Transition from Intravenous to Subcutaneous Daratumumab Formulation in Clinical Practice.

INTRODUCTION: Daratumumab is an anti-CD38 monoclonal antibody widely used for treating patients with newly diagnosed or relapsed/refractory multiple myeloma. The subcutaneous formulation of daratumumab was developed with the purpose of minimizing the treatment burden (to patients and health care system) associated with intravenous daratumumab. Given its recent approval, there is a knowledge gap regarding the best practices that should be instituted for safe administration of subcutaneous daratumumab. METHODS: A retrospective chart review was performed from August 2020 until November 2020 to identify patients either switched to or treated upfront (daratumumab naive) with any subcutaneous daratumumab-based treatment regimen. All patients received appropriate premedications per institutional standards of care. The study end points were to report real-world data regarding administration-related reaction rates (at or following discharge from infusion center), as well as compare their incidence rates to those noted in the COLUMBA study (historical cohort). RESULTS: The study included 58 patients, of whom 38% (n = 22) were daratumumab naive. The majority (84%, n = 49) received subcutaneous daratumumab in combination with various antimyeloma regimens. There were no cases of administration-related reactions at infusion center or after discharge irrespective of previous exposure to intravenous daratumumab. None of the patients included herein required rescue home medications or visited the emergency department within 24 to 48 hours after subcutaneous daratumumab administration. These translated into a significant difference in incidence of administration-related reactions compared with historical cohort (0% vs. 13%, P = .003). CONCLUSION: Subcutaneous daratumumab was extremely well tolerated and could be safely administered without need for monitoring or rescue home medications.

Current trends in the acute treatment of ischemic stroke: analysis from the Paul Coverdell National Acute Stroke Program.

BACKGROUND: The intra-arterial treatment (IAT) of acute ischemic stroke (AIS) is now evidence-based and given the highest level of recommendation among eligible patients. Using a multi-state stroke registry, we studied the trend in IAT among patients with AIS over 11 years and its impact on the utilization of intravenous thrombolysis (IVT) within the same 11 years. METHODS: Using data from the Paul Coverdell National Acute Stroke Program (PCNASP), we studied trends in IVT and IAT for patients with AIS between 2008 and 2018. Trends over time were examined for rates of IVT only, IAT only, or a combination of IVT and IAT (IVT+IAT). Favorable outcome was defined as discharge to home. RESULTS: During the study period there were 595 677 patients (mean age 70.4 years, 50.4% women) from 646 participating hospitals with a clinical diagnosis of AIS in the PCNASP. Trends for IVT only, IAT only, and IVT+IAT all significantly increased over time (P<0.001). Total use of IVT and IAT increased from 7% in 2008 to 19.1% in 2018. The rate of patients discharged to home increased significantly over time among all treatment groups (P<0.001). CONCLUSION: In our large registry-based analysis, we observed a significant increase in the use of IAT for the treatment of AIS, with continued increases in the use of IVT. Concurrently, the percent of patients with favorable outcomes continued to increase.

NIVAS 2019: facing the future in vascular access and infusion therapy.

The 7th National Infusion and Vascular Access Society (NIVAS) conference was held in Manchester, 12-13 June 2019.

Lifelong immunoglobulin replacement is not always necessary: A case description of a patient with recurrent infections and hypogammaglobulinemia.

Humoral immunodeficiency with accompanying infections is an indication for human immunoglobulin replacement therapy. Whether treatment will be lifelong or necessary only temporarily depends on the nature of deficiency: primary (persistent) or secondary (persistent or transient). It is not always easy to distinguish between primary and secondary immunodeficiency, especially in adults. The article presents a case of a 39-year-old patient with anamnesis and medical tests results that suggested primary humoral immunodeficiency. The deficiency was diagnosed for the first time at the age of 38, when the patient was pregnant. The patient was qualified for immunoglobulin G replacement therapy. Clinical improvement was achieved. After the end of pregnancy, systematic improvement in immunological parameters was observed, suggesting the resolution of immunodeficiency. A decision was made to discontinue immunoglobulin replacement. Due to the ability to respond to vaccine, confirmed during diagnosis, preventive vaccines were recommended. There was no recurrence of serious infections. The clinical course finally enabled a diagnosis of secondary immunodeficiency. The presented case shows the importance of an active approach to the diagnostic and therapeutic process, constant assessment of clinical course, monitoring of IgG concentrations, and the awareness that in the situation when we do not have a genetic confirmation of the disease, the diagnosis may change.

