Multi-use Vials Research Articles

Temporal decreases in pathogen colonization and infection among hospitalized neonates following routine skin antisepsis with chlorhexidine gluconate: Botswana 2022 – 2023

Background: Multidrug-resistant Gram-negative bacteria are a major cause of sepsis among hospitalized neonates globally. Aqueous chlorhexidine gluconate (CHG) skin antisepsis has been shown to be safe for use in infants; however, its sustained effectiveness in preventing Gram-negative pathogen colonization, bloodstream infection (BSI), and mortality is unclear. Methods: We conducted a period prevalence survey, with 26 sampling events over 12 months (18 October 2022 – 31 October 2023) at a 33-bed neonatal unit in a tertiary public hospital in Botswana where ESBL-producing Klebsiella pneumoniae and carbapenem-resistant Acinetobacter baumannii are leading causes of BSI. Perirectal and periumbilical skin swabs were collected every two weeks from all inpatients. Swabs were inoculated onto chromogenic media selective and differential for extended-spectrum beta-lactamase producing Enterobacterales (ESBL-E) and Acinetobacter spp. (CHROMagar™ ESBL, Acinetobacter). Colonization status was determined based on culture growth and colony morphology. Contemporaneous data on all-cause mortality and BSI were abstracted from routine surveillance records. Pre- and post-CHG prevalences were compared using a simple Chi-square test. During the surveillance period, an outbreak of K. pneumoniae linked to contaminated multi-use vials was detected, thus BSIs and deaths during the outbreak period (2 February–6 April, 2023) were excluded. In February 2023, the hospital infection prevention and control (IPC) team introduced twice-weekly whole-body cleansing with commercially available 2% aqueous CHG, performed by caregivers and healthcare workers on neonates >24 hours old and weighing ≥1 kg until discharge. Results: There were significant decreases in ESBL-E and Acinetobacter skin and perirectal colonization following the CHG intervention (Table 1; Figure 1). After the CHG intervention, the incidence of Acinetobacter BSIs declined significantly and there was a trend toward a decline in other BSIs and mortality. No adverse events associated with CHG were reported. Conclusions: Twice-weekly CHG application was temporally associated with significant reductions in neonatal ESBL-E and Actinetobacter skin and perirectal colonization and Acinetobacter BSI. This analysis was limited by a short pre-intervention surveillance period and thus may have been influenced by confounders such as seasonality, and intensified IPC efforts following the outbreak. Analysis of the routine CHG use in other settings and over longer surveillance periods are needed to better understand its effectiveness as an IPC strategy in settings where neonatal sepsis incidence is high. Table 1. Colonization prevalence, BSI incidence, and mortality surrounding introduction of CHG skin cleansing in a neonatal unit, 18 October 2022 – 31 October 2023.

Financial impact of fixed-dose versus weight-based dosing approaches for pembrolizumab and nivolumab in the Oncology Care Model for The US Oncology Network (The Network).

e13573 Background: PD-1/PD-L1 antagonists, pembrolizumab and nivolumab, are being used in an increasing number of cancer types. The FDA initially approved both agents based on a weight-based dosing (WBD) approach, but subsequently included a therapeutically equivalent fixed-dose (FD) approach for most indications. The Oncology Care Model (OCM) was a value-based care (VBC) program from Medicare that required total cost of care (TCOC) accountability from participating practices. We evaluated the impact of using the FD vs WBD on TCOC in the OCM for both pembrolizumab and nivolumab. Methods: Using Medicare claims data for 14 OCM-participating practices in The Network from July 2016 to June 2022, and corresponding weight data from the Electronic Health Record (EHR), we evaluated the distribution of patient weights, use of FD vs WBD, and the financial impact of the use of FD vs WBD vs weight-based dosing capped at the fixed dose (WBDc). Results: Summary statistics are shown (Table). In most cases, the FD was higher than the WBD for both nivolumab and pembrolizumab. FD led to an increase in drug cost of 8.4% for nivolumab and 27.2% for pembrolizumab, corresponding to a 11.3% increase in TCOC for the episodes where FD nivolumab and pembrolizumab were used. Conclusions: Fixed-dosing approaches for commonly used high-cost anti-neoplastic drugs can drive increases in TCOC. The use of WBD could lead to a decrease in drug cost and 11.3% savings of TCOC within OCM-like models, likely without impacting clinical outcomes. These findings encourage practices in risk-bearing models to reflect on the widespread adoption of FD. The withdrawal of varying sizes of vials can limit the use of WBD. Pharmaceutical manufacturers should assist with WBD by providing multi-use vials and varying sizes. The feasibility of using the WBD for pembrolizumab with an every 6-week regimen remains to be explored. [Table: see text]

