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Vaccine
Safety
Vaccine
Safety: The Providers Role
Providers
Play an Important Role in Vaccine Safety
Related
Page: Helping
Parents Who Question Vaccines
The United States
currently has the safest, most effective vaccines
in its history. Federal regulations require
that vaccines undergo years of testing before
they can be licensed. Once in use, vaccines
are monitored continually for safety and efficacy.
As an immunization provider, you also play
a key role in helping to ensure the safety
and efficacy of vaccines through proper:
- Vaccine storage
and handling
- Vaccine administration
- Timing and
spacing of vaccine doses
- Observation
of precautions and contraindications
- Management
of vaccine side effects
- Reporting
of suspected side effects
- Communication
about vaccine benefits and risks
Vaccine Storage
and Administration
To
achieve the best possible results from
vaccines, carefully follow the recommendations
for storage, handling, and administration found
in each vaccine’s package insert. Here are
other steps you can take to help ensure vaccine
safety:
- Inspect vaccines
upon delivery and monitor refrigerator and
freezer temperatures to assure maintenance
of the cold chain.
- Rotate vaccine
stock so the oldest vaccines are used first.
- Never administer
a vaccine later than the expiration date.
- Administer
vaccines within the prescribed time periods
following reconstitution.
- Wait to draw
vaccines into syringes until immediately
prior to administration.
- Never mix
vaccines in the same syringe unless they
are specifically approved for mixing by the
Food and Drug Administration (FDA).
- Record vaccine
and administration information, including
lot numbers and injection sites, in the patient's
record.
- If errors
in vaccine storage and administration occur,
take corrective action immediately to prevent
them from happening again and notify public
health authorities.
Timing and
Spacing
The
timing and spacing of vaccine doses are two
of the most important issues in the appropriate
use of vaccines. To ensure optimal results
from each immunization, follow the currently
recommended immunization schedules for children,
adolescents and adults. The recommended childhood
immunization schedule* and influenza
immunization recommendations* are updated
each year.
The following
points also should be remembered:
- Administering
all needed vaccines during the same visit
is important because it increases the likelihood
that children will be fully immunized as
recommended. Studies have shown that vaccines
are as effective when administered simultaneously
as they are individually and carry no greater
risk for adverse side effects.
- There is
no medical basis for giving combination vaccines
separately. Administration of separated combination
vaccines results in more discomfort.
- Some vaccines,
like pediatric diphtheria and tetanus, produce
increased rates of side effects when given
too frequently. Good record keeping, maintaining
careful patient histories, and adherence
to recommended schedules can decrease the
chances that patients receive extra doses
of vaccines.
Observe Valid
Contraindications
Contraindications
and precautions to vaccination indicate when
vaccines should not be given. A contraindication
is a condition in a patient that increases
the chance of a serious, adverse reaction.
In general, a vaccine should not be administered
when a contraindication is present. A precaution
is a condition in a patient that may increase
the chance of a serious side effect or render
a vaccine ineffective. Normally, vaccination
is deferred when a precaution is present.
However, situations may arise when the benefits
of vaccination outweigh the risk of a side
effect, and the provider may decide to vaccinate
the patient. Most contraindications and
precautions are temporary and the vaccine
may be given at a later time. For details,
consult the CDC Guide
to Contraindications to Childhood Vaccinations.
One key to
preventing serious adverse reactions to
vaccines is screening for contraindications
and precautions. Every provider who administers
vaccines should screen every patient before
giving a vaccine dose. Sample screening
questionnaires are available from the Immunization
Action Coalition at www.immunize.org.
Many conditions
are often inappropriately regarded as contraindications
to vaccination. In most cases, the
following are not contraindications:
- Mild acute
illness (e.g., diarrhea and minor upper-respiratory
tract illnesses, including otitis media)
with or without low grade fever
- Mild to moderate
local reactions and/or low grade or moderate
fever following a prior dose of the vaccine
- Current antimicrobial
therapy
- Convalescent
phase of illness
- Recent exposure
to an infectious disease
- Premature
birth
- Breastfeeding
Communicate
About Vaccine Benefits and Risks
While
you can do a number of things to help make
vaccines as safe and effective as possible,
providing patients or parents/guardians with
information about vaccines and immunization
is equally important.
Before you
administer
each dose of certain vaccines, you
are required by law to provide a copy of
the most current Vaccine Information
Statement (VIS) to either the adult
vaccinee or to the child’s
parent/legal guardian. VIS are developed by
the CDC and discuss the benefits and risks
associated with specific vaccines. You must
also record in the patient’s chart the date
that the VIS was given and the publication
date of the VIS. Current VISs are available
on the Vaccine
Information Statements page. Translations
in over 20 languages are available at www.immunize.org/vis/.
Other materials
such as brochures, videos, and resource kits
can assist you in communicating with patients
or parents about vaccine benefits and risks.
Parents can also be referred to credible Internet
and hotline resources, such as:
Parents
Who Question Vaccines (one
page flyer)
Many more
publications are available on the NIP
publications
page.
CDC’s
Information Contact Center 1-800-CDC-INFO
or 1-800-232-4636 (English and
Español).
CDC’s National
Immunization Program web site at www.cdc.gov/nip
Be Prepared
to Manage Vaccine Side Effects
Most
people experience no side effects, or only
mild ones, following immunization. Mild side
effects may include soreness, swelling, or
redness at the injection site or mild fever.
Severe side effects, such as severe allergic
reactions, following vaccination are extremely
rare. However, any provider who administers
vaccines should have procedures in place for
the emergency care of a person who experiences
an anaphylactic reaction. Epinephrine and equipment
for maintaining an airway should be available
for immediate use. All vaccine providers should
be familiar with the office emergency plan,
and should be certified in cardiopulmonary
resuscitation.
Report Suspected
Side Effects to VAERS
The
Vaccine Adverse Event Reporting System (VAERS)
is a national vaccine safety monitoring program.
VAERS collects information about adverse events
(possible side effects) that occur after administration
of U.S. licensed vaccines.
The National
Childhood Vaccine Injury Act requires healthcare
providers to report selected events occurring
after vaccination to VAERS. However, VAERS
encourages reporting of any clinically
significant adverse event that occurs after
administration of any vaccine licensed
in the United States, even if it is not
certain that the vaccine caused the event.
By reporting
possible vaccine side effects to VAERS, you
provide valuable information that is needed
for the ongoing evaluation of vaccine safety.
The CDC and FDA use VAERS information to ensure
the safest strategies of vaccine use and to
further reduce the rare risks associated with
vaccines.
More information
about VAERS, including reporting forms, can
be obtained by calling the VAERS information
line at 800-822-7967, or by visiting www.vaers.org.
For more information
about the topics covered here see the General
Recommendations on Immunization: Recommendations
of the Advisory Committee on Immunization Practices
(ACIP) at http://www.cdc.gov/nip/publications/ACIP-list.htm*
* Accessibility
note: The above ACIP and MMWR links are directly
linked to .pdf formats but are also available
in text-reader format at the following site:
http://www.cdc.gov/mmwr/mmwrpvol.html.
Also, text-reader versions of the VISs are
available on the Vaccine
Information Statements
page.
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