vaccine being administered. vaccines due to risk of causing damage to the sciatic nerve.
When selecting the injection site, the pharmacist should avoid
scars, tattoos, moles, and other skin imperfections when In all cases, use a needle long enough to reach the muscle
possible because these imperfections tend to make for more mass so the vaccine does not seep into SC tissue.45
uncomfortable injections. Pharmacists should also avoid Inadvertent SC administration of IM vaccines may slightly
injecting too high on the deltoid. The entire area surrounding reduce antibody titers ultimately obtained and may be more
the injection site should be exposed to permit an unobstructed painful, but there is no need to repeat these doses. The one
site for the injection. If the patient is wearing clothing that exception is for hepatitis B vaccine. If hepatitis B vaccine is
hinders free access to the area, the patient should be asked administered by any route other than IM, the dose should be
to remove the obstructing article of clothing in a private area considered invalid and must be repeated.13
or change into a short-sleeved shirt. The injection site should
be cleansed with an alcohol swab and the pharmacist should Before vaccinating, pharmacists should make sure the deltoid
allow enough time for the alcohol to dry. The needle should muscle is relaxed. This will reduce post-injection soreness and
be inserted until the hub of the needle rests against the skin. muscle pain. The best way to facilitate this muscle relaxation
The plunger should be depressed at a slow to moderate is to have the patient’s arm hang loosely alongside the body.
rate. The needle should be withdrawn in one smooth Use a needle long enough to reach deep into the muscle.
motion at the same angle used for entry. The safety device Fixed 1-inch needles are acceptable for patients weighing 60
should be activated and the used needle and syringe should kg (132 lb) or less.13 For men and women weighing more than
be immediately discarded into a rigid biohazard sharps 60 kg, it is appropriate to consider using a 1-inch to 1½-inch
container. It is vital for the pharmacist to be familiar with needle to ensure the needle will reach the patient’s muscle.46
the safety device being used and understand the necessary Insert the needle at a 90° angle to the skin with a quick thrust.
steps to safely activate the device following injection. The After inserting the needle, the plunger should be depressed
pharmacist should never recap a contaminated needle after at a slow to moderate rate to allow the muscle to distend and
the needle has been removed from the patient. Pressure accommodate the fluid; otherwise, irritation and discomfort
should be applied to the injection site with a cotton ball and may occur.
an adhesive bandage should be applied. If several injections
are to be given, opposite arms should be used or the injection Subcutaneous Vaccines
sites should be separated by 1 inch or more.13 Vaccines given SC include MMR, meningococcal poly-
saccharide, varicella, and zoster. The pneumococcal poly-
Adult Intramuscular Vaccines saccharide vaccine and inactivated poliovirus vaccine can
Vaccines for adults that are administered by the IM route be given SC but are usually administered by the IM route.
include tetanus and diphtheria (Td), Tdap, inactivated Doses injected SC are absorbed more slowly than IM doses.
influenza, pneumococcal polysaccharide, meningo-
coccal conjugate, hepatitis A, hepatitis B, inactivated SC injections should be administered in the tissue below the
poliovirus, human papillomavirus, H. influenzae type b, and dermal layer of the skin. The recommended sites for injection
combination vaccines that contain these antigens. are either the outer aspect of the upper arm or the fatty area

