The silicone depletion in combination products induced by biologics.

Silicone oil (SO) migration into the drug product of combination products for biopharmaceuticals during storage is a common challenge. As the inner barrel surface is depleted of SO the extrusion forces can increase compromising the container functionality. In this context we investigated the impact of different formulations on the increase in gliding forces in a spray-on siliconized pre-filled syringe upon storage at 2-8 °C, 25 °C and 40 °C for up to 6 months. We tested the formulation factors such as surfactant type, pH, and ionic strength in the presence of one monoclonal antibody (mAb) as well as compared three mAbs in one formulation. After 1 month at 40 °C, the extrusion forces were significantly increased due to SO detachment dependent on the fill medium. The storage at 40 °C enhanced the SO migration process but it could also be observed at lower storage temperatures. Regarding the formulation factors the tendency for SO migration was predominantly dependent on the presence and type of surfactant. Interestingly, when varying the mAb molecules, one of the proteins showed a rather stabilizing effect on the SO layer resulting into higher container stability. In contrast to the formulation factors, those different stability outcomes could not be explained by interfacial tension (IFT) measurements at the SO interface. Further characterization of the mAb molecules regarding interfacial rheology and conformational stability were not adequately able to explain the observed difference. Solely a hydrophobicity ranking of the molecules correlated to the stability outcome. Further investigations are needed to clarify the role of the protein in the SO detachment process and to understand the cause for the stabilization. However, the study clearly demonstrated that the protein itself plays a critical role in the SO detachment process and underlined the importance to include verum for container stability.

Standardized Solutions of Catecholamines in Intensive Care Medicine: Application, Safety and Economic Aspects.

Background/Objectives: Catecholamines are among those agents that are indispensable in modern intensive care medicine. The rapid availability of hygienically impeccable and correctly concentrated injectable solutions, e.g., for syringe pumps, is becoming more and more important. However, little research has been conducted regarding how the use of catecholamines is distributed in different wards and what options can be used to achieve optimal availability. Methods: In a retrospective monocentric study from 2019 to 2022, all continuously applied catecholamines in intensive care units (ICU) and intermediate care units (IMC) were investigated. The focus was on potential optimization by utilizing manufactured ready-to-administer solutions in the context of the economization of patient care. Results: Norepinephrine syringes represented 81% of all syringes administered, appearing to be the most frequently used on all wards. Production by the in-house pharmacy showed both financial advantages and an increase in patient safety compared to syringes produced at the bedside. Discussion: Increasing numbers of critically ill patients coupled with growing staff shortages and an increased awareness of safety requirements are driving the move towards ready-to-use and ready-to-administer solutions in critical care medicine. In-house manufacturing by hospital pharmacies can be a promising option to optimize processes and improve the economics of patient care. Conclusions: Individual calculations of the required catecholamine preparations with regard to possible economic advantages should be carried out in hospitals. In particular, in-house production of ready-to-use and ready-to-administer preparations could significantly increase patient safety and seems to be economically viable.

Physicochemical stability of bortezomib solutions for subcutaneous administration.

For the majority of cytotoxic drug preparations, such as bortezomib, the unit dose information is not available. In addition, there is a lack of information on the physicochemical stability of the pharmaceutical preparation after opening; this information is crucial for its administration to patients in successive visits, and the per-patient cost can be affected. The purpose of our proposed physicochemical stability study is to determine the shelf life of the reconstituted liquid product under refrigeration and clinical practice conditions. This evaluation was extended to both vials and ready-to-use syringes prefilled with the contents of the open vial. The stability test design includes the specified storage conditions and the critical physicochemical parameters of reconstituted injectable bortezomib. Furthermore, this approach includes the determination of impurities, the monitoring of the purity of the mean peak using a photodiode array, the control of the mass balance, the monitoring of subvisible particles using a laser diffraction analyser, and the setting of stability specifications. For the chemical stability study, the amount of bortezomib and its degradation products were determined using a stability-indicating HPLC method. The physical inspection of the samples was performed throughout the stability study, and their pH values were also monitored. Bortezomib (2.5 mg/mL) in 0.9% sodium chloride remained stable for 7 days when stored in both polypropylene syringes and vials at 5 ± 3 °C (refrigeration) and shielded from light. Additionally, it exhibits stability for 24 h under storage conditions simulating clinical use (20-30 °C and protected from light). The proposed protocol provides the stability in the vials once reconstituted and in prefilled refrigerated syringes; this protocol can be used to reduce waste and increase cost savings.

