Crushing the Contents of Valbenazine Capsules for Potential Addition to Soft Foods or Administration via Gastrostomy Tube.

PURPOSE: One-capsule, once-daily valbenazine is approved for tardive dyskinesia and under evaluation for chorea associated with Huntington's disease, conditions in which patients often experience dysphagia. In vitro studies were conducted to assess the suitability of crushing the contents of valbenazine capsules (40 and 80 mg) for mixing with soft foods or liquids or administration via a gastrostomy tube (G-tube). METHODS: In study 1, the dissolution of whole valbenazine capsules and crushed capsule contents were measured serially for 1 hour. In study 2, valbenazine recovery was evaluated after crushed contents were mixed with soft foods, buffer solutions (pH range, 1.2-6.8), and fed-state simulated gastric fluid. In study 3, valbenazine recovery was evaluated after crushed contents were dispersed in water and delivered via a G-tube. In studies 2 and 3, acceptable valbenazine recovery was 90% to 110%. FINDINGS: Study 1 indicated rapid and complete drug release for whole valbenazine capsules and crushed capsule contents, with similar release at 10 minutes (whole, 94%-99%; crushed, 98%-100%) and 60 minutes (whole, 101%-103%; crushed, 101%-102%). Study 2 found acceptable valbenazine recovery within 2 hours of adding crushed capsule contents to tested foods, buffers, or fed-state simulated gastric fluid (recovery, 92%-102%). Study 3 found acceptable valbenazine recovery when crushed contents were added to cold or hot water and delivered via G-tube, with a water cup rinse to capture residual contents (recovery, 91%-97%). IMPLICATIONS: These studies indicate the potential viability of valbenazine formulation(s) that can be added to soft foods or liquids or delivered via G-tube. Such formulations will be important for individuals who require treatment with a vesicular monoamine transporter 2 inhibitor but cannot swallow whole pills.

In-house versus on-call trauma surgeon coverage: A systematic review and meta-analysis.

BACKGROUND: A rapid trauma response is essential to provide optimal care for severely injured patients. However, it is currently unclear if the presence of an in-house trauma surgeon affects this response during call and influences outcomes. This study compares in-hospital mortality and process-related outcomes of trauma patients treated by a 24/7 in-house versus an on-call trauma surgeon. METHODS: PubMed/Medline, Embase, and CENTRAL databases were searched on the first of November 2020. All studies comparing patients treated by a 24/7 in-house versus an on-call trauma surgeon were considered eligible for inclusion. A meta-analysis of mortality rates including all severely injured patients (i.e., Injury Severity Score of ≥16) was performed. Random-effect models were used to pool mortality rates, reported as risk ratios. The main outcome measure was in-hospital mortality. Process-related outcomes were chosen as secondary outcome measures. RESULTS: In total, 16 observational studies, combining 64,337 trauma patients, were included. The meta-analysis included 8 studies, comprising 7,490 severely injured patients. A significant reduction in mortality rate was found in patients treated in the 24/7 in-house trauma surgeon group compared with patients treated in the on-call trauma surgeon group (risk ratio, 0.86; 95% confidence interval, 0.78-0.95; p = 0.002; I2 = 0%). In 10 of 16 studies, at least 1 process-related outcome improved after the in-house trauma surgeon policy was implemented. CONCLUSION: A 24/7 in-house trauma surgeon policy is associated with reduced mortality rates for severely injured patients treated at level I trauma centers. In addition, presence of an in-house trauma surgeon during call may improve process-related outcomes. This review recommends implementation of a 24/7 in-house attending trauma surgeon at level I trauma centers. However, the final decision on attendance policy might depend on center and region-specific conditions. LEVEL OF EVIDENCE: Systematic review/meta-analysis, level III.