of the anterolateral thigh. The immunizing pharmacist should For patients with severe phobias, pharmacists can consult
pinch up the SC tissue to help prevent inadvertent IM adminis- with the patient’s primary care provider to discuss potential
tration. The needle should be inserted at a 45° angle into SC interventions, such as topical anesthetic creams or rapid-acting
tissue for injection. For any age group, a ⅝-inch to ¾-inch benzodiazepines. Motivated patients also may be willing
needle of 23 to 25 gauge should be used for SC injections. to attempt desensitization therapy or cognitive behavioral
therapy with a psychologist.48
Intradermal Vaccines
One intradermal inactivated influenza vaccine is available For children receiving vaccines, the CDC provides recommen-
(Fluzone Intradermal—Sanofi Pasteur). The intradermal flu dations for how the parent should position or hold the child
vaccine uses a much smaller needle than the IM vaccine and (www.cdc.gov/vaccines/parents/tools/holds-factsheet.html).
is injected into the skin instead of the muscle. To administer These techniques allow the parent or caregiver to comfortably
the vaccine, pharmacists should first gently shake the micro- embrace the child, rather than having to overpower and
injection system. Hold the system by placing the thumb and restrain the child. (These techniques are not discussed during
middle finger on the finger pads; the index finger should the live seminar. Pharmacists who plan to administer vaccines
remain free. Next, insert the needle perpendicular to the skin, to children should receive additional training.)
in the region of the deltoid, in a short, quick movement. Once
the needle has been inserted, maintain light pressure on the
surface of the skin and inject using the index finger to push on
the plunger. Finally, remove the needle from the skin. With Managing Adverse Events
the needle directed away from oneself and others, push very Every patient should be monitored following vaccination for
firmly with the thumb on the plunger to activate the needle adverse events, particularly syncope and anaphylaxis.
shield.47
Common Adverse Events

Supporting Patients Who Have a Fear of Needles Most reactions to vaccines are mild, temporary, and can
While many people do not like needles, needle phobia (also be managed at home. These reactions include low fever
called belonephobia) can result in substantial distress and be and swelling or redness. Localized pain or a low fever can
a barrier to receipt of vaccinations for some patients. These be managed with over-the-counter pain relievers such as
patients also are much more likely to have phobias related to acetaminophen or ibuprofen. Evidence does not support
the sight of blood. Needle phobia can result in symptoms of the use of antipyretics before or at the time of vaccination;
anxiety, including rapid heart rate, increased blood pressure, however, they can be used for the treatment of fever and
tremor, feeling faint or actually fainting, nausea, diaphoresis, local discomfort that might occur following vaccination.13 If
and feelings of panic or a panic attack.48 Feelings of being the area around the vaccination site becomes red or swollen,
trapped or in danger can aggravate these responses. patients should be instructed to apply a wrapped ice pack or
cool compress to the area for approximately 10 to 20 minutes.
Vaccines that do not require injections can be used in some
cases, but are not available for many vaccine-preventable Young children may experience drowsiness, fretfulness,
diseases. Several interventions may be attempted to help or poor appetite following vaccination with some children
support vaccine acceptance for patients with needle phobias. refusing to eat for a few hours after a vaccine is administered.
Conveying respect and empathy for the patient’s feelings is Parents should be advised to plan quiet activities and comfort
crucial. Discussing the procedure in detail with the patient their child as needed. Children’s formulations of acetamin-
can help to allay fears and mentally prepare the patient for ophen or ibuprofen can be used to relieve local discomfort,
the injection. Relaxation techniques, distraction, or other however aspirin should not be used by people younger than
cognitive interventions may be helpful for those with less 20 years of age because of the risk of Reye’s syndrome. A
severe phobias. Providing the patient with some control over rash may appear with certain vaccines. A mild skin rash may
the environment, such as selecting a seat or holding the hand arise 7 to 14 days after a child receives the chickenpox or
of a support person, can help with vaccine acceptance.48 MMR vaccine. These types of rashes can last several days
and go away without treatment.

