Implementation of a workflow system with electronic verification for preparation of oral syringes.

PURPOSE: The implementation of a commercially available, Web-based, barcode-enabled workflow management system for filling and checking patient-specific oral syringes at the Cleveland Clinic is described. SUMMARY: Historically, the process for preparing oral syringes has been a manual, repetitive procedure at Cleveland Clinic. Within this process, paper logs are the sole source of information. These logs can be difficult to locate or interpret. It remains a rote process with numerous manual steps offering opportunity for human error. Traditionally, automation, such as barcode scanning, has not been available during oral syringe preparation and checking. Based on increasing regulatory demands and documentation gaps identified, solutions were explored in the pharmacy's nonsterile compounding environment. An electronic verification workflow system was developed, implemented, and evaluated with a focused assessment of throughput and patient safety relative to oral syringe preparation. This was a retrospective study conducted in an academic, tertiary, acute care medical center. Analysis was completed at 3 months to evaluate efficiencies. Data regarding experiences at the Cleveland Clinic shows promising benefits with regards to United States Pharmacopeia chapter 795 compliance, the pursuit of incorporating advanced informatics and automation in manual processes, and standardization of workflow within an enterprise setting. CONCLUSION: Implementation of an electronic workflow verification system that integrates barcode verification and image-capture capabilities has maintained regulatory compliance in the nonsterile compounding environment including preparation of oral syringe doses without impacting throughput.

Pterostilbene on metabolic parameters: a randomized, double-blind, and placebo-controlled trial.

Introduction. The purpose of this trial was to evaluate the effect of pterostilbene on metabolic parameters. Methods. A prospective, randomized, double-blind, and placebo-controlled study that enrolled 80 patients with a total cholesterol ≥200 mg/dL and/or LDL ≥ 100 mg/dL. Subjects were divided into four groups: (1) pterostilbene 125 mg twice daily; (2) pterostilbene 50 mg twice daily; (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily; (4) matching placebo twice daily for 6-8 weeks. Endpoints included lipids, blood pressure, and weight. Linear mixed models were used to examine and compare changes in parameters over time. Models were adjusted for age, gender, and race. Results. LDL increased with pterostilbene monotherapy (17.1 mg/dL; P = 0.001) which was not seen with GE combination (P = 0.47). Presence of a baseline cholesterol medication appeared to attenuate LDL effects. Both systolic (-7.8 mmHg; P < 0.01) and diastolic blood pressure (-7.3 mmHg; P < 0.001) were reduced with high dose pterostilbene. Patients not on cholesterol medication (n = 51) exhibited minor weight loss with pterostilbene (-0.62 kg/m(2); P = 0.012). Conclusion. Pterostilbene increases LDL and reduces blood pressure in adults. This trial is registered with Clinicaltrials.gov NCT01267227.

Analysis of safety from a human clinical trial with pterostilbene.

Objectives. The purpose of this trial was to evaluate the safety of long-term pterostilbene administration in humans. Methodology. The trial was a prospective, randomized, double-blind placebo-controlled intervention trial enrolling patients with hypercholesterolemia (defined as a baseline total cholesterol ≥200 mg/dL and/or baseline low-density lipoprotein cholesterol ≥100 mg/dL). Eighty subjects were divided equally into one of four groups: (1) pterostilbene 125 mg twice daily, (2) pterostilbene 50 mg twice daily, (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily, and (4) matching placebo twice daily for 6-8 weeks. Safety markers included biochemical and subjective measures. Linear mixed models were used to estimate primary safety measure treatment effects. Results. The majority of patients completed the trial (91.3%). The average age was 54 years. The majority of patients were females (71%) and Caucasians (70%). There were no adverse drug reactions (ADRs) on hepatic, renal, or glucose markers based on biochemical analysis. There were no statistically significant self-reported or major ADRs. Conclusion. Pterostilbene is generally safe for use in humans up to 250 mg/day.