Massachusetts Department of Public Health Bureau of Infectious Disease Prevention, Response and Services Vaccinator Training

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Massachusetts Department of Public Health
Bureau of Infectious DiseasePrevention,
Response and Services Vaccinator Training

• Fall 2009

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Learning Objectives

• Upon completion of this program you will be able
  to
• Differentiate between seasonal and pandemic
  influenza
• Discuss influenza vaccine
• Describe H1N1 vaccine
• Identify initial target groups for H1N1 vaccine
• Summarize principles of vaccine management
• Describe proper vaccine storage and handling

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Learning Objectives

• List federal and state requirements for
  vaccination documentation and record keeping
• Explain the screening process prior to
  vaccination
• Review infection control principles
• Describe vaccine preparation and administration
  techniques
• Define vaccine adverse event reporting
• Explain vaccination liability protection
• List available resources

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What is influenza (flu)?

• A contagious respiratory illness
• caused by a virus that affects
• the bodys breathing system,
• including the nose, mouth,
• trachea and lungs.

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Symptoms of Seasonal Influenza

• fever (usually high)
• headache
• extreme tiredness
• dry cough
• sore throat
• runny or stuffy nose
• muscle aches
• stomach symptoms, such as nausea, vomiting, and
  diarrhea, also can occur but more common in
  children than adults

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Impact of Seasonal Influenza

• 36,000 excess deaths annually in the US
• Est. gt 800 MA residents die from complications of
  influenza
• 114,000 or more hospitalizations in the US
• Est. gt 2,600 excess hospitalizations in MA

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Influenza Vaccine Inactivated (TIV) and Live
attenuated (LAIV)

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Flu Vaccine Overview

• Manufacturers (5)
• Novartis
• CS Limited Biotheraputics Inc.
• Glaxo Smith Kline (GSK)
• Sanofi Pasteur
• Medimmune

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Flu Vaccine

• Flu shot - inactivated vaccine (TIV) (killed
  virus)
• Approved for persons gt 6 months of age
• Nasal spray vaccine - live attenuated vaccine
  (LAIV) made with weakened flu viruses that do not
  cause the flu
• Healthy people 2 - 49 years of age who are not
  pregnant.

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Flu Vaccines

• Contains non-infectious virus fragments
• Live, attenuated nasal spray does not replicate
  systemically
• Flu vaccines cannot cause influenza
• It takes 10 14 days for vaccine to be fully
  effective

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Inactivated Flu Vaccine Recommended For

• Children 6 mos 18 y/o and adults gt 50 y/o
• Pregnant women
• Persons lt 18 y/o on long-term aspirin therapy
• Persons gt 6 months of age with
• Chronic pulmonary (inc. asthma), cardiovascular
  (exc. hypertension), renal, hepatic,
  hematological or metabolic disorders (inc.
  diabetes)
• Immunosuppression
• Any condition (e.g., cognitive dysfunction,
  spinal cord injuries, seizure disorders) that
  compromise respiratory function or handling of
  resp. secretions or that increase the risk of
  aspiration
• Residents of long term care (LTC) facilities

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Inactivated Flu Vaccine Recommended For

• Persons who can transmit to high-risk groups
• Health Care Providers (HCP) including home care
• Employees of Long Term Care (LTC) residential
  facilities
• Household contacts of infants lt 6 months and
  other high-risk persons

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Inactivated Flu Vaccine

• Trivalent protects against 3 strains
• Efficacy varies by match, age group and
• underlying illness
• Duration of immunity lt 1 year

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Inactivated Flu Vaccine Efficacy

• 70 - 90 effective in preventing Influenza Like
  Illness (ILI) in healthy young adults
• In Long Term Care patients gt 65 y/o
• 30 - 40 effective in preventing ILI
• 50 - 60 effective in preventing hospitalization
• 80 effective in preventing death

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Inactivated Flu Adverse Reactions

• Local reactions - TIV 15 - 20
• Fever, malaise uncommon
• Allergic reactions rare
• Neurological very rarereactions

