Allergic contact dermatitis caused by isobornyl acrylate in the Enlite glucose sensor and the Paradigm MiniMed Quick-set insulin infusion set.

BACKGROUND: The FreeStyle Libre glucose sensor has caused many cases of allergic contact dermatitis, and isobornyl acrylate (IBOA) in this sensor has been identified as one of the culprit allergens. OBJECTIVES: To report on the presence of IBOA in devices produced by Medtronic, namely, the Enlite sensor and the insulin infusion set Paradigm MiniMed Quick-set. PATIENTS AND METHODS: Five patients reacting to the glucose sensor Enlite and/or the insulin infusion set Paradigm MiniMed Quick-set observed in three clinics (two Belgian and one Swedish) were patch tested with the baseline and other series, as well as with IBOA; four of them also with pieces of adhesive patches from the devices, and two with a thin layer chromatogram of Enlite glucose sensor extracts. Gas chromatography-mass spectrometry (GC-MS) analyses were performed. RESULTS: Four patients reacted to IBOA and one to colophonium, a known allergen in Enlite, and three to the adhesive part of the sensor or the insulin infusion set. IBOA was identified in the sensor by GC-MS, and its presence was indicated in the infusion set. CONCLUSIONS: IBOA is a contact allergen in Enlite glucose sensor, and likely also in the infusion set. Therefore, these devices are not suitable alternatives for patients sensitized to the FreeStyle Libre sensor.

A Retrospective Analysis of the Safety Profile of Intravenous Immunoglobulin in 1176 Patients Receiving Home Infusion Therapy.

OBJECTIVES: This analysis assessed the safety of intravenous immunoglobulin (IVIg) in the treatment of patients with neuroimmunological and immunological disorders in a home-based setting. METHODS: Adverse reactions (ARs) were assessed in a retrospective review of 1176 patients receiving 28,677 home-based IVIg infusions between 1996 and 2013. RESULTS: Of 1176 patients, 648 (55.1%) experienced IVIg-related ARs; 536 (45.6%) were mild, 78 (6.6%) moderate, and 34 (2.9%) severe. Thirty-seven (3.1%) patients were hospitalized because of ARs; of these, headache was most common (51.4%). Mean number of ARs per patient increased from 1.4 (low dose) to 3.6 (high dose). Incidence of ARs increased from 41% in the first 5-year moving average in 2003 to 65% in 2008. The number of ARs correlated with the number of infusions (ρ = 0.24; P < 0.001) and the average IVIg dose (ρ = 0.10; P < 0.001). CONCLUSIONS: Low- and high-dose IVIg were safe and well tolerated with a few serious ARs in patients with neuroimmunological and immunological disorders.

Incidence and risk factors for healthcare utilisation among patients discharged on outpatient parenteral antimicrobial therapy.

Outpatient parenteral antimicrobial therapy (OPAT) programmes facilitate hospital discharge, but patients remain at risk of complications and consequent healthcare utilisation (HCU). Here we elucidated the incidence of and risk factors associated with HCU in OPAT patients. This was a retrospective, single-centre, case-control study of adult patients discharged on OPAT. Cases (n = 63) and controls (n = 126) were patients that did or did not utilise the healthcare system within 60 days. Characteristics associated with HCU in bivariate analysis (P ≤ 0.2) were included in a multivariable logistic regression model. Variables were retained in the final model if they were independently (P < 0.05) associated with 60-day HCU. Among all study patients, the mean age was 55 ± 16, 65% were men, and wound infection (22%) and cellulitis (14%) were common diagnoses. The cumulative incidence of 60-day unplanned HCU was 27% with a disproportionately higher incidence in the first 30 days (21%). A statin at discharge (adjusted odds ratios (aOR) 0.23, 95% confidence intervals (CIs) 0.09-0.57), number of prior admissions in past 12 months (aOR 1.48, 95% CIs 1.05-2.10), and a sepsis diagnosis (aOR 4.62, 95% CIs 1.23-17.3) were independently associated with HCU. HCU was most commonly due to non-infection related complications (44%) and worsening primary infection (31%). There are multiple risk factors for HCU in OPAT patients, and formal OPAT clinics may help to risk stratify and target the highest risk groups.

