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Purpose: Interventions to improve the safety and efficiency of manual sterile compounding are needed. This study evaluated the impact of a technology-assisted workflow system (TAWS) on sterile compounding safety (checks, traceability, and error detection), and efficiency (task time)., Methods: Observations were conducted in an oncology pharmacy transitioning from a manual to a TAWS process for sterile compounding. Process maps were generated to compare manual and TAWS checks and traceability. The numbers and types of errors detected were collected, and task times were observed directly or via TAWS data logs., Results: Analysis of safety outcomes showed that, depending on preparation type, 3 to 4 product checks occurred in the manual process, compared to 6 to 10 checks with TAWS use. TAWS checks (barcoding and gravimetric verification) produced better traceability (documentation). The rate of incorrect-drug errors decreased with technology-assisted compounding (from 0.4% [5 of 1,350 preparations] with the manual process to 0% [0 of 1,565 preparations] with TAWS use; P < 0.02). The TAWS increased detection of (1) errors in the amount of drug withdrawn from vials (manual vs TAWS, 0.4% [5/1,350] vs 1.2% [18/1565]; P < 0.02), and (2) errors in the amount of drug injected into the final container (manual vs TAWS, 0% [0/1,236] vs 0.9% [11/1,272]; P < 0.002). With regard to efficiency outcomes, TAWS use increased the mean mixing time (manual vs TAWS, 275 seconds vs 355 seconds; P < 0.001), had no significant impact on average visual checking time (manual vs TAWS, 21.4 seconds vs 21.6 seconds), and decreased average physical checking time (manual vs TAWS, 58.6 seconds vs 50.9 seconds; P < 0.001)., Conclusion: In comparison to manual sterile compounding, use of the TAWS improved safety through more frequent and rigorous checks, improved traceability (via superior documentation), and enhanced error detection. Results related to efficiency were mixed., (© American Society of Health-System Pharmacists 2022.)

Tafamidis, a non-nonsteroidal anti-inflammatory benzoxazole derivative, acts as a transthyretin (TTR) stabilizer to slow progression of TTR amyloidosis (ATTR). Tafamidis meglumine, available as 20-mg capsules, is approved in more than 40 countries worldwide for the treatment of adults with early-stage symptomatic ATTR polyneuropathy. This agent, administered as an 80-mg, once-daily dose (4 × 20-mg capsules), is approved in the United States, Japan, Canada, and Brazil for the treatment of hereditary and wild-type ATTR cardiomyopathy in adults. An alternative single solid oral dosage formulation (tafamidis 61-mg free acid capsules) was developed and introduced for patient convenience (approved in the United States, United Arab Emirates, and European Union). In this single-center, open-label, randomized, 2-period, 2-sequence, crossover, multiple-dose phase 1 study, the rate and extent of absorption were compared between tafamidis 61-mg free acid capsules (test) and tafamidis meglumine 80-mg (4 × 20-mg) capsules (reference) after 7 days of repeated oral dosing under fasted conditions in 30 healthy volunteers. Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125). Both tafamidis regimens had an acceptable safety/tolerability profile in this population., (© 2020 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.)

Objective: To compare hospital pharmacy practice in France and Canada by identifying similarities and differences in the two institution's pharmacy activities, resources, drug dispensing processes and responsibilities., Setting: Centre hospitalier universitaire Sainte-Justine (SJ), Montréal, Québec, Canada and Hôpital Robert Debré (RD), Paris, France, are two maternal-child teaching hospitals. They share a similar mission focused on patient care, teaching and research., Method: The data were gathered from annual reports, department strategic plans and by direct observation., Main Outcome Measure: The description and comparison of the legal environment, hospital demographics, pharmacy department data, drug dispensing processes and pharmacist activities in the two institutions., Results: The Centre hospitalier universitaire Sainte-Justine and Hôpital Robert Debré are similar with respect to their mission and general demographics; number of beds, annual hospital expenditures, number of admissions, visits and childbirths. The respective pharmacy departments differ in allocated resources. The main operational differences concern compounding, quality control programs and clinical activities. The French department also manages medical devices, medical gases, blood derivatives and the sterilisation unit. These comparisons highlight the more patient-oriented Canadian hospital pharmacy practice against the more product-oriented French hospital practice Factors contributing to these differences include academic curriculum, the attention paid to the legal environment by professional bodies, staffing patterns and culture., Conclusion: There are differences between the hospital pharmacy practice in the studied hospitals in Canada and France. Hospital pharmacy practice in France seems to be more product oriented, and the practice in Canada seems more patient oriented.

A computer software package was developed to perform the calculations involved in compounding neonatal/pediatric parenteral nutrition (PN) solutions. A 16-bit micro-computer was used to develop and evaluate the software. The program requires a minimum of user input and is menu-driven. It performs the calculations, prints appropriate labels, a preparation card and a summary of the nutritional content of the solution. Error check routines and a check for calcium-phosphate compatibility are imbedded in the program. The effect of the package on PN compounding was evaluated using a computer model. The evaluation indicated the computer-assisted system was more efficient than a manual system and the possibility of computational error was reduced. The increase in efficiency with the computer-assisted system was between 12-15% compared to a manual system. Computer modeling appeared to be a useful tool in both evaluating the software package and determining the effect it would have on work flow.