Hepatic arterial infusion pump chemotherapy combined with systemic chemotherapy for borderline resectable and unresectable colorectal liver metastases: phase II feasibility study.

BACKGROUND: Hepatic arterial infusion pump chemotherapy combined with systemic chemotherapy (HAIP-SYS) for liver-only colorectal liver metastases (CRLMs) has shown promising results but has not been adopted worldwide. This study evaluated the feasibility of HAIP-SYS in the Netherlands. METHODS: This was a single-arm phase II study of patients with CRLMs who received HAIP-SYS consisting of floxuridine with concomitant systemic FOLFOX or FOLFIRI. Main inclusion and exclusion criteria were borderline resectable or unresectable liver-only metastases, suitable arterial anatomy and no previous local treatment. Patients underwent laparotomy for pump implantation and primary tumour resection if in situ. Primary end point was feasibility, defined as ≥70% of patients completing two cycles of HAIP-SYS. Sample size calculations led to 31 patients. Secondary outcomes included safety and tumour response. RESULTS: Thirty-one patients with median 13 CRLMs (i.q.r. 6-23) were included. Twenty-eight patients (90%) received two HAIP-SYS cycles. Three patients did not get two cycles due to extrahepatic disease at pump placement, definitive pathology of a recto-sigmoidal squamous cell carcinoma, and progressive disease. Five patients experienced grade 3 surgical or pump device-related complications (16%) and 11 patients experienced grade ≥3 chemotherapy toxicity (38%). At first radiological evaluation, disease control rate was 83% (24/29 patients) and hepatic disease control rate 93% (27/29 patients). At 6 months, 19 patients (66%) had experienced grade ≥3 chemotherapy toxicity and the disease control rate was 79%. CONCLUSION: HAIP-SYS for borderline resectable and unresectable CRLMs was feasible and safe in the Netherlands. This has led to a successive multicentre phase III randomized trial investigating oncological benefit (EUDRA-CT 2023-506194-35-00). Current trial registration number: clinicaltrials.gov (NCT04552093).

Implementation of Infusion Pumps and Filtered Administration Sets for Stem Cell Transplantation.

Stem cell infusion practices vary widely among institutions. A nurse-driven quality improvement project sought to determine whether peristaltic pumps and filtered tubing compromised the safety of stem cell infusion. A preclin.

Infusion pump innovation: Embracing change for patients and bottom lines.

Within the infusion delivery landscape, significant room exists for an improved experience with more intuitive and interoperable solutions. The majority of smart infusion pumps still rely on technology developed more than a decade ago. Many Canadian healthcare institutions regularly undergo a comprehensive re-evaluation of infusion fleets, to modernize infusion delivery for patients across the country. Amid the availability of new technologies with evidence demonstrating their ability to elevate the current standards of care, this article argues for the need for healthcare systems to prepare for, and embrace, change when it comes to new technologies. Clinical informatics consultant, Helen Edwards, delves into why new technologies are needed now more than ever. She shares her experience with the Ivenix Infusion System, capturing how it can help redefine clinical workflows, reduce costs across the entire healthcare continuum, and better support patient care. She also offers insights on how to effectively introduce new technologies and cultivate an environment that is likely to be open and adaptive to the change. As the Canadian healthcare landscape continues to evolve, the proactive adoption of new technologies will be a step towards advancing the outcomes for patients and the sustainability of Canadian healthcare infrastructures.

Flow Rate Deviation in Infusion Pump: Infusion Set Defect Enables Pump Malfunction and Considerable Accuracy Deviation.

Volumetric infusion pumps are used together with infusion sets to deliver medication to patients. Flow rate errors leading to overinfusion or underinfusion are known problems with these devices. Recently, numerous underinfusion flow rate errors were reported at a Swedish hospital. This experimental study reports on the investigation of these errors and specifically investigates the effect of operating the pump with a defective infusion set that has a visible elongation of the silicone segment of the set. Pump flow rate accuracy testing was performed using a gravimetric method. Experiments included a manipulated infusion set and a defective infusion set used in clinic. The use of a defective infusion set resulted in considerable accuracy deviations. The pump reported an infused amount greater than what was infused and did not provide any alarm or information indicating a reduced output. Using an elongated infusion set, the pump can be brought into an erroneous operating state where the infused amount delivered by the pump is considerably less than what has been programmed and what is shown on the pump display. This could put the patient at risk of not receiving the intended medication within the appropriate time.

Mapping Injection Order Messages to Health Level 7 Fast Healthcare Interoperability Resources to Collate Infusion Pump Data.

