1. Vaccination Administration Errors Reported to the Vaccine Adverse Event Reporting System (VAERS) Elaine R. Miller, RN, MPH Beth Hibbs, RN, MPH Barbara Slade, MD CDC Immunization Safety Office

2. Background At least 8 new vaccines licensed since 2005 Increasing complexity of the immunization schedule Combination vaccines Institute of Medicine (IOM) report on medical errors in 2000 and medication errors in 2007 helped to raise awareness

3. CDC Publication on Vaccine Errors-2004 www.cdc.gov/mmwr/preview/mmwrhtml/mm5329a5.htm* www.cdc.gov/mmwr/preview/mmwrhtml/mm5329a5.htm Confusion between Tetanus toxoid containing vaccines and tuberculin purified protein derivative (PPD) –March 2004, approximately 100 pts. in 21 states had received tetanus containing vaccines by the intradermal route instead of PPD –Similarities in packaging might have contributed to the medication errors. –Both products require refrigeration and often are stored side by side. *MMWR 2004; 53 (No.29)

4. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5537a2.htmhttp://www.cdc.gov/mmwr/preview/mmwrhtml/mm5537a2.htm* Inadvertent Misadministration of Meningococcal Conjugate Vaccine –As of Aug. 2005, 101 people in 7 states were reported to have received the meningococcal conjugate vaccine (Menactra®) by the subcutaneous (SQ) route instead of the intramuscular route –The other meningococcal vaccine MPSV4 (Menomune®) which has been licensed for over 30 years, is given by the SQ route whereas Menactra® is licensed for IM route only. –CDC recommended that providers be aware of the licensed route of vaccines prior to administering them. *MMWR 2006; 55 (No.37) CDC Publication on Vaccine Errors-2005

5. CDC Publication with Information on Vaccine Errors-2006 www.cdc.gov/mmwr/PDF/rr/rr5503.pdf (Page 27)* www.cdc.gov/mmwr/PDF/rr/rr5503.pdf DTaP Tdap DTaP and Tdap Administration Errors May have occurred because of the similarity of names and appearance of packaging DTaP (pediatric) was mistakenly given to persons 7 years of age or older Tdap (adolescent/adult) was mistakenly given to children younger than 7 years *MMWR 2006; 55 (RR-3)

6. Study Objectives To analyze VAERS data to learn about trends and types of reported immunization errors during 2006-2007. To use the data in order to develop a survey of health care providers about the causes of vaccine errors and how to prevent them.

7. Vaccine Adverse Event Reporting System (VAERS) National passive surveillance system for reporting adverse events after vaccination Co-managed by CDC and FDA Accepts reports from health care providers and the public VAERS strengths –Voluntary –Easy to report an adverse event –National in scope

8. Methods Search of the VAERS data from 1/1/06 to 9/30/07 for coding terms that indicated errors. Search terms used (MedDRA ® ): –ACCIDENTAL OVERDOSE –UNDERDOSE –DRUG ADMINISTERED AT INAPPROPRIATE SITE –DRUG ADMINISTRATION ERROR –DRUG DISPENSING ERROR –EXPIRED DRUG ADMINISTERED –INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION –INCORRECT ROUTE OF DRUG ADMINISTRATION –INCORRECT DRUG DOSAGE FORM ADMINISTERED –INCORRECT DOSE ADMINISTERED –MEDICATION ERROR –POOR QUALITY DRUG ADMINISTERED –WRONG DRUG ADMINISTERED –WRONG TECHNIQUE IN DRUG USAGE PROCESS All “SERIOUS” reports were reviewed (resulted in death, life threatening-illness, hospitalization, prolongation of existing hospitalization, permanent disability, or other medically important condition). Medical Dictionary for Regulatory Activities (MedDRA®)

9. Increase in VAERS Error Reports vs. All VAERS Reports over Time

10. Preliminary Results 1,895 reports submitted to VAERS between 1/1/06 and 9/30/07 contained a code indicating an error Of these 1,895 reports, 74 (3.9%) were classified as “serious” but the serious adverse events were not necessarily attributed to the medical error

13. Medication Error Reports Classified as “Serious” (1/1/06 – 9/30/07) 74 reports included a “serious” adverse event Of those 74, only 6 adverse events could be attributed to a medical error: 1.Pnemovax® given in intra-articular area in shoulder 2.Flu shot administered in intra-articular area in shoulder 3.When giving an HPV4 shot, the needle accidentally hit a bursa in the patient's arm requiring PT 4.Patient developed a sciatic neuropathy after an HPV4 shot 5.Disseminated varicella, status post varicella vaccination in an immunocompromised host (15 month old with langerhans cell histiocytosis who was recently on chemotherapy) 6.Eye injury to a nurse who inadvertently sprayed vaccine into her own eyes during vaccine preparation

14. Examples of Non-serious Reports Pt. was given 2 varicella doses at the same time. –MMRV in right arm along with a varicella vaccine in left arm,. Each vaccine was administered by a different medical assistant. Vials were retrieved from the refrigerator by a third medical assistant. Zostavax® was reconstituted with Gardasil® Rotateq® was given instead of Rocephin® Pt. with allergy to pertussis vaccine was given Tdap Reports of Rotateq being spit out into patient or providers eyes

15. Recommendations by Reporters Do not cut open boxes of vials until ready to administer Sometimes vials spill out of open boxes and are put in wrong box Separate similar vaccines in different areas of the refrigerator Post a chart to show which vaccines are given by the IM route and which are administered by the SubQ route Separate childhood vaccines from adult vaccines

16. Limitations VAERS data limitations: –Under reporting of medical errors to VAERS likely –Reports can be incomplete or inaccurate –Unknown denominator data e.g. number of doses administered –VAERS form is not designed for medical error surveillance Only “serious” reports were reviewed. Full data analysis in progress

17. Reporting Medication Errors Institute for Safe Medication Practices Accepts reports from consumers and health professionals related to medication. Publishes Safe Medicine, a consumer newsletter on medication errors. 215-947-7797 www.ismp.org/Pages/Consumer.html U.S. Pharmacopeia MedMARX is an anonymous medication error reporting program used by hospitals. www.medmarx.com 800-822-8772 www.usp.org www.usp.org VAERS The Vaccine Adverse Event Reporting System Accepts reports about adverse events following immunization. 800-822-7967 www.vaers.hhs.gov MedWatch Accepts reports about products regulated by the FDA, including drugs and medical devices, through MedWatch, the FDA's safety information and adverse event reporting program. 800-332-1088 www.fda.gov/medwatch/how.htm www.fda.gov/medwatch/how.htm

18. Resources for Preventing Vaccine Errors Immunization Action Coalition www.immunize.org/shop/toolkit_iztechdvd.asp www.immunize.org/shop/toolkit_iztechdvd.asp –DVD: Immunization Techniques "Safe, Effective, Caring” –Vaccine Storage and Handling Training Material Toolkit –Immunization Screening Questionnaire CDC www.cdc.gov/ –Vaccine Storage and Handling Toolkit 2008 –Immunization Practice Toolkit –Epidemiology and Prevention of Vaccine-Preventable Diseases: “the Pink book” Appendix C

19. “5 Rights of Medication Administration” 1) Right patient 2) Right time 3) Right dose 4) Right route 5) Right drug

20. Acknowledgments CDC VAERS team FDA VAERS team John Iskander Donna Weaver VAERS follow-up nurses: Margaret “Peggy” Clapp Sue Sargo Kathleen Reyes-Kelly