Types of vaccination errors To Err Is Human: •Storage and handling • Administration Not to Err Is Better! • Scheduling Vaccination Errors and How to Prevent Them • Documentation
Dec 2019 ▪ Item #S8020 2
Vaccine storage and handling The results of storage and handling errors
• Your patients may get seriously ill from not being immune • Vaccines are fragile and must from a vaccine‐preventable disease be kept at recommended • You must revaccinate anyone who received a dose of temperatures at all times compromised vaccine • Vaccines are expensive • You will have to explain to parents why their children must repeat vaccine doses • Your practice may experience negative publicity It is better to NOT VACCINATE than to administer a dose of vaccine that has been mishandled • You may lose a lot of money
3 CDC 4 CDC
Newspaper Headlines “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” Is any publicity really good publicity? Arkansas; 11/19/04
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Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 1 From our IAC email archive…
HELP! “We have a local practice that had issues with their refrigerator temperatures being too cold for an HELP! extended period. All the vaccines that were given during that time frame are now considered invalid. They have many 2‐year‐old patients who received 4 doses of DTAP all of which were stored improperly…”
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How to avoid storage Vaccine handling basics & handling problems • Open only one vial at a time • Assign a vaccine manager • Store all vaccines appropriately • Store vaccine vials separate from other medications or • If using temperature monitoring device (TMD) that records min/max biologics temps, document min/max once each workday (preferably in • Do NOT store food/beverages in refrigerator or freezer morning); if TMD does not record min/max temps, document with vaccines current temps twice (at beginning and end of workday) • Use only certified calibrated TMDs that use an active display to • Keep light‐sensitive vaccines in their box until ready to use provide continuous monitoring information • Rotate your stocks so vaccine never become outdated • Maintain temp logs for 3 years • Implement a vaccine emergency system • Take immediate action for out‐of‐range temps • Do not store anything else in the refrigerator or freezer 9 Adapted CDC 10
Prefilling syringes
• This practice is strongly discouraged by CDC HELP! “Can you advise as to the safety and efficacy of • May result in vaccine administration errors drawing up flu vaccine ahead of time for mass • May consider in situations of heavy use of a single vaccine vaccination clinics? One place I work is using vaccines (e.g., annual influenza clinic) drawn from a multidose vial as much as a week • Consider using manufacturer‐supplied prefilled syringes before actually giving the vaccine.” • Syringes other than those filled by manufacturer should be discarded at end of clinic day. Also, manufactured prefilled syringes that have had the caps removed and a needle attached to the syringe should be discarded at the end of the day.
11 12 Adapted CDC
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 2 Examples of time limits for using vaccines after reconstitution Live virus vaccines and some inactivated vaccines • Varicella <30 mins (and protect from light) must be administered promptly after reconstitution… • MMRV <30 mins (and protect from light) • Yellow fever <1 hour If not administered within the time limit, these • MMR <8 hours (and protect from light) vaccinations need to be repeated! • Shingrix <6 hrs (and protect from light) (If live virus vaccine, there is a 4‐week minimum interval.) • Menveo <8 hrs (and protect from light)
More information on vaccines with diluents and time limits: www.immunize.org/catg.d/p3040.pdf
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Types of vaccination errors Administering vaccines correctly
• Storage and handling • Ensure staff is adequately trained • Administration • Provide current immunization • Scheduling education • Documentation • Adhere to OSHA guidelines for employee safety • Provide staff with easy‐to‐use resources and guidelines
15 16 Adapted CDC
Types of administration errors A study using the largest medication error reporting • Wrong vaccine or diluent database in the U.S. found that administration of the wrong vaccine was commonly reported. • Wrong dosage • Expired vaccine Such errors usually involved vaccines whose • Incorrect route/site/needle size generic or trade names looked or sounded alike (Tdap/DTaP, Adacel and Daptacel), or which have similar packaging.
