Immunizations Screening Guidelines Practice Considerations MODULE 4

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ImmunizationsScreening GuidelinesPractice
ConsiderationsMODULE 4

• Module content prepared by
• Monica Scheibmeir PhD, ARNP
• Assistant Professor, KU SON

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Topics to be Covered

• Immunizations
• Screening guidelines for children and adults
• Ways to implement health promotion in a clinical
  setting

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HOW VACCINES WORK

• Antibodies Special body proteins that fight
  viruses and bacteria
• Immunologic Memory The bodys ability to respond
  to viruses or bacteria following immunization or
  infection this ability often is retained for
  many years.
• Community Immunity The concept that immunizing
  all children who can be vaccinated protects those
  who have not been or cannot be vaccinated

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Immunizations

• Types of Immunizations
• Live virus (e.g. MMR)
• Killed or attenuated virus (e.g. IPV)
• genetically altered virus/bacteria (e.g.
  acellular pertussis)

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Role of the Clinician in Vaccine Safety

• Proper storage and administration
• Identify contraindications
• Education
• Report and treat Reactions
• Refer as appropriate
• Follow up

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Immunizations

• Adults
• Annually (e.g. influenza vaccine)
• Periodically (tetanus, diptheria
  booster)
• Once only (e.g. pneumococcal vaccine)

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Special Populations

• People with moderate or severe illness
• History of serious vaccine reaction
• Pregnant women
• Recent blood product recipients

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When Is It Safe to Immunize?

• Mild illness
• Disease exposure
• Antibiotic therapy
• Breast Feeding
• Premature birth
• Most allergies
• Family history of vaccine reaction

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Vaccine Reactions

• Local Reactions
• Systemic Reactions
• Allergic Reactions
• Emotional

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Hot Topics in Vaccine Safety
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Autism and Vaccines

• Theory posed that MMR vaccine might play a role
  in autism
• Weight of scientific evidence does not support
• American Academy of Pediatrics Review and
  Institute of Medicine Review conclude no
  association

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Mercury and Vaccines

• Federal Act to reduce mercury exposure
• Thimerosal -mercury based preservative
• Vaccine schedule prior to 1999 for some infants
  could exceed 1 federal mercury guideline
• No evidence of harm
• US vaccines now virtually mercury-free

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Are Additives Contained in Vaccines Safe?

• Additives thoroughly tested tiny amounts used
• Precautions check manuf. info., patient hx, and
  NIPs Guide to Contraindications
• Additives Used
• a. adjuvants enhance immune system
  response
• b. antibiotics prevent bacterial fungal
  growth
• c. stabilizers maintain effectiveness in
  face of adverse conditions
• d. preservatives prevent spoilage

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Can vaccines overload the immune system?

• Giving multiple vaccines at the same time is safe
• People are exposed daily to hundreds of antigens
• Multiple vaccines work with the immune system to
  boost it
• Simultaneous vaccination
• protects against several diseases quickly
• Combo vaccines reduce discomfort and costs

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Where to Find the Latest Recommendations

• Centers for Disease Control
• http//www.cdc.org/nip
• http//www.immunize.org
• American Academy of Family Physicians
• http//www.aafp.org
• American Academy of Pediatrics
• http//www.aap.org

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Immunizations

• Advisory Committee on Immunization Practices
  (ACIP)
• American Academy of Pediatrics
• American Academy of Family Physicians
• American College of Physicians
• American College of Obstetricians and Gynecologist

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1-800-822-7967 www.vaers.org

• Unified national spontaneous reporting
  system/passive surveillance
• Jointly administered by CDC and FDA since 1990
• Receives 11,000 reports per year
• Registry of adverse events

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Types of Adverse Events Reported to VAERS

• Vaccine reaction or side effect
• Vaccine potentiated
• Programmatic or human error
• Coincidental

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VAERS Reports Event Severity 11/90-12/01

excludes foreign and duplicate reports
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Case Follow Up

• Letter to Reporters
• Serious cases
• Medical records
• Deaths
• Autopsy reports
• Not recovered
• 60 day follow up
• 1 year follow up

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VAERS Useful In

• Detecting new vaccine side effects
• Detecting changes in rate of known side effects
• Risk factors for adverse events.

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VAERS Strengths

• National scope
• Detects very rare events
• Timely reporting
• Generates signals
• Low cost

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VAERS Weaknesses

• Complexity
• Coincidental events
• Statistical limitations
• Can not determine vaccine causality by case
• Additional studies required to confirm signals

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Establishing Causal LinkAdverse Event Vaccine
Illness or Syndrome
Vaccination
VAERS biased cell a
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Clinical Immunization Safety Assessment (CISA)
Centers

• Designed to improve scientific understanding of
  vaccine safety issues at the individual patient
  level.
• Activities
• Evaluate known reactions
• Evaluate new and unusual events
• Provide consultation to physicians
• Develop clinical protocols

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Vaccine Injury Compensation Program
1-800-338-2382 WWW.HRSA.DHHS.GOV

