APhA Pharmacy-Based

IMMUNIZATION DELIVERY

A National Certificate Training Program

Module 5. Operating a Pharmacy-Based
Immunization Program

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

 2014 APhA Pharmacy-Based
IMMUNIZATION DELIVERY

Introduction
Learning Objectives Beyond learning the clinical aspects of providing vaccinations,
pharmacists must consider the administrative and operational
At the completion of this activity, participants will be able to: issues of starting, expanding, or joining an immunization
program. This module reviews issues for pharmacists to take
1. Describe important considerations when deciding into account for the operation of an immunization service.
which vaccines to offer.

2. Describe physical space requirements for a vaccine

service. Deciding Which Vaccines to Offer
Determining which vaccines to offer is an important
3. Discuss Occupational Safety and Health
consideration when planning an immunization service.
Administration regulations for the prevention of
Pharmacists should consider state laws and regulations as
employee exposure to bloodborne pathogens and
well as the immunization needs of their patient populations
needlestick injury at worksites where immunizations
and resources required to offer a service.
are administered.

4. Outline principles and procedures for vaccine storage Many pharmacists have initially implemented immunization
and handling. services with influenza vaccine, due in part to the general
high demand for the vaccine, as well as state laws that have
5. Discuss workflow options for administering vaccines supported this approach. Offering seasonal vaccinations for
in pharmacy practice. influenza helps ensure initial demand for the program and a
return on investment. On the other hand, some pharmacists
6. Identify marketing strategies that can be used to begin their immunization services with other vaccines against
promote a pharmacy-based immunization service. diseases that allow a more consistent patient volume and
provide a return on investment year-round. Once pharmacists
7. Explain potential options for obtaining reimbursement become comfortable offering a few vaccines, they may
and compensation for vaccines and vaccine gradually expand to provide a wider range of vaccines.
administration.

8. Describe liability issues related to vaccine

administration, including the Vaccine Injury
Consider State Laws and Regulations
A crucial step for deciding which vaccines to offer is for the
Compensation Program.
pharmacist to determine what is allowed by state laws and
regulations where they practice. As discussed in Module 1, the
vaccines that pharmacists are permitted to administer vary from
state to state. As of October 2013, pharmacists in 45 states are
permitted under law to administer any vaccine. Some states
allow pharmacists to administer vaccines under protocol while
others require a prescription to administer a vaccine.

Notice to Participants In a few states, legislative statutes give pharmacists direct

This module provides an overview of some laws and authority to administer vaccines. In these states, physicians
regulations associated with immunization delivery. Legal do not need to delegate the administration of vaccines to
and regulatory issues are complex and vary from state pharmacists because the pharmacists can administer the
to state. This brief review does not constitute legal vaccine under the authority of their own licenses. However,
advice. Pharmacists have a professional responsibility in most states, a physician must authorize the pharmacist to
to investigate the laws and regulations governing administer vaccines, either through a prescription, protocol,
immunization practice in their state prior to establishing or standing order. In many states, some vaccines (e.g.,
or participating in a pharmacy-based immunization influenza) are allowed by protocol but other vaccines require
program. a prescription. Many states also have minimum patient age
requirements for vaccine administration by pharmacists.

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Notably, some states may have additional requirements for The care delivery setting can have an important effect on
immunizing pharmacists, including completing specialized the selection of services offered. For example, consultant
training prior to administering vaccines (such as this certificate pharmacists who review the care of patients in long-term care
training program), completing cardiopulmonary resuscitation facilities may want to focus on vaccines that can be adminis-
(CPR) training, obtaining approval by the state board of tered to older adults, such as influenza, pneumococcal, herpes
pharmacy, and acquiring continuing pharmacy education to zoster, hepatitis B, and Td/Tdap. Pharmacists who participate
maintain the ability to administer vaccines. in integrated care settings (e.g., medical homes) may choose
to offer a fuller range of vaccination services.
State pharmacy associations are good resources for state-
specific information. A listing of associations is available at One key document pharmacists should review in determining
www.naspa.us/statepharmacy.html. their role with immunizations is the National Vaccine Advisory
Committee (NVAC) Adult Immunization Standards that
describe immunization expectations and roles for health care
Consider Community Needs providers serving the adult population (www.hhs.gov/nvpo/
Gathering information about local immunization needs will nvac/reports/nvacstandards.pdf).
help pharmacists to determine the types of services they
should offer; whenever possible, their programs should
address any unmet needs. Questions to consider when
assessing community needs include:
Administrative and Logistical
• What vaccinations do current patients and community
Considerations
Every pharmacy-based immunization program should develop
members need?
policies and procedures that clearly define operational and
• What health conditions that indicate a need for clinical requirements for how the program will be conducted,
immunization are common among patients in the including any standing orders or protocols that would be
community (e.g., patients with diabetes who may need used in the program. Consideration must also be given to
influenza, pneumococcal, and hepatitis B vaccines)? managing the workflow, physical space requirements for
administering vaccines, Occupational Safety and Health
• What age groups in the community would benefit from
Administration (OSHA) requirements, documentation and
an immunization service (e.g., teenagers who may need
communication, vaccine storage and handling, and inventory
tetanus and diphtheria toxoids and acellular pertussis
management. Pharmacists working for an organization will
[Tdap], influenza, meningococcal, and human papillo-
need to check with management to determine what policies
mavirus [HPV] vaccines)?
and procedures are already in place that govern immunization
• How can a pharmacy-based immunization program practices within the organization.
help meet the needs of this community?
• Do other vaccine providers in the community have
barriers to providing certain vaccines? Standing Orders/Protocols
As noted previously, many pharmacists will need to have a
Contacting the local health department or immunization physician sign a standing order or protocol for the pharmacy-
coalition and speaking with the immunization coordinator is a based vaccination services. Prior to developing a standing
useful way to help determine unmet needs in the community. order or protocol, pharmacists should confirm their state
Pharmacists also should seek to collaborate with other requirements and note any specific rules. For example, some
providers whenever possible. Many primary care providers states require the standing order or protocol to be placed on
encounter logistical and administrative barriers to offering file with the board of pharmacy and many states require that
certain vaccines and would welcome a pharmacy-based these documents be renewed at a regular interval of every 1
immunization service. For example, many vaccines for older to 2 years. In addition, some states may require the physician
adults are reimbursed through Medicare Part D rather than signing the protocol be located or licensed in the state.
Part B. Because pharmacists have the infrastructure to bill
Medicare Part D plans, it may be easier for them to offer these Standing orders are documents that are preapproved and
services and pharmacists could partner with other providers to signed by a collaborating physician who authorizes the
increase immunization rates. pharmacist to administer a vaccine.1 Standing orders are