Clinical efficacy, cost analysis and patient acceptability of outpatient parenteral antibiotic therapy (OPAT): a decade of Sheffield (UK) OPAT service.

Outpatient parenteral antimicrobial therapy (OPAT) has evolved relatively slowly in the UK. This study describes the OPAT service based in a large UK teaching hospital in Sheffield, and examines the clinical efficacy, patient acceptability and costs saved over a 10-year period. Data on 3812 episodes of OPAT administered between January 2006 and January 2016 were retrieved from a prospectively maintained electronic database. This study compared the real costs of the OPAT service with estimated costs of conventional inpatient care for these patient episodes, and analysed patient feedback questionnaires that were administered randomly between January 2014 and January 2015. A wide range of infections were managed during the 10-year period. Skin and soft tissue infections accounted for 57% of OPAT episodes. The total number of bed-days saved was 49,854. A successful outcome (cure or improvement) was found in 3357 (88%) episodes. Re-admission occurred in 265 (7%) episodes. The rates of healthcare-associated infections were low: 15 intravenous-line-related infections were recorded (0.3 per 1000 OPAT patient-days). Patient acceptance and satisfaction with OPAT were high. OPAT cost 15%, 39%, 40% and 44% of inpatient costs for an infectious diseases unit, national average costs, other departments (non-infectious diseases unit), and the minimum national average costs for each diagnostic category, respectively. This study shows that OPAT is safe, clinically efficacious and acceptable for treating a wide range of infections with high levels of patient satisfaction and substantial cost savings.

Infusion therapy.

Essential facts [Figure: see text] 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.

Environmental Exposures and the Risk of Central Venous Catheter Complications and Readmissions in Home Infusion Therapy Patients.

BACKGROUND Patients are frequently discharged with central venous catheters (CVCs) for home infusion therapy. OBJECTIVE To study a prospective cohort of patients receiving home infusion therapy to identify environmental and other risk factors for complications. DESIGN Prospective cohort study between March and December 2015. SETTING Home infusion therapy after discharge from academic medical centers. PARTICIPANTS Of 368 eligible patients discharged from 2 academic hospitals to home with peripherally inserted central catheters and tunneled CVCs, 222 consented. Patients remained in the study until 30 days after CVC removal. METHODS Patients underwent chart abstraction and monthly telephone surveys while the CVC was in place, focusing on complications and environmental exposures. Multivariable analyses estimated adjusted odds ratios and adjusted incident rate ratios between clinical, demographic, and environmental risk factors and 30-day readmissions or CVC complications. RESULTS Of 222 patients, total parenteral nutrition was associated with increased 30-day readmissions (adjusted odds ratio, 4.80 [95% CI, 1.51-15.21) and CVC complications (adjusted odds ratio, 2.41 [95% CI, 1.09-5.33]). Exposure to soil through gardening or yard work was associated with a decreased likelihood of readmissions (adjusted odds ratio, 0.09 [95% CI, 0.01-0.74]). Other environmental exposures were not associated with CVC complications. CONCLUSIONS complications and readmissions were common and associated with the use of total parenteral nutrition. Common environmental exposures (well water, cooking with raw meat, or pets) did not increase the rate of CVC complications, whereas soil exposures were associated with decreased readmissions. Interventions to decrease home CVC complications should focus on total parenteral nutrition patients. Infect Control Hosp Epidemiol 2016;1-8.

Vascular access complications during outpatient parenteral antimicrobial therapy at home: a retrospective cohort study.