Topical ropivacaine hydrochloride 0.5% and lidocaine hydrochloride 2% significantly reduce corneal sensitivity without short-term negative side effects in horses.

To evaluate corneal sensitivity and acute side effects following application of ropivacaine hydrochloride 0.5% and lidocaine hydrochloride 2% on the healthy equine cornea. Eight healthy adult horses. A randomized, masked, crossover study design was utilized. Baseline Semiquantitative Preclinical Ocular Toxicology (SPOT) scores and corneal touch thresholds (CTT) using a Cochet-Bonnet esthesiometer were recorded and measured, respectively, for eight healthy adult horses before medication application. Commercially available eyewash was used as a negative control. Ropivacaine hydrochloride 0.5% or lidocaine hydrochloride 2% solution was sprayed on a randomly selected eye, and the contralateral eye received eyewash. CTT was measured in both eyes at 1, 5, 15, 25, 35, 45, 55, 65, and 75 min post-application. Post-application SPOT scores were recorded immediately following the trial. Linear mixed model statistical analyses (mean ± standard error) were performed (p < .05). Mean eyewash CTT (3.41 cm ± 0.464) was significantly different from ropivacaine-treated (1.44 cm ± 0.562) (p = .008) and lidocaine-treated eyes (1.75 cm ± 0.562) (p = .024); CTT was not significantly different between drug groups (p = .88). Time to maximum anesthesia was not significantly different between ropivacaine (13.25 min ± 3.353) and lidocaine (16.25 min ± 3.353) (p = .40). No side effects were appreciated as confirmed by SPOT. Ropivacaine and lidocaine similarly decreased corneal sensitivity when applied topically without clinically evident short-term ocular side effects. Lidocaine may be preferable in clinical settings due to its large, multi-use vials and similar effects to ropivacaine.

Optimization of Iodinated Contrast Media Inventory Management: Effect of Inventory Diversification on Waste Reduction

PurposeIodinated contrast medium (ICM) is available in single- and multiuse vials of varying sizes, but CT departments often preferentially stock only a single or a limited number of vial sizes. The aims of this study were to assess actual ICM waste at a large safety-net hospital and to compare with estimated waste if single-use vials in a variety of vial sizes or multiuse vials were used. MethodsICM administrations were retrospectively reviewed for all CT examinations performed in 2021 in a department that stocked only 100-mL ICM vials. Administered ICM dose, opened ICM volume and number of vials, and wasted ICM were compared with hypothetical models using optimally sized single-use vials and multiuse vials. Contrast use was also compared by patient class. ResultsIn total, 40,393 ICM administrations over 49,670 CT examinations among 26,028 patients were reviewed, totaling 4,168,335 mL of contrast media. The mean dose was 103 mL, with mode of 100 mL. Exclusive use of 100-mL vials resulted in 1,006,165 mL waste (mean waste, 26 mL/administration). Optimally sized single-use vials resulted in 436,515 mL waste (mean waste, 11 mL/administration). Multiuse vials resulted in 537,074 mL waste (mean waste, 13 mL/administration). The distribution of optimal single-use vial size differed significantly by patient class (P < .001), with inpatient examinations more amenable to the use of smaller single-use vials. ConclusionsOptimizing ICM inventory can reduce contrast waste by 50% to 59%. Regular monitoring of contrast use may help optimize inventory selection across care settings. This retrospective review supports scrutiny of ICM inventory management to reduce waste, save costs, and mitigate the impacts of supply-chain disruptions.