BACKGROUND: When administering an infusion to a patient, it is necessary to verify that the infusion pump settings are in accordance with the injection orders provided by the physician. However, the infusion rate entered into the infusion pump by the health care provider cannot be automatically reconciled with the injection order information entered into the electronic medical records (EMRs). This is because of the difficulty in linking the infusion rate entered into the infusion pump by the health care provider with the injection order information entered into the EMRs. OBJECTIVES: This study investigated a data linkage method for reconciling infusion pump settings with injection orders in the EMRs. METHODS: We devised and implemented a mechanism to convert injection order information into the Health Level 7 Fast Healthcare Interoperability Resources (FHIR), a new health information exchange standard, and match it with an infusion pump management system in a standard and simple manner using a REpresentational State Transfer (REST) application programming interface (API). The injection order information was extracted from Standardized Structured Medical Record Information Exchange version 2 International Organization for Standardization/technical specification 24289:2021 and was converted to the FHIR format using a commercially supplied FHIR conversion module and our own mapping definition. Data were also sent to the infusion pump management system using the REST Web API. RESULTS: Information necessary for injection implementation in hospital wards can be transferred to FHIR and linked. The infusion pump management system application screen allowed the confirmation that the two pieces of information matched, and it displayed an error message if they did not. CONCLUSION: Using FHIR, the data linkage between EMRs and infusion pump management systems can be smoothly implemented. We plan to develop a new mechanism that contributes to medical safety through the actual implementation and verification of this matching system.

Stability of meropenem in portable elastomeric infusion devices: which protocol should be implemented in clinical practice?

Meropenem has an excellent activity against gram-positive and gram-negative bacteria, including multi-resistant microorganisms. Even though meropenem is a great candidate for outpatient parenteral antimicrobial therapy (OPAT), its physicochemical stability is a major challenge. This work aimed to demonstrate the suitability of including meropenem in OPAT by elucidating its physicochemical stability in a range of commonly prescribed concentrations within portable elastomeric infusion devices. Physical and chemical stability were evaluated at two concentrations commonly used in clinical practice (2 and 25 mg/mL), and three temperatures (2°C-8°C, 25°C, and 32°C) using Accufuser portable elastomeric infusion devices. Drug adsorption onto portable elastomeric infusion devices was also determined at the end of the experiment. Meropenem stability significantly decreased at higher temperatures and when higher drug solution concentrations were used. Meropenem solutions at 2 mg/mL kept the drug content above 95% over 24 h at 2°C-8°C but just for 8 h at 25°C. Nevertheless, solutions containing 25 mg/mL of meropenem showed a dramatic decrease in chemical stability after 8 h 2°C-8°C and just after 4 h at 25°C or 32°C. However, physical stability was kept favorable during this period. The drug adsorption on the material of the elastomeric infusion device was below 1%, indicating the suitability of the chosen device. We propose several administration protocols for meropenem in portable elastomeric infusion devices in clinical practice, according to the results obtained in our study. The results obtained in this study open up the possibility of administering meropenem in an OPAT setting despite its short stability.IMPORTANCEAlthough outpatient parenteral antibiotic therapy can be a good approach to treating infections, a lack of data regarding antibiotic stability in portable elastomeric infusion devices restricts its safe and effective use. Actually, meropenem is used for prolonged periods above 24 h, and it is not physicochemically stable, which can compromise efficacy and toxicity. This work is of high importance to show the clinicians the real shelf life of meropenem when administered in portable elastomeric infusion devices. We propose several administration protocols for meropenem in portable elastomeric infusion devices in clinical practice, according to the stability drug results obtained in our study.

Evaluation of oncology infusion pharmacy practices: A nationwide survey.

PURPOSE: Oncology care continues to evolve at a rapid pace including provision of infusion-based care. There is currently a lack of robust metrics around oncology infusion centers and pharmacy practice. The workgroup completed a nationwide survey to learn about oncology-based infusion pharmacy services offered. The objective was to highlight consistent, measureable oncology-based infusion pharmacy metrics that will provide a foundation to describe overall productivity including emphasis on high patient-safety standards. METHODS: A nationwide survey was developed via a workgroup within the Vizient Pharmacy Cancer Care Group beginning in April 2019 and conducted electronically via the Vizient Pharmacy Network from September to November 2020. The survey was designed to capture a number of key metrics related to oncology-based infusion pharmacy services. RESULTS: Forty-one sites responded to the survey. Responses highlighted hours of operation (median = 11.5), number of infusion chairs (median = 45). Staffing metrics included 7.1 pharmacist full-time equivalent (FTE) and 7.6 technician FTE per week. 80.5% of sites had cleanrooms and 95.1% reported both hazardous and nonhazardous compounding hoods. 68.3% of sites reported using intravenous (IV) technology, 50.0% measured turnaround time, and 31.4% prepared treatment medications in advance. CONCLUSION: There was variability among oncology infusion pharmacy practices in regard to survey responses among sites. The survey results highlight the need for standardization of established productivity metrics across oncology infusion pharmacies in order to improve efficiency and contain costs in the changing oncology landscape. The survey provides insight into oncology infusion pharmacy practices nationwide and provides information for pharmacy leaders to help guide their practices.