17 18 Vaccine (2009)27:3890–6
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 3 Similar packaging – Check the vial 3 TIMES Is it Tdap, DTap DTap, or a combo? Td Check the vial 3 times! Tdap
19 CDC 20 http://eziz.org/assets/docs/IMM‐508.pdf
Another source of confusion: More confusion: influenza vaccines Varicella‐containing vaccines
Varivax 12 mos of age and older
Zostavax 60 yrs of age and older ProQuad MMRV 12 mos thru 12 yrs 21 Adapted CDC 22 http://eziz.org/assets/docs/IMM‐859.pdf
HELP! “A 63‐year‐old patient received a high dose flu vaccine. Would the recommendations be to re‐vaccinate with the standard dose, or are they considered AVOID ERRORS covered?” ANSWER Although this is a vaccine administration error, Check the vial 3 TIMES!!! according to CDC, the dose can count. In general, if a person receives a dose that is too large and/or licensed for an older age group, the dose should be considered valid.
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Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 4 Another potential problem… HELP! “One of the nursing staff used the Using the wrong diluent Merck sterile water diluent to reconstitute the ActHib instead of the 0.4% sodium chloride that comes with it. Does it need to ActHIB + 0.4% sodium chloride RabAvert + sterile water be repeated, or will it be considered OK?” Hiberix + 0.9% sodium chloride Rotarix + sterile water, ANSWER calcium carbonate, & xanthan Imovax + sterile water If the wrong diluent is used, the immunization needs Shingrix + AS01B adjuvant to be repeated (except in the case of mixing up the MMR, Varivax, ProQuad diluent between MMR, MMRV, Varivax, and Zostavax, Zostavax + sterile water YF‐VAX + 0.9% sodium chloride which are all made by Merck and use the same sterile water diluent).
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If an INACTIVATED vaccine is reconstituted with the Related error: giving diluent only wrong diluent and is administered, the dose is invalid and should be repeated ASAP. The liquid diluents for Menveo (MenACWY) and Pentacel (DTap‐IPV/Hib) contain vaccine and need to If a LIVE vaccine is reconstituted with the wrong be combined with the lyophilized vaccine (powder) diluent and is administered, the dose is invalid and if to provide all the components. it can’t be repeated on the same clinic day, it needs One more caveat: the liquid diluent portion of the to be repeated no earlier than four weeks after the Shingrix vaccine does not contain any antigen, but it invalid dose. This spacing is due to the effects of does include an adjuvant. Because of this, the CDC generating a partial immune response that could experts recommend waiting 4 weeks for another suppress the live replication of subsequent doses, dose if the Shingrix diluent is inadvertently even of the same live vaccine. administered alone.
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HELP! “We inadvertently gave a child only the HELP! “We mistakenly gave a patient the DTaP‐IPV component of Pentacel, not realizing diluent for Menveo (GSK) meningococcal that this component was intended to conjugate vaccine without adding it to the reconstitute the Hib component. Does this count as a powdered vaccine. What should we do now?” valid dose of DTaP and IPV? Can we mix the unused Hib ANSWER component with sterile water and give it separately?” Menveo’s diluent contains the C, W‐135, and Y serogroups, and the freeze‐dried powder contains serogroup A. Because the patient ANSWER received only the diluent, he or she is not protected against invasive The DTaP‐IPV component will count as valid doses of meningococcal disease caused by Neisseria meningitidis serogroup DTaP and IPV vaccines, but take measures to prevent this A. Invasive disease with N. meningitidis serogroup A is very rare in error in the future. You cannot mix the Hib component the U.S., but is more common in some other countries. If the with sterile water. ActHib must ONLY be reconstituted recipient (of the diluent only) is certain not to travel outside the with either the DTaP‐IPV solution supplied with Pentacel, U.S., then the dose does not need to be repeated. Otherwise, the dose should be repeated with either correctly reconstituted or with a specific ActHib saline diluent. 29 30 Menveo or with a dose of Menctra brand MenACWY.