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usually for one specific vaccine but are not limited to a private patient care area can use that area. If a pharmacy
particular patient. For example, a physician may authorize does not have a patient care area, a screen or moveable
a standing order for the administration of influenza vaccine, office partition can usually provide enough privacy for
which would outline criteria defining patient eligibility to vaccine administration. Pharmacists also should consider
receive the vaccine. A protocol is similar to a standing how they will handle patients who need to remove clothing
order but is usually broader, authorizing the administration (e.g., sweaters, long-sleeved shirts) for accessing the vaccine
of multiple vaccines. A protocol also must be signed by administration site. In general, a private location should be
a collaborating physician. Standing orders and protocols used when administering vaccines to children (who may cry
may limit authorization for pharmacists to vaccinate only the after receiving an injection).
collaborating physician’s patients or may be expanded to
include any patient who visits the pharmacy. Pharmacists must In addition to privacy, the pharmacist should bear in
be aware of specific provisions authorized by their standing mind patient and provider safety when deciding where to
order or protocol and ensure that the document meets any administer vaccines. There should be enough room for the
requirements as defined by their state laws and regulations. pharmacist to move comfortably and properly position the
These documents are similar to those used with physician patient for vaccination. Furthermore, the sharps container
assistants and nurse practitioners. should be placed where the risk of needlesticks is minimized;
the pharmacist should not need to cross his or her body to
Management of adverse reactions should be clearly deposit the syringe in the sharps container after the injection.
addressed in the protocol for the immunization program. The location for vaccine administration should have space for
Because the administration of epinephrine and related the patient to faint without being injured, and a flat surface
interventions usually require an order from an authorized for the patient to lie on if fainting occurs or if the pharmacist
prescriber, pharmacists should ensure their vaccine standing needs to perform CPR.
orders or protocols contain a provision for appropriate
emergency procedures. As with vaccine administration Vaccine administration supplies should be stored and readily
protocols, the template for medical management of vaccine accessible in the immunization area. Table 5.1 contains a list
reactions should be customized as needed.
Table 5.1 Supplies Needed for Vaccine Administration
The Immunization Action Coalition (IAC) has developed
• Vaccine for administration
templates for standing orders for administering various
• Syringes and needles of appropriate gauge and length for
vaccines (www.immunize.org/standing-orders/). Additionally,
administration
a sample standing order for administering seasonal influenza
• Absorbent pads
vaccine to adults is available at www.immunize.org/catg.d/
• Adhesive bandages
p3074.pdf. A template protocol for managing adverse
• Cotton balls or gauze pads
reactions to a vaccine can be found at www.immunize.org/
• Alcohol swabs
catg.d/p3082.pdf. Templates should always be customized
• Disposable gloves
according to local conditions, legal requirements, and the – A supply of non-latex gloves should be available for pharmacists
relationship established between the pharmacist and the and patients with latex allergies
physician authorizing the standing order. • Hand sanitizer (if hand-washing facilities are unavailable)
• Sharps disposal container
• Biohazard disposal bag
The Immunization Area • Current Vaccine Information Statements (VIS)
Vaccinating patients requires little more than a sturdy chair • Screening questionnaires
with side arms and an area that can accommodate the • Vaccination records to document administered vaccines
provider, the patient, and immunization supplies. Pharmacies • Exposure control plan
that offer immunizations typically are able to use patient • Emergency kit (e.g., emergency protocol, multiple doses of
consultation areas or waiting rooms to administer injections. epinephrine, epinephrine dosing chart, blood pressure cuff,
stethoscope, face shields or barriers for cardiopulmonary
resuscitation)
To a reasonable extent and according to applicable
• Refrigerator/freezer (or cooling packs to maintain the cold chain if
regulations, privacy should be provided for patients receiving vaccine will be transported)
vaccinations. Pharmacies with a preexisting semiprivate or
Source: Adapted from Reference 2.

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of vaccine administration supplies.2 The immunization area

should include a clean area for dose preparation as well as OSHA Checklist for Pharmacists Establishing an
access to a sink for hand washing. Waste receptacles and Immunization Program
sharps disposal containers should be positioned for easy • Read the OSHA standards applicable to immunizing
accessibility for the immunizing pharmacist. Ensure that pharmacists.
supplies are secured when the administration area is not in
• Develop an exposure control plan.
use.
• Provide OSHA training for all employees with
An emergency kit should be stored in the immunization area potential exposure to bloodborne pathogens.
and must be available at all times when vaccinations are
‒ 
Create and maintain documentation regarding the
provided in the pharmacy. The emergency kit should contain
completion of training.
a copy of the protocol for managing adverse events, multiple
doses of epinephrine and associated supplies (e.g., syringes, • Educate employees about using universal precautions
needles), a blood pressure cuff, a stethoscope, a CPR mask, to minimize exposure risk.
and any other items necessary to manage an adverse event.
• Review and select safety devices on the basis of
employee feedback.
Occupational Safety and Health Administration • Provide personal protective equipment (e.g., gloves)
OSHA requires specific training that is not provided by this to all employees.
course. The purpose of this section is to highlight the main
• Utilize engineering and work practice controls
components of the OSHA standards applicable to immunizing
(e.g., sharps disposal containers, procedure for
pharmacists, specifically the OSHA Bloodborne Pathogens
proper disposal of needles in the sharps container)
Standard (29 CFR 1910.1030).3
to minimize exposure risk.
Pharmacists who participate in vaccination programs must • Offer hepatitis B vaccine to all employees at risk for
be in compliance with the OSHA Bloodborne Pathogens exposure to bloodborne pathogens.
Standard (www.osha.gov/SLTC/bloodbornepathogens/index.
‒ 
Document receipt or declination of the vaccine for
html). OSHA requirements are designed to reduce the risk of
all employees.
health care worker exposure to bloodborne pathogens such as
HIV, hepatitis B virus, and hepatitis C virus. Any health care • Develop a process for handling and recording
worker handling equipment such as contaminated needles is injuries from sharps supplies. Document all sharps
at risk for exposure to bloodborne pathogens. Pharmacists injuries and the follow-up care provided.
should carefully review the information applicable to health
care workers on the OSHA website to ensure they are in
compliance with all relevant OSHA standards (see box).3 Pathogens Standard, the exposure control plan must include
the following elements:
Training. The OSHA Bloodborne Pathogens Standard
requires the employer to provide training for all personnel with • Exposure determination (i.e., identifying employees who
potential exposure to bloodborne pathogens, which includes are at risk).
immunizing pharmacists. OSHA training must include specific • Communication of hazards to employees.
elements and employers should consult the OSHA standard
to ensure their OSHA training meets all of the requirements. • Methods of compliance (e.g., universal precautions,
OSHA training must be repeated at least annually and sharps disposal).
documentation of each individual’s participation in annual • Annual evaluation of safer medical devices.
training must be kept on file for inspection by OSHA.
• Availability of preexposure vaccination with hepatitis B
Exposure control plan. The employer must establish a vaccine.
written exposure control plan outlining how the employer • Plan for postexposure evaluation and follow-up.
intends to eliminate or minimize potential exposures to
bloodborne pathogens. According to the OSHA Bloodborne • Documentation and recordkeeping.

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Pharmacists developing an exposure control plan should not place themselves or their patients at risk of an accidental
access the OSHA standard for additional information about needlestick when disposing of the contaminated needles.
each of these elements. The exposure control plan must be
readily accessible at all times and the plan must be reviewed Full sharps containers require special disposal procedures.
and updated annually. Immunizing pharmacists should consult applicable state
regulations concerning disposal of these containers. Often,
Universal precautions. According to the OSHA contacting a local waste-disposal company is sufficient to
Bloodborne Pathogens Standard, health care workers must determine any special handling requirements. Pharmacists
use universal precautions when handling equipment that has also may have the option to use a mail-back service for
been exposed to blood. Universal precautions is an infection disposing of used needles and syringes.
control principle that requires the provider to treat all human
blood as infectious. Safety devices. The Needlestick Safety and Prevention Act
of 2000 directed OSHA to redesign its Bloodborne Pathogens
Gloves and hand washing. Gloving is not required Standard to provide more detail in the OSHA guidelines for
by either the Centers for Disease Control and Prevention employers to identify, evaluate, and implement safer medical
(CDC) or OSHA. According to the CDC, “Persons adminis- devices.3 This Act mandates the use of safety devices
tering vaccinations should follow appropriate precautions and health care employers must provide safety devices to
to minimize risk for spread of disease. Hands should be employees to reduce the risk of occupational exposure to
cleansed with an alcohol-based waterless antiseptic hand rub bloodborne pathogens. The law does not recommend specific
or washed with soap and water before preparing the vaccine safety devices; instead, it requires employers to conduct
and between each patient contact. [OSHA] regulations do their own evaluation of the available safety devices, choose
not require gloves to be worn when administering vaccina- an appropriate device, and then document this evaluation.
tions, unless persons administering vaccinations are likely to Nonmanagerial employees must be included in the evaluation
come into contact with potentially infectious body fluids or of devices. Additionally, the safety devices must be
have open lesions on their hands. If gloves are worn, they reevaluated each year.
should be changed between patients.”4
While the risk of a needlestick is significantly reduced with
Gloves are regarded as personal protective equipment. safety devices, risk is not completely eliminated. Data on the
According to OSHA, appropriate size gloves must be safety of health care workers have found that more than 38%
available for employees to wear while providing immuniza- of needlestick injuries occurred even though a safety device
tions. Pharmacists must wash their hands immediately or as was used.5 In most cases, the safety device had not been
soon as feasible after removal of their gloves. activated appropriately thus resulting in an exposure.