Does circle priming improve smart infusion pump and electronic health record interoperability for chemotherapy in a pediatric hematology/oncology setting?

INTRODUCTION: The objective of this project was to assess the percentage of interoperability compliance within our pediatric hematology/oncology patient care areas for intravenous chemotherapy medications before and after the implementation of circle priming. METHODS: We conducted a retrospective quality improvement project at an inpatient pediatric hematology/oncology floor and outpatient pediatric infusion center before and after implementation of circle priming. RESULTS: There was a statistically significant increase in percent interoperability compliance for the inpatient pediatric hematology/oncology floor from 4.1% prior to implementation of circle priming to 35.6% after (odds ratio 13.1 (95% CI, 3.96-43.1), p < 0.001), as well as for the outpatient pediatric infusion center from 18.5% to 47.3%, respectively (odds ratio 3.9 (95% CI, 2.7-5.9), p < 0.001). CONCLUSION: Implementation of circle priming has significantly increased the percentage of interoperability compliance for intravenous chemotherapy medications in our pediatric hematology/oncology patient care areas.

Intravenous Medication Administration Safety with Smart Infusion Pumps in the Neonatal Intensive Care Unit: An Observational Study.

INTRODUCTION: Infants in the neonatal intensive care unit (NICU) are among the most vulnerable patient populations and medication errors are a significant source of risk and harm to neonates. Smart infusion pumps have been implemented to support the safe medication administration process; however, the effect of using smart infusion pumps on medication safety in the NICU is still unclear. METHODS: We conducted an observational study with a prospective point-prevalence approach to investigate intravenous (IV) medication administration errors in the NICU at one academic medical center in the USA. Observations were conducted in 48 days in a 3-month data collection period in 2019. RESULTS: We observed a total of 441 patients with 905 IV medication administrations during the data collection period. The total number of errors was 130 (14.4 per 100 administrations). Of these, the most frequent errors were selecting the wrong drug library entry (5.3 per 100 administrations), unauthorized medication (0.7 per 100 administrations), and wrong dose (0.6 per 100 administrations). Sixty-eight errors (7.5 per 100 administrations) were unlikely to cause harm despite reaching the patient (category C errors), while the rest did not reach the patient. CONCLUSION: We identified the medication errors, which was unique to NICU populations, but no harm to the patients were identified. Most errors occurred due to a lack of compliance of using smart pump technology; therefore, potential exists to maximize safety related to medication administration practices in the NICU through hospital policy change and increasing adherence to appropriate use of smart pump technology.

The effect of patient's body weight, infusion connection point, and infusion pump position on intravenous multi-infusion drug delivery at low infusion rates suitable for premature neonates.

INTRODUCTION: Parenteral drug administration in the neonatal intensive care involves complex pharmacotherapy adjusted for the patient's weight, fluid allowance, and complex multi-infusion systems. OBJECTIVES: We investigated the delivery rate of a model drug through a multi-infusion system consisting of six intravenous infusions. METHODS: Delivery rate of the model drug was determined after infusion initiation and termination. Measurements were collected spectrophotometrically in real time. Time to drug delivery and the amount of drug delivered were measured. KEY FINDINGS: The longest time to drug delivery was observed for a 500 g neonate model with a distal infusion connection point and neutral pump position (337 ± 30 min, P < 0.001). The shortest time was observed for a 1000 g neonate model in the combination of proximal infusion connection point and neutral pump position (18 ± 12 min, P < 0.05). The expected 100% of the drug was delivered only in two combinations: 500 g and 1000 g neonate models, proximal infusion connection point and neutral pump position (100.4 ± 4.7%, P = 0.819 and 100.2 ± 2.7%, P = 0.874, respectively). While the least drug was delivered to a 500 g neonate model in the combination of distal infusion connection point and neutral pump position (27.5 ± 5.8%, P < 0.001). CONCLUSIONS: Delayed drug delivery to premature neonates due to multi-infusion systems may compromise accurate drug administration and lead to dosing errors.

Implementation of a national system for best practice delivery of paediatric infusions.