Emergency Responses space in the immunization area should be arranged to allow

ACIP recommends that vaccine providers strongly consider for fainting without injury and set up for access to a hard
observing patients for at least 15 minutes following a surface in the event CPR is needed.
vaccination.13 While postvaccination waiting is not mandated
by any agency, it is a prudent course of action, particularly Anaphylaxis
for first-time vaccine recipients. At a minimum, immunizing Although anaphylaxis caused by immunizations is rare, it can
pharmacists should follow the standards of their local or state be fatal if not managed properly. Symptoms of anaphylaxis
health departments regarding postvaccination waiting times. include generalized itching, redness, or hives; swelling of the
lips, face, or throat; shortness of breath or wheezing; abdominal
No one should administer immunizations without an emergency cramping; or cardiovascular collapse.51 Requests for water,
plan and training. A basic immunization emergency plan for indicating thirst, and potential difficulty breathing shortly after
pharmacies can rely on three core elements: the community’s vaccination are sometimes the first hint from the patient that
emergency medical system (EMS), often accessed by dialing anaphylaxis might be under way. If the patient reports any of
911; epinephrine; and cardiopulmonary resuscitation/basic the above symptoms, have the patient sit down and monitor him
cardiac life support (CPR/BCLS) training. or her closely. Do not give the patient any substance by mouth
(e.g., water) because this can compromise the patient’s airway.
All immunizing pharmacists must have a written emergency If a patient reports any symptoms of anaphylaxis, immediately
plan in place. It is vital to identify the roles for pharmacy enact the emergency protocol and call 911.
support staff to allow the immunizing pharmacist to focus
attention on the needs of the patient.49 An example of an Epinephrine is the first-line treatment of choice for acute
emergency medical protocol is available at www.immunize. anaphylaxis.13,51 Immunizations should never be administered
org/catg.d/p3082.pdf. Pharmacists should know the location if epinephrine is not available. Multiple doses of epinephrine
of the nearest emergency department and approximately how should be available in case the patient requires more than
long it takes for an emergency crew to reach the pharmacy. 1 dose. Preferably, epinephrine is dosed on the basis of the
Pharmacists also should consider what route an ambulance patient’s body weight. Aqueous epinephrine 1:1000 dilution
crew would take to wheel a stretcher to and from the should be administered at a dose of 0.01 mg per kg body
vaccination setting, and what obstacles would be encountered weight per dose, up to a maximum of 0.5 mg per dose.13
(e.g., doorways, steps, counters, other barriers). Since anaphylaxis occurs so quickly, some providers prefer
to use a preloaded syringe (e.g., EpiPen, EpiPen Jr., Auvi-Q)
Vasovagal Syncope to be able to administer epinephrine quickly. However,
Vasovagal syncope, also known as fainting, is a loss of the preloaded syringes contain fixed doses of epinephrine,
consciousness due to the withdrawal of sympathetic nervous which may be too much or too little for an individual patient.
system tone. Over 60% of fainting episodes occur within Although these devices may be appealing to people who
5 minutes following vaccination and over 80% occur within have not yet given many injections, epinephrine ampules
15 minutes.50 Symptoms of syncope can include paleness, may represent a more flexible alternative because they allow
sweating, light-headedness, dizziness, weakness, nausea, the pharmacist to provide an accurate dose of epinephrine.
and visual disturbances.50 If the patient is seated and feels However, the ampules have limitations because they require
light-headed, have the patient lean forward placing the head calculating a weight-based dose, drawing up the dose using
between the knees. Do not give the patient anything to drink. a filter needle, and switching to another needle prior to
If the patient loses consciousness, place the patient flat on his administration. Regardless of the epinephrine product chosen,
or her back and elevate the patient’s feet. If the patient does the pharmacist must know how to properly calculate a dose,
not regain consciousness quickly, call 911. prepare the dose, and administer it. Epinephrine products
must be protected from exposure to light and expiration dates
Notably, 12% of postvaccination syncope episodes reported must be checked regularly. Just like vaccines, epinephrine
to VAERS were further complicated by head injuries, often should never be stored past its expiration date.
because patients were injured by falling.50 To prevent falls,
the patient should be seated (preferably in a chair with arms) The dose of epinephrine can be repeated every 5 minutes
for the vaccination and the pharmacist should sit alongside according to the patient’s response.13,51 β-Adrenergic
the patient while giving the injection. This practice will make blockers may antagonize epinephrine, which could necessitate
it easier to catch a fainting patient. Furthermore, the physical larger doses or more frequent dosing of epinephrine. Failing

to give epinephrine promptly is more dangerous than using it Table 4.6. Cardiopulmonary Resuscitation Resources for
Pharmacists
improperly. Too much epinephrine can lead to palpitations,
tachycardia, flushing, or headache. These reactions Organizations Providing CPR or BCLS Certification
are unpleasant but pose less danger to the patient than • American Heart Association — www.heart.org — 800-242-8721
anaphylactic shock. • American Red Cross — www.redcross.org — 202-303-4498
In an emergency situation, it is advisable to document a Recommended Emergency Supplies for Pharmacies