Employers should provide hand washing facilities that are Hepatitis B vaccination. Preexposure vaccination with
readily accessible to employees. If hand washing facilities are hepatitis B vaccine must be offered by the employer to all
not readily available, an appropriate antiseptic hand cleanser employees with job responsibilities with potential exposure to
may be used. When antiseptic hand cleansers are used, bloodborne pathogens. (This requirement includes everyone
pharmacists should wash their hands with soap and running who administers injections.) According to OSHA, the vaccine
water as soon as possible. must be offered to employees at no charge. Pharmacists
should receive at least the first dose of the hepatitis B vaccine
Engineering and work practice controls. Employers series before providing immunizations. Documentation of
must utilize engineering and work practice controls (e.g., hepatitis B vaccination should be maintained for all employees
sharps disposal containers, a procedure for proper disposal with potential exposure to bloodborne pathogens. If the
of needles in the sharps container) to protect employees from employee declines the hepatitis B vaccination, it is mandatory
exposure to bloodborne pathogens. Contaminated needles that the employee does so in writing, using the following
must be disposed in a sharps container. Providers should words:
not recap contaminated needles prior to putting them in the
“I understand that, due to my occupational exposure
sharps container. Sharps containers should be located in the
to blood or other potentially infectious materials, I may
vaccine administration area, within reach of the immunizing
be at risk of acquiring hepatitis B virus (HBV) infection.
pharmacist, in a position so the immunizing pharmacists do

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I have been given the opportunity to be vaccinated present to receive them. However, everyone in the pharmacy
with hepatitis B vaccine at no charge to me; however, I who may come in contact with the vaccines should be trained
decline hepatitis B vaccination at this time. I understand regarding appropriate vaccine storage and handling. The
that by declining this vaccine, I continue to be at risk of vaccines should be unpacked immediately upon receipt
acquiring hepatitis B, a serious disease. If in the future and the person doing the unpacking should check any
I continue to have occupational exposure to blood or temperature indicators in the shipping case. If there are no
other potentially infectious materials and I want to be indicators, the person should check to be sure the coolant
vaccinated with hepatitis B vaccine, I can receive the packs have not thawed. If the vaccine has been exposed to
vaccination series at no charge to me.” temperatures outside the recommended range, the vaccine
should be quarantined and stored in the refrigerator or
A template form for declination of hepatitis B vaccine can
freezer (as appropriate). This quarantined vaccine should be
be obtained from the OSHA website (www.osha.gov/SLTC/
clearly marked “do not use” and the manufacturer should be
etools/hospital/hazards/bbp/declination.html).
contacted for further guidance. Pharmacists should document
each of these steps any time there is a break in the cold chain.
Postexposure evaluation and follow-up.
Postexposure management procedures must be clearly Once the vaccines reach the pharmacy, appropriate storage
defined, including specific timelines that must be followed and in a refrigerator or freezer is critical. The CDC toolkit provides
documentation that must be completed. All exposures must be detailed information about the selection and operation
documented in a sharps injury log, and follow-up care should of refrigerators and freezers for vaccine storage. CDC
be provided and documented for each exposure. recommends the use of stand-alone vaccine storage units (i.e.,
self-contained units that only refrigerate or freeze) as a best
practice. (Because freezing of refrigerated vaccines affects
Vaccine Storage and Handling vaccine potency more than other exposure problems, it is
Before initiating an immunization program, pharmacists should especially important that refrigerators be selected and set
identify the specific storage requirements for the vaccines up in a way that eliminates the chance of freezing vaccine.)
they will provide.6-8 The CDC released updated guidelines Purpose-built or pharmacy grade refrigerators and freezers
in the 2012 Vaccine Storage and Handling Toolkit, which is can be used as well. Water bottles can be added to the
available at www.cdc.gov/vaccines/recs/storage/toolkit/ refrigerator and freezer to help regulate temperatures.7
storage-handling-toolkit.pdf. Other useful CDC recommenda-
tions and guidelines related to vaccine storage and handling Food and beverages should not be stored with vaccines.
are located at www.cdc.gov/vaccines/recs/default.htm. IAC Having a medication-dedicated refrigerator will reduce
also provides several resources to support appropriate storage the number of times the door is opened and minimize how
and handling at www.immunize.org/handouts/vaccine- much the temperature is allowed to fluctuate. Dormitory-style
storage-handling.asp. refrigerator/freezer units should not be used for vaccines
because they have greater temperature fluctuations and their
Vaccines must be stored at the recommended temperatures at freezer compartments are not cold enough to meet frozen
all times to ensure potency. The term cold chain refers to the vaccine storage requirements.
temperature-controlled environment that must be maintained
from the time the vaccine is manufactured to the time it is Vaccines should be stored in the middle of the refrigerator, not
administered to the patient. This means that everyone who in the door or on the bottom shelf, because the temperature in
handles the product prior to administration has a responsibility the middle does not change as easily. Thermometers should
to maintain the vaccine at the appropriate temperature and be stored in close proximity to the vaccines, and tempera-
conditions. tures should be monitored and recorded at least twice daily.
CDC recommends using only calibrated thermometers with
Vaccine manufacturers and distributors ship vaccines in a Certificate of Traceability and Calibration Testing (also
insulated containers with coolant packs. In many cases, known as a Report of Calibration). Calibrated thermometers
temperature monitoring cards are included in the shipment to are a requirement for providers who receive vaccines through
indicate whether temperatures have risen too high or dropped the Vaccines for Children (VFC) program or other vaccines
too low during transit. Vaccines should be delivered to the purchased with public funds. CDC recommends thermometers
pharmacy only when someone trained in their handling will be with the following characteristics7:

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• Continuous monitoring information with an active Special Considerations for Ordering Influenza Vaccine
display. The seasonal nature of influenza introduces some challenges
• Digital thermometer with a probe in a glycol-filled bottle. to ordering an appropriate vaccine inventory. Ordering
the appropriate number of doses may be difficult at first,
• Alarm for out-of-range temperatures. until the pharmacist gains experience with the number of
• Reset button (if using a data logger with a minimum and patients the pharmacy will serve. Pharmacists who work for
maximum display). an organization should check with the management before
ordering influenza vaccine because the pharmacy buyers may
• Capability of showing current temperature as well as prebook influenza vaccine for the entire organization.
minimum and maximum temperatures.
• Accuracy within +/–0.5°C (+/–1°F). One approach to ordering influenza vaccine is to calculate
needs early and advise a manufacturer, wholesaler, or
• Low battery indicator. buying group of the quantity anticipated to be purchased for
the upcoming influenza season. For example, contact the
Other suggestions for safe vaccine storage include posting manufacturer, wholesaler, or buying group in November 2014
a “do not unplug” sign next to the refrigerator or freezer, with the quantity needed for the 2015–16 influenza season.
installing an alarm on the refrigerator that would indicate if the Wholesalers will review their purchasing contracts and
door has been left open or a power outage has occurred, and respond to the pharmacy’s request with a guaranteed price.
fastening the plugs to the wall so they cannot be unplugged. Typically, the vaccine is shipped from the wholesaler to the
pharmacy as it becomes available from the manufacturers.