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Inactivated Flu Vaccine Contraindications
Precautions

• Anaphylactic reaction to
• previous flu vaccine
• egg protein or any other component of the
  vaccine (see package insert)
• Vaccine may be postponed in case of febrile or
  acute illness
• History of Guillain Barré syndrome within 6 weeks
  following a previous dose of inactivated flu
  vaccine (precaution)

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Live Attenuated Influenza Vaccine (LAIV)

• Live, attenuated, producing
  mild or no signs/symptoms
  related to flu
• Nasal spray
• Trivalent same virus strains as in TIV
• Does not contain thimerosal, latex
• Contains egg protein

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LAIV

• LAIV can be given to
• Healthy people 2 49 years of age
• HCWs and contacts of people at risk for
  complications from influenza, except for persons
  who are so severely immunosuppressed they require
  a protective environment

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LAIV Adverse Reactions

• Children
• no significant increase in URI symptoms, fever,
  or other systemic symptoms
• increased risk of asthma or reactive airways
  disease in children 12-59 months of age
• Adults
• significantly increased rate of cough, runny
  nose, nasal congestion, sore throat, and chills
  reported among vaccine recipients
• no increase in the occurrence of fever
• No serious adverse reactions identified

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LAIV Contraindications and Precautions

• Children younger than 2 years of age
• Persons 50 years of age or older
• Persons with chronic medical conditions
• Children and adolescents receiving long-term
  aspirin therapy
• These persons should receive inactivated
  influenza vaccine

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LAIV Contraindications and Precautions

• Immunosuppression from any cause
• Pregnant women
• Severe (anaphylactic) allergy to egg or other
  vaccine components
• History of Guillain-Barré syndrome
• Children younger than 5 years with history of
  recurrent wheezing
• Moderate or severe acute illness
• These persons should receive inactivated flu
  vaccine

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LAIV of Children 2-4 Years of Age

• Ask parents or caregivers of children 2-4 years
• In the past 12 months, has a healthcare
  provider ever told you that your child had
  wheezing or asthma?
• Children whose parents answer "yes", or whose
  medical record notes asthma or a wheezing episode
  within the past 12 months, should not receive
  LAIV
• Administer inactivated flu vaccine to children
  with asthma or possible reactive airways diseases

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Use of LAIV Among CloseContacts of High Risk
Persons

• Inactivated flu vaccine is preferred for close
  contacts of severely immunosuppressed persons who
  require care in a protective environment
• Persons who receive LAIV should refrain from
  contact with severely immuno-suppressed persons
  for 7 days after vaccination
• Source MMWR 2006 55 (RR-10)

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Administration of LAIV

• Pregnant Health Care Personnel (HCP) and those at
  increased risk for influenza complications may
  administer LAIV
• Gloves and masks are not required

e.g., pregnant women, persons with asthma and
other chronic medical conditions and persons 50
years of age or older
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Pregnancy and Influenza

• Risk of hospitalization higher than non-pregnant
  women
• Risk of complications comparable to non-pregnant
  women with high risk (HR) medical conditions

Source MMWR 200655 (RR-10)
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Pregnancy and Influenza Vaccine

• No adverse fetal effects associated with
  inactivated flu vaccine
• No data for safety of LAIV and pregnancy
• Vaccinating pregnant women provides some
  protection against flu for newborns and infants
  up to 6 months

Source MMWR 200958
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Flu Vaccines Summary

• Inactivated flu vaccine for
• Children 6 23 mos old
• Adults gt 49 yrs
• Pregnant women
• Persons with medical conditions
• Either inactivated or LAIV for healthy,
  non-pregnant persons 2 49 yrs old

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H1N1 Vaccine What We Expect
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H1N1 Vaccine Shipments in MA

• By end of Oct 2009      1.3M doses
• Nov. and beyond 1M doses/month
  
• while
  demand lasts

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• gt 5 formulations of H1N1 vaccine
• Approved for different age and risk groups
• Live nasal spray and inactivated injectable
• Provided through McKesson with vaccine
• Needles, syringes
• Alcohol swabs
• Sharps containers
• Vaccine record cards
• Does not include bandaids, gauze, Epi-Pens