Investigation of the Transfer of Septum Microbial Contamination by Hypodermic Needles

The likelihood of the transfer of microbial contamination from the surface of a vial septum into the vial liquid, by penetration of a hypodermic syringe needle, has been investigated. Experimental work was carried out with vials containing sterile microbial growth media and the use of needles of three different diameters. Three different concentrations of microbes on the surface of the vial septum (10, 100, and 1000) were used. Microbial contamination that was transferred into the growth media was determined by incubation of the vials following penetration of the septum by the needles. Contamination was detected in 87% of all the vials tested, and was generally found to increase as the concentration of septum challenge organisms and needle diameter increased. Key words: Septum seals, hypodermic needles, multi-use vials, microbial contamination

Outbreak of Acinetobacter baumannii associated with extrinsic contamination of ultrasound gel in a tertiary centre burn unit

SummaryBackgroundDuring 2011 and 2012, an increase in occurrence of multidrug-resistant Acinetobacter baumannii infections was recorded in the Shands Hospital Burn Intensive Care Unit (BICU). An epidemic curve together with strain typing was consistent with an intermittent common source outbreak. An investigation was therefore initiated.AimTo identify risk factors for A. baumannii infection, characterize the source of the pathogen, implement control measures to terminate the outbreak, and institute preventive measures.MethodsWe conducted a retrospective case-control study; reviewed BICU infection control policies, practices and procedures, and patient exposure to healthcare workers (HCWs), and obtained epidemiologically-directed environmental cultures.FindingsEleven patients met the case definition. On multivariate analysis, case-patients were more likely to have undergone an ultrasound procedure in the BICU (adjusted odds ratio [AOR]: 19.5; confidence interval [CI]: 2.4–435) or have a FlexiSeal™ device (AOR: 11.9, CI:1.3–276). Epidemiologically-directed cultures of the environment, ultrasound equipment, and ultrasound gel from opened containers on the ultrasound trolley and in the Ultrasound Department were negative for the outbreak pathogen. Culture of an open ultrasound gel dispenser stored in the Ultrasound Department yielded an A. baumannii strain with DNA banding patterns identical to the outbreak strain.ConclusionsBased on data from our epidemiologic, microbiologic, and observational studies, we believe that inadvertent extrinsic contamination of the gel dispenser occurred in the Ultrasound Department. Contaminated gel was then dispensed into multiuse vials of gel stored on the mobile carts. The outbreak was stemmed by instituting changes in practices in the Ultrasound Department, including introduction of single-use ultrasound vials and storage of ultrasound gel.

Evaluation of Insulin Delivery Strategies for Bronson Health Group

Purpose: The Institute for Safe Medication Practices has published numerous safety alerts in regards to institutional insulin pen use focused on the misuse of insulin pens and subsequent transmission of infections. Other institutions may use floor-stock insulin; however, The Joint Commission has provided recent guidance against using multiuse vials on multiple patients. The purpose of this study is to evaluate Bronson Healthcare Group’s different methods of insulin administration to determine a cost-effective strategy while meeting regulatory requirements. Secondary endpoints will evaluate safety and nursing preference of different types of insulin delivery. Methods: Retrospective data was collected in the form of medication safety event forms, insulin purchasing records, hospital-wide insulin usage reports, number of patient-days reports, and a nursing survey. Insulin use, purchasing data, and safety event reports were collected from August 2013 to August 2014 from Bronson Methodist Hospital and Bronson Battle Creek Hospital. The nursing survey was distributed to inpatient Bronson facilities from January 22 to February 5, 2015. Aggregate data was collected and analyzed via Microsoft Excel. Descriptive statistics were used to evaluate the primary outcome. Chi squared and t-tests were used for secondary outcomes as appropriate. Results: By switching to short-acting insulin administered from 3 mL single-patient insulin lispro vials and pharmacy-drawn long-acting insulin detemir the hospital system could potentially save approximately $22,000 a year. Data did not support there being a safer method of insulin delivery. Nursing preference data indicated that nurses prefer delivery methods with which they are more familiar. Conclusion: In combination with recommended best safety practices as reported by multiple nationally recognized safety organizations, we can conclude that the most cost-effective methods of insulin delivery for the Bronson Health System would be pharmacy technician drawn single doses of long acting insulin detemir and single patient 3 mL vials of insulin lispro.