Managing Vaccine Inventory Another approach is to order directly from manufacturers as

Pharmacists should stock only the amount of vaccine required soon as they announce that reservations are being accepted,
to serve their needs until the next scheduled delivery. This which typically occurs as early as January for the following
strategy will prevent overstocking vaccines and potentially influenza season. Ordering directly from the manufacturer
carrying inventory that will never be used. Every vial of may offer a slightly lower price (especially with volume
vaccine bears an expiration date. The oldest vials of vaccine purchases), but it may require a purchase commitment.
should be placed in the front of the refrigerator or freezer to Manufacturers may not give credit for unused doses purchased
be used first and the newest vaccine vials should be stored by the pharmacy because the formulation of influenza vaccine
toward the back. This stock rotation will help ensure that changes each year and the unused doses cannot be used
every patient receives a fully potent vaccine and the pharmacy in subsequent influenza seasons. Pharmacists must identify
will not have expired inventory that cannot be administered. appropriate disposal methods for unused or expired doses.
As with any other medication, a vaccine should not be used
beyond its expiration date. Pharmacists involved in administering influenza vaccine
to young children or pregnant patients may need to order
Pharmacists should carefully estimate their needs to avoid thimerosal-free formulations, which are available only in the
purchasing more inventory than necessary. Prior to ordering prefilled syringes or single-dose vials.
vaccine supply, pharmacists should consider the needs of
their pharmacy to determine whether one formulation is better Managing Vaccine Shortages
suited than another. Ordering multidose vials often costs less Recent years have seen shortages or delayed shipments of
than ordering prefilled syringes or single-dose vials and may various vaccines. Some shortages have been widespread
be preferred from a cost perspective. However, pharmacies while others have been more localized. Vaccines affected
with a large volume of business may prefer using prefilled in recent years include those for use in routine childhood
syringes because they typically are quicker to prepare and immunizations, as well as Tdap and herpes zoster vaccine.
easier to use than multidose vials. When planning inventory Some of the shortages have resulted in temporary changes
storage, be aware that prefilled syringes require more storage in vaccination recommendations. In past years, there also
space than multidose vials. have been delays in the delivery of influenza vaccine.
When these delays or shortages occurred, CDC has issued
recommendations for how to allocate limited supplies of
vaccines.9 CDC provides information about current vaccine

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shortages and resulting recommendations at www.cdc.gov/ patient’s turn comes up, the pharmacist should review the
vaccines/vac-gen/shortages/default.htm. As members of completed screening form to determine the appropriateness of
the immunization neighborhood, pharmacists are expected vaccination, provide an opportunity for the patient to ask any
to follow CDC and local health department guidelines and questions, and then administer the vaccine.
recommendations.
Other options would be for pharmacists to provide vaccina-
tions during a vaccine clinic or during a designated time of the
Workflow Processes and Options day. The benefit of these arrangements is that the pharmacist
Establishing a pharmacy-based immunization program can select a less busy time or arrange for additional staffing.
may increase the workload or change the workflow of (However, if the clinic does not attract enough patients, it could
the pharmacy. Pharmacists need to consider how the be a suboptimal use of staff time, particularly if additional
immunization program will impact the workload and staff are present.) Yet another option would be for pharmacists
determine how to incorporate the program into the to allow patients to set up an appointment for a vaccination.
pharmacy’s workflow. This strategy provides flexibility for patients and allows the
pharmacist to plan ahead for when the patient needs a
The patient care setting will have an important influence on vaccine. Clinics also may be conducted in other venues, such
how vaccinations are incorporated into the daily routine. For as businesses (including health care organizations which have
example, when providing medication therapy management a need to immunize providers), schools, houses of worship,
(MTM) services, the need for a vaccine can be identified community centers, and other community gathering areas.
during the comprehensive medication review, and the vaccine
can be administered as part of the MTM encounter. (If the When designing the workflow, pharmacists should consider
MTM service is not provided face-to-face, the pharmacist how support personnel can assist the immunization program.
will need to refer the patient to another provider with an The American Pharmacists Association (APhA) is not aware of
immunization program.) Other patient care services, such as any state in which pharmacy technicians have the authority
disease state management services or medication reconcili- to administer vaccines as of December 2013. However,
ation, can incorporate an assessment of vaccine needs pharmacy technicians can serve an important role in a
and vaccine administration as a component of the overall pharmacy-based immunization program. For example,
service. This approach is in compliance with the NVAC Adult pharmacy technicians can help identify patients who may
Immunization Standards. need vaccines (e.g., screening new prescriptions and refills
for patients with medical indications for vaccines), provide
In a community pharmacy setting, there are several options paperwork (e.g., VISs, screening questionnaires) for the patient
for integrating immunization services. Immunizations could to read and complete while waiting for the pharmacist to
be incorporated in the workflow as though they were administer the vaccine, process the vaccine prescription, and
prescriptions, during specific hours when pharmacists’ facilitate the compensation process (e.g., collecting payment
shifts overlap, or administered only during special clinics. from the patient, submitting claims to Medicare or other
Having sufficient staffing is crucial not only to support the third-party payers).
immunization program but also to maintain the workflow of
everyday pharmacy activities. In general, year-round vaccine Student pharmacists may be able to support the pharmacy-
programs more readily lend themselves to being managed as based immunization program. Each state dictates the duties
prescriptions, while influenza programs may require specific a student pharmacist may perform. Appropriately trained
pharmacist hours or clinics to meet seasonal demand. and supervised student pharmacists may administer vaccines
in some states. Pharmacists should check with their state
When treating vaccines like any other prescription, patients board of pharmacy to determine the proper role of student
requesting a vaccine join the queue with the other patients pharmacists in their immunization program. As of October
having prescriptions filled. The patient can fill out any 2013, 39 states allow trained student pharmacist interns to
appropriate paperwork, complete the screening question- administer vaccines under the supervision of an immunizing
naire, and read the Vaccination Information Statement (VIS) pharmacist.
while other prescriptions are being processed. When the

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Marketing an Immunization Program from shingles and availability of the vaccine in the pharmacy.
As discussed previously, there are many cases in which a Flyers can be displayed throughout the store or used as bag
pharmacist will identify vaccination needs for individual stuffers inserted in every shopping bag and attached to every
patients and can provide education and administer vaccines prescription. A copy of the pharmacy flyer also can be used
to those patients. These patients can be identified by their as an advertisement in the local newspaper. All staff in the
current prescription record, through MTM encounters and pharmacy can wear buttons with messages such as “Get your
other patient care services, review of patient charts in direct flu shot today,” or “Ask us how to prevent shingles!”
patient care settings, and during medication reconciliation
at discharge from any care setting. Individuals who attend The CDC provides numerous print marketing materials,
influenza vaccine clinics can have their other vaccine needs including flyers, brochures, and posters. All materials are
reviewed as well. Consider using a checklist that identifies available for free download; for some materials, a limited
which vaccines are indicated for each age group to facilitate number of free print copies can be ordered. Materials for
discussion with patients. marketing influenza vaccines to a variety of populations—
including the general public, people with high-risk conditions,
However, many people with vaccination needs may not be older adults, pregnant women, health care workers,
reached through the means previously discussed (e.g., referrals employers, families and children, American Indians and
from other providers, employer health fairs, school-based Alaska natives, and Spanish-speaking individuals—are
vaccination clinics). A marketing campaign can be used available at www.cdc.gov/flu/freeresources/print.htm.
to educate the public about the need for vaccination and
provide information about the pharmacy’s vaccination service. For other vaccines, CDC provides resources for educating
Marketing the immunization service is also useful to create adult patients at www.cdc.gov/vaccines/hcp/patient-ed/
partnerships that will support the program. adults/index.html. These resources include materials tailored
for special populations and materials that promote the benefits
of vaccination against specific diseases. The CDC also
Marketing Materials provides educational materials through the VFC program,
A number of effective but relatively inexpensive marketing available at www.cdc.gov/vaccines/programs/vfc/awardees/
strategies can be used to promote the immunization service. awareness.html, to help parents understand their children’s
These tools include in-store signage, printed materials vaccines. In addition, IAC provides numerous resources
provided at the point of sale in the pharmacy, and information including patient handouts about vaccine-preventable
provided in electronic media, including the store’s voicemail diseases, available at www.immunize.org/handouts/vaccine-
message and website as well as social media tools and questions.asp, and handouts for parents on topics related to
Internet resources. immunizations for children.