Soundless Trouble: Syringe Pump Malfunction and the Hypotension Threat.

Drug infusion devices have become indispensable tools in ICU patient care, drug delivery, and operation rooms (OR) and for controlled fluid delivery. Syringe pump safety is paramount in healthcare and laboratory settings to ensure accurate medication delivery and prevent adverse events. Healthcare professionals must receive thorough training on syringe pump operation, including loading syringes, programming infusion rates, and responding to alarms. Using the correct syringe size and type is essential to prevent inaccuracies in drug/fluid delivery. Regular calibration and maintenance checks are necessary to ensure the accuracy and reliability of the syringe pumps. Two cases of refractory hypotension are reported here, which were resolved by careful inspection of the infusion pumps.

Efficacy and Reliability of Single Tooth Anesthesia (STA) for Surgical Removal of Impacted Wisdom Teeth: A Comparative Study.

Introduction: Single tooth anesthesia via intra-ligamentary injections has long been used to provide localized pain control with minimal discomfort while avoiding undesirable effects like lip numbness, mainly in pediatric population with definite success. In this study, we aimed to assess the efficacy of single tooth anesthesia (STA) via intra-ligamentary injections using WAND® STA in the surgical removal of impacted third molar. Methodology: Sixty patients were randomly divided into two groups of 30 each where Group I (study group) received local anesthesia via STA system with 4% articaine and Group II (control group) received conventional injection, that is, inferior alveolar nerve block, (IANB) with 4% articaine. Assessment of the effectiveness of the anesthesia was made by noting the onset of action, failure of anesthesia, intra-operative pain and necessity for additional injection. Additional effects such as lip numbness were also noted. Patients were evaluated for pain and discomfort after 24 h. Results: The difference between the mean time for onset of action for STA injections and conventional block and the mean difference in the onset of action between both groups was 2.2 (± 0.25) minutes which was statistically significant (p < 0.05). Statistically significant difference in VAS score was noted only during tooth elevation with Group I reporting higher VAS score than Group II. Additional blocks were indicated in 6.7% for lingual block and 50% for long buccal nerve block in Group I and repetition of long buccal nerve block was indicated in 23.3% patients in group II. Postoperative pain and trismus was found to be higher in Group II. Conclusion: In spite of some limits in the extent of anesthesia achieved, WAND® STA was seen to be able to achieve adequate anesthesia for surgical removal of impacted third molar and is a viable alternative, particularly in patients where blocks are contraindicated due to systemic conditions. Supplementary Information: The online version contains supplementary material available at 10.1007/s12663-023-02017-z.

"I go out of my way to give them an extra smile now:" A study of pharmacists who participated in Respond to Prevent, a community pharmacy intervention to accelerate provision of harm reduction materials.

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.

Subcutaneous immunoglobulin replacement therapy in patients with immunodeficiencies - impact of drug packaging and administration method on patient reported outcomes.

BACKGROUND: Here, the perspective of patients with primary and secondary immunodeficiency receiving subcutaneous immunoglobulin (SCIg) via introductory smaller size pre-filled syringes (PFS) or vials were compared. METHODS: An online survey was conducted in Canada by the Association des Patients Immunodéficients du Québec (APIQ) (10/2020-03/2021). Survey questions included: reasons for choosing SCIg packaging and administration methods, training experiences, infusion characteristics, and switching methods. The survey captured structured patient-reported outcomes: treatment satisfaction and its sub-domains, symptom state, general health perception, and physical and mental function. Respondents using PFS were compared with vial users, overall and stratified by their administration method (pump or manual push). RESULTS: Of the 132 total respondents, 66 respondents used vials, with 38 using a pump and 28 using manual push. PFS (5 and 10 mL sizes) were being used by 120 respondents, with 38 using a pump and 82 using manual push. PFS users were associated with a 17% lower median (interquartile range) SCIg dose (10 [8, 12] vs. 12 [9, 16] g/week, respectively), a significantly shorter infusion preparation time (15 [10, 20] vs. 15 [10, 30] mins, respectively), and a trend for shorter length of infusion (60 [35, 90] vs. 70 [48, 90] mins, respectively) compared with those on vials. Patient-reported treatment satisfaction scores were overall similar between vial and PFS users (including on the domains of effectiveness and convenience), except for a higher score for vials over PFS on the domain of global satisfaction (p=0.02). CONCLUSIONS: Consistent with prescribing that reflects a recognition of less wastage, PFS users were associated with a significantly lower SCIg dose compared with vial users. PFS users were also associated with shorter pre-infusion times, reflecting simpler administration mechanics compared with vial users. Higher global satisfaction with treatment among vial users compared with PFS users was consistent with users being limited to smaller PFS size options in Canada during the study period. Patient experience on PFS is expected to improve with the introduction of larger PFS sizes. Overall, treatment satisfaction for SCIg remains consistently high with the introduction of PFS packaging compared with vials.

