A Framework for Outpatient Infusion of Antispike Monoclonal Antibodies to High-Risk Patients with Mild-to-Moderate Coronavirus Disease-19: The Mayo Clinic Model.

The administration of spike monoclonal antibody treatment to patients with mild to moderate COVID-19 is very challenging. This article summarizes essential components and processes in establishing an effective spike monoclonal antibody infusion program. Rapid identification of a dedicated physical infrastructure was essential to circumvent the logistical challenges of caring for infectious patients while maintaining compliance with regulations and ensuring the safety of our personnel and other patients. Our partnerships and collaborations among multiple different specialties and disciplines enabled contributions from personnel with specific expertise in medicine, nursing, pharmacy, infection prevention and control, electronic health record (EHR) informatics, compliance, legal, medical ethics, engineering, administration, and other critical areas. Clear communication and a culture in which all roles are welcomed at the planning and operational tables are critical to the rapid development and refinement needed to adapt and thrive in providing this time-sensitive beneficial therapy. Our partnerships with leaders and providers outside our institutions, including those who care for underserved populations, have promoted equity in the access of monoclonal antibodies in our regions. Strong support from institutional leadership facilitated expedited action when needed, from a physical, personnel, and system infrastructure standpoint. Our ongoing real-time assessment and monitoring of our clinical program allowed us to improve and optimize our processes to ensure that the needs of our patients with COVID-19 in the outpatient setting are met.

Home intravenous antibiotherapy and the proper use of elastomeric pumps: Systematic review of the literature and proposals for improved use.

Over several decades, the economic situation and consideration of patient quality of life have been responsible for increased outpatient treatment. It is in this context that outpatient antimicrobial treatment (OPAT) has rapidly developed. The availability of elastomeric infusion pumps has permitted prolonged or continuous antibiotic administration by dint of a mechanical device necessitating neither gravity nor a source of electricity. In numerous situations, its utilization optimizes administration of time-dependent antibiotics while freeing the patient from the constraints associated with infusion by gravity, volumetric pump or electrical syringe pump and, more often than not, limiting the number of nurse interventions to one or two a day. That much said, the installation of these pumps, which is not systematically justified, entails markedly increased OPAT costs and is liable to expose the patient to a risk of therapeutic failure or adverse effects due to the instability of the molecules utilized in a non-controlled environment, instability that necessitates close monitoring of their use. More precisely, a prescriber must take into consideration the stability parameters of each molecule (infusion duration, concentration following dilution, nature of the diluent and pump temperature). The objective of this work is to evaluate the different means of utilization of elastomeric infusion pumps in intravenous antibiotic administration outside of hospital. Following a review of the literature, we will present a tool for optimized antibiotic prescription, in a town setting by means of an infusion device.

Fabry disease during the COVID-19 pandemic. Why and how treatment should be continued.

Fabry disease is an X-linked disease due to a deficiency of the lysosomal enzyme alpha-galactosidase A. Clinical symptoms in classically affected males include acroparesthesia, anhydrosis and angiokeratoma, which may present during childhood followed by cardiac, cerebral and renal complications. Even though pulmonary involvement is not widely appreciated by clinicians, an obstructive lung disease is another recognized component of Fabry disease. Coronavirus Disease-19 (COVID-19), caused by the SARS-CoV-2 virus was labeled as a global pandemic and patients with Fabry disease can be considered at high risk of developing severe complications. The impact of COVID-19 on patients with Fabry disease receiving enzyme replacement therapy is still unknown. Many patients who receive treatment in the hospital experienced infusion disruptions due to fear of infection. Effects of temporary treatment interruption was described in more detail in other lysosomal storage diseases, but the recommencement of therapy does not fully reverse clinical decline due to the temporary discontinuation. When possible, home-therapy seems to be the most efficient way to maintain enzyme replacement therapy access during pandemic. Sentence take-home message: Home-therapy, when possible, seems to be the most efficient way to maintain enzyme replacement therapy access during pandemic in patients with Fabry disease.

Home infusion: Safe, clinically effective, patient preferred, and cost saving.

BACKGROUND: As the U.S. healthcare payment system shifts from volume to value, identifying care approaches that improve outcomes while lowering costs are essential. We sought to understand the utility of home infusion versus medical-setting infusion as a mechanism to affect the three-part aim: better care, better health outcomes, and lower costs. STUDY DESIGN: Systematic review. METHODS: We searched MEDLINE, EMBASE, and Science Citation Index for articles related to the safety, clinical effectiveness, quality of life and satisfaction, and/or costs of home infusion as compared with infusion in an outpatient medical facility or hospital. RESULTS: Of 253 potentially relevant articles, 13 met all inclusion criteria. Study design, disease state, and outcomes varied considerably. As compared to medical setting infusion patients, home infusion patients were no more likely to experience adverse drug events or side effects (all p>0.05). Clinical outcomes were as good or better, e.g., for patients with hemophilia, a 40% (0.50-0.70) reduced likelihood of hospitalization for bleeding complications. Patients overwhelmingly preferred home infusion, reporting significantly better physical and mental well being and less disruption of family and personal responsibilities. Home infusion costs were significantly lower than medical setting infusion costs, with savings between $1928 and $2974 per treatment course. CONCLUSIONS: Home infusion care can provide safe, clinically effective care improve patients' quality of life and reduce healthcare costs. As the overhaul of the healthcare payment system gains momentum, the home infusion care delivery model offers strong promise as one in a set of approaches that can improve care and lower costs.

