(2) Learning Objec-ves 1. Describe how to respond to common vaccine . administration errors . 2. List strategies to prevent vaccine administration . errors .
(3) Vaccine Administra-on Errors Cause….. ü Patients inadequately protected from disease ü Recall of patients who received compromised . vaccine or invalid doses of vaccine . ü Dissatisﬁed parents or patients ü Extra cost ü Bad publicity .
(4) VERP Website: http://verp.ismp.org/.
(5) Ins-tute for Safe Medica-on Prac-ces (ISMP) VERP 433 errors reported Sept ’12 – Oct ’13 Outpatient medical clinics (35%) Physician practice (29%) Public health clinics (24%) Most common error reported were ﬂu Vaccine to patients who were not within age indication Wrong route .
(6) When Do Vaccina-on Errors Occur? Storage and Handling Preparation Administration Documentation . .
(8) Ques-on “Our vaccine coordinator was on vacation and her back-‐up failed to check the min/max temps each morning. When the coordinator ran the report from our new digital data logger, she realized the temps in our fridge dipped below 35 degrees”. .
(9) Proper Vaccine Storage & Handling Appoint vaccine manager and back-‐up ü Train all staﬀ on vaccine management plan and emergency plans Store vaccines at recommended temperatures at all . times (even transport or temporary storage) . ü ü . Immediately unpack new vaccine shipments and deliveries Use only approved storage units . Monitor and record temps, including min/max . temperatures, at least twice daily . ü ü . Continuous temp monitoring of vial temps is recommended Use certiﬁed calibrated thermometers .
(10) Take immediate ac-on for out-‐of-‐range temperatures . It is better not to vaccinate then to administer a dose of potentially compromised vaccine.
(11) Vaccine S&H Resources IIC’s Vaccine Storage and Handling Guide CDC’s Vaccine Storage and Handling Toolkit AAP’s Checklist for Proper Storage and Handling . Practices IAC’s Vaccine Storage & Handling Website CHIRP Document Center Temperature Logs Vaccine Management Plan and Emergency Plan Immunization Division Policies & Procedures .
(12) CDC Resources NEW! Resources from CDC in May 2014.
(14) Types of Vaccine Prepara-on & Administra-on Errors Wrong Patient Wrong Vaccine or Diluent Wrong Time Wrong Dosage Wrong Route or Needle Size Wrong Site . .
(15) The “Rights” of Medica-on Administra-on • The Right Patient • The Right Vaccine or . Diluent • The Right Time* • The Right Dosage • The Right Route, Needle-‐ length & Technique • The Right Site • The Right Documentation *correct age, interval and product prior to expiration . Pink Book Appendix D .
(16) Ques-on “A mother brought in her 2 children, ages 2 & 4 years. It was very chaotic in the exam room with the children crying and the mother’s increasing anxiety…. I inadvertently administered the vaccines for the 2 year old to the 4 year old.” .
(17) Right Pa-ent Verify patient name & DOB Has patient used another name previously? Ask the parent or patient to provide you with the patient name and DOB, never ask “are you ______?” Has patient been screened properly for . contraindications? Do you have a current copy of patient’s . immunization record? Have you reviewed the patient’s record? .
(18) Screening The key to preventing the majority of serious . adverse reactions is screening . Every person who administers vaccines should . screen every patient for contraindications and precautions before giving the vaccine dose . .
(19) Screening Checklist . http://www.immunize.org/handouts/view-all.asp.
(20) Ques-ons “When I was doing my vaccine inventory this past month, I noticed that our clinic is running out of diluent for the rotavirus (Rotarix) vaccine. Can we order more diluent?” “We accidently administered a dose of DTaP-‐IPV/Hib (Pentacel) without mixing in the Hib component. What do we do?” “A new employee accidently reconstituted ActHIB with sterile water. Is this dose still valid?” .
(21) Recons-tuted Vaccines There are 12 vaccines with speciﬁc diluents and 2 . vaccines with two-‐component containers that must be mixed prior to vaccine administration Always reconstitute vaccines per manufacturer’s . guidelines . . Live virus vaccines and some inactivated . vaccines must be administered within a certain time after reconstitution . If not administered within the time limit, these . vaccinations need to be discarded. .
(22) +. Never mix two doses of vaccine into one syringe when they should be given in two separate syringes . Adapted CDC.
(23) ARer Recons-tu-on Administer the following vaccines within: . < 30 minutes. *immediately 8 hours 24 hours 35 days. Varivax Proquad Menhibrix* MMR. Pentacel* Zostavax. Menveo. ActHIB Hiberix Rotarix Menomune (multidose).
(25) Errors with Diluent Administering only the diluent or only 1 of 2 vaccine components accounted for 6% of errors reported to VERP during the ﬁrst year of the program. Most reports involved multiple patients .