OBJECTIVES: The need for indwelling vascular access for outpatient parenteral antimicrobial therapy (OPAT) places patients at risk of vascular access complications. The purpose of this study was to describe vascular access complications during OPAT at home, and identify factors associated with their occurrence. METHODS: All OPAT courses carried out at home for patients at Cleveland Clinic in 2013 were identified from the institution's OPAT registry. The first OPAT course per patient was included. Vascular access complications that occurred during the treatment course were abstracted from the electronic medical record. Only complications that triggered a clinical intervention were included. RESULTS: The 1461 included OPAT courses encompassed 33,579 OPAT days of treatment. One-hundred-and-forty-four vascular access complications occurred in 131 OPAT courses (9% of OPAT courses, 4.29 complications per 1000 OPAT days). The most common complication was occlusion (53% of all complications). Hickman catheters [incidence rate ratio (IRR) 0.20, 95% CI 0.03-0.63] and indwelling ports (IRR 0.25, 95% CI 0.04-0.78) were associated with lower complication rates than peripherally inserted central catheters, as was increasing age (IRR 0.99, 95% CI 0.98-1.00). Log OPAT duration (IRR 1.60, 95% CI 1.28-2.03), female sex (IRR 1.62, 95% CI 1.16-2.28) and injection drug use (IRR 3.32, 1.16-7.46) were associated with increased risk of vascular access complications. CONCLUSIONS: Nine percent of OPAT courses at home have at least one vascular access complication requiring clinical intervention. Longer OPAT duration, younger age, female sex and injection drug use are associated with increased risk of vascular access complications.

13,845 home therapy infusions with velaglucerase alfa exemplify safety of velaglucerase alfa and increased compliance to every-other-week intravenous enzyme replacement therapy for Gaucher disease.

BACKGROUND: Lifelong intravenous (IV) enzyme replacement therapy (ERT) every other week for Gaucher disease is appreciated as decreasing quality of life in a palpable way. OBJECTIVE: To review the Israeli experience with the home therapy option for IV velaglucerase alfa (Shire, Lexington MA USA) infusions every-other-week in the clinical trial context, in the early access program (EAP) during a shortage with the standard commercial ERT, and currently with the commercially available drug (VPRIV, Shire). RESULTS: Among 24 patients participating in trials, 1654 infusions were at home; in the EAP and commercial setting, 12,191 infusions were performed at home for a total of 154 patients with 98.4% compliance. There were no incidents of serious adverse events. CONCLUSION: This is the first review of experience of 174 patients and 13,845 intravenous infusions of velaglucerase alfa for Gaucher in the home setting, underscoring its safety.

Outpatient parenteral antimicrobial therapy (OPAT) in patients with cystic fibrosis.

BACKGROUND: To determine complications during outpatient parenteral antimicrobial therapy (OPAT) administrated through a peripheral venous line, PICC-line or PORT-A-CATH (PAC). METHODS: Catheter related complications in patients with cystic fibrosis during OPAT were identified through a retrospective review of patient files supplemented by an interview. RESULTS: In 64 treatment episodes with a peripheral venous line, 51 (79.7 %) used bolus injection and 13 (20.3 %) used infusion pump. 27 out of 51 (53.0 %) bolus injection episodes experienced complications, which required removal. None were observed for infusion pump treatments. The infectious complications requiring removal of peripheral venous line were 9 out of 23 (39.1 %) for the PICC line and 11 out of 26 (42.3 %) for the PAC. No anaphylaxis was observed during the OPAT treatments. CONCLUSIONS: Our data indicate that using an infusion pump to administer the antibiotic treatment minimized peripheral venous line complications. The frequency of complications leading to removal of the catheter is about the same for PICC-lines and PACs, but the average life-time of the latter is much longer. Allergic reactions are not a major problem.

A nurse-led accelerated procedure for infliximab infusion is well tolerated and effective in patients with inflammatory bowel disease.

BACKGROUND: Shorter infusions of infliximab for inflammatory bowel disease seem to be as tolerated as standard procedures and nurses may be able to manage them safely. AIMS: To test tolerability and effectiveness of a fast nurse-led infusion procedure and the related patients' satisfaction. METHODS: We retrospectively compared three different regimens adopted in our outpatient infusion unit from 2010 to 2013: Group 1, a standard procedure with two-hour infusions, preceded by hydrocortisone medication (87 patients, 311 infusions); Group 2, a similar regimen without physician supervision (130 patients, 464 infusions); Group 3, a one-hour nurse-led procedure without routine premedication (176 patients, 1356 infusions). Disease characteristics, infusion reactions, infusions per month and patients' satisfaction were recorded. RESULTS: There were significantly fewer infusion reactions in Group 3 than Group 1 (2.2% versus 5.8% respectively; p=0.001). The only significant risk factor for side effects was premedication (odds ratio 4.71, 95% confidence interval 2.21-10.02, p<0.001) which was related to the presence of previous side effects. Number of infusions per month increased by 27% (83 versus 61, p<0.001) without increasing nurses' workload and patients were satisfied. CONCLUSIONS: Our fast nurse-led procedure was well tolerated, effective and satisfactory for patients.