Come back when you're infected: pharmacy access to sterile syringes in an Arizona Secret Shopper Study, 2023.

BACKGROUND: Pharmacies are critical healthcare partners in community efforts to eliminate bloodborne illnesses. Pharmacy sale of sterile syringes is central to this effort. METHODS: A mixed methods "secret shopper" syringe purchase study was conducted in the fall of 2022 with 38 community pharmacies in Maricopa and Pima Counties, Arizona. Pharmacies were geomapped to within 2 miles of areas identified as having a potentially high volume of illicit drug commerce. Daytime venue sampling was used whereby separate investigators with lived/living drug use experience attempted to purchase syringes without a prescription. Investigator response when prompted for purchase rationale was "to protect myself from HIV and hepatitis C." A 24-item instrument measured sales outcome, pharmacy staff interaction (hostile/neutral/friendly), and the buyer's subjective experience. RESULTS: Only 24.6% (n = 28) of 114 purchase attempts across the 38 pharmacies resulted in syringe sale. Less than one quarter (21.1%) of pharmacies always sold, while 44.7% never sold. Independent and food store pharmacies tended not to sell syringes. There emerged distinct pharmacy staff interactions characterized by body language, customer query, normalization or othering response, response to purchase request and closure. Pharmacy discretion and pharmacy policy not to sell syringes without a prescription limited sterile syringe access. Investigators reported frequent and adverse emotional impact due to pharmacy staff negative and stigmatizing interactions. CONCLUSIONS: Pharmacies miss opportunities to advance efforts to eliminate bloodborne infections by stringent no-sale policy and discretion about syringe sale. State regulatory policy facilitating pharmacy syringe sales, limiting pharmacist discretion for syringe sales, and targeting pharmacy-staff level education may help advance the achievement of public health goals to eliminate bloodborne infections in Arizona.

Unraveling Pre-filled Syringe Needle Clogging: Exploring a Fresh Outlook Through Innovative Techniques.

OBJECTIVE: This 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. METHODS: Staked-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. RESULTS: Neutron 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. CONCLUSIONS: The 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.

Advancing injection force modeling and viscosity-dependent injectability evaluation for prefilled syringes.

The development of PFS requires a detailed understanding of the forces occurring during the drug administration process and patient's capability. This research describes an advanced mathematic injection force model that consisting hydrodynamic force and friction force. The hydrodynamic force follows the basic law of Hagen-Poiseuille but refines the modeling approach by delving into specific properties of drug viscosity (Newtonian and Shear-thinning) and syringe shape constant, while the friction force was accounted from empty barrel injection force. Additionally, we take actual temperature of injection into consideration, providing more accurate predication. The results show that the derivation of the needle dimension constant and the rheological behavior of the protein solutions are critical parameters. Also, the counter pressure generated by the tissue has been considered in actual administration to address the issue of the inaccuracies of current injection force evaluation preformed in air, especially when the viscosity of the injected drug solution is below 9.0 cP (injecting with 1 mL L PFS staked with 29G ½ inch needle). Human factor studies on patients' capability against medication viscosity filled the gap in design space of PFS drug product and available viscosity data in very early phase.

Container-content interactions with radiopharmaceuticals: Seeing is believing.