BACKGROUND: Standard concentration infusions and 'smart-pumps' are recognised as best practice in the paediatric setting. Implementation rates in European hospitals remain low. Children's Health Ireland (CHI) developed a paediatric 'smart-pump' drug library using standardised concentrations. At time of development, other Irish hospitals continued to use traditional pumps and weight-based paediatric infusions. AIM: To expand best paediatric infusion practices by nationalising use of the CHI drug library. SETTING: Tertiary paediatric, maternity and general acute hospitals, and associated transport services in Ireland. DEVELOPMENT: The CHI drug library was first developed for paediatric intensive care and then adapted over a 10-year period for use in emergency departments, general paediatric wards, neonatal units, adult intensive care and transport services. The original library (42 drug lines, 1 'care-unit') was substantially expanded (223 drug lines, 6 'care-units'). A neonatal sub-library was created. IMPLEMENTATION: Executive support, dedicated resources and governance structures were secured. Implementation and training packages were developed. Implementation has occurred across CHI, in paediatric and neonatal transport services, 58% (n = 11) of neonatal units, and 23% (n = 6) of paediatric sites. EVALUATION: A before and after study demonstrated significant reductions in infusion prescribing errors (29.0% versus 8.4%, p < 0.001). Direct observation of infusions (n = 1023) found high compliance rates (98.9%) and low programming errors (1.6%). 100% of nurses (n = 132) surveyed 9 months after general ward implementation considered the drug library had enhanced patient safety. CONCLUSION: Strategic planning and collaboration can standardise infusion practices. The CHI drug library has been approved as a National Standard of Care, with implementation continuing.

Evaluation of the venting principle to reduce start-up delays in syringe infusion pumps used for microinfusions.

Start-up delays of syringe pump assemblies can impede the timely commencement of an effective drug therapy when using microinfusions in hemodynamically unstable patients. The application of the venting principle has been proposed to eliminate start-up delays in syringe pump assemblies. However, effectively delivered infusion volumes using this strategy have so far not been measured. This invitro study used two experimental setups to measure the effect of the venting principle compared to a standard non-venting approach on delivered start-up infusion volumes at various timepoints, backflow volumes, flow inversion and zero drug delivery times by means of liquid flow measurements at flow rates of 0.5, 1.0 and 2.0 mL/h. Measured delivered initial start-up volumes were negative with all flow rates in the vented and non-vented setup. Maximum backflow volumes were 1.8 [95% CI 1.6 to 2.3] times larger in the vented setup compared to the non-vented setup (p < 0.0001). Conversely, times until flow inversion were 1.5 [95% CI 1.1 to 2.9] times shorter in the vented setup (p < 0.002). This led to comparable zero drug delivery times between the two setups (p = 0.294). Start-up times as defined by the achievement of at least 90% of steady state flow rate were achieved faster with the vented setup (p < 0.0001), but this was counteracted by the increased backflow volumes. The application of the venting principle to the start-up of microinfusions does not improve the timely delivery of drugs to the patient since the faster start-up times are counteracted by higher backflow volumes when opening the three-way stopcock.

A novel, small-volume subcutaneous furosemide formulation delivered by an abdominal patch infusor device in patients with heart failure: results of two phase I studies.

AIMS: Subcutaneous (SC) furosemide has potential advantages over intravenous (IV) furosemide by enabling self-administration or administration by a lay caregiver, such as facilitating early discharge, preventing hospitalizations, and in palliative care. A high-concentration, pH-neutral furosemide formulation has been developed for SC administration via a small patch infusor pump. We aimed to compare the bioavailability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of a new SC furosemide formulation with conventional IV furosemide and describe the first use of a bespoke mini-pump to administer this formulation. METHODS AND RESULTS: A novel pH-neutral formulation of SC furosemide containing 80 mg furosemide in ∼2.7 mL (infused over 5 h) was investigated. The first study was a PK/PD study of SC furosemide compared with 80 mg IV furosemide administered as a bolus in ambulatory patients with heart failure (HF). The primary outcome was absolute bioavailability of SC compared with IV furosemide. The second study investigated the same SC furosemide preparation delivered by a patch infusor in patients hospitalized with HF. Primary outcome measures were treatment-emergent adverse events, infusion site pain, device performance, and PK measurements.The absolute bioavailability of SC furosemide in comparison to IV furosemide was 112%, resulting in equivalent diuresis and natriuresis. When SC furosemide was administered via the patch pump, there were no treatment-emergent adverse events and 95% of participants reported no/minor discomfort at the infusion site. CONCLUSION: The novel preparation of SC furosemide had similar bioavailability to IV furosemide. Administration via a patch pump was feasible and well tolerated.

Data-based program management of system-wide IV smart pump integration.

