Strategies to Reduce Errors Associated with 2-Component Vaccines

  • PDF / 1,104,924 Bytes
  • 9 Pages / 595.276 x 790.866 pts Page_size
  • 94 Downloads / 190 Views

DOWNLOAD

REPORT


CURRENT OPINION

Strategies to Reduce Errors Associated with 2‑Component Vaccines Farzana Samad1 · Samantha J. Burton1 · Diana Kwan2   · Noah Porter2 · Judy Smetzer1 · Michael R. Cohen1 · Jeanne Tuttle3 · Danial Baker4 · Dennis E. Doherty5 Accepted: 5 October 2020 © The Author(s) 2020

Abstract The high incidence of error reports received by the US Food and Drug Administration (FDA) involving 2-component vaccines led to collaboration between the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). This collaborating group sought to further understand errors associated with all 2-component vaccines (i.e. vaccine components provided by the manufacturer in physically separate containers) and to provide safe practice strategies for storing, preparing, dispensing, and administering these vaccines as intended. Fourteen available 2-component vaccines were identified. The ISMP National Vaccine Errors Reporting Program (VERP) and the FDA Vaccine Adverse Event Reporting System (VAERS) were searched from the initiation of each respective reporting system through December 31, 2019. The three vaccines with the most reported reconstitution errors in the VERP and VAERS are M ­ enveo® (meningococcal), ® ® ­Pentacel (DTaP, Polio, Haemophilus influenzae type b), and A ­ ctHIB [H. influenzae type b (Hib)]. Manufacturers should design labeling and packaging of vaccines to provide ease of storage and fail-safe preparation to prevent 2-component vaccine errors. Implementing risk reduction strategies, such as training healthcare professionals and affixing storage bin labels, remind healthcare professionals to mix the 2-components and facilitate appropriate administration.

1 Introduction Vaccination, responsible for the prevention of serious diseases that are otherwise debilitating or deadly, is one of the most remarkable advancements in public health [1–3]. To sustain disease prevention, vaccine administration needs to be both widespread and performed correctly [2]. However, errors related to storage and use of vaccines continue to occur, including omission of a vaccine or vaccine component when administering 2-component vaccines [2, 4]. For the purpose of this article, a 2-component vaccine is Jeanne Tuttle: Retired from Pharmacy Benefits Management Services. * Diana Kwan [email protected] 1



Institute for Safe Medication Practices, Horsham, PA, USA

2



United States Pharmacopeia, Rockville, MD, USA

3

Department of Veterans Affairs, Pharmacy Benefits Management Services, Washington DC, USA

4

College of Pharmacy and Pharmaceutical Sciences, Washington State University, Spokane, WA, USA

5

Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, College of Medicine and Chandler Medical Center, Lexington, KY, USA



defined as any vaccine with two components (i.e. vaccine and specific diluent; vaccine liquid component and vaccine powder component) provided by the manufacturer in physically separate containers. The individual components of 2-component vaccines must be mixed