(26) Wrong Diluent If the wrong diluent is used, repeat the dose of . vaccine. . The exception is the diluent used for the MMR, MMRV, Varicella and Zoster vaccines. These are the same (sterile water) Must wait 4 weeks to repeat dose of live vaccine if error discovered not no same clinic day . If only the diluent is administered, administer vaccine . as soon as possible There is additional guidance for Pentacel and Menveo . .
(27) Ques-ons “I accidently gave a 5-‐year-‐old a dose of Tdap, instead . of a DTaP. What should I do?” “A 20 year old hospital employee was inadvertently given a dose of shingles vaccine when he should have received varicella. Is this dose valid?” “I accidently gave a child who received Pediarix a dose of Hep B instead of Hib”. .
(28) Wrong V accine . Administration of the wrong vaccine is most frequently reported with vaccines whose generic or trade name look or sound alike, or vaccines that have similar packaging. .
(29) DTaP and Tdap Administra-on Errors Error: . Action: . DTaP given to person . Count dose as valid . > 7 years . Tdap given to child <7 . years as DTaP #1, 2, or 3 . . . Dose is not valid. . Administer repeat dose as soon as possible . Tdap given to child < 7 Count dose as valid . years as DTaP #4 or #5 .
(31) Varicella Administra-on Errors Action: . Error: Varicella administered . Dose is not valid. Must wait 4 . . . when shingles vaccine is indicated . weeks to administer shingles if vaccine cannot be repeated on same day. . Consider dose valid. 2nd dose . Shingles administered when . varicella is indicated . should be administered 4-‐8 weeks later (if indicated) .
(32) Wrong Vaccine An extra dose of a vaccine or a dose that is larger than . recommended may lead to a stronger local reaction Will rarely cause a serious complication or reaction Apply cold compress to site, consider giving pain . reliever or anti-‐itch medications if reaction does occur . . Always check the vaccine and diluent label 3 times Before drawing up the vaccine After preparation Prior to administration . .
(33) Ques-ons “A child received a dose of MMR 10 days prior to his ﬁrst birthday, does this dose need to be repeated…he was practically 1 at the time of the appointment!”. “ A 6 month old has already received 3 doses of Hepatitis B vaccine. The ﬁnal dose was given at 4 months. Why is CHIRP forecasting another dose?” .
(34) Minimum Intervals and Ages Vaccine doses are not to be given at less than the . minimum intervals or earlier than the minimum age . Decreasing the interval between doses may interfere . with antibody response and protection . Increasing the interval between doses does not . diminish the eﬀectiveness of the vaccine . Never restart a series or add doses of any vaccine due to . an extended interval between doses . .
(36) Live Virus Vaccines – Minimum Interval If live virus vaccines (MMR, Varicella, Yellow Fever and LAIV) are not administered during the same visit, the doses of vaccine should be separated by a minimum of 4 weeks (28 days). Doses administered on the same day a few hours apart are considered to be valid .
(37) Four Day Grace Period ACIP recommends that vaccine doses given up to 4 . days before the minimum interval or age be counted as valid } Exception: interval between live-‐virus vaccines must be at least 28 days A dose given >4 days early is invalid } Dose must be repeated after waiting the minimum interval from that invalid dose or after the child reaches the minimum age ISDH Immunization Program adopted the four day grace period for ‘speciﬁc and limited’ use only .
(38) Ques-ons “Today (August 20, 2013) I administered a dose of injectable inﬂuenza vaccine. The vaccine expiration date was 6/30/2013. Will this harm the patient?” “The expiration date on the vaccine vial is 06/19/2014, can I use the vaccine today?” .
(39) Administering Expired Dose of Vaccine Repeat dose of vaccine if expired vaccine is used. If this is a live vaccine, wait 4 weeks to administer repeat dose . For certain vaccinations, there is the option of . performing serologic testing to check for immunity (e.g. Hep A, measles, mumps, rubella) . .
(40) Vaccine Expira-on Dates Rotate vaccine and diluent stock weekly to ensure products . with closest expiration date are used ﬁrst . If normal in appearance and stored and handled properly, . product can be used through end of day indicated if expiration date is mm/dd/ yyyy (e.g., 06/30/2014 -‐ use through 06/30/2014) through end of month indicated if expiration date is mm/ yyyy (e.g., 06/2014 -‐ use through 06/30/2014) . Multi-‐dose vials can be used through the expiration date on the label unless otherwise indicated in the manufacturer’s package insert Chapter 5 CDC’s Pink Book.
(41) Ques-ons “I inadvertently administered a dose of intradermal ﬂu (Fluzone) to a 67 year old patient. The product is only recommended for patients 18-‐64 years. Do I need to repeat the dose?” “I administered the wrong brand of ﬂu vaccine to a child. The product was not indicated for children his age. Will this dose protect him against ﬂu?” .
(42) Inﬂuenza Vaccines .