PURPOSE: Smart pump bidirectional interoperability offers automated infusion programming and documentation that can improve patient safety and workflow efficiency. This technology has been poorly implemented across US hospitals, and there is little guidance on the tracking or monitoring of interoperability systems. The purpose of this report is to describe the successful implementation of intravenous (IV) smart pump interoperability in a large health system. SUMMARY: Bidirectional IV smart pump interoperability and compliance monitoring were implemented across a large Midwestern health system using ICU Medical's Plum 360 and LifeCare PCA devices and Smith Medical's MedFusion 4000 Syringe Pump devices. The hospital system's experience in implementing and monitoring IV smart pump compliance using automated reports and a dedicated medication safety integration nurse is described. Compliance trends suggest that the implementation of IV smart pump interoperability has achieved a reduction in programming outside of the dose error reduction system, manual overrides, and IV medication administration error rates. CONCLUSION: The monitoring of smart pump compliance has had demonstrated benefits in investigating usability concerns, recognizing system errors, and identifying increased needs for nurse training. This program can serve as an example for other healthcare systems adopting IV smart pump interoperability.

Stability of meropenem in portable elastomeric infusion devices: which protocol should be implemented in clinical practice?

IMPORTANCE: Although outpatient parenteral antibiotic therapy can be a good approach to treating infections, a lack of data regarding antibiotic stability in portable elastomeric infusion devices restricts its safe and effective use. Actually, meropenem is used for prolonged periods above 24 h, and it is not physicochemically stable, which can compromise efficacy and toxicity. This work is of high importance to show the clinicians the real shelf life of meropenem when administered in portable elastomeric infusion devices. We propose several administration protocols for meropenem in portable elastomeric infusion devices in clinical practice, according to the stability drug results obtained in our study.

Gemcitabine with Cisplatin Versus Hepatic Arterial Infusion Pump Chemotherapy for Liver-Confined Unresectable Intrahepatic Cholangiocarcinoma.

BACKGROUND: A post-hoc analysis of ABC trials included 34 patients with liver-confined unresectable intrahepatic cholangiocarcinoma (iCCA) who received systemic chemotherapy with gemcitabine and cisplatin (gem-cis). The median overall survival (OS) was 16.7 months and the 3-year OS was 2.8%. The aim of this study was to compare patients treated with systemic gem-cis versus hepatic arterial infusion pump (HAIP) chemotherapy for liver-confined unresectable iCCA. METHODS: We retrospectively collected consecutive patients with liver-confined unresectable iCCA who received gem-cis in two centers in the Netherlands to compare with consecutive patients who received HAIP chemotherapy with or without systemic chemotherapy in Memorial Sloan Kettering Cancer Center. RESULTS: In total, 268 patients with liver-confined unresectable iCCA were included; 76 received gem-cis and 192 received HAIP chemotherapy. In the gem-cis group 42 patients (55.3%) had multifocal disease compared with 141 patients (73.4%) in the HAIP group (p = 0.023). Median OS for gem-cis was 11.8 months versus 27.7 months for HAIP chemotherapy (p < 0.001). OS at 3 years was 3.5% (95% confidence interval [CI] 0.0-13.6%) in the gem-cis group versus 34.3% (95% CI 28.1-41.8%) in the HAIP chemotherapy group. After adjusting for male gender, performance status, baseline hepatobiliary disease, and multifocal disease, the hazard ratio (HR) for HAIP chemotherapy was 0.27 (95% CI 0.19-0.39). CONCLUSIONS: This study confirmed the results from the ABC trials that survival beyond 3 years is rare for patients with liver-confined unresectable iCCA treated with palliative gem-cis alone. With HAIP chemotherapy, one in three patients was alive at 3 years.

Imaging of the hepatic arterial infusion pump: Primer for radiologists.

Hepatic arterial infusion (HAI) pumps are used to deliver liver-directed therapy by allowing the administration of selective chemotherapy to the liver via a catheter implanted most commonly into the gastroduodenal artery connected to a subcutaneous pump. This selective administration helps maximize the chemotherapeutic effect within the hepatic tumors while minimizing systemic toxicity. While HAI therapy has primarily been used to treat liver-only metastatic colorectal cancer, the indications have expanded to other malignancies, including intrahepatic cholangiocarcinoma. Radiologists play an important role in pre-operative planning, assessment of treatment response, and evaluation for potential complications using various imaging studies, including computed tomography angiography, magnetic resonance imaging, and perfusion scintigraphy. This article describes the radiologist's role as part of a multi-disciplinary oncology team to help maximize the success of HAI therapy and also helps radiologists familiarize themselves with various aspects of HAI pumps.