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ObjectivePre-filled syringes (PFSs) have become popular as a convenient and cost-effective container closure system for delivering biotherapeutics. However, standard siliconized PFSs may compromise the stability of therapeutic proteins due to their exposure to the silicone oil–water interface. To address this concern, silicone oil-free (SOF) glass syringes coupled with silicone-oil free plunger stoppers have been developed. This study aims to compare the impact of silicone oil-free (SOF) and siliconized syringes as primary container on protein stability and device functionality of the combination products.MethodsThe stability of proteins with different modalities was assessed in SOF and siliconized 1 mL glass syringes for up to 6 months at 5℃, 25℃, and 40℃ with levels of subvisible particles and soluble aggregate determined by micro-flow imaging (MFI) and ultra performance size-exclusion chromatography (UP-SEC). The functionality of SOF glass syringes, including break loose force, extrusion force and delivery time in autoinjectors, was evaluated at different time points during the stability study. Additionally, SOF glass syringes were filled with viscosity surrogate ranging from 1 to 90 cP to understand the impact of solution viscosity on break loose force, extrusion force, and autoinjector delivery time.ResultsSOF demonstrates compatibility with proteins and exhibited significantly low particle counts compared to siliconized PFS. SOF syringes show significantly higher break-loose and extrusion forces. However, unlike siliconized syringes where silicone oil migration increases extrusion force, no significant change in functionality was observed in SOF glass syringe during stability testing. Overall, SOF glass syringes showed great potential as an alternative package for biologics with comparable performance on functionality as siliconized PFS.ConclusionsThe combination of SOF glass and its PTFE coated stopper presents a new primary container closure system with both adequate protein stability and desired functionality features.

Preparation errors occur frequently during conventional preparation of parenteral medication in the clinical environment, causing patient harm and costs for the national health care system. The use of ready-to-administer prefilled sterilized syringes (PFSSs) produced by the hospital pharmacy can reduce preparation errors and the risk of bacteremia from contamination of the intravenous medication. The aim of this research is to compare the total costs of the conventional preparation method (CPM) with the PFSS method. In this cost-minimization analysis, costs related to the preparation of the medication, bacteremia from contamination, adverse drug events as a result of preparation medication errors, and wastage of syringes were taken into account. Annual costs in a general Dutch hospital were consistently calculated. Three scenarios were analyzed: (1) all preparations as CPM (864,246 administrations per year), (2) all preparations as PFSSs, and (3) 50% as PFSSs and 50% as CPM. Deterministic and probabilistic sensitivity analyses were performed. The first scenario found higher annual costs at €14.0 million (US$16.0 million) compared with the second scenario (€4.1 million, US$4.7 million). The most realistic situation (third scenario) found savings of €4.9 million (US$5.6 million) compared with the first scenario. Sensitivity analyses revealed that cost savings of PFSSs were strongly influenced by decreased risk of medication errors and contamination of intravenous medication. Extrapolating these results nationwide indicated potential savings of >€300 million (US$342 million) if only PFSSs were used. The use of PFSSs prepared in the hospital pharmacy yielded cost savings compared with the CPM on the ward in the Dutch hospital.

Background The prevention of catheter-related complications is nowadays an important topic of research. Flushing catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing should be carried out both pre- and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, and also increasing the need for manipulation of the venous catheter). Methods/design A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration drugs with flushing procedures, with a double-chamber syringe (arm A) or with classic syringes (arm B). The outcomes assessment will be performed on a daily basis by an unblinded ward team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blinded research team and registered once a day. Discussion The study outlined in this protocol will provide valuable insight regarding the effectiveness and safety of this new medical device. The development of this medical device (dual-chamber syringe, for drug and flush solution) seems to be an important step to facilitate nurses’ adoption of good clinical practices in intravenous procedures, reducing catheter manipulations. Trial registration ClinicalTrials.gov, NCT04046770 . Registered 13 August 2019.

