Types of Vaccine Administration Errors Communicated to IAC January 2015 June IZCoalitions webinar, October 6, 2016 Teresa A. Anderson, DDS, MPH

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Types of Vaccine Administration Errors Communicated to IAC January 2015 June 2016 IZCoalitions webinar, October 6, 2016 Teresa A. Anderson, DDS, MPH CONSULTANT, IMMUNIZATION ACTION COALITION

Background Healthcare professionals and members of the public can contact IAC by writing to admin@immunize.org. I answer ~200 300 such emails each month, with some help from other IAC staff and consultants. Also refer people to nipinfo@cdc.gov. It appears that more errors are being made (IZ schedule more complex, additional available products, alternative schedules, more recommended adult vaccines, etc.) In addition, some types of errors that might have gone undetected in the past are now caught by state immunization information systems.

From January 2015 through June 2016, IAC received questions about approximately 540 medical errors related to vaccination, including errors in vaccine storage and handling, administration, scheduling, and documentation.

120 100 106 Types of Vaccine Administration Errors Communicated to IAC January 2015 June 2016 80 76 75 65 60 51 40 20 37 34 31 22 13 13 12 3 3 0

The result of making such errors can be serious, including harm to the vaccinee from a side effect or vulnerability to disease, inconvenience to the parent/patient and perhaps ill will, unreimbursed cost to the provider, and loss of trust in the provider with possible negative publicity or even legal action. Avoiding such errors benefits everyone.

Examples from healthcare providers "What are the risks if a child <6 months receives an influenza vaccine?" "Somehow, a patient in my clinic received their 3rd Hepatitis B vaccine 1 month after the second. What should I do?" "What are the recommendations for adults who mistakenly received pediatric doses of hepatitis B vaccine instead of the adult doses?" "A Tdap was given to a 2-year-old. Is it necessary to repeat the dose or does it count as the 4th DTaP dose?" "If a child received the diluent only of the Pentacel does that mean they received DTaP and polio? Will they need to come back for Hib? How soon can this be given?"

Example from parent Hi! I was referred to you by a friend because of what happened to us today. I took my twelve month old son in for his well child exam and immunizations and a little while after we left the doctors office I got a call that they had given him the wrong immunizations. They gave him the six month shots and rotovirus oral medicine again instead of the twelve month shots. They said it "won't do any harm" and that we can catch up at his 15 month appt but I really want some non-biased thoughts on this. It's been a few hours now and my baby boy is extra, extra cranky, very sleepy, and not wanting to nurse. I guess I'm just a worried mama and wanting to seek out some more info on the subject of extra vaccines.

ERROR: Not using a screening checklist for contraindications and precautions to vaccination Avoiding this error: Use a reliable screening tool consistently to avoid either 1) giving a vaccine to a patient for whom it is contraindicated (a serious, potentially life-threatening situation) or 2) missing opportunities to vaccinate because of a false contraindication (which can also be life-threatening, as it can leave a patient exposed to a vaccinepreventable disease).

IAC s related handouts: www.immunize.org/handouts/screening-vaccines.asp Also available in Spanish, Arabic, Chinese, French, Hmong, Korean, Russian, Turkish, & Vietnamese See also CDC's Vaccine Contraindications and Precautions web page: www.cdc.gov/vaccines/hcp/admin/contraindications.html

ERROR: Giving a vaccine dose earlier than is recommended by ACIP Avoiding this error: Know the minimum intervals for all vaccine series. Keep an easy-to-read immunization schedule handy for staff. If you still aren't sure if a dose will be valid, check with your state immunization program before giving it. Attempt to locate old vaccination records by contacting previous healthcare providers and reviewing your state registry.

www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/a/age-interval-table.pdf

www.immunize.org/handouts/vaccine-recommendations.asp

ERROR: Administering the wrong vaccine (e.g., DTaP for Tdap, zoster for varicella, PCV for PPSV) Avoiding this error: Check the vial 3 TIMES! Such errors often involve vaccines whose generic or trade names look or sound alike (Tdap/DTaP, Adacel and Daptacel), or which have similar packaging, so store such vaccines separately and mark them clearly in storage and on the patient's tray. Other times, vaccines are mixed up when treating multiple family members such as siblings. See family members at separate times and/or in separate rooms, and always verify names and birthdates.

http://eziz.org/resources/vaccine-admin-job-aids

Toolkit: www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf CDC storage & handling page: www.cdc.gov/vaccines/hcp/admin/storage/index.html

www.cdc.gov/vaccines/hcp/admin/storage/guide/vaccine-storage-labels.pdf

ERROR: Giving the wrong dosage Avoiding this error: Check the vial 3 TIMES! Store vaccines with pediatric and adult dosages on different shelves and clearly marked "pediatric" or "adult." Verify patient's age and check against the vaccine's age indications in the package insert, the VIS, or a vaccine schedule that includes such information.

www.immunize.org/catg.d/p4072.pdf

ERROR: Using vaccine outside of its ACIPrecommended age/dose Avoiding this error: If unsure, check the package insert. For example, DTaP-IPV (Kinrix, Quadracel) is only approved and recommended for the 5th dose of the DTaP and the 4th dose of IPV in children age 4 6 years. MMRV (ProQuad) is approved and recommended for children age 12 months through 12 years. Unless ACIP has made an off-label recommendation, you should use a vaccine as licensed to ensure its efficacy and safety.

www.immunize.org/fda

ERROR: Administering vaccine by the wrong route Avoiding this error: Post a reference so providers can easily verify the administration route and site for all vaccines/ages. Highlight or otherwise mark the route information on the package.

www.immunize.org/handouts/administering-vaccines.asp See also the "Vaccine Administration" chapter from CDC's Pink Book: www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html

To Report Errors 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

In March 2015, ISMP published an excellent guide titled Recommendations For Practitioners To Prevent Vaccine Errors www.ismp.org/newsletters/acutecare/showarticle.aspx?id=104

To Report Errors 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. Adverse events should be reported to VAERS regardless of whether a healthcare professional thinks its related to the vaccine or not, as long as it follows administering a dose of vaccine. https://vaers.hhs.gov/index

Questions? Check out Ask the Experts to see if your question has already been answered: www.immunize.org/askexperts Email CDC s experts: nipinfo@cdc.gov Contact your vaccine representative or call the manufacturer Call your state immunization coordinator (contact information for your state immunization program can be found at www.vaccineinformation.org/stateimmunization-programs) Email IAC: admin@immunize.org