This perspective article addresses the critical issue of container-content interactions in the administration of intravenous medications, with a focus on radiopharmaceuticals used in nuclear medicine. Medication administration errors pose a significant challenge to patient safety. The "five rights" framework-ensuring the right patient, drug, time, dose, and route-serves as a cornerstone for safe drug administration. In the context of radiopharmaceuticals, notable for their use in nuclear medicine, adherence to these principles is paramount due to their unique properties and role in diagnostic and therapeutic procedures. The article explores the impact of container materials, particularly in syringes, on radiopharmaceutical stability and administration accuracy. It delves into the complexities of sorption phenomena, highlighting studies demonstrating its occurrence and potential consequences, including variations in administered doses and compromised diagnostic or therapeutic outcomes. Noteworthy factors influencing sorption include the type of radiopharmaceutical, container composition, molecular properties, and dilution. Findings revealing residual activity in syringes and identifying specific components, such as lubricants, silicon gaskets, and plungers, contributing to adsorption are presented. Migration of metal contaminants from container to content is discussed, emphasizing the potential impact on radiochemical yield and stability. There is a need for comprehensive studies to characterize drug-container interactions and poses crucial questions about the true benefit patients derive from prescribed activities. It challenges current practices, suggesting a need for tailored activity levels, container validation protocols, and rigorous testing of hospital preparations. Ultimately, this perspective paper calls for a deeper understanding of these interactions, urging regulatory consideration and standardization to ensure optimal drug administration and patient outcomes.

The Cost of Safe Injection: Insights on Nonprescription Syringe Price Variability From Systematic Secret Shopping.

BACKGROUND: Although the sale of nonprescription syringes in pharmacies is legal in most states, people who inject drugs (PWID) continue to face obstacles to syringe purchase like stigma, prohibitive costs, restrictive policies, and stocking issues. We examined the consistency of syringe pricing as another possible barrier. METHODS: We analyzed data on syringe prices and other relevant variables from 153 unique secret shopper visits to 2 retail chain pharmacies in Massachusetts (MA), New Hampshire (NH), Oregon (OR), and Washington (WA) as part of the fidelity component of a large pharmacy-focused intervention study. Pretax prices from purchases made between August 2019 and May 2021 were adjusted for inflation to 2022 dollars, and a linear regression of the price of a 10-pack of syringes was constructed to examine the determinants of syringe pricing. RESULTS: The average real price of a 10-pack of syringes across all states was $4.53 (SD = 0.99), with wide variability between pharmacies (max = $11.44, min = $1.70) and between states (mean OR = $5.76, WA = $4.74, MA = $4.33, NH = $4.30). Forty-seven percent (n = 72) of the purchases were taxed despite syringes being tax exempt in MA and WA, and not having a sales tax in NH or OR. The results of the regression suggest that certain needle gauges were associated with lower overall prices, while 1 pharmacy chain and 2 syringe brands were associated with higher overall prices. CONCLUSIONS: The high variability in syringe pricing presents another barrier to pharmacy-based syringe access since high prices may leave PWID no choice but to reuse or share needles, especially in areas with limited alternatives or without a syringe service program. Leadership from healthcare systems, pharmacy chains, and state and local policymakers is essential to reduce stigma and to implement policies that streamline syringe purchases, eliminate the taxation of exempt syringes in accordance with state laws, and reduce the variation in syringe prices.

Comparative Study of Sorption Phenomena Between Three Medications and Syringes Made of Cyclic Olefin Copolymer or Polypropylene.

INTRODUCTION: Medical syringes are widely used in hospitals to store and administer drugs, and the contact time between the drugs and these syringes can vary from a few minutes to several weeks like for pharmaceutical preparations. The aim of this comparative study was to evaluate the potential sorption phenomena occurring between three drugs (paracetamol, diazepam and insulin aspart) and polypropylene syringes (PP) or syringes made of Cyclic Olefin Copolymer (COC). MATERIALS AND METHODS: 50 mL 3-part syringes made of either COC with crosslinked silicone on the barrel inner surface (COC-CLS) and a bromobutyl plunger seal, or PP lubricated with silicone oil (PP-SOL) with a polyisoprene plunger seal were used. RESULTS: COC-CLS syringes induced less sorption of diazepam and insulin than PP-SOL syringes and the plunger seal material seemed to be the main cause of these interactions. An alkalinization of the medications in contact with the PP-SOL syringes was observed. It could be caused by leachable compounds and should be investigated further. CONCLUSION: This work shows once again that it is essential to consider content-container interactions to help improve the safe use of parenteral drugs.

