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Objective: The aim of this study was to investigate the physicochemical stability of morphine-bupivacaine-ziconotide mixtures used in intrathecal analgesia in polypropylene syringes and intrathecal pumps., Materials and Methods: The stability study method was conceived according to International Council for Harmonisation guidelines. For propylene syringes, six different mixtures of morphine-bupivacaine and ziconotide were assessed over seven days. Two storage temperatures were tested (5 °C ± 3 °C and 25 °C ± 2 °C). For implantable pumps, nine different mixtures were assessed over 60 days and stored at 37 °C. Assays were performed using ultrahigh-pressure liquid chromatography. Turbidity and pH also were measured throughout the study., Results: Results confirmed excellent physicochemical stability for morphine and bupivacaine in the study for all conditions investigated (pumps at 37 °C, polypropylene syringes at 5 °C ± 3 °C and 25 °C ± 2 °C). Concerning ziconotide, after seven days, our study showed that every 95% confidence interval calculated had lower bounds >90% for all mixtures stored in polypropylene syringes. In implantable pumps, a decrease of the concentration was observed in all the mixtures studied. Moreover, the appearance of a degradation product confirmed the ziconotide degradation., Conclusion: All results are in favor with a physicochemical stable preparation for six mixture profiles when stored in polypropylene syringes at 5 °C ± 3 °C and 25 °C ± 2 °C. For mixtures stored in implantable pumps, the efficacy should decrease over time owing to the degradation of ziconotide. A trade-off between high morphine concentration and increased refill interval will need to be found by clinicians., Competing Interests: Conflict of Interest The authors reported no conflict of interest., (Copyright © 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Objective: Evaluate the penetration of hydrogen peroxide (HP) into the pulp chamber, bleaching efficacy (BE) and amount of gel expended during in-office bleaching using an applicator brush tip and conventional tip from different commercial brands., Materials and Methods: 104 human premolars were randomly distributed into thirteen groups (n = 8) according to the commercial brand: DSP White Clinic 35 % Calcium (DW), Nano White 35 % (NW), Total Blanc One-Step 35 % (TS), Whiteness HP Blue 35 % (WB), Potenza Bianco Pro SS 38 % (PB), Opalescence XTra Boost 40 % (OB), no bleaching (negative control), and application method: applicator brush tip and conventional tip for all groups. Initial HP concentration (%) was determined via titration and pH was measured with digital pH meter. Concentration (µg/mL) of HP into the pulp chamber was measured using UV-Vis spectrophotometry, the BE (ΔE* ab , ΔE 00 and ΔWI D ) was evaluated with a digital spectrophotometer, and the amount of gel expended was evaluated using a precision analytical digital balance. Statistical analysis included two-way ANOVA, Tukey's, and Dunnett's test. Comparison between HP into the pulp chamber vs BE was performed with Person's correlation (α = 0.05)., Results: Brush tip demonstrated a low amount of HP in the pulp chamber compared to the conventional method for all bleaching gels (p < 0.0003), as well as lower amount of gel expended (p < 0.002). The brush tip did not result in a significant difference in BE compared to the conventional (p > 0.05). No correlations were found between both factors (p > 0.05)., Conclusion: Brush tip showed lower penetration of HP in the pulp chamber and a reduced volume of spent gel when compared to the conventional tip, for all commercial brands., Clinical Relevance: Brush tip is recommended for bleaching gels in an attachable syringe due to its ability to reduce the penetration of HP into the pulp chamber and minimize the amount of bleaching gel used., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that might have seemed to influence the findings presented in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background and Aims: Limited evidence exist regarding the association between ongericimab, a novel recombinant humanized anti-PCSK9 monoclonal antibody, and primary hypercholesterolemia and mixed dyslipidemia. This study aimed to evaluate the efficacy and safety of ongericimab administered by prefilled syringe (PFS) or autoinjector (AI) in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia on stable optimized lipid-lowering therapy., Methods and Results: A total of 255 patients on stable optimized lipid-lowering therapy were randomized in a 2:1:2:1 ratio to receive PFS for the subcutaneous injection of ongericimab 150 mg every 2 weeks (Q2W) or a matching placebo, or AI for the subcutaneous injection of ongericimab 150 mg Q2W or a matching placebo. The primary efficacy endpoint was the percent change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to week 12. Safety was also evaluated. At week 12, the least squares mean percent changes were -72.7% (3.9%) for PFS and -71.1% (3.8%) for AI (all P < 0.001) compared to respective matching placebo groups. Beneficial effects were also seen for all secondary lipid parameters, notably with robust reduction in Lp (a). Treatment-emergent adverse events (TEAEs) and serious AEs with ongericimab were reported in 46.2% and 2.4% of patients, compared to 44.2% and 3.5% with placebo., Conclusion: In Chinese patients with primary hypercholesterolemia and mixed dyslipidemia, a 12-week treatment regimen with ongericimab administered by PFS or AI significantly reduced LDL-C and other lipid parameters, proving to be safe and well tolerated. Patients experienced consistent effects from PFS or AI devices., Clinical Trial Registration: CTR20220027; January 11, 2022; http://www.chinadrugtrials.org.cn/index.html., Competing Interests: Declaration of competing interest Minghui Wang, Yi Zhao, and Xuelian Bai are employees of Shanghai Junshi Biosciences Co., Ltd. The remaining authors declare that they have not received support from any organization for the submitted work, do not have any financial relationships with organizations that might have an interest in the submitted work over the past three years, and have not engaged in any activities that may have influenced the submitted work., (Copyright © 2024 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

A novel sample double dilution calibration method (SDDCM) and an automatic flow system with in-syringe reaction and spectrophotometric detection were developed for determining lithium in biological samples. The method is based on the reaction of lithium with Thorin in an alkaline medium and the signal was measured at 480 nm. The reaction was performed simultaneously for both standards and samples in three syringes of the automatic flow system. The method was validated and successfully applied to the determination of lithium in synthetic and pharmaceutical samples, with results consistent with the ICP OES method. The novel calibration method, developed for the determination of lithium in biological samples, uses a sample with two dilution degrees. Using the method, the concentration of the analyte is determined by relating the signal for a less diluted sample to the calibration plot for a more diluted sample and vice versa. The implementation of the calibration method was facilitated by preparing solutions directly in the flow system. The use of two sample dilutions makes it possible to determine the analyte in the sample without preliminary preparation. Moreover, obtaining two results based on signals for a sample diluted to different degrees allows them to be verified for accuracy. The proposed approach was successfully verified by the determination of lithium in certified reference materials of blood serum and urine. Using the developed method lithium was determined within the concentration range of 0.06-1.5 mg L -1 , with precision (CV, %) less than 6.7, and accuracy (RE, %) better than 6.9. The detection limit was 0.03 mg L -1 ., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