Catheter salvage in home infusion patients with central line-associated bloodstream infection.

In a retrospective study of home infusion patients with central line-associated bloodstream infection, use of a central venous port, cancer diagnosis, and absence of systemic inflammatory response syndrome were associated with use of catheter salvage. Relapse of infection was uncommon.

The prevalence of infections and patient risk factors in home health care: a systematic review.

BACKGROUND: Home health care (HHC) has been the fastest growing health care sector for the past 3 decades. The uncontrolled home environment, increased use of indwelling devices, and the complexity of illnesses among HHC patients lead to increased risk for infections. METHODS: A systematic review of studies evaluating infection prevalence and risk factors among adult patients who received HHC services was conducted and guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Literature was searched using Medline, PubMed, and the Cumulative Index to Nursing and Allied Health as well as hand searching. Two reviewers independently assessed study quality using validated quality assessment checklists. RESULTS: Twenty-five studies met the inclusion criteria and were reviewed. The infection rates and identified risk factors for infections varied dramatically between studies. In general, patients receiving home parental nutrition treatments had higher infection rates than patients receiving home infusion therapy. The identified risk factors were limited by small sample sizes and other methodologic flaws. CONCLUSIONS: Establishing a surveillance system for HHC infections, identifying patients at high risk for infections, tailoring HHC and patient education based on patient living conditions, and facilitating communication between different health care facilities will enhance infection control in HHC settings. Future studies should use a nationally representative sample and multivariate analysis for the identification of risk factors for infections.

Adverse events, healthcare interventions and healthcare utilization during home infusion therapy with daptomycin and vancomycin: a propensity score-matched cohort study.

OBJECTIVES: Vancomycin and daptomycin are the two most frequently prescribed parenteral antimicrobials for resistant Gram-positive bacterial infections. The purpose of this study was to compare antimicrobial adverse event rates and associated healthcare interventions and healthcare utilization in patients treated with the two antimicrobials. METHODS: All patients aged ≥18 years, discharged home from Cleveland Clinic on outpatient parenteral antimicrobial therapy (OPAT) with daptomycin or vancomycin between 1 July 2007 and 30 June 2010 were screened. Logistic regression models were built to calculate propensity to be treated with daptomycin for each patient. Propensity score-matched vancomycin-treated controls were identified for each daptomycin-treated patient. Adverse event, healthcare intervention and healthcare utilization rates during OPAT were compared in the matched cohort using negative binomial regression models. RESULTS: One thousand, two hundred and eighty-eight patients were identified. Three-to-one matching provided the best matching characteristics and identified 119 daptomycin-treated subjects (2518 OPAT days) and 357 vancomycin-treated controls (6649 OPAT days). The mean patient age was 56 years and the mean OPAT duration was 19 days. Antimicrobial adverse event rates for the daptomycin and vancomycin groups were 3.2 and 7.7 per 1000 OPAT days, respectively [relative risk (RR) 0.38; 95% CI 0.15-0.86; P = 0.02]. Antimicrobial intervention rates were 5.6 and 27.1 per 1000 OPAT days, respectively (RR 0.21; 95% CI 0.11-0.36; P < 0.001). Readmissions for worsening infection or treatment complication were not significantly different between daptomycin (5%) and vancomycin (7%). CONCLUSIONS: Patients receiving daptomycin at home have 60% fewer antimicrobial adverse events and require 80% fewer antimicrobial interventions than similar patients receiving vancomycin.

Clinical outcomes of a veterans affairs outpatient antimicrobial treatment program.