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Initial Target Groups
For H1N1 Vaccine

• Pregnant women
• Household (HH) contacts/caregivers of infants lt 6
  months
• Health care personnel (HCP) and EMS
• Persons 6 months 24 years/old
• High Risk (HR) persons 25 - 64 years/old
• 3.4 M in MA

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Chronic medical conditions that confer a higher
risk for flu-related complications

• Pulmonary (including asthma)
• Cardiovascular (except hypertension)
• Renal, hepatic, cognitive, hematologic,
  neurologic/neuromuscular, or metabolic disorders
  (incl. diabetes mellitus)
• Immunosuppression (incl. that caused by
  medications or by HIV)

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When H1N1 Vaccine Supply Increases
Provisional ACIP Recommendations

• When vaccine is sufficient to vaccinate initial
  target groups, expand vaccination to
• Healthy adults 25 through 64 years of age

2 M in MA
In consultation with state and local health
departments
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People gt 65 y/o

• Have some immunity to novel H1N1
• Risk for infection less
• Offer vaccine when demand among target groups met
• Still target group for
• Seasonal flu vaccine
• Pneumococcal vaccine

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H1N1 Vaccine What We Expect

• Most age groups may only need 1 dose
• If 2 doses are needed
• Vaccinators not responsible for patient recall
• H1N1 vaccine should not be kept in reserve for
  later administration of the 2nd dose
• No need to verify target group
• Seasonal and H1N1 vaccine can be given at same
  time (with the exception of LAIV)

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Vaccine Management
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Vaccine Inventory Management

• Order vaccines regularly, do not stockpile
• Rotate stock to use shortest shelf life first
• Conduct physical inventory x1 per month
• Double check expiration dates

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Inactivated Flu LAIV Vaccine Storage
HandlingMaintain proper temperatures

• Refrigerator
• 2o - 8o C
• OR
• 35o - 46o F

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Vaccine Storage Requirements
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Vaccine Storage Requirements

• Maintain required temperature range year-round
• Large enough to hold years largest inventory
• Dedicated to vaccines
• Arrangements for vaccine storage during summer
  months

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Vaccine Storage Handling

• Log temperatures twice a day
• Upon opening in a.m.
• Just before closing for the day
• Develop a back-up plan for power failures
• Share the back up plan!

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Certified Calibrated Thermometers
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Certified Calibrated Thermometers
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The Effect of Thermotrauma on Vaccines

• Live vaccines
• Tolerate freezing
• Live viruses deteriorate rapidly after removal
  from refrigeration
• Inactivated vaccines
• Inactivated by freezing
• Tolerate short times out of refrigeration

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Temperature Control
Refrigerator
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Maintaining the cold chain

• Transporting vaccine from storage
• location using a cooler and cold packs
• If the temperature of the vaccine goes out of
  range, either too high or too low, call the MDPH
  Vaccine Unit immediately!
• [phone]

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Vaccine Storage Handling Tips

• Do not store vaccines on the refrigerator doors
• Do not store biologics with food or drink
• Ensure that vaccines are stacked to allow proper
  air circulation keep away from walls back of
  unit
• Do not keep expired vaccine in refrigeration unit
• Store bottles of H20 ice packs to help maintain
  temperature

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Vaccine Storage and HandlingTake-Home Messages

• Colder is NOT better for inactivated vaccines
• Out of range temperature readings require
  IMMEDIATE action
• It is estimated that gt100 million worth of
  vaccine is exposed to freezing temperatures each
  year in the United States

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Vaccination Key Resources

• MDPH Guidelines for Compliance with Federal and
  State Vaccine Administration Requirements
• MDPH General Protocol for Vaccine Storage,
  Administration, Standing Orders, Immunization
  Clinics, Sept 2009 New
• MMWR General Recommendations on Immunization,
  Recommendations of the Advisory Committee on
  Immunization Practices (ACIP), December 2006
• Epidemiology and Prevention of Vaccine
  Preventable Diseases (CDC) (The Pink Book)

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Vaccination Clinic Supplies

• Vaccine (maintain proper temp)
• Cooler(s) and cold packs
• Syringes
• Alcohol wipes
• Gauze
• Sharps containers
• Bandaids
• Table covering
• Trash bags to line waste baskets
• Forms Screening forms, VIS, vaccine record
  cards,
• Emergency supplies phone, Epi-Pens, Benadryl
  ..