The concept of extractables and leachable has introduced a new era for identifying potential impurities in drug products. Pharmaceutical packaging materials encompass a variety of polymers due to their appealing properties for storing the drug product. However, numerous chemical species may leach into the drug product from these polymers, posing significant health hazards in the public domain. Identifying such leachable is crucial for assessing safety and addressing toxicological concerns. Acrylic acids are commonly used materials for adhering needles to the barrel in pre-filled syringes. In this study, we identified acrylic acid leachable impurities in ganirelix drug products available in the market using mass spectrometry as an analytical technique. These impurities leached into the drug product during storage conditions. Characterization of the impurities was carried out through data obtained from HRMS and MS/MS analysis, revealing them as polyacrylic acid-ganirelix adduct impurities. This study offers valuable insights into identifying leachable and susceptible sites, providing a foundation for potential modifications in similar classes of drug products, thereby enhancing their safety and efficacy., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2024 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

Background: Anaesthetic drug administration is complex, and typical clinical environments can entail significant cognitive load. Colour-coded anaesthetic drug trays have shown promising results for error identification and reducing cognitive load., Methods: We used experimental psychology methods to test the potential benefits of colour-coded compartmentalised trays compared with conventional trays in a simulated visual search task. Effects of cognitive load were also explored through an accompanying working memory-based task. We hypothesised that colour-coded compartmentalised trays would improve drug-detection error, reduce search time, and reduce cognitive load. This comprised a cognitive load memory task presented alongside a visual search task to detect drug errors., Results: All 53 participants completed 36 trials, which were counterbalanced across the two tray types and 18 different vignettes. There were 16 error-present and 20 error-absent trials, with 18 trials presented for each preloaded tray type. Syringe errors were detected more often in the colour-coded trays than in the conventional trays (91% vs 83%, respectively; P=0.006). In signal detection analysis, colour-coded trays resulted in more sensitivity to the error signal (2.28 vs 1.50, respectively; P<0.001). Confidence in response accuracy correlated more strongly with task performance for the colour-coded tray condition, indicating improved metacognitive sensitivity to task performance (r=0.696 vs r=0.447)., Conclusions: Colour coding and compartmentalisation enhanced visual search efficacy of drug trays. This is further evidence that introducing standardised colour-coded trays into operating theatres and procedural suites would add an additional layer of safety for anaesthetic procedures., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Pesticides used in agriculture have low polarity and a tendency to accumulate in fatty tissues, posing potential risks to human health. Effective pre-treatment is crucial due to complex sample matrices and low concentrations of pesticide residues typically encountered in instrument analysis. In this study, polyaniline-coated kapok fiber (PANI-KF) was synthesized successfully using in-situ oxidative polymerization for use as sorbents in in-syringe SPME of pyrethroid pesticides (PYRs) and organochlorine pesticides (OCPs) from aqueous samples. Coating the natural KF with PANI maintained the hollow microtubular structure and fiber morphology while significantly enhancing the extraction efficiency. The extraction process was easily conducted by simply pulling and pushing the syringe plunger. The entire extraction process, utilizing 3 mg of PANI-KF, could be completed in approximately 3 min. Density functional theory results indicated that the adsorption mechanism of PANI-KF towards OCPs and PYRs mainly involved van der Waals interactions, π-π interactions, and weak hydrogen bonding interactions. With the coupling of gas chromatography-mass spectrometry, a quantification method was established that exhibited good linearities (R 2  > 0.990), and relative recoveries (87.2-108.5 %). The limits of detection ranged from 0.4 to 2.0 ng mL -1 and the matrix effects were negligible (-12.3-16.4 %). The validated in-syringe SPME-GC-MS method was successfully applied to determine pesticide residues in fruit juices, oral liquids and herbal extract granules with satisfactory accuracy and precision. PANI-KF exhibits remarkable promise as a sorbent for the extraction and enrichment of pesticide residues in aqueous samples, thereby contributing to the advancement of pesticide residue determination methodologies., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Development of novel pharmaceutical drug modalities has created a need for frozen storage and transportation. Accurate and easy assessment of container closure integrity (CCI) in frozen conditions remains a challenge. Thus, container closure systems (CCS) suitable for low temperatures have been primarily restricted to vials despite the growing popularity of prefillable syringes (PFS) for parenteral administration. A new dye ingress test method, suitable for testing at low temperatures, was developed and applied to PFS across a range of deep-frozen temperatures. The method is versatile and can easily be extended to other common CCS formats over a wide range of temperatures including storage on dry ice (-80 °C). This new method was paired with an orthogonal technique, laser-based CO 2 headspace gas analysis, to evaluate the CCI of a glass PFS at temperatures from -50 °C to -80 °C. Both test methods showed comparable results and consistent CCI failure below a temperature of -70 °C. The primary mode of failure was the plunger-to-barrel interface, likely attributable to dimensional changes and loss of elasticity. This study demonstrates the temperature dependent CCI behavior of glass PFS and underscores the importance of thorough characterization of package integrity for deep frozen drug products., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jessica Baseggio, Odra Pinato, and Anthony Vico are employees of Stevanato Group S.p.A. Anton Zverev, Satish K. Singh, and Jason E. Fernandez are employees of and shareholders in Moderna, Inc., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Formulation screening, essential for assessing the impact of physical, chemical, and mechanical stresses on protein stability, plays a critical role in biologics drug product development. This research introduces a Reciprocal Injection Device (RID) designed to accelerate formulation screening by probing protein stability under intensified stress conditions within prefilled syringes. This versatile device is designed to accommodate a broad spectrum of injection parameters and diverse syringe dimensions. A commercial drug product was employed as a model monoclonal antibody formulation. Our findings effectively highlight the efficacy of the RID in assessing concentration-dependent protein stability. This device exhibits significant potential to amplify the influences of interfacial interactions, such as those with buffer salts, excipients, air, metals, and silicone oils, commonly found in combination drug products, and to evaluate the protein stability under varied stresses., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

Silicone oil is a commonly used lubricant in pre-filled syringes (PFSs) and can migrate over time into solution in the form of silicone oil particles (SiOPs). The presence of these SiOPs can result in elevated subvisible particle counts in PFS drug products compared to other drug presentations such as vials or cartridges. Their presence in products presents analytical challenges as they complicate quantitation and characterization of other types of subvisible particles in solution. Previous studies have suggested that they can potentially act as adjuvant resulting in potential safety risks for patients. In this paper we present several analytical case studies describing the impact of the presence of SiOPs in biotherapeutics on the analysis of the drug as well as clinical case studies examining the effect of SiOPs on patient safety. The analytical case studies demonstrate that orthogonal techniques, especially flow imaging, can help differentiate SiOPs from other types of particulate matter. The clinical case studies showed no difference in the observed patient safety profile across multiple drugs, patient populations, and routes of administration, indicating that the presence of SiOPs does not impact patient safety., (Copyright © 2024 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

