Transcript HELP!

To Err Is Human;
Not To Err Is Better!
Vaccination Errors and How to
Prevent Them
Deborah L. Wexler, MD
Immunization Action Coalition
[email protected]
National Immunization Conference
Dallas, Texas
March 31, 2009
With thanks to Donna L. Weaver, RN, MN,
National Center for Immunization and Respiratory
Diseases, CDC
and
Teresa A. Anderson, DDS, MPH
Consultant, Immunization Action Coalition
Types of vaccination errors
• Storage and handling
• Administration
• Scheduling
• Documentation
Vaccine storage and handling
• Vaccines are fragile
and must be kept at
recommended
temperatures at all
times
• It is better to NOT VACCINATE than to administer
a dose of vaccine that has been mishandled.
Adapted from CDC
The results of storage and handling
errors
• You can lose a lot of money (vaccines are costly!)
• You must revaccinate anyone who received a dose
of compromised vaccine, or, if the problem goes
unnoticed, the patient remains susceptible to the
disease.
• You will have to explain to irate parents why their
children must repeat the vaccine doses.
• The media may find out and provide your
practice with negative publicity.
CDC
Newspaper Headlines
This is the kind of publicity you don’t want
“1,900 doses of flu vaccine spoil in hospital’s faulty fridge”
(West Allis, WI; 11/3/04)
“Kaiser mishandles flu vaccine” (Fresno, CA; 12/15/04)
“Storage errors cause thousands to be vaccinated again”
(Knoxville, TN; 1/21/05)
“U.S. doctor accused of giving last year’s flu vaccine”
(Bellingham, WA; 11/6/04)
“Frozen vaccine could cost state more than
$30,000” (Arkansas; 11/19/04)
How to avoid storage and
handling problems
• Assign a vaccine manager
• Store vaccines appropriately
• Monitor and record refrigerator and freezer temperatures
twice daily and review the results twice a day
• Use only certified calibrated thermometers
• Maintain temperature logs for 3 years
• Implement a vaccine emergency system
• Take immediate action for out-of-range temperatures
• Do not store anything else in the refrigerator
Adapted CDC
Store all vaccine appropriately
Maintain freezer temp
at 5°F (-15°C) or colder
• Live vaccines
– MMR, VAR, MMRV, Zos
tolerate freezing. LAIV and
rotavirus do not.
– deteriorate rapidly after
removal from the refrigerator
• Inactivated vaccines
– are inactivated by freezing
– tolerate short times out of
the refrigerator
Maintain refrigerator temp
at 35-46°F (2-8°C)
Adapted CDC
Take preventive measures
• Use a plug guard or
safety-lock plug
• Post a warning sign at the
plug and on the refrigerator
• Label fuses and circuit
breakers
• Install a temperature alarm
CDC
Vaccine handling basics
• Open only one vial at a time
• Store vaccine vials separate from other
medications or biologics
• Do not store vaccines on the door of the unit
• Do not store food/beverages in refrigerator or
freezer with vaccines
• Keep light sensitive vaccines in their box until
ready to use
• Rotate your stocks so vaccines do not become
outdated
CDC
Pre-filling syringes
• This practice is strongly discouraged by CDC
• May result in vaccine administration errors
• May consider in situations of heavy use of a single vaccine
(e.g., annual influenza clinic)
• Consider using manufacturer-supplied prefilled syringes
• Syringes other than those filled by manufacturer should be
discarded at end of clinic day. Also, manufactured pre-filled
syringes that have had the caps removed and a needle
attached to the syringe should be discarded at the
end of the day.
Adapted CDC
Reconstituting Vaccines
• Live virus vaccines and some inactivated
vaccines must be administered promptly after
reconstitution
• If not administered within the time limit, these
vaccinations need to be repeated! (If a live
vaccine, with a 4-week minimum interval.)
