1. Storing, Handling, and Administering Vaccines Safely
Michael R. Cohen, RPh, MS, ScD
Institute for Safe Medication Practices (ISMP)
Huntingdon Valley, PA 19006

2. USP-ISMP Medication Errors Reporting Program
Operated by the United States Pharmacopeia in Cooperation with the Institute for Safe Medication Practices
Pennsylvania Patient Safety Reporting Program

3. Institute for Safe Medication Practices
USP-MERP
Consumers
Pa-PSRS
Practitioners
FDA MEDWATCH
Regulatory
Other sources
Industry
ISMP Canada
ISMP Spain
ISMP Brazil

4. Committee on Quality of Health Care in America
Preventing Medication Errors
Institute of Medicine
Committee on Quality of Health Care in America
Trademarks and medication errors part of a much larger picture

5. Medication errors with vaccines
Look-Alike or Confusing Labeling and Packaging
Look-Alike and Sound-Alike Names
Non-uniform Expiration Dates
Unclear Communication
Coined names
Vaccine abbreviations
Oral prescriptions
Drug administration practices

6. Look-Alike or Confusing Labeling and Packaging

8. Note position of brand name vs. nonproprietary name

9. Order for “TB x 1” (heard as Td x 1 but DT given)

10. Position of Proper Name on Biologicals
Fed. Reg. 367 (Jan. 10, 1968). “The proper name of the product on the package label shall be placed above any trade-mark or trade name identifying the product and symmetrically arranged with respect other printing on the label.” 33 Fed. Reg. at 369.
Inconsistent with all other drugs
Patient safety issue with combination products

11. Look-Alike or Confusing Labeling and Packaging

12. Nomenclature Drug name mix-ups
Varicella virus vaccine confused with varicella-zoster immune globulin
Pediatric-strength diphtheria–tetanus toxoids (DT) confused with adult-strength tetanus–diphtheria toxoids (Td)

14. Expiration dates
The Aventis Pasteur poliovirus vaccine (inactivated) listed an expiration date of 06 MAR 04.
Practitioners became confused as to whether it meant the drug expired on March 6, 2004, or March 4, 2006.

15. Nomenclature Coined names
Comvax® (hemophilus B/hepatitis B vaccine combination) as “H and H vaccine.”
Twinrix® (hepatitis A, inactivated and hepatitis B, recombinant vaccine) as A and B
“H. Flu vaccine” when Haemophilus b Conjugate vaccine needed (recommend brand name use - (ActHIB, HibTITER, ProHIBiT).
Diphtheria and Tetanus Toxoids and Pertussis Vaccine
Adsorbed referred to as DTP. In some hospitals and clinics a common acronym for a preoperative “cocktail” of Demerol®, Phenergan® and Thorazine® is “DPT”.

16. Vaccine Abbreviations
Drug name abbreviations strongly discouraged by ISMP. However…
CDC approved standard abbreviations for vaccine products since non-standard (coined) abbreviations in common use led to confusion
Standard abbreviations prevent errors and ambiguity in vaccine labeling, medical practice, record keeping, written communications, and scientific publications.
Advantages include communication of vaccine lot numbers on peel off labels for forms

17. Vaccine Abbreviations (over 300 on list including those with specifiers; 150 without)

18. Vaccine Abbreviations
Often, clinicians use just a handful of the more common vaccines on the CDC list. Remaining may not be familiar
Mix-ups include Hib and HBV, Hib and HBVig, HBVig and HBV, DTP and DT, and DT and Td
Use of ad hoc abbreviations, such as “H flu” for Haemophilus influenzae type b (misinterpreted as influenza vaccine), have also led to errors.
Remains to be seen whether uniform abbreviations will help reduce errors.

19. Oral prescriptions Discouraged due to many sound-alike vaccine names.
8-week-old infant given Recombivax HB (hepatitis B vaccine, recombinant) instead of Comvax (Haemophilus b conjugate vaccine with hepatitis B vaccine) after a nurse misheard the spoken order.
Enforce read back to the prescriber for clarification.
Numbers in the teens should be repeated by pronouncing each digit; for example, 16 should be repeated as “one-six” to avoid confusion with the number 60.

20. Drug administration practices
Numerous cases vaccine confusion with refrigerated neuromuscular blocking agents
In 1997 in Yemen 71 schoolchildren were mistakenly given insulin instead of BCG vaccine during a government sponsored TB prevention campaign. A medical worker sent insulin instead of vaccine. Tragically, 21 of the children died.

21. Drug administration practices Vaccines adulterated when vials contaminated or needles or syringes reused.
In 1997, the medical director of Monroe, Connecticut, resigned after administering contaminated vaccines to 468 people. Fresh needles used when preparing doses of vaccine from multiple-dose vials, but syringes not always changed in between patients. Blood aspirated into a syringe during one patient’s injection may have contaminated another patient’s injection. The physician claimed to be unaware that the method he used was improper.
A 1993 CDC report described physicians in Washington, D.C., and Bucks County, Pennsylvania, who injected patients and drew up the next patient’s dose with the same needle but changed the needle before injecting the next patient.

22. Reckless behavior during drug administration 649 children given diluted vaccine by pediatrician
In March, 1996 a Michigan physician confessed that he improperly diluted and administered polio vaccine and mumps, measles and rubella vaccine for administration to as many as 649 children treated at his office. The problem was noticed by an office nurse who realized the vaccine supply was more plentiful than normal. The motivation for this was financial. The office practice was under financial strain. The Michigan State Board has suspended the physician for six months, given him 2 years probation, and placed limitations on his license for 2 years. He will also need to donate 100 hours of professional service, complete 30 hours of CME and allow monitoring of 10% of his charts by another physician. All of the children who were under immunized were being contacted last week for re-immunization.

23. RISK MANAGEMENT AND QUALITY PROCESSES

25. Grabenstein JD, Cohen MR
Grabenstein JD, Cohen MR. Preventing Medication Errors with Immunologic Drugs. In Cohen ed. Medication Errors. American Pharmaceutical Association