Background: Community pharmacies are well-positioned to improve the health of people with opioid use disorder and who use drugs by providing naloxone and other essential public health supplies. Respond to Prevent (R2P) is a clinical trial which sought to accelerate provision of harm reduction materials through a multicomponent intervention that included in-store materials, online training, and academic detailing., Objectives: The objective of this study was to explore pharmacists' attitudes, knowledge, and experiences in providing naloxone, dispensing buprenorphine, and selling nonprescription syringes following participation in the R2P program., Methods: Two online asynchronous focus groups were conducted with community-based chain pharmacists across Massachusetts, New Hampshire, Oregon, and Washington who had participated in the R2P program. Participants accessed an online repository of group interview items and responded to questions over a short period. Each pharmacist participated anonymously for approximately 30 min over 2 ½ days. Pharmacists answered questions on experiences with pharmacy-based harm reduction care and R2P intervention implementation barriers and facilitators. Qualitative data analysis was conducted by a multidisciplinary team using an immersion-crystallization approach., Results: A total of 32 pharmacists participated in the two focus groups. Most participants were female (n = 18, 56%), non-Hispanic (n = 29, 91%), and white (n = 17, 53%). Four major themes were identified related to (1) addressing bias and stigma toward people with opioid use disorder and who use drugs, (2) familiarity and comfort with naloxone provision, (3) perspective and practice shifts in nonprescription syringe sales, (4) structural challenges to harm reduction care in the pharmacy., Conclusions: Community pharmacists across the four states identified attitudes, knowledge, and experiences that create barriers to providing care to people with opioid use disorder and who use drugs. R2P approaches and tools were effective at reducing stigma and changing attitudes but were less effective at addressing structural challenges from the pharmacists' perspective., Competing Interests: Declaration of competing interest Daniel Ventricelli is currently employed by Indivior, Inc., as a Medical Science Liaison. He was employed by the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia, PA when engaged with this work, and he did not contribute further to the study analysis or writing of this manuscript after transitioning employment to Indivior, Inc., in September 2021. This study and the contents of this manuscript are not in any way associated or affiliated with Indivior, Inc. None of the other authors have any conflicts of interest to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

With the remarkably strong growth of the biopharmaceutical market, an increasing demand for self-administration and rising competitions attract substantial interest to the biologic-device combination products. The ease-of-use of biologic-device combination products can minimize dosing error, improve patient compliance and add value to the life-cycle management of biological products. As listed in the purple book issued by the U.S. Food and Drug Administration (FDA), a total of 98 brand biologic-device combination products have been approved with Biologic License Application from January 2000 to August 2023, where this review mainly focused on 63 products containing neither insulin nor vaccine. Prefilled syringes (PFS) and autoinjectors are the most widely adopted devices, whereas innovative modifications like needle safety guard and dual-chamber design and novel devices like on-body injector also emerged as promising presentations. All 16 insulin products employ pen injectors, while all 19 vaccine products are delivered by a PFS. This review provides a systematic summary of FDA-approved biologic-device combination products regarding their device configurations, routes of administration, formulations, instructions for use, etc. In addition, challenges and opportunities associated with biologic-device compatibility, regulatory complexity, and smart connected devices are also discussed. It is believed that evolving technologies will definitely move the boundaries of biologic-device combination product development even further., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: A number of sealers with different chemistries are badged as Bioceramic, implying biological activity, but have dissimilar properties, which has implications on the sealer properties and will affect the quality and outcome of root canal treatment. This study aimed to assess the physical and chemical properties of 3 hydraulic cement-based sealers, namely BC Universal sealer compared with Totalfill BC sealer and AH Plus Bioceramic., Methods: The microstructure and composition of the sealers were assessed using scanning electron microscopy and energy dispersive spectroscopy after setting. The crystalline phases were assessed by X-ray diffraction analysis and the leachates were tested using inductively coupled plasma. All testing was performed at 0, 7, and 28 days. The physical properties of film thickness, flow, radiopacity, and solubility were evaluated using ISO 6876:2012 standards., Results: All 3 sealers contained calcium, zirconium, and silicon. Totalfill BC had the highest calcium release at 7 and 28 days followed by AH Plus Bioceramic and BC Universal sealer. All 3 sealers adhered to the ISO standard in terms of flow and radiopacity. BC Universal sealer was slightly over the range (>50 μm) for film thickness. All sealers exceeded the solubility range set by ISO 6876:2012., Conclusion: Although these hydraulic cement sealers had similar components and delivery, the properties varied significantly. The testing of material properties to confirm the suitability for clinical use is necessary., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

To know the bioavailability of virgin olive oil (VOO) phenols and its impact on health, it is necessary to determine the levels of phenols excreted in urine. We present here a novel strategy for in-syringe solid-phase extraction and analysis of the extract by liquid chromatography-tandem mass spectrometry (LC-MS/MS), using ammonium fluoride as ionization agent to enhance sensitivity. This approach allows avoiding additional steps such as solvent evaporation or analytes derivatization. The method can be used with a previous acid hydrolysis for quantitative determination of tyrosol and hydroxytyrosol to estimate metabolized phenols. We tested this application by analysis of a cohort of volunteers (n = 20) after a standardized intake of VOO. Additionally, the method can be used as such for metabolite profiling of phenolic derivatives in urine using LC-MS/MS in high-resolution data-independent acquisition (DIA). Information about the phenolic profile of the consumed VOO and the human metabolism is thus obtained. The proposed approach represents a simple and versatile tool for qualitative and quantitative characterization of VOO phenolic metabolism., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Feliciano Priego Capote reports financial support was provided by Spain Ministry of Science and Innovation. Feliciano Priego Capote reports a relationship with University of Cordoba that includes: employment., (Copyright © 2023 Elsevier B.V. All rights reserved.)

