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ISMP National Vaccine Errors Reporting Program Part II: Preparing for Immunization Activities and Campaigns

Vaccination ranks high among the greatest public health achievements of the twentieth century. However, analysis of 575 vaccine errors submitted to the ISMP National Vaccine Errors Reporting Program (ISMP VERP) in 2017, which appeared in our June 14, 2018 newsletter (Part I), suggests that vaccine errors continue to occur, potentially undermining the protection immunization provides against serious diseases. Although we have learned important information from the error reports submitted to the ISMP VERP, analysis of the 2017 data differs little from previous years’ analyses. Overall, the vaccines involved in the most frequently reported errors have not changed since 2012 and include DTaP, Tdap, DTaP-IPV, DTaP-IPV/Hib, HepA, HepB, influenza virus vaccines, MMRV, and 9vHPV. Furthermore, these errors occurred for many of the same reasons previously noted during analysis of the ISMP VERP data, particularly:

Product-related contributing factors

  • Age-dependent formulations of the same vaccine
  • Similar brand and generic names, abbreviations, and container labels/packaging
  • Conjugate antigen listed on labels mistaken as the target vaccine name

Knowledge and information-related contributing factors

  • Unfamiliarity with the indicated ages, dosing, and intervals
  • Unfamiliarity with mixing and preparing the vaccines
  • Unfamiliarity with vaccine schedules, including individualized catch-up schedules
  • Incomplete or confusing vaccination history in a state or local vaccine registry

Practice-related contributing factors

  • Failure to verify the patient’s age before administration
  • Failure to check the chart and vaccine registry for date of prior vaccination
  • Failure to document vaccination in the medical record and/or vaccine registry
  • Miscommunication of vaccine orders and ambiguous due dates
  • Preparation of vaccines for multiple patients at the same time
  • Immunizing multiple patients in the same treatment room
  • Unlabeled syringes

In Part II of this newsletter feature, we take all that we have learned about vaccine errors from the ISMP VERP between 2012 and 2017 and provide recommendations to help organizations prepare for immunization activities and vaccine campaigns in hospitals and clinic settings. While not inclusive of all preparations required for immunization activities and campaigns, the recommendations are responsive to the types of errors and contributing factors reported to the ISMP VERP. The recommendations include a list of educational topics and teaching points to cover with staff who will be administering vaccines. The recommendations will also help facilities evaluate their vaccine practices and staff training programs, even if an immunization campaign is not being planned.

Protocols

  • Examine the protocols (and/or standing orders) for vaccines that will be used during an immunization activity or campaign to confirm they include:
    • The full generic name, brand name (if applicable), and current standard abbreviation approved by the Centers for Disease Control and Prevention (CDC)
    • Indication and vaccine schedule for routine and catch-up vaccination
    • Criteria for screening patients for contraindications and precautions
    • A reminder to provide the most current Vaccine Information Statement (VIS) to patients or caregivers prior to immunization
    • Directions for preparing and administering the vaccine, including the dose, vials/containers to use, route of administration, and any special precautions 
    • Details regarding what (e.g., lot number, expiration date), where (e.g., vaccination record, vaccine registries), and how to document vaccine administration and distribution of the VIS
    • An emergency protocol to follow if the patient develops an adverse reaction
    • Information about reporting adverse vaccine events
  • The Immunization Action Coalition (IAC) and Defense Health Agency Immunization Healthcare Branch provide sample protocols/standing orders for most vaccines.

Drug Name Listings

  • Verify that the brand names of vaccines are listed on computer screens and electronic medication administration records (eMARs).
  • Review the way Haemophilus influenzae type b, meningococcal, and pneumococcal conjugate vaccines are listed on automated dispensing cabinet (ADC) screens, pharmacy labels, vaccination records, and eMARs, with a goal to reduce the risk of identifying the conjugate antigen (e.g., tetanus toxoid, diphtheria, meningococcal protein) as the targeted vaccine.

Treatment Areas

  • If multiple patients (e.g., siblings, parent and child, groups) are likely to be immunized, structure the treatment area to allow separation of the patients into distinct areas so only one patient at a time is available in the immediate treatment area. This allows staff to prepare, administer, and document the vaccination of one patient, without the risk of administering the vaccine to the wrong patient.

Vaccine Storage

  • Plan for safe storage of single component vaccines and any associated diluents, and two-component vaccines, during onsite and offsite immunization activities.
  • If refrigeration is necessary, temperatures should be set between 36-46°F.
  • Vaccine vials and syringes should be separated into bins or other containers according to vaccine type and formulation, and never stored together.
  • Adult and pediatric formulations of the same vaccine should be separated.
  • Vaccines with similar names or abbreviations, or overlapping components (e.g., DTaP, DT, Tdap, Td) should not be stored in bins or containers next to each other.
  • If both varicella-zoster immune globulin and the varicella virus vaccine will be available, store them far away from each other to help prevent a product selection error that might lead to the inadvertent administration of varicella virus vaccine to a pregnant woman instead of the varicella-zoster immune globulin.

