Vaccine-Related Errors in Reconstitution in South Korea: A National Physicians’ and Nurses’ Survey

Abstract

Vaccine-related errors (VREs) result from mistakes in vaccine preparation, handling, storage, or administration. We aimed to assess physicians’ and nurses’ experiences of VREs in South Korea, focusing on reconstitution issues, and to understand the barriers to and facilitators of preventing them. This was a cross-sectional study using an internet-based survey to examine experiences of reconstitution-related errors, and experience or preference with regard to ready-to-use vaccines (RTU) by physicians and nurses. A total of 700 participants, including 250 physicians and 450 nurses, responded to the questionnaire. In total, 76.4% and 41.5% of the physicians and nurses, respectively, reported an error related to reconstituted vaccines. All errors had been reported as experienced by between 4.9% and 52.0% of physicians or nurses. The errors were reported to occur in more than one in 100 vaccinations for inadequate shaking of vaccines by 28.0% of physicians and 6.9% of nurses, incomplete aspiration of reconstitution vials by 28.0% of physicians and 6.4% of nurses, and spillage or leakage during reconstitution by 20.8% of physicians and 6.9% of nurses. A total of 94.8% of physicians had experience with RTU vaccines, and all preferred RTU formulations. In conclusion, this study highlights the high frequency and types of reconstitution-related errors in South Korea. RTU vaccines could help reduce the time needed for preparation and reduce the risk of errors in South Korea.

Vaccine preparation time, errors, satisfaction, and preference of prefilled syringes versus RSV vaccines requiring reconstitution: randomized, time and motion study

“…In addition, due to the requirement for reconstitution and additional associated steps, additional errors such as ‘Lack of cleansing of vials rubber stopper after removing the plastic flip off’ or ‘Vial content (adjuvant or reconstituted vaccine) not fully aspired into syringe’ were observed. This is in line with other published studies [13, 16]. A survey-based evaluation of vaccine related errors by Lee et al found 76.4% of physicians and 41.5% of nurses experienced errors related to reconstitution, including ‘vial contents not aspired into syringe’ (52.0% and 14.7%, respectively), ‘inadequate shaking’ (51.6% and 19.1%, respectively), ‘spillage or leakage during reconstitution’ (42.4% and 14.7%, respectively), ‘needle twisted when inserted in vial stopper’ (29.6% and 11.8%, respectively), ‘same needle used for reconstitution and injection’ (23.2% and 10.0%, respectively), ‘forgetting to reconstitute’ (19.2% and 7.6%, respectively), ‘other’ (31.6% and 11.1%, respectively) [16].…”

“…Agreement between reviewers of ≥80% was considered acceptable, and no changes were needed based on quality control. The vaccine-specific error checklist was developed by reviewing all steps listed in the label of approved vaccines and were cross referenced with published literature [13, 16].…”

“…In the selection of vaccine presentations, HCP preference may play a role. Several studies have reported higher HCP preference for PFS presentations, with the most common reasons being reduced number of immunization errors, ease of administration, and work efficiency [11,[14][15][16][17]. HCPs also expressed that using PFS lowers the risk of needle contamination and needle stick injuries and reduces the possibility of dosage errors [15,17].…”

Prevalence and underreporting of immunization errors in childhood vaccination: results of a household survey

“…The most prevalent errors were inadequate interval between vaccines, followed by vaccines administered outside the recommended age. Studies also corroborated these findings ( 9 , 11 , 18 , 23 ) . Health professionals’ lack of knowledge about the recommended intervals and minimum intervals between vaccines exposes them to immunization errors.…”

Estimating the Total Societal Cost of a Hexavalent Vaccine versus a Pentavalent Vaccine with Hepatitis B in South Korea

“…One of them (Hexacima/Hexaxim/Hexyon) is a ready-to-use, fully liquid product that can be rapidly and safely administered skipping the reconstitution step as required for the pentavalent vaccines that are now registered and in use in South Korea [ 12 , 13 ]. With its ready-to-use status, this hexavalent vaccine type prevents several types of immunization errors that may happen [ 14 ]. A previous study has demonstrated that medical errors may occur most frequently during the reconstitution step [ 15 ].…”