In-store signage can be as simple as a sign in the pharmacy Nonprint methods offer the opportunity to reach people who
window or on a door proclaiming: respond well to hearing promotional messages. For example,
in-store overhead audio announcements can run while
• NOW...you can be immunized here. Ask the
patients are waiting for prescriptions to be filled. Including a
pharmacist for details.
message on the interactive voice response systems or on-hold
• NEW...flu shots now available. Ask for details. messaging that patients use to phone in prescription refills is
another vehicle for promoting the immunization service.
• Are you protected? Ask the pharmacist about getting
vaccinated here in the pharmacy.
The Internet provides many opportunities for marketing the
Printed flyers or brochures that promote the service can vaccination service. The pharmacy’s website should provide
mention the specific vaccines offered, the times that immuniza- timely information about vaccine availability in the pharmacy.
tions are available, who is eligible for the vaccines, and what Social media websites and apps, such as Facebook and
a patient needs to do to receive them. A headline such as Twitter, can be used to disseminate immunization messages
“Medicare Customers Welcome” can draw a lot of interest. and may be particularly effective for reaching younger
A flyer with the headline “Does This Sound Like Anyone in adults. Pharmacists also can list their vaccine service with the
Your Family?” that outlines the target groups for herpes zoster HealthMap Vaccine Finder, which is a free marketing tool. To
vaccine can call customers’ attention to the need for protection participate in HealthMap Vaccine Finder, vaccine providers

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create an account at flushot.healthmap.org/admin/signup and Pharmacists who form partnerships with other stakeholders
enter information on their immunization services regarding in the community to increase immunizations can use these
7 kinds of influenza vaccines (i.e., trivalent, quadrivalent, relationships to promote their immunization service. As part
high-dose, intradermal, cell culture–based, recombinant, of developing an immunization program, pharmacists should
and nasal spray) and 10 other adult vaccines (i.e., hepatitis make a strong effort to gather support from local health
A, hepatitis B, HPV, MMR, Td, Tdap, meningococcal, departments, physicians, hospitals, clinics, schools/colleges of
pneumococcal, varicella, and zoster). People wanting to be pharmacy, and other providers in the community. Pharmacists
vaccinated can go to the website, flushot.healthmap.org, and should collaborate with these partners for information,
enter their zip code to locate vaccine providers in their area. support, referrals, and advocacy materials. Doing so will help
the pharmacist to gain acceptance within the community—by
patients and providers alike.
Seasonal Marketing Opportunities
Pharmacists should be immunization advocates year-round Joining an immunization coalition is a useful strategy for
for all vaccines. Even so, some months involve more developing partnerships to promote immunizations. (An
immunization activities than others. Each year, a week during immunization coalition is an organization that brings together
April is designated as National Infant Immunization Week vaccination stakeholders to improve vaccination rates.)
(www.cdc.gov/vaccines/events/niiw/index.html). There are local, state, regional, national, and international
immunization coalitions. IAC maintains a directory of
August has been designated National Immunization immunization coalitions (www.izcoalitions.org/search/
Awareness Month (www.cdc.gov/vaccines/partners/ OrgSearch.asp).10 Pharmacists who join immunization
events/niam.html). The summer months generally offer the coalitions can collaborate with other health care providers
opportunity to focus on getting older children caught up on in the community to promote immunizations and improve
missed immunizations before heading back to school in the vaccination rates.
autumn. August is also an ideal month for pharmacists to
promote adolescent immunizations (i.e., hepatitis B vaccine, There are numerous other opportunities for pharmacists to
meningococcal conjugate vaccine, Tdap, and HPV vaccine). market their immunization service to additional audiences. For
example, pharmacists can explore opportunities to educate
Immunizations in October usually center on efforts to vaccinate local civic groups (e.g., Rotary, Elks, Lions, veterans groups,
people against influenza. October is American Pharmacists parent groups) and volunteer to provide informational sessions
Month (www.pharmacist.com/american-pharmacists-month), regarding the benefits of immunizations. Developing liaisons
creating a particularly strong opportunity for pharmacists to with community groups representing elderly adults and
market their immunization programs to reach the unimmunized patients with chronic diseases (e.g., diabetes, lung disease,
and underimmunized. A date in November is usually heart disease) is also important because these individuals
designated as World Pneumonia Day (worldpneumoniaday. often have vaccine needs.
org). In December, a week is designated as National Influenza
Vaccination Week (www.cdc.gov/flu/nivw/), focusing on Many communities run annual health fairs sponsored by
continuing efforts to get patients immunized against influenza groups such as the local government, the local health
throughout the season. Keep in mind that many vaccine- department, or an area hospital. Explore the possibility
preventable diseases (e.g., tetanus, hepatitis B, pneumococcal of setting up a small booth to distribute information on the
disease) kill people year-round. Pharmacists should strive to benefits of immunization (and offering on-site vaccinations if
immunize susceptible people throughout the year. feasible). Have a stack of flyers ready to hand out to promote
the pharmacy’s immunization program.
Developing Partnerships to Promote a Vaccination Pharmacists can contact local businesses, industries, and
Service schools about providing vaccinations for their employees.
Pharmacists should work to establish their immunization
Many employers are interested in immunizing their employees
service as a part of the immunization neighborhood, which
against influenza to reduce absenteeism and will support
encompasses all stakeholders with a shared interest in the
on-site vaccination clinics. Pharmacists can provide an
use and outcomes of vaccines (i.e., health care providers and
educational program about the need for other vaccines
organizations; federal, state, and local government; insurers,
relevant to this patient population. Pharmacists might even
payers, employers; vaccine manufacturers; and the public).

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take the immunization service right to a senior center or that will help pharmacists identify potential payers and
a skilled or unskilled nursing facility to vaccinate high-risk resources when seeking compensation for immunization
patients. Many other opportunities exist—pharmacists should services. Pharmacists should verify each patient’s coverage
explore their community and be creative. and collect any copayments before administering vaccines.

Valuable billing resources and links to forms that may be

needed to bill for vaccines and vaccine administration are
Compensation and Reimbursement listed in Table 5.2. Content related to Medicare is based
Typically, when pharmacies bill for a pharmaceutical product, on information provided by the Centers for Medicare and
they are paid for the cost of the product and a dispensing fee. Medicaid Services (CMS).11,12 Be aware that immunization
With vaccines, pharmacists should bill for the pharmaceutical providers who contract with Medicare and/or Medicaid are
product (i.e., the vaccine) as well as for administering the prohibited from charging others a lower rate. Also note that
vaccine. When submitting claims, pharmacists administering Medicare Advantage plans provide coverage for both Part B
vaccines must clearly specify that they are seeking both and Part D vaccines.
reimbursement for the vaccine product and compensation for
vaccine administration. Pharmacists may need to work with Any pharmacist or pharmacy planning to electronically submit
their pharmacy software company and/or billing organiza- health information to seek compensation for immunizations
tions to establish the infrastructure necessary to bill for should obtain a National Provider Identifier (NPI). The NPI is
vaccines and their administration. a unique number assigned to identify each individual health
care provider. Use of the NPI is required by the Health
There are many potential sources of compensation for Insurance Portability and Accountability Act for the electronic
immunization services, including Medicare Part B, Medicare transmission of all health information. An application to
Part D, Medicaid, private insurance, employers, and self- acquire an NPI number is available from the CMS National
paying patients. While many third-party payers provide Plan and Provider Enumeration System at https://nppes.cms.
coverage for vaccines, rules vary among payers. The intent of hhs.gov/NPPES/Welcome.do.13 NPI numbers are available
this section of the self-study module is to provide information free of charge.

Table 5.2. Resources and Forms Related to Billing for Vaccinations in Pharmacy Practice
Resource Website
CDC vaccine price list www.cdc.gov/vaccines/programs/vfc/cdc-vac-price-list.htm

CMS-1500 form www.cms.hhs.gov/cmsforms/downloads/CMS1500805.pdf

CMS-855B form www.cms.hhs.gov/cmsforms/downloads/cms855b.pdf

CMS-855I form www.cms.hhs.gov/cmsforms/downloads/cms855i.pdf

CMS adult immunization resources for providers www.cms.hhs.gov/AdultImmunizations/

ICD-10 provider and diagnostic codes www.cms.gov/Medicare/Coding/ICD10/index.html

Local Medicare carrier contact list (by state) www.cms.hhs.gov/MedicareProviderSupEnroll/downloads/contact_list.pdf

Medicare provider/supplier enrollment resources www.cms.hhs.gov/MedicareProviderSupEnroll/

National Plan and Provider Enumeration System: National Provider https://nppes.cms.hhs.gov/NPPES/Welcome.do

Identifier access

Vaccines for Children contact information (by state) www.cdc.gov/vaccines/programs/vfc/contacts-state.htm

CDC = Centers for Disease Control and Prevention; CMS = Centers for Medicare and Medicaid Services; ICD-10 = International Classification of Diseases–10th revision.

Source: Adapted from Reference 2.