• Covers childhood vaccines only
• No fault basis
• Vaccine Injury Table or
• Proof vaccine caused problem
• Proof vaccine aggravated existing health condition

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Parents Safety Concerns and Beliefs

• Most report having confidence in vaccine safety
• Most have at least one safety concern
• Vaccine ingredients (35)
• Too many shots during one visit (23)
• Chronic diseases or learning disabilities (18)
• No concerns (43)
• 20-25 have misconceptions
• My childs immune system could be weakened by
  too many vaccines
• Are more likely to trust immunizations that have
  been around for a while (88)

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Parents Information Sources

• Most influenced by providers (90)
• Friend with medical training (56)
• Family member (55)
• Television, magazine, newspaper (33)
• Internet (19)

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Parents Information Preferences

• Prefer short, simply-written, durable, colored
  pamphlets with graphics, question and answer
  format, headers, bullets, larger print, white
  space
• Other concerned, information-seekers want more
  detailed information
• Want a range of information about the risks and
  benefits of vaccines

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Misconception

• Improved sanitation and hygiene practices
  decreased disease incidence, not vaccines

Measles in U.S., 1912-1999
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Misconception

• Most infectious diseases no longer exist
• The need to vaccinate no longer exists

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Misconception

• Vaccines are not effective
• Most people who get a disease have been vaccinated

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Misconception

• Certain lots of vaccines have been associated
  with more side effects than others

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Providers Risk Communication Practices

• 30 not distributing VIS at all, 40 not giving
  the VIS at every visit.
• 70-75 of office visits include discussion of
  common side effects, schedule, when to call
  clinic
• 61 - severe side effects
• 47 - contraindications
• 47 - vaccine acronyms
• 43 - why so many?
• 26 - statistical risk of side effects
• 25 - personal advice

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Barriers to Vaccine Benefit / Risk Communication

• I dont have enough time (57)
• I dont want to unnecessarily alarm parents
  (24)
• Parents dont want to know (20)
• Parents dont understand (15)

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Cs of Effective Vaccine Communication

• Clarity
• Consistency
• Caringnot condescending
• Compassion
• Conversant
• Confidencenot cockiness
• Cultural sensitivity
• Credit and Congratulate

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National Vaccine Hotline
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Pamphlets
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Brochures
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CDs
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Health Screening

• Why Should We Want To
• To detect early stage disease accurately
• To improve clinical outcomes through early
  detection
• Notion of selective screening e.g. high-risk
  populations

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Test Accuracy

• Sensitivity
• the proportion of persons with disease who
  correctly test positive
• Specificity
• the proportion of persons without the disease who
  correctly test negative

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Interpreting test results for an individual
patient

• Positive Predictive Value (PPV)
• The probability of true disease if a screening
  test is positive
• Negative Predictive Value (NPV)
• The probability of no disease if a screening
  test is negative

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Calculating Sensitivity, Specificity, PPV
NPVhttp//www.cdc.gov/hiv/pubs/rt/sensitivity.htm

Sensitivity () TP / (TP FN) x
100 Specificity () TN / (FP TN) x 100
PPV () TP / (TP FP) x 100 NPV () TN / (FN
TN) x 100
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ChildrenScreening

• Infants
• phenylketonuria, hypothryoidism, sickle cell,
  lead, hemoglobin
• Preschool
• dental, hearing, vision, lead
• School Age
• violence, abuse, illicit drugs, sexual activity,
  depression

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Adults

• Women
• Cervical Cancer
• Pap Smear (age 18 or earlier if sexually
  active), level of monitoring varies depending
  upon the professional group
• Breast Cancer
• Mammogram at age 40 and annually thereafter,
  yearly breast exams by clinician, encourage SBE

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Adults

• Men
• Testicular Cancer
• self-exam, testicular exam by clinician at
  periodic exams
• Prostate Cancer
• PSA recommended at age 50, digital rectal exam
  (DRE) not recommended

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Adults

• Colon Cancer Screening
• options include FOBT, flexible sigmoidoscopy,
  colonoscopy (new ACS guidelines)
• Cholesterol Screening
• age 20, if normal every 5 years
• Selective screening
• blood glucose, HIV, HCV, TSH,

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Electronic Medical Records

• New options for help with monitoring health
  maintenance
• Not always easy to use
• Provider should take full responsibility even if
  EMR is in place
• Other options???

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Case Studies

• Screening
• There are 200 women who have cervical cancer and
  800 women who do not have cervical cancer. 68
  women have a positive pap smear who have cervical
  cancer, and 688 women have a negative pap smear
  who do not have cervical cancer. What is the
  sensitivity, specificity, PPV, and NPV of the pap
  smear?

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Case Studies

• Immunizations
• Bobby is a 6 month old baby in for a well-child
  check up. The mom states that hes had all of
  his shots so far. What immunizations has Bobby
  received in the prior 6 months?

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Case Studies

• Immunizations
• Mary is an 15 month old infant who is way
  behind in her immunizations according to her
  mom. You check the chart and see that she has
  received 2 HIBs, 1 IPV, and 2 DTaP. What
  immunizations do we need to give Mary today?