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With machine learning (ML), we see the potential to better harness the intelligence and decision-making abilities of human inspectors performing manual visual inspection (MVI) and apply this to automated visual inspection (AVI) with the inherent improvements in throughput and consistency. This article is intended to capture current experience with this new technology and provides points to consider for successful application to AVI of injectable drug products. The technology is available today for such AVI applications. Machine vision companies have integrated ML as an additional visual inspection tool with minimal upgrades to existing hardware. Studies have demonstrated superior results in defect detection and reduction in false rejects, when compared with conventional inspection tools. ML implementation does not require modifications to current AVI qualification strategies. The utilization of this technology for AVI will accelerate recipe development by use of faster computers rather than by direct human configuration and coding of vision tools. By freezing the model developed with artificial intelligence tools and subjecting it to current validation strategies, assurance of reliable performance in the production environment can be achieved., (© PDA, Inc. 2023.)

Rationale and Objective: Recent initiatives aim to improve patient satisfaction and autonomy by increasing the use of peritoneal dialysis (PD) in the United States. However, limited knowledge is available about the costs of different dialysis modalities, particularly those incurred by private insurers. In this study, we compared the costs of injectable dialysis drugs (and their oral equivalents) paid by insurers between privately insured patients receiving hemodialysis and PD., Study Design: A retrospective cohort study., Setting and Participants: From a private insurance claims database, we identified patients who started receiving PD or in-center hemodialysis between January 1, 2017, and December 31, 2020., Exposure: Patients started receiving PD., Outcomes: Average annual injectable drug and aggregate expenditures and expenditure subcategories., Analytical Approach: Patients who started receiving PD were propensity matched to similar patients who started receiving hemodialysis based on the year of dialysis initiation, patient demographics, health, geography, and comorbidities. Cost ratios (CRs) were estimated from generalized linear models., Results: We matched 284 privately insured patients who started receiving PD 1:1 with patients started receiving in-center hemodialysis. The average annual injectable drug expenditures for hemodialysis were 2-fold higher (CR: 1.99; 95% CI, 1.62-2.44) than that for PD. Compared those receiving PD, patients receiving hemodialysis incurred significantly lower nondrug dialysis-related expenditures (0.85; 95% CI, 0.76-0.94). The average annual expenditures for non-dialysis-dependent outpatient services were significantly higher among patients who underwent in-center hemodialysis (CR: 1.44; 95% CI, 1.10-1.90). Although aggregate and inpatient hospitalization expenditures were higher for in-center hemodialysis, these differences did not reach statistical significance., Limitations: Small sample sizes may have restricted our ability to identify differences in some cost categories., Conclusions: Compared with privately insured patients who started receiving PD, patients starting in-center hemodialysis incurred higher expenditures for injectable dialysis drugs, whereas differences in other expenditure categories varied. Recent increases in the use of PD may lead to reductions in injectable dialysis drug costs among privately insured patients., Plain Language Summary: Recent initiatives aim to improve patient satisfaction and autonomy by increasing the use of peritoneal dialysis (PD) in the United States. However, limited knowledge is available about the costs of different dialysis modalities, particularly those incurred by private insurers. In this study, we compared the costs of injectable dialysis drugs (and their oral equivalents) provided by insurers between privately insured patients receiving hemodialysis and PD. We found that the average annual injectable drug expenditures for hemodialysis were 2.0-fold higher compared with those for PD. These findings suggest that the recent increase in the use of PD may lead to reductions in injectable dialysis drug costs among privately insured patients., (© 2023 The Authors.)

Context: Injecting intracameral cefuroxime has been found beneficial in reducing the risk of postoperative endophthalmitis but its use has been limited through a lack of approved marketing and of ready-to-use single-units as well as the problem of aseptic compounding. Objective: Our aim was to assess a new automated primary packaging system which should ensure a higher level of sterility, thanks to its closed, sterile, ready-to-use polymer vial called “Crystal® vial”. The chemical stability of a 10 mg/mL cefuroxime solution was compared in 1 mL Crystal® vials and 1 mL Luer-lock polypropylene syringes (actual reference) to eliminate any potential and specific interactions with its cyclic olefin copolymer (COC) body and elastomer stopper. Methods: Cefuroxime solution was introduced into vials and syringes and stored at −20 °C, +5 °C and +25°C/60% Relative Humidity. Cefuroxime concentration and the relative amount of the main degradation product (descarbamoyl-cefuroxime) were both determined by an HPLC/UV method indicating stability. Solutions were considered steady if the concentration remained at over 90% of the initial value. In the adapted storage conditions, the evolution of osmolality, pH and sterility was assessed. Results: Stability profiles were identical between vials and syringes in all storage and temperature conditions. The solution was stable (cefuroxime concentration, pH and osmolality) and still sterile for 365 days at −20°C. The concentration fell below 90% after 21 days at +5 °C and after 16 h at +25°C/60%s relative humidity. Conclusions: The COC and thermoplastic elastomer of the vials had no impact on the degradation process confirming its possible use for a ready-to-use cefuroxime solution single-unit dose. [ABSTRACT FROM PUBLISHER]