Infusion therapy.

Essential facts Many patients admitted to hospital or receiving care in other settings, including their own homes, are recipients of one or more infusion therapies. Total parenteral nutrition, chemotherapy, parenteral antimicrobial therapy, pain relief and other infusion therapies are increasingly delivered in community settings. While the move away from hospital helps meet patients' lifestyles and clinical needs, it can have implications for patient care and safety.

The 2016 Infusion Therapy Standards of Practice.

Approximately every 5 years, the Infusion Nurses Society publishes evidence-based practice standards. This article provides an overview of the process used in standards development, describes the format of the standards, and provides a short summary of selected standards as applied to home care. The Standards are an important document that should be available to every home care organization that provides home infusion therapy.

A survey of patients with haemophilia to understand how they track product used at home.

Record keeping among individuals who manage haemophilia at home is an essential tool of communication between patient and Haemophilia Treatment Center (HTC). Complete records help HTCs monitor patients, their use of factor and ensure treatment is optimal. HTCs provide patients with a number of methods to track infusion practices. The study objectives were to: [1] determine the current methods of record keeping; [2] identify previous methods of record keeping; [3] understand the strengths and weaknesses associated with each method; and [4] gather suggestions for improvement. Survey methods were used to address the research objectives. Of the 83 patients in the Hamilton-Niagara region who received the survey distributed through the local HTC, 51 returned surveys were included into the analysis. Descriptive statistics were used. Results indicate individuals with haemophilia record infusion practices using: paper diaries, excel spreadsheets, hand-held PDAs and/or the online EZ-Log Web Client. The most popular method of record keeping was EZ-Log (45.1%) followed by paper diaries (35.2%). Advantages to using paper methods include the visual tracking of information and retaining hardcopies. The disadvantage was the inconvenience of physically submitting the records monthly. Advantages to using the online EZ-Log Web Client included ease of use and improved accuracy. The primary disadvantage was technical errors that were difficult to troubleshoot. Record keeping practices among individuals with haemophilia seem to vary according to personal preference and convenience. Respondents suggested that saving infusion history, incorporating barcode scanners or a copy and paste function could improve electronic methods.

The safety profile of home infusion of intravenous immunoglobulin in patients with neuroimmunologic disorders.

OBJECTIVES: To assess the overall safety of high-dose intravenous immunoglobulin (IG) products used to treat patients with neuroimmunological disorders in a supervised home-based setting. METHODS: The incidence of adverse reactions was assessed in a retrospective chart review of 420 patients who consecutively received 4076, home-based, individual, intravenous immunoglobulin (IVIG) infusions between January 2009 and December 2009. RESULTS: A total of 90 patients (21.4%) developed adverse reactions related to IVIG administration (2.6% per individual infusion). A total of 95.5% of adverse reactions were mild, and no serious side effects were observed. The incidence of adverse reactions was significantly lower in the subgroup of patients with neuroimmunological disorders who received premedication (18.2% compared with 29.3%, P = 0.02). There was no significant statistical difference in the incidence of side effects among the different brands of IVIG used in this study. CONCLUSIONS: The combination of premedication and well-defined clinical, IVIG infusion policies may reduce the incidence of high-dose IVIG adverse reactions administered in a home-based setting in patients with neuroimmunological disorders.

Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: a prospective clinical trial of emergency anticoagulation reversal.

Prothrombin complex concentrate (PCC) infusion is preferred for emergency reversal of coumarin therapy. Rapid infusion can potentially save crucial time; however, the possible impact of high infusion speed on PCC safety and effectiveness has not been delineated. In a prospective multinational clinical trial with 43 patients receiving PCC (Beriplex P/N) for emergency reversal of coumarin therapy, infusion speeds were selected by the investigators. In a two-phase statistical analysis, the influence of baseline patient variables and dose on selected infusion speed was assessed. Then, the effect of infusion speed on reduction in international normalized ratio (INR) and on thrombogenicity marker pharmacokinetics was evaluated. Infusion speed ranged widely from 2.0 to 40.0 mL min(-1) with a median of 7.5 mL min(-1). Selection of infusion speed was not significantly influenced by gender, age, body mass index, presence of acute bleeding, indication for coumarin therapy, baseline INR, or PCC dose. Infusion speed was higher by a median of 2.2 mL min(-1) (95% confidence interval, 1.0-4.3 mL min(-1)) among patients receiving Beriplex P/N volumes > or =80 mL compared with smaller infusion volumes. Infusion speed did not affect INR attained 30 min following PCC infusion. None of the evaluated thrombogenicity marker pharmacokinetic parameters was affected by infusion speed. Infusions in one patient with questionable hemostatic efficacy and another with a possibly PCC-related thromboembolic event were at moderate and slow speeds, respectively. This study provides the first direct evidence that Beriplex P/N can be rapidly infused for emergency coumarin therapy reversal without altering safety or effectiveness.