Design of a Reciprocal Injection Device for Stability Studies of Parenteral Biological Drug Products.

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.

Comparative analysis of syringes versus pump devices in benchtop aspiration thrombectomy models: A systematic review and meta-analysis.

BACKGROUND: Although direct contact aspiration has emerged as one of the leading techniques for mechanical thrombectomy (MT), there is still ongoing debate about the aspiration/suction pump devices that can optimize recanalization rates. To address this gap, we conducted a meta-analysis comparing the aspiration efficacy of 60 ml syringe and pump devices in benchtop MT models. METHODS: Systematic literature review was conducted using Medline, Embase, Web of Science, and Scopus in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Outcomes of interest included flow rate and vacuum pressure delivered by a 60 ml syringe and several aspiration pumps. We used a random effects model to calculate the mean difference (MD) with 95% confidence intervals (CIs) and a statistically significant difference was considered as a two-sided p-value of less than 0.05. RESULTS: We included six benchtop studies comparing 60 ml syringes and vacuum pumps. Our meta-analysis showed that there were no significant differences in vacuum pressure (MD:0.71inHg, 95% CI: [-0.81;2.23], p = 0.359) and flow rate (MD:0.27 mL/s, 95% CI: [-3,07; 3.61], p = 0.873) between 60 ml syringes and vacuum pumps groups. CONCLUSIONS: Our study demonstrated comparable performance in terms of vacuum pressure and flow rates between a 60 ml syringe and a heterogeneous combination of commercially available aspiration pumps.

Pharmaceutical compounding and storage of faricimab in a syringe for intravitreal injection do not impair stability and bi-specific binding properties.

BACKGROUND: Intravitreal injection (IVI) of antibody biologics is a key treatment approach in ophthalmology. Pharmaceutical compounding and storage of prefilled syringes for IVI must take place without impairing the structure and function of the biologics. This study investigated the effect of withdrawing and storing the therapeutic antibody faricimab (Vabysmo, Roche, Basel, Switzerland) in the Zero Residual silicone oil-free, 0.2-mL syringe (SJJ Solutions, The Hague, the Netherlands). METHODS: To assess the effect of syringe withdrawal on faricimab, we compared samples from syringes prepared at day 0 with samples taken directly from faricimab vials. To assess the effect of syringe storage on faricimab, we kept prefilled syringes in the dark at 4 oC for 7, 14, or 37 days and compared samples from these syringes with day 0. We measured protein concentration (with spectrophotometry), stability and integrity (with sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), size-exclusion chromatography (SEC), and melting temperature (Tm)), as well as binding of faricimab to its cognate antigens: vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2) (with enzyme-linked immunosorbent assay (ELISA)). RESULTS: Faricimab migrated in line with its expected molecular mass under both reducing and non-reducing conditions for all time points when analyzed with SDS-PAGE, without any sign of degradation products or aggregation. The SEC elution profiles were identical for all time points. There were slight variations in Tm for different time points compared to day 0 but without consistent relationship with storage time. ELISA did not detect differences in VEGF-A or Ang-2 binding between time points, and faricimab did not bind the neonatal Fc receptor. CONCLUSIONS: Withdrawal and storage of faricimab in syringes for up to day 37 did not impair the structure and bi-specific binding properties of the therapeutic antibody.

Assessing the Clinical, Economic, and Health Resource Utilization Impacts of Prefilled Syringes Versus Conventional Medication Administration Methods: Results From a Systematic Literature Review.

