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The initiation of cell-mediated immunity can be observed as early as the third month of fetal growth, with active antibody-mediated immunity following approximately one month later.
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Lessons learned from a cluster of immunization errors in newborns.

Loubna Alj1,2, Amina Tebaa3, Ismail Talibi3,4

  • 1Centre Anti Poison et de Pharmacovigilance du Maroc, Ministry of Health and Social Protection, Rue Lamfadel Cherkaoui, Madinate Al Irfane, BP 6671, Rabat, Morocco.

Therapeutic Advances in Vaccines and Immunotherapy
|January 5, 2024
PubMed
Summary

A serious immunization error occurred when six newborns received rocuronium instead of the hepatitis B vaccine, leading to one fatality. This highlights critical safety issues in medication storage and packaging that require immediate attention to prevent future vaccine adverse events.

Keywords:
immunization errorpharmacovigilancepreventabilityrisk minimization actionroot cause analysisvaccine safety

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Area of Science:

  • Medical Safety
  • Pharmacovigilance
  • Vaccinology

Background:

  • A cluster of immunization errors (IEs) involving newborns occurred at a maternity university hospital (MUH).
  • Six newborns were inadvertently administered rocuronium instead of the hepatitis B (HepB) vaccine.
  • The incident resulted in respiratory distress in the affected newborns, with one fatality.

Purpose of the Study:

  • To investigate the findings of this IE cluster.
  • To identify the underlying causes and contributing factors of the errors.
  • To propose risk minimization strategies to improve vaccine safety.

Main Methods:

  • A descriptive analysis of the IE cluster reported to the Moroccan Pharmacovigilance Centre (MPC) was conducted.
  • An investigation followed World Health Organization guidance.
  • Root cause analysis was performed to determine contributing factors.

Main Results:

  • Key factors included look-alike packaging of rocuronium and HepB vaccine, first-time HepB vaccination at MUH, lack of a full-time pharmacist, and unsafe drug storage.
  • Five newborns recovered after Sugammadex administration and transfer to neonatal care.
  • Recommendations included awareness training, improved nursing procedures, pharmacist appointment, and reassessment of drug storage.

Conclusions:

  • Reporting serious IEs is crucial for identifying causes and implementing corrective actions.
  • Lessons learned from such errors are vital for enhancing global vaccine safety protocols.