AimIn paediatrics drugs are prescribed as mg/kg doses to facilitate accurate dosing. Anecdotally, some drugs are prescribed in such a way that the volume to be given is difficult to measure which may lead to inaccuracies and potential for error. Locally, errors have been reported where there has been a misunderstanding of the required dose, especially when decimal points are involved. This audit aimed to evaluate doses prescribed for in-patient children and evaluate whether they can be measured using the printed markings of one oral syringe.MethodData were collected for paediatric in-patients between 16th February and 27th March 2015 from paper drug charts and an electronic prescribing system depending which was in use in each area. Specific data on patient age, weight and prescribed dose were collected. Volumes were then calculated using the enteral products kept in the Trust formulary, including unlicensed specials. The prescribed volumes were reviewed against the Medicina Home® enteral syringes to see if they were measurable on the printed graduations of one oral syringe (in line with local dispensing standards). If they could not be measured, the percentage dose rounding required was calculated to see if doses could be rounded. A judgement was then made as to whether this was within an acceptable safe dose limit.ResultsData for 560 individual medication orders for oral medicine were collected, 257 from electronic prescribing and 303 from paper charts. Of these 457 were liquid doses, 103 were from products only available as tablets or capsules. Of the 257 electronically prescribed doses, 61 (24%) were not measurable. Of the 303 paper chart doses, 57 (19%) were not measurable.Of the 457 liquid doses 77 only needed up to 4% dose adjustment to become measurable. A further 10 doses required up to 9% dose adjustment.Drugs that were frequently prescribed as non-measurable doses were: diazepam, alimemazine, chloral hydrate, azithromycin, metronidazole, paracetamol & ibuprofen.Some doses were not measurable from tablets and no liquid is available in the Trust: clonidine, omeprazole, lansoprazole, nifedipine SR.19/560 (3.4%) of medication orders required a dose to be measured to two decimal places: diazepam, morphine, clonazepam, furosemide, spironolactone, chloral hydrate, ranitidine, chlorothiazide, azithromycin, erythromycin.ConclusionThis audit has shown that by prescribing accurately as mg/kg without any dose rounding almost a quarter of doses cannot be measured accurately. Only a small dose adjustment is required to make the doses measurable. The current electronic prescribing system in use does not appear to have any automatic rounding, indeed the prevalence of difficult to measure doses was slightly worse (although not statistically significant, p value 0.19, Chi squared test), possibly because the prescriber doesn't “sense check” what they are prescribing as it is automated. Particular drugs with unusual strengths are often implicated in having harder to measure doses. Consideration should be made to round doses when prescribing and to add information regarding the strength of liquids available in local clinical guidelines.

AimVancomycin is used as a second line antibiotic in the treatment of late onset neonatal infection for its activity against coagulase negative staphylococci. Vancomycin infusions are prepared within a ward setting for administration to neonates. Differences in preparation techniques on the ward have previously been recognised as a potential source of variation in vancomycin concentrations, as compared to concentrations in pre-made preparations. This study analyses a consecutive series of vancomycin syringes prepared in a ward for administration to neonates, to determine how accurate the concentration of each preparation was compared to the expected concentration.MethodVancomycin concentrations were determined by UV analysis (λ=280 nm) with a UV spectrophotometer (Jenway Genova Plus). A calibration curve for vancomycin was created (R2=0.9996) by manufacturing a series of solutions of vancomycin hydrochloride in glucose 5% w/v.Samples of vancomycin from syringes from which doses were administered to neonates were then analysed to assess their concentration. For each syringe, mean vancomycin concentration±standard deviation was calculated (n=3).Reasonable errors in preparations were calculated based on errors in each step of the preparation process. Theoretical error was calculated based on apparatus used, and experimental error was recorded based on a simulated process. Two preparation methods were compared; the method complying with that described in the local formulary, 1 and an alternative method reported by the nurses preparing the dose.ResultsAnalysis of results showed that concentration of the vancomycin syringes prepared ranged from 0.85 to 8.24 mg/mL. The expected concentration was 4.17 mg/ml.Theoretical error in preparation of vancomycin doses was lower with the formulary-compliant method1 versus an alternative method, as were variations in in vancomycin concentration.Depending on the type of error (theoretical or experimental) and method by which vancomycin syringes were prepared (formulary1 or alternative method), the percentage of syringes with vancomycin concentration outside of the specified ranges varied from 20%–43%. This is higher compared to the findings of the Department of Health2, where it was found that 19.2% of morphine infusions prepared by nurses in the neonatal intensive care unit were outside British Pharmacopoeia concentration limits.ConclusionPreparation of vancomycin doses should follow the formulary method1 to minimise variation in concentration of the final product. Alternatively, pre-made syringes may be preferred as an alternative to ward-made syringes as this removes individualised preparation as a source of error.

Background Australian needle and syringe distribution occurs via a mix of modalities, including syringe dispensing machines (SDMs). SDMs are electronic vending machines providing (often) 24-h access to needles/syringes and may attract greater numbers of people who are younger, female, and/or have limited connection to health care services compared to individuals accessing fixed-site needle and syringe programs (NSPs). However, validating the demographic characteristics of SDM clients has proven difficult in previous research. Methods In this paper, we analyse SDM order and client demographic data from four SDMs located in South-East Melbourne, Australia, and compare this against the managing fixed-site NSP between May 2017 and December 2020. SDM data were collected via a novel 0–9 numeric keypad input tool. Via the tool, SDM clients were requested to input their categorised age, gender and postcode. Given the novelty of the tool, we evaluate the feasibility of the data collection method. We analysed data according to: (1) total SDM orders made, (2) estimated ‘unique SDM presentations’ and (3) describing the demographics of unique SDM clients. Importantly, we noted substantial invalid demographic data, and consequently, severely restricted data for analysis. Results There were 180,989 SDM orders made across the four SDMs to an estimated 90,488 unique SDM presentations. There was little variation in unique presentations across days of the week, but 69% occurred out of NSP operating hours. Across the study period, the SDMs distributed 66% of the number of syringes distributed by the fixed-site NSP. Due to invalid demographic data, our restriction method provided only 10,914 (6% of all data) unique presentations for analysis. There were some demographic differences between SDM and NSP client, but these should be treated with caution. Conclusions The data collection tool provides a novel means of comparing SDM and fixed-site presentations, demonstrating the substantial expansion of service via the SDMs. However, the validity of the demographic data was highly questionable and requires significant data coding, meaning it is not feasible for community NSPs. While we recommend the inclusion of automatically collected SDM order data, the use of a 0–9 numeric keypad to collect demographic data—while an innovation—requires alteration to support NSP data.