The purpose of this technique is to offer patients wishing a labial restoration without morphological changes a simple, fast, discreet, comfortable, adaptable and reversible method by combining the two compounds most used in aesthetic medicine, botulinum toxin and hyaluronic acid. The originality of this combination is based on their mixing in the same syringe and their injection with cannula through a paracommissural approach which makes it possible to treat the entire upper lip in a very homogeneous manner. Botulinum toxin diffuses directly into the underlying muscle layer; hyaluronic acid allows to unfold the damaged cutaneous fan. The useful reciprocal dose of the two products remains intuitive; for starting barcodes the dose of botulinum toxin will be 8-10 Speywood units (4 Allergan units), for those already marked at rest 10-20 Speywood units (4-8 Allergan units); the hyaluronic acid will be chosen according to the depth of the wrinkles. We present a series of 63 patients with an average age of 67 years with a result deemed positive in 79% of cases. The incidents reported are generally due to excessive doses of botulinum toxin which can lead to the classic incidents of fluid leaks in this location (6%). The expected efficacy of the treatment depends on that of the components used (four to six months) but prolonged results have been regularly observed (up to 18 months). All complementary resurfacing treatments have been discarded here since the aim pursued is that of a natural labial restoration allowing an immediate return to socio-professional activities., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Background: Community pharmacies are an important resource for people who inject drugs (PWID) to purchase over-the-counter (OTC) syringes. Access to sterile injection equipment can reduce the transmission of blood-borne illnesses. However, pharmacists and their staff ultimately use discretion over sales., Objective: To identify staff attitudes, beliefs, knowledge, and practices in the sale of OTC syringes in community pharmacies., Methods: This systematic review was reported according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and registered with PROSPERO (CRD42022363040). We systematically searched PubMed, Embase, and Scopus from inception to September 2022. The review included peer-reviewed empirical studies regarding OTC syringe sales among community pharmacy staff (pharmacists, interns, and technicians). We screened records and extracted data using a predefined data extraction form. Findings were narratively synthesized, and critical appraisal was conducted using the Mixed Methods Appraisal Tool., Results: A total of 1895 potentially relevant articles were identified, and 35 were included. Most studies (23; 63.9%) were cross-sectional descriptive designs. All studies included pharmacists, with seven (19.4%) also including technicians, two (5.6%) including interns, and four (11.1%) including other staff. Studies found relatively high support among respondents for harm reduction-related services within community pharmacies, but less common reports of staff engaging in said services themselves. When studies investigated the perceived positive or negative impacts of OTC syringe sales, prevention of blood-borne illness was widely understood as a benefit, while improper syringe disposal and safety of the pharmacy and its staff commonly reported as concerns. Stigmatizing attitudes/beliefs toward PWID were prevalent across studies., Conclusion: Community pharmacy staff report knowledge regarding the benefits of OTC syringes, but personal attitudes/beliefs heavily influence decisions to engage in sales. Despite support for various syringe-related harm reduction activities, offerings of services were less likely due to concerns around PWID., (Copyright © 2023 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Closed system transfer devices (CSTDs) are a major challenge for drug manufacturers to assess and assure drug compatibility and acceptable dosing accuracy for a range of clinical administration strategies. In this article, we systematically investigate parameters affecting the loss of product during transfer by CSTDs from vials to infusion bags. We show that liquid volume loss increases with vial size, vial neck diameter, and solution viscosity - while dependent on stopper design. We further compared CSTDs' performance with a traditional syringe transfer and learned that loss is larger for CSTDs than for syringe transfer. Based on experimental data, a statistical model was developed to predict drug loss upon transfer by CSTDs. The model predicted that, for single dose vials with USP<1151> conforming overfill, a complete extraction and transfer of the full dose can be assured for a broad range of CSTDs, product viscosities, and vial types (2R, 6R, 10R, 20R) if a flush (of syringe, syringe adaptor, bag spike) is performed. The model also predicted that complete transfer cannot be achieved for fill volumes ≤ 2.0 mL. For multi-dose vials and pooling of several vials, respectively, the effective dose transfer (i.e., ≥ 95%) for all CSTDs tested was predicted to be achieved if a minimum of 5.0 mL is transferred., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

Prefilled syringes (PFS) as a primary container for parenteral drug products offer significant advantages, such as fast delivery time, ease of self-administration and fewer dosing errors. Despite the benefits that PFS can provide to patients, the silicone oil pre-coated on the glass barrels has shown migration into the drug product, which can impact particle formation and syringe functionality. Health authorities have urged product developers to better understand the susceptibility of drug products to particle formation in PFS due to silicone oil. In the market, there are multiple syringe sources provided by various PFS suppliers. Due to current supply chain shortages and procurement preferences for commercial products, the PFS source may change in the middle of development. Additionally, health authorities require establishing source duality. Therefore, it is crucial to understand how different syringe sources and formulation compositions impact the drug product quality. Here, several design of experiments (DOE) are executed that focus on the risk of silicone oil migration induced by syringe sources, surfactants, protein types, stress, etc. We utilized Resonant Mass Measurement (RMM) and Micro Flow Imaging (MFI) to characterize silicone oil and proteinaceous particle distribution in both micron and submicron size ranges, as well as ICP-MS to quantify silicon content. The protein aggregation and PFS functionality were also monitored in the stability study. The results show that silicone oil migration is impacted more by syringe source, siliconization process and surfactant (type & concentration). The break loose force and extrusion force across all syringe sources increase significantly as protein concentration and storage temperature increase. Protein stability is found to be impacted by its molecular properties and is less impacted by the presence of silicone oil, which is the same inference drawn in other literatures. A detailed evaluation described in this paper enables a thorough and optimal selection of primary container closure and de-risks the impact of silicone oil on drug product stability., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

Prefilled syringes are widely used as a primary container for therapeutic proteins because they are more convenient than glass vials. The stability of biologic molecules can be affected by different syringe materials and techniques, such as silicone oil levels and coating method, amount of tungsten remaining in the glass barrel after using a tungsten pin to create the needle hole, and end of the syringe, which can be Luer locked or pre-staked with a needle. We investigated the impact of these parameters by using a monoclonal antibody to collect the antibody's stability profile and the prefilled syringes' functionality data. Silicone oil levels had no impact on aggregation levels, and particle counts were lowest for silicone oil-free syringes. Functionality performance was similar and did not change throughout all stability time points for all syringe configurations. The break-loose force for Ompi syringes was initially lower and increased over time to align with those of the other configurations, all of which remained well below 25 N. Tungsten contaminants and agitation stress from shipping studies did not impact quality attributes. This work can help guide the development of similar products in prefilled syringes to ensure selection of the primary container that provides adequate stability for the protein, as well as maintain the desired functionality features over the shelf life of the drug product., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

Background: As rates of overdoses involving opioids continue to rise in the United States, community pharmacies are uniquely positioned as a central access point of care for individuals to access harm reduction supplies, such as naloxone and nonprescription syringes (NPS)., Objectives: This study aimed to identify the facilitators and barriers of obtaining naloxone and NPS at community pharmacies that participated in Respond to Prevent (R2P), a multicomponent intervention to increase dispensing rates of naloxone, buprenorphine, and NPS., Methods: Pharmacy customers were recruited to participate in semistructured qualitative interviews conducted immediately after they obtained, or attempted to obtain, naloxone and NPS (when applicable) from R2P-participating pharmacies. Thematic analysis was conducted on the transcribed interviews, and content coding was applied to ethnographic notes and text messages from participants., Results: Of the 32 participants, most (n = 28, 88%) successfully obtained naloxone and most of those seeking NPS successfully (n = 14, 82%) purchased them as well. Participants reported positive overall experiences at the community pharmacies. Participants described using the intervention advertising materials, as designed, to facilitate the request for naloxone. Many participants shared that they felt respected by pharmacists and that they valued naloxone counseling sessions that were tailored to meet their needs and allowed space for them to ask questions. Barriers included experiences where the intervention did not address structural challenges that prohibited the purchase of naloxone and where certain types of staff lacked knowledge, treated participants poorly, or did not adequately provide expected naloxone counseling., Conclusion: Pharmacy customer experiences obtaining naloxone and NPS in R2P-participating pharmacies identify facilitators and barriers to access that may be used to reform implementation and future interventions. Barriers identified can help enhance strategies or inform policies to improve pharmacy-based harm reduction supply distribution not addressed through existing interventions., (Copyright © 2023 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