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Vaccine Questions

• MDPH Vaccine Management Unit
• [phone]
• MDPH Immunization/Epidemiology Division
• [phone] ext. 6828
• [phone] (24x7)
• Always consult with MDPH Immunization Program
  before removing improperly stored vaccine from
  the storage unit

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Vaccine Administration
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Immunization Standing Orders

• You must use a standing order that is signed by a
  physician or medical director
• Model standing orders are
• available

http//www.mass.gov/dph/imm
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Standing Orders Vaccinator Responsibilities

• Being educated about storage, handling,
  administration, contraindications, reporting of
  adverse events and documentation required
• Completing accurate and legible entries
• Relaying to the patient information on the risks
  and benefits of accepting or refusing vaccine

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Standing Orders Vaccinator Responsibilities

• Understanding the method for documenting informed
  consent receipt of information
• Assessing for allergy history of the patient
  prior to administration of vaccine
• Being able to access and use emergency equipment
• Current CPR certification

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Clinic Immunization Recording Sheet

• Type of vaccine
• Dose number
• Dose amount
• Manufacturer
• Lot number and expiration date
• Date the vaccine was administered
• Anatomic site and route
• Name and address of the person giving the vaccine
• Date the Vaccine Information Statement was given
• Publication date of the Vaccine Information
  Statement

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Inside of H1N1 Vaccine Record
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What is a Vaccine Information Statement (VIS)

• A vaccine information statement is an
  information sheet produced by CDC informing
  vaccine recipients or their parents/guardians of
  the benefits and risks of a vaccine

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VIS Benefit and Risk Communication

• VISs must be given before each dose of vaccine
• Provide opportunities for questions
• Signature from vaccinee is not required, except
  for a minor when the parent is not on-site
• VIS in English and other languages at
  www.immunize.org/vis

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Always screen vaccinees for contraindications
according to the standing orders
www.immunize.org/catg.d/p4060.pdf
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Preparation

• Prepare patient for vaccination considering their
  age and stage of development. Encourage
  parents/patients to take active role before,
  during and after vaccine administration
• Screen patient for contraindications and
  precautions for each scheduled using screening
  tool
• Be prepared to discuss the benefits and risks of
  vaccines using the VIS

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Preparation

• Display confidence and establish a sense of
  security and trust for the patient
• Use techniques to minimize the stress and
  discomfort, esp. with children
• Accommodate patient's comfort, safety, age,
  activity level, and the site of administration
  when considering patient positioning and
  restraint
• For a child, encourage parent to hold the child
  during administration. If the parent is
  uncomfortable, ask someone else

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Patient Comfort

• Counsel patient about the use of non-aspirin pain
  relievers to decrease discomfort and possible
  fever following vaccination
• Use age-appropriate non pharmacologic techniques
  to provide distraction

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Infection Control

• Wash hands or use alcohol-based hand sanitizer
  before vaccine preparation and between patients
• Gloves are not required unless the person
  administering the vaccine is likely to come into
  contact with potentially infectious body fluids
  or has open lesions on the hands.
• Gloves cannot prevent needle stick injuries

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Infection Control

• Report needle stick injuries immediately to site
  supervisor, with appropriate care and follow-up
• Use safety needles if available
• Do not detach, recap or cut used needles before
  disposal
• Place used syringe/needle in puncture proof
  sharps (biohazard) container to prevent needle
  sticks and reuse
• Dispose of empty or expired vaccine vials as
  medical waste

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Vaccine Preparation
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Intramuscular (IM) Injection Procedure