ObjectiveThis study aimed to investigate the movement of liquid in the needle region of staked-in-needle pre-filled syringes using neutron imaging and synchrotron X-ray tomography. The objective was to gain insights into the dynamics of liquid presence and understand the factors contributing to needle clogging.MethodsStaked-in-needle pre-filled syringes were examined using neutron radiography and synchrotron X-ray phase-contrast computed tomography. Neutron radiography provided a 2D visualization of liquid presence in the needle, while synchrotron X-ray tomography offered high-resolution 3D imaging to study detailed morphological features of the liquid.ResultsNeutron radiography revealed liquid presence in the needle region for as-received samples and after temperature and pressure cycling. Pressure cycling had a more pronounced effect on liquid formation. Synchrotron X-ray tomography confirmed the presence of liquid and revealed various morphologies, including droplets of different sizes, liquid segments blocking sections of the needle, and a thin layer covering the needle wall. Liquid presence was also observed between the steel needle and the glass barrel.ConclusionsThe combination of neutron imaging and synchrotron X-ray tomography provided valuable insights into the dynamics of liquid movement in staked-in-needle pre-filled syringes. Temperature and pressure cycling were found to contribute to additional liquid formation, with pressure changes playing a significant role. The detailed morphological analysis enhanced the understanding of microstructural arrangements within the needle. This research contributes to addressing the issue of needle clogging and can guide the development of strategies to improve pre-filled syringe performance.

Background Australian harm reduction services are provided via a mix of modalities, including fixed-site needle and syringe programmes (NSP) and syringe-dispensing machines (SDMs). SDMs are cost-effective and provide 24-h anonymous access to needles/syringes, often to underserved geographic areas, and can attract clientele who may choose not to use NSPs. The introduction of COVID-19 control measures saw disruptions and adaptations to the provision of harm reduction services. It is possible that SDMs filled the gap in otherwise disrupted harm reduction services in Melbourne. In this paper, we use data from four SDMs and an NSP to explore changes to harm reduction usage during periods of COVID-19 lockdowns in Melbourne, Australia, in 2020. Methods Our data span September 2017–December 2020. We analysed daily counts of SDM use and monthly counts of NSP use, according to unique presentations to both. Auto-regressive integrated moving average (ARIMA) time-series models were fitted to the data with the effects of lockdowns estimated via a step function. Results Across the study period, we estimated 85,851 SDM presentations and 29,051 NSP presentations. Usage across both the SDMs and the NSP declined during the COVID-19 lockdowns, but only the decline in SDM usage was significant in ARIMA analysis. Conclusions The slight, but significant decline in SDM use suggests barriers to access, though this may have been mitigated by SDM users acquiring needles/syringes from other sources. The decline, however, may be a concern if it led to lowered needle/syringe coverage and a subsequent increase in injecting risk. Further work is needed to properly explore potential changes in preference for needle/syringe acquisition site and associated barriers. Importantly, this work adds to the body of literature around the impacts of COVID-19 on harm reduction provision and potential areas of improvement.

Background Numerous states, including Georgia in April 2019, have advanced policies designed to increase availability of sterile syringes in pharmacies for people who inject drugs (PWID); however, the extent to which pharmacies are willing to sell syringes to PWID is unclear. We examine sterile syringes sales practices in Georgia pharmacies to PWID following a recent policy change and pharmacists’ cited reasons for these practices. Methods We conducted a telephone survey from October 2020 through May 2021 of one pharmacist (staff or manager) per pharmacy in a sample of Georgia retail pharmacies stratified by urbanicity. The 15-question survey queried respondents about the pharmacy’s current practices regarding nonprescription sterile syringe sales and the respondents’ perceptions of syringe sales and counseling practices to those purchasing syringes. Pharmacy and pharmacist demographics were collected and correlations between these characteristics were estimated using unadjusted logistic regression models. Results We obtained responses from 119 pharmacies (response rate = 34%). Most surveyed pharmacies (81%) reported that they did not sell syringes to patients without a prescription for nonmedical uses, including intravenous drug use. There were no differences in whether pharmacies were more or less likely to sell syringes by level of urbanicity, local poverty rate, local racial/ethnic composition, or pharmacy type (i.e., chain vs. independently owned). The most common reasons cited for not selling syringes were security concerns, that syringe sales encourage drug use, and corporate policy. Among pharmacists in pharmacies not currently selling syringes, only 54% of were aware of the state law change allowing sales of syringes without a medical reason. Conclusions Despite an important policy change advancing harm reduction through sterile syringe access, availability of sterile syringes to PWID in Georgia pharmacies was likely still hampered by lack of dispensing by pharmacies. Implementation efforts following important policy changes—including building awareness of the new policy, encouraging support of harm reduction efforts, and continuing education around substance use disorders—are essential for achieving the intended outcomes of the policy.