Vaccine Errors Reported to ISMP September 2012 to June 2015

Transcription

1 Vaccine Errors Reported to ISMP September 2012 to June 2015 Michael R. Cohen, RPh, MS, ScD (hon), DPS (hon), FASHP Institute for Safe Medication Practices (ISMP) July 29,

2 Voluntary practitioner reporting program Established September 2012 in cooperation with the California Department of Public Health Collect data about the types of vaccine errors and causes 1,256 total reports, average 48 per month, range 22 to % of errors reached the patient Wrong age and wrong vaccine are the most common error types each is 21% of the total Use individual reports for learning Analyze the aggregate data annually 2

3 Facilities and Practitioners Mostly Outpatients Type of Facility n % Medical Clinic (outpatient) % Physician Practice % Public Health Immunization Clinic % Hospital (ambulatory) % Military Locations % Hospital (inpatient) % Community Pharmacy % Pharmacy based Health Clinic 1 0.1% MA Medical Clinics, Physician Practices Nurses Public Health, Inpatient Hospital Physicians Ambulatory Hospitals, Physician Practices Mostly Family Practice, Pediatrics, Public Health Type of Practice n % Family Practice % Pediatrics % Public Health % Pharmacy % Internal Medicine % OB GYN 7 0.6% Mostly MA, RN, LPN, Physician Practitioners Involved (total) n % Medical Assistant (MA) % Registered Nurse (RN) % Licensed Practical Nurse (LVN/LPN) % Physician % Nurse Practitioner % Pharmacist % Physician Assistant % Student (e.g., medicine, nursing, pharmacy) % 3

4 Vaccines Involved in Errors Vaccine Number Percent (%) Influenza Virus (All Types) DTaP IPV HepA Tdap DTaP HepB 86 7 HPV MMRV 77 6 DTaP IPV/Hib 68 5 Varicella Virus 58 5 DTaP HepB IPV 56 5 Haemophilus b Conjugate

5 Vaccines by Setting Setting Vaccines % Medical Clinic Physician Practice DTaP IPV 16 DTaP 12 Influenza Virus 12 Tdap 11 HepA 10 HPV4 9 Tdap 15 DTaP IPV 14 Influenza Virus 14 DTaP 11 HepA 9 DTaP IPV/Hib 9 Setting Vaccines % Public Health Immunization Clinic Ambulatory Hospital HepA 20 DTaP IPV 14 Influenza Virus 13 MMRV 10 HepB 8 HPV4 7 Influenza Virus 22 PCV13 12 Varicella Virus 11 PPSV23 9 DTaP IPV/Hib 8 HepB 5

6 Vaccines by Setting (cont d) Setting Vaccines % Military Locations Community Pharmacy Influenza Virus 30 Anthrax 18 HepA 15 Yellow Fever 12 HepB 9 RV5 9 Influenza Virus 50 Zoster 35 Tdap 5 DTaP 5 PPSV23 5 Setting Vaccines % Inpatient Hospital Influenza Virus 41 HepB 23 Tdap 18 Td 14 Haemophilus b (Tetanus Toxoid Conjugate) 9 6

7 Type of Vaccine Errors 5% 5% 4% 3% 24% Wrong Age Wrong Vaccine Extra Dose 7% Overdose Expired Vaccine 8% Wrong Interval Component Omission 10% 24% Underdose Wrong Patient 10% Wrong Route 7

8 60% 50% 40% Contributing Factors For Wrong Age Errors 49% 30% 20% 30% 21% Contributing Factors 10% 0% Not familiar with indicated patient ages for vaccines Patient's age not verified before administration Age dependent formulations of the same vaccine 8

9 Wrong Age Errors by Vaccine Vaccine % DTaP IPV (Kinrix) 31 Influenza Virus Fluzone (39%) Fluzone High Dose (19%) Fluvirin (16%) MMRV (ProQuad) 10 DTaP Daptacel (62%) Infanrix (23%) HepA Havrix (83%) VAQTA (17%) Vaccine % Tdap (Boostrix, Adacel) 5 Influenza Virus, Intranasal 5 (FluMist Quadrivalent) RVS (RotaTeq) 5 HepB (Recombivax HB, Engerix 2 B) DTaP HepB IPV (Pediarix) 2 HPV4 2 9

10 Contributing Factors for Wrong Vaccine Errors 30% 25% 25% 20% 20% 15% 16% 14% 10% 11% 9% 5% 8% 0% Contributing Factors 10

11 Wrong Vaccine Errors A Mixed Up With B % Mix ups Tdap (15% of all mix ups) DTaP 66 Td 10 DTaP IPV 7 DTaP HepB IPV 5 DTaP IPV (10% of all mix ups) DTaP 39 DTaP HepB IPV 30 DTaP IPV/Hib 8 Tdap 4 A Mixed Up With B % Mix ups DTaP (6% of all mix ups) Tdap 82 DTaP HepB IPV 12 DTaP IPV/Hib 6 MMRV (6% of all mix ups) Varicella Virus 63 MMR 18 HPV4 (6% of all mix ups) HPV2 53 HepB 13 IPV 13 11