The demand for accurate control of the flowrate/pressure in chemical analytical systems has given rise to the adoption of mechatronic approaches in analytical instruments. A mechatronic device is a synergistic system which combines mechanical, electronic, computer and control components. In the development of portable analytical devices, considering the instrument as a mechatronic system can be useful to mitigate compromises made to decrease space, weight, or power consumption. Fluid handling is important for reliability, however, commonly utilized platforms such as syringe and peristaltic pumps are typically characterized by flow/pressure fluctuations and slow responses. Closed loop control systems have been used effectively to decrease the difference between desired and realized fluidic output. This review discusses the way control systems have been implemented for enhanced fluidic control, categorized by pump type. Advanced control strategies used to enhance the transient and the steady state responses are discussed, along with examples of their implementation in portable analytical systems. The review is concluded with the outlook that the challenge in adequately expressing the complexity and dynamics of the fluidic network as a mathematical model has yielded a trend towards the adoption of experimentally informed models and machine learning approaches., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

A sample preparation method involving tandem implementation of protein precipitation and salting-out homogenous liquid-liquid extraction was developed for the determination of beta-blockers in serum. The entire procedure was automated using a computer-controlled syringe pump following the Lab-In-Syringe approach. It is based on the denaturation of serum proteins with acetonitrile followed by salt-induced phase separation upon which the proteins accumulate as a compact layer at the interphase of the solutions. The extract is then separated and diluted in-syringe before being submitted to online coupled UHPLC-MS/MS. A 1 mL glass syringe containing a small stir bar for solution mixing at up to 3000 rpm, was used to deal with sample volumes as small as 100 μL. A sample throughput of 7 h -1 was achieved by performing the chromatographic run and sample preparation procedure in parallel. Linear working ranges were obtained for all analytes between 5 and 100 ng mL -1 , with LOD values ranging from 0.4 to 1.5 ng mL -1 . Accuracy values in the range of 88.2-106% and high precision of <11% RSD suggest applicability for routine analysis that can be further improved using deuterated standards., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

The fill-finish process for vials and syringes, although considered standard in the biopharmaceutical industry, comes with numerous technical challenges when manufacturing high concentration products. This paper includes case studies, illustrating the operational challenges associated with the filling unit operation for three of the commonly used filling technologies for biopharmaceutical products - piston pump, time over pressure pump and peristaltic pump. First case study consists of a piston pump filling operation and evaluates impact of product related parameters such as a) protein concentration, b) product viscosity and c) surface tension. The second study encompasses peristaltic pump filling. It delves into characterization of fluid flow and pump parameters while examining failure modes such as product drying. The third case study details challenges with time-pressure filling operation. In summary, for the three filling technologies, the operational challenges encountered during bench-scale and manufacturing operations implicate drug product-nozzle interactions (drying of high-viscosity material), inadequate pump clearances (piston, again, drying + seizure) and lack of optimized control parameters as key factors contributing to filling line stoppages. In each instance, recommendations are provided to mitigate these operational challenges., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

In the work limitations of deep eutectic solvents in the flow-based analysis are discussed. Deep eutectic solvents based on terpenes and fatty acids with low viscosity were studied as extraction solvents for liquid-liquid microextraction into a lab-in-syringe system for the first time. As a result an automated deep eutectic solvent-based microextraction approach was proposed. The procedure involved aspiration of deep eutectic solvent (based on terpene and fatty acid) and aqueous sample solution followed by phases mixing by a magnetic stirrer inside a syringe of flow system. After phase separation the extract phase was transferred from the syringe into a vial followed by analysis by a high-performance liquid chromatography with diode-array detection. The determination of Sudan I, Sudan II and Sudan III in chili-based sauces was considered as an analytical task. The mass-transfer intensification performed by the magnetic stirring inside the syringe allowed to perform fast (2 min) and efficient (extraction recoveries 87-95%) extraction. The limits of detection, calculated from a blank test based on 3σ, were from 0.003 to 0.005 mg kg -1 , RSD was <9%. The microextraction procedure did not involve the use of hazardous organic solvents, only 100 μL of natural deep eutectic solvent was required for dyes preconcentration., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Point-of-care hepatitis C virus (HCV) RNA testing can facilitate single-visit diagnosis and treatment. This study evaluated a single-visit test and treat intervention integrating point-of-care HCV RNA testing, linkage to nursing care, and peer-supported engagement/delivery of treatment among people with recent injecting drug use at a peer-led needle and syringe program (NSP)., Methods: TEMPO Pilot is an interventional cohort study of people with recent injecting drug use (previous month) recruited between September 2019-February 2021 from one peer-led NSP in Sydney, Australia. Participants received point-of-care HCV RNA testing (Xpert HCV Viral Load Fingerstick), linkage to nursing care, and peer-supported engagement/delivery of treatment. The primary endpoint was the proportion initiating HCV therapy., Results: Among 101 people with recent injecting drug use (median age 43; 31% female), 27% (n = 27) were HCV RNA detectable. Treatment uptake was 74% (20 of 27; sofosbuvir/velpatasvir, n = 8; glecaprevir/pibrentasvir, n = 12). Among people initiating treatment (n = 20), 45% (n = 9) initiated treatment at the same visit, 50% (n = 10) in the next 1-2 days, and 5% on day 7 (n = 1). Two participants initiated treatment outside the study (overall treatment uptake 81%). Reasons for not initiating treatment included loss to follow-up (n = 2), no reimbursement (n = 1), not suitable for treatment (mental health) (n = 1), and inability to perform liver disease assessment (n = 1). In the full analysis set, 60% (12 of 20) completed treatment and 40% (8 of 20) had a sustained virological response (SVR). In the evaluable population (excluding people without an SVR test), SVR was 89% (8 of 9)., Conclusion: Point-of-care HCV RNA testing, linkage to nursing, and peer-supported engagement/delivery led to high HCV treatment uptake (majority single-visit) among people with recent injecting drug use attending a peer-led NSP. The lower proportion of people with SVR highlights the need for further interventions to support treatment completion., Competing Interests: Declarations of Interest J.G. is a consultant/advisor and has received research grants from Abbvie, Biolytical, Camurus, Cepheid, Gilead Sciences, Hologic, Indivior, and Merck/MSD. G.D. reports grants from Gilead, Abbvie, and Merck. P.R. has received honoraria for speaking and advisory board fees from Abbvie and Gilead Sciences, and research funding from Gilead Sciences., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

The multi-dose vial (MDV) is widely used for most biopharmaceuticals that are repackaged in plastic syringes before use. However, subvisible particle formation with the use of plastic syringes containing silicone oil (SO syringes) for handling therapeutic proteins can be problematic. This study aimed to evaluate the extent of and trends in microparticle (>1 μm) formation and accumulation in repackaged syringes from MDVs containing human immunoglobulin (IgG) and lipid nanoparticles (LNPs). Light obscuration (LO) and flow imaging (FI) were used to analyze the microparticles. The number of microparticles observed with the use SO syringes was greater than that with SO-free syringes, and the number of microparticles continuously increased as did the number of times of repackaging in syringes for both drugs. However, a large variation was observed across different brands of SO syringes. In contrast, using a different technique of drug withdrawal from the vial significantly reduced the number of microparticles. Furthermore, the use of filter-integrated needles or the inclusion of stabilizers such as acetyl-arginine and Tween 20 into the formulation also helped reduce particle formation., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

