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

Abstract

AbstractIntroductionRSV infections can lead to serious outcomes, especially among older adults. Two United States (US) Food and Drug Administration (FDA) approved vaccines, both requiring reconstitution (VRR) prior to administration, are recommended by the Advisory Committee on Immunization Practices (ACIP) for adults aged 60+ years. An alternative vaccine employing a ready-to-use prefilled syringe (PFS) is currently under evaluation by the FDA. The current study compared a PFS versus two VRRs (VRR1 and VRR2) to evaluate preparation time, errors, satisfaction, and preference in a randomized, single-blinded time and motion (T&M) study.MethodsParticipants were recruited and randomized to a preparation sequence of the three vaccines. Participants read instructions, then consecutively prepared the three vaccines with a 3- to 5-minute washout period in between. Preparations were video recorded and reviewed by a trained pharmacist for preparation time and errors using predefined, vaccine-specific checklists. Participant demographics, satisfaction with vaccine preparation, and vaccine preference were recorded. Within-subjects analysis of variance (ANOVA) was used to compare preparation time. Mixed-effects Poisson and ordered logistic regression models were used to compare number of preparation errors and satisfaction scores, respectively.Results63 pharmacists (60%), nurses (35%), and pharmacy technicians (5%) participated at four sites in the US. The least squares (LS) mean preparation time per dose for PFS was 141.8 seconds (95% CI:156.8, 126.7; p<0.0001) faster than for VRR1, 103.6 seconds (118.7, 88.5; p<0.0001) faster than for VRR2, and 122.7 seconds (95% CI: 134.2, 111.2; p<0.0001) faster than the pooled VRRs. Overall satisfaction (combined ‘Very’ and ‘Extremely’) was 87.3% for PFS, 28.6% for VRR1, and 47.6% for VRR2. Most participants (81.0%) preferred the PFS vaccine.ConclusionPFS vaccines can greatly simplify the vaccine preparation process, allowing administrators to prepare almost four times more doses per hour than with vial and syringe systems.Key Summary PointsWhy carry out this study?Two US FDA approved vaccines against RSV require reconstitution. An alternative vaccine employing a ready-to-use prefilled syringe (PFS) is currently under evaluation by the FDA.●We conducted the current study to compare the impact of RSV vaccine format on preparation time, errors, satisfaction and preference between a ready-to-use single-dose prefilled syringe (PFS) RSV vaccine versus two RSV vaccines requiring reconstitution (VRRs).What was learned from the study?Preparation time with PFS was reduced by a factor of 4 compared to VRRs.Most healthcare professionals were extremely satisfied and preferred a PFS presentation over VRRs.PFS vaccines can help vaccine administrators save time on preparation resulting in nearly quadruple their hourly vaccine preparation rate compared to VRRs.