Administration Errors Associated with Shingles Vaccine

Shingrix (Recombinant zoster vaccine) has been associated with vaccine administration errors since it hit the market, according to a new CDC report.

Shingrix (recombinant zoster vaccine [RZV]) has been associated with vaccine administration errors since it hit the market, according to a new CDC report. The RZV vaccine was approved October 2017 for adults aged 50 years and older for the prevention of herpes zoster (shingles). It is administered as a 2-dose intramuscular (IM) series, with the second dose given anytime from 2 to 6 months after the first. The CDC now recommends RZV as the preferential shingles prevention vaccine.

Vaccine Administration Errors

The RZV was monitored October 20, 2017-February 20, 2018 through the CDC’s Vaccine Adverse Event Reporting System (VAERS).1 During this timeframe, there were 155 reports involving RZV, 13 (8%) documenting an administration error (Table).1

Table: Vaccine Administration Errors1

Vaccine Error

Vaccine Error Description

Inappropriate route of administration

Administered RZV by subcutaneous (SQ) route instead of IM route; caused injection site reactions (e.g. pain, erythema, and pruritus)

Inappropriate age

Vaccine administration to patients 39 and 48 years of age

Wrong drug information distributed

Two patients received the vaccine information statement for ZVL instead of RZV

Lack of patient counseling

Two patients did not receive instructions to return for the second dose

Administration of wrong vaccine

RZV was administered instead of the intended varicella (Varivax) vaccine with unreported age

Incorrect storage

Administration of RZV vaccine after frozen storage

Failure to reconstitute

Administration of the adjuvant component without reconstitution with the vaccine antigen

The vaccine administration errors occurred in a pharmacy for the majority (9) of the reports, and a healthcare office.1 One disadvantage of the VAERS is the inability to assess the cause of the administration errors. The VAERS is a national program managed by the CDC, and is a good way to monitor vaccines through identification of adverse effects, and administration errors. There are likely more vaccine errors that may not have been reported. It is important for pharmacists to continue reporting vaccine errors through VAERS to play an integral role in the postmarketing surveillance process.

Pharmacist Education

RZV has become more widely available at pharmacies since its approval, so it is important for pharmacists to be familiar with the vaccine, including the route of administration and storage requirements. Before reconstitution, both vials should be refrigerated. RZV should be prepared by reconstituting the antigen component with the adjuvant component. The dose is 0.5 ml of the reconstituted vaccine, and it must be administered as an IM injection.2 After reconstitution, RZV should be administered immediately or stored in the refrigerator and used within 6 hours.2

It is important for pharmacists not to confuse the route of administration with the ZVL (SQ) vaccine, as this can result in an increased risk of adverse effects at the injection site. Pharmacists should remind patients to return to the pharmacy within 2 to 6 months to receive their second vaccine dose. Reminder follow-up phone calls may help to increase patient compliance.

References

  • Shimabukuro TT, Miller ER, Strikas RA, et al. Notes from the Field: Vaccine Administration Errors Involving Recombinant Zoster Vaccine — United States, 2017-2018. MMWR Morb Mortal Wkly Rep 2018;67:585 586.DOI:http://dx.doi.org/10.15585/mmwr.mm6720a4.
  • Shingrix [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2017.