• Child/Adult IM landmarks deltoid muscle
  two-three fingers below acromion and above armpit
• Infant/Toddler Vastus lateralis muscle is on the
  outside of the leg in the mid- to upper-thigh

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IM Injection Procedures Needle sizes

• Assess patients muscle mass
• 1 inch for infants, children and adults up to
• 130 lbs
• 1-1½ inches for females 130-200 lbs and males
  130-260 lbs
• 1½ inches for females and males gt 260 lbs
• 5/8 inch needle length may be used in some age
  groups
• anatomic sites

www.immunize.org/catg.d/p2020.pdf
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Vaccine Administration

• Do not aspirate
• Inactivated and live attenuated vaccine can be
  given at the same time (e.g. can give Inactivated
  (TIV) IM vaccine and H1N1 intranasal vaccine at
  the same time)
• Two live vaccines should not be given together
  if only live vaccines are available, separate by
  4 weeks
• May be different interval for H1N1 vaccine

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FluMist Administration Instructions

• 1. Check expiration date. Product must be used
  before the date on sprayer label
• 2. Remove rubber tip protector. Do not remove
  dose-divider clip at the other end of the sprayer
• 3. With the patient in an upright position, place
  the tip just inside the nostril to ensure FluMist
  is delivered into the nose

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FluMist Administration Instructions

• 4. With a single motion, depress plunger as
  rapidly as possible until the dose divider clip
  prevents you from going further
• 5. Pinch and remove the dose-divider clip from
  the plunger
• 6. Place the tip just inside the other nostril
  and with a single motion, depress plunger as
  rapidly as possible to deliver remaining vaccine

http//www.flumist.com/Professional/Dosing-Adminis
tration/Default.aspx
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Be Prepared for the Unexpected

• While hypersensitivity/allergic reactions
  following
• vaccination are rare You still need to be
  prepared
• with personnel, facilities and equipment/supplies
  
• Emergency Standing Orders need to be signed by
  physician or medical director before the start of
  clinic
• Observe patient for 20 minutes if possible
  following vaccination
• Have emergency supplies available and know how to
  use them
• Emergency Standing Orders can be found at

http//www.mass.gov/dph/imm
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Vaccine Adverse Event Reporting

• Report Adverse Events to Vaccine Adverse Events
  Reporting System (VAERS) www.vaers.hhs.gov
  1-800-338-2382
• Report Vaccine Administration Errors to the
  Institute for Safe Medication Practices
  www.ismp.org

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Vaccinator Liability Protection

• M.G.L. c. 112, 12C provides complete immunity
  from liability for physicians and nurses who work
  in government-funded public health programs.
• PREP Act (Public Readiness and Emergency
  Preparedness Act) provides immunity from tort
  liability under state and federal law
• MA Public Health Council Regulations (08/12/09
  9/9/09)

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MDPH Educational Tools

• Flu Care at Home Booklets
• Comprehensive
• Multiple languages
• New Basic Literacy
• Give people tools needed to take care of
  themselves at home should they become ill

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MDPH Staff Resources Available To Guide You

• MDPH Epidemiology/Immunization Program
• 617-983-6800 (24x7)
• 888-658-2850
• MDPH Vaccine Unit
• 617-983-6828

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Online Resources

• Massachusetts Department of Public Health (MDPH)
  www.mass.gov/flu
• MDPH Immunization Program
• http//www.mass.gov/dph/imm
• Immunization Action Coalition
• www.immunize.org
• Centers for Disease Control and Prevention (CDC)
  http//www.cdc.gov/h1n1flu/
• Epidemiology and Prevention of Vaccine-Preventable
  Diseases, The Pink Book Course Textbook (11th
  Edition), May 2009 http//www.cdc.gov/vaccines/pub
  s/pinkbook/default.htmdownload  

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Online Resources

• Mass 211 (for general public) http//www.mass211.o
  rg/emergencyinfo.html
• MassPro for Flu clinic locations
• http//flu.masspro.org
• World Health Organization
• http//www.who.int/csr/disease/swineflu/en/

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