Trends in Infusion Administrative Practices in US Health Care Organizations: An Exploratory Analysis.

While specialized infusion clinical services remain the standard of care, widespread curtailing and disbanding of infusion teams as a cost-cutting measure has been documented in health care organizations for nearly 2 decades. Owing to this trend, as well as recent government interventions in medical error control, the authors engaged in an exploratory study of infusion administration practices in the US health care industry. This article presents the authors' exploratory findings, as well as their potential implications.

Predicting resource utilization of elderly burn patients in the baby boomer era.

BACKGROUND: Census predictions for Florida suggest a 3-fold increase in the 65 and older population within 20 years. We predict resource utilization for burn patients in this age group. METHODS: Using the Florida Agency for Healthcare Administration admission dataset, we evaluated the effect of age on length of stay, hospital charges, and discharge disposition while adjusting for clinical and demographic factors. Using US Census Bureau data and burn incidence rates from this dataset, we estimated future resource use. RESULTS: Elderly patients were discharged to home less often and were discharged to short-term general hospitals, intermediate-care facilities, and skilled nursing facilities more often than the other age groups (P < .05). They also required home health care and intravenous medications significantly more often (P < .05). Their length of stay was longer, and total hospital charges were greater (P < .05) after adjusting for sex, race, Charleson comorbidity index, payer, total body surface area burned, and burn center treatment. CONCLUSIONS: Our data show an age-dependent increase in the use of posthospitalization resources, the length of stay, and the total charges for elderly burn patients.

Drip-and-ship thrombolytic treatment paradigm among acute ischemic stroke patients in the United States.

BACKGROUND AND PURPOSE: To provide a national assessment of thrombolytic administration using drip-and-ship treatment paradigm. METHODS: Patients treated with the drip-and-ship paradigm among all acute ischemic stroke patients treated with thrombolytic treatment were identified within the Nationwide Inpatient Sample. Thrombolytic utilization, patterns of referral, comparative in-hospital outcomes, and hospitalization charges related to drip-and-ship paradigm were determined. All the in-hospital outcomes were analyzed after adjusting for potential confounders using multivariate analysis. RESULTS: Of the 22 243 ischemic stroke patients who received thrombolytic treatment, 4474 patients (17%) were treated using drip-and-ship paradigm. Of these 4474 patients, 81% were referred to urban teaching hospitals for additional care, and 7% of them received follow-up endovascular treatment. States with a higher proportion of patients treated using the drip-and-ship paradigm had higher rates of overall thrombolytic utilization (5.4% versus 3.3%; P<0.001). The rate of home discharge/self-care was significantly higher in patients treated with drip-and-ship paradigm compared with those who received thrombolytics through primary emergency department arrival in the multivariate analysis (OR, 1.198; 95% CI, 1.019-1.409; P=0.0286). CONCLUSIONS: One of every 6 thrombolytic-treated patients in United States is treated using drip-and-ship paradigm. States with the highest proportion of drip-and-ship cases were also the states with the highest thrombolytic utilization.

A rapid infusion protocol is safe for total dose iron polymaltose: time for change.

BACKGROUND: Intravenous correction of iron deficiency by total dose iron polymaltose is inexpensive and safe, but current protocols entail prolonged administration over more than 4 h. This results in reduced patient acceptance, and hospital resource strain. We aimed to assess prospectively the safety of a rapid intravenous protocol and compare this with historical controls. METHODS: Consecutive patients in whom intravenous iron replacement was indicated were invited to have up to 1.5 g iron polymaltose by a 58-min infusion protocol after an initial 15-min test dose without pre-medication. Infusion-related adverse events (AE) and delayed AE over the ensuing 5 days were also prospectively documented and graded as mild, moderate or severe. RESULTS: One hundred patients, 63 female, mean age 54 (range 18-85) years were studied. Thirty-four infusion-related AE to iron polymaltose occurred in a total of 24 patients--25 mild, 8 moderate and 1 severe; higher than previously reported for a slow protocol iron infusion. Thirty-one delayed AE occurred in 26 patients--26 mild, 3 moderate and 2 severe; similar to previously reported. All but five patients reported they would prefer iron replacement through the rapid protocol again. The presence of inflammatory bowel disease (IBD) predicted infusion-related reactions (54% vs 14% without IBD, P < 0.001) and the serum C-reactive protein was higher in those with reactions (P = 0.043). CONCLUSION: Iron polymaltose can be successfully administered using a rapid total dose infusion protocol and was well accepted by patients. It offers significant cost, resource utilization and time benefits for the patient and hospital system.

