Preparing for Vaccine
Administration: Warnings,
Precautions and Contraindications
Ruth Carrico PhD RN FSHEA CIC
Associate Professor
Division of Infectious Diseases
University of Louisville
Objectives
• Review preparation for vaccine immunization
with a patient safety strategy
• Identify the differences between warnings,
precautions and contraindications relative to
vaccines
• Explore steps that may prevent inappropriate
withholding of vaccines due to
misunderstandings of warnings, precautions,
and contraindications
Basics of assessment and triage prior to
pharmaceutical agent administration
• Be aware of purpose of the pharmaceutical
intervention
• Know the agent (action, the 5 Rs,
contraindications, other safety issues)
• Know the type of vaccine (live or killed)
• Know the targeted patient population
• Special needs necessitate special interventions
Contraindications v. Warnings and
Precautions
• Contraindications- Reasons to withhold the
medication or treatment. May or may not be
absolute.
• Warnings and Precautions- Reasons to consider
the risk v. benefit of the agent in relation to
existing medical conditions
• Know absolute contraindications before
administering any agent
• Know the process for verifying proper action
when there are questions of contraindications or
precautions
Contraindications v. Warnings and
Precautions
• May also need to consider adverse reactions
and drug interactions
• Not included in the warnings/precautions lists,
but should receive equal consideration
Special/Function Needs Populations
• Cultural context, age, literacy, health literacy
• Language or other communication needs
• May need medical care or other medical
interventions
• Independence
• Supervision
• Transportation
Package Inserts
• Primary document to obtain information relative
to FDA approval of the vaccine
• Explicit information about contraindications,
warnings and precautions
• Will prove information about what occurred
during clinical trials, but not about populations
that were not studied
• It is critical that this information be read prior to
administering any vaccine
• FDA approval information may not mirror what is
in APIC recommendations
http://www.immunize.org/packageinserts/
Case Study
• A 25 year old healthcare worker wants FluMist
instead of a flu shot. This healthcare worker
has a history of exercise-induced asthma.
Would this healthcare worker be able to
receive FluMist?
Case Study
• A 25 year old healthcare worker wants FluMist
instead of a flu shot. This healthcare worker has
a history of exercise-induced asthma. Would this
healthcare worker be able to receive FluMist?
• Contraindications: severe allergic reaction
• Warnings and Precautions: Hx of GBS;
immunocompromised
• Special populations: pregnant women, nursing
mothers, geriatrics
Case Study
• 65 year old healthcare worker working as the
primary environmental services personnel in
the neonatal ICU. Facility policy includes
immunization for persons working in areas at
high risk for pertussis. Can this healthcare
worker receive this vaccine? Can he receive
this at the same time as his flu vaccine?
Case Study
• 65 year old healthcare worker working as the primary
environmental services personnel in the neonatal ICU.
Facility policy includes immunization for persons
working in areas at high risk for pertussis. Can this
healthcare worker receive this vaccine? Can he receive
this at the same time as his flu vaccine?
• Contraindications: severe allergic reaction,
encephalopathy
• Warnings and Precautions: latex, GBS, Unstable
neurologic conditions, arthus-type reaction within last
10 years
Case Study
• 21 year old female has not completed her
human papillomavirus (HPV) vaccine series.
She had the first one when she was 18, but
fainted afterward. Now, she is afraid that it
was a serious reaction and the next dose
could cause her significant harm. How do we
talk with this person about the HPV vaccine?
Case Study
• 21 year old female has not completed her
human papillomavirus (HPV) vaccine series.
She had the first one when she was 18, but
fainted afterward. Now, she is afraid that it
was a serious reaction and the next dose
could cause her significant harm. How do we
talk with this person about the HPV vaccine?
• Contraindications: Severe allergic reaction
• Warnings and Precautions: syncopal episodes
Summary
• Contraindications are the absolutes unless
otherwise stipulated (usually by public health
statement)
• Warnings and precautions should prompt a
risk/benefit assessment
• Adverse reactions should prompt preparation
and patient education
• A vaccine-supporting strategy employs an optout approach rather than an opt-in approach