Stability of antineoplastic agents in use for home-based intravenous chemotherapy.

AIM OF THE REVIEW: The aim of this work was first to define which antineoplastic agents with sufficiently long stability could be eligible in the circuit of home-based therapy (centralised preparation, transport to the patient's home and administration by nurses) and, second, to propose a standardisation of the stability data of anticancer drugs in use for home hospitalisation. METHOD: A survey carried out in six hospital pharmacies of the Assistance Publique-Hôpitaux de Paris (AP-HP) hospitals, with important activity in oncology, listed the stability data used locally by each site. The final goal is to reach a consensus for the stability of cytotoxic drugs, which was the result of an original collaboration between the pharmacists of the compounding unit and the quality control unit. These results were compared to marketing authorisation data. RESULTS: The survey showed that eight antineoplastic agents of 34 were prepared under identical conditions (infusion diluent, concentration range, protection from light, temperature) by all hospitals (3 < or = n < or = 6): the stability was identical between each site for only two cytotoxic drug preparations (fotemustine and gemcitabine) and varied by up to 168 h or 7 days for the preparations of dacarbazine, epirubicine and cisplatin. Stability validated by pharmacists and those provided by marketing authorisation ranged respectively from "extemporaneously prepared" at 1,344 h (median = 168 h) to "extemporaneously prepared" at 720 h (median = 4 h). For 11 antineoplastic drugs, no information about the stability after compounding was specified in the marketing authorisation. Of all cytotoxic drugs used in the Hospital at Home of AP-HP, stability after compounding validated by pharmacists was less than 30 h for six of them, between 30 and 78 h for four and exceeding 78 h for the remaining 24. CONCLUSION: Considering the lack of data about cytotoxic drugs stability provided by the pharmaceutical companies and the difficulties in retrieving and interpreting the literature data, a consensus on the stability of cytotoxic drug preparations is essential for the current practice. With this approach, initiated for home hospitalisation, we propose in this study an initiative of the standardisation of stability data which offers a decision support for other centres.

Safety and efficacy of home intravenous antimicrobial infusion therapy in older patients: a comparative study with younger patients.

BACKGROUND: Home intravenous antimicrobial infusion therapy has proved its safety and efficacy in a great number of infections. Despite this there are few published studies about this way of managing in the elderly patient. OBJECTIVE: To study the safety and efficacy of home intravenous antimicrobial infusion therapy in elderly patients. STUDY DESIGN: A prospective and comparative study of an elderly group of patients > or =70 years old vs. a cohort of younger adult patients as a control group. All patients were followed until 3 months after discharge. SETTING: Hospital at Home Programme (HHP) as part of the Internal Medicine Department at Valle de Hebrón Hospital, Barcelona, Spain. PATIENTS: All patients admitted to HHP diagnosed of infections requiring intravenous antibiotic therapy between March 2006 and March 2007. RESULTS: We included 145 patients, 90 of whom were 70 years or older. Diabetes mellitus, heart failure and respiratory tract infection were more frequent in these elderly patients. In this group 14 (12%) developed some type of adverse event during treatment, phlebitis being the most common. The majority of those in the elderly patients group were discharged because of satisfactory clinical evolution and only 7 (7%) were re-admitted to hospital. Another 13 (14%) were re-admitted to hospital 3 months after discharge from HHP, mostly for chronic diseases. There were no significant differences between these results and those obtained from the control group. CONCLUSION: Home intravenous antimicrobial infusion therapy in elderly patients is safe and effective.

Integrating standards into practice. Revised standards for home care infusion: what has changed?

In 2006, the latest revision of the Infusion Nursing Standards of Practice was published by the Infusion Nurses Society. The Standards define the scope of practice and educational requirements for nurses who practice in infusion therapy in all healthcare settings. This article provides a description of the Standards, including a discussion of 12 Standards to illustrate their application in home care.

Home care versus hospital care in patients with multiple myeloma treated with pamidronate.

Long-term bisphosphonate therapy has been shown to offer clinical benefit in the management of multiple myeloma. This study sought to explore the feasibility and potential advantages of monthly home-based intravenous infusions of pamidronate in patients with multiple myeloma. In a prospective crossover, multicentre trial, 37 patients were randomly allocated to receive 3 months of treatment with pamidronate given in the home followed by 3 months of treatment with pamidronate given in hospital or vice versa. Results from a patient preference questionnaire indicated most patients preferred treatment at home. Quality-of-life measurement was undertaken using the EORTC QLQ-C30 questionnaire. The results indicated a small, generally consistent, although not statistically significant, trend in favour of home care treatment. Extra nursing specialist time was required for home therapy. Home therapy with pamidronate in patients with multiple myeloma appeared feasible and safe and was preferred by patients in this study.