12 Most Common Contributing Factors Age dependent formulations of same vaccine 18% Not familiar with indicated patient ages 10% Routine check for expired product not done 9% Patient chart not checked prior to administration 7% Patient age not verified before administration 7% Miscommunication of vaccine order 5% Not familiar with product 5% Similar vaccine abbreviations 4% Similar vaccine container labels/packaging 4% 12

13 Contributing Factors by Vaccine Similar brand names Vaccine % Influenza (Fluzone, Fluzone High 20 Dose, Fluarix, FluLaval) Tdap (Boostrix/Daptacel, 20 Adacel/Daptacel, Adacel/Decavac) Prevnar 13/Pneumovax Similar generic names Vaccine % Tdap and DTaP 33 HepB and HepA 14 Zoster and Varicella Virus 14 Similar abbreviations Vaccine % Tdap and DTaP 56 DTaP and DTaP IPV 28 Similar labeling/packaging Vaccine % Pediarix (GSK)/Infanrix (GSK) 10 Infanrix (GSK)/Kinrix (GSK) 7 Pediarix (GSK)/Fluzone (Sanofi) 7 Pediarix (GSK)/Havrix )GSK) 7 Daptacel (Sanofi)/Pentacel (Sanofi) 7 13

14 Contributing Factors by Vaccine Influenza HepB Contributing Factor % Age dependent formulations of 27 the same vaccine Not familiar with indicated ages 9 for vaccine or dosing Age not verified 6 HepA Contributing Factor % Age dependent formulations of 40 the same vaccine Not familiar with indicated 9 patient ages for vaccine or dosing Age not verified 5 Contributing Factor % Age dependent formulations of 23 the same vaccine Routine check for expired 11 products not conducted Miscommunication of order 8 MMRV Contributing Factor % Not familiar with indicated ages 15 for vaccine Not familiar with vaccine 10 Similar vaccine labels/packaging 5 14

15 Contributing Factor by Vaccine DTaP IPV Tdap Contributing Factor % Not familiar with indicated patient ages for vaccine Age dependent formulations of the same vaccine Confusion regarding components of vaccine DTaP IPV/Hib Contributing Factor % Not familiar with how to mix or 23 prepare the vaccine Check for expired drugs not done 8 Not familiar with indicated ages for the vaccination 4 6 Contributing Factor % Similar vaccine abbreviations 14 Vaccine order miscommunicated 7 Not familiar with indicated 6 patient ages for vaccine Similar vaccine generic names 6 DTaP Contributing Factor % Age not verified 16 Similar vaccine abbreviations 9 Not familiar with indicated ages for the vaccine or dose Age dependent formulations of the same vaccine

16 Packaging issues one component of two component vaccine given Menveo container labels identical Bar codes identical Some other vaccines with diluent or two components: ActHIB MMR II Menomune Rabies Pentacel Rotarix (oral) Varivax Zostavax (frozen) 16

17 Insulin or other substance instead of influenza vaccine: Drug and vaccine storage November 2014 Forty one corrections officers who work at a jail in Portland, Maine inadvertently given intradermal influenza vaccine instead of tuberculin skin tests. Maine county jail staff given flushots by mistake/ October 2014 St. Louis County Missouri occurred where five teachers received insulin instead of influenza vaccine ( seeking flu shotsinstead given insulin). In January 2010 in Wellesley, Massachusetts staffers at a school there received insulin instead of influenza vaccine ( Did School Staffers Get Insulin Instead of Flu Vaccine ). In 2007 case where a teacher in nearby Attleboro received insulin instead of flu vaccine. In November 2009 in Holland, 11 elderly residents in a nursing home received insulin instead of influenza vaccine news/34510 insulin insteadmexican flu shot/. In another case, also in Holland, a patient died after insulin was given instead of influenza vaccine. In 2008 in Bedford County Virginia, five school employees went to the hospital after the school nurse accidently gave insulin instead of the flu shot. school employees mistakenly get insulinnot flu vaccine/article_622f43da 189b 563d b01d 1ce8f679a5db.html?mode=jqm. 17

18

19 Packaging issue RotaTeq vs. Rotarix Rotarix injected instead of given orally RotaTeq diluent in between other GSK vaccines that ARE injected 19

20 Look alikes 20

21 Hepatitis B vaccine 21

22 Name or Abbreviation Confusion DTaP Tdap Adacel (Tdap) Daptacel (DTaP) Kinrix (DTaP/Polio) Pediarix (DTaP/Polio/hepatitis B) Hep B Hib HPV HBV Varicella virus vaccine varicella zoster immune globulin (VZIG) Varivax Zostavax 22