Background: Lumbar puncture is a procedure that is commonly performed in emergency departments. Despite their absence from procedure kits, emergency physicians often use skin markers to delineate landmarks for a lumbar puncture. We prefer to create a temporary indentation in the skin using the suction of a syringe. This "syringe hickey" eliminates the need for a skin marker., Discussion: We created a photo demonstration comparing the syringe hickey to a skin marker for site marking. The syringe hickey was created using a 10-mL syringe aspirated to 5 mL on the forearm for 1 min. The syringe hickey lasted over 30 min on a range of skin tones across the Fitzpatrick Scale. The skin marker faded but the syringe hickey maintained its definition after application of ultrasound gel and sterilization with either chlorhexidine or betadine., Conclusions: The syringe hickey is a simple skin marking technique that is resistant to antiseptic agents and ultrasound gel. The syringe hickey may be useful for other procedures that require puncture site marking., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Anaesthetic procedures are complex and subject to human error. Interventions to alleviate medication errors include organised syringe storage trays, but no standardised methods for drug storage have yet been widely implemented., Methods: We used experimental psychology methods to explore the potential benefits of colour-coded compartmentalised trays compared with conventional trays in a visual search task. We hypothesised that colour-coded compartmentalised trays would reduce search time and improve error detection for both behavioural and eye-movement responses. We recruited 40 volunteers to identify syringe errors presented in pre-loaded trays for 16 trials in total: 12 error present and four error absent, with eight trials presented for each tray type., Results: Errors were detected faster when presented in the colour-coded compartmentalised trays than in conventional trays (11.1 s vs 13.0 s, respectively; P=0.026). This finding was replicated for correct responses for error-absent trays (13.3 s vs 17.4 s, respectively; P=0.001) and in the verification time of error-absent trays (13.1 s vs 17.2 s, respectively; P=0.001). On error trials, eye-tracking measures revealed more fixations on the drug error for colour-coded compartmentalised trays (5.3 vs 4.3, respectively; P<0.001), whilst more fixations on the drug lists for conventional trays (8.3 vs 7.1, respectively; P=0.010). On error-absent trials, participants spent longer fixating on the conventional trials (7.2 s vs 5.6 s, respectively; P=0.002)., Conclusions: Colour-coded compartmentalisation enhanced visual search efficacy of pre-loaded trays. Reduced fixations and fixation times for the loaded tray were shown for colour-coded compartmentalised trays, indicating a reduction in cognitive load. Overall, colour-coded compartmentalised trays were associated with significant performance improvements when compared with conventional trays., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objective: To examine the difference in incidence of ocular hypertension (OHT) following the introduction of filtered anti-vascular endothelial growth factor (anti-VEGF) medication in silicone-free syringes., Design: Retrospective cohort study., Methods: A retrospective review of consecutive treatment-naive patients receiving intravitreal anti-VEGF injections in a group practice was performed. Data from the cohort receiving nonfiltered anti-VEGF in insulin syringes (IS group) was collected from June 2015. Data from the cohort receiving filtered anti-VEGF in silicone-free syringes (SFS group) was collected from June 2019. Follow up data were collected at 1 year. Exclusion criteria included prior anti-VEGF treatment, known glaucoma or diagnosis of glaucoma suspect before anti-VEGF treatment, neovascular glaucoma, steroid use, or vitrectomy during follow-up. Primary outcome was the cumulative incidence of intraocular pressure (IOP) > 21 mmHg and IOP ≥ 30 mm Hg at any follow-up visit. The use of IOP lowering therapy was also recorded., Results: The mean age (71 ± 13 years), mean number of injections (9.6 ± 2.7), and median follow-up time (392 ± 57 days) were similar between groups. The incidence of IOP ≥ 21 mm Hg was 34% (34/100) in the IS group and 15% (15/100) in the SFS group (p = 0.025). The incidence of IOP ≥ 30 mm Hg was 8% (8/100) in the IS group and 0% (0/100) in the SFS group (p =0.004). The incidence of IOP-lowering therapy was 13% in the IS group and 0% in the SFS group (p =0.0002)., Conclusion: The incidence of OHT and treatment with IOP-lowering therapy significantly decreased after the introduction of filtered anti-VEGF medication and silicone-free syringes., (Copyright © 2021 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.)

Background: People who inject drugs (PWID) are subject to injection-related harm, including skin and soft tissue infections. Syringe services programs (SSPs) provide sterile syringes, disposal of used syringes, and other supportive services. Given their contact and credibility with PWID, SSPs could facilitate triage and treatment of wounds and access to immunizations for communicable diseases., Objective: This work aimed to assess wound care and immunization needs among participants accessing mobile SSP services in Austin, TX., Methods: A 21-item mixed-methods survey was created to assess frequency and severity of wounds, wound care approaches, and vaccination status. Participants were included if they reported injection drug use and experienced a related wound in the previous 6 months. Interview sections included screening, demographics, wound care, and immunization status., Results: A total of 21 participants completed the semistructured interview. A majority identified as male (n = 13, 61.9%), white (n = 12, 57.1%), and were unhoused (n = 12, 57.1%). The primary drug of injection was heroin alone (n = 14, 66.7%). Many avoided seeking wound care from health care providers (n = 16, 76.2%) owing to stigmatization (n = 13, 61.9%) and previous negative experiences (n = 7, 33.3%). Self-treatment of wounds included over-the-counter medications (n = 10, 47.6%), over-the-counter supplies (n = 10, 47.6%), and antibiotics (n = 9, 42.8%). In the past 5 years, few had received vaccination for hepatitis A and B (n = 3, 14.3%) or tetanus (n = 7, 33.3%), and many expressed interest in receiving vaccinations through the SSP. Interest for other expanded services included access to antibiotics, an on-site provider, wound care supplies, and education., Conclusions: PWID may avoid professional health care for wound care or immunizations owing to perceived stigma. Expanding availability of wound care services and immunizations directly through mobile SSPs is desired by participants and could positively affect public health., (Copyright © 2022 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Syringe services programs are community-based prevention programs that provide evidence-based, lifesaving services for people who use illicit drugs, including access to syringes, naloxone, fentanyl test strips, infection screening, and linkage to treatment. Historically, syringe services programs did not exist within the Veterans Health Administration owing to many factors, including lack of clarity regarding legality for federal agency-purchased syringes. Three champions at Veterans Affairs facilities in Danville, IL, Orlando, FL, and San Francisco, CA, worked to clarify legal considerations, address barriers, and implement syringe services programs that are integrated in the health care systems. Since 2017, these 3 programs have engaged approximately 400 Veterans and distributed nearly 10,000 syringes, 2500 fentanyl test strips, 50 wound care kits, and 45 safer sex kits. These programs, both led by and in collaboration with clinical pharmacist practitioners, paved the way for nationwide implementation within the Veterans Health Administration. This commentary describes successes, challenges, and proposed next steps to increase Veteran access to syringe services programs, written from the perspective of 3 facility-based champions., (Published by Elsevier Inc.)