(43) Ques-on “I accidently gave a pediatric dose of the Hepatitis A vaccine to 25 year old. Is this dose valid?” “I administered a 0.5 mL ﬂu dose to a 2 year old. What should I do?” .
(44) Wrong Dose If less than the age-‐appropriate dose is administered, . the dose is invalid and needs to be repeated . Administer additional dose during same visit if possible . If more than the age-‐appropriate dose is . administered consider the dose valid . Administering larger than recommended doses does . not negate the need for future doses .
(45) Ques-on “I accidently gave a dose of MMR vaccine IM instead of SC. Will this dose count?” “I gave a vaccine by mistake in the gluteal muscle” .
(46) Vaccine Routes of Administra2on Oral Intranasal Intradermal (ID) Subcutaneous (SC) Intramuscular (IM) PPSV23 and IPV can be administered SC or IM .
(47) Proper Injec-on Technique . SC Injection. IM Injection.
(48) Intramuscular (IM) Injec-ons Needle should be at 90 degree angle Patient Age Site. Needle Size. Infants (birth to Vastus lateralis 12 mos) muscle. 5/8” to 1” needle 23 - 25 gauge. Young children Vastus lateralis (12 to 36 mos) until deltoid muscle is adequate. 5/8” to 1” needle 23 - 25 gauge. Older children (>36 mos) & adults. Thickest portion 1” to 2” needle of deltoid muscle 23 - 25 gauge.
(49) Subcutaneous (SC) Injec-ons Needle should be at a 45 degree angle Patient Age Site. Needle size. Infants (birth to 12 mos). Fatty area of the thigh. 5/8” to 1” needle 23 - 25 gauge. Young children (12 to 36 mos). Fatty area of thigh or outer aspect of upper arm Outer aspect of upper arm. 5/8” to 1” needle 23 - 25 gauge. Older children (>36 mos. of age) & adults. 5/8” to 1” needle 23 - 25 gauge.
(50) Nonstandard Route & Site of Administra-on Most doses administered by the non-‐standard . route will be valid Repeat vaccines when: Rabies or hepatitis B vaccine given in gluteus (buttocks) Hepatitis B vaccine given any route other than IM HPV given SC . .
(52) Proper Documenta-on of Vaccines Vaccine name Date of administration Name of manufacturer Lot number Expiration date (recommended) Name & title of person who administered vaccine Address where vaccine was given Date that vaccine information statements (VIS) was . given to parent/guardian . Publication date of VIS given .
(53) Vaccine Informa-on Statement Most current Vaccine Information Statement (VIS) to . the parent/guardian of each child being vaccinated The VIS must be given before every dose of every vaccine Permanent copy of a VIS can be read in the oﬃce Federal law does not require a signature be obtained Can be downloaded into wireless devices . Sign up for email alerts of VIS changes: www.cdc.gov/vaccines/pubs/vis/ default.htm . .
(54) Where to Find Current VIS State and Local Health Departments Internet ◦ CDC www.cdc.gov/nip/publications/VIS ◦ Immunization Action Coalition (IAC) www.immunize.org/vis Over 30 foreign languages Audio .
(55) You Discover an Error…What Next? Use your resources. The dose may be valid . Notify the patient and/or legal guardian Let them know an error occurred Ensure no adverse events have taken place Explain any follow-‐up that is necessary Document the incident following your agency’s policy . Submit to VAERS if adverse event is reported or if . vaccination error poses safety risk to patient. .
(56) VAERS .
(57) References and Resources Centers for Disease Control & Prevention (CDC) Pink . Book: . http://www.cdc.gov/vaccines/pubs/pinkbook/index.html . ACIP Recommendations: . http://www.cdc.gov/vaccines/acip/index.html . IAC’s “Ask the Experts” Q&As http://www.immunize.org/askexperts Subscribe to IAC Express for weekly updates . http://www.immunize.org/subscribe . .
(58) More Help! Email CDC’s experts: firstname.lastname@example.org Contact ISDH Immunization Division (800) 701-‐0704 email@example.com . Contact your vaccine rep or call the manufacturer Contact information is located on back of temp logs . .
(59) Strategies to Prevent VAE’s 1. Involve staﬀ in selection of vaccine products 2. Place job aides in highly visible locations, especially 3. . 4. 5. 6. . the medication prep areas Rotate vaccine stock by placing closest expiration dates in front. Remove expired diluent and vaccine immediately Place sound-‐alike and look-‐alike products in diﬀerent areas of the vaccine storage unit Only administer vaccines you’ve prepared. Triple check your work Educate parents on vaccine schedules and the importance of maintaining records . Pink Book Appendix D .
(60) Education is Important! • • • . Ensure new staff are adequately trained on the proper technique for administering vaccines Review package insert for all products prior to administering any doses of vaccine Provide current immunization education • Immunization schedules • Skills assessment.
(61) Questions? firstname.lastname@example.org (317) 233-‐7560 .