I.v. risk reducers.

The trend of rapid advancements in infusion therapy continues, specifically regarding catheters and insertion techniques.

Trends in the safety of high dose bolus interleukin-2 administration in patients with metastatic cancer.

BACKGROUND: Administration of recombinant high dose interleukin-2 (IL-2) can mediate tumor regression in patients with metastatic melanoma and renal carcinoma. Significant trends in the safety of high dose IL-2 administration at a single institution over a 12-year study period were reviewed. METHODS: A consecutive series of 1241 metastatic cancer patients treated with intravenous bolus infusions of IL-2 (720,000 IU/kg every 8 hours) were evaluated for the incidence of specific treatment-related toxicities, the maximum number of administered IL-2 doses, and objective response rates. RESULTS: Significant decreases in the incidence of Grade 3 and/or Grade 4 toxicities were found when the initial group of 155 patients was compared with the final group: Grade 3/4 line sepsis (18% vs. 4%), Grade 3/4 diarrhea (92% vs. 12%), Grade 4 neuropsychiatric toxicity (19% vs. 8%), pulmonary intubations (12% vs. 3%), Grade 3/4 hypotension (81% vs. 31%), and Grade 4 cardiac ischemia (3% vs. 0%). No treatment-related deaths were noted in the final 809 patients. Laboratory abnormalities, such as increased creatinine, hyperbilirubinemia, and thrombocytopenia, were less severe, whereas percent weight gain remained stable over the 12-year period. The maximum number of administered IL-2 doses during the first cycle of therapy decreased from an initial median of 13 doses to 7 doses per first treatment cycle. No significant differences in overall and ongoing complete response rates to high dose bolus IL-2 were observed for melanoma patients (two-tailed P value = 0.40 and 1.0, respectively), or renal carcinoma patients (two-tailed P value = 0.92 and 0.89, respectively) over the study period. CONCLUSIONS: Progressive reduction in morbidity and mortality was found with the systemic administration of high dose IL-2-based therapies over the 12-year study period. The improvement in safety most likely reflects the development of strategies to screen eligible patients, optimize therapeutic conditions, and judiciously terminate dosing when significant toxicities are noted. Despite these interventions, the overall and ongoing complete response rates for melanoma and renal carcinoma have not shown significant compromise. These trends suggest that high dose IL-2 can be safely administered to metastatic cancer patients under the current treatment guidelines and result in durable responses in a small subset of patients.

Monitoring chronic outpatient infections: providing comprehensive home healthcare pharmacy services.

Management of acute illness has been increasingly shifted to community practitioners. Expansion of community pharmacy into home healthcare has brought new opportunities and responsibilities to community practitioners. These practitioners are gaining expertise in total parenteral nutrition, intravenous infusion systems, intravenous catheters, parenteral antibiotics, and clinical pharmacokinetics--areas historically managed by hospital and long-term care facility pharmacists. This shift to community pharmacy-based care has brought with it the need for community pharmacists to develop expertise in therapeutic monitoring of chronic disease states. Dose adjustment of medications based upon careful analysis of blood concentrations is no longer limited to institutional pharmacy practice. Community pharmacists now must master basic infectious disease principles and possess internal medicine knowledge to ensure appropriate monitoring of their patients. This article discusses several disease states currently managed with community pharmacy-based home healthcare, summarizing basic monitoring parameters for comprehensive patient care, and provides sample supply lists and documentation forms for home healthcare providers.

A cost-effective approach to managing infectious disease.

Outpatient intravenous therapy (OIT) offers a safe, practical, and cost-effective means for long-term antimicrobial treatment of certain infectious diseases. The author compares the efficacy, frequency of administration, and cost of the most suitable parenteral agents and cites criteria for patient selection. An efficient and safe OIT program requires a multidisciplinary approach that integrates support from the physician, nurse-educator, social services, and pharmacy. Several small studies indicate that OIT can result in an impressive savings when compared with inpatient costs.