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Medicare Part B Administrative Contractor (A/B MAC). Their non-immunization

All Medicare Part B enrollees have coverage for claims will still be paid by the Durable Medical Equipment
pneumococcal and influenza vaccines, while hepatitis B Medicare Administrative Contractor (DME-MAC). A
vaccine is covered only for specific high-risk patients and supplier must complete an 855 application to enroll as a
pharmacists are limited from billing Medicare Part B for mass immunizer to render influenza and pneumococcal
hepatitis B vaccine. vaccinations.

Applying for a Medicare Provider Number Reimbursement for the administration of the influenza and
To claim reimbursement under Medicare Part B, the pharmacist pneumococcal vaccines is based on the locality of the
must request a Medicare provider number from the local provider. Therefore, if the practice sites were in different
Medicare Part B carrier. (Pharmacists filing claims for Durable payment localities, then it would be necessary for each
Medical Equipment, Prosthetics, Orthotics, and Supplies to obtain a separate Medicare provider number for each
[DMEPOS]: this Medicare provider number is different from practice site. The only exception to this is an entity that
the Medicare supplier number that the pharmacy uses to file participates in the CMS Centralized Billing program.
claims for DMEPOS.) Under Medicare Part B, the pharmacist,
the pharmacy, or both can obtain a Medicare provider Providers who conduct immunization activities within their
number for administering vaccines: community—but outside their main practice site—can utilize
their practice’s provider number if they are operating at those
• Individual pharmacists can apply using form CMS-855I community sites under the auspices of their main practice.
(Medicare Enrollment Application for Physicians and
Non-Physician Practitioners), available at www.cms. Submitting Claims to Medicare Part B
gov/Medicare/CMS-Forms/CMS-Forms/CMS-Forms- To receive compensation for immunization services,
Items/CMS019477.html pharmacists must submit form CMS-1500 (Health
• Pharmacies may apply for a group of pharmacists using Insurance Claim Form). Currently, the CMS-1500 can
form CMS-855B (Medicare Enrollment Application for be submitted either electronically or as a paper form for
Clinics/Group Practices and Certain Other Suppliers), compensation for immunization services. Pharmacists
available at www.cms.gov/Medicare/CMS-Forms/ should contact their local Medicare carrier to determine
CMS-Forms/CMS-Forms-Items/CMS019476.html which billing method is preferred. If paper forms are used,
information about purchasing the CMS-1500 paper claim
Revenue from Medicare is reported to the Internal Revenue form is available at www.cms.gov/Medicare/Billing/
Service on the basis of the individual or corporate name ElectronicBillingEDITrans/16_1500.html.
associated with the provider number.
Pharmacists working for an organization should check with
Both the CMS-855I and CMS-855B are designed for a wide the management to determine if a process has already
variety of health care providers including, but not limited to, been established for submitting Medicare Part B claims for
surgeons, dentists, helicopter ambulance companies, and immunizations.
pharmacists. Immunizing pharmacists need to complete only
the portions of the form relevant to their practice. Pharmacists When submitting a paper claim to Medicare Part B,
should allow a minimum of 4 to 8 weeks for a Medicare pharmacists should file claims using a “roster bill.” To roster
provider number to be issued after submitting the appropriate bill Medicare, the pharmacist should complete one CMS-1500
paperwork. and then attach a roster bill to the completed CMS-1500.
The pharmacist should provide the usual information on the
Providers and suppliers may use their existing provider CMS-1500 (e.g., provider name, provider number, date of
numbers and use the roster billing process as long as they service). The roster should be a document that lists specific
provide the influenza virus and/or pneumococcal vaccine information for each beneficiary served (e.g., patient name
service to multiple beneficiaries and agree to accept and address, date of birth, sex, Medicare health insurance
assignment on the service. DMEPOS suppliers (in particular claim number, the patient’s signature or a stamped “signature
pharmacies) require separate enrollments and Provider on file”). Using this format, the pharmacist can list multiple
Transaction Access Numbers (PTAN) with the National qualifying immunizations administered by the same provider
Supplier Clearinghouse and their Part A and Part B Medicare on one roster and can include from 2 to 99 patients on a

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single roster. Patients will need to provide their Medicare However, influenza and pneumococcal immunizations for
insurance number and full name as recorded on the Medicare Medicare Part B beneficiaries should not be advertised as
file for the pharmacist to bill Medicare Part B. “free.” Providers may advertise that there will be no charge
to the beneficiaries, but they should make it clear that a claim
When both pneumococcal and influenza vaccines are adminis- will be submitted to Medicare on their behalf. This claim
tered, the pharmacist should submit separate CMS-1500 forms will be reflected in notices mailed to the beneficiaries later.
and rosters for each vaccine (i.e., a CMS-1500 and roster For patients receiving the hepatitis B vaccine, their usual
bill for pneumococcal vaccine plus a CMS-1500 and roster deductible and a 20% coinsurance does apply.11
bill for influenza vaccine). Billing codes for these immuniza-
tions are available at www.cms.hhs.gov/MLNProducts/
downloads/qr_immun_bill.pdf.11 Mass immunizers, including Medicare Part D
pharmacists, should bill using specialty code 60. The block on Since January 2008, all Medicare Part D prescription
the CMS-1500 where “60” is entered varies with each carrier; drug plans (PDP) are required to cover all commercially
pharmacists will need to ask their Medicare carrier where they available vaccines not already covered under Medicare Part
should insert this specialty code. B.14 In general, Medicare Part D should cover all vaccines
recommended for Medicare beneficiaries when the vaccine
For pneumococcal vaccine, Medicare requirements stipulate is deemed necessary for prevention of illness. For example,
that prior vaccination status be checked and that the vaccine the Td/Tdap and herpes zoster vaccines are covered under a
be administered only to eligible patients. patient’s Medicare Part D plan.

Medicare Reimbursement Rates The pharmacy must be contracted with the patient’s PDP to
The formula for Medicare reimbursement and compensation be reimbursed. Notably, unlike Medicare Part B, vaccines
for vaccinating patients is the vaccine cost plus the adminis- billed to a patient’s Part D plan are affected by deductibles,
tration fee. While there is a nationally established payment copayments, and the “donut hole.” If Medicare patients
for the cost of the vaccine, compensation for the vaccine receive a Medicare Part D vaccine in the pharmacy, they
administration fee can vary from one geographic area will be responsible for paying some portion of the bill.
to another.12 The vaccine cost is calculated at 95% of Pharmacists should determine the amount that the patient will
the average wholesale price (AWP). The vaccine cost owe and collect payment before administering the vaccine.
reimbursement is determined once the first lot is released by The network pharmacy should then bill the beneficiary’s
the Food and Drug Administration. Providers can find updated Medicare Part D plan for the vaccine and administration,
information about reimbursement and compensation rates for and the pharmacy will receive the contracted rate for both
influenza and pneumococcal vaccines on the CMS website at elements.
www.cms.gov/Medicare/Prevention/Immunizations/
and information about Medicare Part B pricing at www.cms.
hhs.gov/McrPartBDrugAvgSalesPrice/10_VaccinesPricing. Billing Other Third-Party Payers
asp#TopOfPage. Current administration rates are listed at The Affordable Care Act of 2010 requires that all plans
www.cms.gov/apps/physician-fee-schedule. (except grandfathered plans) provide coverage for preventive
services, including immunizations recommended by the
Medicare Part B providers of immunizations (e.g., pharmacists) Advisory Committee on Immunization Practices. Vaccines
must accept assignment on both the vaccine and its adminis- are covered with no cost-sharing requirements when they
tration fee. “Accepting assignment” means accepting the are provided by an in-network provider. (However, some
reimbursement rates set by Medicare as payment in full. plans may cover vaccines as a medical benefit rather than a
Medicare Part B providers of immunizations may not charge pharmacy benefit; pharmacists will need to verify the billing
the beneficiary more than the rates approved by Medicare. requirements of each plan with whom they contract.) Plans
such as Tricare, Federal Employees Health Benefits, and Blue
Medicare Part B beneficiaries do not pay coinsurance or Cross also provide coverage for immunizations. Several
deductible amounts for pneumococcal or influenza immuniza- Medicaid programs provide coverage for immunizations;
tions.11,12 Medicare waives the costs to the patient for these pharmacists should contact their state Medicaid agency for
immunizations, paying the entire cost of the vaccine and its specific information (www.medicaid.gov/Medicaid-CHIP-
administration fee, according to Medicare’s allowed rate. Program-Information/By-State/By-State.html).