OBJECTIVES: The outpatient parenteral antibiotic therapy (OPAT) program of the Portland Veterans Affairs Medical Center (PVAMC), which has a self-administration model, is staffed by visiting nurses from a specialist infusion company. This study evaluates the clinical outcomes of these patients. METHODS: This study was a retrospective chart review of 262 patients at PVAMC who had received OPAT between 2007 and 2009. Patients were included only if they received ongoing care at PVAMC. The data collected included conditions and organisms being treated and types and durations of antibiotics used. Clinical cure was defined as documented cure at the end of treatment and 90 days post-OPAT. RESULTS: One hundred ninety patients of 262 were analyzed. The mean age was 63.2 years. Diabetes was the main comorbid factor (17%). The most common indications for OPAT were osteomyelitis (38%), urinary tract infection (23%), and skin and soft tissue infection (12.6%). Mixed bacterial culture (26%) and Staphylococcus aureus (31%) were the most common organisms treated. Vancomycin was the most frequently used antibiotic (26%) followed by ceftriaxone (12%). The median duration of OPAT was 30 days. The rate of clinical cure at end of treatment observed for all infections treated was 78%, which then decreased to 58% at 90 days post-OPAT (P < 0.001). Patients with diabetes and osteomyelitis had an increased risk of relapse at 90 days post-OPAT on multivariate analysis (P = 0.025). CONCLUSIONS: An OPAT program using a self-administration model treating patients who were military veterans had successful outcomes. Patients with diabetes and osteomyelitis had worse clinical outcomes 90 days after the completion of OPAT therapy.

Home infusion program for Fabry disease: experience with agalsidase alfa in Argentina / Programa de infusión domiciliaria para la enfermedad de Fabry: experiencia con agalsidasa alfa en la Argentina

Fabry disease is an X-linked lysosomal storage disorder caused by inherited deficiency of the enzyme α-galactosidase A. Enzyme replacement treatment using agalsidase alfa significantly reduces pain, improves cardiac function and quality of life, and slows renal deterioration. Nevertheless, it is a life-long treatment which requires regular intravenous infusions and entails a great burden for patients. Our objective was to evaluate retrospectively the safety and tolerability of the home infusion of agalsidase alfa in patients with Fabry disease in Argentina. We evaluated all the patients with Fabry disease who received home infusion with agalsidase alfa 0.2 mg/kg between January 2005 and June 2011. The program included 87 patients; 51 males (mean age: 30 years) and 36 females (mean age: 34 years). A total of 5229 infusions (mean: 59 per patient; range: 1-150) were administered. A total of 5 adverse reactions were seen in 5 patients (5.7% of patients and 0.9% of the total number of infusions). All were mild in severity and resolved by reducing the rate of infusion and by using antihistaminics. All these 5 patients were positive for IgG antibodies, but none of them presented IgE antibodies and none suffered an anaphylactic shock. In our group 18 patients were switched from agalsidase beta to agalsidase alfa without complications. Home infusion with agalsidase alfa is safe, well tolerated and is associated to high compliance.

La enfermedad de Fabry es un trastorno de almacenamiento lisosomal hereditario ligado al cromosoma X ocasionado por el déficit de la enzima alfa galactosidasa A. La terapia de reemplazo enzimático utilizando agalsidasa alfa reduce significativamente el dolor, mejora la función cardíaca y la calidad de vida y enlentece el deterioro renal. Sin embargo, es un tratamiento de por vida que requiere infusiones intravenosas regulares y supone una gran carga para los pacientes. Nuestro objetivo fue evaluar retrospectivamente la tolerabilidad y la seguridad del procedimiento de infusión domiciliaria de agalsidasa alfa en pacientes con enfermedad de Fabry en Argentina. Evaluamos a todos los pacientes con enfermedad de Fabry que recibieron infusiones domiciliarias de 0.2 mg/kg de agalsidasa alfa entre enero del 2005 y junio del 2011. El programa incluyó 87 pacientes; 51 hombres (edad media: 30 años) y 36 mujeres (edad media: 34 años). Se administraron un total de 5229 infusiones (media: 59 por paciente; rango: 1-50). Se observaron un total de 5 reacciones adversas en 5 pacientes (5.7% de los pacientes y 0.9 % del número total de infusiones). Todas fueron de gravedad leve y se resolvieron reduciendo la velocidad de la infusión o usando antihistamínicos. Los 5 pacientes fueron positivos para anticuerpos IgG, pero ninguno presentó anticuerpos IgE o sufrió un shock anafiláctico. En nuestro grupo, 18 pacientes fueron cambiados de agalsidasa beta a agalsidasa alfa sin complicaciones. La infusión domiciliaria de agalsidasa alfa es segura, bien tolerada y logra una alta adherencia al tratamiento.