Background: Coronavirus disease 2019 (COVID-19) lockdowns disrupted access to harm reduction supplies and services known to be effective in overdose prevention and contributed to a worsening of the opioid crisis. However, because pharmacies can provide naloxone and sell over-the-counter (OTC) sterile syringes, their continued operation throughout the pandemic potentially reinforced a public health role as a distribution hub for safer use supplies., Objectives: The objective of this analysis was to examine patterns of naloxone and OTC syringe sale volume at 463 community pharmacies in 2 states with high overdose rates during the COVID-19 pandemic., Methods: We analyzed weekly pharmacy-level dispensing data from January 5, 2020, to December 31, 2020, from one corporate community pharmacy chain in Massachusetts (n = 415 pharmacies) and New Hampshire (n = 48 pharmacies). Descriptive statistics and visualizations over the analytical period were generated as initial explorations of the outcome. Zero-inflated Poisson and negative binomial models were used to analyze distribution data along with county-level COVID-19 case rates and store-level COVID-19 testing location status during the same time. Interactions tested the effect of COVID-19 case rates on naloxone and OTC syringe sales., Results: Pharmacies that reported selling nonprescription syringes and dispensing naloxone during the study period averaged 210.13 OTC syringes sold and 0.53 naloxone prescriptions per week. Pharmacies in communities that experienced greater COVID-19 case burden also exhibited higher naloxone dispensing and OTC syringe sales during this period. The odds of selling OTC syringes increased over time but naloxone dispensing remained constant over the pandemic year. Pharmacies hosting COVID-19 testing tended to have lower OTC syringe sales and naloxone provision than nontesting sites., Conclusion: During the COVID-19 pandemic, pharmacies provided harm reduction services and dispensed lifesaving medications by quickly adapting to fulfill community needs without disrupting co-located services for COVID-19 response., (Copyright © 2022. Published by Elsevier Inc.)

Silicone oil is often applied to the inner surface of glass syringes and cartridges to reduce friction between the glass surface and elastomeric plunger stopper. This oil can appear as intrinsic and non-proteinaceous particles in the ejected fluid or drug product. Limited data is available to understand the impact of age (time between syringe manufacture and filling) on silicone oil migration into the drug product. This study compares subvisible particle count and extrusion force of siliconized syringes from two different manufacturers stored at ambient condition for 2-3 (fresh syringes) and 13-14 (aged syringes) months then filled and placed at 40°C for an additional three months. The fresh syringes exhibit a 2.5-fold increase in subvisible particle count compared to those aged ones. Moreover, the fresh syringes exhibit up to a 2-fold increase in extrusion force. These findings suggest the degree and amount of silicone oil migration is influenced by the time in storage of the glass syringe prior to filling. This rapid communication highlights syringe storage time prior to filling as a factor to be considered during development., Competing Interests: Declaration of Competing Interest The authors declare there is no conflict of interest., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Plastics are one of the ubiquitous and artificial types of substrates for microbial colonization and biofilm development in the aquatic environment. Characterizing plastic-associated biofilms is key to the better understanding of organic material and mineral cycling in the "Plastisphere"-the thin layer of microbial life on plastics. In this study, we propose a new method to extract biofilms from environmental plastics, in order to evaluate the properties of biofilm-derived organic matter through stable carbon (δ 13 C) and nitrogen (δ 15 N) isotope signatures and their interactions with radionuclides especially radiocesium ( 137 Cs). The extraction method is simple and cost-effective, requiring only an ultrasonic bath, disposable plastic syringes, and a freeze drier. After ultrasound-assisted separation from the plastics, biofilm samples were successfully collected via a sequence of syringe treatments, with less contamination from plastics and other mineral particles. Effective removal of small microplastics from the experimental suspension was satisfactorily achieved using the method with syringe treatments. Biofilm-derived organic matter samples (14.5-65.4 mg) from four river mouths in Japan showed 137 Cs activity concentrations of <75 to 820 Bq·kg -1 biofilm (dw), providing evidence that environmental plastics, mediated by developed biofilms, serve as a carrier for 137 Cs in the coastal riverine environment. Significant differences in the δ 13 C and δ 15 N signatures were also obtained for the biofilms, indicating the different sources, pathways, and development processes of biofilms on plastics. We demonstrate here a straightforward method for extracting biofilms from environmental plastics; the results obtained with this method could provide useful insights into the plastic-associated nutrient cycling in the environment., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Syringe services programs (SSPs) provide critical evidence-based public health services that decrease harms from drug use for people who use drugs (PWUD). Many SSPs have experienced significant and evolving COVID-19-related disruptions. We aimed to characterize the impacts of COVID-19 on SSP operations in the United States approximately one year into the pandemic., Methods: Participating sites, selected from a national sample of SSPs, completed a semi-structured interview via teleconference and brief survey evaluating the impacts of COVID-19 on program operations. Data collection explored aspects of program financing, service delivery approaches, linkages to care, and perspectives on engaging PWUD in services one year into the pandemic. Interview data were analyzed qualitatively using Rapid Assessment Process. Survey data were analyzed using descriptive statistics and triangulated with qualitative findings., Results: 27 SSPs completed study-related interviews and surveys between February 2021 - April 2021. One year into the pandemic, SSPs reported continuing to adapt approaches to syringe distribution in response to COVID-19, and identified multiple barriers that hindered their ability to engage program participants in services, including 1) isolation and decreased connectivity with participants, 2) resource restrictions that limit responsiveness to participant needs, 3) reduced capacity to provide on-site HIV/HCV testing and treatment linkages, and 4) changing OUD treatment modalities that were a "double-edged sword" for PWUD. Quantitative survey responses aligned with qualitative findings, highlighting increases in the number of syringes distributed, increases in mobile and home delivery services, and reductions in on-site HIV and HCV testing., Conclusion: These data illuminate persistent and cascading risks of isolation, reduced access to services, and limited engagement with program participants that resulted from COVID-19 and continue to create barriers to the delivery of critical harm reduction services. Findings emphasize the need to ensure SSPs have the resources and capacity to adapt to changing public health needs, particularly as the COVID-19 pandemic continues to evolve., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier B.V.)