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When submitting an electronic claim to a third-party payer, Vaccines for Children

the pharmacist should bill the payer for the vaccine product In October 1994, the federal government began the VFC
as well as for administration of the vaccine. Pharmacists program to offer vaccination to children under the age of 18
must use specific codes when submitting a claim to indicate years who meet at least one of the following criteria: eligible
that they administered the vaccine. The National Council for for Medicaid, uninsured or underinsured, American Indian, or
Prescription Drug Programs (NCPDP) has three Professional Alaska native.15 The VFC program is federally funded and
Pharmacy Services codes designated for medication adminis- state operated. Vaccines covered under VFC include tetanus,
tration. These codes have been added to the NCPDP diphtheria, pertussis, hepatitis A, hepatitis B, Haemophilus
Telecommunication Standard (v.5.0 and higher) and should be influenzae type b, measles, mumps, rubella, varicella,
used by the pharmacist when submitting an electronic claim poliovirus, pneumococcal, influenza, meningococcal, rotavirus,
for vaccine administration: and human papillomavirus.15
• Reason for Service Code (NCPDP Field 439–E4)
Providers obtain vaccines for free through this program. In
– PH = Preventive Health Care some instances, a patient may be charged a small adminis-
• Professional Service Code (NCPDP Field 440–E5) tration fee, but no child may be turned away because of the
– MA = Medication Administration inability to pay. Any provider participating in the VFC program
• Result of Service Code (NCPDP Field 441–E6) must agree to site auditing of vaccine storage and handling,
documentation, and administration procedures. They also must
– 3N = Medication Administration
agree to report statistical information (e.g., how many children
Although the NCPDP codes exist, relatively few pharmacy in each patient group received specific vaccines).
benefit managers currently provide compensation for
medication administration. Some third-party plans covering Pharmacists can become a VFC program registered
vaccine administration by pharmacists utilize a modified provider.16 If a pharmacist is granted the authority to
dispensing fee to cover the cost of administering the vaccine. administer vaccine by state law (whether by prescription,
Other third-party payers may provide reimbursement to the protocol, or prescribing authority), the pharmacist is eligible
pharmacy for the cost of the vaccine product but not the cost to become a VFC program registered provider within the
of administering the vaccine. Plans also may pay pharmacists state. In jurisdictions where pharmacists are not authorized
reduced rates if they are not in-network providers. If a to administer vaccines except under the direct supervision of
third-party payer does not cover the entire cost for the vaccine a physician, then the supervising physician must co-sign the
and administration, pharmacists should be prepared to bill the provider enrollment agreement along with the pharmacist in
patient for the balance. However, be aware of the limitations order for the pharmacist to be enrolled as a VFC registered
for the amount that can be charged directly to Medicare provider. Specialty providers (e.g., pharmacists) enrolled in
patients. the VFC program, at the discretion of the grantee, may limit
their VFC practice to particular relevant vaccines. For more
Receipts for Cash-Paying Patients information on the VFC program, pharmacists can access
If a patient pays out of pocket for all or part of the the VFC webpage for health care providers (www.cdc.gov/
vaccination, the pharmacist should provide a detailed receipt. vaccines/programs/vfc/providers/questions/index.html) and
At a minimum, the receipt should include the patient’s name should contact their state VFC program coordinator (www.cdc.
and address, the date of vaccination, the type of vaccine, and gov/vaccines/programs/vfc/contacts-state.htm).
appropriate billing codes to facilitate the process for patients
to apply to their own insurance company for reimbursement.
Many companies have their claim forms available online,
which patients can download and print to use for submitting Liability Issues
the claim. Some payer groups also accept a paper copy of This section provides an overview of some liability issues
the CMS-1500, which the pharmacist can complete for the associated with immunization delivery. Liability issues are
patient to assist with submitting the claim. complex and this brief review does not cover every nuance
of the law. This section does not constitute legal advice. If
pharmacists have specific questions, they should ask their
attorney and/or insurance carrier before making personal or
policy decisions.

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Pharmacists providing vaccinations must address liability issues. VICP Requirements

In general, malpractice risks for health care providers who The VICP covers any patient, regardless of age, receiving
immunize are low because a federal program, the Vaccine a vaccine containing any of the following antigens:
Injury Compensation Program (VICP), provides some protection. diphtheria, tetanus, pertussis, poliovirus, measles, mumps,
However, no law provides absolute protection from liability if rubella, hepatitis A, hepatitis B, influenza (inactivated or
the provider is negligent in administering a vaccine. live attenuated), H. influenzae type b, meningococcal,
pneumococcal conjugate, human papillomavirus, rotavirus, or
varicella.19 This list is subject to change as new vaccines are
Vaccine Injury Compensation Program approved (www.hrsa.gov/vaccinecompensation/index.html).
In the early 1980s, pharmaceutical companies and health
care providers were overwhelmed by lawsuits based on The VICP protects any authorized vaccine provider who meets
severe adverse events in children allegedly caused by the following requirements.17 Vaccine administrators must:
vaccines. Manufacturers were on the verge of stopping
production and withdrawing vaccines from the U.S. market, 1. Provide a copy of the most up-to-date version of the
which would have left children and adults in this country VIS to the patient or the patient’s caregiver before
unprotected against many devastating diseases. In 1986, the administering the vaccine. If a combination vaccine is
U.S. Congress enacted the National Childhood Vaccine Injury provided and a combination VIS is not available, the
Act (NCVIA) to address this situation. Under the NCVIA, an practitioner must provide the VIS for each component
excise tax is levied on each dose of vaccine sold in the United contained in the vaccine. As discussed in Module 4,
States to fund the VICP.17 The intent of the VICP is to balance current versions of VISs (in English and translations in
an individual patient’s risk of harm with society’s benefit from a variety of foreign languages) can be obtained from
having vaccines available that reduce disease transmission. the CDC (www.cdc.gov/vaccines/Pubs/vis/default.
htm) or IAC (www.immunize.org/vis).
The VICP provides a no-fault insurance fund that covers 2. Permanently record the following information for all
vaccine-related injuries listed in the Vaccine Injury Table vaccines covered by the VICP:
(VIT).18 Injuries listed in the table may be presumed to be
caused by vaccines whenever the injuries are temporally – Patient name.
associated with the receipt of vaccines. If a patient – Date vaccine administered.
experiences an event listed in the VIT, damages may be – Vaccine manufacturer and lot number.
awarded through the VICP fund. To receive damages,
–N
 ame, address, and title of person administering
the patient must file a claim with the VICP that satisfies the the vaccine.
eligibility criteria and provide appropriate documentation for
– Date printed on the VIS.
the alleged injury.19 In some cases, patients may experience
adverse events that are not listed on the VIT, and if they are –D
 ate the VIS is given to the vaccine recipient or that
able to prove a link between the vaccine and their injury, the person’s legal representative.
VICP may award damages to them.
3. Report the occurrence of any adverse event listed in
In exchange for this simplified no-fault proceeding, petitioners the VIT to the Vaccine Adverse Event Reporting System
give up the right to file claims for punitive damages or family (vaers.hhs.gov/index). These events include but are
claims against the provider of the vaccine. If a patient or not limited to: anaphylaxis, brachial neuritis, encepha-
family pursues redress under the VICP, the health care provider lopathy or encephalitis, chronic arthritis, thrombocyto-
who administered the vaccine cannot be sued while the matter penic purpura, vaccine-strain measles infection in an
is being investigated. A petitioner who accepts an award immunodeficient recipient, and paralytic poliomyelitis.
under the VICP is prohibited from filing a malpractice claim in
the tort system at a later time. Petitioners do have the ability
to reject an award made under VICP and pursue their case Professional Liability
under tort law, but few patients opt for this route. Although vaccine providers are protected by a strong set of
legal provisions, no law provides absolute protection from
liability for harm caused and the possibility still exists for a
claim to be made against the provider for negligence. Often,