Time limits for using vaccines after
reconstitution
•
•
•
•
•
•
•
Varicella ≤ 30 min (and protect from light)
Zostavax ≤ 30 min (and protect from light)
MMRV ≤ 30 min (and protect from light)
Yellow fever ≤1 hour
MMR ≤ 8 hours
Menomune single dose vial ≤ 30 min
TriHIBit ≤ 30 min (DTaP/ActHib)
Storage and handling resources
from IAC – 1
• Checklist for Safe Vaccine Handling and Storage
www.immunize.org/catg.d/p3035.pdf
• Don’t Be Guilty of These Errors in Vaccine Storage and
Handling www.immunize.org/catg.d/p3036.pdf
• Vaccine Handling Tips www.immunize.org/catg.d/p3048.pdf
• Maintaining the Cold Chain During Transport
www.immunize.org/catg.d/p3049.pdf
• Emergency Response Worksheet
www.immunize.org/catg.d/p3051.pdf
Storage and handling resources
from IAC – 2
• Temperature Log for Vaccines (Fahrenheit)
www.immunize.org/catg.d/p3039.pdf
• Temperature Log for Vaccines (Celsius)
www.immunize.org/news.d/celsius.pdf
• “Do Not Unplug” sign (color)
www.immunize.org/news.d/2090plugy.pdf
• “Do Not Unplug” sign (black and white)
www.immunize.org/news.d/2090plug.pdf
Storage and handling resources
from CDC
CDC’s comprehensive “Vaccine Storage and
Handling Training Material Toolkit” can be
accessed online at
www2a.cdc.gov/vaccines/ed/shtoolkit
Storage and handling resources from
CDC
This 20-page guide provides shipping
requirements; condition upon arrival;
storage requirements; shelf life;
instructions for reconstitution and use;
shelf life after reconstitution, thawing
and opening; and any special
instructions for all recommended
vaccines. Go to:
www.cdc.gov/vaccines/pubs/
downloads/bk-vac-mgt.pdf
Types of vaccination errors
• Storage and handling
• Administration
• Scheduling
• Documentation
Types of Administration Errors
• Wrong vaccine or wrong diluent
• Wrong dosage
• Expired vaccine
• Wrong route / site / needle size
Use the right vaccine:
Check the vial label 3 TIMES
• PPD
(tuberculin skin test)
• DT
• Td
CDC
Diphtheria, tetanus, & pertussis vaccines
• DTaP (6 wks-6 yrs):
Think of DTaPeds
• Tdap: Think of
Talldap
Adapted CDC
From our IAC email archive…
HELP!
HELP! “A community health center in our area
inadvertently gave a dose of Tdap to a 5-year-old,
instead of a DTaP. What is their next best step to take
under this circumstance?
HELP! “Someone in our clinic gave DTaP to a 50-yearold instead of Tdap. How should this be handled?”
DTaP and Tdap errors
Error
DTaP given to person ≥7yrs
Action
Count dose as valid
Tdap given to child <7yrs as
DTaP #1, 2, or 3
Do not count dose; give
DTaP now
Tdap given to child <7yrs as
DTaP #4 or 5
Count dose as valid
www.cdc.gov/mmwr/PDF/rr/rr5503.pdf (ACIP Tdap recs, p. 27)
CDC
More errors . . . using the wrong diluent –
Get it right!
Vaccines + Diluents
ActHIB –
diluent is 0.4% NaCl
M-M-R II, Var, MMRV,
and Zos –
TriHIBit –
(DTaP+Hib – 12-15 mos)
for TriHibit the ActHIB
diluent is Tripedia
diluent is sterile water
Menomune –
diluent is sterile water
As a general rule, diluents are not
interchangeable
• Exception: the diluent for MMR and MMRV. The
diluent is the same (sterile water) and made by the
same company.
• If the wrong diluent is inadvertently used, the
immunization needs to be repeated.
Giving the wrong vaccine will rarely
cause a serious problem, but…
• Additional doses can lead to more vigorous local
reactions
• Patient may be left unprotected against disease
• Additional cost
• Inconvenience to patient/parent
• May cause loss of faith in provider or complaint
to state board
HELP! “Yesterday I took my two year old twins to the doctor
for their check-up. They were given their vaccinations at
that time. Today we received a phone call that one of the
vaccinations they were given was the wrong one… I do not
know if this will cause them any harm or if I should worry
that down the road they may experience problems as a
result of this mess-up. I am just wondering what I should
do. I am planning to find someone else to care for my
twins. It is scary that not only the doctor messed up the
order, but the nurses that gave the vaccinations did not
question it.”
Another administration error: giving
the wrong dose
HELP! One of our staff gave a dose of pediatric
hepatitis A vaccine to an adult patient by mistake.
How do we remedy this error?
ANSWER
If less than a full age-appropriate dose of any vaccine
is given, the dose should not be counted. The person
should be revaccinated with the appropriate dose as
soon as possible.
http://www.immunize.org/catg.d/p2081.pdf
The right dose: split or partial doses
• Split or partial (incomplete)
doses are NOT valid doses
+
– But the following DO count
• LAIV if person sneezes
• Rotavirus vaccine if infant
regurgitates, spits out, or vomits
CDC
The right dose: combining vaccines
+
• Vaccines should
NEVER be
combined in the
same syringe
unless FDA
approved for this
purpose
CDC
Another administration error:
using expired vaccine
CDC
HELP! “A physician just called and gave a child a dose
of expired vaccine. I am assuming the dose should be
re-administered. Please advise.”