chronological report of the events that occurred, including • E pinephrine — either multidose vial, single-use ampules, or
the time, dose, and site of medications administered during prefilled syringes (e.g., EpiPen). A dosing chart should be
the incident and the patient’s vital signs (e.g., blood pressure, prominently posted in the immunization area. Ensure that all
pulse). This information is vital to share with the EMS crew epinephrine is in date and an adequate supply is available.
when they arrive to care for the patient. It is also important for • CPR Pocket Mask — available from most local fire departments
reporting adverse event data, which is described in the next and local chapters of the American Red Cross.
section of this module. Any patient experiencing anaphylaxis Note: The American Pharmacists Association highly recommends that all
should be referred for follow-up care. Observation for several immunizing pharmacists maintain current CPR or BCLS certification. A successful
hours in an acute care setting may be appropriate. Biphasic Certificate of Achievement from this program is not considered valid unless the
and protracted anaphylaxis can present any time from pharmacist can present valid CPR certification.
5 hours to more than 24 hours later, even with adequate BCLS = basic cardiac life support; CPR = cardiopulmonary resuscitation.
initial management.
Emergency protocol templates may include the option of using All immunization providers have a professional responsibility
diphenhydramine for the treatment of patient symptoms. If to report any serious, rare, or unexpected adverse events
diphenhydramine is included in the emergency protocol, the to VAERS. This reporting system was created to help better
protocol should clearly specify how and when it would be understand the frequency and nature of vaccine adverse
used to treat a patient. effects. Reporting serious events to VAERS is required for the
VICP program, which will be discussed further in Module 5.
All pharmacists involved in providing immunizations should
contact the local fire department, local chapter of the Reports are required for the following events: anaphylaxis,
American Red Cross, or local chapter of the American Heart brachial neuritis, encephalopathy, encephalitis, chronic
Association for CPR/BCLS training courses being held in arthritis, thrombocytopenic purpura, vaccine-strain measles
their community. Table 4.6 provides contact information for infection in an immunodeficient recipient, or paralytic polio-
these national organizations. Pharmacists should be CPR myelitis.13,14 In addition to these events, any other significant
certified prior to giving vaccines. In addition, the Certificate of adverse events should be reported to VAERS. Pharmacists
Achievement from this program is not considered valid unless should report adverse events even if they are unsure whether a
the pharmacist’s CPR certification is up to date. vaccine caused them. Anyone can report an adverse event to
VAERS, including patients.
Safety Monitoring and Adverse Event Reporting When providing postvaccination counseling, the patient
for Vaccines should be encouraged to report any adverse events to the
pharmacist for it to be reported to VAERS and recorded in the
Vaccine Adverse Event Reporting System patient’s vaccination record. When filling out VAERS forms,
VAERS is a national vaccine postmarketing safety surveil- provide as much information as possible. However, do not
lance program of the CDC and the FDA (www.vaers.hhs. spend an unnecessary amount of time trying to collect specific
gov/index). Detection of serious, rare, or unexpected events pieces of information required on the form if that information
is among the primary objectives of VAERS. This monitoring is not readily available. Submitting a partially completed
system collects information about adverse events that occur form is better than not submitting the form at all. For forms or
after the administration of vaccines in the United States to additional information, go to www.vaers.hhs.gov/index. The
identify potential vaccine safety concerns. CDC and FDA form can be completed and submitted most easily online.
officials review VAERS reports weekly.