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 5 Giving the wrong vaccine will rarely cause a serious problem, but…
• Additional doses can lead to more vigorous local reactions HELP! “Yesterday my 18‐month‐old’s pediatrician • Patient may be left unprotected against disease informed me that they made a mistake with her • Additional cost vaccines. They gave her two doses of Prevnar and did not vaccinate for Hib. Will this harm my child? • Inconvenience to patient/parent Do I need to get a lawyer and attack this • May cause loss of faith in provider or complaint to state incompetent practice? I am very concerned for my board child and the impact it could have on her.”
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Another administration error: If you give less than a full age‐appropriate dose of giving the wrong dose any vaccine, the dose is invalid. You should revaccinate the person with the appropriate dose as soon as feasible.* Exceptions are if a patient sneezes HELP! “If an adult patient got a child’s dose of hepatitis B after nasal spray vaccine or an infant regurgitates, vaccine, should he be given an adult dose? If so, how spits, or vomits during or after receiving oral soon?” rotavirus vaccine.
HELP! “We had an incident recently where a 5‐year‐old * With Hep A, Hep B, and influenza vaccines, the pediatric and adult products are the same –just different amounts –so if this error is presented for ‘catch up immunizations,’ but was given discovered immediately (same clinic day), it is permissible to administer an adult dose of hep A. We are wondering about side the other half and count the two as a full dose. But if the error is discovered later, the patient should be recalled and given a full age‐ effects or other possible issues.” appropriate dose.
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Another dosage error: split or partial doses If you give more than an age‐appropriate dose of a vaccine, count the dose as valid and notify the • Split or partial (incomplete) patient/parent about the error. Using larger than doses are NOT valid doses. recommended dosages can be hazardous because of This includes situations where + the patient moves before the excessive local or systemic concentrations of injection is completed. antigens or other vaccine constituents. – Exceptions to partial doses • LAIV if person sneezes • Rotavirus if infant regurgitates, spits out, or vomits
35 36 CDC
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 6 Another dosage error: Another administration error: combining vaccines using expired vaccine
Vaccines should NEVER be combined + in the same syringe unless FDA approved for this purpose.
37 CDC 38 CDC
HELP! “A physician just called and gave a Another administration error: child a dose of expired vaccine. I am assuming the dose should be repeated. Incorrect route, site, or needle size Please advise.” ANSWER The dose should be repeated. If the expired dose is a live virus vaccine, you should wait at least 4 weeks after the previous (expired) dose was given before repeating it. If the expired dose is not a live vaccine, the dose should be repeated as soon as possible. (An exception to this rule is recombinant zoster vaccine, Shingrix; you should wait 4 weeks to give a repeat dose after the invalid dose.) If you prefer, you can perform serologic testing to check for immunity for certain vaccinations (e.g., measles, mumps, rubella, varicella, and hepatitis A). However, commercial serologic testing might not always be sufficiently sensitive or standardized for 39 detection of vaccine‐induced immunity. 40 Adapted CDC
HELP! “One of our nurses accidentally gave Types of vaccination errors Hep B SC rather than IM. Can you tell me what we need to do? • Storage and handling ANSWER • Administration Vaccines should always be given by the route recommended by the manufacturer. However, ACIP and/or CDC have stated that the • Scheduling action to be taken if an IM dose is inadvertently administered SC varies by vaccine, as shown below. • Documentation
Count dose as valid if inadvertently Vaccine administered SC rather than IM? Hepatitis B, rabies, HPV, inactivated No. Repeat the dose. influenza PCV13, Hib, DTaP Left to provider discretion Hep A, MenACWY, IPV, PPSV23, RZV Yes. No need to repeat the dose. Tdap, Td, MenB, Typhim VI, JE‐VC ACIP/CDC has no recommendation
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Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 7 Scheduling errors: giving doses at too young an age • Giving the 1st dose of MMR or varicella before age 12 months • Giving the 4th dose of DTaP before age 12 months or less HELP! “While registering her for kindergarten, it was than 6 months after 3rd dose brought to my attention by the school RN that my • Finishing infant’s hepB series before age 24 weeks daughter’s initial MMR vaccine may not be valid. • Giving any vaccine (except hepatitis B) before 6 weeks of She received this dose 25 days before her first age birthday. I do not want to re‐administer a 3rd vaccine if it is not necessary. It is painful and excessive. What, if any, steps can I take to avoid re‐vaccinating my daughter?