Introduction: The Obstetric Anaesthetists' Association has released a statement outlining the disruption to supply of the Portex® Loss of Resistance Syringe (Smiths Medical, UK) which is commonly used for epidural insertion within our Trust. We sought to investigate the use of standard available syringes for epidural insertion and whether tactile feedback when getting loss of resistance was similar., Methods: Using an epidural trainer model, we asked anaesthetists regularly working in the maternity unit to trial three alternative syringes (10 mL BD Emerald, 10 mL BD syringe from our epidural packs, and 20 mL BD Plastipak) (Becton Dickinson U.K. Limited, UK) and to complete a qualitative questionnaire about their experience., Results: Responses from 16 anaesthetists, including individuals with a range of obstetric anaesthetic experience who regularly provide obstetric anaesthesia, were collected. With the BD Emerald 10 mL syringe, 81% considered there was no difference or only a slight difference when feeling for loss of resistance. For the BD 10 mL syringe, this figure was 75%. With the 20 mL syringe 66% reported either a reasonable or marked difference in tactile feel. The most popular syringe was the 10 mL BD Emerald syringe., Conclusion: Using an epidural training mannequin, this study suggests that it is still possible to elicit clear loss of resistance using alternative syringes. Of the three alternative syringes commonly available in our organisation, the BD Emerald 10 mL syringe was the most popular., Competing Interests: Declaration of interests None., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Purpose: Comminuted intra-articular fractures and fracture dislocations of the metacarpophalangeal (MCP) and interphalangeal joints are challenging. Dynamic external fixation, permitting early joint motion while still minimizing forces across the healing joint, can result in acceptable postoperative active range of motion (AROM). However, some fractures are not initially stable enough for early dynamic motion; further, many available dynamic external fixation systems are costly and cumbersome. We reviewed our experience using an external fixator made from a 1-mL syringe and K-wires and report outcomes using it as a static fixator, dynamic fixator, or configured as a static fixator and then converted to a dynamic fixator in the clinic., Methods: Patients with intra-articular fractures and fracture dislocations of the MCP and proximal interphalangeal (PIP) joints treated between 2014 and 2020 using syringe external fixators were retrospectively reviewed. We reviewed demographics, mechanisms, treatment types and durations, and postoperative AROM, as well as complications including infection, pin loosening, nonunion, hardware failure, and need for further surgery. Patients were analyzed by the level of joint injury (MCP versus PIP) and by treatment pattern., Results: After excluding 23 patients with 25 joint injuries who were lost to follow-up or had inadequate outcome data, 27 patients with 29 joint injuries were reviewed. The average follow-up was 171 days after surgery. The postoperative AROM at the MCP level averaged 55° for static fixation and 30° for static-to-dynamic fixation. The postoperative AROM at the PIP level averaged 64° for static fixation, 66° for static-to-dynamic fixation, and 80° for dynamic fixation. Three pin site infections and 2 loose pins were reported., Conclusions: The syringe external fixator is an inexpensive, effective, and customizable treatment for intra-articular MCP and interphalangeal fractures and fracture dislocations, and results in acceptable postoperative AROM outcomes and complication rates., Type of Study/level of Evidence: Therapeutic IV., (Copyright © 2022 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Introduction: Ralstonia insidiosa, a gram-negative waterborne bacteria able to survive and grow in any type of water source, can cause nosocomial infections, and are considered emerging pathogens of infectious diseases in hospital settings. In this study, we report an outbreak of R. insidiosa at our center related to contaminated heparinized syringes., Material and Methods: The present study was conducted in a tertiary care university hospital in Turkey. An outbreak analysis was performed between September 2021 and December 2021. Microbiological samples were obtained from environmental sources and from patient blood cultures. Species identification was performed using matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS). To investigate the clonality of strains, all confirmed isolates were sent to the National Reference Laboratory and pulsed-field gel electrophoresis (PFGE) was used to perform molecular typing., Results: Seventeen R. insidiosa isolates were identified from the blood cultures of 13 patients from various wards and intensive care units. Isolates from seven patient blood cultures and two heparinized blood gas syringes were characterized by PFGE. All isolates were found to belong to the same clone of R. insidiosa., Conclusion: R. insidiosa was identified as the cause of a nosocomial infection outbreak in our hospital, which was then rapidly controlled by the infection-control team. When rare waterborne microorganisms grow in blood or other body fluid cultures, clinicians and the infection-control team should be made aware of a possible outbreak., (Copyright © 2022 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

A lab-in-syringe flow system exploiting dispersive liquid-liquid micro-extraction in a solvent lighter than water is proposed for the spectrophotometric determination of lead in industrial residual waters. The steps inherent to both liquid-liquid extraction and monitoring of the formed compound are in-syringe carried out. The classical carbon tetrachloride is not used as the extracting solvent, as it does not present the friendly characteristics inherent to the Green Analytical Chemistry. Aiming at a cleaner alternative for this determination, xylene is selected. Enrichment factor, linear dynamic range, detection limit, sample throughput and residue volume inherent to the proposed procedure were estimated as 36, 50.0-250 μg L -1 , 9.0 μg L -1 , 13 h -1 , and 2.0 mL, respectively., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Lab-In-Syringe direct immersion single drop microextraction is proposed as an automated sample pretreatment methodology and coupled online to HPLC with fluorescence detection for the determination of fluoroquinolones in environmental waters. For the first time, a drop of a natural deep eutectic solvent (NADES), synthesized from hexanoic acid and thymol, has been used as an extractant in automated single-drop microextraction. The extraction procedure was carried out within the 5 mL void of an automatic syringe pump. A 9-position head valve served the aspiration of all required solutions, air, waste disposal, and hyphenation with the HPLC instrument. Sample mixing during extraction was done by a magnetic stirring bar placed inside the syringe. Only 60 μL of NADES were required omitting toxic classical solvents and improving the greenness of the proposed methodology. By direct injection, linear working ranges between 0.1 and 5 μg L -1 were achieved for all fluoroquinolones. The limit of quantification values and enrichment factors ranged from 20 ng L -1 to 30 ng L -1 and 35 to 45, respectively. Accuracies obtained from the analysis of spiked surface water and wastewater treatment plant effluent analysis at two concentration levels (0.5 and 4 μg L -1 ) ranged from 84.6% to 119.7%, with RSD values typically <3%., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Introduction: Among people with an opioid use disorder in the United States, only 10% receive buprenorphine treatment. The Ryan Haight Act is a federal law that has regulated buprenorphine delivery, requiring an in-person examination between a patient and provider before initiating treatment. At the beginning of the COVID-19 pandemic, federal agencies waived in-person examination requirements for buprenorphine treatment initiation. We examined whether Ryan Haight Act waiver improved implementation of telehealth buprenorphine within syringe service programs (SSPs) - organizations that serve people with historically low access to treatment., Methods: We surveyed all known SSPs operating in the US in 2021 (N = 421) of which 77% responded (n = 325). We calculated the prevalence and accompanying 95% confidence intervals (CI) for implementation of telehealth buprenorphine inductions at SSPs in 2020. Multivariable logistic regression was used to assess differences in implementing telehealth buprenorphine inductions by organizational characteristics., Results: In 2020, the prevalence of implementing buprenorphine inductions via telehealth was 24% (95% CI:19-30%). Non-governmental SSPs had a higher odds of telehealth buprenorphine inductions (adjusted odds ratio (aOR)= 2.92; 95% CI:1.22-7.00; p = 0.016), compared to governmental SSPs. Furthermore, the larger the organization's annual budget, the higher the odds of telehealth buprenorphine implementation (aOR=2.00 per quartile (95% CI:1.33-2.99; p = 0.001). SSPs located in states with higher opioid overdose mortality rates did not have significantly higher likelihood of telehealth buprenorphine implementation., Conclusion: A substantial number of SSPs implemented telehealth buprenorphine after waiver of the Ryan Haight Act. Permanent adoption of this waiver will be critical and providing financial resources to SSPs is vital to support implementation of new innovations., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)