National Vaccine Error Reporting Program (VERP) Pharmacists can consult the local health department to
The Institute for Safe Medication Practices (ISMP) has inquire about current availability. In addition, the IAC has
developed a National Vaccine Error Reporting Program immunization cards available for purchase on its website
(VERP; www.verp.ismp.org) to collect data on errors that (www.immunize.org).
occur with the handling of vaccine products and their
administration in an effort to facilitate process changes and Another vaccination record option is the International
to provide education. Items that ISMP VERP seeks in the Certificate of Vaccination, which is sometimes referred to as
reporting include: the “yellow shot record” or form CDC 731 (formerly form
PHS-731). This multipage record is approved by the World
• Description of what went wrong, any causes or
Health Organization for international travel. Copies can be
contributing factors, how the event was discovered or
ordered from the U.S. Government Printing Office online at
intercepted, and the outcome of the patient(s) involved.
bookstore.gpo.gov using stock numbers 017-001-00567-3 for
• Recommendations for error prevention. 25 copies or 017-001-00566-5 for 100 copies.
• Any associated materials (e.g., product photographs,
containers, labels, de-identified prescription order scans)
that help support the information being submitted.
Using Automated Recordkeeping
Software for an automated system to help simplify
ISMP is a federally certified patient safety organization, immunization recordkeeping is available from the CDC. The
providing legal protection and guaranteeing confidentiality Comprehensive Clinical Assessment Software Application
of submitted patient safety data and error reports (www. (CoCASA) is a stand-alone software tool that interfaces with
ismp.org/docs/PSOguidelines.pdf). The report information most desktop systems. CoCASA offers a wide variety of
is forwarded, in confidence, to VAERS. When applicable, useful features for clinicians in any practice setting and is
the report information will be forwarded to product vendors available for free download from the CDC at www.cdc.gov/
to inform them about vaccine labeling, packaging, and VACCINES/programs/cocasa/index.html.
nomenclature issues that may foster errors by their design.
An alternative to a stand-alone immunization software
package is the use of the pharmacy prescription database
for storing vaccine information. If immunization records are
Keeping Immunization Records stored in prescription profiling software, these records must
Careful recordkeeping is an essential component of any be permanent and readily retrievable. They should never be
immunization program. Appropriate documentation will help deleted or purged from an active profiling system. If electronic
ensure that patients receive the proper immunizations because records are purged, pharmacists should be sure to keep a
it informs clinicians about the vaccines that the patient has permanent hard copy in a readily accessible location.
already received. Immunizations should become part of the
patient’s permanent record and should be kept for the patient’s
lifetime. These records are confidential patient records and
must be stored appropriately to protect patient privacy. Sharing Records With Patients and Other Health
Care Providers
The VICP requires vaccine providers to record specific
information in the patient’s immunization record. Pharmacists It is vital to give the patients, parents, or guardians a personal
should refer to Module 5 for a discussion of required copy of the vaccination record and educate them about the
information to document in a patient’s immunization record. importance of keeping their record up to date. Encourage
patients to take these records to every health visit and show
Vaccination record blanks are available from a variety of them to their health care providers. Records are more likely to
sources. Some states have their own versions of a personal be complete if all vaccinations are recorded on a single card
immunization record card, which can be obtained through or in one booklet. Patients should be educated to maintain
the state immunization coordinator. There are vendors that their immunization records and keep them accessible at all
provide record books and cards that can be purchased times. A simple strategy that patients can use is to keep their
by health care providers and made available to patients. immunization record with their current medication list.

Some states have an immunization information system (IIS) Conclusion

sponsored by the public health department. Although these Identifying patients in need of immunization and determining
electronic immunization recordkeeping systems were originally which vaccines they should receive are crucial activities for
developed for tracking children’s immunizations, IISs may be pharmacists. Furthermore, pharmacists must be able to apply
expanded to include adolescents and adults in some states. immunization schedules to real-world patients, and assess
Pharmacists should contact their local health department for contraindications and precautions to make appropriate
information on accessing and contributing to their state’s IIS. vaccination recommendations.
A list of contacts for each state’s IIS is available at www.cdc.
gov/vaccines/programs/iis/contacts-registry-staff.html. Explaining the risks and benefits of the vaccine to the patient
is important and pharmacists should provide education to
Even in states without an IIS for reporting purposes, reports of counter any misperceptions the patient has about vaccines.
immunizations need to be shared with the patient’s primary Finally, appropriate administration technique, emergency
care provider. During every immunization encounter, ask response plans, recordkeeping, and follow up are necessary
patients if they have a physician to whom their immunization for providing appropriate patient care.
record should be sent. Providing documentation in a timely
manner is important to ensure continuity of care. Ideally
this can be done through electronic health records. If this References
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up” Immunization Schedules—United States, 2013. Available at:
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return appointments for administration of multidose vaccines immunizations: requirements and laws. Available at: http://www.
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while patients are still in the pharmacy and give them a 20, 2013.
written reminder of the follow-up date. Pharmacists can send
7. Centers for Medicare and Medicaid Services. Immunization standard
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2014 APhA Pharmacy-Based

