Estimated glomerular filtration rate with and without race for drug dosing: Cystatin C vs. serum creatinine.

The goal of this study was to use a model kidney function clearance-dependent drug (vancomycin) to understand the gain or loss of precision in dosing with use of serum creatinine (Scr ), serum cystatin C (Scys ) and race and nonrace-based equations of the estimated glomerular filtration rate (eGFR). In this study of hospitalized patients, we compared Scr , Scys and their combination to estimate kidney function and vancomycin clearance. The nonrace-based Scys eGFR model outperformed other clearance models and improved the probability of target attainment by 15%. When Scys is not available, we show that the new 2021 CKD-EPI eGFRcr equation (no race factor) performs as well as the current conventional approach. This improvement in model performance does not negate the need for individualized dosing but exemplifies the need to remove race as a factor of kidney-function dose adjustment.

Single-patient expanded access: A primer for pharmacists.

PURPOSE: The process of providing treatment with investigational drugs through expanded access is explained. Roles and informational resources for pharmacists are discussed. SUMMARY: Expanded access is a regulatory pathway for the treatment of serious or life-threatening diseases or conditions with investigational agents outside of clinical trials. In the setting of no available therapies or ineligibility for clinical trials, a patient and their treating physician may pursue therapies that are not approved by the Food and Drug Administration (FDA). The drug manufacturer, FDA, and institutional review boards are required stakeholders in the expanded access process. Other pathways for obtaining investigational agents outside of clinical trials, including federal Right to Try and emergency use authorization, exist but differ in their level of involvement of these key stakeholders. Pharmacists are equipped to be involved in therapy identification, risk vs benefit evaluations, therapy preparation and administration, supportive care, transitions of care, and regulatory compliance. Specific websites, publications, and organizations can aid in navigating expanded access. CONCLUSION: Combining elements of traditional clinical care and research, expanded access involves direct treatment with non-FDA-approved agents outside of a clinical trial. Healthcare providers should be aware of the possibility of providing investigational treatments after all approved options have been exhausted.

Assessment of impact of daily huddles and visual displays on medication delivery timeliness in a large academic medical center.

PURPOSE: To evaluate the impact of pharmacy team huddles and near real-time performance dashboards on the punctuality of medication delivery departures from the adult inpatient pharmacy of a multihospital medical center. METHODS: Baseline delivery punctuality was established during a 2-week unannounced preintervention period, followed by the implementation of daily huddles focused on delivery timeliness along with visual displays of delivery performance metrics. The 5- to 15-minute huddles included pharmacy technicians, pharmacists, and managers. Printed visual displays that tracked hour-by-hour timeliness over the prior 24 hours were prominently displayed in the pharmacy. The primary outcome was the overall change in the percentage of punctual medication delivery departures (ie, deliveries leaving the pharmacy at the scheduled time) during the 2 weeks after implementation of huddles and visual displays (the postintervention period). Punctuality was assessed at both the day and shift levels using generalized estimating equations in a piecewise regression model. A multivariable model was constructed using a forward stepwise selection process to assess the potential impacts of workload drivers and staffing levels on medication delivery punctuality. RESULTS: During the pre- and postintervention periods, the punctuality of a total of 1,032 deliveries was recorded. Punctuality of deliveries across all shifts increased by 37% (95% confidence interval [CI], 18%-56% [P < 0.001]), from 50% to 87%, immediately following implementation of the huddle intervention. When punctuality was assessed by individual shift, we observed statistically significant increases for the day (35% [95% CI, 13%-57%], P = 0.002), evening (34% [95% CI, 12%-56%], P = 0.003) and night (57% [95% CI, 35%-79%], P < 0.001) shifts. During the forward stepwise multivariable model-building process, order volume, message volume, and technician staffing levels were not significantly correlated with delivery punctuality at the day or shift level. CONCLUSION: Daily huddles with visual displays were successful in improving the punctuality of medication delivery departures from the pharmacy, independent of workload drivers and staffing levels.