Vaccine
Safety
Vaccine Safety: The
Providers Role
Providers Play an
Important Role in Vaccine Safety
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.
http://www.cdc.gov/nip/recs/child-schedule.pdf
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http://www.cdc.gov/mmwr/PDF/rr/rr5004.pdf
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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. The Centers
for Disease Control and Prevention’s (CDC) Guide to
Contraindications to Childhood Vaccinations can be ordered
on-line.
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 publications
page.
Translations in over 20 languages
are available at www.immunize.org
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:
CDC’s National Immunization
Information Hotline 1-800-232-2522 (English), 1-800-232-0233
(Spanish)
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
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* 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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