A National Certificate Training Program

13-561 © 2014, American Pharmacists Association. All rights reserved.

Module 4. Patient Care Considerations for Immunizing Pharmacists 2

Diabetes Insulin, oral hypoglycemics

Source: References 2–4.

Module 4. Patient Care Considerations for Immunizing Pharmacists 3

clinic appointment) when the patient presents to the pharmacy

Module 4. Patient Care Considerations for Immunizing Pharmacists 4

Module 4. Patient Care Considerations for Immunizing Pharmacists 5

Module 4. Patient Care Considerations for Immunizing Pharmacists 6

Table 4.2. Contraindications and Precautions by Vaccine

Persistent, inconsolable crying lasting ≥3 hours within 48 hours

Seizure within 3 days following previous dose.

Guillain-Barré syndrome <6 weeks following previous dose of

History of Arthus-type hypersensitivity reactions after a previous dose

Moderate or severe acute illness with or without fever.

Moderate or severe acute illness with or without fever.

Immunosuppression due to leukemia,

Untreated active tuberculosis.

(continued on next page)

Module 4. Patient Care Considerations for Immunizing Pharmacists 7

Table 4.2. Contraindications and Precautions by Vaccine (continued)

Patients ≥50 years of age.

Patients with asthma.

Patients with chronic medical conditions.

Children or adolescents receiving long-term

(continued on next page)

Module 4. Patient Care Considerations for Immunizing Pharmacists 8

Table 4.2. Contraindications and Precautions by Vaccine (continued)

Severe combined immunodeficiency. Previous history of intussusception.

Spina bifida or bladder exstrophy.

History of Arthus-type hypersensitivity reaction following previous

a In general, vaccines should not be administered if a contraindication is present.

Module 4. Patient Care Considerations for Immunizing Pharmacists 9

Module 4. Patient Care Considerations for Immunizing Pharmacists 10

Module 4. Patient Care Considerations for Immunizing Pharmacists 11

In addition to recommending vaccines, pharmacists can

Module 4. Patient Care Considerations for Immunizing Pharmacists 12

Table 4.4. Selected Sources for Reliable Vaccine Information

Centers for Disease Control and Prevention www.cdc.gov/vaccinesafety/

Immunization Action Coalition www.immunize.org

Institute of Medicine www.iom.edu

Vaccine Education Center at the Children’s Hospital of Philadelphia www.chop.edu/service/vaccine-education-center/

World Health Organization www.who.int/vaccine_safety/en/

Vaccinations also provide protection to those around the

Module 4. Patient Care Considerations for Immunizing Pharmacists 14

For example, in the autumn of 2005, meningococcal polysac-

Module 4. Patient Care Considerations for Immunizing Pharmacists 15

Module 4. Patient Care Considerations for Immunizing Pharmacists 16

Module 4. Patient Care Considerations for Immunizing Pharmacists 17

Module 4. Patient Care Considerations for Immunizing Pharmacists 18

Table 4.5. Preparation Instructions for Selected Vaccines

(continued on next page)

Module 4. Patient Care Considerations for Immunizing Pharmacists 19

Table 4.5. Preparation Instructions for Selected Vaccines (continued)

Fluarix (GlaxoSmithKline) Shake well before administration.

Influenza live, FluMist Quadrivalent No indication.

(continued on next page)

Module 4. Patient Care Considerations for Immunizing Pharmacists 20

Table 4.5. Preparation Instructions for Selected Vaccines (continued)

Pneumococcal Pneumovax 23 (Merck) No indication.

(continued on next page)