The bacterial contamination rate of glucose meter test strips in the hospital setting.

Objectives:To assess the rate of bacterial contamination of the multi-use vial and single-use packed glucose meter strips, and to identify the type and frequency of various bacterial contamination in different hospital wards.Methods:This prospective observational study was conducted by a team from the Strategic Center for Diabetes Research in 7 general hospitals in the Central region of Saudi Arabia during the period from August to September 2014 to assess the bacterial contamination rate of the unused strips. A total of 10,447 strips were cultured using proper agar media and incubated both aerobically and anaerobically.Results:The total bacterial contamination rate for the multi-use vials glucose strips was 31.7%, while single-use packed strips were not contaminated at all. Ministry of Health hospitals had the highest contamination rates compared with other hospitals. Critical, obstetric, and surgical wards had the highest bacterial isolates number, where most were in the risk group 3 according to the National Institute of Health guidelines. Staphylococcus species were the most common bacteria found.Conclusion:Glucose meter strips should be recognized as a source of bacterial contamination that could be behind serious hospital acquired infections. The hospital infection control team should adopt proper measures to implement protocols for glucose meter cleaning and glucose strips handling.

Watch out for a revival of peginesatide in sports.

The erythropoietin-mimetic peptide (EMP) peginesatide belongs to the group of erythropoiesis-stimulating agents (ESAs) that are prohibited when misused in sports. Peginesatide is a synthetic pegylated homodimer of two cyclic 21-amino acid chains. It was approved for the treatment of anaemic patients with chronic kidney disease in the USA in 2012, but recalled in 2013 due to prevalent cases of acute severe anaphylactoid reactions and associated fatalities (0.02%). The drug was considered obsolete for athletes and part of the anti-doping scene lost sight of it. However, recent research indicates that the adverse events were not caused by the drug substance, but by the drug product formulated in multi-use vials. These vials contained comparably high levels of subvisible particles. Phenol was identified as a critical component of the drug formulation, which caused the release of histamine from mast cells. Tricky athletes might consider peginesatide a pharmacologically safe ESA in an appropriate formulation. In addition, other EMPs may get a second wind for therapy including misuse in sports. Therefore, it is very important to proceed in developing electrophoretic, immunological, and mass spectroscopic methods for detecting peginesatide and other EMPs in human urine and blood samples. Copyright © 2016 John Wiley & Sons, Ltd.

Safety of Prefilled Buffered Lidocaine Syringes With and Without Epinephrine.

Lidocaine is often used in conjunction with epinephrine and sodium bicarbonate for local anesthesia. Compounding lidocaine as needed can be highly disruptive to clinic flow, which has led many dermatology clinics to prefill syringes with these solutions, but current regulations recommend the disposal of these preparations within 12 hours, creating medical waste. To evaluate the safety of buffered lidocaine with and without epinephrine drawn from multiuse vials and stored for up to 4 weeks. Syringes were filled with lidocaine 1%, lidocaine 1% with 1:100,000 epinephrine, lidocaine 1% with bicarbonate (10:1 ratio), or lidocaine 1% with 1:100,000 epinephrine with bicarbonate (10:1 ratio). The samples were stored for 4 weeks either at controlled room or controlled cold temperature. They were then centrifuged and cultured for anaerobic bacteria, aerobic bacteria, and fungus. Prefilled lidocaine syringes are not subject to bacterial or fungal growth after being stored for 4 weeks. Prefilled syringes of lidocaine remain safe to use for up to 4 weeks, and the current regulations placed on the disposal of these solutions should be revisited.