OBJECTIVE: The objective of this systematic review was to assess the clinical, economic, and health resource utilization outcomes associated with the use of prefilled syringes in medication administration compared with traditional preparation methods. DATA SOURCES: We conducted a systematic literature review to evaluate outcomes such as medication errors, wastage, time savings, and contamination in prefilled syringes. Our search encompassed multiple databases, including PubMed and Embase, for studies published between January 1, 2017, and November 1, 2022. STUDY SELECTION AND DATA EXTRACTION: Peer-reviewed publications meeting our inclusion criteria underwent rigorous screening, including title, abstract, and full-text article assessments, performed by two reviewers. DATA SYNTHESIS: Among reviewed articles, 24 met our eligibility criteria. Selected studies were primarily observational (46%) and conducted in Europe (46%). Our findings indicated that prefilled syringes consistently reduced medication errors (by 10%-73%), adverse events (from 1.1 to 0.275 per 100 administrations), wastage (by up to 80% of drug), and preparation time (from 4.0 to 338.0 seconds) (ranges varied by drug type, setting, and dosage). However, there was limited data on contamination. Economically, prefilled syringes reduced waste and error rates, which may translate into overall savings. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This review highlights the value of prefilled syringes, which can streamline medication delivery, save nursing time, and reduce preventable medication errors. Moreover, prefilled syringes have the potential to minimize medication wastage, optimizing resource utilization and efficiency in health care settings. CONCLUSION AND RELEVANCE: Our findings provide new insights into clinical and economic benefits of prefilled syringe adoption. These benefits include improved medication delivery and safety, which can lead to time and cost reductions for health care departments, hospitals, and health systems. However, further real-world research on clinical and economic outcomes, especially in contamination, is needed to better understand the benefits of prefilled syringes.

Drug waste of ready-to-administer syringes in the intensive care unit: Aseptically prepared syringes versus prefilled sterilized syringes.

BACKGROUND: The availability of ready-to-administer (RTA) syringes for intravenous (IV) drugs facilitates rapid and safe administration in emergency and intensive care situations. Hospital pharmacies can prepare RTA syringes through aseptic batchwise filling. Due to excess production of these RTA syringes for sufficient availability for patient care and their limited (microbiological) shelf-life, waste is unavoidable, which contributes to environmental pollution. RTA prefilled sterilized syringes (PFSSs) have much longer shelf-lives than aseptically prepared RTA syringes and might contribute to reducing drug waste. AIM: This study aimed to evaluate the difference in drug waste between RTA syringes that were prepared through aseptic batchwise filling and RTA PFSSs in the Intensive Care Unit (ICU). METHODS: We measured drug waste of RTA syringes over an 8-year time period from August 2015 to May 2023 in the 32-bed ICU of the University Medical Center Utrecht. We distinguished between RTA syringes prepared through aseptic batchwise filling by our hospital pharmacy ("RTA aseptic syringes", shelf-life of 31 days) and RTA PFSSs (shelf-life of 18 months). An intervention group of three drug products that were replaced by PFSSs was compared to a control group of five drug products that were not replaced by PFSSs during the study period. We then defined four different periods within the total study period, based on quarantine time of the RTA aseptic syringes and time of PFSS introduction: 1) no quarantine, 2) 3-day quarantine, 3) 7-day quarantine and 4) PFSS introduction. Our primary endpoint was the number of RTA syringes that was wasted, expressed as the percentage of the total number of syringes dispensed to the ICU in each of these four periods. We used a Kruskall-Wallis test to test if waste percentages differed between time periods in the control and intervention groups, with a post-hoc Dunn's test for pairwise comparisons. Furthermore, we applied two interrupted time series (ITS) analyses to visualize and test the effect of introducing different quarantine times and the PFSSs on waste percentage. RESULTS: Introduction of PFSSs significantly decreased drug waste of RTA syringes irrespective of drug type in the intervention group, from 31% during the 7-day quarantine period to 5% after introduction of the PFSS (p<0.001). The control group showed no significant decrease in drug waste over the same time periods (from 20% to 16%; p=0.726). We observed a significant difference in the total drug waste of RTA aseptic syringes between time periods, which may be attributed to the implementation of different quality control quarantine procedures. The ITS model of the intervention group showed a direct decrease of 17.7% in waste percentage after the introduction of PFSSs (p=0.083). CONCLUSION: Drug waste of RTA syringes for the ICU can be significantly decreased by introducing PFSSs, supporting hospitals to enhance environmental sustainability. Furthermore, the waste percentage of RTA syringes prepared through aseptic batchwise filling is significantly impacted by duration of quarantine time.