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Scheduling errors: giving doses without CDC’s 4‐day “grace period” the minimum spacing • Giving 2nd dose of hepatitis A vaccine less than 6 months • Vaccine doses administered up to 4 days before the after the first dose minimum interval or age can be counted as valid • Giving the hepatitis B vaccine series without at least 4 wks • This grace period should not be used when scheduling between doses 1 and 2; 8 wks between doses 2 and 3; and future vaccination visits, or applied to the 28–day interval 16 wks between doses 1 and 3 between two different live parenteral vaccines not administered at the same visit • Giving the 3 dose HPV vaccine series without at least 4 wks between doses 1 and 2; 12 wks between doses 2 and 3; • The grace period cannot be used for rabies vaccine and 24 wks between doses 1 and 3 • Use of the grace period may conflict with state daycare or • When the 2 dose HPV schedule is used (acceptable only school entry vaccination requirements for those starting the series before the 15th birthday), the minimum interval between the 2 doses is 5 months
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• Doses administered 5 or more days before the minimum age should be repeated on or after the patient reaches the minimum age. If the vaccine is a live vaccine, waiting at least 28 days from the invalid dose is recommended. A dose administered 5 or more days earlier than the • ACIP does not require a minimum interval when an recommended minimum interval between doses is inactivated vaccine is given before the minimum age. Once not valid and must be repeated. The repeat dose the minimum age is reached, the repeat dose can be given should be spaced after the INVALID dose by the and can be counted. recommended minimum interval. • HOWEVER, some state immunization registries follow a stricter rule, and, when a dose is given before the minimum age, require that the next dose be given after both the minimum age and interval.
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Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 8 A clinician’s best friend…
CDC’s “Recommended and Minimum Ages and Intervals Between Doses of Routinely Recommended Vaccines” www.cdc.gov/vaccines/pubs/pinkbook/downloads/ appendices/A/age‐interval‐table.pdf
Or check with your state registry about when the next dose should be given!
www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/a/age‐interval‐table.pdf 49 50
Other scheduling errors HELP! “A client received an MMR vaccine at one clinic, and 7 days later received varicella • Giving rotavirus vaccine after age 8 months 0 days vaccine at another clinic. I assume the • Giving PPSV every 5 years varicella is not valid. What about the MMR?” • Giving PPSV and PCV at the same time ANSWER • Not allowing 6 months between the next‐to‐last and last If two live virus vaccines are administered less than 4 doses of IPV weeks apart and not on the same day, the vaccine • Using Kinrix or Quadracel for the wrong dose or at the given second should be considered invalid and wrong age repeated. The repeat dose should be administered at • Giving live vaccines not administered at the same visit least 4 weeks after the invalid dose. Alternatively, less than 4 weeks apart one can perform serologic testing to check for immunity, but this option may be more costly and/or may result in a false negative. 51 52
And the classic: IMPORTANT RULE:
Vaccine doses should not be administered at Re‐starting a vaccine series because of intervals less than the recommended minimal intervals or earlier than the minimal ages. a longer‐than‐recommended interval But there is not maximum interval! (except for oral typhoid vaccine in some circumstances)
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Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 9 Types of vaccination errors Types of documentation errors
• Storage and handling • Not providing a Vaccine Information Statement (VIS) every time a vaccine is given • Administration • Not using the most current VIS • Scheduling • Not knowing if written consent is required • Documentation • Not recording all required information in the patient’s chart