Rate of microbiological contamination of multi-use vials of bevacizumab and risk of endopthalmitis

Introduction: To determine the rate of microbiological contamination in multi-use vials of bevacizumab used for multiple intravitreal injections and to determine the rate of endophthalmitis in patients who received intravitreal injections from these vials. Methods: Eighteen 100-mg (4 mL) vials of bevacizumab (Avastin; F. Hoffmann-La Roche Ltd. Switzerland) were used for 327 intravitreal injections in period of 18 months. These vials were stored in refrigerator at 2 – 8oC for 30 days. From each vial, two samples of 0.05ml of avastin was withdrawn with the help of 1ml syringe at 7 and 30 days after the opening the vial. These samples were send for bacterial and fungal staining and culture. 327 patients who received intravitreal injections were monitored for signs and symptoms of inflammation or endopthalmitis. Results: No evidence of microbiological contamination was detected in 18 vials sent for microbiological staining and culture. 327 patients who received intravitreal injections from these vials did not showed any signs or symptoms of inflammation or endopthalmitis. Conclusions: Using the muti-use vials of bevacizumab for intravitreal injections which are stored for up to 30 days in refrigerator at 2–8oC is safe. Keywords: Bevacizumab, Endopthalmitis, Microbiological contamination, Multi-use vial

Prevalence of Bacterial Contamination of Glucose Test Strips in Individual Single-Use Packets versus Multi-Use Vials

Glucose measurement is the cornerstone of diabetes control. In the hospital setting, the same device and package of test strips (50 or 100 strips) can be used to monitor glucose in several patients, which can increase cross contamination. The objective of our study is to measure bacterial contamination in glucose test strips, comparing results in individual single-use packets (one hospital) versus multi-use vials (two hospitals) in Spain. Test strips were collected from five different wards. Each hospital also collected two unopened vials from a single ward as controls. They were sent to a reference laboratory for microbiologic study. A number equal or higher than two colony forming units per strip was considered as a positive result. Out of 423 glucose test strips collected and cultured, 146 were contaminated (34%); only 7% of individually packed strips were contaminated versus 45% of strips packed in multi-use vials, with a high statistical significance (p &lt; .001). In the strips from multi-use vials, a high contamination rate was found and highly pathogenic organisms were identified, such as methicillin-resistant Staphylococcus epidermidis or Staphylococcus hemolyticus. In contrast, in strips packed individually, there was a much lower contamination rate and no such pathogen organisms were found. Therefore, in the hospital setting, the use of blood glucose test strips in individual packages would be more advantageous (mainly from a clinical point of view, but also from a financial one) than those packed in multi-use vials.

Peginesatide: First once-monthly ESA

Peginesatide: First once-monthly ESA

Pseudo-outbreak of multidrug-resistant Mycobacterium tuberculosis associated with presumed laboratory processing contamination.

An investigation prompted by six positive cultures for multidrug-resistant Mycobacterium tuberculosis during a 7-week period found that an unusual resistance pattern, temporal proximity of laboratory processing, and identical DNA fingerprints supported the theory of cross-contamination. Laboratory processing procedures included specimen batching and multi-use vials of buffer solution. Processing procedures were changed and no additional cases of suspected cross-contamination have been observed.

Topical Haemostatic Agents: Avoid Multi-Use Containers

The Australian Journal of Hospital PharmacyVolume 30, Issue 5 p. 229-229 Letter to the EditorFree Access Topical Haemostatic Agents: Avoid Multi-Use Containers Fotios Ambados BPharm, Fotios Ambados BPharm Senior Pharmacist fotios.ambados@nwahs.sa.gov.au The Queen Elizabeth Hospital 28 Woodville Road, Woodville South SA 5011Search for more papers by this author Fotios Ambados BPharm, Fotios Ambados BPharm Senior Pharmacist fotios.ambados@nwahs.sa.gov.au The Queen Elizabeth Hospital 28 Woodville Road, Woodville South SA 5011Search for more papers by this author First published: 01 October 2000 https://doi.org/10.1002/jppr2000305229AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. References 1Mc Murchie M. Contamination of multi-dose vials. Aust Fam Physician 1991; 20: 1207. 2Mortimer PP. Away with multi-use vials! AIDS 1999; 13: 1779– 81. 3Jetmore AB, Heryer JW, Conner WE. Monsel's solution: a kinder, gentler hemostatic. Dis Colon Rectum 1993; 36: 866– 7. 4Manca DP. Stopping cervical bleeding. Can Fam Physician 1997; 43: 2121. 5Ratliff CR. Preventing cervical bleeding with Monsel's solution. Oncol Nurs Forum 1992; 19: 664. Volume30, Issue5October 2000Pages 229-229 ReferencesRelatedInformation