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the cause of successful malpractice suits is negligence by of vaccines unless it is legal for them to do so, they are able
the provider. Pharmacists who are providing immunization to comply with all state regulations, and the activity is covered
services should be knowledgeable and up to date about by the pharmacy’s and pharmacist’s professional liability
the vaccines they are administering and must properly insurance policies. For example, if the pharmacist plans to
assess whether patients are appropriate candidates offer vaccinations outside the pharmacy, it is important to
prior to vaccinating. Another common theme in vaccine confirm with the insurance carrier that the liability policy will
litigation is failure to warn. Although most vaccines have cover these activities.
few contraindications and precautions, pharmacists who
are providing vaccines should make sure that patients are Three Steps to Reduce Liability
informed of any risks prior to giving the vaccine. Proper As described in the previous section, pharmacists who provide
screening techniques and patient education, including vaccines to patients are protected by the VICP, however it
providing the appropriate VIS, will help to minimize potential is still possible that a claim could be made against them for
risk for the immunizing pharmacist. negligently providing a vaccine. For example, pharmacists
could be found negligent if they vaccinate a patient despite an
Professional Liability Insurance Policies obvious contraindication. The best defenses against this type
It is prudent for the immunizing pharmacist and the pharmacy of liability are good training and competent performance.
where he or she is employed to carry professional liability Immunizing pharmacists should receive specialized training
insurance. The insurance for the pharmacy will usually be prior to administering vaccinations, stay up to date with the
the primary coverage for any incident, and it is important to changes in immunization practice, educate their patients
ensure that the insurance policy for the pharmacy expressly during each vaccination encounter, and emulate local
covers vaccinations. The insurance policy should specifi- safeguards at all times. These steps can help pharmacists
cally state that medication administration is included in the reduce the potential for litigation.
coverage or broadly state that all acts under the pharmacist’s
scope of practice are covered. If the policy does not Step 1. Immunizing pharmacists should receive specialized
include a statement of this sort, the pharmacist or pharmacy training in immunization delivery from a source acknowledged
management should request the insurance company include by professional peers and regulators. Training offered or
language in the policy to indicate that the pharmacist recognized by the CDC is an excellent way for pharmacists to
administers medications. begin and expand their immunization expertise. Successfully
completing the requirements of a national certificate training
Pharmacists who are covered by an employer’s policy may program (e.g., APhA’s Pharmacy-Based Immunization Delivery) will
want to purchase individual professional liability policies earn the pharmacist a Certificate of Achievement. However, it
to provide additional protection and address any gaps in does not designate the pharmacist as a certified immunization
coverage. APhA encourages individual pharmacists to provider. The term “certification” refers to a credential that
obtain their own liability insurance policies to cover their can be earned from an authoritative organization, such as
immunization, patient care, and consulting activities—over a Board of Pharmacy Specialties certification. Pharmacists
and above the coverage provided by their employer. In must appreciate the difference between the two and use the
general, individual liability policies are advisable in a litigious appropriate language when discussing their training.
society, where plaintiffs may seek compensation from every
party involved, including the immunizing pharmacist. When Pharmacists need to recognize that a one-time training course
choosing an individual liability policy, the pharmacist must is not enough to sustain a successful immunization practice;
check that the policy covers activities such as vaccine adminis- staying current with ongoing information updates is essential
tration. Individual professional liability insurance can be following the initial training. The practice of immunizations
obtained through several carriers. changes frequently and providers must make a commitment
to staying current to maintain a quality immunization practice.
Regardless of the coverage type, both the commercial This can be accomplished through additional training,
pharmacy policy and the individual pharmacist policy will continuing pharmacy education, and review of updates and
provide protection only if pharmacists act within the scope of information by electronic mailing lists, which were discussed in
pharmacy laws in the state where they practice. Pharmacies Module 1.
and pharmacists should not be engaged in the administration

Module 5. Operating a Pharmacy-Based Immunization Program 17

 2014 APhA Pharmacy-Based
IMMUNIZATION DELIVERY

Step 2. Pharmacists should educate and inform patients and property owners is to remove defects or dangerous conditions
their caregivers about the benefits and risks of vaccination. on the premises or to warn business patrons about them. This
A common theme in many cases of vaccine litigation is the duty would apply to immunization services in addition to all
failure to warn. Providing information so patients can make other business activities. Businesses normally carry standard
informed decisions is an important step to minimize the risk of commercial insurance coverage for accidents caused by
litigation. Pharmacists should use the appropriate and most conditions of the premises to persons visiting the business, such
current VIS to help patients and their caregivers understand the as patients presenting at the pharmacy. Each business should
benefits as well as the risks of vaccination. Pharmacists may verify its coverage to make sure that it is properly protected.
either review the VIS with the patient prior to vaccination or
have the patient read the VIS independently and then provide
an opportunity for the patient to ask questions prior to vaccine Physician Liability
administration. Some vaccine providers have patients sign a Physicians who sign standing orders or protocols to authorize
form indicating they have read the information and agree to pharmacy-based immunizations may have liability concerns.
the vaccination, thereby providing informed consent to receive Pharmacists should be prepared to respond to physicians’
the vaccine. Pharmacists should determine if informed consent concerns by discussing their level of training, reviewing the
is required in their state, and if so, ensure they have documen- pharmacy’s policies and procedures, and reinforcing the
tation methods that meet the state’s standard. importance of improving vaccination rates.

Step 3. Immunizing pharmacists should develop a quality Furthermore, it is important to recognize that physicians are
program that emulates local standards and abides by the not liable for licensed pharmacists who negligently practice
accepted standard of care. Pharmacists should emulate the pharmacy, such as making a dispensing error. The physician’s
controls and precautions adopted at local health clinics. For scope of practice ends where the pharmacist’s scope of practice
example, pharmacists should observe patients for anaphylaxis begins. As long as the pharmacist is engaged in the practice
following vaccination for the same length of time as area of pharmacy and acting under the authority of a pharmacist
health clinics. In addition, pharmacists should adopt similar license, the physician would not be liable for the dispensing
procedures for screening patients for contraindications, error. The same holds true for vaccine administration. To
documenting immunization records, and providing informed the extent that vaccine administration is included within the
consent prior to vaccination. Pharmacists should practice scope of practice of a pharmacist, physicians would not be
according to the accepted standard of care, following the liable for pharmacists who negligently administer vaccines. In
most up-to-date practice recommendations. situations where pharmacy-based vaccine administration is
authorized by a physician through a protocol or standing order,
Does Failing to Vaccinate Constitute Negligence? the authorizing physician should verify that the information
Notably, IAC reports an accumulating series of court cases contained in the protocol or standing order is accurate and
in which negligence is claimed for failing to vaccinate. Such meets the standards of practice. Prior to authorizing a protocol
cases, which are frequently settled out of court, suggest that all or standing order, the physician also should verify that the
health care professionals have a responsibility to protect their pharmacist can competently administer an immunization (e.g.,
patients against preventable infection. training in proper injection technique, certification in CPR).

In a case of interest, a Missoula, Montana, jury awarded

$1.3 million to the family of a young man who died from Conclusion
pneumococcal sepsis. The jury decided that the hospital, Establishing a quality pharmacy-based immunization program
in which the young man was a patient several months prior, requires time, enthusiasm, and dedication. Once the clinical
was negligent for not immunizing him against the illness even aspects of the program have been established, it is crucial
though he had a clear indication (i.e., asplenia) for receipt of to identify feasible methods for obtaining compensation for
the vaccine.20 vaccines and vaccine administration for the service to be
sustainable. Marketing the immunization program to target
groups for vaccination is essential for the success of the
Business Liability service. Pharmacists should continually seek ways to improve
In addition to professional liability, the pharmacy should the program by learning from past experiences and moving
consider general business liability. The normal duty of forward with new methods to reach potential vaccine recipients.

Module 5. Operating a Pharmacy-Based Immunization Program 18

 2014 APhA Pharmacy-Based
IMMUNIZATION DELIVERY

References 12. Centers for Medicare and Medicaid Services. 2012–2013

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Module 5. Operating a Pharmacy-Based Immunization Program 19