This study analyzed the use of injectable drugs with oral-formulation alternatives in the outpatient setting in South Korea. We conducted a retrospective cross-sectional data analysis using 2008 National Health Insurance claims data. All active ingredients were categorized into dual-formulation ingredients (DFIs) and single formulation ingredients (SFIs), and were identified by the type of healthcare service provider (HSP) and anatomical therapeutic chemical (ATC) group. 14.6 % (102/701) of total drugs were extracted as DFIs at about the same rate as that for drugs in the World Health Organization database (14.45 %), showing similar patterns by ATC group. The rate of injectable drug use varied more substantially for DFIs (range 0.94-4.54 %) than for SFIs (range 0.27-1.12 %) by the type of HSP. For DFIs, the highest proportion of injectable drug use was observed in group H (all hormonal preparations, 22.74 %) and group M (anti-inflammatory and anti-rheumatic preparations, 10.23 %) among ATC groups. The proportion of injectable drug use was higher in clinics and small hospitals than in tertiary hospitals and general hospitals where patients with more severe cases tend to visit. The results imply the potentially inappropriate or excessive use of injectable drugs and suggest the need to develop standard guidelines for injectable drug use and strategies to promote high-quality healthcare including education on rational prescribing. [ABSTRACT FROM AUTHOR]

DU6859a was evaluated for its in vitro and in vivo antibacterial activities in comparison with those of imipenem, meropenem, cefpirome, vancomycin, gentamicin, ciprofloxacin and levofloxacin. DU6859a had activity comparable to that of imipenem against methicillin-susceptible staphylococci and penicillin-susceptible and-resistant Streptococcus pneumoniae, with MICs at which 90% of strains tested are inhibited (MIC)≤0.063μg/mL. Against methicillin-resistant staphylococci and enterococci, DU6859a was as active as vancomycin and more active than other drugs tested, with MICs ranging from 1 to 4 μg/mL. DU6859a was as active as ciprofloxacin and more active than other drugs tested against imipenem-resistant Pseudomonas aeruginosa. Differences in activity between DU6859a and reference drugs against ciprofloxacin-resistant and gentamicin-resistant P. aeruginosa were particularly striking. The in vivo efficacy of subcutaneous injections of DU6859a against experimental septicemia, respiratory and pyelonephritic infections caused by gram-positive and-negative bacteria, including methicillin-resistant Staphylococcus aureus and imipenem-resistant P. aeruginosa, reflected its potent in vitro activity. [ABSTRACT FROM AUTHOR]

Objectives: Amikacin is the only second-line injectable antituberculosis (anti-TB) drug still recommended for multidrug-resistant tuberculosis (MDR-TB) treatment when a short MDR-TB regimen is designed. Mutations in rrs and eis are reported to be associated with resistance to amikacin. In this study, we investigated the incidence of rrs, eis, tap and whiB7 mutations in amikacin-resistant Mycobacterium tuberculosis clinical isolates to find the proportion of different mutations related to amikacin resistance., Methods: A total of 395 clinical isolates of M. tuberculosis were used for phenotypic drug susceptibility testing (DST) to 10 drugs with the Löwenstein-Jensen (L-J) method. We sequenced rrs, eis, tap and whiB7 genes in 178 M. tuberculosis clinical isolates (89 amikacin-resistant isolates and 89 of 306 amikacin-susceptible isolates)., Results: Our data showed that 22.53% (89/395) M. tuberculosis clinical isolates were resistant to amikacin. Of the 89 amikacin-resistant isolates, 89.89% (80/89) were MDR-TB, of which 12.36% (11/89) were pre-extensively drug-resistant TB (pre-XDR-TB) and 77.53% (69/89) were XDR-TB. The rrs mutations were found in 82% (73/89) in amikacin-resistant M. tuberculosis clinical isolates. The A1401G alteration in the rrs gene was the most dominant mutation (80.90%; 72/89). Five mutations were detected as new in rrs, tap and whiB7. Notably, 13.48% (12/89) amikacin-resistant isolates had no known mutation in these genes., Conclusions: Our data reveal that the rrs mutation is a predominant molecular marker of amikacin resistance in southern China. Analysis of the rrs gene mutations will significantly reduce the time and cost to diagnose amikacin resistance in TB patients. Other unknown amikacin resistance mechanism(s) exist., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Objectives: Infusion in care units, and all the more in intensive care units, is a complex process which can be the source of many risks for the patient. Under cover of an institutional approach for the improvement of the quality and safety of patient healthcare, a risk mapping infusion practices was performed., Methods: The analysis was focused on intravenous infusion situations in adults, the a priori risk assessment methodology was applied and a multidisciplinary work group established., Results: Forty-three risks were identified for the infusion process (prescription, preparation and administration). The risks' assessment and the existing means of control showed that 48% of them would have a highly critical patient security impact. Recommendations were developed for 20 risks considered to be most critical, to limit their occurrence and severity, and improve their control level. An institutional action plan was developed and validated in the Drug and Sterile Medical Devices Commission., Conclusion: This mapping allowed the realization of an exhaustive inventory of potential risks associated with the infusion. At the end of this work, multidisciplinary groups were set up to work on different themes and regular quarterly meetings were established to follow the progress of various projects. Risk mapping will be performed in pediatric and oncology unit where the risks associated with the handling of toxic products is omnipresent., (Copyright © 2015 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

The physicochemical interactions of injectable drugs administered through a Y-site injection port are little known phenomena, poorly documented but very frequent. Physicochemical incompatibility is defined as a chemical reaction between two injectable drugs which come into contact with each other. This chemical reaction may be visible on a macroscopic level or completely invisible. The risks of these interactions are not harmless, ranging from inefficacy to the toxicity of the newly-formed compounds., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)