ANSWER
The dose should be repeated. If the expired dose is a
live virus vaccine (e.g., MMR, Var) you must wait at
least 4 weeks after the previous (expired) dose was
given before repeating it. The repeat dose of an
expired inactivated vaccine can be given on the same
day or any other time.
Another administration error:
incorrect route, site, or needle size
Adapted CDC
Intramuscular (IM) injections
•
•
•
•
•
•
•
•
•
•
•
DTaP, DT
Hep A
Hep B
Hib
HPV
Influenza (TIV)
IPV (SC or IM)
MCV4
PCV
PPSV (SC or IM)
Tdap, Td, TT
• DTaP + Hib (Trihibit)
• DTaP + Hep B + IPV
(Pediarix)
• Hep A + Hep B (Twinrix)
• Hep B + Hib (Comvax)
• DTaP + Hib + IPV
(Pentacel)
• DTaP + IPV (Kinrix)
CDC
Multiple vaccinations
• Use the thigh for multiple IM injections in infants and
young children
• The deltoid muscle can be used for children older than
one year and adults
• Separate each injection by at least 1”
• Administer vaccine and immune globulin at separate
sites
• Combination vaccines can reduce the number of
injections needed
CDC
Administering multiple vaccinations
www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/D/
site-map.pdf
HELP! “One of our nurses accidentally gave zoster
vaccine IM instead of SC. Can you tell me what we
need to do?”
ANSWER
Vaccines should always be given by the route
recommended by the manufacturer. If this does
inadvertently happen, ACIP recommends that vaccines
given by the wrong route be counted as valid with two
exceptions: hepatitis B or rabies vaccine given by any
route other than IM (and in the deltoid or anterolateral
thigh muscle) should not be counted as valid and should
be repeated.
Miscellaneous administration hints
• Syncope occurs most often in adolescents and young adults;
consider observing patients 15-20 minutes after vaccination.
• OSHA regulations do not require the wearing of gloves when
administering vaccinations, unless the person administering
the vaccine is likely to come into contact with potentially
infectious body fluids or has an open lesion on their hand.
• It is not recommended to change needles after a vaccine
dose has been drawn into a syringe.
• ACIP does not recommend aspiration when
administering vaccines because no data exist
to justify the need for this practice.
Vaccine administration resources
from IAC
• How to Administer Intramuscular (IM) Injections
www.immunize.org/catg.d/p2020.pdf
• How to Administer IM and SC Injections to Adults
www.immunize.org/catg.d/p2020a.pdf
• Administering Vaccines to Adults: Dose, Route, Site,
Needle Size, and Preparation
www.immunize.org/catg.d/p3084.pdf
• Administering Vaccines: Dose, Route, Site, and
Needle Size www.immunize.org/catg.d/p3085.pdf
Vaccine administration resource from
Calif. Dept. of Health Services
"Immunization Techniques: Safe, Effective,
Caring" is a 35-minute DVD that teaches best
practices about how to administer IM and SC
vaccines. It is designed for use as a "handson" instructional program for staff
The DVD discusses the following:
• Anatomic sites
www.immunize.org/shop
• Choice of needle size
• Routes of administration
• How to draw up doses of vaccine
Types of vaccination errors
• Storage and handling
• Administration
• Scheduling
• Documentation
Common scheduling errors - 1
• Giving the 4th dose of DTaP before age 12 months or
less than 6 months after 3rd dose
• Giving the 1st dose of MMR before age 12 months
• Giving PPSV every 5 years
• Finishing infant’s hepB series before 24 wks
Common scheduling errors - 2
• Giving TriHIBit (DTaP / ActHib) at 2, 4, and 6 mos
• Giving rotavirus vaccine after 8 months 0 days
• Giving any vaccine (except hepatitis B) before age
6 weeks
• Restarting any vaccine series because of a
longer-than-recommended interval
IMPORTANT RULE:
Vaccine doses should not be administered
at intervals less than the recommended
minimal intervals or earlier than the
minimal ages.
But, there is no maximum interval!
(Except for oral typhoid vaccine in some circumstances.)
HELP! “I plan to visit China and stay a year. My doctor
said I can have the first dose of hepatitis A vaccine right
now and then get the second dose three months later. But
from your website, I saw ‘second dose no sooner than
6 months after the first dose.’ From CDC website I saw
6-18 months after the first dose. From NIH website, I saw
6 months after the first dose. Who is correct?”
It might be embarrassing if your patients have to
correct you! Know the minimum intervals and ages
www.cdc.gov/vaccines/pubs/pinkbook/downloads/
appendices/A/age-interval-table.pdf
Know how to use the 4-day “grace period”
Since 2002, ACIP recommends that doses administered up to 4
days before the minimum interval or age can be counted as valid.