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HELP! My 2‐month‐old was recently inoculated How to ensure you are using the current VIS at his pediatrician’s office. The day following the immunizations my son spiked a high fever, and I • Check CDC’s VIS web page was extremely concerned. I called our local hospital and www.cdc.gov/vaccines/hcp/vis/index.html found out that I should have been given a VIS sheet for • Check IAC’s VIS web page each of the inoculations that my child received. I did bring www.immunize.org/vis 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 • Subscribe to IAC Express and be notified of any new and mandated they give information sheets out. My question revised VISs and translations every Wednesday is, to whom do I report this incident? I no longer take my www.immunize.org/subscribe child to their office, but I want them to start doing things right.” A minor side effect becomes a big problem
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HELP! “For a child, do we have the parent Required information to document sign each time we give a vaccine in a series, or is it enough to have them sign for the first • Type of vaccine (e.g., MMR or Hib, NOT brand name) one? • Vaccine manufacturer and lot number ANSWER • Date the vaccination was given There is no federal law requiring written consent to • Name, office address, and title of the healthcare provider vaccines. VISs cover both benefits and risks associated administering the vaccine with vaccination, and they provide enough • VIS edition date information that anyone reading them should be • Date the VIS was given to the patient, parent, or guardian adequately informed. However, some states or • Use your state’s Immunization Information System institutions have written informed consent laws. (registry)! Check with your state immunization program
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Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 10 Made a vaccination error? The Institute for Safe Medication Practices (ISMP) has a website to report vaccine errors –the Vaccine Error Reporting Program (VERP). VERP was created to allow healthcare professionals and patients to report vaccine errors confidentially. By collecting and quantifying information about these errors, ISMP will be better able to advocate for changes in vaccine names, labeling, or other appropriate modifications that could reduce the likelihood of vaccine errors in the future. http://verp.ismp.org 61 62
In March 2015, VERP published an excellent guide on avoiding vaccine errors: Made a vaccination error? (cont.) CDC recommends that healthcare professionals also report vaccine errors to the Vaccine Adverse Events Reporting System (VAERS). If an adverse event occurs following a vaccine administration error, a report should definitely be sent to VAERS. www.ismp.org/newsletters/acutecare/showarticle.aspx?id=104 Adverse events should be reported to VAERS regardless IAC also has two comprehensive guides: of whether a healthcare professional thinks it’s related to Don’t Be Guilty of These Preventable Errors in Vaccine Administration! the vaccine or not, as long as it follows administration of www.immunize.org/catg.d/p3033.pdf a dose of vaccine. Don’t Be Guilty of These Preventable Errors in Vaccine Storage and Handling! www.immunize.org/catg.d/p3036.pdf http://vaers.hhs.gov/index 63 64
How to avoid vaccine errors… Educate yourself • Read CDC’s “Pink Book” cover to cover www.cdc.gov/vaccines/pubs/pinkbook/chapters.html HELP! HELP! HELP! • Look for answers in the relevant ACIP recommendations www.immunize.org/acip HELP! HELP! • Read IAC’s “Ask the Experts” Q&As www.immunize.org/askexperts HELP! • Subscribe to IAC Express for weekly updates HELP! www.immunize.org/subscribe
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Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 11 Educate yourself (cont.) Need more help? • “Immunization Techniques” DVD • Contact CDC’s experts: cdc.gov/cdc‐info www.immunize.org/dvd • Contact your vaccine rep or call the manufacturer IAC’s resources related to: • Storage & handling • Call your state immunization coordinator www.immunize.org/handouts/vaccine‐storage‐handling.asp (contact information can be found at www.immunize.org/coordinators) • Vaccine administration www.immunize.org/handouts/administering‐vaccines.asp • Vaccine recommendations, including scheduling www.immunize.org/handouts/vaccine‐recommendations.asp • Documentation www.immunize.org/handouts/document‐vaccines.asp 67 68
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org www.immunize.org/catg.d/s8020.pdf • Item #S8020 (12/19) 12