Staffing and Training

  • Staff the immunization activities or campaign with trained providers who have demonstrated competencies related to the vaccine(s) being administered and error-prevention strategies associated with the common error types. See the tool for educational topics and teaching points, which are associated with frequently reported vaccine errors, to cover with staff who will be administering vaccines.  Three contact hours of free continuing education associated with immunization best practices is also available from the CDC.    
  • When possible, plan to include a pharmacist on the immunization team. Significant reductions in vaccine errors, invalid vaccine doses, and missed opportunities to vaccinate have been documented when including pharmacists on the team.1 
  • Confirm that staff involved in the vaccine activities or campaigns know how to search the vaccine registry (if available), understand the information provided and its level of reliability, and how to document immunizations in the registry.

Reference Materials

Dispensing Vaccines

  • Plan to use commercially available, prefilled syringes of vaccines whenever possible.
  • Investigate purchasing differing age-specific formulations of the same vaccine from different manufacturers to help distinguish them. However, stock and dispense just one brand of the hepatitis A vaccine and the hepatitis B vaccine (adult and pediatric/adolescent formulations from the same manufacturer have the same concentration, while vaccines from different manufacturers may have different concentrations [e.g., ENGERIX-B 20 mcg/mL, RECOMBIVAX HB, 10 mcg/mL]).
  • When space permits, plan to affix auxiliary labels or highlight important label information with a marker for the following vaccine products prone to confusion:
    • Vaccines with similar names or components, to promote correct selection
    • Varicella virus vaccines, to avoid use during pregnancy
    • Vaccines prone to administration by the wrong route (e.g., influenza; rotavirus; measles, mumps, rubella; varicella; zoster; meningococcal vaccines), to draw attention to the correct route
    • Vaccines with different age formulations, to help identify targeted ages
    • Polysaccharide conjugate vaccines, to draw attention to the target vaccine’s name
    • Diluents supplied with vaccines, to ensure staff do not believe the diluent alone is the vaccine (see next main bullet)
    • Two-component vaccines, to ensure that they are mixed together prior to administration (see next main bullet)
  • Establish a process to keep two-component vaccines together, and to keep diluents and their corresponding vaccines together if storage requirements do not differ.
  • If barcode technology is used prior to drug administration, plan to affix a barcode to dispensed vaccines or ensure that a manufacturer’s barcode is easily scannable.
  • Check for expired vaccines prior to the immunization activity or campaign. Implement measures to avoid dispensing an expired vaccine. 

Verification of Immunization Status

  • Confirm that policies and procedures require staff to verify the patient’s current immunization status prior to vaccination by checking the patient’s health record, vaccination record, and/or vaccine registry. Policies and procedures should direct staff to locate missing vaccination records whenever possible by contacting previous healthcare providers and reviewing vaccine registries. If records cannot be located, patients should be started on an age-appropriate vaccination schedule.

Patient Education

  • Be prepared to provide a current VIS (if available) to patients, parents, or legal guardians prior to vaccination, in the primary languages of the target population. VISs are available on the CDC and IAC websites and have been translated into more than 40 languages. The VISs can be printed or viewed on smart phones, tablets, or other mobile devices, and can be linked to the vaccination record or eMAR so they are readily available.
  • Check your VIS stock to be sure you have the most current versions (e.g., recent updates in 2018 include anthrax, MMR, MMRV, rotavirus, varicella, and zoster).

Documentation of Vaccine Administration

  • Examine the vaccine administration records that will be used during an immunization activity or campaign to confirm they:
    • Prompt for all information required to be documented (e.g., vaccine generic and brand name, date of vaccination, funding source [federal, state, private], route, site [if injection], lot number/expiration date of vials/diluents, manufacturer, publication date of the VIS and date provided to the patient/caregiver, vaccinator name)
    • Provide enough space to list full brand and generic vaccine names
  • Determine who will document vaccine administration in available local or state vaccine registries, and establish a plan to ensure said documentation occurs.

Other

In response to prior VERP analyses, ISMP has provided recommendations to improve vaccine safety in the following ISMP Medication Safety Alert! newsletters:

 

Reference

  1. Haas-Gehres A, Sebastian S, Lamberjack K. Impact of pharmacist integration in a pediatric primary care clinic on vaccination errors: a retrospective review. J Am Pharm Assoc. 2014;54(4):415-8.
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Teaching Tool to Prevent Errors with Vaccine Administration