The 4-day "grace period" should not be used when scheduling
future vaccination visits, or applied to the 28-day interval between
live parenteral vaccines of two different vaccines not administered
at the same visit. It should be used primarily when reviewing
vaccination records (for example, when evaluating a vaccination
record prior to entry to daycare or school).
Use of the grace period may create a conflict with state daycare or
school entry vaccination requirements.
HELP! “If the schedule for Gardasil (HPV) is interrupted
and a patient is way late for a second or third shot, is there
a need to start the vaccines over again? ”
ANSWER
No! If the series is interrupted after the first dose, the second
dose should be administered as soon as possible, and the
second and third doses should be separated by an interval
of at least 12 weeks, but there at least 24 weeks between
doses #1 and#3. If only the third dose is delayed, it should
be administered as soon as possible.
HELP! “How can we quickly determine how to
catch up children who have fallen behind on their
shots?”
ANSWER
Infants or children who are more than 1 month or 1 dose behind
schedule should be on an accelerated schedule, which means the
intervals between doses should be reduced to the minimum
allowable. Catch-up schedules for children and adolescents are
included with each year's U.S. Recommended Immunization
Schedule that is issued by ACIP, AAP, and AAFP.
Scheduling resources from IAC
• Summary of Recommendations for Childhood
and Adolescent Immunization www.immunize.org/childrules
• Summary of Recommendations for Adult Immunization
www.immunize.org/adultrules
• Pneumococcal Polysaccharide Vaccine (PPSV):
CDC answers your questions
www.immunize.org/catg.d/2015pne.pdf
Where to get immunization schedules
• Official child and adult IZ schedules on CDC website in various
sizes (pocket to 11”x17”), in color and B & W, and for office or
commercial press printers at
www.cdc.gov/vaccines/recs/schedules.
• IAC sells 6-page laminated 8.5”x11” versions of the child/teen and
adult schedules that include a list of contraindications and
precautions www.immunize.org/shop
• Society of Teachers of Family Medicine has schedules that
can be downloaded to a Palm OS Handheld. Go to
www.immunizationed.org/AnyPage.aspx?pgid=2
Types of vaccination errors
• Storage and handling
• Administration
• Scheduling
• Documentation
Types of documentation errors
• Not providing VISs
• Not knowing if written consent is required
• Not recording all needed information
HELP! “My 2 month old child was recently inoculated at his
pediatrician’s office. The day following the immunizations my
son spiked a high fever and I was extremely concerned. I called
our local hospital and found out that I should have been given a
VIS sheet for each of the inoculations that my child received. I
did bring this matter up with the pediatrician’s office and I was
told by the office manager that she didn’t know of any law that
mandated they give information sheets out… My question is to
whom do I report this incident to? I no longer take my child to
their office, but I want them to start doing things right.”
A minor side effect becomes a big problem
because the parent wasn’t given a VIS…
HELP! “For a child, do we have the parent sign each
time we give a vaccine in a series or is it enough to
have them sign for the first one?”
ANSWER
There is no federal law requiring written consent to vaccines. VISs
cover both benefits and risks associated with vaccinations and they
provide enough information that anyone reading them should be
adequately informed. However, a few states have informed consent
laws covering either procedural requirements (e.g., whether consent
may be oral or must be written) or substantive requirements (e.g.,
types of information required). Check with your state
immunization program.
Required information to document
•
•
•
•
•
•
•
•
•
Type of vaccine e.g., (MMR-V) (DTaP-Hib)
Date vaccine is administered
Vaccine source (Federally- or State-supported or private)
Site given (RA, LA, RT, LT, IN, PO)
Vaccine lot #
Manufacturer
Date of the VIS
Date the VIS was given
Signature/initials of vaccinator
www.immunize.org/catg.d/p2022.pdf
How to avoid vaccine errors…
HELP!
HELP!
HELP!
HELP!
HELP!
HELP!
HELP!
Keep yourself current!
• Read CDC’s “Pink Book”
www.cdc.gov/vaccines/pubs/pinkbook/pinkchapters.htm
• Find answers in relevant ACIP recommendations
www.immunize.org/acip
• Read IAC’s “Ask the Experts” Q&As
www.immunize.org/askexperts
• Subscribe to IAC Express for weekly updates
www.immunize.org/subscribe
Need more help?
• Email CDC’s experts: [email protected]
• Contact your vaccine rep or call the manufacturer
• Call your state immunization manager -- contact
information can be found at
www.immunize.org/coordinators
• Email IAC: [email protected]
The End